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EU adopts new rules on organ transplants

Published 20 May 2010 - Updated 21 May 2010
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In a drive to facilitate the donation, transplantation and exchange of organs in Europe, the European Parliament voted yesterday (19 May) to pass legislation that sets common EU quality and safety standards for transplants.

The common quality and safety standards were endorsed by 643 votes to 16, amid eight abstentions.

The House also backed the Commission's 2009-2015 action plan on organ donation and transplantation.

The proposal for a directive and accompanying 10-point action plan were put forward by the Commission in December 2008. The aim is to help increase the supply of organ donors across the EU, enhance the efficiency and accessibility of transplantation systems and ensure the quality and safety of the procedures.

The directive, which has already received political backing from EU member states, will enter into force later in 2010 and national governments will have two years to transpose it into national legislation.

New organ authorities

According to the new rules, EU member states must set up a national authority responsible for maintaining quality and safety standards for organs intended for transplantation (EurActiv 17/03/10).

These authorities will approve procurement organisations and transplant centres, set up reporting and management systems for serious adverse reactions, collect data on the outcome of transplants and supervise organ swaps with other member states and third countries.

Voluntary, unpaid donations to fight trafficking

The rules insist that all organ donations must be voluntary and unpaid, while living donors may receive compensation "provided it is strictly limited to making good the expenses and loss of incomes related to the donation".

Member states are required to ban any advertising of the need for - or the availability of - human organs where the aim is financial gain.

EU database

MEPs further recommended creating an EU database containing information about organs intended for donation and transplantation and about living or deceased donors.

They also asked for a pan-European certification system to provide proof that human organs and tissues have been obtained legally.

Positions: 

EU Health Commissioner John Dalli welcomed the vote as "a major step forward for the over 50,000 European patients waiting for an organ transplant".

"This is a concrete example of how EU legislation can work to save lives and foster create solidarity in Europe. I look forward to a swift implementation of this text by the member states," he added.

Slovak MEP Miroslav Mikolášik (European People's Party), the European Parliament's rapporteur on the file, expressed satisfaction with the protection of donors and recipients via "the principle of altruism" - voluntary and unpaid donation.

"These principles governing organ donation significantly aim to prevent any commercialisation of human organs as well as illegal organ trafficking," the EPP Group said in a statement.

Spanish MEP Andrés Perelló (Socialists & Democrats), author of the parliamentary report on the action plan, said that "a successful transplant system is not only based on the solidarity of the donors, but mostly on the right use of the information and a good network to share this information. We don't want a person to die in Portugal, let's say, because we never knew that there was a heart or a kidney suitable for him in France".

Perelló also underlined the importance of public awareness. The report asks member states to look into schemes whereby citizens are given the option of directly joining an organ-donor register when completing administrative procedures, such as applying for a passport or driving licence.

Conservative MEP Marina Yannakoudakis (UK, European Conservatives and Reformists) said she was "delighted that MEPs have recognised that post mortem donations can not achieve the supply of organs needs alone. We have set up controls and guidelines to ensure that living organ donation can be widened, potentially saving lives and enabling people outside of the immediate family circle to help if they want to". 

Welcoming the vote, Belgian MEP Frédérique Ries (Alliance of Liberals and Democrats for Europe; ALDE) said "there are 60,000 people in Europe currently waiting for a transplant, and they need help now - and 12 patients die every day because they have been waiting too long". 

"We are seeking new laws that will inform Europe's citizens, bring down administrative barriers and ensure high standards of quality and safety for donors and recipients," Ries continued, adding: "The time to act is now."

Bulgarian ALDE MEP Antonyia Parvanova said "a clear legal framework for organ donation and transplantation is essential to ensure safe, efficient and responsible cooperation across the Union. Today's vote is a great signal for all patients in need. It is also proof positive that Europe can work together to take the concrete steps necessary to improve the health of its citizens".

Next steps: 
  • June 2010: Council of Minsiters to adopt directive.
  • June 2010: Publication of directive in Official Journal.
  • By July 2012: Member states must have transposed directive into national law.
Background: 

Over the past 50 years, organ transplantation has become an established practice worldwide and is often the only treatment available. However, queues are long, with 60,000 patients now on waiting lists in the EU. Every day 12 people die while on a list.

This has sparked an upsurge in illegal organ trafficking, a practice which benefits criminal gangs and can have profoundly negative consequences, particularly for the donor.

Efforts to boost voluntary organ donation through public awareness campaigns have met with limited success. Some countries operate an "opt in" system where citizens are presumed not to be donors unless they actively choose to register. Others have an "opt out" system, whereby citizens are automatically registered as donors unless they explicitly choose not to be.

Spain and others have boosted voluntary organ donation rates by establishing a network of transplant coordinators, who liaise with families of deceased people to discuss transplantation options.

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