Embryo Protection Authority (Protocol) Regulations, 2022

L.N. 215 of 2022

EMBRYO PROTECTION ACT

(CAP. 524)

Embryo Protection Authority (Protocol) Regulations, 2022

IN EXERCISE of the powers conferred by article 23 of the

Embryo Protection Act, the Minister responsible for health, in

concurrence with the Minister responsible for justice, have made the

following regulations:-

(1) The title of these regulations is the Embryo Citation and

coming into

Protection Authority (Protocol) Regulations, 2022.

force.

(2) These regulations shall come into force on such date or

dates as the Minister responsible for health and the Minister

responsible for justice, may by notice in the Gazette establish and

different dates may be so established for different provisions and, or

purposes of these regulations.

EMBRYO PROTECTION AUTHORITY PROTOCOL

PROTOCOL

Third Edition - July 2022

Contents

User guide to the Protocol

Regulatory principles for licensed tissue establishments

Guidance Notes

Staff

1. The licence holder and the Responsible person

2. Staff

Treating people fairly

The Protocol as defined in article 2 of the Embryo Cap. 524.

Protection Act is hereby published by means of these regulations in the

Schedule.

Treating people fairly

Counselling

Infertility counselling and patient support

Information and consent

Information to be provided prior to consent

Consent to treatment, storage, donation and disclosure of

information

Legal parenthood and parental responsibility

Multiple births

Multiple births

Additional Fertilisations

Additional Fertilisation Permissions

Welfare of the child

Welfare of the child

Preimplantation Genetic Testing

Pre-implantation Genetic Testing for Monogenic Diseases

Donations

Donor recruitment, assessment and screening

Use of gametes and embryos

Screening and storage of samples to prevent cross-

contamination

Procuring, processing and transporting of gametes and

Transfers, Imports and Exports of gametes and embryos

previously stored

Storage of Gametes and Embryos

Embryo Adoption

Witnessing and assuring patient and donor identification

19. Traceability

Donor Assisted Conception

Intra-Cytoplasmic Sperm Injection (ICSI)

Research and unlawful procedures

Research and unlawful procedures

Facilities and administration

Quality Management System

24. Complaints

Third Party Agreements

Premises, practices and facilities

Equipment and Materials

Adverse Incidents

Record keeping and other obligations

Confidentiality and privacy

Record keeping and document control

Obligations

and

reporting

requirements

of

tissue

establishments

Fees to be paid to the Embryo Protection Authority (EPA)

by all Service Providers of Tissue establishments/clinics both Public

and Private

User Guide to the Protocol

What is the purpose of the Protocol?

The Embryo Protection Act (the Act) covers the use and storage

of sperm, eggs and embryos for human application. One of the ways

we help licensed tissue establishments (Tissue Establishments) comply

with the Acts by publishing the Protocol. We have a duty under the Act

to maintain a protocol that gives guidance about licensed activities and

the people who carry them out.

This Protocol also serves as a useful reference for patients,

researchers and those working in the fertility sector.

How is the Protocol structured?

The Protocol consists of

Regulatory principles for licensed tissue establishments

whether private or public, and

Guidance notes

This Protocol has been prepared in line with EU Directives,

National Legislations, HFEA Code of Practice as well as the BICA

Practical Manual.

Regulatory Principles for Licensed Tissue Establishments

The Act requires the Embryo Protection Authority (EPA) to

maintain a statement of the general principles that we consider should

be followed in carrying out activities covered by the Act.

The principles

A summary of the key behaviours and outcomes the EPA expects

each licensed tissue establishment to demonstrate, and

A means of communicating to the responsible person and staff at

each licensed tissue establishment, patients, and the public the areas of

compliance that the EPA regards as key.

Compliance and enforcement

The EPA has a duty to promote compliance with

The Act, and

The Protocol.

Regulatory principles will inform the inspection process. If the

EPA becomes aware that a tissue establishment has not complied with

the legislation or the Protocol, we may take action in line with

provisions in the Act.

Regularity Principles

The EPA expects the responsible person to ensure that their

licensed tissue establishment demonstrates adherence to the following

principles when carrying out activities licensed under the Embryo

Protection Act.

Licensed tissue establishments must

1. Treat prospective and current patients fairly, and ensure

that all licensed activities are conducted in a non-discriminatory way

2. Have respect for the privacy, confidentiality, dignity,

comfort and well-being of prospective and current patients

3. Have respect for the special status of the embryo when

conducting licensed activities

4. Take account of the welfare of any child who may be born

as a result of the licensed treatment provided by the tissue

establishment, and of any other child who may be affected by that birth

5. Give prospective, current patients and donors sufficient,

accessible and up-to-date information to enable them to make

informed decisions

6. Ensure that the patient or patients and the donors have

provided all relevant consents before carrying out any licensed activity

7. Conduct all licensed activities with skill and care and in an

appropriate environment, in line with good clinical practice, to ensure

optimum outcomes and minimum risk for patients, donors and

offspring

8. Ensure that all premises, equipment, processes and

procedures used in the conduct of licensed activities are safe, secure

and suitable for the purpose

9. Ensure that all staff engaged in licensed activity are

competent and recruited in sufficient numbers to guarantee safe

clinical and laboratory practice

10. Maintain accurate records and information about all

licensed activities

11. Report all adverse incidents (including serious adverse

events and serious adverse reactions) and near misses to the EPA. As

well as report all quality and safety issues relating to quality and safety

of gametes and embryos during processes and storage. Investigate all

complaints properly, and share lessons learned appropriately

12. Conduct all licensed activities with regard to the regulatory

framework governing treatment involving gametes or embryos in

accordance with the Embryo Protection Act 2012, the Embryo

Protection (Amendment) Act 2018, and the Various Laws relating to

Assisted Procreation (Amendment) Act 2022. including

maintaining up-to-date awareness and understanding of

legal obligations

responding promptly to requests for information and

documents from the EPA, and

co-operating fully with inspections and investigations by

the EPA or other agencies responsible for law enforcement or

regulation of healthcare.

13. Reporting of activities supported by EPA forms and

documentation including testing results, should include but are not

limited to

Request for permission to cryopreserve gametes in

oncology cases

Request for permission to cryopreserve gametes in fertility

preservation

Request for permission to cryopreserve gametes by

transgender persons prior to starting hormone therapy treatment

Request for permission to discard gametes

Request for permission to transfer gametes/embryos

between licenced tissue establishments in Malta

Request for permission to transfer gametes/embryos from a

Malta Tissue establishment to abroad and from abroad to a Malta

Tissue establishment

Request for ART Procedures (IUI, IVF, ICSI) as well as

procedures making use of thaw and transfer of cryopreserved embryos

and storage of gametes for patients undergoing an ART cycle

Request for Additional Fertilisation of oocytes to be made

in line with the EPA Protocol as approved by the Parliament Health

Committee

Request for Embryo Cryopreservation and potential

Embryo Donation

Request for Use of Third-Party Donation and duly inform

immediately every donation made with full identity details of the

Prior Authorisation by the Authority for patients to undergo

Prior Authorisation by the Authority for the donation of

cryopreserved Embryos

Prior Authorisation by the Authority of the Agreement

between the prospective parent or prospective parents and the licensee

to regulate the cryopreservation of embryos.

Prior authorisation by the Authority to be granted to a

prospective parent or prospective parents who had cryopreserved

embryos in tissue establishments abroad to bring two cryopreserved

embryos to be transferred locally into the prospective parent or

prospective parents for each cycle

Outcomes of all procedures and storage carried out.

To provide the Authority with all documentation and data

in regard to reporting obligation of the Authority to the House of

Representatives

To pass on information to the Authority without delay of all

confidential registers held by the licensee with full details of every

medically assisted procreation procedure, germ line cell donation,

cryopreservation of germ line cells and cryopreservation of embryos.

To pass on information to the Authority re any Alterations

to premises and equipment within the Tissue Establishment.

Henceforth, all requests for permissions are to be submitted before the

actual activities are embarked upon.

To pass on information to the Authority when new

personnel join or existing personnel leave the Tissue Establishment.

Any other documentation that the Authority as Regulator

may request in terms of the Embryo Protection Act

14. Ensure that all fees (as per schedule of fees) are paid to the

Embryo Protection Authority within the timescale mentioned in the

schedule of fees

15. Ensure that requests for information and/or documents

from the Embryo Protection Authority are responded to promptly

16. Ensure that data provided to the Embryo Protection

Authority about activities and data, which the Embryo Protection

Authority is required to hold on its Register of Information, is accurate

and provided by dates specified

17. Breaches in reporting duties with regards to the EPA may

lead to prosecution by the Authority in accordance with the Embryo

Protection Act.

18. Notify the Embryo Protection Authority immediately if s/

he becomes aware of any decision or proposal to close their tissue

establishment.

In the event of termination of activities, for whatever

reason, the Responsible Person (RP) must ensure that all stored

gametes and embryos are transferred to another licensed tissue

establishment or licensed tissue establishments. The RP must ensure

that all relevant information including traceability data and

information concerning the quality and safety of gametes and embryos,

is transferred with any stored gametes, embryos, or that records

containing this information are made accessible as required.

Guidance Notes

1. The Licence Holder and the Responsible Person

1.1 The licence holder and the Responsible person should be

separate individuals. Clinics operating within a hospital or other

healthcare organisation may find it advantageous for a senior hospital

manager to hold the post of licence holder.

1.2 It is the responsibility of the licence holder to inform the

EPA if the Responsible person is unable to perform their duties. Where

the tissue establishment no longer has a Responsible person, the

licence holder should seek the advice of the EPA as soon as possible

on continuing to provide licensable activities.

Either the Responsible person or the licence holder may apply for

a licence or for its variation or revocation.

However, only the licence holder may apply to a licence

Authority to vary a licence in order to designate another individual to

be the Responsible person.

Qualifications for the Role of the Responsible Person

1.3 The Responsible person should have enough understanding

of the scientific, medical, legal, social, ethical and other aspects of the

tissue establishment’s work to be able to supervise its activities

properly. It is also important that the Responsible person possesses

integrity, and managerial authority and leadership capability.

1.4 When applying to vary a licence in order to appoint a new

responsible person, the licence holder must provide evidence that the

proposed individual has the managerial authority and capability

necessary to perform their duties.

1.5 The EPA expects the Responsible person to take any

necessary specialist advice to allow them to run the tissue

establishment professionally.

1.6

The role of the Responsible person should include

(a) ensuring that human tissues and cells intended for

human applications in the establishment for which that person is

responsible are procured, tested, processed, stored and

distributed in accordance with the Directives and the Acts.

(b) Maintaining

an

up-to-date

awareness

and

understanding of legal obligations

(c) responding promptly to requests for information and

documents from the EPA

(d) co-operating fully with inspections and investigations

by the EPA or other agencies responsible for law enforcement,

regulation or healthcare, and

(e) informing the EPA of any change to their professional

registration.

1.7 The Responsible person is accountable for the overall

performance of the Tissue Establishment and should ensure that there

are clear responsibilities, roles and systems of accountability to

support good governance. The RP is also to ensure that appropriate

action is taken following feedback from the EPA, patients and staff

including feedback outcomes from inspections, audits and any patient

complaints.

1.8 The responsible person should ensure that all staff possess

the competencies necessary for their role and have access to learning

and professional development.

All staff are encouraged, as

appropriate, to contribute to discussions and decisions about

improving patient care. The RP is also to ensure that all staff maintain

an up-to-date awareness and understanding of legal obligations.

2. Staff

Tissue Establishment Staff

2.1 The tissue establishment should establish documented

procedures for staff management, ensuring all staff have

(a)

initial basic training and updated training as required

(b) an adequate knowledge and understanding of the

scientific / technical process and principals relevant to their

designated tasks

(c) adequate information of the broader legal, ethical and

regulatory context of their work

(d) on-going competence assessment, with audits of this

assessment

(e)

an annual joint review (with their line manager)

(f)

continuing education and professional development

(g)

staff records

(h)

appropriate access to meetings and communications,

and

(i) A health care professional is under no obligation to

participate in any procedure for the application of any technique

of medically assisted procreation regulated by the Act when such

professional considers such participation objectionable as a

matter of conscience and declares his objection beforehand as

per Article 20 of the Embryo Protection Act, 2012.

2.2

Staff records should include

(a) job description that accurately reflects their task and

responsibilities

(b)

terms and conditions of employment

(c)

a record of staff induction and orientation

(d)

a record of health and safety training

(e) a record of education and training, including

continuing professional development

(f)

relevant educational and professional qualifications

(g)

certificate of registration, if relevant

(h)

absence record

(i)

accident record

(j)

a record of annual joint reviews

(k)

occupational health record, and

(l)

a record of any disciplinary action.

The tissue establishment should ensure that confidentiality of

staff records is in line with best practice and relevant legislation.

2.3 All staff should maintain an up-to-date awareness and

understanding of legal obligations and should support the responsible

person in monitoring and improving the performance of the Tissue

Establishment.

2.4

All staff should participate in an annual joint review that

examines the needs of the tissue establishment and of the individual to

improve the quality of the service to users and to encourage productive

working relationships. Staff performing annual reviews must receive

appropriate training.

2.5 The tissue establishment should have an effective way of

communicating information to and receiving suggestions from staff.

Tissue establishment management should also ensure that the

accountabilities and reporting relationships shown in the tissue

establishment’s organisational chart are communicated within the

tissue establishment.

2.6 Tissue establishment management should ensure that staff

members who are in contact with patients, donors and their partners

where applicable

(a)

follow the tissue establishment’s patient support

policy

(b) are prepared to offer appropriate emotional support to

people suffering distress at any stage before, during and after

treatment.

(c)

understand and can explain the role of counselling,

and

(d) know when and how to refer people to the tissue

establishment’s qualified and warranted counsellor.

2.7 Tissue establishment management is responsible for

delivery of the patient support policy and for using intelligence to

monitor and evaluate the effectiveness of the policy. Tissue

establishment management should ensure that the policy addresses the

emotional support needs of patients, donors, and their partners where

applicable, in order to continuously improve their experience of

treatment services.

2.8 Tissue establishments should require all prospective and

existing staff to report promptly all criminal convictions they have had

to the person responsible. In deciding whether or not an individual

shall take part in a licensed activity at the tissue establishment, the

responsible person should take into account relevant previous

convictions and breaches of regulations.

Medical Staff

2.9 The Responsible person should ensure that staff who must

be registered with professional bodies are registered, their registration

is up to date, and records of this are kept.

2.10 The individual with overall medical responsibility for

treatment services involving in vitro fertilisation should

(a) have completed training recognized by the Specialist

Accreditation Committee.

(b) be on the General Medical Council’s Specialist

Register, and

(c) participate in a recognised programme of continuing

medical education and professional development.

2.11 If the centre is licensed to provide insemination services

only, the individual with overall clinical responsibility should

(a)

be a registered medical practitioner, and

(b) have sufficient experience in an established fertility

centre to be qualified to take full charge of the centre’s treatment

services.

2.12 Other medical staff who takes part in providing treatment

services should be registered medical practitioners with sufficient

experience under supervision to qualify them to do so. Medical staff

who do laparoscopies should be recognised by the Specialist

Accreditation Committee. Medical staff in training should follow

relevant training programmes under appropriate supervision.

Nursing Staff

All nursing staff must be appropriately qualified and registered.

2.13 Nurses should be

(a) working towards competencies set nationally, to

ensure appropriate standards of clinical competence, and

(b) able to provide evidence of competence in the duties

performed (for example, a certificate from a recognised body and

qualification competent in that discipline or function).

Counselling Staff

2.14 Treatment tissue establishments should ensure that

Infertility counsellors are appointed to fulfil the role of counsellors.

Every tissue establishment should see that enough counsellors are

enrolled to offer a 24-hour service of counselling.

All counsellors should have specialist competence in infertility

counselling and

(a) hold a recognised counselling, clinical psychology,

counselling psychology, psychotherapy or family therapy

qualification to the level of diploma of higher education or

above, and

(b) have received Infertility training of the British

Infertility Counselling Association (or an equivalent body).

(c)

have a Warrant in Counselling.

2.15 A member of staff appointed to the role of counsellor

should be able to provide evidence of being an accredited member of

or working towards accredited membership of, a recognized

professional counselling body. The body should have a complaint/

disciplinary procedure, and the individual should have agreed to abide

by an appropriate code of conduct or ethics.

Prospective parent or parents shall not be provided with

treatment services of any kind unless they have been given a suitable

opportunity to receive proper counselling about the implications of

being provided with treatment.

Before a person gives consent for treatment

(a) s/he must be given a suitable opportunity to receive

proper counselling about the implications of taking the proposed

steps, and

(b) s/he must be provided with such relevant information

as is proper.

2.16 Treatment establishments carrying out pre-implantation

genetic diagnosis should ensure that patients have access to

counsellors with appropriate knowledge and expertise in these

specialisms, including a good understanding of the risks and

implications for patients who have treatment and any children that

may be born following such treatment.

Staff Engaged in Scientific Services

2.17 Tissue establishment management should ensure that the

Tissue Establishment has access to a nominated registered scientist to

advise on and oversee scientific activities.

2.18 All healthcare scientists working in licensed tissue

establishment should be registered or show evidence of working

towards registration with a registered body where applicable.

All staff should be registered with a registered body within one-

year of their becoming eligible, including those eligible as

international applicants after training overseas.

2.19 Healthcare scientists from overseas who are registered in

their own country but working in a licensed tissue establishment as a

visiting scientist, should seek temporary registration with a registered

body in Malta (such as Specialist Accreditation Committee or

equivalent body).

2.20 Healthcare scientists employed in roles should follow an

appropriate induction and training programme for the tasks performed.

Each individual should maintain proper records of this training.

2.21 The individual responsible for the seminology laboratory

should

(a) possess a degree or higher national diploma in a

relevant discipline

(b) have acquired sufficient experience in such a

laboratory to supervise and be responsible for one, and

(c) be registered with a registered body as a clinical

scientist or biomedical scientist, or be able to demonstrate

equivalent training or expertise.

2.22 The individual responsible for the clinical embryology

laboratory should

(a)

possess an appropriate scientific or medical degree

(b) have had sufficient experience in such a laboratory to

be able to supervise and be responsible for one, and

(c) be registered with a registered body as a clinical

scientist with specific expertise in clinical embryology.

Competence and Training of ICSI and embryo biopsy

practitioners

2.23 The

responsible

person

should

ensure

that

micromanipulation procedures such as ICSI and embryo biopsy are

carried out only by practitioners who have the necessary competence.

2.24 Following training, the competence of each person

performing micromanipulation procedures and embryo biopsy should

be evaluated at intervals specified in the quality management system.

Retraining should be given when required.

2.25 In the case of embryo biopsy, only the embryologist(s)

practitioner(s) who have been designated and named on the clinic’s

licence may carry out the biopsy. If the clinic wishes to change the

designated embryologist or add to the list of designated embryologists,

the clinic will need to apply to the EPA Authority and the Licencing

Authority.

Staff involved in genetic testing

2.26 A senior clinical geneticist should be involved in the

decision making process when deciding whether a patient should

receive treatment involving embryo testing.

2.27 The tissue establishment should ensure that a

multidisciplinary team is involved in providing the service. Where

relevant the team should include reproductive specialists,

embryologists, clinical geneticists, genetic counsellors, cytogeneticist

and molecular geneticists. It should maintain close contact with the

primary care physician or the referring clinician.

2.28 If the tissue establishment offers an embryo service, the

individual responsible for this laboratory should

(a)

hold an appropriate scientific or medical degree

(b) have acquired sufficient experience in an

appropriately accredited medical genetics diagnostic laboratory

to supervise and be responsible for one, and

(c) be registered with the equivalent body as a clinical

scientist with specific expertise in clinical genetics.

2.29 If genetic testing of those seeking treatment or considering

donation is offered, the tissue establishment should ensure that an

individual is available who understands the

(a)

nature of the tests conducted

(b)

scope and limitations of the tests

(c)

accuracy and implications of the tests, and 4

(d)

meaning of the test results.

2.30 The tissue establishment should ensure that people seeking

treatment have access to clinical geneticists and genetic counsellors

where relevant.

2.31 The centre should work closely with the local genetics team

of those seeking treatment.

3. Treating People Fairly

Relevant Legislation

3.1 The Maltese Legislation protects people (including Tissue

Establishment staff, current and prospective parents) from direct and

indirect discrimination, harassment and victimisation on the basis of

(a)

race

(b)

any disability

(c)

gender

(d)

religion or belief

(e)

sexual orientation, and

(f)

age.

3.2 The responsible person should have and be familiar with

documented procedures to ensure their tissue establishment complies

with equalities legislation.

3.3 The responsible person should ensure that the tissue

establishment’s systems, policies and procedures comply with current

equality legislation and guidance.

3.4 Tissue establishments should ensure that staff, patients,

donors and other visitors to the tissue establishment are treated fairly

and with respect for their dignity and human rights. Tissue

establishment staff should have received up-to-date training and be

able to show they are competent in their obligations under equality

law.

3.5 Attitudes towards assisted conception, gamete donation and

the use of gametes and embryos may vary significantly between

individuals, cultures and religions. All healthcare professionals should

be sensitive to this. The responsible person should ensure employees

have access to training and support to help them identify and meet the

widest possible range of patients’ and donors’ needs and preferences.

3.6 Tissue establishments should be aware that for some

patients, gender identity and sex orientation may be distinct and

different. Tissue establishments treating trans patients should ensure

that they take account of the particular needs of these patients and

make appropriate changes to relevant processes and practices to

accommodate their needs.

3.7 Tissue establishments should ensure that all activities and

clinical structures and functions show respect for equality and

diversity. Tissue establishments should review policies and procedures

regularly to ensure they reflect equality and diversity adequately.

Tissue establishments should also consider having equality policies.

3.8 The tissue establishment should ensure that all licensed

activities are conducted in a non-discriminatory way and with proper

respect for the privacy, confidentiality, dignity, comfort and well-being

of all prospective and current patients.

3.9 A tissue establishment should provide or arrange

investigations and treatments based on professional assessment and

clinical judgment. They should take into account the needs and

preferences of prospective or current patients, donors and others

visiting the tissue establishment, including any reasonable

adjustments, aids or help they may need.

3.10 Staff at a tissue establishment should not refuse or delay

treatment because they believe that a patient’s actions have contributed

to their condition. All prospective and current patients must be treated

with respect, whatever their life choices or beliefs.

3.11 The responsible person for a National Public Health

Service tissue establishment should consider relevant policies of their

primary care before refusing treatment.

3.12 Staff at the tissue establishment must not harass or

victimise patients or donors by allowing their own personal views or

judgments (For instance, their views about a patient’s age, disability,

gender reassignment, marriage and civil partnership, pregnancy and

maternity, race, religion or belief, sex or sexual orientation) to

adversely affect their professional relationship with the patients or

donors, or the treatment they provide or arrange should challenge

colleagues if they believe their behaviour does not comply with this

guidance, or with the relevant legislative requirements.

Conscientious objection

3.13 The tissue establishment should give prospective

employees a full description of the tissue establishment’s activities,

and at the interview draw their attention to the provision that anyone

who has a conscientious objection to participating in a particular

activity done in the centre must not be obliged to do so.

3.14 If a staff member has a conscientious objection to

providing a particular licensed activity governed by the Act, they

should inform the responsible person. The responsible person should

ensure that the patient, patient’s partner or donor is given information

on or referred to alternative sources of the treatment.

3.15 The responsible person should satisfy themselves that the

staff member has a conscientious objection to providing a particular

licensed activity and is not unlawfully discriminating against a patient

on the basis of a protected characteristic.

3.16 If all staff at the tissue establishment conscientiously object

to providing a particular licensed activity, the responsible person

should

(a) try to refer the person to another tissue establishment

for treatment, and

(b) provide the patient with a written explanation of why

the tissue establishment cannot treat them.

3.17 The responsible person should record

(a) the reason(s) for the conscientious objection of any

member of staff

(b) their efforts to provide the particular activity at the

tissue establishment, and

(c) if that activity cannot be provided at the tissue

establishment, efforts they have made to ensure the patient

receives treatment elsewhere.

Addressing Communication Barriers

3.18 The tissue establishment should consider the needs of

people whose first language is not Maltese or English and those who

face other communication barriers. Where consent is obtained, the

tissue establishment should record any difficulties in communicating

the implications of giving consent and in providing other information

to the person (e.g. language barriers or hearing impairment) and an

explanation of how these difficulties were overcome(e.g. the use of an

independent interpreter).

3.19 The tissue establishment should ensure it establishes and

accommodates any disabled patient’s preferred means of

communication. If appropriate, it should consider providing

information in a variety of formats such as large print, ‘easy read’ or

Braille.

4. Infertility Counselling and Patient Support

The psychological and social stress of infertility and assisted

conception treatment has been well documented. There is general

agreement in the literature that stress and distress in some form are

significant sequel of infertility. This may involve depression, anxiety,

sexual dysfunction, damaged self-esteem and a range of difficulties in

interpersonal relationships. A review of the evidence into the efficacy

of counselling suggests that psychological therapies have benefit in a

range of somatic complaints including gynaecological problems,

bereavement/loss and depressive disorders.

The purpose of counselling for infertility and assisted conception

is to

(i) Enable people to reflect upon and understand the

implications of a proposed course of action for that person, their

family, children born as a result and anyone else affected by the

treatment

(ii) To provide emotional support before, during and after

treatment, particularly if the person is experiencing stress,

ambivalence or distress

(iii) To assist people in developing successful coping

strategies for dealing with both the short and longer-term

consequences of infertility and treatment

(iv) To help people to try to adjust and to accommodate to

their particular situation.

The law requires that prospective parent or parents respectively

receive independent clinical counselling to be offered before,

throughout and after the procedures. Thus, counselling is to be offered

when

(a) prospective parents seek treatment that will create

embryos in vitro

(b)

prospective parents seek to store their gametes

4.1 The tissue establishment should provide counselling after

the individual or couple has received oral and written information

about the services to be provided and before they consent to treatment,

donation, or to the storage or use of gametes or embryos. Counselling

should be accessible in terms of location. The timing and frequency of

counselling sessions should be agreed between counsellor and the

person or couple concerned, in order to meet their needs.

