White Paper on organ donation to allow opt-in, opt-out principles

A White Paper piloted by the parliamentary secretariat for health is set to provide people a legal framework by which they could decide to become organ donors, or not. 

Organ and tissue donation and transplantation provide a second chance at life for thousands of people each year. In Malta, some 2,000 people sign up to be organ donors every year, ranking Malta among the highest donor rates in Europe.

Yet, organ donors do not always have the last word, as the final decision ultimately lies with the next of kin who have to give their consent for organ removal.

The planned law would ensure that a person who signed up to become an organ donor would have their request honoured.

Last year, some reported 30,000 individuals were registered for organ donation.

Yet, the list of patients waiting for an organ donation remains substantial. 

Near the end of 2014, some 80 to 85 patients were still waiting for a kidney, while 15 patients – throughout the year – successfully received kidney transplants. Ten were from cadaver donors. A heart, and 13 cornea transplants were also performed. 

During the previous year, 15 patients received a kidney from deceased person and three from living donors.

MaltaToday is informed that the White Paper, set to be launched for consultation in the coming weeks, will provide people with four principles: the soft opt-in; the hard opt-in; the soft opt-out; and the hard opt-out. The aim is to have a more coordinated approach with all stakeholders involved. 

The soft opt-in principle would see the removal and use of organs permissible only if consent from the potential donor’s next of kin has been obtained after the donor’s death. The deceased would have indicated the wish to be a donor during their lifetime. 

The hard opt-in proposal would be based on the organ donor’s express decision to become a donor, abolishing the consent of the donor’s next of kin.

In the case of the soft opt-out, the removal and use of organs would be permissible unless the deceased opted out during his or her lifetime. Nonetheless, it would still remain imperative that the deceased donor’s next of kin consent is obtained. 

The hard opt-out system would allow the removal and use of organs from deceased persons unless the deceased person had formally opted out of donation during lifetime. In this case, the deceased’s decision cannot be overturned by the next of kin.

The availability of donor organs is often a question of life and death for patients requiring a transplant. With transplantation now a commonplace technique, one of the main factors limiting the number of transplants is the shortage of organs. 

According to the Council of Europe, each day, on average, 12 people died across the EU while waiting for a transplant. 

In December 2008, the European Commission adopted a proposal for a Directive that defines quality and safety requirements for human organs intended for transplantation, and an action plan for improving co-operation between member states in this field.