Addressing immunoglobulin shortages: EHA and EBA’s strategic recommendations at the EMA
In recent years, shortages of immunoglobulins (Ig) have become a growing concern in the European Union (EU). Since 2018, the European Medicines Agency (EMA)—the EU agency that evaluates and supervises medicines—has received an increasing number of shortage reports.
In light of this, the EU has placed the issue of immunoglobulin shortages and plasma supply sustainability at the forefront of healthcare policy. EHA has been actively involved in tracking developments and providing recommendations.
Presentations to the EMA SPOC Working Party
The EMA's Medicine Shortages Single Point of Contact (EMA SPOC) Working Party, responsible for monitoring and managing the supply of medicines, plays a crucial role in addressing issues around Ig supply.
On October 8, 2024, the European Blood Alliance (EBA) and EHA were invited by the EMA SPOC Working Party to present their recommendations. These were based on research conducted as part of the EU4Health SUPPLY project, which concluded in February 2024.
SUPPLY’s key recommendations
Peter O’Leary (EBA) presented SUPPLY’s key recommendations for recognizing plasma as a strategic resource.
- Recognize plasma as essential: The EU should establish laws treating plasma as a critical resource for public health, comparable to essential medicines.
- Foster collaboration: Legal frameworks should encourage cooperation between public and private blood collection systems.
- Remove barriers to sharing: Legal obstacles hindering plasma pooling and manufacturing agreements between EU countries should be addressed.
- Prioritize domestic plasma: Plasma products sourced from within the EU should be used first to meet the needs of EU citizens.
- Increase plasma collection: Support programs to boost both the quantity and quality of plasma collection across EU member states.
SUPPLY Work Package 6 recommendations
Gauthier Quinonez (EHA) presented recommendations from SUPPLY Work Package 6 on the appropriate use and prioritization of Ig.
- Develop national Ig databases: A comprehensive database should be created to track immunoglobulin usage at the patient level, including clinical efficacy and discharge summaries for specific conditions (e.g., PID, CIDP).
- Share information consistently: Harmonize the indications for Ig use across EU member states to ensure consistency in treatment.
- Create a European prioritization plan: Develop a flexible, Europe-wide plan for Ig usage that can be adapted to each country’s healthcare system and resources.
- Establish Ig management protocols: Implement standardized protocols across Europe for switching brands, using alternative treatments, and managing shortages.
- Include patient advocacy: Involve patients and advocacy groups in discussions on the therapeutic value and future use of Ig.
SoHo Regulation
As immunoglobulin shortages become a more pressing issue, collaboration between blood banks, medical societies, regulators, the EMA, and all relevant stakeholders is essential to safeguard plasma supplies and ensure equitable access to treatment.
The Substance of Human Origin (SoHO) Regulation, entering into force in August 2027, will play a critical role in this effort. In particular, it will establish stronger safety and quality standards for plasma collection and supply across the EU. The regulation will also promote cross-border cooperation and plasma sharing, which will enhance the resilience of the healthcare system.
By recognizing plasma as a strategic resource and adopting harmonized approaches to Ig usage, the EU can strengthen healthcare resilience and protect public health.
If you have any questions
For inquiries about EHA’s work on the EU SoHO legislation or the SUPPLY project, please contact europeanaffairs@ehaweb.org.
Image of EMA building by Ceescamel, CC BY-SA 4.0.
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