345 tal-2012 Regolamenti tal-2012 dwar il-Kwalità u s-Sigurtà fit-Trapjant ta’ Organi

L.N. 345 of 2012

HUMAN BLOOD AND TRANSPLANTS ACT

(CAP. 483)

Organ Transplants (Quality and Safety) Regulations, 2012

BY virtue of the powers conferred by article 16 of the Human

Blood and Transplants Act, the Minister for Health, the Elderly and

Community Care, after consultation with the Licensing Authority, has

made the following regulations:-

(1)

The title of these regulations is the Organ Title and scope.

Transplants (Quality and Safety) Regulations, 2012.

(2) The scope of these regulations is to transpose the European

Parliament and Council Directive 2010/53/EU of 7 July 2010 on

standards of quality and safety of human organs intended for

transplantation.

ORGAN AND DONOR CHARACTERISATION

PART A

Minimum data set

Minimum data - information for the characterisation of organs and donors,

which has to be collected for each donation in accordance with regulation 7(1)(b)

and without prejudice to regulation 7(2).

Minimum data set

The establishment where the procurement takes place and other general data

Type of donor

Blood group

Gender

Cause of death

Date of death

Date of birth or estimated age

Weight

Height

Past or present history of IV drug abuse

Past or present history of malignant neoplasia

Present history of other transmissible disease

HIV; HCV; HBV tests

Basic information to evaluate the function of the donated organ

PART B

Complementary data set

Complementary data - information for the characterisation of organs and

donors to be collected in addition to minimum data specified in Part A, based on

the decision of the medical team, taking into account the availability of such

information and the particular circumstances of the case, in accordance with

regulation 7(1)(b).

Complementary data set

General data

Contact details of the procurement organisation/the establishment where the

procurement takes place necessary for coordination, allocation and traceability of

the organs from donors to recipients and vice versa.

Donor data

Demographic and anthropometrical data required in order to guarantee an

appropriate matching between the donor/organ and the recipient.

Donor medical history

Medical history of the donor, in particular the conditions which might affect

the suitability of the organs for transplantation and imply the risk of disease

transmission.

Physical and clinical data

Data from clinical examination which are necessary for the evaluation of the

physiological maintenance of the potential donor as well as any finding revealing

conditions which remained undetected during the examination of the donor’s

medical history and which might affect the suitability of organs for transplantation

or might imply the risk of disease transmission.

Laboratory parameters

Data needed for the assessment of the functional characterisation of the

organs and for the detection of potentially transmissible diseases and of possible

contraindications with respect to organ donation.

Image tests

Image explorations necessary for the assessment of the anatomical status of

the organs for transplantation.

Therapy

Treatments administered to the donor and relevant for the assessment of the

functional status of the organs and the suitability for organ donation, in particular

the use of antibiotics, inotropic support or transfusion therapy.

€1.44

In these regulations unless the context otherwise requires

Interpretation.

"authorisation" means authorisation, accreditation, designation,

licensing or registration;

"disposal" means the final placement of an organ where it is not

used for transplantation;

"donation" means donating organs for transplantation;

"donor" means a person who donates one or several organs,

whether donation occurs during lifetime or after death;

"donor characterisation" means the collection of the relevant

information on the characteristics of the donor needed to evaluate

such person’s suitability for organ donation, in order to undertake a

proper risk assessment and minimise the risks for the recipient, and

optimise organ allocation;

"European organ exchange organisation" means a non-profit

organisation, whether public or private, dedicated to national and

cross-border organ exchange, in which the majority of its member

countries are Member States;

"operating procedures" means written instructions describing

the steps in a specific process, including the materials and methods to

be used and the expected end outcome;

"organ" means a differentiated part of the human body, formed

by different tissues, that maintains its structure, vascularisation, and

capacity to develop physiological functions with a significant level of

autonomy. A part of an organ is also considered to be an organ if its

function is to be used for the same purpose as the entire organ in the

human body, maintaining the requirements of structure and

vascularisation;

