ACT No. XXVIII of 2016 An ACT to provide for human organs, tissues and cell donation and transplantation in Malta and to provide for matters ancillary or consequential thereto.

I assent.

M ARIE- L OUISE

(L.S.)

C OLEIRO P RECA

President

10th June, 2016

ACT No. XXVIII of 2016

An ACT to provide for human organs, tissues and cell donation

and transplantation in Malta and to provide for matters ancillary or

consequential 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 Human Organs,

Tissues and Cell Donation Act, 2016.

(2) The provisions of this Act shall come into force on such a

date as the Minister responsible for Health may by notice in the

Gazette establish, and different dates may be so established for

different provisions or different purposes of this Act.

(1) This Act shall apply without prejudice to the Human

Blood and Transplants Act and any subsidiary legislation made

thereunder.

(2) This Act shall apply to all human organ, tissue and cell

donations by persons residing in Malta.

(3) Human organ, tissue and cell donation for research and

autologous organ, tissue and cell donation as well as embryo

donations fall outside the scope of this Act.

In this Act, unless the context otherwise requires

Interpretation.

"autologous use" means cells or tissues removed from and

applied to the same person;

"cells" means individual diploid human cells or a collection of

diploid human cells when not bound by any form of connective tissue;

"clinician" means a health professional being a doctor or

consultant whose practice is based on direct observation and

treatment of a patient;

"donation" means the act of giving human organs, tissues or

cells intended for human transplantation;

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

tissues or cells, whether donation occurs during lifetime or after

death;

"donor coordinator" means a person who confirms that the

donor has the medical characteristics that ensures a successful

transplantation;

"guardian" means a person appointed by a court to make

decisions regarding the support, care, education, health, or welfare of

an individual and includes a person who has been appointed in

guardianship of a person in terms of the Civil Code;

"health care professional" shall have the same meaning assigned

to it under the Health Care Professions Act;

"human organ" and "organ" means a differentiated part of the

human body, formed by different tissues, that maintains its structure,

vascularisation and capacity to develop physiological functions with

a significant level of autonomy

Provided that a part of an organ is also considered to be an

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

organ in the human body, maintaining the requirements of structure

and vascularisation;

"Minister" means the Minister responsible for Health;

"parent" means a person having parental authority;

"parental authority" shall have the same meaning assigned to the

term under the Civil Code;

"procurement organization" means a health care establishment,

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

undertakes or coordinates the procurement of organs, and is

authorised to do so by the Superintendent;

"recipient coordinator" means a person who ensures that the

patient is in a suitable state to accept a successful transplant;

"register" shall refer to the National Human Organ and Tissue

Donation Register defined in article 4;

"Superintendent" means the Superintendent of Public Health in

terms of the Health Act;

"tissue" means all constituent parts of the human body formed

by cells;

"transplant co-ordinator" means a health care professional who

coordinates activities related to organ donation and transplantation. A

transplant coordinator can either be a donor coordinator or a recipient

coordinator;

"transplantation centre" means a health care establishment, a

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

transplantation of organs, tissues and cells and which is authorised to

undertake such transplantation by the Superintendent.

(1) There shall be a National Human Organ and Tissue

Donation Register which shall be maintained by the Superintendent in

physical or electronic form as may be determined by the Minister.

(2) The Register shall record information in accordance with

this article and other provisions of this Act and in such manner as

may be prescribed from time to time. In accordance with this sub-

article, the Superintendent shall record the following in the Register

(a)

details of persons residing in Malta who wish to

donate their organs, tissues or cells following their demise;

(b) details of persons residing in Malta who expressly

declare that they do not wish to donate their organs, tissues or

cells following their demise;

(c)

any particular organ, tissue and cell a person chooses

to donate; and

(d) any particular organ, tissue and cell a person chooses

not to donate.

(3) The Register shall be the only organs, tissues and cells

register having legal validity for purposes of a donation under this

Act.

