Brussels – The European Commission is set to present a draft law on critical medicines in Strasbourg, a response to demands from member states that began over a year ago.

This legislative initiative arrives at a time when the European Union is grappling with heightened geopolitical tensions and an increase in military spending, leading to worries that the continent’s reliance on foreign pharmaceutical supplies could pose significant risks to its healthcare system.

Currently, between 60 and 80 percent of the active pharmaceutical ingredients (APIs) used for generic drugs in the EU are imported from India and China, while approximately 90 percent of global antibiotic production occurs in Asia.

This dependency has raised alarms with health ministers from eleven EU member states—Belgium, Spain, Germany, the Czech Republic, Greece, Latvia, Estonia, Lithuania, Portugal, Slovenia, and Cyprus—who have indicated that such reliance might be a critical vulnerability in emergency situations.

The shortages of essential medicines are not unprecedented within member states; they prompted the European Commission to create a list of critical medicines last year and to form an alliance dedicated to essential medicines.

Ursula von der Leyen, President of the European Commission, has incorporated the Critical Medicines Act into her policy guidelines for her second term.

Olivér Várhelyi, the EU Commissioner for Health, has committed to presenting this proposal within the first hundred days of his term.

European Parliament members are poised to scrutinize the Commission's measures aimed at reinstating pharmaceutical manufacturing within Europe and promoting joint procurement strategies during upcoming discussions.

The eleven member states have suggested that funding from the Critical Medicines Act could be linked to the EU’s broader defense spending initiatives, underscoring the imperative of ensuring essential medicines for maintaining defense capabilities.

In tandem, Belgium, Cyprus, France, Greece, Italy, Malta, Portugal, Romania, Spain, and Hungary have distributed a non-paper, a type of informal document advocating for robust legislation to tackle the shortages of essential medicines in the EU. The document acknowledges complex causes for the shortages, particularly the decline of domestic pharmaceutical production in favor of offshoring, which amplifies vulnerability to crises.

The non-paper proposes the establishment of an industry-wide list of vulnerable medicines by 2025, aimed at prioritizing support for and diversifying EU-based manufacturing.

It recommends the European Medicines Agency (EMA) compile a database of pharmaceutical shortages with input from member states.

Such efforts are considered foundational for developing a targeted investment strategy that would require improved cooperation and coordination across the EU, including potential adjustments to EU state aid rules and financial frameworks.

Furthermore, the non-paper emphasizes the urgent need for supply chain diversification and encourages Brussels to explore potential international partnerships for essential medicines.

Lessons drawn from the COVID-19 pandemic have highlighted the importance of joint procurement practices, which member states assert must be clearly defined in the forthcoming Critical Medicines Act.

They stress that while bolstering manufacturing capacity in Europe is crucial, it must be complemented by more effective purchasing strategies.

The recommendations encapsulated in the non-paper are expected to be integrated into the proposal that Várhelyi will present to the European Parliament's plenary session.

This proposal will subsequently be reviewed by relevant ministers from member countries and the EU Parliament’s Committee on Public Health, who will be instrumental in finalizing the legislative framework.