The European Union Critical Medicines List and the Critical Medicines Act have identified plasma-derived medicinal products, such as immunoglobulins, as “critical medicines” because of the seriousness of the diseases they address and the lack of suitable alternatives. Plasma-derived medicines are made from donated human plasma and require complex processing called fractionation to isolate essential proteins.
But critical medicine status has not protected plasma-derived medicinal products (PDMPs) from cost containment measures, such as clawbacks, which endanger future access to these treatments for patients who have rare and serious diseases, according to the white paper.
Watch the video clips to hear from the white paper’s authors.
“Strengthening the availability and security of supply of critical medicinal products, including PDMPs, is being addressed by the European Commission’s March 2025 Critical Medicines Act (CMA) proposal. To be effective, the CMA must be accompanied by national-level action to alleviate the burden of cost-containment measures on these medicines,” the authors wrote in the paper.
Clawbacks on immunoglobulin medicines represent no more than 2% of all clawback government revenue, offering minimal and disproportionate savings to payers and having a detrimental impact on the sector’s economic viability, according to the paper.
The authors state that exemptions, such as those already in place in several EU member states, cost payers little while they ensure that patients have access to essential care in a timely manner, and nations can meet economic and security aims in the health sector.