4.2 The tissue establishment should make patients, donors and

their partners (if applicable) aware that the offer of counselling is

obligatory as specified in the Act. The offer should include written

information giving the name(s) of the qualified counsellor(s),

explaining their role, when they are available and how to access the

service. The tissue establishment should allow enough time before

treatment starts for patients to have counselling sessions.

4.3 The tissue establishment should take all practicable steps to

provide counselling throughout the treatment, donation or storage

processes, and afterwards if requested. Counselling should routinely

be offered following adverse events and/or unsuccessful outcomes. If a

person who has previously received treatment, or previously donated

gametes or embryos requests further counselling at any point, the

tissue establishment should take all practicable steps to help them

obtain it.

4.4 If the possibility of treatment with donated gametes or

embryos arises, the tissue establishment should give counselling about

the implications of treatment with donated gametes and embryos,

separately from counselling about the implications of treatment in

general, and before treatment with donor gametes or embryos starts.

4.5 If the possibility of donating gametes or embryos for the

treatment of others arises, the tissue establishment should give

counselling about the implications of donation separately from

counselling about the implications of treatment before the treatment

starts. If treatment has already begun, it should continue only if the

potential donor and, if applicable, his or her partner have been given

counselling about the implications of donation.

4.6 The tissue establishment should offer people the

opportunity to have counselling either with their partner or alone,

depending on what each person prefers. In the case of counselling on

the implications of treatment or donation, if two people are being

treated together, then we would recommend they both attend the

counselling session. Group sessions may also be offered in addition to

individual and couple sessions.

The Provision of Counselling

4.7 The provision

of

counselling

should

be

clearly

distinguished from

(a) the assessment of a person’s suitability to receive

treatment, or to store their gametes or embryos

(b) the provision of information before obtaining consent

or providing treatment.

4.8 The counselling service should comply with current

professional guidance on good practice in infertility counselling.

Counselling should be provided only by qualified and warranted

counsellors.

4.9 The tissue establishment should ensure that arrangements

are in place to provide, or refer people for, specialist counselling if

appropriate, taking account of their duty of confidentiality under the

EPA Act. This might include genetic counselling, and counselling for

oncology patients or others requiring the long-term storage of gametes.

4.10 The tissue establishment should ensure that counselling

facilities provide quiet and comfortable surroundings for private,

confidential and uninterrupted sessions. The tissue establishment

should also consider the use of other media for counselling sessions,

such as video or audio calls in order to make counselling as accessible

as possible for patients and donors.

Counselling Records and Confidentiality

4.11 Information obtained during counselling should be

confidential (although it may be disclosed in certain circumstances, for

example if it gives rise to concerns about the suitability of a person to

receive treatment). The written records of the professional counsellor

should be kept in a secure place. These written records are confidential

and should not be shared with others, including clinic staff. The Tissue

establishment should ensure that their policies on record keeping and

data protection include information on when the counselling records

form part of the patient’s medical record and therefore could be

disclosed to the patient.

Oncology Sperm Preservation

4.12 Counselling for oncology sperm banking may take place

prior to the start of medical or surgical treatment but not necessarily.

Many patients do not have the time or opportunity for counselling at

this stage. However, if oncology patients do present as clients,

counsellors should be aware of the very considerable stress that they

are likely to be experiencing as a result of dealing with both life and

fertility threatening issues. Great sensitivity is needed and it may not

be appropriate to explore many of the longer-term issues in a first

session, but wherever possible, counsellors should encourage and

support them in considering some or all of the following

(i)

the emotional and physical issues concerning the

need to deposit sperm

(ii)

where fertility issues fit into their priorities

(iii) thinking and planning for a future family in a present

crisis situation

(iv) the reactions of partner, family and close friends

(v) issues around fertility to be considered for informed

decision making

(vi)

the assisted reproduction options open to them in the

future

(vii) the possibility that fertility treatments may fail or

that other pregnancy related difficulties may arise

(viii) the possibility of cancer recurrence after a child is

born and the implications for the child and family

(ix) the eventual disposal of the preserved sperm

(x)

current legal position

Oncology Egg Preservation

4.13 Women who are considering egg preservation/vitrification

prior to the start of oncology medical and/or surgical treatment should

be encouraged to consider counselling about the implications of this

treatment before making any final decision. If oncology patients do

present as clients, counsellors should be aware of the very

considerable stress that they are likely to be experiencing as a result of

dealing with both life and fertility threatening issues. Great sensitivity

is needed and it may not be appropriate to explore many of the longer-

term issues in a first session but, wherever possible,

counsellors should encourage and support them in considering

the same issues as those listed for oncology sperm preservation as well

as

(i) the emotional issues related to the need to go through

egg collection at a time of crisis

(ii) the possible risks involved for their health by

undergoing fertility treatment

(iii) the possible risks associated with carrying a

pregnancy after cancer therapy

(iv) the possibility of cancer recurrence after a child is

born and the implications for the child and family

(v) the eventual disposal of stored eggs should they not

be used in treatment

(vi) the current legal position

4.14 It is important to note that in cases where the oncology

patient is under18, counsellors should have particular expertise in

counselling young people.

Oncology Embryo Storage

4.15 Couples who are considering IVF procedures prior to the

start of the women’s oncology medical and/or surgical treatment

should be encouraged to consider counselling about the implications of

embryo creation and storage before making any final decision. Tissue

establishments should have sufficient counselling resources to ensure

that they can respond quickly and appropriately to patient’s requests

for counselling in these circumstances.

If oncology patients and their partners do present as clients,

counsellors should be aware of the very considerable stress that they

are likely to be experiencing as a result of dealing with both life and

fertility threatening issues. Great sensitivity is needed and it may not

be appropriate to explore many of the longer-term issues in a first

session but, wherever possible, counsellors should encourage and

support them in considering the same issues as those listed for

oncology egg preservation.

Fertility Preservation (Social Reasons) Egg Preservation

4.16 Counselling for women who have requested egg storage for

social reasons should be encouraged and counsellors should support

these clients in considering the following issues

(i) The emotional issues arising from the need to

consider egg preservation.

(ii)

Where fertility issues fit into her priorities at this

time in her life.

(iii) If the client is in a relationship

Whether both partners feel ready to commit having a

family

Whether embryo freezing has been considered

(iv) Whether the client feels any undue pressure to

preserve eggs

(v)

The attitudes of family and close friends

(vi) The realistic assisted reproduction options open to her

/ them in the future.

(vii) The possibility that treatment will fail when she / they

decide to use the stored eggs

(viii) The possibility of eventual disposal of unused stored

eggs.

Gamete Preservation for Transgender Persons

4.17 The Gender Identity, Gender Expression and Sex

Characteristics Act of 2015 (Cap 540) of the Laws of Malta was

enacted in 2015. The vision of the Maltese Government as detailed in

the Consultation Document on Transgender Healthcare is to develop a

trans inclusive health care system and to organise gender affirmative

health care for transgender persons using a person-tissue establishment

approach that tends to the physical, mental and social aspects of care

of the individual whilst respecting the person’s gender identity.

Some transgender persons will want to have children. Since

feminising / masculinising hormone therapy limits fertility it is

important for patients to

make decisions concerning fertility such as cryopreserving of

gametes, before starting hormone therapy or undergo surgery to

remove / alter their reproductive organs.

Trans patients, particularly those of a younger age, shall be able

to store their gametes depending on their individual circumstances and

if they comply with the requirements of the Embryo Protection Act.

Embryo Storage and potential embryo donation

4.18 Couples who are considering IVF procedures with embryo

cryopreservation should receive counselling about the implications of

embryo creation, storage and potential embryo donation in

circumstances as specified in the Embryo Protection (Amendment)

Act, 2018, before making any final decision. Tissue establishments

should have sufficient counselling resources to ensure that they can

respond quickly and appropriately to patient’s requests for counselling

in these circumstances.

Counsellors should be aware of the very considerable stress that

the prospective parent/s are likely to be experiencing as a result of

dealing with both life and fertility issues. Great sensitivity is needed

and Counsellors should be conversant with the Adoption

Administration Act.

Implications counselling for pre-implantation genetic testing

4.19 The tissue establishment should ensure that any person

intending to begin treatment with PGTM has implications counselling.

The implications counselling should be provided by a qualified

counsellor. This should address potential risks and implications of

PGTM and should allow full opportunity for the prospective parents to

ask questions and discuss any concerns.

Patient support

4.20 The tissue establishment should develop a patient support

policy, to outline how the centre ensures that patients, donors and their

partners (where applicable) receive appropriate psychosocial support

from all staff they encounter before, during and after treatment.

Psychosocial support is delivered by all members of staff and includes,

but is not limited to, access to counselling. All patients, donors and

their partners (where applicable) should be treated with sensitivity and

respect, and supported through all aspects of their treatment and, in

particular, if they are suffering distress at any stage.

4.21 The policy should include

(a) a definition of patient-centred care and how this will

be delivered at the tissue establishment

(b) a statement regarding each individual staff member’s

responsibility for supporting patients and managing their

expectations

(c) a list of written and online information to be provided

and how patients will be able to access this

(d)

what the tissue establishment will provide in terms of

(i)

support groups

(ii)

forums for patients to engage with each other

(iii) signposting to external groups and forums

(iv) other events/groups/open evenings etc

(e) the expectations about how all staff will communicate

with patients, donors and their partners

(f) an outline of customised support interventions at

different stages of treatment and for different types of patients

(g) the annual programme of training that will be

provided to staff on different aspects of patient support,

including skills training, adapted as appropriate to reflect staff

members’ role within the clinic

(h) feedback mechanisms for collecting data on the

patient/donor experience and

(i) quality indicators for systematically monitoring and

evaluating the tissue establishment’s provision of patient support

and patient care as contained in this policy.

5. Information to be provided prior to consent

Distinguishing the provision of information from the offer of

counselling

5.1 The provision of information

should

be

clearly

distinguished from the offer of counselling.

Information specific to the tissue establishment

5.2 Before treatment is offered, the tissue establishment should

give the woman seeking treatment and her partner, if applicable,

information about

(a)

the tissue establishment’s policy on selecting patients

(b) the tissue establishment’s statutory duty to take

account of the welfare of any resulting or affected child

(c)

the expected waiting time for treatment

(d) fertility treatments available, including any treatment

add ons which may be offered and the evidence supporting their

use

(e) the availability of facilities for freezing and storing

eggs, sperm and embryos

(f) where patients freeze and store eggs, sperm or

embryos the tissue establishment should provide information

about future use including information about consent to

posthumous use

(g) the importance of informing the treatment tissue

establishment about the eventual outcome of the treatment

(including if no live birth results)

(h)

the tissue establishment’s complaints procedure.

Information about the treatment

5.3 Before treatment is offered, the tissue establishment should

give the woman seeking treatment and her partner, if applicable,

information about

(a) the likely outcomes of the proposed treatment (data

provided should include the national live birth rate and clinical

pregnancy rate, and the tissue establishment’s most recent live

birth rate and clinical pregnancy rate. Tissue establishments are

encouraged to provide data per embryo transferred where

relevant)

(b) the nature of the proposed treatment and any

treatment add ons, including evidence of effectiveness. The

tissue establishment should provide information in a lay format

(c) the implications of treatment, including for example,

the possibility of a negative outcome which could cause distress

or multiple pregnancy

Information about the risks of treatment

5.4 Before treatment is offered, the tissue establishment should

give the woman seeking treatment and her partner, if applicable,

information about

(a) the potential immediate and longer-term risks of the

treatment and any treatment add ons used, including the risk to

the patient and of any children conceived having developmental

and birth defects

(b) the nature and potential risks of any alternative

treatment options available so the patient can make an informed

decision about their treatment

(c) the possible side effects and risks to the woman being

treated and any resulting child

(d) the

possibility

of

developing

ovarian

hyperstimulation syndrome (OHSS). Any information provided

should include the possible symptoms of OHSS, what the woman

being treated should do and who to contact if experiencing

symptoms of OHSS

(e) the nature and potential risks (immediate and longer-

term) of using emerging or unproven treatments, including

reference to the clinic’s experience and wider evidence base

(f) the potential risk of emotional distress associated

with negative outcomes both during and after treatment.

Information about success rates

5.5 The tissue establishment should ensure that the information

provided on its website complies with the following guidance. This

also applies to other relevant marketing communications of the tissue

establishment and associated satellite and transport tissue

establishments.

(a) The information should include the most recent data

available from the past three years.

(b) Tissue establishments are encouraged to display live

birth rate data per embryo transferred where relevant and this

may be displayed alongside other success rate measures. The

information should not highlight a high success rate that is not

statistically significant where it applies only to a small, selected

group of patients.

(c) The data should show split by maternal age and, if

appropriate, by treatment type.

(d) The information should provide raw numbers rather

than just percentages.

(e) The website should provide the national rate and like-

for-like comparisons (the same year, maternal age, treatment

type, etc.).

(f) The tissue establishment’s published success-rate

data should refer to the EPA as the source of national

information.

(g) The information must state clearly that information

on success rates is of limited value in comparing tissue

establishments and choosing where to seek treatment.

(h) If the information refers to comparative costs, it

should indicate the likely total cost for a typical cycle, based on

the actual costs for recent patients, not individual items in tariffs.

Information about the cost of treatment

5.6 Before treatment, storage or both are offered, the tissue

establishment should also give the person seeking treatment or storage,

and their partner (if applicable) a personalised costed treatment plan.

The plan should detail the main elements of the treatment proposed

(including investigations and tests), the cost of that treatment and any

possible changes to the plan, including their cost implications. The

tissue establishment should give patients the opportunity to discuss the

plan before.

Further information to provide

5.7 There are different kinds of information tissue

establishments should give, where appropriate, to patients, patients’

partners and donors prior to obtaining consent to treatment, storage or

donation. Tissue establishment staff should familiarise themselves

with all the appropriate information to provide. This information is

contained in the following list of guidance notes

(a) Consent to treatments, storage, and disclosure of

information

(b)

Legal parenthood

(c)

Multiple births

(d)

Welfare of the child

(e)

Donor recruitment, assessment and screening

(f)

Procuring, processing and transporting gametes and

embryos

(g)

Storage of gametes and embryos

(h)

Donor assisted conception

(i)

Embryo donation

(j)

Intra-cytoplasmic sperm injection (ICSI)

(k)

Confidentiality and privacy

Additional information for treating trans patients

5.8 The tissue establishment should be aware that there are

multiple terms used to refer to trans people and that terminology in this

area is evolving. For inclusivity, this Protocol uses the term "trans" to

refer to all trans identities, including persons who consider themselves

"non-binary" (ie, identify as somewhere, either fixed or moveable, on

the male-female continuum) and "non-gendered" (ie, neither male,

female, nor on the male-female continuum).

5.9 Before treatment or storage is offered to a trans person, the

tissue establishment should (as with all patients) consider the

treatment and storage options that are available to the patient,

depending on their individual circumstances. For example, if a trans

person is visiting the clinic prior to gender reassignment they may be

seeking options for fertility preservation (ie, storage of either testicular

or ovarian tissue, or eggs or sperm depending on whether they have

undergone puberty); or if a trans person is visiting the clinic after

gender reassignment they may be seeking ways to use their preserved

tissue, eggs or sperm in treatment with a partner, or extend their

storage periods due to premature infertility.

5.10 Before treatment, storage or both are offered, the tissue

establishment should inform a trans person (as with all patients) that

they may need to be screened as a donor at the time of egg or sperm

collection depending on the treatment options they may wish to pursue

in the future and explain the reasons why.

5.11 Before treatment, storage or both are offered to a person

who is yet to undergo gender reassignment or who is not yet living in

their acquired gender, the tissue establishment should inform them that

should they change their identity before returning for further

treatment, it will be necessary for them to provide evidence of their

acquired identity and to verify that they are the person previously

treated.

5.12 The tissue establishment should recognise the sensitivities

of treating trans patients, and have practical ways of accommodating

their needs with dignity and respect. For example, rather than making

assumptions about how a trans patient would like to be addressed,

tissue establishments should ask how they would prefer to be

addressed. Tissue establishments may also need to explain why

gender at birth may be noted in medical records, should avoid making

assumptions when referring to gender (eg, if a telephone enquiry is

received regarding sperm storage, avoid assuming the caller is male),

and should take privacy and sensitivity into consideration.

6. Consent to Treatment,

Storage,

Donation

and

Disclosure of Information

6.1 The tissue establishment should obtain written, effective

consent from a person before using their gametes for their own

treatment or their partner’s treatment.

6.2 When a woman is to undergo additional fertilisation and an

embryo transfer, the tissue establishment should

(a) obtain her consent to the proposed number of eggs to

be fertilised (especially in cases where the medical practitioner

has requested permission from the EPA to fertilise more than two

eggs up to the maximum allowed by the Protocol), or embryos to

be transferred (maximum two) and

(b)

record her consent in her medical records.

6.3 The tissue establishment should establish and use

documented procedures to ensure that no activity involving the

handling or processing of gametes or embryos is carried out without

the appropriate consent having been given. This should include a

documented assurance process to ensure that all relevant consent

forms have been properly and correctly completed before treatment.

6.4 If, following treatment, the tissue establishment discovers

errors in the consent provided by a patient or their partner, the tissue

establishment should

(a) take all reasonable steps to notify the affected patient

at the earliest opportunity

(b) assess the error(s) and potential impact, and consider

the remedial actions that should be taken

(c) take all reasonable steps to support any affected

patients (and their partner, if applicable), and

(d)

report any error(s) as an adverse incident.

6.5 The tissue establishment should ensure that the person

giving consent is able to give their consent freely. The tissue

establishment should not pre-complete consent forms on behalf of the

person giving consent. For example, a person giving consent to the

storage of their gametes and/or embryos should be free to choose how

long to consent to store for, within what is permitted by regulations.

6.6 The tissue establishment should give anyone seeking

treatment or considering donation or storage enough time to reflect on

their decisions before obtaining their consent. The tissue establishment

should give them an opportunity to ask questions and receive further

information, advice and guidance.

6.7 If the possibility of donating gametes or embryos for the

treatment of others, arises during the course of treatment, the tissue

establishment should allow potential donors enough time to consider

the implications and to receive counselling before giving consent.

6.8

The tissue establishment should ensure that consent is

(a) given voluntarily (without pressure to accept

treatment or agree to donation)

(b)

given by a person who has capacity to do so

(c) taken by a person authorised by the establishment to

do so, and

(d) given at the clinic (with both parties if a couple is

being treated) where possible, clinics should record why a

patient is not able to sign at the clinic and should have a

documented process for ensuring consent forms being signed

outside the clinic are signed by the correct person

6.9 The tissue establishment should ensure that anyone giving

consent has been

(a) given enough information to enable them to

understand the nature, purpose and implications of the treatment

or donation

(b) given a suitable opportunity to receive proper

counselling about the implications of the proposed procedures

(c) given information about the procedure for varying or

withdrawing consent, and

(d) given information in writing that is correct and

complete.

6.10 If gametes or embryos are to be transferred/exported to a

tissue establishment outside the Maltese Islands, the tissue

establishment must obtain the consent of the gamete provider(s) to

their transfer/export, to the country in which the receiving tissue

establishment is situated. Such consent must then be provided to the

tissue establishment receiving the gametes or embryos.

6.11 If gametes or embryos are to be transferred/imported into

the Maltese Islands from a tissue establishment outside the Maltese

Islands, the responsible person for the Malta tissue establishment must

be satisfied that the provider has given written consent to the transfer/

import of the gametes or embryos to the Maltese Islands and has not

withdrawn that consent.

6.12 The tissue establishment should inform prospective parent/

s that, according to the Embryo Protection (Amendment) Act 2018 the

cryopreservation of embryos shall be regulated by an agreement

between the prospective parent or prospective parents and the licensee

subject to the prior authorisation of the Embryo Protection Authority

and shall have a maximum term of validity of five years renewable up

to a maximum permissible age for the transfer thereof into the

prospective parent. Provided further that when the maximum

permissible age for the transfer of the embryo into the prospective

parent is reached, the Embryo Protection Authority shall authorise the

donation of the cryopreserved embryos.

6.13 Tissue establishments should take all reasonable steps to

verify the identity of anyone accepted for treatment, including partners

who may not visit the centre during treatment. The centre should

establish the relationship between a patient and their partner and a

record of this should be retained in the patients’ notes. If a patient’s

identity is in doubt or if a tissue establishment has reason to question

whether the person is who they claim to be, the tissue establishment

should verify their identity, including examining photographic

evidence such as a passport or a photocard driving licence. The tissue

establishment should record this evidence in the patient’s medical

records. Tissue establishments should have a process in place to verify

the identity of a patient (and their partner, if applicable) if they return

to the centre for subsequent treatment, to ensure the patient and their

partner are the same people they treated initially. The clinic should

establish whether the patient and their partner’s personal

circumstances have changed in the period since their last treatment, for

example, whether the couple has divorced or separated since their

previous treatment and give consideration to whether any changes in

their personal circumstances impact on consent.

6.14 Where a patient has changed their name (eg, where

someone has changed their name by deed, has married and taken their

partner’s surname, or has obtained a gender recognition certificate) or

has changed their physical appearance (eg, where someone has

undergone gender reassignment or is living in the gender they most

closely identify with but which is different from their gender at birth)

since their previous consultation, examination or donation, centres

should take all reasonable steps to verify the patient’s identity. This is

to ascertain that a patient presenting for treatment or donation is the

same person the centre previously engaged with or treated. Tissue

establishments should verify a patient’s identity by asking for evidence

of their previous name (eg, a passport or photocard driving licence)

and verifying details against the person’s medical records. This can be

a sensitive issue, and tissue establishments should take care to address

identity issues with consideration. As evidence of their new name,

centres should ask the person to provide one of the following

(a)

a marriage certificate, or

(b)

evidence of a change in name (such as via deed)

For trans patients

(c)

a birth or adoption certificate in an acquired gender

(d)

a Gender Recognition Certificate, or

(e)

a letter from a doctor or medical consultation

confirming that the change of gender is likely to be permanent,

and evidence of a change in name (such as via deed).

Tissue establishments must ensure that a patient’s records

are updated to accurately reflect their new identity.

6.15 To avoid the possibility of misrepresentation or mistake,

the tissue establishment should check the identities of patients and

their partners, against identifying information in the medical records.

This should be done at each consultation, examination and treatment

or donation. If the partner of a patient who is having treatment has not

visited the clinic throughout the treatment, or does not return with the

patient for subsequent treatment, tissue establishments should take

reasonable steps to find out whether the patient’s partner still consents

to the treatment. This may include contacting the partner to confirm

that their circumstances have not changed and that their consent is still

valid. The tissue establishment should not commence treatment until it

is satisfied that the partner in fact consents to the treatment.

6.16 The tissue establishment should consider the needs of

people whose first language is not Maltese or English and those who

face other communication barriers. Where consent is obtained, the

tissue establishment should record

(a) any difficulties in communicating the implications of

giving consent and providing other information to the person

(e.g. language barriers or hearing impairment), and

(b) an explanation of how these difficulties were

overcome (e.g. the use of an independent interpreter).

Recording Consent and Related Information

The law requires consent, or any subsequent variation or

withdrawal of consent, to be in writing and signed by the person giving

consent.

6.17 The tissue establishment should keep a copy of a person’s

signed consent form(s) electronically or as a hard copy and make a

copy available to those giving consent and to EPA and made available

to them upon request.

6.18 The tissue establishment should ensure that it documents in

the medical records, that relevant information has been provided to the

person giving consent and that the person has been offered counselling

before giving consent.

Additional Consent Requirements for Storing Gametes and

Embryos

6.19 Written consent to the storage of gametes must

(a)

specify the maximum period of storage, and

(b) state what should be done with the gametes, if the

person giving the consent dies or cannot, because of mental

incapacity, with draw or vary the terms of the consent.

6.20 The tissue establishment should normally ask patients to

give consent to storage at the same time as consent to the use of

gametes and embryos. However, the tissue establishment should

accommodate anyone seeking long-term storage of gametes who may

wish to consent to storage separately from consent to use. Any patient

who has given consent to storage but who has not given consent to use,

should be informed that their gametes cannot lawfully be used in

treatment unless they have given consent to use.

6.21 Provided that the cryopreservation of embryos shall be

regulated by an agreement between the prospective parent or

prospective parents and the licencee subject to the prior authorisation

of the Embryo Protection Authority and shall have a maximum term of

validity of five years renewable up to a maximum permissible age for

the transfer thereof into the prospective parent in terms of Article 7 of

the Embryo Protection (Amendment) Act, 2018.

6.22 When an individual gives consent to the use of gametes for

the treatment of others, the tissue establishment need not get consent

from the donor’s partner or spouse. However, if the donor is married,

in a civil partnership or in a long-term relationship, the tissue

establishment should encourage them to seek their partner’s support

for the donation of their gametes.

Consent to Examination and Treatment

6.23 Everyone has the right to withhold or give consent to

examination and treatment. Unless there are exceptional

circumstances, the tissue establishment may not examine, treat or

receive gametes from people without first obtaining their consent. The

only exceptional circumstance likely to arise during fertility treatment

is

(a)

where the procedure is necessary to save the patient’s

life, and

(b) the treatment cannot be postponed, and the patient is

unconscious or mentally incapacitated so cannot indicate their

wishes.

6.24 The tissue establishment should comply with current

professional guidelines on consent.

Consent to the Presence of Observers

6.25 If a member of the tissue establishment’s team wishes an

observer to be present when a patient is being examined, treated or

counselled, they should explain why beforehand and state who the

observer is. The tissue establishment should give the patient

appropriate information about the proposed observation and ask them

whether they consent to the observer’s presence.

Patients have the right to decide what identifying information

should be disclosed and to whom.

Tissue establishments should obtain a patient’s written consent

before disclosing information relating to their treatment (or providing

gametes for a partner’s treatment), or the storage of gametes.

In addition, consent is needed from any person who could be

identified through disclosure of information about a person’s treatment

or the storage of gametes. For example, consent would be needed from

a patient’s partner if they could be identified through disclosure of

information about the patient’s treatment.

