ACT No. XXIV of 2018 AN ACT to amend the Embryo Protection Act, Cap. 524.

I assent.

(L.S.)

MARIE-LOUISE

COLEIRO PRECA

President

21st June, 2018

ACT No. XXIV of 2018

AN ACT to amend the Embryo Protection Act, Cap. 524.

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 Short title and

(Amendment) Act, 2018, and this Act shall be read and construed as one commencement.

with the Embryo Protection Act, hereinafter referred to as "the principal Cap. 524.

Act".

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

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

different dates may be so appointed for different provisions or different

purposes of this Act.

Article 2 of the principal Act shall be amended as follows

(a) immediately after the definition "Directive", there

shall be added the following new definition

" "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; siblings whether of the full or half-

blood; persons related by affinity in the direct line shall not be

permissible;";

(b) immediately after the definition "embryo" there shall

be added the following new definitions

" "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;";

(c) the definition of "medically assisted procreation"

shall be substituted by the following new definition

" "medically assisted procreation" means all

treatments or procedures that include the in vitro handling

of human oocytes, 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;";

(d) the definition of "prospective parent" shall be

substituted by the following new definition

" "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;"; and

(e) immediately after the definition "prospective parent"

there shall be added the following new definitions

" "Protocol" means the protocol established in

writing by the Authority in terms of this Act;

"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.".

Article 4 of the principal Act shall be amended as follows

Amendment of

article 4 of the

principal Act.

(a)

in sub-article (1) thereof

(i) in paragraph (a), for the words "medically assisted

procreation;" there shall be substituted the words "medically

assisted procreation and gamete donation;";

(ii) in paragraph (c), for the words "article 18 is" there

shall be substituted the words "this Act are";

(iii) paragraph (f) shall be renumbered as paragraph (h) and

immediately after paragraph (e) thereof, there shall be added the

following new paragraphs

"(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

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;";

(b)

sub-article (2) thereof shall by substituted by the following

"(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.";

(c) sub-article (3) thereof shall be renumbered as sub-article (4)

and immediately after sub-article (2), there shall be added the following

new sub-article

"(3) The adoption of an embryo may only take

p l a c e i f t h e A u t h o r i t y, o n t h e a p p l i c a t i o n o f 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 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 simultaneous

implantation of embryos originating from different

persons in a prospective parent during the same cycle is

prohibited.";

(d)

in the first proviso to sub-article (4) thereof as re-numbered

(i) immediately after the words "Provided that"

there shall be added the words "in the exceptional case when

the embryo has not yet been adopted by the prospective

parent or prospective parents";

(ii) for the words "into the womb" there shall be

substituted the words "into the womb of the prospective

parent"; and

(iii) the second proviso shall be substituted by the

following

"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."; and

(iv) immediately after sub-article (4) thereof as

renumbered there shall be added the following new sub-

articles

"(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 irrevocable.".

Article 6 of the principal Act shall be amended as follows

(a) in paragraph (a) thereof, for the words "woman from

whom the cell originated;" there shall be substituted the words

"prospective parent;";

(b) paragraph (b) thereof shall be substituted by the

following

"(b) intentionally fertilizes more than five egg cells

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

and up to a maximum of five fertilized egg cells within one

treatment cycle provided that this is done in accordance

with the Protocol established in writing by the Authority.

Such Protocol shall be discussed in the Parliamentary

Committee for Health within four weeks from date of

publication

Provided further that no more egg cells can be

fertilized until all the cryo-preserved embryos have been

implanted in the prospective parent from any prior medically

assisted procreation treatments

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) paragraph (c) thereof shall be substituted by the

following

"(c) transfers more than two embryos into the

prospective parent within each treatment cycle;"; and

(d) paragraph (i) of the proviso thereof shall be substituted

by the following

"(i) the prospective parent in respect of the

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

Article 7 of the principal Act shall be substituted by the Substitution of

article 7 of the

principal Act.

(1) Sperm cells may be cryo-preserved in

"Cryo-preservation

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 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 prior to the coming into force of this Act, 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.".

6. Article 8 of the principal Act shall be amended as follows

(a)

sub-article (1) thereof shall be substituted by the following

"(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."; and

(b) in sub-article (2) thereof, for the word "embryo" there shall be

substituted the words "fertilised egg".

7. Article 9 of the principal Act shall be substituted by the

(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

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)

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 person from whom an adopted embryo

originated shall be accessible to the child conceived

from the germ line cells of such donor either upon the

child reaching eighteen years of age or, subject to the

consent of the Authority, at any earlier stage in

exceptional circumstances in which the life or health of

the child born from such germ line cells is at risk

Provided further that the Authority shall keep

the records of the identity of the donor for a period of

hundred and ten 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.

(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, 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.".

8. Article 12 of the principal Act shall be amended as follows

(1)

in sub-article (1) thereof

(a)

in paragraph (c)

(i) immediately after the words "a man" there shall

be added the words "before or"; and

(ii) immediately after the words "after his death"

there shall be added the words", except in the case where the

deceased has donated his sperm";

(b)

in paragraph (d)

(i) immediately after the words "a woman" there

shall be added the word "before or"; and

(ii) immediately after the words "after her death"

there shall be added the words ", except in the case where

the deceased has donated her egg cells"; and

(2)

sub-article (2) thereof shall be substituted by the following

"(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.".

9. Article 18 of the principal Act shall be amended as follows

Amendment of

article 18 of the

principal Act.

(a)

sub-article (1) thereof shall be substituted by the following

"(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.";

(b)

sub-article (2) thereof shall be amended as follows

(i) for the words "both prospective parents" there shall be

substituted the words "the prospective parent or prospective

parents";

(ii) paragraph (f) thereof shall be substituted by the

following

"(f) the bioethical issues, including the cryo-

preservation process involved as referred to in article 4 and

article 7;";

(iii) in paragraph (g) thereof for the word "procedure."

there shall be substituted the word "procedure;"; and

(iv) immediately after paragraph (g) thereof, there shall be

added the following new paragraph

"(h) the circumstances in which the Authority may

give for adoption embryos to a third party in terms of this

Act."; and

(v) in sub-article (4) thereof, for the words "both

prospective parents" there shall be substituted the words "the

prospective parent or prospective parents".

Article 19 of the principal Act shall be substituted by the

(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.".

11. Article 22 of the principal Act shall be substituted by the Substitution of

article 22 of the

principal Act.

(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.".

12. In paragraph (a) of sub-article (1) of article 115 of the Civil Consequential

Code, for the words "not more than forty-five years" there shall be amendment

article 115 of

substituted the words "not more than forty-eight years".

the Civil Code.

13. In sub-regulation (1) of regulation 2 of the Leave for Medically Consequential

Assisted Procreation National Standard Order the definition amendment

the Leave for

"prospective parents" shall be substituted by the following

Medically

Assisted

Procreation

" "prospective parent" means any person National

Standard Order.

regardless of gender or sexual orientation, who has S.L. 452.114.

attained the age of majority and is a receptor or user of

the medically assisted procreation techniques regulated

under the Embryo Protection Act and for the purpose of

these regulations shall also include oocytes donors;".

Passed by the House of Representatives at Sitting No. 133 of the

19th June, 2018.

ANĠLU FARRUGIA

Speaker

RAYMOND SCICLUNA

Clerk of the House of Representatives

€1.44