The European Union is taking significant steps to bolster its pharmaceutical industry and ensure a stable supply of essential medicines. On , the European Parliament adopted proposals aimed at reducing critical medicine shortages, increasing manufacturing capacity within the EU, and decreasing reliance on external suppliers. This initiative addresses growing concerns about the vulnerability of medicine supply chains, particularly highlighted by recent global events.
Addressing the Root of Shortages
Over half of reported medicine shortages are attributed to manufacturing issues, according to the European Parliament. The new measures prioritize investment in EU manufacturing capacity to enhance the region’s autonomy in pharmaceutical production. This includes the creation of industrial “strategic projects” designed to modernize and expand existing facilities, as well as establish new ones. National governments and the EU itself are encouraged to prioritize financial support for these projects within current and future budgets.
A key component of the plan involves ensuring that companies receiving public financial support commit to prioritizing supply to the EU market. This aims to prevent situations where medicines produced within the EU are diverted to more profitable markets outside the region during times of scarcity. The focus extends to critical medicines such as antibiotics, insulin, vaccines, and treatments for chronic diseases.
A “Buy European” Approach to Procurement
The proposals also introduce a “Buy European” approach to public procurement. Contracting authorities within the EU will be required to favor producers who manufacture a significant portion of these critical medicines within the EU. This policy is intended to incentivize domestic production and strengthen the competitiveness of the European pharmaceutical sector. The goal is to create a more resilient supply chain that is less susceptible to disruptions caused by geopolitical instability or global health crises.
Stimulating cross-border procurement is another element of the strategy. Encouraging collaboration among EU member states in purchasing medicines can lead to more effective cost management and improved access to essential treatments. This collaborative approach is seen as a way to leverage the collective bargaining power of the EU and secure more favorable pricing agreements.
The Critical Medicines Act: A Broader Framework
These measures are part of a broader initiative known as the Critical Medicines Act. The Act seeks to improve the availability, security, and supply-chain resilience for essential medicines across the EU. It aims to diversify the supply chain, reducing dependence on a limited number of suppliers, and provide incentives for collaborative procurement. A central objective is to boost EU pharmaceutical manufacturing, lessening reliance on non-EU countries for critical medicines.
As Tomislav Sokol, a Member of the European Parliament (MEP) and member of the Committee on Public Health, stated on , “The adoption of the Critical Medicines Act will strengthen EU coordination on national stockpiles and contingency reserves, boost the competitiveness of Europe’s pharmaceutical industry, and help prevent medicine shortages by ensuring patients can access the medicines they need.”
Securing the API Supply Chain
A critical aspect of ensuring a robust pharmaceutical supply chain is securing the supply of Active Pharmaceutical Ingredients (APIs). APIs are the biologically active components of drugs, and a significant portion of the EU’s API supply currently comes from outside the region. The Critical Medicines Act specifically addresses this vulnerability by promoting the development of domestic API production capacity within the EU. This will reduce the risk of disruptions caused by geopolitical factors or supply chain bottlenecks affecting API availability.
The move towards greater self-sufficiency in API production is seen as essential for long-term supply security. It will also contribute to the creation of high-skilled jobs within the EU pharmaceutical industry and enhance the region’s overall economic competitiveness.
Looking Ahead
The European Parliament’s adoption of its position on the Critical Medicines Act marks a significant step forward in addressing the challenges of medicine shortages and supply chain vulnerabilities. The next phase involves finalizing the law through negotiations with the Council of the EU. Once the law is enacted, it will require member states to implement the necessary measures to ensure its effective implementation. This includes establishing national stockpiles, promoting domestic manufacturing, and adopting procurement policies that prioritize EU-based producers.
The EU’s commitment to strengthening its pharmaceutical industry and securing its medicine supply chain reflects a growing recognition of the importance of public health security. By investing in domestic production, diversifying supply chains, and fostering collaboration among member states, the EU aims to ensure that its citizens have reliable access to the essential medicines they need, now and in the future.
