Medicines shortages are a persistent concern across Europe, affecting important categories of medicines including antibiotics, insulin, cancer treatments and vaccines. There is a mixed picture in different EU countries, with many medicines still authorised on a national basis rather than centrally, and some products not made available in all countries.
In response, the EU is introducing two sets of measures to strengthen supply resilience and address national differences. The current reforms to EU pharmaceutical legislation – the “Pharma Package” - will use regulatory changes to help prevent medicines shortages. In addition, the proposed Critical Medicines Act will promote the diversification of supply chains and support EU manufacturing, as well as enabling closer cooperation between EU member countries to improve access to medicines.
Pharma Package changes
The current pharmaceutical regulatory framework contains only limited, high-level obligations addressing supply disruptions. The new Pharma Package includes a suite of new measures to improve EU-wide availability and mitigate shortages of medicines.
This includes expanded obligations on marketing authorisation holders (MAHs), as well as extensive communication between national authorities and the EMA to support a coordinated approach to supply issues.
Where a MAH intends to withdraw a marketing authorisation, or cease or suspend sales of a product in part or all of the EU, it will have prior notification obligations. Where a product is considered to be a “critical medicinal product” or a “priority antimicrobial”, there will be additional obligations to take steps towards sale of the marketing authorisation or allowing access to the data file so that another company can take over supply of the product. There are requirements to keep regulators informed of negotiations and to demonstrate that they are not being unreasonable.
For prescription medicines, and other products identified as being particularly important, MAHs will be required to maintain shortage prevention plans and implement mitigation measures where risks arise. For other products, MAHs must carry out regular documented risk assessment of potential supply chain risks and, where necessary, take mitigating measures.
Where a product benefits from regulatory data protection or market exclusivity, national regulators can require a MAH to take steps towards launch of the product, including pricing and reimbursement processes. If a MAH fails to do so, the data protection and market exclusivity will fall away. For centrally authorised products, an additional mechanism will apply with the possibility of further sanctions yet to be introduced.
Countries will be able to oversee cross border distribution of products, and take steps to control this where it could lead to shortages in the source country.
Political agreement on this suite of reforms was reached in December 2025, with a finalised text expected in autumn 2026. Obligations relating to supply shifted during the legislative process to become more stringent, reflecting legislators’ focus on this issue.
The Critical Medicines Act
This legislation is yet to be finally settled, but aims to address the underlying causes of shortages by:
- supporting diversification of supply chains
- incentivising EU-based manufacturing and strategic projects
- encouraging collaborative procurement and stockpiling mechanisms.
Two categories of medicines are identified; “critical medicines” designated under the Pharma Package, and “medicines of common interest” identified by agreement between countries. The critical medicines list has already been established in anticipation of the reform package taking effect, and includes many older, generic medicines.
A central theme is reducing reliance on a limited number of suppliers and jurisdictions, which has been identified as a key driver of shortages in recent years. The Critical Medicines Act would see the establishment of a Critical Medicines Coordination Group. The membership and roles of this group are currently under discussion, but it would facilitate coordination of the planned security of supply measures.
Procurement rules would shift away from a narrow price focus toward a broader assessment of supply security and resilience. Tenders for critical medicines will increasingly be awarded on multi factorial criteria (e.g. Most Economically Advantageous Tender/MEAT or resilience requirements). This is likely to mean that contracts will embed commitments on reliable supply, diversified sourcing, manufacturing location (often favouring EU production), and delivery performance, not just price. As a result, pharma suppliers are likely to face contractual obligations around continuous availability, supply chain transparency, and reporting of risks or disruptions, with these operational commitments becoming central to both bid evaluation and contract performance.
Strategic projects for improved manufacturing located within the EU would receive fast-tracked approvals and financial and other support.
Together these reforms will place extensive new obligations on manufacturers of both old and new medicines. They will promote manufacturing located within the EU and constrain suppliers’ freedom to choose how and when to launch or withdraw products. Producers of innovative therapeutics and off-patent, generic medicines will need to familiarise themselves with the new rules and adapt to their requirements.
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