Donation of tissues and cells should be voluntary and, in most cases, anonymous, Members of the European Parliament (MEPs) have agreed.
Healthcare remains a national responsibility, but European Union (EU) member states should cooperate better on cross-border donations, the MEPs agreed, adopting a non-binding resolution at the European Parliament in plenary session in Strasbourg on September 11.
Backing the resolution – put forward by UK MEP Marina Yannakoudakis of the European Conservatives and Reformists (ECR) group – on a 551-14 vote with 81 abstentions, the legislators urged all EU member states to ban financial incentives for donations and to define clearly the conditions under which financial compensation might be granted, for example to reimburse travel expenses or loss of earnings.
Currently, only a minority of EU countries have guiding principles on compensation or incentives, and the parliamentarians also called on the European Commission to propose legislation designed to guarantee the principle of unpaid donation.
The approved resolution highlights the value of bilateral agreements that help countries to meet general tissue or cell shortages to find a donor match when they cannot do so domestically, but it also says that patients could benefit further if EU countries worked more closely with Eurocef, the European registry of tissues and cells.
“Bone marrow and stem cell transplants are often the only hope for people with leukaemia or other blood diseases,” said Ms Yannakoudakis.
“In multi-ethnic areas, such as my constituency of London, patients often need to look for donors abroad. Here is where we can tap into the value-added of the European Union, by sharing donor registries across the EU and saving lives,” she added.
Her report also points to the potential benefits to medicine of using stem cells. Public and private cord blood/stem cell banks should cooperate better, and EU member states should provide a regulatory framework to ensure that the banks operate in a highly transparent and safe way, it adds.
The plenary also adopted changes to existing legislation to tighten up the EU system for identifying and evaluating potential problems with medicinal products in any EU member state, starting in 2013.
The new rules, agreed between Parliament and EU ministers, will introduce an automatic emergency procedure, including an EU safety evaluation and possible EU-wide withdrawal if, for example, a member state were to withdraw a medicine from the market. This procedure would also be triggered if a company decided not to renew a marketing authorisation for safety reasons.
The move to better monitor harmful effects of medicines aims to prevent any further cases like that of Servier’s Mediator (benfluorex), which was approved for the treatment of diabetes but also prescribed as an appetite suppressant, and was allegedly implicated in 500-2,000 deaths.
The changes will also force companies to be more transparent. If a firm withdraws a medical product from the market, it will have to state explicitly whether it has done so for safety reasons, in order to determine whether the “commercial reasons” sometimes given by companies for withdrawing a product actually mask safety concerns, say parliamentary sources.
In 2010, the EU decides to update its pharmacovigilance rules, but in light of the Mediator case, the Commission subjected these rules to “stress tests” which revealed potential loopholes that still needed to be closed.
The vote also requires the European Medicines Agency (EMA) to set up a system to ensure that all new medicines and any for which regulators have ongoing safety concerns are labelled with a black symbol, to enable healthcare professionals and patients to identify them,