(1) The Superintendent shall only register a person Registration and

requesting to become a donor under this Act after having satisfied role

Superintendent.

himself that the said person

(a)

has attained the age of sixteen years;

(b) is not suffering from any mental disorder which

renders him incapable of taking care of his own affairs;

(c)

has done so voluntarily, out of his own free will;

(d) has had adequate information on the meaning and

consequences of registration as a donor under this Act and has

been certified under article 14.

(2) The Superintendent shall amend the said Register,

whenever it appears to him necessary or appropriate to do so for

giving effect to the provisions of this Act, and in particular for

ensuring the accuracy of information contained in the Register, or for

bringing up to date, or otherwise correcting any information entered

into the Register.

(3) It shall be the duty of the Superintendent to ensure that the

processing of the information contained in the Register is carried out

in compliance with the Data Protection Act

Provided that the information shall, for purposes of this

Act upon a potential donation taking place, be accessed solely to

determine whether a person is a registered donor or a person who has

registered his intention of not being a donor.

(1) Any person who has attained the age of sixteen may Eligibility for

register to donate his organs and, or tissues and, or cells. Registration registration.

shall be made in such forms as the Minister may so establish, by

regulations made under this Act. All registrations shall be recorded in

the Register.

(2) A person who chooses to donate his organs, tissues or cells

shall specify which organs, tissues or cells he would wish to donate

and if he wishes to exclude particular organs, tissues or cells from

being donated.

A person having registered as a donor under this Act shall

be entitled to retract his choice of becoming a donor and to apply for

de-registration with the Superintendent who shall forthwith record

this information and de-register the said person.

A person who has expressly declared that he does not wish

to donate his organs, tissues or cells may at any time thereafter

register as a donor under this Act.

Upon the death of a minor who, at the time of death, is still

under the age of sixteen, the parents or legal guardians shall be

consulted with regards to an organ, tissue or cell donation taking

place.

(1) The next of kin of a deceased person who is not a

registered donor may be approached by a transplant coordinator or a

clinician to declare whether they consent to the donation taking place

Provided that this sub-article shall not apply where the

deceased has registered his wish not to be a donor.

(2) In the event where consent is given under this article the

donation shall take place and the said person shall be deemed to have

been a registered donor for purposes of this Act.

(3) In the event of a donation under this article taking place,

this shall be annotated by the Superintendent in the Register.

Notwithstanding that a deceased person may have been a

registered donor, a clinician shall have the right to decide that the

organ or tissue object of the donation is unfit or unsuitable for

transplantation.

(1) Cadaveric organ, tissue and cell donation shall be

considered in patients who are certified brain dead by a clinician.

(2) The Superintendent shall maintain updated and peer

reviewed guidelines for the diagnosis of brain death for the purposes

of organ, tissue and cell donation.

Procurement organisations and transplantation centres

shall be bound to have in place a framework approved by the

Superintendent to assess all potential live organ donors and to decide

whether the transplant should be approved, based on the following

criteria

(a) in the case of donation between blood relatives and

family members who are not blood relatives, an organ must be

donated to an identified recipient;

(b) in other non-related donations a pre-existent close

emotional link has to be present between the donor and the

recipient for such a donation to be acceptable; and

(c)

in the case of non-directed altruistic organ donation

the principle of distributive justice shall be adopted by which a

donated organ shall be allocated to a recipient according to his

medical needs. Such a decision shall be taken by the

Superintendent.

(1) A clinician involved in the donation process must Duties of

ascertain and certify that the donor fully understands the nature and clinician

certification.

consequences of the donation.

(2) A clinician shall not certify any donor who due to mental

incompetence cannot understand the nature and consequences of the

donation.

(3) In the case of a living minor under the age of sixteen a

clinician shall only approve the donation and transplantation of

regenerative hematopoietic stem cells for blood relatives.

The Minister may make regulations to implement and to Regulations.

give better effect to the provisions of this Act and without prejudice

to the generality of the foregoing may, by such regulations, prescribe

anything that is to be or which may be prescribed and provide for any

matter consequential, incidental to or connected with the provisions

of this Act.

