ACT No. XXI of 2012 AN ACT to provide for the protection of human embryos and other ancillary matters.

I assent.

G EORGE A BELA

(L.S.)

President

4th December, 2012

ACT No. XXI of 2012

AN ACT to provide for the protection of human embryos and

other ancillary matters.

BE IT ENACTED by the President, by and with the advice and

consent of the House of Representatives, in this present Parliament

assembled, and by the authority of the same as follows:-

(1)

The short title of this Act is the Embryo Protection

Act, 2012.

(2) This Act shall come into force on such date as the Minister

responsible for justice, with the concurrence of the Minister

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

different dates may be so established for different provisions and

different purposes thereof.

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;

"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;

"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;

"medically assisted procreation" means that process whereby an

embryo would develop following the bringing together of gametes,

which process would have been aided or assisted by means which go

beyond the workings of the natural process, and which includes all

types of intervention, be they intracorporeal or extracorporeal that

help the bringing together of gametes, and their implanting or the

implanting of the embryo that could have developed from this

intervention within the reproductive system of the female;

"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 either of two persons of the opposite

sex who are united in marriage, or who have attained the age of

majority and are in a stable relationship with each other.

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

Protection Authority, which shall consist of a Chairman and such and

of the Embryo

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

Authority.

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

to continue in office or has become incapable of properly 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 following

(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;

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

suspicion that the provisions of this Act 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

article 18 is 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

(ii) the codes of practice established under

paragraph (a);

(f)

to perform such other functions as may, from time to

time, be prescribed by regulations made under this Act.

(2) Notwithstanding the provisions of article 7 but subject to

the provisions of article 18, the Authority may give for adoption the

fertilized egg cells, in the case where, after the fertilization of the egg

cells but before the implantation of the fertilized embryos into the

womb has taken place, death of the woman ensues or where for any

other reason the implantation of the fertilized embryo into the womb

cannot take place.

(3) 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 during the period from the day in which the

implantation of the fertilized embryo into the womb 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 prospective parent or parents, or in their

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

of the Authority for giving for adoption the fertilized egg cells or

within one year from the day in which the implantation of the

fertilized embryo into the womb could not take place for a reason or

reasons above mentioned, file an application taken upon oath asking

the Civil Court (Family Section) to decide in the supreme interest of

the embryo to whom the embryo should be given for adoption.

(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 woman

from whom the cell originated;

(b) intentionally fertilizes more than two egg cells from

one woman within one treatment cycle

Provided that in exceptional cases the medical

practitioner in charge of the medically assisted procreation may

decide to transfer up to a maximum of three fertilized egg cells

from one woman within one treatment cycle provided that this

is done in accordance with a protocol established in writing by

the Authority after consulting the associations which, according

to law, represent the medical practitioners who exercise their

profession in the fields of obstetrics and paediatrics. Such a

protocol shall include, without prejudice to other criteria, clear

criteria regarding the age of the woman who will be

participating in such a procedure and after how many cycles in

accordance with paragraph (b) may the medical practitioner

decide to fertilize up to a maximum of three egg cells

Provided further that the above mentioned Protocol

may be substituted by a Protocol agreed upon by the Authority

and the associations which, according to law, represent the

medical practitioners who exercise their profession in the fields

of obstetrics and paediatrics which specifies in a detailed

manner the best medical practice in the field of medically

assisted procreation. If such an agreement on a Protocol

between the Authority and the associations cannot be agreed

upon, then the Protocol established in writing by the Authority

under the first proviso shall apply

Provided further that authenticated copies shall be

sent within two days to the Minister responsible for Health and

the Speaker of the House of Representatives. The Speaker of the

House of Representatives, or in his absence the Deputy Speaker,

shall put the authorised copy of the document on the Table of

the House on the next first Parliamentary sitting

Provided further that where the person is a medical

practitioner, no criminal proceedings can be undertaken against

that medical practitioner if the medical practitioner is strictly

acting in good faith and according to the Protocol mentioned;

(c) does not transfer all embryos produced into a

woman within one treatment cycle;

(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;

(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 woman from whom the egg cell or

embryo originated, 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.

All forms of preservation, including cryo-preservation of

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 where the transfer of the fertilized embryos

into the womb is not possible owing to grave and certified force

majeure not predictable at the moment of fertilization, it shall be

lawful to preserve such embryos up to the date of such transfer which

shall take place as soon as possible

Provided further that when there has been a breach of any

provision of this Act, the Authority may order the freezing of any

embryo to preserve its life.

(1) Whosoever, other than for the purpose of

implantation in a woman 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 woman

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 embryo 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.

The use, transfer or the fertilisation of any germ line cells Improper use

not originating from the prospective parent is prohibited and any etc., of gametes.

person, who contravenes this article 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

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 within the meaning of this

Act.

(1) Whosoever artificially fertilizes a human egg cell Prohibition of

with a sperm cell that is selected for the sex chromosome contained in selection of sex.

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 Prohibition of

genetically identical to another embryo, foetus, or human being, cloning.

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 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 after his death,

(d) knowingly artificially fertilizes an egg cell of a

woman after her death,

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

by the same person from whom the sperm or egg was taken and

frozen for the generation of an embryo with a person of the opposite

sex

Provided that nothing in this Act shall be construed as

allowing, at any stage, the transfer and, or donation of the human egg

cells and, or the human sperm cells.

(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-

Prohibition of

formation of

chimerae and

(a)

unites embryos with different genetic material to a

hybrids.

cell 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 Prohibition of

prohibited and whosoever contravenes this sub-article shall be guilty experimentation

on human

of an offence and, on conviction, shall liable to the punishment of a embryos.

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 no other alternative medical method or

procedure is available and the consent of the prospective parents has

been given in writing and there is no undue risk to the embryo and to

the mother.

(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.

(1) The consent of both prospective parents who are to

have access to medically assisted procreation procedures is to be

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

regulations under this Act, to, and in the presence of the medical

practitioner in charge of the procedure

Provided that such consent may only be withdrawn in

writing by either of the prospective parent 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 both 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 freezing process

involved as referred to in article 4(2); and

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

procedure.

(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

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 both

prospective parents received the required counselling.

Any child born as a result of any medically assisted Status of child

procreation procedure shall be considered to be the child of the born.

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 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.

(1) A health care professional is under no obligation to Conscientious

participate in any procedure for the application of any technique of objection.

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.

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.

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.

Passed by the House of Representatives at Sitting No. 528 of the

26th November, 2012.

M ICHAEL F RENDO

Speaker

R AYMOND S CICLUNA

Clerk to the House of Representatives