Author
Dr. Ing. Heinz Stutzenberger, as published in Alpha1 Journal 2/2023.
A key objective of the EU is the smooth exchange of goods and services between its member states. An important contribution to achieving this objective is the harmonization of rules and regulations in key economic sectors, including healthcare.
Among the many different products generated and exchanged within the healthcare system are "substances of human origin," abbreviated "SoHO." With the exception of whole organs, this includes all substances extracted from the human body, such as skin, breast milk, egg and sperm cells, stem cells, bone marrow, blood, and blood plasma. The SoHO Regulation aims to standardize the safety of these substances, as well as their donors and recipients, to a high standard. It is currently being drafted within the relevant EU bodies and, following its adoption, expected in the second quarter of 2024, will be binding and must be implemented by all member states.
Both blood plasma and the products derived from it, such as alpha-1 antitrypsin needed for substitution and augmentation therapy, are scarce resources within the EU. Only four countries—Germany, Austria, the Czech Republic, and Hungary—meet the demand for plasma. This is possible because two different donation methods exist independently side-by-side in these countries:
- Public blood donation centers, such as the Red Cross, which are particularly popular in rural areas, offer blood donation appointments at schools or gyms at regular intervals of several months.
- Privately operated plasma donation centers are only profitable to operate in urban areas with high visitor frequency.
All other EU member states – like the EU as a whole – are undersupplied and heavily reliant on imports from the USA. The instability of this supply chain became evident during the COVID-19 pandemic, when supplies from the USA were restricted, leading to shortages of some plasma products in Europe. This experience led to the lesson that Europe must become self-sufficient in the supply of blood plasma and products derived from it. So far, measures to achieve this self-sufficiency are barely discernible, let alone implemented. The SoHO Regulation, developed with the commendable goal of increasing safety, contains, in the version adopted by the European Parliament in its first reading on September 12, 2023, a few passages that will hinder or even prevent the achievement of self-sufficiency in blood plasma.
Firstly, plasma donation is classified as a significant health risk for the donor.
- The underlying assumption is that the frequent removal of blood components causes their concentration in the donor's blood to drop below a level necessary for maintaining health (it's important to know that in Germany, plasma can be donated up to 60 times a year because it is quickly replenished in the liver; whole blood is only slowly replenished in the large bones and can therefore only be donated 4 times a year for women and 6 times for men).
- Statistical analyses have shown that even with twice the permissible donation frequency, no adverse health effects on donors are observed; although the concentrations of relevant blood components decrease slightly, they remain at a level sufficient for maintaining good health.
- There are even good reasons to believe that the health risk for donors decreases: Firstly, because they typically adopt a healthier lifestyle and, for example, abstain from excessive alcohol consumption and smoking, and secondly, because their blood is frequently and closely examined, allowing diseases to be detected early.
Secondly, the requirements for compensating the donor's expenses are very narrowly defined.
- Only actual expenses, such as a train ticket, may be compensated.
- For example, the donor's time loss during plasma collection and travel to and from the donation site, as well as the discomfort of the physical procedure, must not be compensated.
- The form of expense allowance practiced in Germany, with a fixed amount, would no longer be permitted.
""Both blood plasma and the products derived from it are a scarce commodity within the EU member states."“
In the past, Alpha1 Germany and other patient advocacy groups have drawn attention to such grievances and problems by submitting position papers, statements, and open letters to politicians. However, the response was usually minimal, and sometimes there was no reply at all. In our search for more effective means of exerting influence, we discovered the possibility of petitioning the EU. Unlike petitions at the national level, this does not require a minimum number of supporters. At the EU level, a petition can be submitted by an individual residing in the EU, and if necessary, also on behalf of an organization based in the EU.
Therefore, we decided to pursue the route of an EU petition to draw attention to what we consider problematic wording and to urge for a remedy. The central demands of our petition are:
- 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 recipients of blood plasma products in the SoHO Regulation, in particular the security of the supply of blood plasma products in Europe without dependence on imports
You can read the full text of the petition on our website.
The secretariat of the EU Petitions Committee unfortunately does not provide information on the processing time of a petition. Since the SoHO regulation is due to be adopted in just a few months, time was of the essence, and we submitted our petition on September 12, 2023.
That was also the day the European Parliament adopted its draft text of the regulation at first reading, as mentioned above. Now the European Commission and the member states will be consulted, and afterwards the final text will be agreed upon by all parties involved. The regulation is expected to be adopted in the second quarter of 2024. We are very eager to see how things proceed. The next steps are as follows:
- First, the petition is translated into all official EU languages by the Secretariat of the Committee on Petitions and then forwarded to the Committee on Petitions along with a recommendation for further consideration.
- This person then decides on acceptance and further action.
- If the petition is to be considered by committee, it will be published beforehand; after publication, it will be possible to express support; if our petition goes that far, we will of course ask for support.
Whatever happens next, we will keep you informed!
