EBA suggests key improvements to Critical Medicines Act

The European Blood Alliance (EBA) welcomes the recent publication of the Critical Medicines Act (CMA) and believes it can have a positive impact in addressing some bottlenecks and improving patient access to critical medicines. Nevertheless, the future regulation must better consider the specificities of Plasma-derived medicinal products (PDMPs), or risk failing to improve patient access to these medicines.

EBA welcomes in particular the possibility in the proposal for Member States to recognise Strategic Projects that create or increase capacity for collecting active substances to critical medicines. Plasma collection from human donors is the only possible way to collect the active substances for PDMPs and the CMA should be a tool for Member States to invest in plasma collection. EBA believe that the proposal can still be improved with clearer wording in the related articles.

EBA is also pleased that the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) of the European Medicines Agency (EMA) takes a very similar view in its very timely new guidelines to address anti-D immunoglobulin supply chain vulnerabilities.

Regarding the financial incentives proposed, EBA would like to see clearer references to all relevant Union programmes, and in particular to regional policy funding programmes, which represent a third of the EU budget but are currently absent from the proposal.

Download the full EBA response below.