Wednesday, March 12, 2025
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EU proposes Critical Medicines Act to tackle drug shortages

The European Union unveiled plans to address drug shortages and reduce reliance on foreign suppliers by boosting local manufacturing of critical medicines, according Politico.

The Critical Medicines Act, set to be presented by European Health Commissioner Olivér Várhelyi and Commission Executive Vice President Teresa Ribera, aims to overhaul procurement rules, provide subsidies for production, and forge new international partnerships to ensure a stable supply of essential drugs.

Countries will no longer prioritise the cheapest drugs but will instead consider factors like supply chain security, stockholding obligations, and supplier diversification. Contracts will include performance clauses, require transparency in supply chain monitoring, and procure from multiple suppliers to reduce dependency on single sources.

The EU will provide financial support for “strategic projects” that create, expand, or modernise manufacturing capacity for critical medicines and their components within the EU.

Meanwhile, a new group, comprising two representatives from each EU country, will share information on manufacturing capacity, state-supported projects, and supply chain vulnerabilities. The Commission will also explore opportunities to diversify supplies of critical medicines, active ingredients, and starting materials through new global partnerships.

The EU currently relies heavily on India and China for the production of generic drugs and active pharmaceutical ingredients (APIs). The over-reliance has made supply chains vulnerable to disruptions, such as geopolitical tensions, trade restrictions, or production halts, leading to shortages of essential medicines in Europe.

The Critical Medicines Act aims to reduce this dependency by incentivising local production and diversifying supply chains. It complements the EU’s broader efforts to revise pharmaceutical legislation, ensuring access to affordable medicines while boosting the bloc’s competitiveness in the global pharmaceutical market.

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