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

These medicines are currently the only available treatment for the prevention of RhD immunisation during pregnancy. RhD immunisation happens when a pregnant person with RhD-negative blood type is exposed to RhD-positive blood from their foetus. This can lead to an immune reaction that can seriously impact the health of the foetus, and later of the newborn, and have potentially fatal outcomes.

Plasma, the liquid part of blood, collected from donors and containing the anti-D immunoglobulin is currently the only source for manufacturing these medicines. The numbers of donors are declining, and anti-D immunoglobulins are only produced in a limited number of countries, all located outside the European Union (EU). For this reason, the MSSG has been monitoring the supply chain of these medicines and has issued these recommendations to national regulators, the European Commission, as well as to the plasma industry and relevant research organisations, to support actions to strengthen their availability and prevent serious shortages.

EU Member States are recommended to create plans to secure the supply of anti-D immunoglobulins in the EU, guided by relevant safety, legal, ethical and regulatory aspects. These plans should also focus on reducing unnecessary use, for example through non-invasive pre-natal screening. Countries should support development and validation of alternatives to these medicines through research and funding and create prioritisation guidelines to manage shortages. In addition, they should implement communication campaigns to increase awareness of plasma collection for the development of plasma-derived medicinal products, such as anti-D immunoglobulins.

The European Commission is encouraged to identify measures to ensure supply continuity of these medicines and support and coordinate Member States’ activities. Policy measures set out in the proposed Critical Medicines Act could be leveraged, such as joint procurement of manufacturing services to establish or increase supply of these medicines to the EU.

Finally, industry should ensure the adequate supply of anti-D immunoglobulins in Europe, including through investments in optimising manufacturing capacity and developing alternatives to plasma-derived anti-D immunoglobulins.

Anti-D immunoglobulins are included in the Union list of critical medicines; therefore a stable supply of these medicines is considered vital for the functioning of EU health systems and the wellbeing of its citizens.

While the recommendations address the anti-D immunoglobulin supply chain, the principles are also applicable to address vulnerabilities in the supply chain of other plasma-derived medicines.