"organ characterisation" means the collection of the relevant

information on the characteristics of the organ needed to evaluate its

suitability, in order to undertake a proper risk assessment and

minimise the risks for the recipient, and optimise organ allocation;

"preservation" means the use of chemical agents, alterations in

environmental conditions or other means to prevent or retard

biological or physical deterioration of organs from procurement to

transplantation;

"procurement" means a process by which the donated organs

become available;

"procurement organisation" means a healthcare establishment, a

team or a unit of a hospital, a person, or any other body which

undertakes or coordinates the procurement of organs, and is

authorised to do so by the Authority under the regulatory framework

in the Member State concerned;

"recipient" means a person who receives a transplant of an

organ;

"serious adverse event" means any undesired and unexpected

occurrence associated with any stage of the chain from donation to

transplantation that might lead to the transmission of a communicable

disease, to death or life-threatening, disabling or incapacitating

conditions for patients or which results in, or prolongs, hospitalisation

or morbidity;

"serious adverse reaction" means an unintended response,

including a communicable disease, in the living donor or in the

recipient that might be associated with any stage of the chain from

donation to transplantation that is fatal, life-threatening, disabling,

incapacitating, or which results in, or prolongs, hospitalisation or

morbidity;

"traceability" means the ability to locate and identify the organ

at each stage in the chain from donation to transplantation or disposal,

including the ability to

-

identify

the

donor

and

the

procurement

organisation,

-

identify any recipient at any transplantation centre,

and locate and identify all relevant non-personal information relating

to products and materials coming into contact with that organ;

"transplantation" means a process intended to restore certain

functions of the human body by transferring an organ from a donor to

a recipient;

"transplantation centre" means a healthcare establishment, a

team or a unit of a hospital or any other body which undertakes the

transplantation of organs and is authorised to do so by the Authority

under the regulatory framework in the Member State concerned.

(1)

The Superintendent of Public Health shall be the The Licensing

Authority.

Licensing Authority for the purposes of these regulations.

(2) The Licensing Authority, hereinafter referred to as "the

Authority", shall have the following functions

(a)

to ensure that procurement organisations and

transplantation centres have in place a framework for quality

and safety in accordance with regulation 4;

(b)

to indicate to the procurement organisations and

transplantation centres which activities they may undertake;

(c)

to establish conditions applicable to procurement

organisations and transplantation centres;

(d)

to issue, renew, amend, vary, suspend or revoke

any licence that may be required by or under these regulations;

(e)

to carry out inspections of procurement

organisations, conditions of procurement and transplantation

centres and to organize control measures in such procurement

organisations and transplantation regularly and in any case not

less than once every two years;

(f)

to grant, suspend, or withdraw, as appropriate, the

authorisations of procurement organisations or transplantation

centres or prohibit procurement organisations or transplantation

centres from carrying out their activities where control

measures demonstrate that such organisations or centres are not

complying with the requirements of these regulations;

(g)

to establish guidelines concerning the conditions of

the inspections and control measures, and on the training and

qualification of the officials involved in order to reach a

consistent level of competence and performance;

(h)

to put in place a reporting system and management

procedure for serious adverse events and reactions as provided

for in regulation 11(1) and (2);

(i)

to issue appropriate guidance to healthcare

establishments, professionals and other parties involved in all

stages of the chain from donation to transplantation or disposal,

which may include guidance for the collection of relevant post-

transplantation information to evaluate the quality and safety of

the organs transplanted;

(j)

supervise organ exchange with other Member

States and with third countries as provided for in regulation

18(1);

(k)

to ensure that the fundamental right to protection of

personal data is fully and effectively protected in all organ

transplantation activities, in conformity with the Data

Protection Act and European Union legal provisions on the

protection of personal data, in particular Directive 95/46/EC.

(3) The Licensing Authority may by rules delegate any of the

functions referred to in sub-regulation (2) to any other body it deems

competent. Such a body may also assist the Authority in carrying out

its functions.

