-
New step towards building a strong European Health Union
-
Reinforcing the principle of voluntary and unpaid donation in the EU
-
High level of human health protection and strengthened supply
On Wednesday, Parliament gave its final green light to revised rules ensuring improved protection for citizens that donate or are treated with blood, tissues or cells.
The regulation, adopted with 461 votes in favour, 56 against and 66 abstentions, updates EU measures governing the use of so-called substances of human origin (SoHO), such as blood and its components (red/white cells, plasma), tissues and cells – used for transfusions, therapies, transplantations or medically assisted reproduction.
Voluntary and unpaid donations
Member states will be able to compensate living SoHO donors, in accordance with the principle of voluntary and unpaid donation and based on transparent criteria, including through fixed allowances or through non-financial forms of compensation. The conditions for such compensation will be established in national legislation.
Promotion and publicity activities in support of SoHO donations (for example, campaign billboards or posters, television, newspaper or magazine advertisements) must not refer to compensation. National authorities will therefore have to ensure that compensation is not used as an incentive to recruit donors.
Safeguarding supply
EU countries will establish and regularly update “national SoHO emergency plans”, setting out measures to ensure the security of supply for critical substances.
Quote
Rapporteur Nathalie Colin-Oesterlé (EPP, FR) said:
“This law constitutes a new chapter in building a strong European Health Union that guarantees the highest safety standards for those that donate and receive substances of human origin, strengthens the national collection systems to lower the risks of shortages and is based on the fundamental ethical principle of voluntary and unpaid donation.”
Next steps
Council needs to formally approve the agreement as well before it can enter into force.
Background
Every year, EU patients benefit from over 25 million blood transfusions, a million cycles of medically assisted reproduction, over 35,000 transplants of stem cells (mainly for blood cancers) and hundreds of thousands of replacement tissues (e.g. for orthopaedic, skin, cardiac or eye problems).
In adopting this legislation, Parliament is responding to citizens’ expectations to establish common minimum healthcare standards at EU level, as expressed in proposal 10(1) of the conclusions of the Conference on the Future of Europe.