Substances of Human Origin (cepAnalyse zu COM(2022) 338)
Blood, plasma and other Substances of Human Origin (SoHOs) are becoming increasingly important, especially in the fight against rare diseases. Since essential products are not sufficiently available in the EU, dependence on imports, especially from the USA, is growing. The Centrum für Europäische Politik (cep) believes that the Commission's goal of providing better care for EU citizens in the future is right - but that some of the planned measures are questionable.
"It is desirable to ensure the protection of patients. However, not all steps are useful and necessary," says Nathalja Nolen. The cep health expert has analysed the planned regulation with cep jurist Patrick Stockebrandt.
The planned obligation to exchange data between the Commission, Member States and SoHO entities makes sense. This could better protect EU citizens from possible side effects and avoidable health risks, for example, and have positive effects on supply , new authorisations and readiness to donate. Especially the willingness to donate is important because there is a growing demand for certain SoHO, such as plasma, in the EU.
The cep experts call on the Commission to define certain points in the regulation more clearly to ensure a uniform interpretation, especially by SoHO experts, in the EU. Member States should, as planned by the EU, regulate the supply and demand of certain SoHOs such as plasma and bone marrow themselves instead of relying on supplies from third countries.
Most recently, the urgent need was also addressed in a question to the German government. Lifesaving medicines can be produced especially from blood plasma. The willingness to donate within the population is decreasing, while the need is constantly increasing. The Charter of Fundamental Rights of the EU prohibits the making of profits, but donors can, among other things, be granted compensation for expenses. The present proposal for a regulation remains unspecific in this respect and leaves the design to the Member States.