New rules on procurement, stockpiling and security of supply.

One of the central priorities of Health Commissioner Olivér Várhelyi was to present the Critical Medicines Act (CMA) within the first 100 days of his mandate and to advance negotiations swiftly thereafter. Both objectives have now been achieved. Only around one year after the publication of the legislative proposal, the Council and the European Parliament reached a political agreement on the new regulation during trilogue negotiations in the night from 11 to 12 May.

The aim of the CMA is to better prevent medicine shortages, strengthen security of supply in Europe and reduce dependencies on production sites in third countries. At the same time, the regulation seeks to expand European production capacities for critical medicines and active pharmaceutical ingredients. With its 31 articles, the regulation brings together a broad range of political instruments for the prevention, management and coordination of medicine shortages.

Expansion of the scope

A key issue during the negotiations concerned the scope of the regulation. The European Parliament succeeded in broadening the scope beyond medicines included on the “Union List of Critical Medicines”. In the future, so-called “Medicinal Products of Common Interest” (MPCI) will also fall within the scope of the regulation. In addition, orphan medicines are expected to benefit from strategic projects and joint procurement mechanisms. However, Parliament did not succeed in extending the scope to include contraceptive and abortive medicines.

New procurement requirements

For statutory health insurance funds, the new provisions on public procurement are of particular relevance. In future procurement procedures, contracting authorities will no longer be allowed to focus exclusively on price, but will also be required to take diversification and resilience criteria for production and supply chains into account. For medicines with a high dependency on individual third countries, additional possibilities have been created to support European production sites more directly.

According to the European Parliament, procurement authorities may, among other things, give preference to suppliers proportionally to the share of medicines and active pharmaceutical ingredients produced within the EU. However, the final compromise appears to be considerably more flexible than initially proposed by Parliament and aligns more closely with the Council’s position.

Joint procurement and stockpiling

On joint procurement and stockpiling, the negotiations largely followed the more member state-oriented approach of the Council. While the European Commission will in future be able to launch joint procurement procedures at the request of five Member States, a previously envisaged stronger role for the Commission under Article 23 was ultimately removed from the compromise text. Joint procurement therefore remains voluntary.

Stockpiling of critical medicines also remains primarily the responsibility of the Member States. National stockpiling requirements are expected to be transparent and consistent with the principles of solidarity and proportionality, but their concrete design remains largely within national competence. In addition, the existing voluntary solidarity mechanism for the exchange and, where necessary, redistribution of critical medicines is expected to be further clarified.

What the compromise means for Statutory Health Insurance Funds

Overall, the political agreement follows many of the negotiation dynamics that had already been foreseeable. Given the positions of both Parliament and Council, it was expected that procurement procedures would in future have to consider resilience and diversification criteria alongside price. The decisive question now will be how the final legal provisions – particularly Article 18 – are ultimately formulated and how much flexibility remains for contracting authorities in practice.

From the perspective of the German Social Insurance system (DSV), it is important that procurement authorities retain sufficient flexibility and that legally secure rules are established. The DSV takes a more critical view of the expansion of the regulation’s scope. In its view, the CMA should have remained focused on medicines listed on the European Medicines Agency’s Union List of Critical Medicines. The planned extension – including to orphan medicines – goes significantly beyond the regulation’s original objective of strengthening security of supply (cf. DSV statement at the start of the trilogue negotiations).

Outlook

The political agreement must now still be formally confirmed at working level. In the Council, this requires endorsement by the Committee of Permanent Representatives (COREPER), while in the European Parliament the agreement must be approved by the Committee on Public Health (SANT). This will be followed by legal-linguistic revision and translation into all official EU languages. Only afterwards can Parliament and Council formally adopt the regulation. Publication in the Official Journal of the European Union is therefore expected only after completion of these steps.