Feedback from German Social Insurance on 8th May 2025
European Commission call for evidence of an EU stockpiling strategy
Preliminary remarks
The European Commission intends to present a new stockpiling strategy on 25th June 2025. Ensuring an innovative, affordable, safe and high-quality supply of medicinal products and medical devices to patients is a common challenge in the European Union (EU). Changing geopolitical conditions and risks due to climate change and environmental degradation require action in European health policy.
Measures to strengthen Europe's competitiveness and reduce its dependence on other regions of the world for the production and supply of medicinal products are to be welcomed in principle. This also includes building up stocks of supply-critical medicines in order to improve the EU's crisis preparedness and resilience. We therefore support the proposals to expand stockpiling as part of the Critical Medicines Act (CMA) and the announced stockpiling strategy.
Opinion
The aim of the stockpiling strategy should be to ensure the availability of supply-critical medicinal products in cross-border or crisis scenarios affecting multiple Member States. Increased stockpiling can improve the market availability of these products and delay or completely avoid the occurrence of supply bottlenecks. Pharmaceutical packaging must be made marketable across the EU either as multilingual packs or via QR codes. A sensible EU stockpiling strategy for medicinal products should follow the following principles:
- Late in the production chain: Stockpiling of finished medicinal products is fundamentally better than stockpiling of precursors and active ingredients, as it covers all upstream bottleneck risks in the supply chain. For example, a reserve of active ingredients does not help if a production facility fails, or an auxiliary or packaging material is not available.
- Early in the supply chain: Terminal stockpiling by pharmacies, hospitals or even patients is significantly more complex, more expensive and can only be called up to a limited extent and with a delay in the event of supra-regional demand. In contrast, early and centralised stockpiling is cost-efficient due to economies of scale, enables routine stability tests and, in an emergency, allows rapid and supra-regional distribution via existing supply structures.
- For critical medicines: In close alignment with general pharmaceutical legislation and the Critical Medicines Act, stockpiling should focus on critical medicines that are of central importance in the treatment of serious diseases and cannot be substituted.
The EU should therefore introduce a stockpiling obligation for critical finished medicinal products for pharmaceutical companies operating in this area. Current demand should be met from these stocks on a rolling basis so that no medicines have to be discarded. Such an obligation would be justified in terms of protecting public health and would be linked to the existing supply obligation under Article 81 of Directive 2001/83/EC (‘Directive on the Community code relating to medicinal products for human use’). Non-compliance by marketing authorization holders with the obligation to stockpile their critical medicines must be subject to tangible sanctions.
The EU stockpiling strategy should be subsidiarily complemented in the Member States by stockpiling mechanisms that are appropriate to their supply structures and take into account existing national provisions and structures. Germany, for example, has already introduced stockpiling provisions at almost all trade levels in order to be prepared for temporary interruptions in supply.
As the shelf lives stated by manufacturers are too conservative in many cases according to scientific studies, a ‘Shelf Life Extension Programme’ should be set up at the EMA to enable it to carry out its own shelf life studies for medicinal products subject to mandatory stockpiling and, based on these studies, to obtain a change in the product information.
The safe availability of medicinal products requires close integration of the various EU instruments as well as an improvement in the information and data stock levels at all stages of the supply chain.
About us
The German Federal Pension Insurance (DRV Bund), the German Social Accident Insurance (DGUV), the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the national associations of statutory health and longterm care insurance funds as well as the Social Insurance for Agriculture, Forestry and Horticulture (SVLFG) have joined forces to form the "German Social Insurance – Working Group Europe" (Deutsche Sozialversicherung Arbeitsgemeinschaft Europa e.V.) with a view to their common European policy interests. The association represents the interests of its members vis-à-vis the bodies of the European Union and other European institutions and advises the relevant players in the context of current legislative projects and initiatives. As part of a statutory insurance system, health and long-term care insurance with 75 million insured people, pension insurance with 57 million insured people and accident insurance with more than 70 million insured people in 5.2 million member companies, citizens in Germany are provided with effective protection against the consequences of major life risks.