On 20 January 2026, the European Parliament approved the Critical Medicines Act by a broad, cross-party majority.
A politically significant outcome, to be read not only as a response to the medicine shortages that have emerged in recent years, but also as a clear message to the pharmaceutical industry and the European manufacturing value chain.
The issue is no longer merely a matter of public health.
It is industrial, strategic, and geopolitical.
From shortages to an industrial policy
Over the past five years, the European Union has experienced a structural vulnerability: recurring shortages of essential medicines, dependence on extra-EU supplies, and fragile supply chains.
The Critical Medicines Act was conceived to turn emergency-driven management into a structured policy framework, integrated with the broader reform of European pharmaceutical legislation.
The stated objective is twofold:
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to ensure continuity of access to critical medicines
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to strengthen Europe’s manufacturing capacity
European manufacturing and procurement as strategic levers
One of the most relevant elements for the sector is the strengthened role of public procurement as an instrument of industrial policy.
The text explicitly opens the door to:
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tender criteria that value EU-based production
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joint procurement mechanisms
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tools designed to support local manufacturing capacity in the most vulnerable segments
For many companies—particularly those operating in the mature, low-margin medicines segment—this represents a potential shift in perspective: from the risk of disinvestment to renewed strategic centrality.
Supply chain: resilience over efficiency
The CMA also marks a cultural shift. Resilience—understood as the system’s ability to withstand shocks, crises, and disruptions without interrupting access to medicines—formally enters the regulatory objectives, alongside quality, safety, and cost efficiency.
For the value chain, this translates into:
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greater focus on the localisation of APIs
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reduced dependence on single countries or suppliers
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a possible rethinking of just-in-time models
This is not yet an explicit reshoring policy, but the direction is clear.
Expected impacts on the pharmaceutical industry
From an industrial perspective, the Critical Medicines Act raises several key questions:
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which manufacturing segments will be deemed “critical”?
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what concrete incentives will accompany the new requirements?
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how will costs, economic sustainability, and supply obligations be balanced?
The Parliament’s vote does not close the debate, but it raises the political bar ahead of the trilogue negotiations with the Council and the Commission.
A building block of the European Health Union
The CMA fits into the vision of a more integrated European Health Union, where access to medicines is treated as a matter of collective security.
Within this framework, industry is not merely a supplier, but a systemic actor—called upon to engage on production, stockpiling, planning, and risk.
What happens next
The text now enters the interinstitutional negotiation phase. The coming months will be decisive in determining:
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the degree of flexibility for companies
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the concrete impact on manufacturing models
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the level of coordination among Member States
One thing is certain: critical medicines are now firmly embedded in the European industrial agenda.