Consent to Disclose Identifying Information

6.26 Before obtaining consent to disclose information, the tissue

establishment should give the person enough information for them to

make a properly informed decision, including

(a)

precisely what information is to be disclosed

(b)

the terms on which it is to be disclosed

(c) the reasons for disclosure (e.g. to keep the person’s

general practitioner (GP) informed about the fertility treatment)

(d)

the implications of disclosure

(e) the categories of people to whom the information is to

be disclosed.

6.27 The tissue establishment should seek consent to disclosure

to the following categories of people

(a)

the patient’s GP or the patient’s partner’s GP

(b)

other healthcare professionals outside the tissue

establishment (so they can provide the patient or the patient’s

partner with the best possible medical care)

(c) auditors or administrative staff outside of the tissue

establishment (so they can perform their functions in connection

with the tissue establishment’s licensable activities), and

(d) medical or other researchers (so they can contact the

patient about specific research projects or carry out non-contact

research).

6.28 The tissue establishment should consider circumstances

where they may need to disclose a person’s gender history (eg, to those

within the tissue establishment who need to know of a trans patient’s

previous identity to deliver safe and appropriate care) to determine

whether they need to obtain the person’s consent to disclosure of this

information. This should be discussed in detail with the person and any

consent obtained should be filed with their medical records.

6.29 The tissue establishment should renew consent to

disclosure if the nature of treatment changes after initial consent has

been given (eg, if during treatment, it is proposed that donor gametes

are used instead of the patient’s own.

6.30 The tissue establishment should ensure that people to

whom they disclose identifying information know that the information

remains protected by the existing common law on confidentiality.

Those receiving information should also be told

(a) the precise terms upon which it was disclosed and for

which consent has been given, and

(b) that if they disclose the information they have

received, a child might learn in an inappropriate way that they

were born as a result of fertility treatment.

Cases where Consent is not required for Storage

6.31 Before storing someone’s gametes without their consent,

the tissue establishment should judge that the person is not competent

to consent to the storage of gametes. When assessing the competence

of children and adults to consent, the tissue establishment should

follow current guidance produced by the Department of Health, the

Medical Council and other professional bodies.

6.32 The tissue establishment should presume that it is in the

child’s best interests to store gametes unless circumstances suggest

otherwise, (in cases of oncology treatment). When assessing whether it

is in a child’s best interests to procure and store their gametes, the

tissue establishment should consider the child’s short and long-term

best interests. Consent should be sought from the child when they

reach competence.

6.33

The tissue establishment should provide written

information that children and young people can read and understand

easily. This information should be given by a member of staff

experienced in communicating with children.

Competence

6.34 If the tissue establishment’s staff doubts someone’s

competence to consent to a proposed procedure, or to the storage or

use of gametes, they should

(a)

follow the current guidelines of professional bodies

(b) if they remain in any doubt, the tissue establishment

should seek legal advice.

Variation and Withdrawal of Consent

6.35 If someone wishes to withdraw consent to the storage or

use of gametes they must do so in writing, except if they are unable to

do so because of illness, injury or incapacity. In these cases, they can

direct someone to sign on their behalf, provided that the person

withdrawing consent is present at the time, and that the signature is

also witnessed and attested to by at least one other person.

6.36 The tissue establishment should check the identity of

anyone withdrawing or varying consent against identifying

information held in the medical records. The tissue establishment

should also ensure that the person withdrawing or varying consent has

been given sufficient information to enable them to make an informed

decision about doing so.

6.37 The tissue establishment should have procedures for

dealing with disputes that may arise when one gamete provider

withdraws their consent to the use or storage of gametes (e.g. in cases

of separation / divorce). In this situation the tissue establishment

should stop treatment and notify all relevant parties. Tissue

establishments should provide information about counselling or

mediation services as appropriate.

The End of Storage

6.38

The tissue establishment should make efforts to stay in

contact with patients who have gametes in storage for their own

treatment. The tissue establishment should also explain to gamete

providers and current patients the importance of informing the tissue

establishment of any change in their contact details.

6.39 Tissue establishments should inform patients who have

gametes in storage for their own treatment when the end of the

permitted storage period is approaching. Patients should be provided

with information about the options available to them as the end of their

permitted storage period approaches. They should be given enough

notice to enable them to consider those options, and to access

appropriate advice.

6.40 The Tissue Establishment should establish and use

documented procedures to contact prospective parent/s who have

gametes or embryos in storage for their own treatment when the end of

the permitted storage period is approaching but long enough in

advance to allow the Tissue Establishment and prospective parent/s to

take any steps necessary to comply where extension of storage is an

option for the prospective parent/s.

6.41 The Tissue Establishment should use all contact details

available to them, including at least one written form of contact.

6.42 Prospective parent/s should be provided with information

about the options available to them as the end of their permitted

storage period approaches.

6.43 They should be given enough notice to enable them to

consider those options and to access appropriate advice.

6.44 Options could include the donation of the gametes or

embryos for the treatment of others.

6.45 If contact with the prospective parent/s is not possible, the

Tissue Establishment should without delay inform the Embryo

Protection Authority

(a)

in the case of embryos these will be given for

adoption

(b) in the case of gametes, the Tissue Establishment is to

record the steps it has taken in the patient’s medical records.

7. Legal Parenthood and Parental Responsibility

7.1 As defined in the "Embryo Protection (Amendment) Act

2018", "prospective parent" means "any person regardless of gender or

sexual orientation, who has attained the age of majority and is a

receiver or user of the medically assisted procreation techniques

regulated under this Act.

7.2 For the purposes of this Protocol, the Embryo Protection

Authority establishes that the woman who is entitled to treatment

should be between the age of 18 and 48 years if using the woman’s

own oocytes which have been retrieved prior to the women attaining

46 years.

7.3 It further establishes that the woman referred in Guidance

Note 7.2 above, if after undergoing retrieval up to the maximum age of

45 years will still have cryopreserved embryos, then the maximum age

of that woman will be extended to 48 years.

7.4 It further establishes that the woman who is entitled to

treatment should be between the age of 18 and 48 years if using

donated oocytes.

7.5 Prospective parent / parents referred in Guidance Notes 7.2

to 7.4 above are referred to treatment if they have one of the following

(a)

Identified causes of infertility amenable to treatment

by IVF

(b) Unexplained infertility for at least 2 years. In all

cases where investigations show that there is no chance of

pregnancy with expectant management and where IVF is the

only effective treatment, the couple is to be referred directly for

IVF without having to wait for the two-year period.

(c)

Same sex lesbian couples making use of donated

sperm

(d) Single/partnered biological woman, irrespective of

legal identity

(e) Has a family history of a monogenic disease which is

listed as one of the diseases in the Guidance Notes 11 for Pre-

Implantation Genetic Diagnosis for Monogenic diseases

7.6 The maximum permissible age of the prospective parent for

implantation of embryos shall be 48 years in all cases.

7.7 Article 19 of the Embryo Protection Act states that “Any

child born as a result of any medically assisted procreation procedure,

including cases where the child was born from donated germline cells

or a donated embryo, shall be considered to be the child of the

prospective parent or parents who have expressed their consent in

writing as provided in article 18 of the same Act, and shall for all

intents and purposes of law be deemed to have been naturally born of

the same prospective parent or parents without the intervention of any

procedure as aforesaid; and notwithstanding the provision of any other

law, any such child shall be registered in any act of civil status as the

direct descendant of such prospective parents who shall enjoy such

rights and bear such duties according to law in respect of such child.

8. Multiple Births

8.1 The Embryo Protection Authority requires tissue

establishments to have a documented strategy to minimise multiple

births and should have documented standard operating procedures for

egg and embryo transfer.

Its purpose is to reduce the annual rate of multiple births

resulting from treatments at the tissue establishment.

The strategy must set out

(a) how the tissue establishment aims to reduce the

annual multiple birth rate following treatment at that tissue

establishment

(b) the circumstances in which the clinician together with

the responsible person would consider it appropriate to

recommend single embryo transfer (SET) to a patient (in setting

out such circumstances, the tissue establishment should give

proper consideration to relevant professional guidance) and

(c) the criteria for transferring eggs during gamete intra-

fallopian transfer (GIFT).

8.2 The responsible person should ensure that the tissue

establishment’s annual multiple birth rate are well recorded.

8.3 When implementing the tissue establishment’s strategy to

minimise multiple births, the responsible person together with the

clinician should consider the higher rate of multiple births from

blastocyst transfers.

The tissue establishment must document regular audits that

(a)

assess progress in reducing its multiple birth rate, and

(b)

help evaluate the effectiveness of its strategy.

Limits on Egg Fertilisation and Embryo Transfer

8.4 The tissue establishment should not transfer more than two

embryos in any treatment cycle.

8.5 If the treatment involves the use of super ovulatory drugs or

the transfer of multiple eggs or embryos (maximum of two embryos)

in any one cycle (whether fresh or previously cryopreserved), the

tissue establishment should give people seeking treatment information

about the risks of multiple pregnancy for the woman, the embryo and

any resulting child(ren), including

(a) the higher risk of miscarriage and complications

during pregnancy

(b) the higher rate of premature birth and the problems

arising from low birth weight, the higher rate of still birth, and

the higher rate of perinatal mortality

(c) the higher rate of disability and other health

problems, plus the potential need for extended stays in hospital

before and after birth, and

(d) the possible practical, financial and emotional impact

on the family and any children.

8.6 The tissue establishment should give the woman the

opportunity to discuss the number of eggs or embryos to be transferred

before egg collection and just before embryo transfer.

8.7 If a woman is to undergo an egg or embryo transfer, the

tissue establishment should

(a) obtain her consent to the proposed number of eggs or

embryos to be transferred and the reasons for this (including her

acceptance of the risk of multiple births), and

(b)

record her consent in her medical records.

8.8 The tissue establishment should not fertilize more than two

egg cells from one woman within one treatment cycle using her own

eggs or donated eggs, where the prospective parent or prospective

parents undergoing medically assisted procreation procedures do not

expressly give their consent to the cryopreservation of embryos and to

the donation of embryos if necessary in terms of Article 18 of the Act.

9. Additional Fertilisation Permissions

9.1 The medical practitioner in charge of the medically assisted

procreation may, in consultation with the multidisciplinary team and

with the permission of the Embryo Protection Authority, decide to

fertilise more than two egg cells

from one woman within one

treatment cycle, provided that this is done in accordance with the

established Protocol as discussed and approved in the Parliamentary

Health Committee as per hereunder

Methodology of Applications and Process

9.2 The Clinical ART Multidisciplinary Team composed of the

ART Consultant, Embryologists, Geneticist and Urologist assess on a

case-by-case basis each patient that will be receiving ART treatment

and the possibility of having additional fertilisation requests. The

decision taken by the multidisciplinary team will be later

communicated and discussed with the patient receiving treatment.

9.3 The ART Consultant together with and after discussions

held with the prospective parent/s receiving infertility treatment, will

take an informed decision on the number of oocytes that will be

practical to fertilise, the two allowed by law and any additional

oocytes to allow the possibility of having viable embryos that could

result in a pregnancy and the possibility of a live birth.

9.4 The Consultant is then to apply to the Authority by filling

the necessary required information on the already existing Additional

Fertilisation Request Form (AFR Form), on the EEART online system.

This is to be sent to the

Authority together with a detailed report of why an

additional request is being made. This is to be also accompanied

by any supporting documentation.

9.5 The application is vetted by the Authority CEO. This

application will then be presented in detail by the CEO in the next

Authority Board meeting.

9.6 During these Additional Fertilisation Request (AFR)

sittings the Board is assisted by two representatives appointed by the

Obstetrics and Gynaecology Association and representatives

appointed by the Paediatric Association of Malta and a Urologist when

necessary.

Criteria for Permissions to allow Additional Fertilisation

9.7

The requests will be presented and discussed on a case-by-

case basis and decisions for granting permission for additional

fertilization will be based on the prospective parent/s receiving

treatment infertility indicators, which include but not exclusive of

female factors (low ovarian reserve, PCOS, blocked tubes, etc.), male

factor (azoospermia, oligospermia, evidence of testicular failure,

morphology and motility issues), age of women receiving treatment,

previous failed Assisted Reproduction Cycles, Oncology cases in male

and female patients, fertility preservation, and any other medical

conditions.

9.8 The decision taken by Board and Representatives is to

clearly state either if no permission is granted and thus only two

oocytes will be allowed to be fertilized; or if permission is granted, the

number of oocytes that will be allowed to be fertilized: up to a

maximum of twelve (12) as per hereunder.

(a) Women who have not attained age 39 can be granted

up to a maximum of 5 oocytes.

(b) Women aged 39 and who have not attained 46 years

can be granted up to a maximum of 8 oocytes.

(c) Prospective parents undergoing PGTM will be

allowed up to a maximum of 12 oocytes as per hereunder

(i) Prospective parents where the woman has not

attained 36 years of age will be allowed up to a maximum

of 8 oocytes/embryos to undergo PGTM.

(ii) Prospective parents where the woman has

attained 36 years of age and has not attained 46 years of

age, will be allowed up to a maximum of 12 oocytes/

embryos to undergo PGTM.

9.9 The decision of the Authority is Final and will be

communicated in writing on the EEART system by the CEO of the

Authority to the Consultant who had made the original request.

9.10 The Consultant is to inform the prospective parent/s with

the Authority’s decision before the IVF/ICSI cycle is performed.

Cases of Patients who already have Cryopreserved Embryos

The Authority will not allow any fertilisation of oocytes, (Not

even the two oocytes allowed by the EPA Act) if the person/s seeking

treatment already have cryopreserved embryos, unless the embryos

were cryo-preserved for medical reasons known to the Authority.

10. Welfare of the Child

A woman must not be provided with treatment services unless

account has been taken of the welfare of any child who may be born as

a result of the treatment (including the need of that child for supportive

parenting), and of any other child who may be affected by the birth.

10.1 This guidance note applies to all fertility treatments

regulated by the Embryo Protection Authority, including intrauterine

insemination (IUI).

10.2 The tissue establishment should have documented

procedures to ensure that proper account is taken of the welfare of any

child who may be born as a result of treatment services, and any other

child who may be affected by the birth.

10.3 The tissue establishment should assess each patient and

their partner (where applicable) before providing any treatment, and

should use this assessment to decide whether there is a risk of

significant harm or neglect to any child referred to in 10.2.

10.4 Counsellors should make their own independent decision in

line with their professional codes of ethical practice as to whether they

undertake welfare of the child assessments.

10.5 If such assessments are undertaken by the counsellor, it

should be explained to the patient(s) that they are acting on behalf of

the clinic and that this role differs from the typical therapeutic

counsellor/client relationship. The tissue establishment should have an

arrangement that enables patients to access support from another

counsellor who may be a member of the team or who works

independently.

10.6 Limitations to confidentiality should be discussed with the

patient, including the extent to which information will be shared with

other members of the multidisciplinary team.

10.7 If it is necessary to contact external agencies (such as

Appogg, Sedqa, or any other designate Child Protection Agencies),

prior approval for same is to be sought from EPA, for additional

information. The patient or patients should be asked to give written

consent by completing the necessary form. The patient or patients

should receive a copy of any correspondence sent out to external

agencies.

10.8 If the assessment involves a couple, they would usually be

seen together. A comprehensive history will be taken as part of the

assessment process and this should include

(a)

Length of existing relationship

(b)

Any existing children and their ages

(c) Number of children living with the prospective parent

or parents (if any)

(d)

Details of physical and mental health

(e)

Details of substance or alcohol misuse (if any)

(f) Any safeguarding issues (including children and

vulnerable adults)

(g) Any contact with police, probation, social services,

and the reason for this contact

(h) The couple or individual’s perception of the welfare

of the child issue

(i) Any other information that the couple or individual

choose to provide

10.9 The information gathered at the assessment is recorded in

accordance with the confidentiality conditions explained to the patient

or patients. It is kept in a secure place, which may be separate from the

medical notes and may be shared with other members of the licensed

tissue establishment multidisciplinary team to help determine the next

course of action.

10.10 External agencies may be contacted, after the tissue

establishment has sought approval from the Embryo Protection

Authority, and the case may be referred to an Ethics Committee as part

of the decision-making process to offer or decline treatment.

Information to be shared with an Ethics Committee should be agreed

with the patient(s) and presented in an anonymous way so that the

patient(s) cannot be identified.

10.11 The tissue establishment should inform the patient(s) at

each stage of this process and ensure that they are aware of their right

to appeal and the opportunities for obtaining appropriate counselling if

the decision made is not in their favour.

10.12 The tissue establishment should repeat the assessment if

(a)

the tissue establishment has been out of contact with

the patient for two years or more

(b)

the patient has a new partner

(c) a child has been born to the patient since the previous

assessment, or

(d) the tissue establishment has reason to believe that the

patient’s medical or social circumstances have changed

significantly.

10.13 Those seeking treatment are entitled to a fair assessment.

The tissue establishment is expected to consider the wishes of all those

involved, and the assessment must be done in a non-discriminatory

way. In particular, patients should not be discriminated against on

grounds of gender, race, disability, sexual orientation, religious belief

or age.

10.14 The tissue establishment should take a medical and social

history from each patient and their partner (when applicable). Where

appropriate, the patient and their partner may be interviewed

separately. The information gathered should relate to the factors in

paragraphs 10.15–10.16 below.

Factors to take into Account during the Assessment Process

10.15 The tissue establishment should consider factors that are

likely to cause a risk of significant harm or neglect to any child who

may be born or to any existing child of the family. These factors

include any aspects of the patient’s or their partner’s

(a) past or current circumstances that may lead to any

child mentioned above experiencing serious physical or

psychological harm or neglect, for example

(i)

previous

convictions

relating

to

harming

children

(ii) child protection measures taken regarding

existing children, or

(iii) violence or serious discord in the family

environment

(b) past or current circumstances that are likely to lead to

an inability to care throughout childhood for any child who may

be born, or that are already seriously impairing the care of any

existing child of the family, for example

(i)

mental or physical conditions

(ii)

drug or alcohol abuse

(iii) medical history, where the medical history

indicates that any child who may be born is likely to suffer

from a serious medical condition, or

(iv) circumstances that the tissue establishment

considers likely to cause serious harm to any child

mentioned above.

10.16 When considering a child’s need for supportive parenting,

tissue establishments should consider the following.

Supportive parenting is a commitment to the health, wellbeing

and development of the child. It is presumed that all prospective

parents will be supportive parents, in the absence of any reasonable

cause for concern that any child who may be born, or any other child,

may be at risk of significant harm or neglect. Where tissue

establishments have concern as to whether this commitment exists,

they may wish to take account of wider family and social networks

within which the child will be raised.

Obtaining further Information during the Assessment

Process

10.17 The tissue establishment should obtain consent from the

prospective parent and their partner (where applicable) to approach

any individuals, agencies or authorities for any factual information

required for further investigation if

(a) information provided by the prospective parent or

parents suggests a risk of significant harm or neglect to any child

(b) the prospective parents have failed to provide any of

the information requested

(c) the information the prospective parents have provided

is inconsistent, or

(d)

there is evidence of deception.

A refusal to provide consent to disclosure of information should

not, in itself, be grounds for denying treatment but the tissue

establishment should take this into account in deciding whether to

provide treatment.

The tissue establishment should discuss with the prospective

parent or parents the reason for refusing to provide consent.

Furthermore, the tissue establishment should inform the EPA about the

refusal from the prospective parent or parents.

10.18 If information has been provided in confidence to a

member of staff, the staff member should seek consent from the

information provider to discuss it with other staff. If such consent is

refused and the member of staff considers the matter to be crucial to a

decision, they should use their discretion, based on good professional

practice, in deciding whether to break that confidence. In line with

professional guidance, patients should normally be informed of the

decision to break confidence and the reasons for it, before the

information is shared with other members of staff.

Refusing Treatment

10.19 The tissue establishment should refuse treatment if it

(a) concludes that any child who may be born or any

existing child of the family is likely to be at risk of significant

harm or neglect, or

(b) cannot obtain enough information to conclude that

there is no significant risk.

10.20 In deciding whether to refuse treatment, the tissue

establishment should

(a) take into account the views of all staff who have been

involved with caring for the patient and their partner, and

(b)

give the patient and their partner the opportunity to

respond to the reason or reasons for refusal before the tissue

establishment makes a final decision.

10.21 If treatment is refused, the tissue establishment should

explain, in writing, to the patient and their partner

(a)

why treatment has been refused

(b) any circumstances that may enable the tissue

establishment to reconsider its decision

(c)

any remaining options, and

(d)

opportunities for obtaining appropriate counselling.

10.22 Decision of refusal by the Tissue Establishment should be

communicated immediately to the Embryo Protection Authority.

Record Keeping

10.23 In all cases, the tissue establishment should record in the

patient’s medical records the information it has considered during the

assessment. If further information has been sought or discussion has

taken place, the record should reflect the views of those consulted in

reaching the decision and the views of the prospective parents.

11. Pre-implantation

Genetic

Testing

for

Monogenic

diseases (PGTM)

11.1 In Malta, PGTM is regulated by the Embryo Protection

Authority (EPA). The Authority maintains a list of conditions for

which PGTM has been approved, as per table reproduced hereunder

List of Conditions approved by EPA for PGTM

Finnish Nephrotic Syndrome

Gangliosidosis

Huntington Disease

Joubert Syndrome

Maple Syrup Urine Syndrome

Nemaline Myopathy

Spinal Muscular Atrophy

Tay-Sachs Disease

Walker-Warburg Syndrome

11.2 For conditions not already on the list, the EPA considers a

number of factors, including how serious the condition is, the

likelihood of it being inherited and the testimony of people affected by

the condition before deciding whether to approve it for PGTM testing.

11.3 In order for a new condition to be considered for PGTM

testing approval, a couple must have a licensed PGTM clinic apply to

the EPA on their behalf.

11.4 When pre-implantation genetic diagnosis (PGTM) is used

to combine IVF and genetic testing as a means of avoiding the

transmission of a genetic disease, the medical practitioners shall

follow the principles of the Ethical Guidelines as per hereunder

11.4.1 Pre-implantation genetic diagnosis (PGTM) is a

technique that may be used to combine IVF and genetic testing as a

means of avoiding the transmission of a genetic disease as listed in the

protocol. PGTM shall not be allowed for the selection of embryos for

eugenic purposes.

11.4.2 PGTM should only be used for the detection of serious

genetic conditions as approved by the Authority, and which conditions

significantly affect the health of an individual who might be born.

11.5 The use of PGTM should be a matter of discussion between

those seeking PGTM (i.e., the prospective parents) and the clinical

team on the seriousness of the genetic condition.

11.6 A senior clinical geneticist should be involved in the

decision-making process when deciding whether a particular patient

should receive treatment involving PGTM.

11.7 The Tissue Establishment offering treatment should ensure

that a multidisciplinary team is involved in providing the PGTM

service.

The team should include reproductive specialists,

embryologists, clinical and molecular geneticists, genetic counsellors.

It should also maintain close contact with the primary care medical

doctor or the referring clinician.

11.8 If the Tissue Establishment offers the PGTM service, the

individual responsible for this laboratory should

(a)

hold an appropriate scientific or medical degree

(b) have acquired sufficient experience in an

appropriately accredited medical genetics diagnostic laboratory

to supervise and be responsible for one, and

(c) be registered with a recognised body by the EPA as a

clinical scientist with specific expertise in clinical genetics and is

conversant on the nature of tests conducted, the scope and

limitations of the tests, accuracy and implications of the tests and

the meaning of the test results.

11.9 The Tissue Establishment should ensure that the

prospective parents seeking treatment should have access to the

clinical geneticists and the genetic counsellors.

11.10 Genetic counselling requires specialist training and

knowledge. Tissue Establishments are to ensure, that genetic

counselling should only be undertaken by an infertility counsellor if s/

he has additional qualification in genetic counselling. In the absence

of this, patients should be referred to specialist genetic counselling

services. Genetic counselling addresses the risk of patients using their

own gametes, but it does not address the emotional issues associated

with infertility. Therefore, the Tissue Establishment’s counselling

service should continue to be available before, throughout and after the

investigations, decision-making and treatment.

11.11 The Tissue Establishment should consider the following

factors when deciding if PGTM is appropriate in particular cases

(a) the views of the people seeking treatment in relation

to the condition to be avoided, including their previous

reproductive experience

(b) the likely degree of suffering associated with the

condition

(c)

the availability of effective therapy, now and in the

future

(d)

the speed of degeneration in progressive disorders

(e)

the social support available, and

(f) the family circumstances of the people seeking

treatment.

11.12 The Tissue Establishment may offer PGTM but withhold

the patient’s test results (PGTM with non-disclosure). However, this

should only be offered under the following conditions

(a) that patients are given the opportunity to receive

genetic counselling on the implications prior to giving consent,

(b) that protocols are established to limit, as far as

possible, the risk of unwanted disclosure to the patients. Tissue

Establishments should consider using a different embryology

laboratory from their own, in order to minimise the number of

Tissue Establishment staff who know the patient’s genetic status.

11.13 The Tissue Establishment should document its reasons for

offering PGTM with non-disclosure to a patient. This record should

include

(a) written informed consent from the patient to perform

PGTM with non-disclosure,

(b) a statement from the people seeking treatment

confirming that they have been given the opportunity to receive

genetic counselling and that they have, prior to giving consent,

received information

(i)

on the risks of inadvertent disclosure,

(ii) that where all embryos are suitable for transfer

this is not evidence of the patient’s genetic status,

(iii) that where no embryos are suitable for transfer

this is not evidence of the patient’s genetic status.

11.14 The clinical team of the Tissue Establishment, having

discussed with the prospective parents seeking PGTM, and determined

the condition to be sufficiently serious to warrant PGTM, need to

apply to the Regulatory Authority EPA and provide the EPA with a

report prior to starting any PGTM procedure, detailing

(a)

the nature of the genetic condition,

(b) if testing is to be for Polar Body PGTM, Day 3

Blastomere PGTM or on a Day 5 Blastocyst PGTM,

(c) proof that the prospective parents have received

genetic counselling and have given a joint informed consent to

undergo the procedure,

(d) original or copy of results of genetic testing,

karyotypes or other specific testing of the index patient, spouse

or partner, children, or other family members (when

appropriate),

(e) female reproductive history, gynaecological and

fertility status,

(f) male reproductive history, andrological history,

fertility status, results of sperm analysis (especially in cases

where the genetic disorder(s) for which PGTM is desired has

effects on sperm parameters,

(g) reports on health problems of female and male

partners that may affect genetic diagnosis, or the outcome of IVF

and pregnancy (when appropriate). Health status may need to be

re-evaluated over time,

(h)

a genetic counselling report

11.15 The Authority, if the condition is listed in the approved

conditions, will issue a permission for the prospective parents to

undergo PGTM. It is only after an approval is granted that a PGTM

procedure can go ahead as per hereunder

(a) Prospective parents where the woman has not

attained thirty-six (36) years of age will be allowed up to a

maximum of eight oocytes/embryos to undergo PGTM.

