ACT No. XI of 2022 AN ACT to amend various laws relating to Assisted Procreation and to make ancillary and consequential provisions thereto.

I assent.

(L.S.)

FRANK BEZZINA

Acting President

27th July, 2022

ACT No. XI of 2022

AN ACT to amend various laws relating to Assisted Procreation

and to make ancillary and consequential provisions thereto.

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 Various Laws relating to Short title and

commencement.

Assisted Procreation (Amendment) Act, 2022.

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

Minister responsible for health and the Minister responsible for social

policy may, by notice in the Gazette, establish and different dates may

be so established for different provisions and, or purposes of this Act.

PART I

AMENDMENTS TO THE EMBRYO PROTECTION ACT

This Part amends the Embryo Protection Act and it shall be

read and construed as one with the Embryo Protection Act, hereinafter

in this Part referred to as "the principal Act".

Article 2 of the principal Act shall be amended by the

following

(a) the proviso to the definition "donor" thereof shall be

substituted by the following

"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;"; and

(b) the definition "Protocol" thereof shall be substituted

by the following

" "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;".

Article 4 of the principal Act shall be amended by the

following

(a) in paragraphs (b) and (c) and sub-paragraph (i) of

paragraph (e) of sub-article (1) thereof, immediately after the

word "Act" there shall be added the words "and any regulations

made thereunder";

(b) in paragraph (h) of sub-article (1) thereof, the words

"under this Act." shall be substituted by the words "under this

Act;" and immediately thereafter there shall be added the

following new paragraph

"(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."; and

(c)

immediately after the third proviso to sub-article (3)

thereof there shall be added the following new proviso

"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:".

Article 6 of the principal Act shall be amended by the Amendment of

article 6 of the

following

principal Act.

(a)

in paragraph (b) thereof the words "more than five

egg cells" shall be substituted by the words "more egg cells than

the maximum amount established by the Protocol";

(b) in the first proviso to paragraph (b) thereof the words

"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" shall be substituted

by the words "within one (1) treatment cycle provided that this is

done in accordance with the Protocol";

(c) in the second proviso to paragraph (b) thereof

immediately after the words "prospective parent" there shall be

added the words "from whom they originate" and immediately

after the words "from any prior medically assisted procreation

treatments" there shall be added the words "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"; and

(d) in paragraph (e) thereof the words "eugenic

purposes;" shall be substituted by the words "eugenic purposes:"

and immediately thereafter there shall be added the following

new proviso

"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;".

In sub-article (5) of article 7 of the principal Act the words "A

prospective parent or prospective parents, who prior to the coming into

force of this Act, have cryo-preserved embryos" shall be substituted by

the words "A prospective parent or prospective parents who have cryo-

preserved embryos".

Article 9 of the principal Act shall be amended by the

following

(a) immediately after the first proviso to sub-article (1)

thereof there shall be added the following new proviso

"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:";

(b) in sub-article (3) thereof immediately after the words

"of thirty-six (36)" there shall be added the words "years on day

of donation";

(c) the first and second provisos to sub-article (4) thereof

shall be substituted by the following new provisos

"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:";

(d) immediately after sub-article (5) thereof there shall

be added the following new sub-article

"(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 such a way as to ensure their

traceability and such record shall be forwarded to the

Authority without delay."; and

(e) in sub-article (6) thereof immediately after the words

"to keep a register with updated records thereof," there shall be

added the words "including the records traceable to the donors".

The proviso to sub-article (3) of article 15 of the principal Act Amendment of

article 15 of the

shall be substituted by the following new proviso

principal Act.

"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.".

Article 23 of the principal Act shall be amended by the Amendment of

article 23 of the

following

principal Act.

(a) article 23 of the principal Act, in its entirety, shall be

renumbered as sub-article (1) thereof;

(b) in paragraph (c) of sub-article (1) thereof, as

renumbered, the words "medically assisted procreation." shall be

substituted by the words "medically assisted procreation;" and

immediately thereafter there shall be added the following new

paragraph

"(d) enact or to bring into force any Protocol

referred to in this Act and to revoke, amend or vary the

same."; and

(c) immediately after sub-article (1) thereof, as

renumbered, there shall be added the following new sub-article

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

published in the English language only.".

PART II

AMENDMENT TO THE ADOPTION ADMINISTRATION ACT

This Part amends the Adoption Administration Act and shall

be read and construed as one with the Adoption Administration Act,

hereinafter in this Part referred to as "the principal Act".

In paragraph (g) of sub-article (1) of article 4 of the principal

Act, the words "any regulations made thereunder." shall be substituted

by the words "any regulations made thereunder;" and immediately

thereafter there shall be added the following new paragraph

"(h) making recommendations to the Embryo

Protection Authority regarding the eligibility and

suitability of prospective parent or parents relative to

adoption of an embryo as provided in sub-article (4) of

article 4 of the Embryo Protection Act.".

Passed by the House of Representatives at Sitting No. 26 of the 6th

July, 2022.

ANĠLU FARRUGIA

Speaker

RAYMOND SCICLUNA

Clerk of the House of Representatives

€0.36