EMBRYO PROTECTION ACT

EMBRYO PROTECTION

CHAPTER 524

EMBRYO PROTECTION ACT

To provide for the protection of human embryos and other ancillary

matters.

1st January, 2013 *

ACT XXI of 2012 , as amended by Acts XXIV of 2018 and XI of 2022.

The short title of this Act is the Embryo Protection Act.

In this Act, unless the context otherwise requires

"Authority" means the Embryo Protection Authority established

by article 3;

"the Council" means the Medical Council established by article 9

of the Health Care Professions Act;

"Directive" means the Commission Directive 2004/23/EC of the

European Parliament and of the Council of 31 March, 2004 on

setting standards of quality and safety for the donation,

procurement, testing, processing, preservation, storage and

distribution of human tissues and cells;

"donor" means a third party who donates germ line cells to be

used in medically assisted procreation

Provided that donations by an ascendant to a descendant,

descendant to an ascendant, from sibling to sibling, whether of the full

or half-blood, shall not be permissible;

"embryo" means the human organism that results from the

fertilisation of a human egg cell by a human sperm cell which is

capable of developing and shall further include each totipotent cell

removed from a human embryo or otherwise produced, that is

assumed to be able to divide and to develop as a human being under

the appropriate conditions;

"embryo adoption" means that process established in this Act

whereby embryos that are not transferred are gratuitously donated

to the prospective parent or prospective parents

Provided that this term does not have the same meaning

and shall not produce the same effects of "adoption" under the

Civil Code and the term "adoptive" shall be construed accordingly;

"embryo donation" means the transfer of an embryo resulting from

gametes (spermatozoa and oocytes) that did not originate from the

prospective parent or prospective parents;

"germ line cells" means all egg and sperm cells which may lead

to the resultant human being;

"health care professional" shall have the same meaning assigned

to it by article 2 of the Health Care Professions Act;

" m e d i c a l l y a s s i s t e d p r o c r e a t i o n " means all treatments or

procedures that include the in vitro handling of human oocytes,

*see article 1(2) as originally enacted, and Legal Notice 455 of 2012 .

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spermatozoa or embryos for establishing a pregnancy. This includes,

but is not limited to, intra-uterine insemination, in vitro fertilisation,

intracytoplasmic sperm injection, embryo transfer, gamete, germinal

tissue and embryo cryo-preservation, oocyte and embryo donation;

"medical practitioner" means a person licensed under the Health

Care Professions Act to practice as a medical practitioner;

"Minister" means the Minister responsible for health;

"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;

"Protocol" means the Protocol established in writing by the

Authority and brought into force by regulations made by the Minister

under this Act, as published in the Gazette;

"tissue establishment" means a facility or a unit of a hospital or

another body where the activities of processing, preservation, storage

or distribution of human tissues and cells for human application are

undertaken and it may also be responsible for procurement and, or

testing of tissues and cells.

(1) There shall be a body, to be known as the Embryo

Protection Authority, which shall consist of a Chairman and such

number of other members not being less than four who shall be

appointed by the Minister.

(2) The Chairman shall be a person in possession of a warrant

to exercise the profession of Advocate and who has exercised that

profession for at least twelve years or a retired Judge or a retired

Magistrate.

(3) A person shall not be qualified to hold office as a member

of the Authority if he

(a) is a Minister or Parliamentary Secretary;

(b) is a member of, or a candidate for election to, the

House; or

(c) is a member of a local government authority; or

(d) has a financial or other interest in any enterprise or

activity which is likely to affect the discharge of his

functions as a member of the Authority.

(4) Subject to the provisions of this article, the office of a

member of the Authority shall become vacant -

(a) at the expiration of five years from the date of his

appointment or at such earlier time as may be specified

in the instrument by which he was appointed; or

(b) if any circumstances arise that, if he were not a

member of the Authority, would cause him to be

disqualified for appointment as such.

(5) A member of the Authority may be removed from office by

the Minister if, in the opinion of the Minister, such member is unfit

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t o c o n t i n u e i n o ff i c e o r h a s b e c o m e i n c a p a b l e o f p r o p e r l y

performing his duties as a member, whether arising from infirmity

of mind or body or any other cause, or for misbehaviour.

(6) If the office of a member of the Authority is vacant or if a

member is for any reason unable to perform the functions of his

office, the Minister may appoint another person as a temporary

member of the Authority until the member who was unable to

perform the functions of his office resumes those functions.