(b) Prospective parents where the woman has attained

thirty-six (36) years and have not attained forty-six (46) years of

age will be allowed up to a maximum of twelve oocytes/embryos

to undergo PGTM.

11.16 The Tissue Establishment should ensure that people

seeking PGTM are given the appropriate information about the

treatment. This should include

(a) the process, procedures and possible risks involved in

IVF and biopsy procedures when providing a sophisticated

genetic test,

(b) the experience of the Tissue Establishment in

carrying out the procedure,

(c) that sophisticated genetic tests can reveal additional

genetic information about an embryo(s) and that the clinical

effect of these findings on a child born may not be known,

(d) All information, oral and written, should be in

language that can be understood by a layperson as technical

terminology may lead to patient misunderstanding,

(e) Written information about treatment should be

available prior to a consultation,

(f) When PGTM involves the treatment of a couple, both

partners should, when possible, attend consultations,

(g) An independent interpreter should be present, when

necessary, although a family member could act as translator in

the absence of an alternative,

(h) Counselling should be offered both before, during

and after each IVF/PGTM cycle. The counselling provided

should be non-directive and include all reproductive options

available to the couple, enabling them to reach their own

conclusion about the suitability of treatment,

(i) Costs and timelines should also be discussed to

ensure that patients are fully informed of all aspects of IVF and

PGTM before treatment starts. The social and psychological

impact needs to be considered, especially in couples already

responsible for the care of affected children,

(j) Additional counselling may

be

needed

after

completion of the laboratory work-up,

(k) Individualised post-consultation letters

should

contain a summary of the information discussed,

(l) The patients should sign a written informed consent

for all procedures they will undergo, and which are PGTM-

related.

11.17 The Tissue Establishment should also provide information

to those seeking treatment to help them make decisions about their

treatment, including

(a) genetic and clinical information about the condition

being tested for,

(b) the likely impact of the condition on those affected

and their families,

(c) information about treatment and social support

available, and

(d) information from a relevant patient support group or

the testimony of people living with the condition, if those

seeking treatment have no direct experience of it themselves.

11.18 If the person seeking treatment has already been given

information about the particular genetic disorder, for example from

another genetics Tissue Establishment, the Tissue Establishment need

not provide this information again. However, the Tissue Establishment

should ensure that the information has been provided to a satisfactory

standard of breadth and clarity.

11.19 Before providing PGTM, the Tissue Establishment should

ensure that those seeking treatment have had sufficient opportunity to

fully consider the possible outcomes of genetic testing and their

implications.

11.20 Embryos from which biopsies have been taken or resulting

from gametes from which biopsies have been taken, should not be

transferred with any other (non-biopsied) embryos in the same

treatment cycle.

11.21 Embryos that after biopsies have been carried out result

that they have a gene that will develop a serious disease, cannot be

discarded as per the Embryo Protection Act, thus, such embryos are to

be cryopreserved in a dedicated storage facility, separate from

embryos not diagnosed with the disease.

11.22 Any embryos, that after undergoing PGTM biopsies have

inconclusive diagnosis, are to be clearly labelled and cryopreserved in

the same dedicated storage facility as the embryos diagnosed with the

disease.

11.23 Any embryos that after undergoing PGTM result that they

are not diagnosed with the disease being tested for but might be

carriers of that disease can be transferred into the prospective parents

requiring treatment and are to be cryopreserved with the embryos not

diagnosed with the disease.

11.24 The use of an embryo known to have a gene of a serious

disease as described above, should be subject to consideration of the

welfare of any resulting child and should have approval from the

Authority. Prior to use, the prospective parents must give their consent,

after receiving adequate information for same use.

11.25 Embryos known to have a gene of serious disease as

described above, will only be placed for adoption once an effective

treatment for same disease has been found.

11.26 If a Tissue Establishment decides that it is appropriate to

provide treatment services to a woman using an embryo known to have

a gene of a serious disease as described above, it should document the

reason for the use of that embryo and inform the Authority without due

delay.

11.27 The Tissue Establishment should have an adequate

labelling system, written or barcoded (electronic), with two unique

patient identifiers plus the embryo/cell(s) number is used to match the

sample’s diagnostic result with the embryo from which that sample

was taken. This should ensure traceability throughout the IVF and

PGTM process until reporting of the final results.

11.28 The labelling system should be comprehensible and

practical for both the IVF and PGTM centres. Printed sticker labelling

may be superior to pens, as labelling should be legible and uneditable.

11.29 Labelling and sample identification should be confirmed

for critical and high-risk steps by an independent observer and signed.

11.30 After biopsy, the sample may be analysed in house or sent

for genetic testing in another centre.

11.31 The PGTM work-up report should contain at least the

following information

(a) administrative information including

(i)

title or name of the report;

(ii) number of the report (as used for document

control, when available);

(iii) pagination including the actual and total

number of pages (the patient identifier and report name/

number must be present on each additional page);

(iv) full date of the report;

(v)

name and address of the physician referring the

patient;

(vi) identification of the person(s) performing the

diagnosis/authorising the release of the report and their

signature;

(vii) identity of the IVF/PGTM centre with full

contact details;

(b)

patient (male and female)/sample identification

(i) full given name(s) and surname, or unique

patient identification code;

(ii)

unequivocal date of birth;

(iii) gender;

(c)

specific for the preclinical work-up report

(i)

date of DNA sample collection;

(ii)

date of DNA sample arrival in the laboratory;

(iii) samples and genetic status of relevant family

members can be mentioned only with their informed

consent and should be in accordance with general data

protection regulations (GDPR) and/or local privacy

regulations;

(d) restatement of the clinical question, i.e., the

indication(s) being requested for analysis, the type of required

testing, the referral reason, parental karyotypes/genomes;

(e)

specification of genetic tests used

(i)

brief information on the methods used in the

analysis;

(ii) full details of the extent of the tests, including

software, where appropriate;

(iii) where a commercially available kit is used, this

should be clearly identified in the report, including the

reference and version of the kit.

(f)

a clear description and interpretation of results;

(g)

a clear summary of the results;

(h) error rates/limitations of the test/misdiagnosis (a

general figure should be stated for the overall cycle/treatment).

11.32 Before starting a clinical PGTM cycle, relevant documents

should be available, labelling of samples should be checked, and

genetic counselling provided to the prospective parent/s.

11.33 The PGTM laboratory should ensure that it has clearly

documented procedures for all steps of the examination process

(explicit instructions and a summary of validation results) and release

of results (diagnosis, reporting, embryo transfer policy). These

procedures should be covered in a service-level agreement between the

PGTM and IVF centres.

11.34 The IVF Centre should ensure that the method used for

PGTM should have been previously implemented, tested, and

validated in the PGTM centre.

11.35 Clinical results are to be reviewed and signed or

electronically validated by a suitably qualified person (name,

qualification, date).

11.36 The PGTM clinical cycle report contains an interpretation

of the clinical results and guidance on which embryos are genetically

transferable. The same recommendations apply as specified for the

preclinical work-up report, together with the following items

(a)

unique cycle/treatment code;

(b)

date of oocyte retrieval;

(c)

date of biopsy;

(d)

date of biopsy sample arrival in the laboratory;

(e) information on the sample type (including number of

samples and controls);

(f) unique ID number for each cycle and/or biopsy

sample tested;

(g)

indication for PGTM.

11.37 When scoring results from polar body (PB) testing, it is

recommended to report what was detected in each PB and then infer

the oocyte diagnosis. It is recommended to test both PBs.

11.38 When scoring results from blastomere/trophectoderm (TE)

testing, it is recommended to report what was detected in the sample

and then infer the embryo diagnosis.

11.39 A written or electronic report should be securely

transmitted to the IVF centre to ensure transfer and/or

cryopreservation of the correct embryos. Results should not be

communicated orally.

11.40 Reporting time should be kept as short as possible and

when fresh transfer is intended, reporting time should be adapted to

allow the IVF centre to organise the embryo transfer.

11.41 The report should be clear, concise, accurate and easily

understandable by non-geneticists and that the overall result and

interpretation (including transfer recommendation) are presented per

embryo.

11.42 In case of no diagnosis and re-biopsy to try and obtain a

result, this should be included in the report.

11.43 The final clinical cycle report must be signed by

appropriately qualified (authorised) personnel (name, qualification,

date), and the clinical cycle results are discussed with the couple

before embryo transfer.

11.44 The report is stored in the patient file in both the PGTM

and the IVF centre, according to local regulations and a copy of which

is sent to the Regulatory Authority EPA together with cryopreservation

details of the embryos that can be transferred as well as the

cryopreservation details of the embryos diagnosed with the disease.

11.45 Tissue establishments should compare PGTM live birth

rates and matched non-PGTM [routine IVF or intracytoplasmic sperm

injection (ICSI)] live birth rates within that IVF centre.

11.46 When in-house genetic analysis is not feasible, transport

PGTM is an option. In transport PGTM, patients have the IVF

treatment (oocyte retrieval, embryo culture, biopsy and transfer,

pregnancy follow-up) at their local IVF centre, but genetic testing is

performed at a collaborating PGTM centre with significant experience

in PGTM.

11.47 The IVF centre and PGTM centre should have in place an

official agreement (Service-Level Agreement) dealing with legal,

insurance and accountability issues about the transport PGTM

procedures.

11.48 Transportation companies entitled to transport biopsied

material should certify their suitability to transport the biopsied

material, provide the likelihood of a sample loss or sample delivery

delay and provide actions taken against these risks.

11.49 The IVF centre and outsourced PGTM centre should make

arrangements to ensure that patients have had adequate PGTM

counselling.

11.50 The IVF centre and PGTM centre should have in place a

set of clinical/laboratory validated protocols, including tubing/

spreading protocols, and shipment protocols specifying approximate

transportation time and ensuring cell and/or DNA integrity.

11.51 In addition, practical and logistic arrangements on who

will be responsible for the various stages of the PGTM treatment

should be clearly established.

11.52 The IVF centre and PGTM centre should delineate clear

and sufficient lines of communication as documented in written

procedures and compliant with the GDPR during all stages of a

transport PGTM treatment.

11.53 The IVF/PGTM centres should agree on the feasibility, the

number, and the timing of transport PGTM cycles and define a

schedule.

11.54 All diagnostic results and reports are sent in written form

(complying with the GDPR).

11.55 PGTM centres should be accredited and certified, as PGTM

is of a multidisciplinary nature, the various units involved should each

be accredited/certified for their defined tasks and according to the

most appropriate quality standards. For each unit, responsibilities

should be clearly outlined/described and transition of responsibility

from one unit to the other during the PGTM process should be well

defined and guaranteed.

12. Donor Recruitment, Assessment and Screening

12.1 As per the Embryo Protection (Amendment) Act, 2018

Article 9(1) "The donation of germ line cells for the purpose of

medically assisted procreation shall be a confidential agreement

between donor and the licensee".

12.2 The donation of germ line cells for the purpose of

medically assisted procreation shall be limited to one donation only

and such donation shall be used in one prospective parent only.

12.3 The Embryo Protection Authority shall keep the records of

the identity of the donor for a period of sixty-five years.

Age of Prospective Donors.

12.4 All prospective donors both male and female must be over

eighteen years but has not attained the age of thirty-six years on date of

donation.

General Enquiries to be made

12.5 The recruiting tissue establishment should take reasonable

steps to verify the identity of the prospective donors by asking for

appropriate identification (identification card or passport). Failure to

obtain satisfactory evidence the tissue establishment shall reject the

gametes for treatment.

12.6 Where a donor has changed their name (eg, where someone

has changed their name by deed, has married and taken their partner’s

surname, or has obtained a gender recognition certificate) or has

changed their physical appearance (eg, where someone has undergone

gender reassignment or is living in the gender they most closely

identify with but which is different from their gender at birth) since

their previous consultation, examination or donation, tissue

establishments should take all reasonable steps to verify the donor’s

identity. This is to ascertain that a donor presenting for donation is the

same person the tissue establishment previously engaged with or

treated.

Tissue establishments should verify a donor’s identity by asking

for evidence of their previous name (eg, a passport or photocard

driving licence) and verifying details against the donor’s medical

records. This can be a sensitive issue for donors and tissue

establishments should take care to address identity issues with

consideration. As evidence of their new name, tissue establishments

should ask donors to provide one of the following

(a)

a marriage certificate, or

(b)

evidence of a change in name (such as via deed)

Tissue establishments must ensure that a donor’s records are

updated to accurately reflect their new identity.

12.7 When obtaining gametes or embryos for treatment of others

(whether directly from donor, from another licensed tissue

establishment or from a foreign supplier), the tissue establishment

should take appropriate steps to discover whether gametes from that

donor have been obtained for use in licenced treatment before and, if

so

(a) establish which tissue establishment is the primary

tissue establishment for that donor

(b) notify that tissue establishment that is proposes to use

that donor’s gametes

(c)

seek authorisation to do so, if appropriate, and

(d) ensure that the limit in Malta of one family per donor

is not exceeded

Family and other Relevant History

12.8 Before a prospective donor provides gametes, the

recruiting tissue establishment should take their medical family

histories (when available). The tissue establishment should encourage

prospective donors to provide as much other non-identifying

biographical information as possible, so that is may be available to

prospective recipients, parents and resulting children. If a prospective

donor cannot give a full and accurate family history, the tissue

establishment should record this fact and take it into account in

deciding whether or not to accept their gametes or embryos for

treatment.

12.9 The tissue establishment should seek the prospective

donor’s consent to approach their GP for further factual information if

it suspects the donor might be unsuitable. The tissue establishment

should always seek further information if

(a) information provided by the patients suggests there

are risk factors that might affect anyone treated using their

gametes or a child born as a result.

(b) the prospective donor has failed to provide any

information requested

(c) the information provided by the prospective donor is

inconsistent, or

(d)

there is evidence of deception.

12.10 If the prospective donor refuses to give such consent, the

tissue establishment should take this into consideration when deciding

whether to accept that donor. Such refusal should not in itself be

grounds for not accepting the donor. The tissue establishment should

discuss with the prospective donor their reason for refusing.

Suitability of Donor and Selection Criteria

12.11 Donors must be selected on the basis of their age, health

and medical history, provided on a questionnaire and through a

personal interview performed by a qualified and trained healthcare

professional. This assessment must include relevant factors that may

assist in identifying and screening out persons whose donation could

present

(a) A health risk to others, such as the possibility of

transmitting diseases (such as sexually transmitted infections), or

(b) Health risks to themselves (e.g. superovulation,

sedation or the risks associated with the egg collection procedure

or

(c)

The psychological consequences of being a donor

12.12 The donors must be negative for

(a)

HIV 1 and 2: Anti-HIV-1,2

(b)

Hepatitis B: HBsAg & Anti-HB

(c)

Hepatitis C: Anti-HCV-Ab and

(d)

syphilis

on a serum or plasma sample, tested in accordance with Annex

III, of the EUTCD 2006/17/EC

12.13 Sperm donors must additionally be negative for chlamydia

on a urine sample tested by the nucleic acid amplification technique

(NAT)

12.14 HTLV-I antibody testing must be performed for donors

living in or originating from high-incidence areas or with sexual

partners originating from those areas or where the donor’s parents

originate from those areas

12.15 In certain circumstances, additional testing may be

required depending on the donor’s history and the characteristics of the

cells donated (e.g. RhD, malaria, CMV, T. cruzi).

12.16 The tests must be carried out by a qualified laboratory,

authorised as a testing tissue establishment by the competent authority,

using EC-marked testing kits where appropriate. The type of test used

must be validated for the purpose in accordance with current scientific

knowledge.

12.17 The biological tests will be carried out on the donor’s

serum or plasma; they must not be performed on other fluids or

secretions such as the aqueous or vitreous humour unless specifically

justified clinically using a validated test for such a fluid.

12.18 Tissue establishments should take a blood sample and

screen potential donors both before accepting them as donors, and

before using the donated gametes and embryos in treatment.

12.19 Sperm donations other than by partners will be

quarantined for a minimum of 180 days, after which repeat testing is

required. If the blood donation sample is additionally tested by the

nucleic acid amplification technique (NAT) for HIV, HBV and HCV,

testing of a repeat blood sample is not required. Retesting is also not

required if the processing includes an inactivation step that has been

validated for the viruses concerned.

12.20 Genetic screening for autosomal recessive genes known to

be prevalent, according to international scientific evidence, in the

donor’s ethnic background and an assessment of the risk of

transmission of inherited conditions known to be present in the family

must be carried out, after consent is obtained. Complete information

on the associated risk and on the measures undertaken for its

mitigation must be communicated and clearly explained to the

recipient.

12.21 Before accepting gametes for the treatment of others, the

recruiting tissue establishment should consider the suitability of the

prospective donor. In particular, the tissue establishment should

consider

(a)

personal or family history of inheritable disorders

(b) personal history of transmissible infection (as

outlined by the superintendence of public health (SPH).

(c) the level of potential fertility indicated by semen

analysis (when appropriate)

(d) the implications of the donation for the prospective

donor and their family, especially for any children they may have

at the time of donation or in the future, and

(e) the implications for any children born as a result of

the donation, in the short and long term.

12.22 Where a prospective recipient is happy to accept a donor

from a different ethnic background, the tissue establishment can offer

ART treatment, subject to the normal welfare of the child assessment.

12.23 Tissue establishments should not perform treatment that

involves donations by an ascendant to a descendant; descendant to an

ascendant; and siblings whether of the full or half blood.

12.24 The tissue establishment should ensure that its procedures

for recruiting donors are fair and non-discriminatory.

12.25 A prospective donor should not be accepted if the tissue

establishment concludes that a recipient or any child born as a result of

treatment using the donor’s gametes is likely to experience serious

physical, psychological or medical harm, or where the tissue

establishment cannot get enough further information to conclude there

is no significant risk.

12.26 When the tissue establishment decides that a prospective

donor is unsuitable to donate, it should record the reasons and explain

them to the prospective donor. The tissue establishment should present

the reasons for the decision sensitively and answer any questions in a

straightforward and comprehensive way.

12.27 The tissue establishment should offer counselling to all

prospective donors who are considered unsuitable for any reason.

When the tissue establishment refuses to accept a prospective gamete

donor because of physical or psychological problems that require

separate treatment or specialist counselling, the tissue establishment

should provide reasonable assistance to the individual to obtain

relevant treatment or counselling.

12.28 If information affecting the suitability of a prospective

donor becomes known after the selection process, the tissue

establishment should review the prospective donor’s suitability and

take appropriate action.

12.29 The tissue establishment should tell gamete donors that

they should inform the tissue establishment if, after the donation

(a) they discover they are affected by an unsuspected

genetic disease, or

(b) they find they are a carrier of a harmful recessively

inherited condition (eg, through the birth of an affected child).

12.30 If a tissue establishment learns that a donor has a

previously unsuspected genetic disease or is a carrier of a harmful

inherited condition, the tissue establishment should

(a)

notify the Embryo Protection Authority immediately

(b) Notify other tissue establishments who have received

gametes obtained from that donor (applicable where there is

transfer of gametes between tissue establishments)

(c) The Embryo Protection Authority is to inform

patients who have had a live birth as a result of treatment with

gametes from that donor, and offer these patients appropriate

counselling if the child has still not reached age of majority.

Inform the donor conceived child if he has reached aged of

majority

(d) Carefully consider when and how a woman who is

pregnant, as a result of treatment with gametes from that donor,

is given this information.

Information for Prospective Donors

12.31 Before any consents or samples are obtained from a

prospective donor, the recruiting tissue establishment should provide

information about

(a) What information (both non-identifying and

identifying) about the donor must be collected by the tissue

establishment and held on the Embryo Protection Authority

Register

(b) The Tissue establishment will disclose non-

identifying information about the donor, for example to

prospective recipients (prior to choosing a donor).

(c) The Embryo Protection Authority’s obligation to

disclose non-identifying, medical and identifying information to

a donor-conceived child, who applies for such information on

attaining age of majority

(d) The screening that will be done, and why it is

necessary

(e) The possibility that the screening may reveal

unsuspected conditions (eg, low sperm count, genetic anomalies

or HIV infection) and the practical implications

(f) The scope and limitations of the genetic testing that

will be done and the implications for the donor and their family

(g) The importance of informing the recruiting tissue

establishment of any medical information that may come to light

after donation that may have health implications for any woman

who receives treatment with those gametes or for any child born

as a result of such treatment

(h) The procedure used to collect gametes, including any

discomfort, pain and risk to the donor (eg, from the use of super

ovulatory drugs)

(i) The legal parenthood of any child born as a result of

their donation (There shall be no link of filiation in accordance

with the provisions of the Civil Code between the embryo

fertilised using donated germ line cells and the donor)

(j) The restriction on using gametes from an individual

donor when the prospective parent gives birth as a result of

treatment using such gametes (one donation one parent).

(k) The importance of supplying up-to-date contact

information to the tissue establishment.

(l) The importance of the identifying information being

provided to people born as a result of their donation.

(m) the procedure for donors to withdraw consent for the

use of their gametes prior to those gametes being fertilised.

12.32 Except in cases of a direct donation, the prospective

parents or prospective parent shall only be entitled to obtain such

generic information as specified in the Protocol about the donor whose

identity shall in all cases remain confidential.

12.33 The tissue establishment should inform donors that

anyone born as a result of their donation will have access to the

following non-identifying information provided by them on the Donor

Identification Form or reaching age of majority

(a)

Physical description

(i)

Height

(ii)

Weight

(iii) Skin Colour

(iv) Eye Colour

(v)

Hair Colour

(b)

Year and Country of birth

(c)

Ethnic group

(d) If the donor had any genetic children on date of

registration

(i)

Number of children

(ii)

Sex of those children

(iii) In Malta or Abroad

(e)

Other details the donor may have chosen to provide

(i)

Religion / Belief

(ii)

Current Occupation

(iii) Hobbies / Interests

(iv) Other Skills

(f)

Marital status (at the time of donation)

(g)

Ethnic group(s) of the donor’s parents

(h) If the donor was adopted or donor conceived (if they

are aware of this)

(j)

Reason for donating altruistically

(k)

Details of virology and genetic screening tests

(i)

A personal message

12.34 The medical records that may affect the health of the child

and the Identity of the donor or of the person from whom an adopted

embryo originated shall be accessible to the child conceived from the

germ line cells of such donor either upon the child reaching eighteen

years of age or, subject to the consent of the Embryo Protection

Authority, at any earlier stage in exceptional circumstances in which

the life or health of the child born from such germ line cells is at risk.

12.35 The tissue establishment should inform donors that

anyone born as a result of their donation will have access to the

following identifying information provided by them on the Donor

Identification Form or reaching age of majority

(a)

Full names (and any previous names at registration)

(b)

Date of birth

(c)

Place and Town of birth

(d)

Last known postal address

(e)

If postal address has not been updated since

registration, address at time of registration will be given

12.36 The Embryo Protection Authority shall keep the records of

the identity of the donor for a period of sixty five years.

12.37 If the Embryo Protection Authority becomes aware of

serious illness it shall be obliged to disclose the information to the

parent or parents and, in the case that the child has attained majority, to

the child.

12.38 The Responsible Person must obtain and retain (for three

years) written evidence that the sending (exporting) Tissue

Establishment is accredited, designated, authorised or licensed in

accordance with the requirements of the European Tissues and Cells

Directive (EUTCD). A copy of the information retained must be

provided to the Embryo Protection Authority.

Provision of Counselling to those Considering Donation

12.39 If the possibility of donating gametes or embryos for the

treatment of others, arises during the course of treatment, the tissue

establishment should allow potential donors enough time to consider

the implications and to receive counselling before giving consent.

12.40 Where someone intends to donate gametes or embryos for

the treatment of others, the tissue establishment should ensure it

obtains written consent to do so from that person.

12.41 The tissue establishment is not required to obtain the

consent of the donor’s partner or spouse. However, if the donor is

married, in a civil partnership or in a long-term relationship, the tissue

establishment should encourage them to seek their partner’s support

for the donation of their gametes.

Requirements for the Procurement of Gametes

12.42 Procurement of gametes shall be carried out by persons

who have successfully completed a training programme specified by a

clinical team specialising in the tissues and cells to be procured or a

tissue establishment authorised for procurement.

12.43 The tissue establishment shall have written agreements

with the staff or clinical teams responsible for donor selection, unless

they are employed by the establishment, specifying the procedures to

be followed to assure compliance with the selection criteria for donors.

12.44 The tissue establishment shall have written agreements

with the staff or clinical teams responsible for gamete procurement,

unless they are employed by the same establishment, specifying the

type(s) of gametes to be procured and the protocols to be followed

12.45 There shall be standard operating procedures (SOPs) for

the verification of

(a)

donor identity;

(b) the details of donor or donor family consent or

authorisation;

(c)

the assessment of the selection criteria for donors

(d)

the assessment of the laboratory tests required for

donors

12.46 There shall also be SOPs describing the procedures for

procurement, packaging, labelling and transportation of the gametes to

the point of arrival at the tissue establishment.

12.47 Procurement shall take place in appropriate facilities,

following procedures that minimise bacterial or other contamination of

procured tissues and cells, in accordance with EUTCD.

12.48 Procurement of materials and equipment shall be managed

in accordance with the standards and specifications laid down in

relevant national and international regulation, standards and guidelines

covering the sterilisation of medicines and medical devices. Qualified,

sterile instruments and procurement devices shall be used for gamete

procurement.

12.49 Procurement of gametes from donors shall take place in an

environment that ensures their health, safety and privacy.

12.50 The procedures for the procurement of tissues and cells

shall be carried out in accordance with the requirements of the

EUTCD.