(4) The Licensing Authority shall levy such fees as may be

prescribed for the purpose of this Act.

(1)

Procurement organisations and transplantation

centres shall be bound to have in place a framework for quality and

safety covering all stages of the chain from donation to

transplantation or disposal.

(2) The framework shall provide for the adoption and

implementation of operating procedures for

(a)

the verification of donor identity;

(b)

the verification of the details of the donor’s or the

donor’s family’s consent, authorisation or absence of any

objection, in accordance with the national rules that apply where

donation and procurement take place;

(c)

the verification of the completion of the organ and

donor characterisation in accordance with regulation 7 and the

Schedule;

(d)

the procurement, preservation, packaging and

labelling of organs in accordance with regulations 5, 6 and 8;

(e)

the transportation of organs in accordance with

regulation 8;

(f)

ensuring traceability, in accordance with regulation

10, guaranteeing compliance with European Union and national

legal provisions on the protection of personal data and

confidentiality;

(g)

the accurate, rapid and verifiable reporting of

serious adverse events and reactions in accordance with

regulation 11(1);

(h)

the management of serious adverse events and

reactions in accordance with regulation 11(2).

(3) Procurement organisations and transplant centres shall

ensure that the healthcare personnel involved at all stages of the chain

from donation to transplantation or disposal are suitably qualified or

trained and competent, and shall develop specific training

programmes for such personnel.

Procurement of organs shall take place in, or be carried out Procurement

by, procurement organisations that comply with the rules laid down in organisations.

these regulations.

(1)

Medical activities in procurement organisations, Requirements

such as donor selection and evaluation, shall be performed under the for

procurement of

advice and the guidance of a doctor of medicine as referred to in human organs.

Directive 2005/36/EC of the European Parliament and of the Council

of 7 September 2005 on the recognition of professional qualifications.

(2) Procurement shall take place in operating theatres, which

are designed, constructed, maintained and operated in accordance

with adequate standards and best medical practices so as to ensure the

quality and safety of the organs procured.

(3) Procurement materials and equipment shall be managed

with due regard to relevant national and international regulations,

standards and guidelines covering the sterilisation of medicines and

medical devices. Qualified, sterile instruments and procurement

devices shall be used for organ procurement.

(1) (a) All procured organs and donors thereof shall be

characterised before transplantation through the collection of the

information set out in the Schedule.

(b) The information specified in Part A of the

Schedule contains a set of minimum data which has to be collected

for each donation. Information specified in Part B of the Schedule

contains a set of complementary data to be collected in addition,

based on the decision of the medical team, taking into account the

availability of such information and the particular circumstances of

the case.

(2) Notwithstanding the provisions of sub-regulation (1), if

according to a risk-benefit analysis in a particular case, including in

life-threatening emergencies, the expected benefits for the recipient

outweigh the risks posed by incomplete data, an organ may be

considered for transplantation even where not all of the minimum

data specified in Part A of the Schedule are available.

(3) In order to meet the quality and safety requirements laid

down in these regulations, the medical team shall endeavour to obtain

all necessary information from living donors and for that purpose

shall provide them with the information they need in order to

understand the consequences of donation. In the case of deceased

donation, where possible and appropriate, the medical team shall

endeavour to obtain such information from relatives of the deceased

donor or other persons. The medical team shall also endeavour to

make all parties from whom information is requested aware of the

importance of the swift transmission of that information.

(4) The tests required for organ and donor characterisation

shall be carried out by laboratories with suitably qualified or trained

and competent personnel and adequate facilities and equipment.

(5) Organisations, bodies and laboratories involved in organ

and donor characterisation shall have appropriate operating

procedures in place to ensure that the information on organ and donor

characterisation reaches the transplantation centre in due time.

(6) Where organs are exchanged between Member States, the

information on organ and donor characterisation, as specified in the

Schedule, shall be transmitted to the other Member State with which

the organ is exchanged.

