Brussels, 20/05/2010 (Agence Europe) - In Strasbourg on Wednesday 19 May 2010, the European Parliament approved a draft directive on standards of quality and safety of human organs intended for transplant, which aims to facilitate the provision of organs from one country to another within the EU. The draft directive was a compromise negotiated with the Council of Ministers based on a report by Miroslav Mikolasik (EPP, Slovakia) and was adopted by 643 to 16 with 8 abstentions. The Council is expected to formally adopt the directive in the very near future.
The agreement between the Parliament and the Council sets out general principles that should cover organ donation and transplant while respecting subsidiarity. When it comes to organ donation agreement by the deceased and/or his or her family, the directive leaves power for this in the hands of national legal systems although it would usually increase the numbers of organs available if tacit agreement were assumed unless the deceased expressed objection to organ donation during their lifetime. Along with a raft of safety measures on the removal and transport of organs, the legislation lays down how organs should be labelled and how traceability is to be ensured. A key stage here is the designation of the authority responsible in each Member State for quality and safety standards for human organs intended for transplant and responsibility for rejecting organs that fail to meet the quality and safety standards set out in the directive. The Member States will be allowed to keep or introduce stricter measures if they wish. The competent authorities will authorise organ-collection organisations and transplant centres and will introduce management systems and reports on serious undesirable reactions and collate data on the outcome of organ transplants. They will also supervise the sending and receipt of organs to and from other Member States and countries outside the EU. Confidentiality and security of information will be ensured. The directive sets out the minimum information details that should normally be collected for each donated organ but exceptions are possible here if the risk-benefit assessment shows that the benefits outweigh the risks. The compromise requires Member States to ensure that all healthcare staff involved have followed suitable training, have suitable skills and are suitably qualified.
In line with the compromise amendments, Member States will have to ensure that living donors are protected to as high a standard as possible. Human organ donation must be voluntary and not a service for which donors receive payment, but the MEPs added that the principle of non-payment should not prevent living donors from receiving compensation as long as it is strictly limited to payment for expenses and loss of income due to organ donation. It is in the area of organ donation between living human beings where the directive negotiated with the Council differs the most from the Mikolasik Report adopted by an EP committee in January 2010 (see information about the report in EUROPE 10065). The compromise has removed the restricted definition of donation among living human beings which assumed that only family members ever donate organs and also assumed that such organ donations are only made when organs from deceased individuals are not available.
In order to facilitate cooperation, the Commission will set up a network of competent authorities and lay down procedures for the provision of information among Member States. They may also sign agreements with European organ donation organisations and delegate certain work connected with organ exchange to these bodies. The Commission has been conferred powers to introduce pieces of legislation required to put the new directive into action and which will have to be transposed into Member States' legal systems within two years of the directive coming into force.
The European Parliament also adopted a report by Spanish Socialist Andres Perello Rodriguez backing the Commission's organ donation action plan (2009-2015). The action plan explains that organ donor coordinators should be appointed in every hospital and exchange of information and best practices will help countries which have few organs available to encourage more people to donate organs. Parliament invites the Member States to consider giving people the option of joining a donor register when they apply for a passport or a driving licence and for passports and driving licences to state whether the holder agrees to donate organs upon their death. Member States should examine whether people can sign national and/or European donor registers online. The Parliament also wants the Commission to examine drawing up a system covering the organ donation desires of people in as many Member States as possible.
Over the past 50 years, organ transplants have increased and are now carried out around the world. Organ transplants are often the only form of treatment for some patients but there are long waiting lists. Around 60,000 patients are currently on organ donation waiting lists in the EU and 12 people from the waiting list die every day. (O.J. trans fl)