(7) The members of the Authority, in the exercise of their

functions, shall act on their own individual judgement and shall not

be subject to the direction or control of any person or authority.

(1) The functions and powers of the Authority shall be the

(a) to ensure that high standards of ethics are maintained

by all medical practitioners, paramedics and other

personnel involved in procedures of medically assisted

procreation and gamete donation;

(b) to request and obtain, in cases of reasonable suspicion

that the provisions of this Act and any regulations made

thereunder are not being followed, information and

copies, in any form, of documents required by the

Directive to ensure traceability of human cells;

(c) 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 this Act and any

regulations made thereunder are being kept

appropriately and for this purpose to access clinics and

any other places as necessary;

(d) to maintain a statement of the general principles

which, in its opinion, should be followed

(i)

in carrying out its activities under this Act; and

(ii) in carrying out its functions in relation to such

activities under this Act;

(e) to ensure, in relation to activities under this Act,

compliance with

(i)

the obligations and requirements imposed by or

under this Act and any regulations made

thereunder; and

(ii) the codes of

practice

established

under

paragraph (a);

(f)

to determine the eligibility and suitability or otherwise

of a prospective adoptive parent in terms of the

Protocol in those cases where it may give for adoption

the embryos in terms of this Act and keep a register

thereof;

(g) to keep a register of every medically assisted

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procreation procedure, germ line cell donation, cryo-

preservation of germ line cells, cryo-preservation of

embryos and embryo donation and adoption in terms

of this Act which shall in all cases remain confidential;

(h) to perform such other functions as may, from time to

time, be prescribed by regulations made under this Act;

(i)

to establish and maintain a Protocol in writing, which

shall consist of the regulatory principles that shall be

followed in carrying out its functions under this Act

Provided that such Protocol shall be discussed in the

Standing Committee on Health within four (4) weeks

from the date of publication of the regulations referred to

in the definition "Protocol" in article 2.

(2) Notwithstanding the provisions of any other law and

notwithstanding the provisions of article 7 but subject to the

provisions of article 18, the 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; or

(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 or has reached the

maximum permissible age for the implantation thereof

or fails to renew the contract with the licensee where

the cryo-preserved embryos are being stored for future

use

Provided that the Authority shall give for adoption the embryos

when the prospective parent has reached the maximum permissible age

for the implantation thereof.

(3)

The adoption of an embryo may only take place if the

Authority, on the application of a prospective parent or prospective

parents, so decides

Provided that the 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 determining the

eligibility and suitability or otherwise of the prospective parent or

prospective parents

Provided further that the Authority shall make all reasonable

efforts to match prospective adoptive parents with the embryos who

require an adoption placement

Provided further that, without prejudice to the provisions of

sub-article (4) of article 9, the identity of the adopter or adopters and the

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persons from whom the germ line cells originated shall in all cases

remain anonymous and the prospective parents shall only be entitled to

such generic information as specified in the Protocol

Provided further that the Authority shall be obliged to provide

the prospective parent or prospective parents with medical and, or

diagnostic information concerning the embryo as specified in the

Protocol defined in article 2

Provided further that the simultaneous implantation of embryos

originating from different persons in a prospective parent during the

same cycle is prohibited.

(4) Nothing in this article shall prejudice the authority or the

exercise of any function or power of the Licencing Authority under

the Human Blood and Transplants Act

Provided that in the exceptional case when the embryo has not

yet been adopted by the prospective parent or prospective parents

during the period from the day in which the implantation of the

fertilized embryo into the womb of the prospective parent cannot take

place for the reasons mentioned in this article until the day of

giving the embryo for adoption, the Authority shall be deemed to

be curator of the embryo for all intents and purposes of the law and

the Authority shall immediately and during the duration of the

curatorship inform and consult with the prospective parent or

parents, or in their absence their legal heir, on the decisions which

need to be taken on the embryo. In the case that both prospective

parents can still be consulted, the Authority shall, in so far as it is

possible, respect the wishes of the prospective parents within the

parameters of this Act

Provided that any person having a juridical interest, or in

their absence their legal heir, within twenty days from the date of

decision of the Authority for giving for adoption the embryos may

file a sworn application in the Civil Court (Family Section) to

enquire into the validity of the decision of the Authority and there

shall be a right of appeal therefrom to the Civil Court (Family

Section) before the Court of Appeal by means of an application

filed within twenty days from the date of the decision of the Civil

Court (Family Section). Where no application is filed before the

Civil Court (Family Section) according to the provisions of this

article, or where the judicial proceedings are withdrawn or

discontinued, or where the judicial proceedings become res

judicata, the decision of the Authority or the court becomes final

Provided further that the embryo shall remain cryo-preserved

until the decision of the Authority or the court becomes final.

