IPOPI welcomes the adoption of the EU Regulation on Substances of Human Origin

The International Patient Organisation for Primary Immunodeficiencies (IPOPI) warmly welcomes the European Regulation on the Substances of Human Origin (SoHO). The new text seeks to increase European plasma collection autonomy so as to reduce its dependence on plasma coming from third countries and increase the availability of life-saving plasma-derived medicinal products such as immunoglobulin therapies.

A majority of patients with primary immunodeficiencies (PIDs) require immunoglobulin replacement therapy. Immunoglobulin therapies are medicines obtained from the fractionation of human plasma and they need to be administered lifelong at regular intervals so that patients can fight off bacterial and viral infections. Patients with PIDs in need of immunoglobulins do not have any alternative treatment.

In Europe, the biggest safety concern for patients with PIDs does not relate to the products themselves, but to their supply and the lack of continued and stable access. For instance, on June 3rd 2024, the European Medicines Agency issued a notification on the shortage of immunoglobulins affecting 14 European countries and expected to occur throughout 2024. One of the main reasons for the immunoglobulin shortages is related to the scarcity of the starting material: human plasma.

IPOPI sees as a very positive step the recognition of the importance of guaranteeing the availability of these substances to ensure optimal patient access and the recognition of the unique nature of plasma for fractionation (different from blood in many different aspects). The acknowledgement of the necessity to increase plasma collection to meet patient needs in plasma-derived medicinal products which are finished pharmaceuticals subjected to the EU general pharmaceutical legislation while respecting Member States’ competencies in the organisation of blood and plasma collection and donor retention is much appreciated. We believe that plasmapheresis is the collection method that needs to be prioritized in Europe to enable greater volumes of plasma to be collected whilst we also need to embrace public-private collaboration when it comes to plasma collection.

IPOPI calls for a smooth interplay between the SoHO regulation and the pharma legislation (when approved) so as to ensure that the raw material addressed in the first one (plasma for fractionation) is also acknowledged as paramount when it comes to accessing the final medicinal products (immunoglobulins and plasma-derived medicinal products at large).

IPOPI looks forward to working with Member States and other stakeholders to ensure that the ultimate objective of meeting patients’ need for life-saving plasma-derived medicines, such as immunoglobulin therapies, is met.

Read the statement in Spanish and French.