(1)

The following requirements shall be met during the

transportation of organs

(a)

the organisations, bodies or companies involved in

the transportation of organs shall have appropriate operating

procedures in place to ensure the integrity of the organs during

transport and a suitable transport time;

(b)

the shipping containers used for transporting

organs shall be labelled with the following information

(i) identification of the procurement organisation

and the establishment where the procurement took place,

including their addresses and telephone numbers;

(ii) identification of the transplantation centre of

destination, including its address and telephone number;

(iii) a statement that the package contains an

organ, specifying the type of organ and, where applicable,

its left or right location and marked "HANDLE WITH

CARE";

(iv) recommended transport conditions, including

instructions for keeping the container at an appropriate

temperature and position;

(c)

the organs transported shall be accompanied by a

report on the organ and donor characterisation.

(2) The requirements laid down in sub-regulation (1)(b) need

not be met where the transportation is carried out within the same

establishment.

(1)

Transplantation shall take place in, or shall be Transplantation

centres.

carried out by, transplantation centres that are duly authorised.

(2) The Licensing Authority shall indicate in the authorisation

which activities the transplantation centre concerned may undertake.

(3) The transplantation centre shall verify before proceeding

to transplantation that

(a)

the organ and donor characterisation are completed

and recorded in accordance with regulation 6 and the Schedule;

(b)

the conditions of preservation and transport of

shipped organs have been maintained.

(4) The Licensing Authority shall, upon the request of the

European Commission or another Member State, provide information

on the national requirements for the authorisation of transplantation

centres.

(1)

Procurement organisations and transplantation

centres shall ensure that

(a)

all organs procured, allocated and transplanted on

their territory can be traced from the donor to the recipient and

vice versa in order to safeguard the health of donors and

recipients;

(b)

they have a donor and recipient identification

system that can identify each donation and each of the organs

and recipients associated with it.

(2) With regard to such a system, it shall be ensured that

confidentiality and data security measures are in place in compliance

with the provisions of article 16 of the Data Protection Act.

(3) (a)

The bodies involved in the chain from donation to

transplantation or disposal shall keep the data needed to ensure

traceability at all stages of the chain from donation to transplantation

or disposal and the information on organ and donor characterisation

as specified in the Schedule, in accordance with the framework for

quality and safety.

(b)

Data required for full traceability shall be kept for a

minimum of thirty years after donation. Such data may be stored in

electronic form.

(4) Where organs are exchanged between Member States, the

procurement organisations and transplant centres shall transmit the

necessary information to ensure the traceability of organs, in

conformity with the procedures established by the European

Commission pursuant to Article 29 of Directive 2010/53/EU.

(1)

Procurement organisations and transplant centres

shall establish and maintain a system to report, investigate, register

and transmit relevant and necessary information concerning serious

adverse events that may influence the quality and safety of organs and

that may be attributed to the testing, characterisation, procurement,

preservation and transport of organs, as well as any serious adverse

reaction observed during or after transplantation which may be

connected to those activities.

(2) Procurement organisations and transplant centres shall

have an operating procedure in place for the management of serious

adverse events and reactions.

(3) In particular, and with regard to sub-regulations (1) and

(2), procurement organisations and transplant centres shall ensure that

operating procedures are in place for the notification, in due time, of

(a)

any serious adverse event and reaction to the

Licensing Authority and to the concerned procurement

organisation or transplantation centre;

(b)

the management measures with regard to serious

adverse events and reactions to the Authority.

(4) Where organs are exchanged between Member States, the

procurement organisations and transplant centres shall ensure that

serious adverse events and reactions are reported in conformity with

the procedures established by the European Commission pursuant to

Article 29 of Directive 2010/53/EU.

(5) Procurement organisations shall, where relevant, ensure

the interconnection between the reporting system referred to in sub-

regulation (1) and the notification system established in accordance

with regulation 8 of the Tissues and Cells (Quality and Safety) L.N. 271 of

2006. Regulations, 2006.

(1)

Healthcare personnel directly involved in the chain Healthcare

from donation to the transplantation or disposal of organs shall be personnel.

suitably qualified or trained and competent to perform their tasks and

are provided with the relevant training, as referred to in regulation

4(3).