(5) When the decision of the Authority or the court giving an

embryo for adoption becomes final, that embryo shall be considered as

the embryo of the adopter or adopters and the persons from whom the

embryo originated shall lose all rights and shall be freed from all

obligations with respect thereto.

(6) Save as otherwise provided in this article, once the decision of

the Authority giving an embryo for adoption becomes final, it shall be

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irrevocable.

(1) Any prospective parent shall have access to medically

assisted procreation procedures

Provided that these procedures may only be resorted to

where there is a reasonable chance of success and the procedures

do not entail any known undue risk to the health of the woman or

the child, beyond those already well known as inherently associated

with the procedure itself.

(2) Any person who provides, or assists in, any medically

assisted procreation procedure to a person other than a prospective

parent shall be guilty of an offence and shall, on conviction, be

liable to a fine (multa) of not less than ten thousand euro (€10,000)

and not exceeding twenty-three thousand euro (€23,000) or to

imprisonment not exceeding five years or to both such fine and

imprisonment

Provided that where the person is a medical practitioner,

who performs the said procedure, the medical practitioner shall be

exempt from criminal liability where he shows that he took

reasonable care to determine that the person on whom the

procedure was performed or attempted was entitled to access to

such procedure.

Whosoever -

(a) artificially fertilizes any egg cell for any purpose other

than that of bringing about the pregnancy of the

prospective parent;

(b) intentionally fertilizes more egg cells than the maximum

amount established by the Protocol from one woman in

one cycle of treatment

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 Authority,

decide to fertilize more than two egg cells within one (1) treatment

cycle provided that this is done in accordance with the Protocol

Provided further that no more egg cells can be fertilized

until all the cryo-preserved embryos have been implanted in the

prospective parent from whom they originate from any prior

medically assisted procreation treatments except in those instances

which may be specified in the Protocol and with the prior authorisation

of the Authority, in which case, the fertilisation of more egg cells shall

be permissible

Provided further that where the prospective parent or

prospective parents undergoing medically assisted procreation

procedures do not expressly give their consent to the cryo-preservation

of embryos and to the donation of fertilized eggs if necessary, in terms

of article 18, it shall not be lawful to fertilize more than two (2) eggs

within each treatment cycle.

(c) transfers more than two embryos into the prospective

parent within each treatment cycle;

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(d) removes an embryo from a woman before the

completion of implantation in the womb in order to

transfer the embryo to another woman;

(e) 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;

(f)

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),

shall be guilty of an offence and, on conviction, shall be liable to

the punishment of a fine (multa) of not less than five thousand euro

(€5,000) and not exceeding fifteen thousand euro (€15,000) or to

imprisonment not exceeding three years or to both such fine and

imprisonment

Provided that -

(i)

the prospective parent in respect of the conduct

referred to in paragraphs (a) and (d); and, or

(ii) the woman into whom the egg cell or embryo

will be transferred, in respect of the conduct

referred to in paragraph (f);

shall have the punishment decreased by one or two degrees.

(1)

Sperm cells may be cryo-preserved in authorized

tissue establishments during the lifetime of the person from whom

they originate.

(2)

Oocytes may be cryo-preserved 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 this Act

Provided that, in any case, it shall not be lawful to extract and

commence cryo-preservation of oocytes after the death of the person

from whom they originate.

(3)

Embryos which cannot be transferred into the prospective

parent within a treatment cycle shall be cryo-preserved in licensed

tissue establishments for future use by that prospective parent

Provided that the cryo-preservation of embryos shall be

regulated by an agreement between the prospective parent or

prospective parents and the licensee subject to the prior authorisation

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of the 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 the Protocol

Provided further that when the maximum permissible age

for the transfer of the embryo into the prospective parent is reached,

the Authority shall authorize the donation of the cryo-preservated

embryo.

