Improved consideration of the interests of recipients of blood plasma products in the EU regulation „Substances of Human Origin (SoHO)“
Author
Dr. Heinz Stutzenberger, 2nd Chairman
Alpha1 Germany eV.
Many people in the EU depend on blood plasma-based products:
- People with rare diseases need plasma components to be able to lead a dignified or reasonably normal life, or to extend their otherwise severely shortened lifespan.
- In some acute situations, such as during surgery, the availability of plasma products can be a matter of life or death.
Our association represents the interests of currently 980 people with alpha-1 antitrypsin deficiency (AATD). These individuals inherit a deficiency of sufficient AAT in their blood, which typically leads to a gradual decline in lung function, often starting at a young age, and significantly reduces their average life expectancy. The rate of lung function decline can be slowed by weekly intravenous administration of AAT derived from human blood plasma.
Within the EU, only a very few countries collect enough blood plasma to supply their own recipients of blood plasma products—namely, only those where both public and privately run blood and plasma donation centers exist side by side. Overall, however, the EU is heavily dependent on imports from the USA. A shortage of imports during the COVID-19 pandemic led to supply bottlenecks for some European recipients, resulting in a broad consensus that achieving EU-wide self-sufficiency in blood plasma supply is now a high-priority public health goal. To achieve this goal, the willingness to donate plasma among the population must be increased, and at the same time, adequate political and organizational frameworks must be established to enable the collection and processing of more blood plasma.
The EU Parliament is currently preparing a regulation concerning "Substances of Human Origin", which, in its current draft stage, unfortunately contains provisions that are completely contrary to these goals and will make their achievement more difficult or even prevent it:
- Firstly, the current draft classifies plasma donation as a significant risk to the donor's health.
- which will slow down the public's willingness to donate
- However, there is no scientific evidence for this; on the contrary, scientific studies prove the exact opposite (among other things, because the donated plasma is examined very closely, allowing diseases of the donor to be detected early).
- This leads to an unnecessarily low number of permissible annual plasma donations, meaning that the plasma donation potential is only partially utilized.
- Secondly, the standards for possible compensation for donors are formulated very restrictively.
- justified by the supposed necessity of protecting blood donations to public institutions to prevent so-called "crowding-out"„
- although the examples of the aforementioned self-sufficient EU countries show that public and privately owned blood and plasma donation organizations together are necessary to ensure adequate supply, and their successful coexistence can be ensured through smart regulations.
We therefore demand:
- Refraining from classifying blood plasma donation as a health risk for the donor
- Allowing for compensation options for donors' expenses to such an extent that, in addition to the public sector, the establishment of donation centers under private ownership becomes or remains attractive.
- greater consideration of the interests of Recipient of blood plasma products in the SoHO Regulation, in particular the security of supply of blood plasma products in Europe without dependence on imports