12.51 A unique identifying code shall be allocated to the donor

and the donated tissues and cells, during procurement or at the tissue

establishment, to ensure proper identification of the donor and the

traceability of all donated material. The coded data shall be entered in

a register maintained for the purpose.

12.52 The Embryo Protection Authority shall ensure that all

tissue establishments, including importing tissue establishments (as

defined in Directive 2015/565/EU, as amended) –

(a) allocate a Single European Code (SEC) as required

by the EU Commission Directive 2004/23/EC on standards of

quality and safety for donation, procurement, testing, processing,

preservation and distribution of all human tissue and cells

intended for human application. The directive also sets out that

to facilitate traceability it is necessary to establish a unique

identifier applied to tissues and cells (including reproductive

cells) distributed in the EU (by way of a SEC) providing

information on the main characteristics and properties of those

tissues and cells.

(b) The SEC is applied to the movement of gametes and

embryos between licensed clinics (or tissue establishments)

within and outside of Malta. Movement of ‘partner’ embryos and

gametes are exempt from the requirements if distributed between

tissue establishments in Malta. This code is to be applied at the

latest before distribution / export for human application

(c)

allocate a donation identification sequence after

procuring the tissues and cells, or when receiving them from a

procurement organisation, or when importing tissues and cells

from a third country supplier. The donation identification

sequence shall include

(i) their EU tissue establishment code as assigned

in the EU Tissue Establishment Compendium;

(ii) a unique donation number allocated by the

tissue establishment, unless such number is allocated

centrally at national level or is a globally unique number as

used by the ISBT128 coding system. Where allowed, in

case of pooling of tissues and cells, a new donation

identification number shall be allocated to the final

product;

(d) do not alter the donation identification sequence once

it is allocated to tissues and cells released for circulation, unless

it is necessary to correct an encoding error; any correction

requires proper documentation;

(e) use one of the permitted product coding systems and

the corresponding tissue and cell product numbers included in

the EU Tissue and Cell Product Compendium at the latest before

their distribution for human application;

(f) use an appropriate split number and expiry date. For

tissues and cells for which no expiry date is defined, the expiry

date shall be 00000000 at the latest before their distribution for

human application;

(g) apply the Single European Code on the label of the

product concerned in an indelible and permanent manner and

mention that code in the relevant accompanying documentation

at the latest before its distribution for human application. The

tissue establishment may entrust this task to a third party or third

parties, provided the tissue establishment ensures compliance

with Directive 2015/565/EU, as amended, in particular in terms

of uniqueness of the code. Where the label size precludes the

application of the Single European Code on the label, the code

shall be unambiguously linked to tissues and cells packaged with

such a label through the accompanying documentation;

(h)

notify the competent authority when

(i) information contained in the EU Tissue

Establishment Compendium requires an update or

correction;

(ii) the EU Tissue and Cell Product Compendium

requires an update;

(iii) the tissue establishment observes a situation of

significant noncompliance with the requirements relating to

the Single European Code concerning tissues and cells

received from other EU tissue establishments;

(i) take the necessary measures in case of incorrect

application of the Single European Code on the label



12.53 The Embryo Protection Authority will check compliance at

inspections, by sampling donor gamete and embryo movements into

and out of the clinic to ensure the SEC has been applied appropriately.

12.54 Tissue establishments identifying an error or change in

relation to its details held on the EU Tissue establishment compendium

must notify the EPA inspector as soon as practicable.

12.55 Clinics receiving gametes or embryos from a licensed

clinic or tissue establishment without a SEC must note this is a serious

adverse incident and report it to the EPA using the current incident

reporting channel.

Payments or other Benefits for Donors

12.56 No person shall pay consideration to a donor or to any

other person to arrange for the services of a donor or offer to pay such

consideration.

12.57 Oocytes donors may be compensated for the costs and

expenses of the Stimulation treatments.

12.58 Oocytes donors will be entitled as prospective parents to

avail themselves of the Leave for Medically Assisted Procreation as

per National Legislation (SL 452.114).

12.59 The tissue establishment should ensure that donors

understand that donating gametes and embryos is voluntary and unpaid

and that oocytes donors may be compensated as per paragraph 12.57

above.

12.60 Tissue establishments should keep a central log of all

expenses paid to oocytes donors. This log should be made available to

EPA inspectors, and should contain the following information

(a)

date of payment

(b)

amount of payment

(c)

donor (name or unique identifier)

(d) reason for payment (nature of expense: visit to clinic

for oocytes tracking and / or medications for stimulation)

(e)

total amount paid to the oocytes donor to date for the

cycle

(f)

receipts that show all expenses incurred.

13. Screening and Storage of Samples to Prevent Cross-

Contamination

13.1 The tissue establishment should ensure that no gametes or

embryos are placed in storage unless the people who provided the

gametes have been screened in accordance with current professional

guidelines.

13.2 Prior to the processing of patient gametes or embryos,

intended for use in treatment or storage, the tissue establishment must

(a) carry out the following biological tests to assess the

risk of cross contamination (for donors biological tests refer to

Chapter 12)

(i)

HIV 1 and 2: Anti-HIV – 1, 2

(ii)

Hepatitis B: HBsAg/Anti-HBc

(iii) Hepatitis C: Anti-HCV-Ab

(b)

devise a system of storage which clearly separates

(i)

quarantined/unscreened gametes and embryos,

(ii) gametes and embryos which have tested

negative, and

(iii) gametes and embryos which have tested

positive.

13.3 Tissue establishments should

(a) assess the risks of cross-contamination during the

quarantine period

(b)

put procedures in place to minimise these risks, and

(c) document the rationale for the chosen quarantine

procedures.

14. Procuring, Processing and Transporting of Gametes and

Embryos

14.1 In respect of gametes and embryos preparation processes,

these shall require compliance with the Commission Directive 2004/

23/EC of the European Parliament and of the Council of 31 st March,

2004 on setting standards of quality and safety for the donation,

procurement, testing, processing, preservation, storage and distribution

of human tissues and cells.

14.2 These shall also require compliance with the requirements

laid down in the provisions of the third Directive. Directive 2006/86/

EC (the third Directive) implements Directive 2004/23/EC as regards

traceability requirements, notification of serious adverse reactions and

events and certain technical requirements for the coding, processing,

preservation, storage and distribution of human tissues and cells.

Relevant Provisions of the Third Directive

(a) Reception of gametes and embryos at the tissue

establishment Annex II, Part A

(b) Processing of gametes and embryos (validation,

documentation and evaluation of critical procedures) Annex II,

Part B

(c) Storage and release of gametes and embryos (criteria

to be complied with, including standard operating procedures

Annex II, Part C

(d) Distribution and recall of gametes and embryos

(criteria to be complied with, including procedures to be

adopted) Annex II, Part D

(e) Final labelling of gametes and embryo containers for

distribution (information to be shown on container label or in

accompanying documentation) Annex II, Part E

(f) External labelling of the shipping container

(information to be shown on label on shipping container) Annex

II, Part F

14.3 There must be a documented system in place that ensures

the identification of all gametes and embryos from procurement to use.

14.4 There must be a documented system in place for ratifying

that gametes and/or embryos meet appropriate specifications of safety

and quality for use and for their transportation/distribution.

14.5 The tissue establishment should, where appropriate, have

documented procedures that cover

(a)

superovulation regimes

(b)

egg retrieval

(c)

sedation

(d)

resuscitation

(e)

sperm aspiration

(f)

gamete and embryo transfer

(g)

insemination

(h) follow-up after treatment, including management of

complications, and establishing if any patients have experienced

OHSS, and

(i) prevention and management of ovarian hyper-

stimulation

syndrome

including

maintaining

clinical

relationships with local hospitals who may treat the licensed

tissue establishments patients for OHSS and seeking to put in

place agreements around related appropriate information and

data sharing.

14.6 In addition to meeting the requirements in licence

conditions, the tissue establishment should, at the time of procurement,

label each package containing gametes and embryos in a way that is

not susceptible to unauthorised or undetectable alteration. If the size of

the packaging permits, the identity of the patient, patient’s partner or

donor should also be noted.

14.7 The tissue establishment should not obtain gametes for

treatment from anyone under the age of 18 unless

(a) those gametes are intended for the patient’s own

treatment in oncology cases and transgender persons

(b) the tissue establishment can satisfy itself that the

patient is capable of giving effective consent to the use of the

gametes for that purpose, and

(c) the patient has given effective consent to the use of

their gametes for that purpose.

14.8 A tissue establishment should store or use only sperm that

has been obtained directly from the provider, another licensed clinic or

a centre with which the licensed centre has a transport arrangement, or

that has been imported in line with EPA approvals.

14.9 The tissue establishment should ensure that if sperm is

produced at another part of the hospital / treatment centre and not

within the tissue establishment itself, it should follow protocols to

ensure, that

(a)

the identity of the sperm provider is confirmed

(b)

the sperm provider confirms he produced the sperm

(c) the date and time of the sperm production is

confirmed, (and is no more than two hours before the tissue

establishment received the sperm)

(d)

the sperm has not been interfered with, and

(e) the sperm receptacle is clearly labelled with the

sperm provider’s full name and unique identifier.

The tissue establishment’s documented procedures should ensure

that this information is recorded in the patient’s medical records.

Reception at the Tissue Establishment of Prospective Parents

own Gametes / Embryos previously stored at another Tissue

Establishment

14.10 The tissue establishment must put in place, maintain and

implement a procedure for the receipt of gametes and/or embryos from

another tissue establishment or third-party premises to ensure that

(a) the consignment of gametes and/or embryos is

verified against Standard Operating Procedures (SOPs) and

specifications. These must include information relating to the

transport

conditions,

packaging,

labelling,

patient

documentation, and any other associated documentation and

samples. These must also include the technical requirements and

other criteria considered by the establishment to be essential for

the maintenance of acceptable quality, and

(b) the gametes and embryos received are quarantined

until they, along with associated documentation, have been

inspected or otherwise verified as conforming to requirements.

The review of relevant patient/donor and procurement

information and thus acceptance of the donation needs to be

carried out by specified/authorised persons

14.11 The following data must be registered at the tissue

establishment

(a) consent including the purpose(s) for which the

gametes and/or embryos have been imported (such as storage in

Malta for use in IVF procedures already scheduled)

(b) patient identification and characteristics: age, sex and

presence of risk

(c) all required records relating to the procurement and

the taking of the patient history

(d) gametes

and

embryos

obtained

and

relevant

characteristics, and

(e)

the results of laboratory tests and of other tests.

(f) a properly documented review of the complete

patient/donor evaluation against the selection criteria by an

authorised and trained person.

14.12 In addition to the requirements in licence conditions, the

documented procedures against which each consignment of gametes

and embryos is verified should include requirements for

(a)

patient, patient’s partner, donor verification

(b)

packaging and transport

(c)

labelling of containers for procured gametes, and

(d) labelling of shipping containers and any associated

documents.

14.13 The documented procedure for the receipt of gametes or

embryos from another tissue establishment should also ensure that

records are kept to demonstrate that before gametes or embryos are

released, all appropriate specifications have been met.

14.14 The tissue establishment’s documented procedures should

ensure that the relevant legal requirements are met for registering

patients, patients’ partners and donors.

14.15 If a container used to ship packaged gametes or embryos

has not been validated by the manufacturer or supplier for specified

transport conditions, these conditions should be validated by the tissue

establishment or third party responsible for transport.

14.16 The tissue establishment’s documented procedures should

ensure that the following are recorded

(a) packaging and labelling procured gametes for

distribution

(b)

transporting gametes and embryos

(c)

labelling shipping containers, and

(d)

recalling gametes and embryos.

14.17 All gametes and embryos must be packaged and

transported in a manner that minimises the risk of cross-contamination

and preserves the required characteristics and biological functions of

the gametes or embryos. The packaging must also prevent

contamination of those responsible for packaging and transportation.

14.18 The packaged gametes/embryos must be shipped in a

container that is designed for the transport of biological materials and

that maintains the safety and quality of the gametes or embryos.

14.19 The transport conditions, including temperature and time

limit, must be specified and the labelling of every shipping container

must include as a minimum

(a) a label marked "TISSUES AND CELLS" and

"HANDLE WITH CARE"

(b) the identification of the establishment from which the

package is being transported (address and telephone number) and

a contact person in the event of problems

(c) the identification of the tissue establishment of

destination (address and telephone number) and the person to be

contacted to take delivery of the package

(d)

the date and time of the start of transportation

(e)

the type of gametes/embryos plus their identification

code

(f) specifications concerning conditions of transport

relevant to the quality and safety of the gametes or embryos

(g) specifications concerning storage conditions such as

"DO NOT FREEZE"

(h) in the case of all gametes and embryos, the following

indication: "DO NOT IRRADIATE"

(i)

when a product is known to be positive for a relevant

infectious disease marker, the following indication

"BIOLOGICAL HAZARD".

If any of the information under the points above cannot be

included on the primary container label, it must be provided on a

separate sheet accompanying the primary container. The sheet must be

packaged with the primary container in a manner that ensures that they

remain together.

14.20 The container/package must be secure and ensure that the

gametes or embryos are maintained in the specified conditions. All

containers and packages need to be validated as fit for purpose.

Quality and Safety of Gametes and Embryos

14.21 The tissue establishment should establish and use

documented procedures to ensure that

(a) procedures involving the manipulation of gametes or

embryos (e.g. sperm preparation, separation of eggs from

cumulus cells, and fertilisation of eggs) are performed in a

controlled environment with appropriate air quality

(b) the risk of bacterial or other contamination is

minimised

(c) appropriate measures are in place for handling

contaminated samples

(d) gametes or embryos are handled in a way that

protects those properties that are required for their ultimate

clinical use, and

(e) all blood products with which gametes or embryos

may come into contact, except those of the woman receiving

treatment, are pre-tested for HIV, hepatitis B and hepatitis C.

14.22 Where tissues or cells are exposed to the environment

during processing, without a subsequent microbial inactivation

process, an air quality with particle counts and microbial colony

counts equivalent to those of Grade A as defined in the current

European Guide to Good Manufacturing Practice (GMP), Annex 1 and

Directive 2003/94/EC is required with a background environment

appropriate for the processing of the tissue/cell concerned but at least

equivalent to GMP Grade D in terms of particles and microbial counts.

If the environmental air quality drops below Grade D during a

procedure involving the manipulation of gametes or embryos, those

gametes or embryos should be used in treatment only if the tissue

establishment can assure itself that this poses no extra risk to the

woman to be treated or to any resulting child.

14.23 Air quality monitoring should be used as a routine

measure of quality assurance (e.g. through particle counts or the use of

settle plates, recording any cultures observed). The process of

validating air quality should include

(a)

documenting culture conditions, and

(b) mapping temperature and using control charts to

predict the effects of any change in procedures.

14.24 Where possible, cryopreserved gametes should be

accompanied by documents that indicate their expected post-thaw

quality.

14.25 The tissue establishment should not use for treatment

gametes exposed to a material risk of contamination or damage that

may harm recipients or resulting children. If in any doubt about these

risks, the tissue establishment should seek expert advice.

15. Transfers, Imports and Exports of Gametes and

Embryos Previously Stored

15.1 Where a tissue establishment wishes to import gametes or

embryos into Malta, or export them from Malta, the responsible person

must ensure that

(i) where the gametes are exported or imported for the

use of a patient and that the gametes are of the patient, any of the

prospective parent or parents or donor, that the patient or donor

is registered with the EPA, and the relevant registration forms are

completed.

15.2 Any tissue establishment which is to import germline cells

or embryos shall comply with the EU directive 2004/23/EC of the

European parliament and of the council, Maltese Legislation

subsidiary legislation 483.08 "Equivalent Standards of quality and

safety of imported tissues and cells regulations" and Embryo

Protection (Amendment) Act, 2018.

Information for Patients

15.3 Before a patient considers obtaining his / her gametes or

embryos from outside Malta, the tissue establishment should inform

them that special criteria relating to Malta standards must be met and

that they are to comply with the importing of embryos as per the

Embryo Protection (Amendment) Act, 2018.

Imports and Exports Decisions

15.4 The decision listed hereunder summarises what tissue

establishments must consider when transferring gametes and embryos

(a)

within Europe

(b)

outside Europe.

15.5 Where a tissue establishment wants to export or import

gametes or embryos to or from another European state, the responsible

person must obtain and retain (for three years) written evidence that

the receiving or sending tissue establishment is accredited, designated,

authorised or licensed in accordance with the requirements of the

European Tissues and Cells Directive (EUTCD).

15.6 If all the above conditions are met then the Malta tissue

establishment can complete the import or export and must then notify

the Embryo Protection Authority by completing the Embryo or

Gamete movement forms as applicable.

15.7 For transfers to or from tissue establishments within

Europe, this evidence may include documented certification from the

competent authority that the tissue establishment complies with the

requirements of the EUTCD, is included in a national database of

registered tissue establishments, or both.

15.8 A copy of the information retained must be provided to the

Authority.

15.9 All other requirements on import and export of gametes

and embryos relating to identification, consent, parenthood, use of the

gametes and embryos, and screening must be met.

15.10 Where a tissue establishment wants to export or import

gametes or embryos to or from a country outside Europe (third

Country), the responsible person must obtain and retain (for three

years) written evidence that

(a) the receiving or sending tissue establishment is

accredited, designated, authorised or licensed under the laws or

other measures of the country in which it is situated in relation to

quality and safety

(b) the tissue establishment has appropriate quality

management and traceability systems, and

(c) the gametes or embryos have been procured and

processed in appropriate facilities and following procedures that

minimise bacterial or other contamination.

15.11 If all the above conditions are met, then the Malta tissue

establishment can complete the import / export and must then notify

the Embryo Protection Authority by completing the Embryo or

Gamete movement form as applicable.

15.12 A copy of the information retained must be provided to the

Authority.

15.13 All other requirements on import and export of gametes

and embryos relating to identification, consent, parenthood, use of the

gametes and embryos, and screening must be met.

15.14 As per Article 7(5) of the Embryo Protection

(Amendment) Act, 2018. A prospective parent or prospective parents,

who have cryopreserved embryos in Tissue Establishments abroad

may apply to be granted an authorisation by the Embryo Protection

Authority to bring two cryopreserved embryos to be transferred locally

into the prospective parent/s for each cycle

15.15 The Embryo Protection Authority shall not authorise the

transfer of more than two embryos for each cycle

16. Storage of Gametes and Embryos

16.1 Cryopreservation and storage of gametes will be allowed

for

(a)

Supernumerary gametes resulting from IVF cycles

(b)

Oncology Cases

(c)

Fertility Preservation

(d)

Transgender persons prior to starting hormone

therapy.

16.2 Oocytes may be cryopreserved in authorized tissue

establishments up to the maximum permissible age for the fertilization

and transfer thereof into the prospective parent unless they are donated

in terms of the Act.

16.3 It shall not be lawful to extract and commence

cryopreservation of oocytes after the death of the person from whom

they originate.

16.4 Sperm cells may be cryopreserved in authorized tissue

establishments during the lifetime of the person from whom they

originate.

16.5 Embryos which cannot be transferred into the prospective

parent within a treatment cycle shall be cryopreserved in licensed

tissue establishments for future use by that prospective parent/s.

16.6 Cryopreservation of embryos shall be regulated by an

agreement between the prospective parent/s and the licensee subject to

the prior authorisation of the Embryo Protection Authority and shall

have a maximum term of validity of five years renewable up to the

maximum permissible age for the transfer thereof into the prospective

parent.

16.7 The consent of the prospective parent or parents is to be

expressed in writing specifying whether they consent to

cryopreservation of any supernumerary embryos and whether they

consent to the donation of embryos, to and in the presence of the

medical practitioner in charge of the procedure.

16.8 Where the prospective parents are married or in a stable

relationship, their consent shall be expressed jointly in writing in the

prescribed Embryo Protection Authority form, for Embryo Storage and

Embryo donation.

16.9 When the prospective parent/s give their consent to

cryopreservation of any supernumerary embryos and for the donation

of embryos if necessary, the medical practitioner in charge of the

procedure shall implant up to a maximum of two embryos.

16.10 When the prospective parent/s do not give their consent to

the cryopreservation of any supernumerary embryos and to the

donation of embryos if necessary, the medical practitioner in charge of

the procedure shall only fertilize up to a maximum of two eggs.

16.11 Consent to cryopreservation may only be withdrawn in

writing by the prospective parent or prospective parents jointly before

fertilisation.

16.12 The tissue establishment should establish documented

procedures to ensure that all storage and handling of gametes and

embryos comply with licence conditions, regulations, and relevant

patient and donor consent.

16.13 The tissue establishment should ensure that the storage

facilities for gametes and embryos

(a) are dedicated for the purpose, and adequate for the

volume and types of activities

(b) are designed to avoid proximity to ionising radiation

(radioactive material), any known potential source of infection,

or chemical or atmospheric contamination, and

(c)

have a storage-location system that minimises the

amount of handling required to retrieve gametes and embryos.

16.14 The tissue establishment should also have emergency

procedures to deal with damage to storage vessels, failure of storage

conditions or both. These should also include a third-party agreement

to transfer to another tissue establishment if the need arises.

16.15 The tissue establishment’s documented procedures should

also ensure that

(a) gametes and embryos are stored under controlled

conditions that are validated and monitored

(b) gametes and embryos are packaged for storage in a

way that

(i)

prevents any adverse effects on the material

(ii)

minimises the risk of contamination

(c) records are kept indicating every occasion when

gametes and embryos are handled during storage and release,

and by whom

(d) records are kept indicating that gametes and embryos

meet requirements for safety and quality before release, and

(e) risk assessments (approved by the responsible

person) are done to determine the fate of all stored material

whenever any of the following is introduced

(i)

a new donor selection criterion

(ii) a new criterion for testing donors, patients’

partners or patients

(iii) a new processing step to enhance safety, quality

or both

(iv) a new procedure for appropriate disposal of

gametes and embryos.

Safety of Equipment Used to Store Cryopreserved Gametes

and Embryos

16.16 Tissue establishments should store gametes and embryos

in a designated area. Access to this area should be limited to staff

authorised under the terms of the tissue establishment’s licence.

Cryopreservation dewars should be fitted with local alarms and be

linked to an auto-dial or similar facility (e.g. a link to a fire alarm

board) to alert staff to non-conformities outside normal working hours.

16.17 The tissue establishment should have adequate staff and

funding for an "on-call" system for responding to alarms out of hours,

and adequate spare storage capacity to enable transfer of samples if a

dewar fails.

16.18 A tissue establishment storing gametes and/or embryos for

oncology patients and / or patients whose future fertility may be

impaired by a medical condition or procedure should divide individual

patients’ samples into separate storage vessels, in case of dewar

failure.

Information for those Seeking Storage of Gametes or

Embryos

16.19 If the treatment involves the creation of embryos in vitro,

the tissue establishment should give people seeking treatment

information about the availability of facilities for freezing embryos,

and about the implications of storing and then using stored embryos.

16.20 When a tissue establishment enters into a contractual

agreement with a patient regarding the practicalities of storage (eg, an

agreement to pay storage fees or store whilst funding is available) the

patient should be given enough information to understand the terms

and conditions of the agreement and the steps the tissue establishment

will take if these terms and conditions are broken.

16.21 This agreement should be separate from the consent

provided by the patient. Depending on the terms of the agreement, the

tissue establishment should provide information about the

circumstances in which the patient’s gametes or embryos could be

removed from storage before their consent expires. For example, that

the tissue establishment may only continue to store the patient’s

gametes or embryos for the period specified in their consent if the

patient, or their funding provider, continues to pay the storage fees.

16.22 If there is an intention to store gametes or embryos, or

where this possibility arises during treatment, in addition to relevant

information about treatment and donation, the tissue establishment

should give those providing the gametes or embryos relevant

information about

(a) the possible deterioration or loss of viability of

gametes or embryos as a result of storage, and the potential risk

of cross-contamination between samples

(b) statutory storage periods for gametes and embryos

which permit patients to store. In the case of embryos, patients

should also be given relevant information about the requirement

for both gamete providers to consent to any extension of storage

(c) the likelihood of a live birth resulting from previously

cryopreserved embryos or gametes, and

(d) screening tests to be done, the cost of these, the

reason for them and the implications of the tests for the gamete

providers.

16.23 Oncology patients and other patients requiring long-term

storage should be given specific information tailored to their needs and

circumstances. Where relevant, this should include information

appropriate for children and young people.

16.24 The tissue establishment should ensure that, before

someone consents to gametes or embryos being stored, they are told

(a) the options available if a person providing gametes or

resulting embryos dies or becomes mentally incapacitated

(b) that it is unlawful to store embryos and gametes

beyond the period of consent, the tissue establishment having a

legal obligation to dispose of gametes once consent has expired.

In case of embryos the Embryo Protection Authority will

authorise embryo adoption.

Treatment using Cryopreserved Eggs

16.25 The tissue establishment should ensure that the following

sets of eggs or embryos are only transferred during the same treatment

cycle in exceptional circumstances, with an upper limit of 2% of all

cases

(a)

fresh eggs and eggs that have been cryopreserved, or

(b) The circumstances justifying such a transfer should

be specified in the patient’s notes.

Storage Review

16.26 The tissue establishment should establish documented

procedures to ensure that

(a) reviews of stored gametes are done at least once

every two years to

(i) reconcile the tissue establishment’s records

with material in storage

(ii)

review the purpose and duration of storage, and

(iii) identify any action needed.

16.27 The tissue establishment should operate a bring-forward

system in order to ensure sufficient advance notice of the end of the

statutory storage period (or such shorter period as specified by a

person who provided the gametes) for gametes in storage.

End of Storage

16.28 The tissue establishment should make efforts to stay in

contact with patients who have gametes or embryos in storage for their

own treatment, and with any woman to be treated with stored gametes

or embryos (where she is not a gamete provider.) The tissue

establishment should also explain to gamete providers and current

patients the importance of informing the tissue establishment of any

change in their contact details

16.29 The tissue establishment should establish and use

documented procedures to contact patients who have gametes or

embryos in storage for their own treatment when the end of the

permitted storage period is approaching but long enough in advance to

allow the centre and patient to take any steps necessary.

16.30 The tissue establishment should use all contact details

available to them, including at least one written form of contact.