(4)

Subject to the foregoing sub-articles, all other forms of

preservation, of germ line cells and embryos are prohibited and

whosoever contravenes this article shall be guilty of an offence and, on

conviction, shall be liable to the punishment of a fine (multa) of not

less than five thousand euro (€5,000) and not exceeding fifteen

thousand euro (€15,000) or to imprisonment not exceeding three years

or to both such fine and imprisonment

Provided that when there has been a breach of any provision

of this Act, the Authority may order the cryo-preservation of any

embryo.

(5)

A prospective parent or prospective parents who have cryo-

preserved embryos in tissue establishments abroad may apply to be

granted an authorisation by the Authority to bring two cryo-preserved

embryos to be transferred locally into the prospective parent or

prospective parents for each cycle

Provided that the Authority shall not authorise the transfer of

more than two embryos for each cycle.

(1) Whosoever, other than for the purpose of implantation in a

prospective parent as may be authorized by the provisions of this 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, shall be guilty of an offence

and, on conviction, shall be liable to the punishment of a fine (multa) of

not less than five thousand euro (€5,000) and not exceeding fifteen

thousand euro (€15,000) or to imprisonment not exceeding three years

or to both such fine and imprisonment.

(2) Whosoever causes a human fertilised egg to develop further

outside the body for any purpose other than in order to bring about

a pregnancy, shall be guilty of an offence and, on conviction, shall

be liable to the punishment of a fine (multa) of not less than five

thousand euro (€5,000) and not exceeding fifteen thousand euro

(€15,000) or to imprisonment not exceeding three years or to both

such fine and imprisonment.

(1)

The donation of germ line cells for the purpose of

medically assisted procreation shall be a confidential agreement

between the donor and the licensee

Provided that prior to entering into such an agreement, the

licensee shall duly inform the donor of the consequences thereof in

terms of this Act

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Provided further that where the donor has donated the germ

line cells in a tissue establishment abroad in accordance with the

Human Blood and Transplants Act and these germ line cells are to be

distributed and, or imported to a tissue establishment in Malta, there

shall be a third-party agreement signed between the Maltese licensee

and the licensee of the foreign tissue establishment

Provided further that 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.

(2)

A donor must be over eighteen (18) years of age, have the

legal capacity to contract and of good mental and physical health and

further satisfies the criteria specified in the Protocol.

(3)

A donor must not have attained the age of thirty-six (36)

years on day of donation

Provided that the Authority may authorise a donor above

this age limit in exceptional circumstances specified in the Protocol.

(4)

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

Provided that the medical records that may affect the health

of the child and the identity of the donor or of the persons from whom

an adopted embryo originated shall be accessible to the child

conceived from the germ line cells of such donor upon the child

reaching eighteen (18) years of age and, subject to the consent of the

Authority, the medical records that may affect the health of the child

shall be accessible to the parent or parents 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

Provided further that the Authority shall keep the records

traceable to the identity of the donor for a period of sixty-five (65)

years

Provided further that if the 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.

(5)

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.

(5A) Cryo-preserved germ line cells which have not been used in

Malta may be exported and, or distributed to tissue establishments

abroad

Provided further that the exportation and, or distribution of

germ line cells to tissue establishments abroad shall be recorded in

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such a way as to ensure their traceability and such record shall be

forwarded to the Authority without delay.

(6)

It shall be the responsibility of every licensee receiving

donor germ line cells to verify the eligibility and suitability of the

donor and the prospective parent to whom the germ line cells are

donated in terms of the foregoing provisions, to keep a register with

updated records thereof, including the records traceable to the donors

and to inform the Authority without delay the full details of every

donation.

(7)

Whosoever uses, transfers or fertilises any germ line cells in

contravention of this article shall be guilty of an offence and, on

conviction, shall be liable to the punishment of a fine (multa) of not

less than ten thousand euro (€10,000) and not exceeding twenty-three

thousand euro (€23,000) or to imprisonment not exceeding five years

or to both such fine and imprisonment

Provided that where the person is a medical practitioner he

shall be exempt from criminal liability where he shows that he took

reasonable care to determine that the person from whom the germ line

cells originated was a prospective parent or an eligible donor within

the meaning of this Act.

(8)

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

Provided that oocytes donors may be compensated for the costs

and expenses of the stimulation treatments.

(1) Whosoever artificially fertilizes a human egg cell with

a sperm cell that is selected for the sex chromosome contained in it,

shall be guilty of an offence and, on conviction, shall and liable to

the punishment of a fine (multa) of not less than four thousand euro

(€4,000) and not exceeding ten thousand euro (€10,000).

