Guaranteeing self-sufficiency in blood products: a health sovereignty imperative

Expert panel at SantExpo

Guaranteeing self-sufficiency in blood products: a health sovereignty imperative.”

Introduction

According to a study conducted by the EU Policy Lab in 2023, nearly 15 million blood donors provide an average of 25 million units (bags) of blood in Europe every year. These donations are essential in the daily lives of hundreds of thousands of patients, to provide emergency transfusions following a hemorrhage, or to ensure the chronic management of rare diseases such as blood disorders or cancers. Blood collection is also essential for the manufacture of blood-derived medicinal products, which are industrially produced by fractionating plasma to treat diseases such as hemophilia and immunodeficiencies.

At European level, the term of office now drawing to a close saw the adoption of the Regulation on Substances of Human Origin (Soho), which paves the way for improving the safety and quality of blood, tissues and cells used in healthcare. Following on from this work, the renewed European Parliament, as well as national authorities when transposing and adapting European regulations, will need to continue to reflect on the challenges facing the blood sector, in particular in order to create conditions conducive to Europe’s self-sufficiency in blood products. That’s why, as part of its public affairs strategy for the 2024 European election campaign, Macopharma has developed a position paper for the various heads of list, to highlight the various advocacy issues involved in guaranteeing Europe’s self-sufficiency in blood products.

Against this backdrop, a panel of experts met at SanteExpo on May 22, during which discussions focused on the actions needed to guarantee self-sufficiency in blood products in France and Europe. The event was moderated by Salomé Chelli-Enriquez, Director of RPP France, and attended by Stéphane VIRY, Member of Parliament for the Vosges and member of the Social Affairs Commission, Laurent BUTOR, Deputy Director of Health Product Policy and Quality of Practice and Care at the DGS, and Caroline HERNU, CEO of Macopharma.

Self-sufficiency in blood products, a prerequisite for health sovereignty

According to the European Blood Alliance, between 67,000 and 70,000 units of blood are needed every day in the European Union (EU) to meet all the above requirements. Some member states collect less than 10 donations per 1,000 inhabitants, due to a lack of donors and insufficient stocks.To avoid shortages, some countries, such as France, are forced to import 65% of their plasma and two-thirds of their blood-derived medicinal products from the United States, creating a dangerous situation of dependence in the event of a protectionist withdrawal by the United States or the development of an infectious agent that would render this plasma unusable.

On this point, Laurent Butor underlines France’s good performance in blood collection, describing the country as the “light of the world” on this subject. Indeed, during the health crisis, France did not lack a single bag of blood, but for him, donor renewal remains a major challenge. He emphasizes the strategic importance of the DGS in blood collection in France, and the protection of the EFS. In his view, the French model, managed by the Établissement Français du Sang (EFS), is efficient but still too complex. He stresses the importance of reconciling blood collection and donation with the highly integrated, global pharmaceuticals market. Laurent Butor also points out that certifications, such as a “Made in Europe” label, could encourage the relocation of production to Europe, provided that its deployment is carefully planned and concerted with SMEs.

On the subject of blood donors, Stéphane Viry hopes that the Établissement Français du Sang (EFS) can review its collection practices to increase the number of potential donors. In his view, the problem lies not only in the lack of donors, but also in the obstacles limiting the EFS’s ability to collect plasma, such as the complex business model, the long distances involved in donating blood, the reduction in the number of collection centers and the age limit for donors. In his view, legislative measures are needed to improve the situation. To this end, he recently tabled a bill to allow young people to donate blood from the age of 17. For the deputy, it is also essential that the Ministry of Health adequately supports and funds the EFS.

Caroline Hernu underlines the crucial role played by industry in the supply of blood products. Through the ongoing supply of medical devices for collection and transfusion, the industry plays an important role in moving towards self-sufficiency. Macopharma supplies 60% of transfusion kits in Europe, and 85% of its products are manufactured in Europe. What’s more, Macopharma is the only company in the sector to be ISO 22301 certified, a demanding standard for purchasing strategies that guarantees the company’s implementation of a continuitý policy for the supply of its products, demonstrating Macopharma’s ability to anticipate disruptions in order to maintain and preserve its activitý.

Caroline Hernu points out that Macopharma’s medical devices also make it possible to collect whole blood from a single donor, thus obtaining the three blood components required: plasma, red blood cells and platelets. These medical devices ensure efficient collection and support self-sufficiency in blood products. It also highlights the imminent need to raise public awareness.

Ensuring transfusion safety through access to safe, high-quality, innovative medical devices

The new regulations on medical devices and endocrine disruptors require rigorous preparation for adaptation by medical device companies. Laurent Butor points out that the new European rules aim to harmonize safety requirements. In his view, it is vital that the French Ministry of Health plays an active role in raising manufacturers’ awareness of these issues. Stéphane Viry considers the new regulations to be good and well thought-out, as they bring greater rigor and safety. To support the SMEs that make up the medical device network, two solutions are essential: simplify administrative procedures and avoid overburdening them. Directives must be clear and new requirements easily understood, while promoting innovation. Caroline Hernu, whose company has integrated research and innovation into its day-to-day environment, points out that new regulations must not be allowed to undermine the dynamics of innovation.

Caroline Hernu points out that 70% of the R&D and regulatory affairs teams have already been involved in transposing medical devices to the new regulations for 5 years, or even 10 for the scientific aspects. What’s more, some of Macopharma’s devices have to comply with 10 different standards, which she feels is too many. Although some improvements have been noted, she would like to see more widespread use of administrative simplification, a reduction in the overlapping of standards, and more reasonable deadlines for reviewing dossiers and ensuring compliance. Finally, when it comes to the marketing of innovative medical devices, Caroline Hernu insists on the need for mutual recognition of studies and authorizations granted in one country of the European area, thus putting an end to the nonsense of validating a medical device in country A when its neighbor B does not authorize it.

Conclusion

In conclusion, the speakers stressed the need for collaboration at all levels. In their view, it is crucial to give full support to European companies producing medical devices, and to give them confidence by encouraging them to innovate. In this respect, Laurent Butor, Stéphane Viry and Caroline Hernu have high expectations of the next term of office of the European Parliament, convinced that, with real political will, these decisions must be taken and implemented at Community level.