Patients should be provided with information about the options

available to them as the end of their permitted storage period

approaches. They should be given enough notice to enable them to

consider those options and to access appropriate advice.

17. Embryo Adoption

17.1 The Embryo Protection Authority may give for adoption

the embryos to a third party who qualifies for medically assisted

procreation procedures, in those cases where

(a) After the fertilization of the egg cells but before the

implantation of the embryos into the womb has taken place,

death of the woman ensues;

(b) For any other reason the implantation of the embryos

into the womb of the prospective parent cannot take place

including those cases where the prospective parent refuses said

implantation;

(c) Prospective parent has reached the maximum

permissible age for the implantation;

(d) Prospective parent/s fail to renew the contract with

the licensee where the cryopreserved embryos are being stored

for future use.

17.2 The adoption of an embryo may only take place if the

Embryo Protection Authority, on the application of a prospective

parent or prospective parents, so decides.

17.3 The Embryo Protection Authority shall inform the Social

Care Standards Authority of embryo availability.

17.4 The Embryo Protection Authority shall only issue its

authorisation if the prospective parent or prospective parents have

been declared as physically fit by a medical practitioner for the

transfer of an embryo and following a favourable recommendation

issued by the Adoption Board in accordance with the Adoption

Administration Act (Cap 495) determining the eligibility and

suitability or otherwise of the prospective parent or prospective

parents.

17.5 If the prospective parent or parents wish to give their

embryos for adoption before they have reached the permissible age of

transfer they shall do so in writing to the EPA. If the prospective

parents are married or in a stable relationship their consent shall be

done jointly.

18. Witnessing

and

assuring

Patient

and

Donor

identification

Witnessing Clinical and Laboratory Procedures

18.1 Witnessing protocols should ensure that every sample of

gametes or embryos can be identified at all stages of the laboratory and

treatment process to prevent any mismatches of gametes or embryos.

18.2 Tissue establishments are responsible for ensuring that

witnessing protocols are relevant to their local systems and condition.

18.3 Electronic systems such as barcoding and radio frequency

identification (RFID) for assisted conception are appropriate, subject

to a risk assessment as set out in paragraph 18.31 –18.43.

18.4 Witnessing protocols should be followed when any of the

following clinical or laboratory procedures takes place

(a)

Collecting eggs

(i) Cross-check identifying information that the

egg provider gives against records and laboratory data

sheets, or cross-check information entered into the

electronic system and the allocation of the barcode or RFID

tag.

(ii) Cross-check information marked on egg

collection dishes and lids against the patient’s medical

records. This step does not need to be manually witnessed

if an electronic system (barcoding or RFID) is being used.

(b)

Collecting sperm

(i) Cross-check identifying information that the

sperm provider gives against records, the laboratory data

sheet and sperm receptacle, or cross-check information

entered into the system and the allocation of the barcode or

RFID tag.

(c)

Preparing sperm

(i) Cross-check information on tubes against the

documents and information on the sperm receptacle (when

the sperm sample is transferred onto a preparation column).

This step does not need to be manually witnessed if an

electronic system (barcoding or RFID) is being used.

(d)

Mixing sperm and eggs or injecting sperm into eggs

(i) Verify identifying information on the dishes and

tubes and confirm that the sperm and eggs should be mixed

or the sperm injected into eggs.

(e)

Transferring gametes or embryos between tubes or

dishes

(i) Cross-check information marked on dishes and

tubes against the patient’s records, and the information

marked on the dishes and tubes that the gametes or

embryos are being transferred from.

(f)

Transferring embryos into a woman

(i) Cross-check identifying information that the

patient provides against the patient’s medical records or the

electronic system (or both) and the laboratory data sheet,

and confirm that these are the correct embryos to transfer.

(g) Inseminating a woman with sperm prepared in the

laboratory

(i) Cross-check identifying information that the

patient provides against the patient’s medical records, or

cross-check information entered into the electronic system

and the allocation of a barcode or RFID tag.

(ii) Verify the sperm provider’s identifying

information in their records, the electronic system and on

the sperm container, and confirm that this is the correct

sperm provider.

(h)

Placing gametes or embryos into cryopreservation

(i) Cross-check identifying information on the

storage container against the patient’s records and the

information on the tube or dish that the gametes or embryos

are being transferred from.

(ii) Cross-check where in the dewar the gametes or

embryos are placed.

(i)

Removing gametes or embryos from cryopreservation

(i) Cross-check information on the storage

container against information in the patient records to

confirm they are the correct gametes or embryos to remove.

(ii)

Cross-check information from the storage

container and the patient records or their information on the

electronic system against the thaw dish or tube (and, if

applicable, attach a barcode or RFID tag to the thaw dish or

tube).

(j)

Disposing of gametes

(i) Cross-check information on the storage

container against information in the patient records to

confirm they are the correct gametes or embryos to dispose

of. In case of embryos these will be given for donation.

(k)

Transporting gametes or embryos

(i) Cross-check information on the storage

container against information in the patient’s medical

records to check that these are the correct gametes or

embryos to transport.

(ii) Check that information on the storage container

is correct.

18.5 Each stage of the witnessing trail should check the

patient’s or donor’s and their unique identifying code. The dishes or

tubes should be labelled with the female patient’s name and unique

identifying code as soon as possible.

Keeping a Record of Witnessing

18.6 The checking of identifying samples, patients and donors,

and the witnessing of these checks, should be recorded when the

clinical and laboratory procedures take place. This means that

embryologists performing procedures that need to be witnessed cannot

work alone. This will ensure that the witnessing protocol has the

maximum potential to identify errors in the treatment process at the

time the procedures take place.

18.7 When the witnessing check of the procedure takes place, a

record should be made in the patient or donor notes stating

(a)

the procedure and witnessing check

(b) the date and time of the procedure and of the

witnessing check

(c) the signature of the person doing the procedure, and

doing the witnessing check

(d)

the signature of the witness.

A hard copy of electronic witnessing should be retained.

18.8 There should be a separate record of the name, job title and

signature of everyone who carries out or witness’s laboratory and

clinical procedures.

Witnessing Training

18.9

Tissue establishments should have an induction

programme for new staff to ensure they understand the principles of

witnessing and follow the tissue establishment’s protocols. Staff

should receive refresher training as the tissue establishment decides is

appropriate.

18.10 Staff should receive appropriate training if a new system

for witnessing is introduced.

Appropriate Person to Witness

18.11 Tissue establishments should consider who is the most

appropriate person to witness clinical and laboratory procedures. This

will usually be someone who has completed the tissue establishment’s

training programme for new staff, and refresher training (as

appropriate), to ensure they fully understand the principles of

witnessing procedures and follow the tissue establishment’s protocols.

For exceptions to this, refer to paragraphs 18.13 and 18.14.

18.12 At egg collection and embryo transfer, the appropriate

person to witness is another embryologist, clinician or nurse.

18.13 At sperm collection, tissue establishments may consider

the patient or donor to be the appropriate person to witness the

crosschecking of their identifying information against their records,

the laboratory data sheet and the sperm receptacle.

18.14 Insemination clinics performing intrauterine insemination

(IUI) with partner sperm may consider the patient to be the appropriate

person to verify the sperm provider’s details.

Interruptions and Distractions in the Clinic and Laboratory

18.15 The tissue establishment should consider the implications

of distractions in the clinic and laboratory, such as from phones and

external noise, and ensure they are minimised.

18.16 When considering the protocol its uses for witnessing

procedures, and the most appropriate person to witness checks, the

tissue establishment may wish to take into account the implications of

interruptions to the work of laboratory and clinical staff, particularly

embryologists performing critical procedures. Interrupting and

returning to a task is a common source of human error.

Patient and donor Identification

18.17 Tissue establishments should establish procedures to

ensure patients, donors, and their gametes and embryos are accurately

identified.

At the assessment stage, tissue establishments should use

appropriate evidence to verify the identity of donors and patients

seeking treatment (e.g. Identity card, passport or photocard driving

licence).

18.18 When collecting eggs or sperm, transferring embryos and

carrying out insemination, staff should ask patients and donors to give

their own identifying information (full name and date of birth), rather

than asking the patient to confirm or reject information read out to

them.

18.19 Tissue establishments should consider how patients and

donors with disabilities or whose first language is not Maltese or

English will be asked to identify themselves. If possible, tissue

establishments should provide an independent interpreter for patients

and donors whose first language is not Maltese or English.

18.20 Tissue establishments should ensure that each sample of

gametes and embryos is uniquely identified. All samples of gametes

and embryos should be labelled with at least the patient or donor’s full

name and a unique identifier. If, when using donor gametes, it is not

possible to label the dishes or tubes with the donor name

(a) the dishes or tubes should be labelled with the donor

code to uniquely identify that donor, and

(b) the dishes or tubes should be labelled with the female

patient’s name and further identifier as soon as possible.

18.21 Tissue establishments should allocate a unique identifier

to each sample of gametes or embryos to ensure it can be accurately

identified at all stages of the laboratory and treatment process. This

identifier should use the patient’s or donor’s full name and two or more

of the following identifiers

(a)

the patient’s or donor’s date of birth

(b)

Identity card number

(c)

Hospital number

(d)

a Donor code

18.22 Tissue establishments should consider the most

appropriate way to label dishes or tubes when they are likely to be seen

by the patient.

18.23 Tissue establishments should consider when to change the

labelling from showing the male partner’s identifying information to

the female patient’s identifying information. Tissue establishments

may consider it appropriate to label all dishes and tubes with both

partners’ names and identifying codes throughout.

18.24 Tissue establishments should ensure that other patients or

donors gametes or embryos are not introduced into the critical working

area until the procedure is complete. In particular, during sperm

preparation, no more than one sample should be processed in the

critical working area at any one time. However, it is acceptable for

tissue establishments to cryopreserve gametes from more than one

patient at one time, provided that procedures are in place to keep the

samples separate.

Risk Assessment

18.25 Tissue establishments should do a risk assessment before

introducing or changing witnessing protocols. Tissue establishments

should consider integrating protocols into the whole laboratory and

clinical process and risk-reduction procedures. Tissue establishments

may wish to identify and specify key points when mismatching of

gametes and embryos is most likely to occur.

18.26 Tissue establishments should be aware of the risks

associated with staff doing repetitive activities. The risk of

mismatching gametes and embryos is higher when repetitive activities

are taking place. Tissue establishments should bear this in mind when

selecting the most appropriate person to witness procedures. Similarly,

when using witnesses, tissue establishments should consider staff

workload and hours, and should ensure staff takes regular breaks.

18.27 Tissue establishments should have formal risk control

measures to minimise the risk of writing incorrect or incomplete

identifying data on patient’s medical records. There is a risk of error

when copying details from sample containers and patient’s records to

other records. The risk is particularly high when a record sheet

becomes separated from the patient’s records and is relied on during a

witnessed step.

18.28 As part of a quality review, audits of the patient’s medical

records should include checking for transcription errors (or omissions)

in patient identifiers, such as the misspelling of names and the absence

of unique identifiers on a record sheet, particularly in laboratory

records.

18.29 Tissue establishments should check their compliance with

witnessing protocols regularly, including during the audit of their

quality management system.

18.30 As part of their risk assessment for sperm preparation,

tissue establishments may consider witnessing the cross-checking of

information on tubes only at the start and end of the procedure, not at

every stage in it.

Risk Assessment: Electronic Witnessing Systems

18.31 Before introducing new electronic systems or protocols

for witnessing, tissue establishments should do a risk assessment

covering the following

(a) Tissue establishments should ensure that any system

will not harm gametes and embryos. In establishing that this is

the case, tissue establishments should consider what the supplier

or manufacturer has done to satisfy itself that the system will not

harm gametes and embryos (e.g. commissioned independent

reports or carried out irradiance readings)

(b) Tissue establishments should be aware that the

reliability and safety of different electronic systems may vary

(c) Tissue establishments should evaluate the evidence

that the supplier or manufacturer provides to support the safety

and reliability of its system (e.g. false positive and negative

matches and breakdown), plus any other relevant studies

(d) Any software should be fully tested, quality assured

and risk assessed

(e) Tissue establishments should consider what the

manufacturer has done to ensure that any labels and tags will

continue to be effective when placed in long-term cryo-storage.

18.32 Tissue establishments should be aware that although they

cannot completely eliminate the potential for human error in any

electronic witnessing system, effective risk assessment should mitigate

this.

18.33 If tissue establishments use an electronic system (barcode

or RFID) with "forcing functions" (which prevent the user omitting

key matching tasks in the process by preventing them from proceeding

with subsequent task steps), then as part of their risk assessment they

may wish to consider that manually witnessing transfer steps are not

necessary.

This exemption should not apply however to

(i)

mixing sperm and eggs,

(ii)

injecting sperm into eggs, and

(iii) placing eggs and sperm into and removing them from

cryo-preservation.

18.34 Tissue establishments should consider any potential

loopholes in the system that could allow users to circumvent key steps,

thus negating safeguards against error. Tissue establishments should

consider implementing a system that allocates a unique identifier to

each system user.

18.35 Tissue establishments should not rely solely on electronic

systems to check the identity of patients and samples.

18.36 Tissue establishments should have procedures to ensure

that all witnessing steps can still be done if the electronic system fails,

and that witnessing staff maintain their manual witnessing skills for all

critical steps.

18.37 In addition to using the electronic system of identification

(information stored on barcodes or RFID tags), tissue establishments

should continue to manually label all culture dishes, tubes, lids and

straws with the patient’s full name and unique identifier. If the

electronic identification fails (e.g. losing a barcode label or RFID tag

from a sample), tissue establishments should revert to manual

identification.

18.38 Tissue establishments should consider whether the

barcode or RFID tags are suitable for use on storage containers (i.e. are

able to withstand long periods of cryopreservation).

Risk Assessment: Barcoding

18.39 Tissue establishments considering installing a barcode

system should consider as part of their risk assessment

(a) the type and power of light used in the barcode

equipment

(b) the length of time the gametes and embryos are likely

to be exposed to it, and

(c) whether exposure to this light is likely to harm the

gametes and embryos.

18.40 Although there is substantial evidence about using

barcodes with human tissue, as far as the EPA is aware no independent

studies have yet been done on the effect of light on human gametes and

embryos. So the EPA does not have enough evidence to consider

barcoding to be risk free.

18.41 Barcoding equipment may use a range of light sources.

The EPA is aware of two types of barcoding systems marketed for use

in assisted conception: those using white-light-emitting diodes and

those using laser light.

18.42 Considering the evidence of damage to human cells from

some powers of laser light, tissue establishments must weigh up the

degree of possible risk of using laser light barcoding systems. Tissue

establishments should only consider using class 1 or 2 lasers.

18.43 Barcode equipment that uses ultraviolet or infrared light

should not be used. These sources of radiation are known to heat, and

so potentially damage human cells.

Risk Assessment: Radio Frequency Identification Systems

18.44 Tissue establishments considering installing an RFID

system should, as part of their risk assessment, consider the frequency

of the radio waves used in the RFID system and whether exposure to

them is likely to harm gametes and embryos.

Tissue establishments should be aware that detectable changes in

temperature may result in DNA damage. Tissue establishments should

do this risk assessment in the context of other risk factors in the tissue

establishment and the environment (e.g. mobile phone signals).

18.45 Although there is evidence for the use of RFID in a

medical setting, as far as the EPA is aware no independent studies have

yet been done on the effect of electromagnetic radiation on human

gametes and embryos. So, there is not yet a compelling evidence base

to enable the EPA to consider RFID systems to be risk free.

Establishing, Maintaining and Documenting the Quality

Management System

18.46 Tissue establishments should identify and evaluate risks

and the impact of work processes. Any potential failures that may

affect patient or donor safety should be taken into account. A risk

should be

(a)

adequately identified

(b)

assessed

(c)

entered into a risk register

(d)

maintained and reviewed in accordance with the

level of risk identified

(e) all decisions and actions in response to a risk should

be adequately documented

(f) written documentation should be available to support

and oversee the process.

19. Traceability

19.1 Traceability means the ability

(a) to identify and locate gametes and embryos during

any step from procurement to use

(b) identify the donor and recipient of particular gametes

or embryos

(c) to identify any person who has carried out any

activity in relation to particular gametes or embryos, and

(d) to identify and locate all relevant data relating to

products and materials coming into contact with particular

gametes or embryos and which can affect their quality or safety.

Traceability Requirements

19.2 Procedures for ensuring traceability of gametes and

embryos should be documented. Tissue establishments should ensure

(a)

they uniquely and accurately identify

(i)

the patient

(ii) the patient’s partner, donor or both, as

applicable

(iii) gametes and embryos, and

(iv) any containers used for the receipt and

distribution of gametes and embryos.

(b) quarantined, non-quarantined and rejected material is

clearly distinguishable at all processing stages

(c) they keep records of the equipment and materials

used to receive, process, store gametes and embryos and discard

gametes

(d) they keep registers of received, processed, stored,

distributed gametes or embryos. Registers should enable a tissue

establishment to investigate adequately if a problem is identified

after the gametes have been used. Registers should also enable

the tissue establishment to identify

(i)

a patient, patient’s partner or donor

(ii) processing steps applied to gametes or embryos

(or both) and, if applicable, third parties involved in

processing

(iii) individual

procurement

of

gametes

and

embryos

(iv)

the institution from which gametes and

embryos have come

(v)

distributed gametes or embryos, and

(vi) the institutions to which gametes or embryos

have been sent (for a patient’s use).

19.3 For the system of identification, tissue establishments

should use an identifying code that contains at least the following

information

(a)

for donors

(i)

their identity, and

(ii)

the tissue establishment’s identity.

(b)

for gametes and embryos

(i)

a unique code

(ii)

split number (if applicable), and

(iii) end of statutory storage period.

19.4 The tissue establishment’s traceability procedures should

cover any materials or equipment that could affect the quality or safety

of gametes and embryos, for example

(a)

culture media

(b) serial numbers or batch numbers of equipment and

materials coming into contact with gametes and embryos, and

(c) records of the monitoring and maintenance of the

required conditions in incubators and storage tanks.

19.5 For gametes that have been stored at the tissue

establishment (e.g. for oncology or fertility preservation patients) and

then supplied to another tissue establishment (e.g. to be stored or used

in treatment), the tissue establishment will not be expected to hold

traceability data for subsequent processes involving those gametes

outside the tissue establishment. However, the storing tissue

establishment ’s record keeping procedures should show a link to the

tissue establishment to which the gametes are supplied, so that the

complete process from procurement to use or disposal can be traced if

needed.

20. Donor Assisted Conception

Information for People Seeking Treatment with Donated

Gametes and Embryos

20.1 The tissue establishment should give people seeking

treatment with donated gametes or embryos

(a) non-identifying information about donors whose

gametes are available to them, including the goodwill message

(b) information about genetic inheritance and, in

particular, the likelihood of inheriting physical characteristics

from the donor, and

(c) information about the age of the donor and the

associated risk of miscarriage and chromosomal abnormalities.

20.2 The tissue establishment should provide information to

people seeking treatment with donated gametes or embryos about legal

parenthood, and the collection and provision of information,

specifically

(a) there shall be no link of filiation between the child

born from donated germ line cells or adopted embryos and the

persons from whom donated germ line cells or adopted embryos

originated

(b)

information that tissue establishments must collect

and register with the Embryo Protection Authority about the

donors

(c) what information may be disclosed to people born as

a result of donation and in what circumstances, and

(d) a donor-conceived person’s right to access non-

identifying (generic) information and identifying information

about the donor from the age of 18.

20.3 The tissue establishment should give people seeking

treatment with donated gametes or embryos information about genetic

and other screening of people providing gametes. This information

should include details about

(a)

the sensitivity and suitability of the tests, and

(b) the possibility that a screened provider of gametes

may be a carrier of a genetic disease or infection

(c) in the case of fresh egg donation, the screening

requirement of the donor and the risk of infection for the

recipient

20.4 The tissue establishment should provide information that

explains the limitations of testing procedures and the risks of treatment

to anyone seeking treatment with donated gametes or embryos. The

tissue establishment should make available appropriate counselling.

20.5 If a woman is to receive donor insemination treatment,

then, before treatment commences, the tissue establishment should

discuss with her the number of treatment cycles to be attempted if she

does not conceive initially. The tissue establishment and the woman

should together review this situation regularly.

20.6 Women should be informed that the simultaneous

implantation of embryos originating from different persons in a

prospective parent during the same cycle is prohibited.

The importance of informing children of their donor origins

20.7 The tissue establishment should tell people who seek

treatment with donated gametes or embryos that it is best for any

resulting child to be told about their origin early in childhood. There is

evidence that finding out suddenly, later in life, about donor origins

can be emotionally damaging to children and to family relations.

20.8 The tissue establishment should encourage and prepare

patients to be open with their children from an early age about how

they were conceived. The tissue establishment should give patients

information about how counselling may allow them to explore the

implications of treatment, in particular how information may be shared

with any resultant children.

Implications of Donor Conception and the Provision of

Counselling

20.9 If it is possible that the question of treatment with donated

gametes or embryos may arise, the tissue establishment should raise

this with the person or couple seeking treatment before their treatment

starts. The tissue establishment should allow people enough time to

consider the implications of using donated gametes or embryos, and to

receive counselling before giving consent.

Access to Information for Donor-Conceived People and

Parents

20.10 The tissue establishment should inform people seeking

treatment with donated gametes or embryos that any resulting children

will have access to the following non-identifying information about

the donor from the age of 18

(a)

Physical description

(i)

Height

(ii)

Weight

(iii) Skin Colour

(iv) Eye Colour

(v)

Hair Colour

(b)

Year and place of birth

(c)

Ethnic group

(d) If the donor had any genetic children on date of

registration

(i)

Number of children

(ii)

Sex of those children

(iii) In Malta or Abroad

(e)

Other details the donor may have chosen to provide

(i)

Religion / Belief

(ii)

Current Occupation

(iii) Hobbies / Interests

(iv) Other Skills

(f)

Marital status (at the time of donation)

(g)

Ethnic group(s) of the donor’s parents

(h) If the donor was adopted or donor conceived (if they

are aware of this)

(i)

Reason for donating altruistically

(j)

Details of virology and genetic screening tests

(k)

A personal message

20.11 The tissue establishment should inform people seeking

treatment with donated gametes or embryos that the medical records

that may affect the health of the child and the Identity of the donor or

of the person from whom an adopted embryo originated shall be

accessible to the child conceived from the germ line cells of such

donor either upon the child reaching eighteen years of age or, subject

to the consent of the Embryo Protection Authority, at any earlier stage

in exceptional circumstances in which the life or health of the child

born from such germ line cells is at risk.

20.12 The tissue establishment should inform people seeking

treatment with donated gametes or embryos that any children born as a

result of the donation will have access to the following identifying

information about the donor, from the age of 18

(a)

Full names (and any previous names at registration)

(b)

Date of birth

(c)

Place and Town of birth

(d)

Last known postal address

If postal address has not been updated since registration, address

at time of registration will be given.

21. Intra – Cytoplasmic Sperm Injection (ICSI)

Information for People Seeking Treatment with ICSI

21.1 Before treatment is offered, the tissue establishment should

give the woman seeking treatment and her partner, if applicable,

specific information about the risks of ICSI which might lead to

(a) a reduced number of eggs being available for

treatment (compared to IVF), due to eggs being immature or

damaged by the process of ICSI

(b) children conceived having inherited genetic,

epigenetic or chromosomal abnormalities (including cystic

fibrosis gene mutations, imprinting disorders, sex chromosome

defects and heritable sub-fertility).

21.2 Where appropriate, tissue establishments should also

provide patients with information about the possibility of genetic

testing of the male partner.

The use of ICSI

21.3 The tissue establishment’s clinical protocols should set out

when ICSI can be used. The reasons for using ICSI in any particular

case should be explained in the patient’s medical records.

21.4 With respect to any ICSI programme, the tissue

establishment should ensure that

(a) ICSI and other embryos are transferred during the

same treatment cycle only in exceptional circumstances, with an

upper limit of 2% of all ICSI embryo transfers, (maximum

transfer of two embryos in each cycle)

(b) the circumstances justifying such a transfer are

specified in the patient’s notes, and

(c) oocytes that have failed to fertilise by normal IVF or

ICSI are not re-inseminated by any means.

22. Research and Unlawful Procedures

Unlawful Procedures

In terms of the statutory provision under the Embryo Protection

Act 2012, the Embryo Protection (Amendment) Act, 2018, and the

Various Laws relating to Assisted Procreation (Amendment) Act 2022,

it is prohibited to

22.1 Artificially fertilizes any egg cell for any purpose other

than that of bringing about the pregnancy to the prospective parent;

22.2 Intentionally fertilizes more egg cells than the maximum

amount established by this Protocol from one woman within one

treatment cycle

Provided that the medical practitioner in charge of the

medically assisted procreation may, in consultation with the

multidisciplinary team and with the permission of the Embryo

Protection Authority, decide to fertilise more than two egg cells within

one treatment cycle, provided that this is done in accordance with this

Protocol.

22.3 No more egg cells can be fertilized until all the

cryopreserved embryos have been implanted in the prospective parents

from whom they originate from any prior medically assisted

procreation treatment, except in those instances which may be

specified in this Protocol and with the prior authorisation of the

Authority, in which case, the fertilisation of more egg cells may be

permissible.

22.4 When the prospective parent or parents undergoing

medically assisted procreation procedures do not give consent to

cryopreservation of embryos and the donation of fertilized eggs if

necessary, in terms of article 18, it shall not be lawful to fertilize more

than two eggs within each treatment cycle.

22.5 In one treatment cycle no more than two embryos shall be

transferred into the prospective parent or parents

22.6 removes an embryo from a woman before the completion

of implantation in the womb in order to transfer the embryo to another

woman;

22.7 selects or discards an embryo for eugenic purposes

Provided that the Protocol may specify that certain exceptional

circumstances shall not constitute selection of embryos for eugenic

purposes; provided, however, also that the medical experts as listed in

the Protocol shall provide information and explanations relating to the

testing of human egg cells (oocytes) and other testing which is

available to the prospective parent or prospective parents and the said

prospective parent or prospective parents shall decide which testing

shall be carried out after consulting with the medical experts

22.8 carries out an artificial fertilization of, or transfers a human

embryo into, a woman who is prepared to give up her child

permanently after birth (surrogate mother).

