The European Committee on Blood Transfusion (CD-P-TS), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, has played an important role for many years in addressing the scientific, technical and policy challenges related to anti-D immunoglobulin (anti-D IgG).

Anti-D IgG is an essential plasma-derived medicinal product used to prevent haemolytic disease of the foetus and newborn (HDFN), a potentially severe and life-threatening condition. Since its introduction in the 1970s, anti-D IgG has dramatically reduced maternal sensitisation and improved neonatal outcomes. It remains the only effective prophylactic treatment available in Europe and is included on the European Union list of critical medicines.

Despite the essential role played by anti-D IgG medicinal products, Europe remains almost entirely dependent on anti-D plasma collected outside Europe, particularly in the United States. This structural dependency represents a serious public health vulnerability. Any disruption to the supply chain could compromise access to this essential medicine, placing pregnant women and newborns at risk. Ensuring a secure and sustainable anti-D IgG supply is therefore a critical public health priority requiring co-ordinated European action.

The CD-P-TS has undertaken a series of targeted initiatives to address this challenge and support the development of sustainable anti-D plasma collection and anti-D IgG manufacturing programmes in Europe.

The CD-P-TS has been actively addressing anti-D IgG supply challenges through scientific guidance, stakeholder co-ordination and targeted technical initiatives for many years. It published a position paper on monoclonal anti-D antibodies in 2010, and a report on anti-D alloimmunisation, immunoprophylaxis and self-sufficiency in 2014, laying the groundwork for more recent initiatives.

To heighten awareness and strengthen stakeholder engagement, the EDQM co-ordinated a series of international webinars in September and October 2023.

These webinars brought together experts from blood establishments, regulatory authorities, manufacturers and clinical communities to address:

• challenges in anti-D plasma collection;
• manufacturing and supply chain vulnerabilities;
• regulatory and operational considerations;
• emerging alternatives and future developments.

The webinar series helped build a shared understanding of risks and opportunities and laid the foundation for co-ordinated European initiatives.

 Anti-D immunoglobulin: Anti-D Immunoglobulin: Exploring collection, production and alternatives: View the webinar recordings and download the programme and presentations of this event in the EDQM e-Learning collection.

 Can We Have European Anti-D Plasma Collection Programmes? (Forthcoming)

“Strengthening supply chain of anti-D immunoglobulins”: in July 2025, 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), issued recommendations to strengthen the security of the anti-D IgG supply chain.

The CD-P-TS work complements these recommendations by providing technical, scientific, regulatory and operational expertise to support their implementation. This includes identifying practical pathways to support the (re-)establishment of European anti-D plasma collection programmes.

Through its technical work and stakeholder co-ordination, the CD-P-TS is contributing to the development of sustainable European solutions.

Key priorities include:

• developing a European roadmap to support the (re-)establishment of anti-D plasma collection programmes, including donor identification, immunisation and collection protocols;
• supporting the establishment of European plasma pooling approaches to enable efficient and sustainable manufacture;
• encouraging dedicated policy and financial support from European member states and institutions;
• promoting optimisation of clinical use through wider implementation of foetal RhD genotyping and appropriate dosing strategies;
• supporting research and development of sustainable alternative therapeutic approaches.

Ensuring a secure and sustainable supply of anti-D immunoglobulin is essential to protect maternal and neonatal health across Europe.

Through targeted scientific, technical and co-ordination activities, the CD-P-TS continues to work with national authorities, regulators, blood establishments and international partners to build resilience in the anti-D IgG supply in Europe and support the development of sustainable anti-D plasma collection programmes.