(2) Procurement of organs shall be carried out by persons who

have successfully completed a training programme specified by a

clinical team specialising in the organs to be procured, or in a centre

authorised for procurement.

(1)

Donations of organs from deceased and living Principles

governing organ

donors shall be voluntary and unpaid.

donation.

(2) The principle of non-payment shall not prevent living

donors from receiving compensation, provided it is strictly limited to

making good the expenses and loss of income related to the donation.

The Authority shall define the conditions under which such

compensation may be granted, while avoiding there being any

financial incentives or benefit for a potential donor.

(3) It shall be illegal to advertise the need for, or availability

of, organs where such advertising is with a view to offering or

seeking financial gain or comparable advantage.

(4) A person who engages in an activity to which sub-

regulation (3) applies does not commit an offence under that sub-

regulation if he is designated by the Licensing Authority as a person

who may lawfully engage in the activity.

(5) The procurement of organs shall be carried out on a non-

profit basis.

(1)

The Authority shall lay down the standards

expected in relation to the obtaining of consent.

(2) The procurement of organs shall be carried out only after

all requirements relating to consent, authorisation or absence of any

objection have been met.

(3) The procurement of organs shall be carried out only when

(a)

all prospective organ donors, their relatives or any

other person granting consent on behalf of donors, have been

given information in accordance with guidelines and

authorisation requirements as established by the Authority;

(b)

information in accordance with guidelines and

authorization requirements established by the Authority has

been obtained from all persons who are willing to donate

organs, their relatives or any other person granting consent on

behalf of donors.

(1)

Procurement organisations and transplant centres

shall take all necessary measures to ensure the highest possible

protection of living donors in order to fully guarantee the quality and

safety of organs for transplantation.

(2) Procurement organisations and transplant centres shall

ensure that living donors are selected on the basis of their health and

medical history, by suitably qualified or trained and competent

professionals. Such assessments may provide for the exclusion of

persons whose donation could present unacceptable health risks.

(3) Procurement organisations and transplant centres shall

keep and maintain a register or record of the living donors.

(4) Living donors shall be followed up and procurement

organisations, transplant centres and institutions responsible for the

follow up of living donors shall have a system in order to identify,

report and manage any event potentially relating to the quality and

safety of the donated organ, and hence of the safety of the recipient,

as well as any serious adverse reaction in the living donor that may

result from the donation. Such adverse events and reactions shall be

reported to the Authority.

Procurement organisations and transplant centres Protection of

shall ensure that the fundamental right to protection of personal data personal

confidentiality

is fully and effectively protected in all organ donation and and

processing.

transplantation activities, in conformity with the provisions on the Cap. 440.

protection of personal data laid down in the Data Protection Act.

(2) Procurement organisations and transplant centres shall take

all necessary measures to ensure that

(a)

the data processed are kept confidential and secure

in accordance with articles 25 and 26 of Data Protection Act;

(b)

donors and recipients whose data are processed

within the scope of these regulations are not identifiable, except

as permitted by article 15 of the Data Protection Act;

(c)

the principles relating to data quality, as set out in

article 7 of the Data Protection Act, are met.

(3) Procurement organisations and transplant centres shall

(a)

data security measures are in place, as well as

safeguards against any unauthorised data additions, deletions or

modifications to donor files or deferral records, and transfer of

information;

(b)

procedures

are

in

place

to

resolve

data

discrepancies;

(c)

no unauthorised disclosure of information occurs,

whilst guaranteeing the traceability of donations;

(d)

the identity of any recipient is not disclosed to the

donor or his family and vice-versa;

(e)

the information which is collected for the purposes

of these regulations is held securely to ensure that -

(i) the information is available for the purpose of

tracing donations;

(ii) the information is only disclosed in

accordance with an order by the courts, upon request by

the Licensing Authority or as permitted by law.