Improper use of Human Embryos

22.9 other than for the purpose of implantation in a prospective

parent, as may be authorized by the provisions of the Act disposes of,

hands over or acquires a human embryo produced outside the body, or

removes such embryo from a prospective parent before the completion

of implantation in the womb

22.10 causes a human fertilised egg to develop further outside

the body for any purpose other than in order to bring about a

pregnancy.

Prohibition of Selection of Sex

22.11 artificially fertilizes a human egg cell with a sperm cell

that is selected for the sex chromosome contained in it.

22.12 Nothing contained in Article 10 sub-article (1) of the

Embryo Protection Act, 2012, shall be understood as preventing the

selection of a sperm cell by a medical practitioner in order to prevent

the child from falling ill with a sex-linked genetic illness.

Prohibition of Cloning

22.13 Any intervention seeking to create a human being

genetically identical to another embryo, foetus, or human being,

whether living or dead, is prohibited and for the purpose of this article,

the term "genetically identical" means a human being sharing with

another the same nuclear gene set.

Unauthorised Fertilisation, Embryo Transfer, and Artificial

Fertilisation after Death

22.14 Artificially fertilizes an egg cell without the consent of the

woman, whose egg cell is to be fertilized, or without the consent of the

man, whose sperm cell will be used for fertilization.

22.15 Transfers an embryo into a woman without her consent.

22.16 Knowingly artificially fertilizes an egg cell with the sperm

of a man before or after his death except in the case where the

deceased person has donated his sperm, and

22.17 Knowingly artificially fertilizes an egg cell of a woman

before or after her death except in the case where the deceased person

has donated her egg cells.

22.18 Nothing in the Embryo Protection Act shall be construed

or interpreted in a way as to impede, for medical reasons and

according to accepted medical norms, the taking and freezing of sperm

or egg of a person with the aim of making use of that same sperm or

egg at a later stage for the generation of an embryo.

Prohibition of Artificial Alteration of Human Germ Line

Cells

22.19 Wilfully alter in an artificial way the genetic information

of a human germ line cell.

22.20 Knowingly uses a human germ line cell with artificially

altered genetic information for fertilization.

22.21 No offence shall arise, against the medical practitioner

carrying out the medically assisted procedure, under article 13 sub-

article (1)of the Embryo protection Act, 2012, where the alteration of

the genetic information of a germ line cell is the unintended

consequence of inoculation, radiation or chemotherapeutic or

treatment.

Prohibition of Formation of Chimerae and Hybrids

22.22 Unites embryos with different genetic material to a cell

conglomerate using at least one human embryo; or

22.23 joins a human embryo with a cell that contains genetic

information different from the embryo cells and induces them to

develop further; or

22.24 fertilizes a human egg cell with the sperm of an animal or

fertilizes an animal’s egg cell with the sperm of a man, with the

intention of generating an embryo capable of development,

22.25 transfers to a woman or an animal an embryo arising out

of a procedure described in article 14 sub-article (1) of the Embryo

Protection Act, 2012, or transfers to an animal a human embryo

Prohibition of Experimentation on Human Embryos

22.26 Any experimentation on human embryos is prohibited.

22.27 The creation of human embryos for the purpose of

research or experimentation or for any other purpose not permitted

under the Embryo Protection Act, is prohibited

22.28 Clinical interventions on a human embryo are allowed on

condition that said interventions pursue an exclusively diagnostic and,

or therapeutic purpose related to the embryo and are in the interests of

the health and development of the embryo itself. Provided that nothing

shall in any way be construed as prohibiting clinical interventions

deemed permissible in terms of the Protocol, nor prohibiting the

prospective parent and, or prospective parents from opting for the

cryopreservation of the human embryo after the carrying out of any

such intervention wherever such an option is deemed permissible in

terms of the Protocol

Wilful Cause of Death of Embryos

22.29 wilfully causes the death of any embryo

22.30 This article shall also apply to any human clone created in

breach of article 11 of the Embryo Protection Act, 2012.

22.31 All of the above Unlawful Procedures carry fines and/or

imprisonment, or both.

23. Quality Management System

Definition of the Quality Management System

23.1 The quality management system is defined as

"The organisational structure, defined responsibilities,

procedures, processes and resources for implementing quality

management (i.e. the co-ordinated activities to direct and control an

organisation with regard to quality), including all activities which

contribute to quality, directly or indirectly". (International

Organization for Standardization)

NOTE: This definition indicates that every process and activity

taking place in the tissue establishment is a part of the quality

management system.

23.2 The tissue establishment shall determine external and

internal issues that are relevant to its purpose and its strategic direction

and that affect its ability to achieve the intended results of its quality

management system.

23.3 The tissue establishment shall monitor and review

information about these external and internal issues. Issues can include

positive and negative factors or conditions for consideration.

Understanding the external context can be facilitated by considering

issues arising from legal, technological, competitive, market, cultural,

social and economic environments, whether international, national,

regional or local. Understanding the internal context can be facilitated

by considering issues related to values, culture, knowledge and

performance of the tissue establishment.

23.4 Due to their effect or potential effect on the tissue

establishment’s ability to consistently provide products and services

that meet patient and applicable statutory and regulatory requirements,

the tissue establishment shall determine

(a) the interested parties that are relevant to the quality

management system

(b) the requirements of these interested parties that are relevant

to the quality management system.

23.5 The tissue establishment shall monitor and review

information about the interested parties and their relevant

requirements.

23.6 The tissue establishment shall determine the boundaries

and applicability of the quality management system to establish its

scope. When determining this scope, the tissue establishment shall

consider

(a)

the external and internal issues

(b)

the requirements of relevant interested parties

(c)

the products and services of the tissue establishment.

23.7 The tissue establishment shall apply all the requirements of

the International Standard if they are applicable within the determined

scope of its quality management system. The scope of the tissue

establishment’s quality management system shall be available and be

maintained as documented information. The scope shall state the types

of products and services covered, and provide justification for any

requirement of the International Standard that the tissue establishment

determines is not applicable to the scope of its quality management

system. Conformity to the International Standard may only be claimed

if the requirements determined as not being applicable do not affect the

tissue establishment’s ability or responsibility to ensure the conformity

of its products and services and the enhancement of patient

satisfaction.

23.8 The tissue establishment shall establish, implement,

maintain and continually improve a quality management system,

including the processes needed and their interactions, in accordance

with the requirements of this International Standard.

23.9 The tissue establishment shall determine the processes

needed for the quality management system and their application

throughout the tissue establishment, and shall

(a) determine the inputs required and the outputs

expected from these processes

(b) determine the sequence and interaction of these

processes

(c) determine and apply the criteria and methods

(including monitoring, measurements and related performance

indicators) needed to ensure the effective operation and control

of these processes

(d) determine the resources needed for these processes

and ensure their availability

(e) assign the responsibilities and authorities for these

processes

(f) address the risks and opportunities as determined in

accordance with the requirements

(g) evaluate these processes and implement any changes

needed to ensure that these processes achieve their intended

results

(h)

improve the processes and the quality management

system.

23.10 To the extent necessary, the tissue establishment shall

(a) maintain documented information to support the

operation of its processes

(b) retain documented information to have confidence

that the processes are being carried out as planned.

23.11 The tissue establishment should

(a) identify the processes needed for quality

management, for providing and managing resources and for

assisted conception procedures, and

(b) ensure these processes, including the interaction

between them, are effective and continually improved.

Establishing, Maintaining and Documenting the Quality

Management System

23.12 Tissue establishment management should ensure the

quality management system is established and maintained by

(a)

appointing a quality manager

(b)

establishing a quality policy

(c)

establishing quality objectives and plans

(d) ensuring resources are available to implement and

maintain the system

(e) making tissue establishment staff aware of the

importance of the system and the need to keep to its

requirements

(f) defining responsibilities, authorities and reporting

relationships in the tissue establishment

(g)

conducting management reviews of the system, and

(h)

establishing and reviewing contracts with third

parties.

23.13 Tissue establishment management should appoint a

quality manager who, regardless of their other responsibilities, must be

responsible for

(a) ensuring that the quality management system is

implemented and maintained

(b) reporting to tissue establishment management on how

the quality management system works and how effective it is,

(c) co-ordinating awareness of tissue establishment

users’ needs and requirements.

23.14 The tissue establishment’s documents to support its

quality management system should include

(a)

the quality policy, with quality objectives and plans

(b)

a quality manual

(c) documents

needed

to

ensure

the

tissue

establishment’s processes are planned and operate effectively,

and

(d)

records and procedures required by this Protocol.

The tissue establishment should ensure that all documents are

available for inspection by the EPA.

Quality Policy and Quality Objectives

23.15 The quality policy is defined as

"The overall intentions and direction of an organisation related to

quality as formally expressed by tissue establishment management. A

quality policy statement defines or describes an organisation’s

intentions and commitment to quality and provides a framework for

setting quality objectives and planning". (International Organization

for Standardization)

23.16 Tissue establishment management should ensure the

quality policy includes a commitment to

(a) providing a service that meets its users’ needs and

requirements. This should include ensuring that all staff who

come into contact with patients, donors and their partners (where

applicable) provide the good quality supportive care before,

during and after treatment, as outlined in the tissue

establishment’s patient support policy

(b) meeting the provisions of this Protocol and standard

licence conditions

(c) continually improving the effectiveness of the quality

management system

(d)

upholding good professional practice, and

(e) ensuring the health, safety and welfare of all staff and

visitors to the tissue establishment.

23.17 The quality policy should be

(a)

signed and issued by the responsible person

(b)

communicated, understood and available throughout

the tissue establishment, and

(c)

reviewed for continuing suitability.

23.18 Tissue establishment management should establish

documented quality objectives. These should

(a) include objectives needed to meet users’ needs and

requirements, including their need for supportive care and

treatment, from clinic staff, before, during and after treatment or

donation

(b)

be measurable and consistent with the quality policy,

(c)

be reviewed regularly.

23.19 Tissue establishment management should establish a plan

to achieve and maintain the quality objectives. The plans should be

reviewed regularly.

Quality Manual

23.20 The tissue establishment should establish and maintain a

quality manual.

The quality manual should include

(a) a brief description of the tissue establishment,

including its legal identity, and the scope of its services

(b)

the quality policy, or reference to it

(c) an organisation chart defining accountability and

reporting relationships in the tissue establishment

(d) text to accompany the organisational chart and a

definition of the tissue establishment’s place in any parent

organisation, and

(e) an outline of the processes and documentation

established for the quality management system.

The Quality Management Review

23.21 The review of the quality management system should

include consideration of changes in

(a)

the volume and scope of work

(b)

staff

(c)

premises

(d) the performance of third parties that could affect the

quality management system or the tissue establishment’s

services, and

(e)

the results of the following activities

(i) quality indicators for monitoring the tissue

establishment’s performance in the provision of emotional

support and patient care

(ii) assessment of user satisfaction, and the

monitoring and resolution of complaints

(iii) staff suggestions

(iv) an internal audit of all elements of the quality

management system, including assisted conception

processes

(v) participation in external reviews, and inter-

tissue establishment and inter-laboratory comparisons

(vi) identification, investigation, control, recording

and notification of serious adverse events and reactions,

(vii) continual improvement, including the status of

corrective and preventive actions.

23.22 The tissue establishment should normally review its

quality management system at least every 12 months but more often

when a quality management system is being established.

23.23 The management review should include the results of

monitoring, evaluation and improvement activities.

23.24 The results of the review of the quality management

system should be recorded and should include the decisions and

actions for improving the quality management system. Tissue

establishment staff should be informed of the results of the quality

management review.

Quality Indicators

23.25 The tissue establishment should establish quality

indicators for systematically monitoring and evaluating the tissue

establishment’s contribution to the provision of emotional support and

patient care.

Assessing User Satisfaction

23.26 The tissue establishment should assess whether or not the

service has met users’ needs and requirements, including the extent to

which they felt supported before, during and after their treatment or

donation. It should keep records of the information it collects and the

actions it takes. Methods should include user surveys for all aspects of

the service.

Staff Suggestions

23.27 Tissue establishment management should encourage staff

to make suggestions for improving any aspect of the tissue

establishment’s service. Suggestions should be evaluated,

implemented as appropriate, and feedback provided to the staff.

Records of suggestions and management action should be maintained.

Internal & External Audits

23.28 The tissue establishment should establish an internal audit

process to determine whether the quality management system

(a) conforms to the planned arrangements for assisted

conception processes

(b) conforms to the requirements of this Protocol and to

the standards established by the tissue establishment, and

(c)

is effectively implemented and maintained.

23.29 The tissue establishment should establish a documented

procedure to

(a) define

the

responsibilities

for

planning

and

conducting audits

(b)

define the audit criteria, scope, frequency and

methods

(c)

ensure audits are carried out by trained staff

(d)

ensure action is taken promptly to start corrective

action

(e) check the effectiveness of the action taken, in a

subsequent audit, and

(f)

keep records of audits, to include

(i)

the processes, areas or items audited

(ii) any areas that do not comply with the quality

management system

(iii) recommendations and timescales for action, and

(iv)

action taken and its effectiveness.

23.30 The quality manager should plan the audit programme. It

must take into account the importance of the processes and areas to be

audited, and the results of previous audits. Auditors should not audit

their own areas of responsibility. The Quality Manager should ensure

that second party audits are carried out wherever necessary on

procured suppliers taking evidence obtained from Third Party

Agreements.

23.31 The audit should focus in particular on quality indicators

established for systematically monitoring and evaluating the tissue

establishment’s assisted conception processes.

Participating in External Reviews, and

Inter-Tissue

Establishment and Inter-Laboratory Comparisons

23.32 The tissue establishment should, where possible,

participate in inter-tissue establishment comparisons and inter-

laboratory comparisons. The tissue establishment should evaluate the

results of these comparisons and use relevant findings to improve its

service.

23.33 For inter-laboratory comparisons, the laboratory should

establish documented procedures to define the responsibilities and

requirements for participation to ensure that

(a) a record of participation is maintained, to include

reasons for failure to participate

(b) supervisory staff and staff doing the examinations

evaluate the returned results against agreed performance criteria,

and, when nonconformities are identified, participate in

implementing and recording corrective action, and

(c) the effectiveness of the corrective action is verified.

When a formal inter-laboratory comparison programme is not

available, the laboratory should develop a way of determining

the acceptability of procedures not otherwise evaluated.

Whenever possible, this should use external materials, such as

exchange of samples with other laboratories.

23.34The tissue establishment should assess any external

reviews indicating nonconformities or potential nonconformities and

take appropriate corrective or preventive action to ensure it continues

to comply with the requirements and expectations of this Protocol. The

tissue establishment must keep a record of corrective and preventive

action it takes.

Monitoring, Evaluation and Improvement

23.35 The tissue establishment’s processes for monitoring,

evaluation and improvement should

(a) show that procedures and outcomes are satisfactory

when judged against relevant professional standards

(b) show that the assisted conception processes are

followed in a way that meets users’ needs and requirements

(c)

ensure conformity of the quality management system,

and

(d) continually improve the effectiveness of the quality

management system.

23.36 The tissue establishment shall ensure that third party

provided processes, products and services conform to requirements.

23.37 The tissue establishment shall determine the controls to be

applied to third party provided processes, products and services when

(a) products and services from third party providers are

intended for incorporation into the tissue establishment’s own

products and services

(b) products and services are provided directly to the

patients by third party providers on behalf of the tissue

establishment

(c)

a process, or part of a process, is provided by a third

party provider as a result of a decision by the tissue

establishment.

23.38 The tissue establishment shall determine and apply criteria

for the evaluation, selection, monitoring of performance, and re-

evaluation of third party providers, based on their ability to provide

processes or products and services in accordance with requirements.

The tissue establishment shall retain documented information of these

activities and any necessary actions arising from the evaluations.

23.39 The tissue establishment shall ensure that third party

provided processes, products and services do not adversely affect the

tissue establishment’s ability to consistently deliver conforming

products and services to its patients.

23.40 The tissue establishment shall

(a) ensure that third party provided processes remain

within the control of its quality management system

(b) define both the controls that it intends to apply to a

third party provider and those it intends to apply to the resulting

output

(c) take into consideration the potential impact of the

third party provided processes, products and services on the

tissue establishment’s ability to consistently meet patient and

applicable statutory and regulatory requirements and the

effectiveness of the controls applied by the third party provider

(d) determine the verification, or other activities,

necessary to ensure that the third party provided processes,

products and services meet requirements.

23.41 The tissue establishment shall ensure the adequacy of

requirements prior to their communication to the third-party provider.

23.42 The tissue establishment shall communicate to third party

providers its requirements for

(a)

the processes, products and services to be provided

(b) the approval of products and services, the methods,

processes and equipment and the release of products and services

(c)

competence, including any required qualification of

persons

(d) the third party providers’ interactions with the tissue

establishment

(e) control and monitoring of the third party providers’

performance to be applied by the tissue establishment

(f) verification or validation activities that the tissue

establishment intends to perform at the third party providers’

premises.

23.43 The tissue establishment should establish a documented

procedure to identify and manage nonconformities and incident

findings. These findings should be appropriately investigated and

documented to include the following actions taken

(a)

remedial or immediate actions

(b) root cause analysis to determine the causes of

nonconformities

(c) evaluating the need

for

action

to

ensure

nonconformities do not recur

(d)

promptly determining and implementing action

needed

(e)

recording the results of corrective action taken, and

(f) reviewing the corrective action taken and its

effectiveness, and

(g)

risk based thinking and opportunities

23.44 When planning for the quality management system, the

tissue establishment shall consider the issues and determine the risks

and opportunities that need to be addressed to

(a) give assurance that the quality management system

can achieve its intended results

(b)

enhance desirable effects

(c)

prevent, or reduce, undesired effects

(d)

achieve improvement.

23.45 The tissue establishment shall plan

(a)

actions to address these risks and opportunities

(b) how to integrate and implement the actions into its

quality management system processes and evaluate the

effectiveness of these actions.

23.46 Actions taken to address risks and opportunities shall be

proportionate to the potential impact on the conformity of products and

services.

23.47 Options to address risks can include avoiding risk, taking

risk in order to pursue an opportunity, eliminating the risk source,

changing the likelihood or consequences, sharing the risk, or retaining

risk by informed decision.

23.48 Opportunities can lead to the adoption of new practices,

launching new products, opening new markets, addressing new

patients, building partnerships, using new technology and other

desirable and viable possibilities to address the tissue establishment’s

or its patients’ needs.

24. Complaints

Complaint Procedure

24.1 The tissue establishment should ensure that staff

understands the complaints procedure and the right of people to

complain.

24.2 It may be appropriate to deal with a complaint as soon as it

arises, without using a formal complaints procedure. In such cases,

staff should deal promptly and thoroughly with issues as they are

raised. Staff should treat all complaints seriously and show the

complainant due respect, however minor the complaint may appear.

Staff should not deter people from making formal complaints if they

wish to do so.

24.3 The tissue establishment should ensure that staff is given

appropriate training in complaints handling and that there are written

procedures for

(a)

acknowledging and investigating complaints, and

(b)

collecting suggestions and compliments.

The Complaints Officer and Complaints Register

24.4 The tissue establishment should nominate a member of

staff to act as complaints officer. The complaints officer should be

(a) the first point of contact when a person makes a

formal complaint, and

(b) responsible for investigating complaints and ensuring

the complaints procedure operates effectively.

24.5

The tissue establishment should display notices

prominently to explain the complaints procedure and give the

complaints officer’s name and contact details. This information should

also be given to patients.

24.6 The tissue establishment should ensure there is someone

else of at least equivalent seniority available to deal with complaints in

case a person feels unable to complain to the complaints officer.

24.7 The tissue establishment’s complaints officer should keep

an accurate complaint register. For each complaint, the following

should be recorded in the register

(a)

what has been done to resolve the complaint

(b) all communication with the complainant (including

verbal), and

(c)

the outcome, and any action taken as a result.

24.8 The tissue establishment’s complaints register should be

made available to EPA inspectors during inspections.

Investigating Complaints

24.9 Complaints should be investigated by staff who were not

involved in the circumstances that gave rise to the complaint.

24.10 If a complainant is unhappy with the outcome of the

investigation of their complaint, they should be informed of further

action they could take (e.g. going to the EPA or the Ombudsman).

24.11 In NHS tissue establishments, the complaints procedure

should comply with standards required of NHS services. In private

tissue establishments, the procedures should comply with this

Protocol.

25. Third Party Agreements

25.1 A licensed tissue establishment should establish a third-

party agreement where a third party is carrying out the following two

categories of activity

(a) procuring, testing or

processing

gametes

and

embryos, or both, for example

(i)

laboratories preparing sperm

(ii) Tissue establishments where patients are

assessed, given fertility-stimulating drugs and monitored,

and eggs are retrieved (transport tissue establishments /

tissue establishments)

(iii) tissue establishments where sperm is procured

(b) supplying goods or services (including distribution

services) that may affect the quality and safety of gametes and

embryos, for example

(i) companies supplying equipment and materials,

eg, suppliers of culture media

(ii) companies

monitoring

air

quality

in

laboratories

(iii) clinical or laboratory premises leased from a

hospital or other institution, e.g. using theatres for

collecting eggs under general anaesthetic

(iv) courier companies.

25.2 Third party premises may be inspected as part of the EPA

process and when investigating adverse incidents. If third party

premises are unsuitable, the Embryo Protection Authority will refer to

the Licencing Authority so the licence holder’s licence may be varied

or revoked.

25.3 If facilities or services that a third party provides are used

in a treatment process, the responsible person for that process should

be satisfied that the provider’s procedures can be integrated with the

tissue establishment’s quality system. In particular, the third party’s

procedures should

(a) allow the entire service to be audited, and samples to

be fully traced

(b)

minimise cross-contamination (where relevant)

(c)

follow relevant professional guidelines, and

(d)

ensure that adverse incidents are reported and that

any affected gametes and embryos can be effectively recalled.

Transport Tissue Establishments / Tissue establishments

25.4 Transport tissue establishments / tissue establishments

should give attention to requirements covering information,

counselling, the welfare of the child and confidentiality. The

responsible person should put in place effective procedures to ensure

such tissue establishments are given relevant information about these

requirements and any changes to them, in a clear and timely way.

These requirements should form part of a third-party agreement.

Third Party Procurement of Gametes and Embryos

25.5 If a tissue establishment has a third-party agreement with

another tissue establishment for procuring gametes and embryos, that

tissue establishment should keep extra third-party procurement

documents that should include, but not be limited to

(a) identification, name and address of the tissue

establishment to receive the gametes

(b)

patient, patient’s partner or donor identification

(c)

identification of the procured gametes and embryos

(d) identification of the staff member responsible for the

procurement session

(e)

date and time of procurement

(f) a record of any procedures performed on the gametes

and embryos

(g)

a record of any adverse incidents, and

(h) where appropriate, identification or batch numbers

(or both) of any reagents and transport media used.

Agreements between Licensed Tissue Establishments

25.6 Where a licensed tissue establishment arranges for any part

of treatment to take place at another licensed tissue establishment, the

responsible person at the original tissue establishment retains overall

responsibility for that treatment. The responsible person at the original

tissue establishment should therefore satisfy themselves that treatment

arranged at other licensed tissue establishments complies with all

relevant legal requirements, quality and safety considerations, and

Protocol guidance. This will include giving attention to requirements

covering information, counselling, the welfare of the child and

confidentiality.

25.7 The responsible person at the original tissue establishment

should check with EPA regarding any inspection reports about the

second tissue establishment, and establish regular written confirmation

from the second tissue establishment. Where the original tissue

establishment sends a large volume of treatment to a particular tissue

establishment, checks should be carried out regularly and no less than

annually.

26. Premises, Practices and Facilities

Definition of Premises

26.1 The Embryo Protection Authority defines premises as the

specific area where a tissue establishment conducts its business, as

identified on a floor plan submitted by the tissue establishment to the

Embryo Protection Authority.

26.2 The tissue establishment should provide the EPA with a

floor plan that defines the licensed premises, including the purpose of

each room.

26.3 The tissue establishment should ensure it can provide

ongoing assurance that its premises are fit for purpose, and evidence

of

(a)

maintenance of lifts

(b)

fire safety

(c)

maintenance of ventilation and heating systems

(d)

electrical safety

(e)

medical gas safety

Moving to New Premises

26.3 Before moving to new premises, the tissue establishment

should contact and inform the Embryo Protection Authority. The tissue

establishment should notify the EPA in writing of the intended move,

by submitting an application with information about the new premises.

The EPA will consider the application and information, and may need

to inspect the premises.

Changing Existing Premises

26.4 The tissue establishment should notify the EPA in writing

of any planned changes to the premises by submitting, in advance, an

application with information on the planned changes.

26.5 The EPA will consider the application and information, and

may need to inspect the premises.

Acquiring Additional Premises

26.6 If a tissue establishment wishes to conduct licensed

activities not subject to a third-party agreement in premises other than

those specified on the current licence (e.g. in a different building), it

should notify the EPA in writing. The tissue establishment should also

submit an application with information about the additional premises.

Tissue Establishment Facilities

26.7 The tissue establishment should provide for the privacy,

dignity and respect of all prospective and current patients and donors,

as well as providing a safe working environment for all staff.

Consultation and the exchange of personal information should be

carried out in private (i.e. cannot be overlooked or overheard by

others).

26.8 The tissue establishment should have facilities for

reception, clinical and counselling activity, laboratory work, storage of

confidential records, storing gametes and embryos, and staff.

26.9 The tissue establishment should display a copy of its

Certificate of Licence where it can easily be read by current and

potential patients and donors.

26.10 The tissue establishment should have appropriate

procedures to ensure premises comply with relevant requirements for

safety and air quality, and these procedures should be validated.

26.11 The responsible person together with clinicians should

assess how many treatment cycles can safely be accommodated by the

tissue establishment. The assessment should consider the tissue

establishment’s premises, equipment, staffing levels and the skill mix

of staff members. Activity should be adjusted according to the findings

of the assessment.

Clinical Facilities

26.12 The tissue establishment should ensure that its clinical

facilities

(a)

provide privacy and comfort for those

(i)

considering donation and seeking treatment

(ii)

undergoing examination and treatment, and

(iii) producing semen specimens.

