What are the expectations for the revision of the EU legislation on blood, plasma and tissue?

Various actors have voiced growing concerns about the existing blood and plasma legislation. The most prominent questions revolve around supply and demand, spurred by an ongoing shortfall of 3.8 million litres of blood and plasma across the EU. On the one hand, this shortfall is due to demand increases for plasma from the pharmaceutical industry. Moreover, that demand increase mirrors a rising global expectation and use of plasma-derived medicines. On the other hand, there are issues on the supply side. There is a severe shortage of voluntary unpaid donations, to the extent that the EU must currently import blood and plasma from the USA and other third countries. The EU Member States are under enormous pressure to develop citizen engagement with blood donations programs and increase domestic blood bank supplies.  

To address the issue of supply and demand, stakeholders have expressed two desires. The first wish is to introduce a concrete goal for the growth of the intra-EU supply of blood and plasma. This wish is often paired with the call for more support for dedicated plasma collection on behalf of the medical and pharmaceutical industries. The second wish expressed by several stakeholders is to encourage (non-)financial reimbursements for blood donors. It is possible that the combination of a specific supply goal and guidance on (non-)financial rewards for blood donors will be reflected in a future revision of the EU legislation on blood and plasma donations.   

Besides supply and demand, there is the critical issue of safety. The questions remain: how can we further minimise the risk of transmitting diseases in blood/plasma/tissue transfusion? And how can the health of the blood donor be secured? The solutions involve juxtaposing safety concerns with demands for more efficiency. Some stakeholders call for new, predictive or risk-based technologies in pre-donation screenings as a substitute for potentially superfluous or duplicative tests. Predictive or risk-based technologies promise to overcome the apparent juxtaposition of safety and efficiency. Therefore, it can be expected that these new technologies will play a role in revising the existing legislation.   

The question of safety is often discussed in connection with another concern that the Commission has identified: the degree of regulatory harmonisation. The EU Member States, contingent on their resources, have contrasting approaches to safety inspections. Some stakeholders have suggested that the resulting complexities are hard to justify and have even gone as far as to argue that regulatory differences may sometimes be linked to market distortions. One can expect that remote, risk-based inspections instead of physical, and empirical inspections will have an expanded role in the regulatory revision. Other actors have indicated support for creating more private blood establishments, which might be an effective option in some situations. In addition to the above, one might predict that procedural and quality-related standards will be further harmonised across the EU. 

Predictive and risk-based technologies are not the only kind of new technology likely to play a role. Demand for more targeted, personalised treatment methods and drugs through Advanced Therapy Medicinal Products (ATMPs) has increased significantly throughout the years. Stakeholders have asked to clarify the status of blood, plasma and tissue-based ATMPs in the legislation.    

Lykke Advice has years of experience in lobbying the various EU institutions. Our team has extensive knowledge about the different issues and challenges faced by stakeholders in the pharmaceutical and medical sectors. We can help you create a network in Brussels for you to be able to influence the new upcoming legislation and make policymakers aware of the challenges and opportunities of your company or organisation. Feel free to reach out to us! 

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