A legal notice which bans advertising of the need for, or the availability of, transplant organs has been published in the Government Gazette.
The Organ Transplants (Quality and Safety) Regulations transpose EU regulations on standards of quality and safety of human organs intended for transplantation.
It specifically lays down that:
"Donations of organs from deceased and living donors shall be voluntary and unpaid. The principle of non-payment shall not prevent living donors from receiving compensation, provided it is strictly limited to making good the expenses and loss of income related to the donation."
The authority responsible for transplants shall define the conditions under which such compensation may be granted, while avoiding there being any financial incentives or benefit for a potential donor.
"It shall be illegal to advertise the need for, or availability of, organs where such advertising is with a view to offering or seeking financial gain or comparable advantage," the regulations say, adding that the procurement of organs shall be carried out on a non-profit basis.
Earlier this year, the Mater Dei organ transplant ethics committee had decided it would not allow kidney donations to specific patients by strangers who came forward following an advert offering money.
It concluded that this would go against the principle of distributive justice. The donors, however, could contact the hospital to start the process to donate their kidney - that would go to whoever needs it most urgently.
More than 20 donors had come forward after Sarah Borg posted an advert on Malta Park, an online trading site, asking for a kidney for her former partner, 30-year-old Chris Bartolo – the father of her son Zac, 10.
In the advert she offered €5,000 as compensation, which she later explained was meant to cover loss of earnings by the donor during the recovery period.
The new legal notice sets out detailed regulations to ensure the quality of transplants, safety, consent and personal data protection.
The Superintendent of Public Health shall be the Licensing Authority with the authority to establish guidelines, issue licenses and supervise all operations including inspections to ensure safety and data protection.
Procurement organisation
The legal notice states that procurement of organs shall be carried out by licensed procurement organisations.
It says that all procured organs and donors shall be characterised before transplantation. The information has to include a set of minimum data which has to be collected for each donation.
But if, according to a risk-benefit analysis in a particular case, including in life-threatening emergencies, the expected benefits for the recipient outweigh the risks posed by incomplete data, an organ may be considered for transplantation even where not all of the minimum data are available.
To meet the quality and safety, medical teams have to endeavour to obtain all necessary information from living donors and, for that purpose, provide them with the information they need to understand the consequences of the donation.
In the case of deceased donation, where possible and appropriate, the medical team shall endeavour to obtain such information from relatives of the deceased donor or other persons, the regulations say.
Traceability
Procurement organisations and transplantation centres have to ensure that: all organs procured, allocated and transplanted on their territory can be traced from the donor to the recipient and vice versa in order to safeguard the health of donors and recipients; they have a donor and recipient identification system that can identify each donation and each of the organs and recipients associated with it.
With regard to such a system, it has to be ensured that confidentiality and data security measures are in place.
Consent requirements.
The procurement of organs shall be carried out only when:
* All prospective organ donors, their relatives or any other person granting consent on behalf of donors, have been given information in accordance with guidelines and authorisation requirements as established by the Authority;
*Information in accordance with guidelines and authorization requirements established by the Authority has been obtained from all persons who are willing to donate organs, their relatives or any other person granting consent on behalf of donors.
Quality and safety aspects of living donation
Procurement organisations and transplant centres have to ensure that living donors are selected on the basis of their health and medical history, by suitably qualified or trained and competent professionals. Such assessments may provide for the exclusion of persons whose donation could present unacceptable health risks.
Procurement organisations and transplant centres will also need to keep and maintain a register or record of the living donors.
Living donors shall be followed up and procurement organisations, transplant centres and institutions responsible for the follow up of living donors shall have a system in order to identify, report and manage any event potentially relating to the quality and safety of the donated organ, and hence of the safety of the recipient, as well as any serious adverse reaction in the living donor that may result from the donation.
Any use of systems or data that makes the identification of donors or recipients possible with a view to tracing donors or recipients (except where allowed by regulations) is punishable by law.