(b) are equipped with backup and emergency clinical

facilities that

(i)

are equivalent to those provided as standard

practice in other medical facilities

(ii) are appropriate to the degree of risk involved in

any planned procedure, and

(iii) can cope with emergencies known to occur in

this clinical field.

Counselling Facilities

26.13 The tissue establishment should ensure that counselling

facilities provide quiet and comfortable surroundings for private,

confidential and uninterrupted sessions.

Laboratory Facilities

26.14 The tissue establishment’s laboratories should comply

with current professional guidelines, legislation and regulations.

26.15 Procedures must be evaluated for hazards to laboratory

staff, and precautions put in place to minimise potential hazards.

Staff Facilities

26.16 The tissue establishment should have staff amenities that

are easily accessible and include

(a)

toilet facilities

(b) a rest area with basic catering facilities and a supply

of drinking water

(c) a changing area and secure storage for personal

belongings, and

(d)

storage for protective clothing.

Infection control

26.17 Infection control policies should ensure that staff and

patients are protected from acquiring infections in the course of

providing treatment. In particular, these policies should ensure that

(a) there are effective procedures in place for preventing

and controlling infections, such as hand decontamination,

policies on wearing sterile gloves, dress code, and the safe use

and disposal of sharps

(b)

staff are aware of their role in these procedures

(c) a person is identified as the infection control lead for

the centre

(d) management systems are in place to ensure infection

control issues are dealt with.

Management of medicines

26.18 Where controlled drugs are used, tissue establishments

should be aware of the legal requirements, and have a controlled drugs

accountable officer.

26.19 Tissue establishments should have policies and procedures

in place for

(a) storing, disposing of, and managing the wastage of

medicines, ensuring medicines can be accurately identified, are

within date, and are kept safely (to prevent unauthorised access)

(b) managing medicine stock, ensuring staff can identify

and respond when new stock is needed

(c) prescribing and dispensing medicines, ensuring only

suitably qualified staff prescribe medicines, patients are given

information on the risks and side effects, and patients receive

appropriate medicines (taking into account factors such as

medical history and allergies)

(d) administering medicines, ensuring only suitably

qualified staff do so, and patients who self-administer receive

clear written and spoken instructions

(e)

dealing effectively with any emergencies following

the administration of medicines by developing appropriate

contingency plans.

26.20 Centres should ensure they keep accurate records that

clearly set out the medication a patient is receiving.

The surgical pathway

26.21 Before doing an operation, tissue establishments should

assess the suitability of a patient to have this, including a review of

their medical history, allergies and known reactions to medicines.

26.22 The consultant anaesthetist or person administering the

sedative should review the patient’s notes before an operation. This

review should take into account that patients having operations, under

either general anaesthetic or sedation, are at risk of compromise to

airway, breathing and circulation. There should be an anaesthetic chart

in the patient’s notes, containing information such as

(a)

known drug allergies

(b)

previous problems with anaesthetics or sedatives

(c)

airway assessment

(d)

whether the patient is taking any regular medication

(e) any post-operative instructions (eg, whether the

patient will need antibiotics).

26.23 When doing a surgical procedure, tissue establishments

should ensure that they

(a)

use a theatre check list

(b) monitor the patient before inducing the anaesthetic or

sedative, and throughout the procedure

(c) have contingency plans in case problems arise during

an operation, such as a severe allergic reaction or major bleeding

(d) have a contingency plan is case that patient needs to

be admitted to a hospital in emergency situations

(e) have a discharge policy, ensuring that patients are

discharged appropriately and by suitably trained staff.

26.24 Tissue establishments should keep accurate documentation

about the operation undertaken, including the anaesthetic or sedative

given, and details of patient monitoring.

26.25 Tissue establishments should ensure patients receive safe

and appropriate post-operative care in line with professional

guidelines. Where a general anaesthetic or sedative is used, Tissue

establishments should have a fully equipped recovery area, staffed by

recovery staff trained to professional standards. Second recovery areas

should provide close and continued supervision of all patients, who

should be visible to the nursing staff.

26.26 Where recovery areas are not available or not required,

Tissue establishments should consider how they can be sure that the

relevant staff and equipment are in place for safe post-operative care.

26.27Tissue establishments should ensure that their procedures

are suitable for the type of anaesthetic or sedative provided.

26.28 Tissue establishments should ensure that only an

appropriately qualified person provides an anaesthetic.

26.29 If an anaesthetic is used at remote sites, Tissue

establishments should have a resuscitation team led by an Advanced

Life Support provider. Where this is not the case, the anaesthetists

should provide competency-based evidence of their ability to provide

both advanced life support and the safe transport of a patient requiring

multi-system support

Safeguarding

26.30 Tissue establishments are expected to have a policy and

procedures for safeguarding those who use their services. These

should set out what staff should do if they suspect that a person has

been abused, neglected or harmed in any way. The policy and

procedure should include

(a) a statement of roles and responsibilities, authority and

accountability that is specific enough to ensure all staff

understand their roles and limitations

(b) how to deal with allegations of abuse, including

procedures for providing immediate protection in emergency

situations, assessing abuse and deciding when intervention is

appropriate, and reporting suspicions to the Embryo Protection

Authority and police when necessary

(c)

what to do if necessary action is not taken

(d) a comprehensive list of points of referral, explaining

how to access support, advice and protection at all times

(including outside normal working hours), with contact

addresses and telephone numbers

(e) how to record allegations of abuse, any investigations

and subsequent action

(f)

a list of sources of expert advice

(g) a full description of channels of inter-agency

communication, for example with local authorities, and

procedures for decision making

(h) a list of all services that might offer victims access to

support or redress.

26.31 Tissue establishments should review procedures annually,

or more often to incorporate any lessons learned or changes to

legislation.

26.32 Tissue establishments should provide training for staff on

the safeguarding policy and their responsibilities, including

(a) awareness that abuse can happen, and the duty to

report this

(b) recognition

of

abuse,

and

responsibilities

for

reporting this.

26.33 If abuse, neglect or harm is suspected, it may be in the best

interests of the individual to disclose confidential patient information.

The safeguarding policy should set out the principles governing the

sharing of information. These principles can be summarised as

(a) Information should be shared only on a ‘need to

know’ basis, when it is in the best interests of the patient or

donor.

(b)

Confidentiality and secrecy are two different things.

(c) The individual should give informed consent to

disclosure, but if this is not possible, it may be necessary to

disclose personal or sensitive personal information, despite a

duty of confidentiality or legislation that would ordinarily

prohibit disclosure.

(d) It is inappropriate to give assurances of absolute

confidentiality in cases where there are concerns about abuse.

(e) Exchange or disclosure of personal information

should be in line with the General Data Protection Regulation

(GDPR) where this applies.

27. Equipment and Materials

27.1 For the purpose of this Protocol, ‘equipment and materials’

includes all equipment, disposables, reagents, and calibration and

control materials used in the conduct of assisted procreation processes.

Protection and Hygiene of Staff

27.2 The tissue establishment should provide proper clothing

and equipment for the personal protection and hygiene of staff

carrying out licensed activities, together with written instructions for

their use.

Managing Equipment and Material

27.3 The tissue establishment should establish documented

procedures for managing equipment and materials, including

(a)

selecting and procuring equipment and materials

(b) ensuring the traceability of any products or materials

that come into contact with gametes or embryos and that affect

their quality and safety, and

(c) maintaining inventory information and records for

stock control.

(d) ensuring software-driven equipment is effectively

validated, and revalidated after any software update.

CE marking

27.4 The tissue establishment should use only media and

consumables that have been CE-marked at a classification suitable for

their intended purpose. Modifying existing devices (for example,

adding calcium ionophore to culture medium) or using them ‘off label’

for purposes not intended by the manufacturer (for example, using a

medium for a different purpose from that specified) has safety

implications.

Safety of Equipment used to Store Cryopreserved Gametes

and Embryos

27.5 All tissue establishments storing gametes and embryos

should have effective alarms and monitoring systems to ensure the

safety of cryopreserved gametes and embryos. These systems should

have

(a) local alarms (i.e. on individual dewars for either

temperature or liquid nitrogen level)

(b) an auto-dial facility or similar (e.g. link to fire-alarm

board) to contact staff outside normal working hours

(c) adequate staffing and funding to implement formal

emergency procedures, including having on-call arrangements,

and

(d) adequate spare storage space or vessels to enable

transfer of samples if a vessel fails.

28. Adverse Incidents

Definitions

28.1 An "adverse incident" is any event, circumstance, activity

or action which has caused, or has been identified as potentially

causing harm, loss or damage to patients, their embryos and/or

gametes, or to staff or a licensed tissue establishment. This includes

serious adverse events, serious adverse reactions, breaches of

confidentiality, and ovarian hyper stimulation syndrome (OHSS)

which has a severity grading of severe or critical.

28.2 A serious adverse event is defined as

(a) any untoward occurrence which may be associated

with the procurement, testing, processing, storage or distribution

of gametes or embryos intended for human application and

which, in relation to a person who receives treatment services or

non-medical fertility services–

(i) might lead to the transmission of a

communicable disease, to death, or life-threatening,

disabling or incapacitating conditions, or

(ii) might result in, or prolong, hospitalisation or

illness, or

(b)

any type of gametes or embryo misidentification or

mix-up’.

28.3 A serious adverse reaction is defined as

An unintended response, including a communicable disease, of

gametes intended for human application or a person who receives

treatment services or non-medical fertility services, which may be

associated with the procurement or human application of gametes or

embryos and which is fatal, life threatening, disabling, incapacitating

or which results in, or prolongs, hospitalisation or illness.

28.4 A "near miss" is an occurrence that, but for luck, skill or

judgment, would in all probability have become an adverse incident.

Reporting and Timescales

EPA requires tissue establishments to report all adverse incidents

and near misses to the EPA. This includes adverse incidents occurring

at third party premises, where there is a third-party agreement in force

between the tissue establishment and that third party.

Tissue establishments must report all adverse incidents or near

misses to the EPA by telephone within 12 working hours of their

identification. This verbal notification must include the

(a)

tissue establishment’s name

(b)

tissue establishment identification number

(c)

contact details of the person responsible

(d)

date of the initial notification or report

(e)

name of any individual affected

(f)

date and time of the adverse incidents and near misses

(g) details of gametes or embryos involved in the

incident, and

(h) type of incident, including any transmission of

infectious agents.

28.5 In addition, the tissue establishment must inform the EPA

in writing of all adverse incidents or near misses occurring at that

tissue establishment (or, if the event relates to treatment that involves a

third party, at a tissue establishment with which it has a third-party

agreement) by completing an adverse incident form.

28.6 The tissue establishment’s documented procedures should

ensure that any adverse incident or near miss that may result in harm to

the patient, patient’s partner or donor is recorded and reviewed.

28.7 If an adverse incident or near miss occurs, tissue

establishments are expected to

(a) review relevant procedures to minimise the risk and

avoid re-occurence of the incident happening again, and

(b)

inform the EPA of the revised procedures.

28.8 When investigating serious adverse events and reactions,

the tissue establishment should evaluate all assisted procreation

processes directly related to the adverse event, and all relevant

processes involving the

(a)

management of resources

(b)

training and competence of staff

(c)

equipment

(d)

materials

(e)

information systems, and

(f)

control of environment.

A copy of the investigation report should be submitted to the

EPA.

28.9 When reporting cases of OHSS with a severity grading of

severe or critical the tissue establishment must complete the OHSS

incident report on the EEART platform within 5 working days from

occurrence.

28.10 The Authority also expects tissue establishments to report

adverse incidents that arise from the use of equipment and materials, to

the EPA.

28.11 The Authority also expects tissue establishments to report

adverse incidents that arise from the use of equipment and materials.

Reports of this nature should be sent to the EPA. An "adverse incident"

in this context is an incident that produces, or has the potential to

produce, unwanted effects involving the safety of patients, users and

others.

28.12 The tissue establishment should, in line with professional

body guidance, inform patients and patient’s partner where applicable,

of any adverse incidents that may have resulted in harm to them, their

gametes or their embryos.

29. Confidentiality and Privacy

Confidentiality

29.1 Tissue establishments must treat all patients with dignity

and respect and must take appropriate measures to maintain their

confidentiality.

29.2 The tissue establishment should ensure that information

provided in confidence, including all information relating to donors,

patients and children born as a result of treatment, is kept confidential

and disclosed only in the circumstances permitted by law. The tissue

establishment should ensure that patients, their partners, and donors do

not have access to any other person’s records without first getting that

person’s consent.

29.3 If the tissue establishment is in doubt about whether a

proposed disclosure is lawful, it should seek independent legal advice.

Breach of Confidentiality

29.4 If confidentiality is breached (including disclosure of

information in breach of either the Embryo Protection Act, the General

Data Protection Regulation (GDPR), the tissue establishment should

consider it an adverse incident and therefore investigate the cause(s) of

the breach, take appropriate remedial action, and notify and submit a

full explanation to the EPA. This is to include what mitigating actions

have been put in place to prevent a similar breach taking place.

Consideration should also be given, depending on the level of

risk to the data subject, to whether the breach should be reported to the

Commissioner of Data Protection, and whether any patients affected

by the breach should be informed, particularly if their sensitive

personal data (including ‘special category data’) has been disclosed or

if there is a risk of detriment to the patient.

Access to Medical Records

29.5 For the purposes of this Protocol, a record is defined as

information created, received and maintained as evidence by a tissue

establishment or person, in meeting legal obligations or in transacting

business. Records can be in any form or medium provided they are

readily accessible, legible and indelible.

29.6 The tissue establishment must establish a documented

procedure for controlling access to medical records. This should

ensure that arrangements are in place for

(a)

properly identifying applicants

(b) promptly considering and responding to applications

for access to confidential records

(c) a designated individual in the tissue establishment

being responsible for receiving, checking and arranging

authorised access to confidential records

(d) giving all individual patients and donors who provide

information about themselves access to their own individual

records of that information and an opportunity to correct any

information that is incorrect

(e) ensuring proper procedures are in place to maintain

confidentiality when records are stored off site, and

(f) ensuring that individuals are aware of their rights

under the Data Protection Act to access their own medical

records.

NOTE: When the tissue establishment is part of a larger

organisation, the appropriate department of the parent organisation

may do some of these procedures, where relevant.

29.7 The tissue establishment should have clear security

procedures to prevent unauthorised access to records, and take

particular care if records are kept outside the licensed premises (eg,

when counselling takes place outside the tissue establishment). The

security procedures should be appropriate to the record keeping

system, whether paper-based, electronic or in any other format. Extra

scrutiny is recommended if the tissue establishment has laboratory

equipment that stores patient-identifying information electronically.

29.8 To mitigate the risks of unauthorised people inadvertently

gaining access to patient-identifying information through electronic

records, the tissue establishment should

(a) ensure that such information cannot be transferred to

portable media-storage devices

(b) ensure that when hardware is removed from the

premises, identifying information has been removed

(c) consider making it a policy that no data is stored on

any third-party device unless there is a process for anonymising

or deleting the data

(d) record and audit potential access to identifying

information

(e) have systems in place to reduce the risks of malicious

access to data; these systems should include anti-virus software,

firewalls, and network segmentation (including user-/network-

level usernames and passwords)

(f) know what software is installed

on

tissue

establishment systems and what it allows

(g) ensure agreements/contracts

with

the

relevant

providers set out expectations.

29.9 If the tissue establishment’s service providers require

access to identifying information to do their job, then the tissue

establishment must take steps to ensure that any person accessing data

is suitable.

29.10 A person whose medical records are held by the tissue

establishment is normally entitled to receive a copy of their own

medical records, so long as they ask in writing (including by electronic

means). The source of the information and an explanation of any

unusual or technical terms should be given.

Requests under the Data Protection Act

29.11 The tissue establishment should comply promptly with

"access requests" made under the Data Protection Act. Usually, such

requests will be for copies of medical records. The tissue

establishment must check the identity of the person making the request

and may also request written consent and proof of identity from the

partners of applicants if the medical record contains information

relating to them.

Disclosing Non-Identifying Information: General

29.14 The tissue establishment may disclose information that

does not identify or could not reasonably be expected to lead to the

identification of a person owed a duty of confidentiality. If the tissue

establishment is unsure whether information it proposes to disclose

could identify the person, it should seek independent legal advice.

Authorised Disclosure

29.15 If the tissue establishment refers a person seeking

treatment to another licensed tissue establishment, it should provide

relevant information in line with good clinical practice. The tissue

establishment must always supply information relevant to the welfare

of the child.

29.16 Before obtaining consent to disclose information, the

tissue establishment should give the person enough information for

them to make a properly informed decision, including

(a)

precisely what information is to be disclosed

(b)

the terms on which it is to be disclosed

(c) the reasons for disclosure (e.g. to keep the person’s

GP informed about the fertility treatment)

(d)

the implications of disclosure,

(e) the categories of people to whom the information is to

be disclosed.

29.17 The tissue establishment should seek consent to disclosure

to the following categories of people

(a)

the patient’s GP or the patient’s partner’s GP

(b) other healthcare professionals outside the tissue

establishment (provide the patient or the patient’s partner with

the best possible medical care)

(c) auditors or administrative staff outside of the tissue

establishment (so they can perform functions designated to them

in connection with the tissue establishment’s licensable

activities), and

29.18 The tissue establishment should renew consent to

disclosure if the nature of the treatment changes after initial consent

has been given.

29.19 The tissue establishment should ensure that people to

whom they disclose identifying information know that the information

remains protected by the existing common law on confidentiality.

Those receiving information should also be told

(a) the precise terms upon which it was disclosed and for

which consent has been given, and

(b) that if they disclose the information they have

received, a child might learn in an inappropriate way that they

were born as a result of fertility treatment.

30. Record Keeping and Document Control

Records to Keep

30.1 This guidance note does not summarise all the record

keeping requirements of a licensed tissue establishment. The

responsible person should familiarise themselves with the Chapters,

which have been discussed in the guidance notes of this Protocol as

well as refer to the Embryo Protection Act 2012, the Embryo

Protection (Amendment) Act 2018, and the Various Laws relating to

Assisted Procreation (Amendment) Act 2022, requirements.

Definitions

30.2 A record is hereby defined as "information created or

received, and maintained as evidence by a tissue establishment or

person, in meeting legal obligations or in transacting business.

Records can be in any form or medium providing they are readily

accessible, legible and indelible."

30.3 A documented procedure is hereby defined as "a set of

written instructions describing the steps in a specific process,

including the materials and methods to be used, and the expected end

product. This term has the same meaning as standard operating

procedures."

Document Control

30.4 The tissue establishment should have document control

procedures in place to

(a)

ensure that all documents include

(i)

a unique identifier (for instance, the edition, or

current revision date or revision number)

(ii) page numbers and total number of pages (e.g.

"page 5 of 10")

(iii) authority for their issue, and

(iv) author identification

(b)

control all records required to

(i)

provide evidence of conforming to legal

requirements

(ii) operate

the

quality

management

system

effectively, and

(iii) conduct assisted conception processes.

The procedures must cover the identification, collection,

indexing, access, storage, maintenance, confidentiality and safe

disposal of records.

30.5 When a tissue establishment’s document control system

allows documents to be amended by hand pending their re-issue, the

procedures and authority for such amendments should be defined;

amendments should be clearly marked, initialled and dated; and a

revised document should be re-issued as soon as practicable.

30.6 Documents should be reviewed, revised and reapproved at

a frequency that ensures they remain fit for purpose. The maximum

interval between reviews should be 12 months.

30.7 Access to registers and data must be restricted to people

authorised by the responsible person and the EPA for inspection

purposes.

Managing Information

30.8 The tissue establishment should establish documented

procedures for managing data and information. These should include

(a)

accurate recording of information

(b) security of data and safeguards against unauthorised

modification, addition, deletion, disclosure or transfer of

information

(c)

resolution of data discrepancies

(d)

maintenance and disaster recovery

(e)

storage, archiving and retrieval, and

(f)

secure disposal.

30.9 If using off-site storage facilities for archived records, the

tissue establishment should establish procedures to ensure patient

confidentiality is maintained. These should include

(a) removal of all patient identifying information that

might be visible to staff outside the licensed tissue

establishment, and

(b) ensuring files are properly sealed when they are being

transported between the tissue establishment and storage facility

31. Obligations and Reporting Requirements of Tissue

Establishments

31.1 One of the functions and powers of the EPA as stated in

Article 4 of the Act is to carry out inspections in order to ensure that

the standards of best practice are being respected and implemented and

that all information and documentation required under article 18 of the

Act is being kept appropriately and for this purpose to access clinics

and any other places as necessary.

Legal Obligations toward the EPA

31.2 Tissue establishments have various legal obligations

toward the EPA. The responsible person should familiarise themselves

with these, which include

(a) allowing EPA inspectors to enter tissue establishment

premises or relevant third-party premises at all hours

(b) allowing EPA inspectors to inspect tissue

establishment or relevant third-party premises, including

inspecting equipment and records, taking away copies of records

and other required items, and observing any activity, and

(c) notifying the EPA of any new activities or treatment

services, before those services or activities are carried out.

31.3 The law also requires tissue establishments to provide

certain information to the EPA, either on request or at intervals or by

deadlines specified by EPA. This includes information relating to

(a)

the quality or safety of gametes and embryos

(b)

the traceability of gametes and embryos

(c)

adverse incidents and near misses

31.4 It shall be the duty of every licensee to keep a confidential

register with full details of every medically assisted procreation

procedure including IUI’s, germ line cell donation, cryopreservation of

germ line cells and cryopreservation of embryos in terms of the

Embryo Protection Act and to pass on this information to the Embryo

Protection Authority without delay

(a)

register information, including

(i) registration information for donors, patients and

patients’ partners (where applicable)

(ii) information on the intention to treat

(iii) IVF treatment and embryo creation information

(iv)

treatment outcome information.

Collecting and recording information for the EPA

31.5 The responsible person should ensure that mechanisms

used to monitor data collection, recording and submission are

regularly reviewed to ensure that requirements are met.

31.6 The responsible person should ensure that checks on the

quality of data submitted to the Embryo Protection Authority include

reconciliation of Register data to source documentation (ie, patient and

donor records) held by the tissue establishment. Some system and

process errors may be identified only in this way.

31.7 The responsible person should inform the Embryo

Protection Authority, immediately, if staff move out of the tissue

establishment. Such a move may mean that staff will still have access

to previous data, (ie, patient and donor registration, and linked gamete

source/treatments and pregnancy outcomes) of patients, if such

information does not reach EPA on time, to block the staff from being

a user on the EEART platform.

31.8 The responsible person should tell the Embryo Protection

Authority as early as possible, if they expect to close the tissue

establishment, and should make adequate arrangements for

(a)

accessing and storing patient and donor records in the

future

(b)

submitting outstanding information to the Authority,

and

(c) providing outcome data that will be pending when the

tissue establishment closes.

32. Fees to be paid to the Embryo Protection Authority

(EPA) by all Service Providers of Tissue Establishments / Clinics

both Public and Private

32.1 The Embryo Protection Authority is funded from a

combination of fees from the sector it regulates and from the

Government Budget. In line with moving forward so that the

Authority become totally autonomous, it is envisage that fees from the

sector will cover the majority of the full cost of Regulation, with the

vision that when the number of cycles increase these will fully fund

the cost of regulation.

32.2 The EPA does not charge individual patient for fertility

treatment. It is the Service Providers of Tissue establishments both

public and private, that pay a fee to the EPA towards the costs of being

regulated and inspected.

32.3 The Annual fees must be paid on 2 nd January of each year,

while the procedure and storage fees will be paid on the submission of

forms and reports within a month from procedure / storage taking

place.

32.4 Hereunder list of Fees coming into effect on date of

publication of this Protocol.

32.5 Annual Fees

IVF

treatment

Annual Fee € 1500.00

and storage tissue

establishments

Storage

only

Annual Fee € 500.00

tissue

establishments

IUI

treatment

Annual Fee € 500.00

centres

32.6 Recurrent Fees

IUI Treatment using

No fee will be charged

partner gametes

IUI Treatment using

€100.00 per procedure performed

donor gametes

irrespective of outcome

IVF/ ICSI treatment

€ 175.00 per procedure performed

using partner gametes

irrespective of outcome

IVF/ ICSI treatment using

€ 200.00 per procedure performed

donor gametes

irrespective of outcome

Embryo

Transfer

€ 150.00 per procedure performed

procedures

irrespective of outcome

TESA/PESA procedures

€ 100.00 per procedure performed

for surgical extraction of irrespective of outcome

sperm

Biopsy prior to PGTM

€ 50.00 per embryo biopsied

procedures

irrespective of outcome

Storage

of

Gametes

€ 80.00 per storage procedure

including storage after performed irrespective number of oocytes/

movement from other sperm stored

tissue establishments and

storage of donor gametes

after

distribution/

importation

Embryo Cryopreservation

€ 325.00 per embryo cryopreserved

including storage after

movement from other

tissue establishments

32.7 Variation Fees

All Tissue establishments

€ 1000.00 for each change

– Variation to services or

Change of Premises

This Protocol has been compiled and approved by the members

of Embryo Protection Authority during the Authority’s Board

meetings.

Embryo Protection Authority Board is composed of

Chairman

The Hon. Mr Justice Philip Sciberras LL.D,

UOM

Vice Chairperson

Ms. Josephine Abdilla MBA Henley, DIP

Mang. Henley

Members

Profs. Victor Grech MD PhD. FRCPCH

FRCP

Ms. Mariella Meachen B.Psych (Hons MA

(Psycotherapy) R.N

Ms. Sarah Camilleri Dip Economic and

Political Studies

Chief

Executive

Ms. Simone Attard RRCouns; PGCert.

Officer

PGDip Systemic Family Therapy (Tavistock and

Portman NHS Trust UK); MBICA; GHZ; OLJ.

Authority Secretary

Ms. Moira Gialanze’

This Protocol has been submitted to the Deputy Prime Minister

and Minister for Health to be published together with a Legal Notice

and to the Chairperson of the Health Committee of the House of

Representatives to be discussed at the Health Committee and placed on

the Table of the House of Representatives of the Parliament of Malta.

€6.84