HUMAN ORGANS, TISSUES AND CELL DONATION ACT

CHAPTER 558

HUMAN ORGANS, TISSUES AND CELL

DONATION ACT

To provide for human organs, tissues and cell donation and

transplantation in Malta and to provide for matters ancillary or

consequential thereto.

16th December, 2016 *

ACT XXVIII of 2016, as amended by Act VIII of 2026.

The short title of this Act is the Human Organs, Tissues

and Cell Donation 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

"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" m eans 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;

*see article 1(2) of this Act as originally promulgated, and Legal Notice 421 of 2016.

"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

requesting to become a donor under this Act after having satisfied

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

r e g i s t e r t o d o n a t e h i s o rg a n s a n d , o r t i s s u e s a n d , o r c e l l s .

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) Deceased organ, tissue and cell donation shall be

considered in persons who are certified dead using neurological or

circulatory criteria by a clinician.

(2) The Superintendent shall maintain updated and peer reviewed

guidelines, which shall be published on the Ministry’s website, for the

diagnosis of death using neurological and circulatory criteria 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

ascertain and certify that the donor fully understands the nature and

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

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.