(4) The medical director responsible for the procurement

organisation or the transplantation centre shall ensure that the results

of the donor evaluation and testing procedures are documented and

any major anomalies are reported to the Licensing Authority.

(5) Any unauthorised accessing of data or systems that makes

identification of donor or recipients possible shall be punishable in

accordance with regulation 20.

(6) Any use of systems or data that makes the identification of

donors or recipients possible with a view to tracing donors or

recipients other than for the purposes permitted by articles 12, 13, 14

and 15 of the Data Protection Act, or as provided in these regulations,

shall be punishable in accordance with regulation 20 of these

regulations.

(1)

L-organizzazzjonijiet ta’ ksib u ċentri ta’ trapjanti Protezzjoni ta’

għandhom jiżguraw illi d-dritt fundamentali għall-protezzjoni ta’ data

kunfidenzjalità

data personali jkun kompletament u effettivament imħares f’kull u ipproċessar.

donazzjoni ta’ organi u attivitajiet ta’ trapjant, konformement mad-

dispożizzjonijiet dwar il-protezzjoni ta’ data personali li jinsabu fl-

Att dwar il-Protezzjoni u l-Privatezza tad-Data.

(2) L-organizzazzjonijiet ta’ ksib u ċentri ta’ trapjanti

għandhom jieħdu l-miżuri kollha meħtieġa biex jiżguraw illi

(a)

id-data

ipproċessata

jinżammu

b’mod

kunfidenzjali u sikur kif hemm fl-artikoli 25 u 26 tal-Att dwar Kap. 440.

il-Protezzjoni u l-Privatezza tad-Data;

(b)

id-donaturi u r-riċevituri li jkollhom id-data

tagħhom ipproċessati fil-kuntest tal-iskop ta’ dawn ir-

regolamenti ma jkunux identifikabbli, ħlief kif permess bl-

artikolu 15 tal-Att dwar il-Protezzjoni u l-Privatezza tad-Data; Kap. 440.

(ċ)

jitħarsu l-prinċipji li għandhom x’jaqsmu mal-

kwalità ta’ data, kif stabbiliti fl-artikolu 7 tal-Att dwar il- Kap. 440.

Protezzjoni u l-Privatezza tad-Data.

(3) L-organizzazzjonijiet ta’ ksib u ċentri ta’ trapjanti

għandhom jiżguraw illi

(a)

jkunu qegħdin jiffunzjonaw miżuri ta’ sikurtà ta’

data, kif ukoll salvagwardji kontra kull żieda, tħassir jew tibdil

ta’ data mhux awtorizzat fil-files jew rekords ta’ differiment ta’

donatur, u t-trasferiment ta’ informazzjoni;

(b)

jkunu qegħdin jiffunzjonaw proċeduri li jirrisolvu

diskrepanzi fid-data;

(ċ)

ma jseħħ ebda żvelar mhux awtorizzat ta’

informazzjoni, filwaqt li tiġi garantita t-traċċabilità ta’

donazzjonijiet;

(d)

ma tiġi żvelata l-identità ta’ ebda riċevitur lid-

donatur jew lill-familja tiegħu u viċi versa;

(e)

l-informazzjoni li tinġabar għall-finijiet ta’ dawn

ir-regolamenti tinżamm b’mod sikur hekk li tiżgura li -

(i) l-informazzjoni tkun disponibbli għall-fini li

jiġu ttraċċati d-donazzjonijiet;

(ii) l-informazzjoni tiġi biss żvelata meta jkun

hemm xi ordni tal-qorti, fuq talba tal-Awtorità dwar il-

Liċenzi jew hekk kif ikun permess bil-liġi.

(4) Id-direttur mediku responsabbli għall-organizzazzjoni ta’

ksib jew għaċ-ċentru ta’ trapjant għandhom jiżguraw illi jiġu

dokumentati r-riżultati tal-evalwazzjoni u tal-proċeduri ta’ ittestjar

tad-donatur u li kull anomalija maġġuri tiġi rappurtata lill-Awtorità

dwar il-Liċenzi.