The Criminal Code shall be amended as follows

Consequential

amendments to

the Criminal

(a)

article 248C thereof shall be re-numbered as sub-

Code.

article (1) thereof, and immediately thereafter there shall be

added the following new sub-article

"(2) For purposes of this article, the removal of

organs, tissues and cells shall include the conduct

referred to in article 248CA(1).".

(b) immediately following article 248C thereof, there

shall be added the following new article

" Trafficking in

248CA. (1)Whosoever removes a human

human organs.

organ, tissue or cell from living or deceased

donors in any of the following circumstances -

(a)

where the removal is not

performed under the Act with the free,

informed and specific consent of the living

or deceased donor, or, in the case of the

deceased donor, without the removal being

authorised under the Act;

(b) where, in exchange for the

removal of organs, tissues or cells the

living donor, or a third party, has been

offered or has received a financial gain or

comparable advantage;

(c)

where, in exchange for the

removal of organs, tissues or cells from a

deceased donor, a third party has been

offered or has received a financial gain or

comparable advantage,

shall be guilty of an offence and shall be liable

on conviction to the punishment of

imprisonment for a term from six to twelve

years.

(2) A person who does any of the

following acts shall be guilty of an offence

against this article -

(a)

makes use of illicitly removed

organs, tissues or cells as described in sub-

article (1), for purposes of implantation or

other purposes than implantation;

(b) the implantation of human

organs, tissues or cells from living or

deceased donors where the implantation is

not performed under the Act or where the

implantation is, in any manner, performed

in breach of the Act;

(c)

solicits or recruits an organ

donor or a recipient for financial gain or

comparable advantage;

(d) prepares, preserves or stores

illicitly removed human organs, tissues or

cells as described in sub-article (1);

(e)

transports, transfers, receives,

imports or exports illicitly removed human

organs, tissues or cells as described in sub-

article (1),

and shall be liable on conviction to the

punishment laid down in sub-article (1).

(3) The provisions of articles 115 and

121(3) shall, mutatis mutandis, apply to an

offence under this article.

(4) For purposes of this article -

"Act" means the Human Organs, Tissues

and Cell Donation Act;

"human organ" means a differentiated part

of the human body, formed by different tissues,

that maintains its structure, vascularisation and

capacity to develop physiological functions with

a significant level of autonomy

Provided that a part of an organ is also

considered to be an organ if its function is to be

used for the same purpose as the entire organ in

the human body, maintaining the requirements

of structure and vascularisation;

"financial gain or comparable advantage"

shall not include compensation for loss of

earnings and any other justifiable expenses

caused by the removal or by the related medical

examinations, or compensation in case of

damage which is not inherent to the removal of

organs.";

(c)

in article 248D thereof, for the words "to 248C"

there shall be substituted the words "to 248CA";

(d) in article 248DA thereof, for the words "to 248C"

there shall be substituted the words "to 248CA"; and

(e)

sub-article (2) of article 248E thereof shall be

amended as follows

(i) in paragraph (a) thereof, for the words "has

caused grievous bodily harm" there shall be substituted

the words "or has resulted in harm to the physical or

psychological health of the victim";

(ii) in paragraph (e) thereof, for the words "article

article 208A(2);" there shall be substituted the words

"article 208AC(2)"; and

(iii) in paragraph (f) thereof, for the word

"trafficked," there shall be substituted the words

"trafficked; or" and immediately thereafter there shall be

added the following new paragraphs

"(g) when the offender has been previously

convicted of an offence under this article; or

(h) is committed by a member of the child’s

family, a person cohabiting with the child or a

person who has abused a recognised position of

trust or authority,".

Passed by the House of Representatives at Sitting No. 399 of the

6th June, 2016.

A NĠLU F ARRUGIA

Speaker

R AYMOND S CICLUNA

Clerk of the House of Representatives

€0.90