December 15, 2023

IPOPI’s advocacy on the future EU legislation on plasma

IPOPI has been busy following the discussions on the EU future legislation the standards of quality and safety for substances of human origin intended for human application (SoHO) over the past months. The proposal for a regulation on substances of human origin was originally published in July 2022 but in the second half of 2023 the EU Parliament and the Council of the EU (representing the governments of the 27 EU countries) were highly focused on this file.

The European Parliament worked on its position with the intention of increasing European plasma collection autonomy, reduce EU’s dependence on plasma coming from third countries and increasing the availability of life-saving plasma-derived medicinal products such as immunoglobulin replacement therapies, whilst safeguarding the safety and quality standards of SoHOs. IPOPI discussed with the leading MEPs working on this file to convey the views of patients living with a PID. The European Parliament voted on its final position on September 12. Whilst many of the provisions contained in the final position were welcomed by IPOPI, there were still certain elements on donation compensation and risk considerations that IPOPI considered could play against the general objective of having a truly patient-centred legislation and improve protection to patients dependent on plasma-derived medicinal products (more info on IPOPI’s position on the European Parliament vote here). In this sense, IPOPI and many of its NMOs called on to member states, Members of the European Parliament, and the Council of the EU to consider the patients perspective and ensure that the future legislation has not negative and unintended consequences during its implementation at national level and it is flexible enough to evolve with science and scientific evidence.

The Council (national governments of the 27 EU countries) reached a negotiated position at the end of October, following which IPOPI published a  position statement on the Council’s position on the SoHO proposal which can be found here.

Discussions are now ongoing among the Parliament, the Council, and the European Commission to find legislation that accommodates the views of the EU institutions. The compromise is expected to happen in the coming months, just in time for the legislation to be approved before the EU Parliament is dissolved ahead of the EU elections in June 2024. Stay tuned for future developments!