(2) Nothing contained in sub-article (1) 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.

(1) 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.

(2) Whosoever intervenes or participates in any artificial

intervention as referred to in sub-article (1) shall be guilty of an

offence and, on conviction, shall liable to the punishment of a fine

(multa) of not less than ten thousand euro (€10,000) and not

exceeding twenty-three thousand euro (€23,000) or to

imprisonment not exceeding five years or to both such fine and

imprisonment.

(3)

Whosoever transfers into a woman an embryo as referred to

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in sub-article (1) shall be liable to the same punishment laid down

in sub-article (2).

(1) Whosoever -

(a) 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;

(b) transfers an embryo into a woman without her consent;

(c) knowingly artificially fertilizes an egg cell with the

sperm of a man before or after his death, except in the

case where the deceased has donated his sperm;

(d) knowingly artificially fertilizes an egg cell of a woman

before or after her death, except in the case where the

deceased has donated her egg cells,

shall be guilty of an offence and shall, on conviction, be liable to a

fine (multa) of not less than ten thousand euro (€10,000) and not

exceeding twenty-five thousand euro (€25,000)

Provided that the punishment shall be decreased by one or

two degrees -

(i)

as regards the woman whose egg has been

fertilized, in respect of paragraph (c); and

(ii) as regards the man whose sperm was used for

fertilisation in respect of paragraph (d).

(2) Nothing in this 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.

(1) Subject to the provisions of sub-article (3), whosoever

shall willfully alter in an artificial way the genetic information of a

human germ line cell shall be guilty of an offence and, on

conviction, shall liable to the punishment of a fine (multa) of not

less than ten thousand euro (€10,000) and not exceeding twenty-

three thousand euro (€23,000) or to imprisonment not exceeding

five years or to both such fine and imprisonment.

(2) Whosoever knowingly uses a human germ line cell with

artificially altered genetic information for fertilization shall be

guilty of an offence and shall be liable to the same punishment laid

down in sub-article (1).

(3) No offence shall arise, against the medical practitioner

carrying out the medically assisted procedure, under sub-article (1)

where the alteration of the genetic information of a germ line cell is

the unintended consequence of inoculation, radiation or

chemotherapeutic or treatment.

(1) Whosoever-

(a) unites embryos with different genetic material to a cell

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conglomerate using at least one human embryo; or

(b) joins a human embryo with a cell that contains genetic

information different from the embryo cells and

induces them to develop further; or

(c) 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,

shall be guilty of an offence and, on conviction, shall liable to the

punishment of a fine (multa) not less than ten thousand euro

(€10,000) and not exceeding seventy thousand euro (€70,000) or to

imprisonment not exceeding seven years or to both such fine and

imprisonment.

(2) Whosoever transfers to a woman or an animal an embryo

arising out of a procedure described in sub-article (1) or transfers to

an animal a human embryo shall be guilty of an offence and shall

be liable to the same punishment laid down in sub-article (1).

(1) Any experimentation on human embryos is prohibited

and whosoever contravenes this sub-article shall be guilty of an

offence and, on conviction, shall liable to the punishment of a fine

(multa) not exceeding seventy thousand euro (€70,000) and to

imprisonment not exceeding seven years.

(2) The creation of human embryos for the purpose of research

or experimentation or for any other purpose not permitted under

this Act is prohibited and whosoever contravenes this sub-article

shall be guilty of an offence and shall be liable to the same

punishment laid down in sub-article (1).

(3) 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 in this sub-article 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.

(1) Whosoever wilfully causes the death of any embryo

shall be guilty of an offence and shall, on conviction, be liable to a

fine (multa) not exceeding twelve thousand euro (€12,000) or to

imprisonment not exceeding two years or to both such fine and

imprisonment.

(2) This article shall also apply to any human clone created in

breach of article 11.

The provisions of articles 121D and 248E(4) of the

Criminal Code shall, mutatis mutandis, apply to persons found

guilty of an offence under this Act.