(5) Kull aċċess mhux awtorizzat ta’ data jew ta’ sistemi li

jagħmlu l-identifikazzjoni ta’ donatur jew riċevituri possibbli għandu

jkun penalizzat kif hemm fir-regolament 20.

(6) Kull użu ta’ sistemi jew data li jagħmlu l-identifikazzjoni

ta’ donaturi jew riċevituri possibbli bil-għan li jiġu ttraċċati d-

donaturi jew ir-riċevituri ħlief għall-finijiet permessi bl-artikoli 12,

13, 14 u 15 tal-Att dwar il-Protezzjoni u l-Privatezza tad-Data, jew

kif provdut f’dawn ir-regolamenti, għandu jkun penalizzat kif hemm

fir-regolament 20.

(1)

The Licensing Authority shall

(a)

keep a record of the activities of procurement

organisations and transplantation centres, including aggregated

numbers of living and deceased donors, and the types and

quantities of organs procured and transplanted, or otherwise

disposed of in accordance with European Union and national

legal provisions on the protection of personal data and statistical

confidentiality;

(b)

draw up and make publicly accessible an annual

report on activities referred to in paragraph (a);

(c)

establish and maintain an updated record of

procurement organisations and transplantation centres.

(2) The Licensing Authority shall, upon the request of the

European Commission or another Member State, provide information

on the record of procurement organisations and transplantation

centres.

(1)

The Licensing Authority shall authorise and

supervise organ exchange with third countries. For this purpose, the

Licensing Authority may authorise procurement organisations and

transplant centres to conclude agreements with counterparts in third

countries.

(2) The supervision of organ exchange with third countries

may be delegated by the Licensing Authority to European organ

exchange organisations.

(3) European organ exchange organisations may conclude

agreements with counterparts in third countries.

(4) Organ exchange, as referred to in sub-regulation (1), shall

be allowed only where the organs

(a)

can be traced from the donor to the recipient and

vice versa;

(b)

meet quality and safety requirements equivalent to

those laid down in these regulations.

The Licensing Authority may authorise procurement European organ

organisations and transplant centres to conclude agreements with exchange

organisations.

European organ exchange organisations, provided that such

organisations ensure compliance with the requirements laid down in

these regulations, delegating to those organisations, inter alia

(a)

the performance of activities provided for under the

framework for quality and safety;

(b)

specific tasks in relation to the exchanges of organs

to and from Member States and third countries.

(1)

Any person who fails to comply with any of the Penalties.

provisions of these regulations or rules made thereunder, shall be

guilty of an offence and shall, on conviction, be liable a fine (multa)

not exceeding eleven thousand six hundred and forty-six euro

(€11,646).

(2) (a)

Notwithstanding any other law providing for the

trial of offences, where the Authority believes that a person has

committed an offence against these regulations, the Licensing

Authority shall give notice in writing to such person describing the

offence of which the person is accused, indicating the steps to be

taken to remedy the offence and the penalty he is required to pay in

respect of that offence.

(b)

The Minister may further prescribe the penalties

that may be demanded by the Licensing Authority in relation to any

specified offence provided that such penalty shall not exceed the

amount of eleven thousand six hundred and forty-six euro (€11,646).

(3) Where a notice under this article has been given, the Special

person named in the notice may, within twenty-one days of the procedure.

service of the notice, accept responsibility for the offence specified in

the notice and within the same period pay the penalty indicated in the

notice, and comply with the relative provision of these regulations or

rules made thereunder and no further proceedings may be taken under

this Act in respect of such offence.

(4) Where the person to whom notice is given under sub-

regulation (1) has not paid the penalty within the twenty-one day

period referred to in sub-regulation (3) and has not, within the time

specified, complied with the requirements of these regulations,

criminal proceedings may be taken against him in accordance with

the provisions of the Criminal Code, of these regulations and of any

other law applicable to the offence.