EMA and HMA to strengthen Anti-D Immunoglobulin supply chain

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) have issued new recommendations to address weaknesses in the supply of anti-D immunoglobulins. 

These medicines are essential in preventing RhD immunisation during pregnancy, a condition that occurs when a pregnant individual with RhD-negative blood is exposed to RhD-positive blood from the foetus. This immune response can lead to severe complications for the foetus and newborn, sometimes with life-threatening consequences. 

Currently, anti-D immunoglobulins are made only from human plasma donated by individuals, and they are produced in just a few countries outside the European Union. With a decrease in plasma donors and limited global production, the supply chain is under pressure. To address this, the MSSG has recommended coordinated efforts by regulators, the European Commission, the plasma industry, and research organisations. 

EU countries are urged to develop national plans to ensure the continued availability of anti-D immunoglobulins. These plans should be based on safety, legal, ethical, and regulatory considerations. 

The European Commission is advised to find ways to secure the ongoing supply of anti-D immunoglobulins and to help EU Member States carry out their plans. The proposed Critical Medicines Act may offer helpful tools, such as joint procurement, to boost manufacturing and ensure supply within the EU. 

Industry partners are expected to take steps to secure a consistent supply in Europe. This includes investing in improved manufacturing processes and developing alternatives to current plasma-based anti-D treatments.