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(1) The consent of the prospective parent or parents who

are to have access to medically assisted procreation procedures is

to be expressed in writing in such form, as may be prescribed by

regulations under this Act also specifying whether they consent to

cryo-preservation of any supernumerary embryos and whether they

consent to the donation of embryos, if necessary, to and in the

presence of the medical practitioner in charge of the procedure

Provided that where the prospective parents are married or

in a stable relationship, their consent shall be expressed jointly in

writing in the prescribed form

Provided further that when the prospective parent or

prospective parents give their consent to cryo-preservation 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

Provided further that when the prospective parent or

prospective parents do not give their consent to the cryo-

preservation of any supernumerary embryos and to the donation of

fertilised eggs if necessary, the medical practitioner in charge of the

procedure shall only fertilize up to a maximum of two eggs

Provided further that consent to cryo-preservation may only be

withdrawn in writing by the prospective parent or prospective parents

before fertilisation.

(2) For the purposes of informed consent and before applying

any procedure leading to medically assisted procreation, the

medical practitioner in charge of the procedure shall inform in

detail and in writing the prospective parent or prospective parents on

(a) the methods and treatment of any procedure to be

employed;

(b) the complications that may arise for the woman and

potential offspring;

(c) the probable chances of success of the said procedure;

(d) all the risks involved to both prospective parents and

the offspring;

(e) the possible psychological effects as a result of the

application of the said procedure to both prospective

parents and offspring;

(f)

the bioethical issues, including the cryo-preservation

process involved as referred to in article 4 and article 7;

(g) where applicable, on the cost of the entire procedure;

(h) the circumstances in which the Authority may give for

adoption embryos to a third party in terms of this Act.

(3) The medical practitioner in charge of the procedure shall

ensure that the prospective parents respectively receive independent

clinical counselling before, throughout and after the procedure.

(4)

Every medical practitioner responsible for a procedure of

EMBRYO PROTECTION

medically assisted procreation shall ensure that a copy is kept of all

the documentation required under this Act, including such

documentation certifying that the informed consent required under

this article was obtained after the same medical practitioner gave

the prospective parents all the information and after ensuring that

the prospective parent or prospective parents received the required

counselling.

(1)

Any child born as a result of any medically assisted

procreation procedure, including cases where the child was born from

donated germ line cells or a donated embryo, shall be considered to be

the child of the prospective parent or prospective parents who have

expressed their consent in writing as provided in article 18 and shall

for all intents and purposes of law be deemed to have been naturally

born of the same prospective parent or prospective 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 parent or

prospective parents who shall enjoy such rights and bear such duties

according to law in respect of such child.

(2) 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.

(1) 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 this Act when such

professional considers such participation objectionable as a matter

of conscience and declares his objection beforehand. Such a

declaration shall be communicated within three months from the

coming into force of this Act, to the Authority and to the director of

the hospital or medical establishment with whom the health care

professional is employed.

(2) The objection declared as provided in sub-article (1) may

be revoked or the said objection may be declared even after the

lapse of the period referred to in sub-article (1) but in such a case

the declaration raising the objection shall only come into effect

after the lapse of a month from the date of its communication as

provided in sub-article (1).

(3) The objection declared as provided in sub-articles (1) or (2)

shall have the effect of exempting the health care professional who

makes the declaration from any participation in any procedure or

activity specifically and necessarily directed towards the

implementation of the technique or procedure leading to a

medically assisted procreation but does not exempt him from

providing assistance before or after the said procedure or activity.

Without prejudice to any punishment as may be prescribed

by this Act or by any other law, where the person convicted of an

offence under this Act is a medical practitioner or a health care

professional, the Court shall order that a copy of the judgment be

served upon the competent council under the Health Care

Professions Act and on the Minister.

EMBRYO PROTECTION

(1)

No premises may be used for any activity related to

medically assisted procreation unless the premises are licensed for the

purpose by the Licensing Authority according to the Human Blood

and Transplants Act and any regulations made thereunder.

(2) It shall be the duty of every licensee to keep a confidential

register with full details of every medically assisted procreation

procedure, germ line cell donation, cryo-preservation of germ line

cells and cryo-preservation of embryos in terms of this Act and to pass

on this information to the Authority without delay.

(1) The Minister shall, with the concurrence of the Minister

responsible for justice, have power to make regulations to

(a) prescribe anything which may be prescribed for the

implementation and execution of the provisions of this

Act;

(b) regulate the licensing of any premises used for the

execution of any procedure of medically assisted

procreation including the conditions required for a

medical practitioner to practice any such procedure in

such premises;

(c) lay down any conditions for the execution of such

procedures of medically assisted procreation;

(d) enact or to bring into force any Protocol referred to in this

Act and to revoke, amend or vary the same.

(2) The Protocol issued in terms of this Act may be published

in the English language only.