The European Parliament’s Public Health Committee has adopted a draft bill supporting measures to increase investment and strengthen the supply of the European Union’s critical medicines. The measures cover a range of treatments including antibiotics, vaccines, insulin and medicines for chronic diseases.
The aim of the draft bill is to reduce the EU’s dependency on third party countries, while boosting the competitiveness of the bloc’s pharmaceutical sector. In calling for the draft text, the European Commission said in March this year: “The EU faces increasing challenges to secure a stable and resilient supply of medicines that are critical to ensure the health of the EU patients. Recent global events, including the COVID-19 pandemic and Russia’s war against Ukraine, have exposed vulnerabilities in the EU’s pharmaceutical supply chains. Shortages of critical medicines present substantial risks to patients and public health and undermine the functioning of healthcare systems.”
The draft text sets out a plan to create, modernise and improve manufacturing capacity of critical medicines or their base substances through ‘strategic projects.’ MEPs are calling for guidelines to ensure legal certainty and promote a coordinated approach to these projects, as well as guidelines to support their assessment.
MEPs also want to see public procurement procedures allow for the award of contracts to multiple suppliers for the same product to promote diversification of supply and ensure that production is distributed across different manufacturers and geographical locations within the EU.
To support these developments the drafts text also seeks to prioritise financial support for these strategic projects, with MEPs wanting to establish dedicated “critical medicines security fund” within the EU’s next multi-annual framework.
“Industrial challenges have been pointed out as impacting the availability of critical medicines in the EU including the lack of investments in EU manufacturing capacity which has contributed to the increased supply dependency from outside the EU. Fragmented procurement practices across the member states constitute a challenge and do not contribute to creating the most favourable conditions for investments. Additionally, workforce shortages and the need for specialised skills in pharmaceutical manufacturing further strain the industry’s capacity to ensure a stable supply of critical medicines,” the Commission added in setting out its reasons for the proposal earlier this year.
MEPs also want the Commission to have the power to decide on, as a last resort, the redistribution of medicines from a EU coordinated mechanism for national stockpiles and contingency stocks of critical medicines.
While welcoming the development in the Parliament, Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations warned that there were still risks to be managed. “Europe needs a Critical Medicines Act that works rather than one that tries to address everything. Our region’s resilience will not be strengthened by layering interventions across the entire pool of medicines, but from targeted, evidence-based measures that reflect how pharmaceutical supply chains actually operate. To deliver secure supply, Europe must focus on real risks, use the right tools and remain a competitive environment for manufacturing and innovation,” she said.
Public Health Committee Rapporteur Tomislav Sokol said: “We are committed to strengthening the availability and supply of critical medicines for all EU citizens. We are tackling persistent shortages and reducing our dependence on a limited number of external suppliers.”
Parliament's position is expected to be adopted during the January 2026 plenary session, after which negotiations with EU governments can begin.
Further reading:
- Antimicrobial resistance: Not enough antibacterials in the pipeline, says WHO
- UK a challenging environment for innovation says pharma companies
- Life Sciences leadership: The UK and the EU set out plans for sector growth and investment
- Pandemic Agreement: How the world will tackle future disease outbreaks
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