The European Union wants to strengthen the availability and security of supply of those medicines considered critical in the Union, and also increase the availability of innovative and high-cost therapies, such as various drugs for rare diseases.
The medicines affected include antibiotics, insulin, vaccines and drugs for chronic diseases. A regulation presented by the Commission, now under discussion in the EU Parliament and Council, aims to reduce dependencies on third countries, increase production capacity in Europe and make the response to shortages more coordinated, with tools that impact industrial investments, public procurement and inventory management.
The position of the House
The European Parliament approved its position in plenary with 503 votes in favour, 57 against and 108 abstentions, asking, among other things, strategic projects to strengthen production capacity in the EU, new rules on public purchasing to make the supply chain more stable and greater use of joint purchases between member states, in particular for high-cost medicines and rare diseases.
The Strasbourg Chamber also calls for a national stockpile coordination system to manage emergencies and reduce external dependencies. The proposal aims to guarantee a high level of public health protection for EU citizens and strengthen the competitiveness of the European pharmaceutical sector, also because more than 50 percent of reported shortages are due to production problems.
“We have established a clear and strong principle for public procurement: price can no longer be the only criterion for awarding contracts for medicines”, claimed the rapporteur of the text, the Croatian popular Tomislav Sokol. “Security of supply, resilience of production chains and manufacturing capacity within the EU must be taken into account,” he added.
Strategic projects
A first central element is support for the creation of industrial projects defined as “strategic” within the EU. The objective is to create, modernize or upgrade plants capable of producing critical medicines or their basic substances, with the idea that health resilience also depends on a more solid manufacturing base on European territory.
To encourage a coordinated approach and reduce uncertainty for investors, Parliament requests that the Commission adopt guidelines for the evaluation of these projects, so as to guarantee common criteria and greater predictability. Companies benefiting from public funding will have to comply with clear obligations, including priority of supply to the EU market.
Dedicated funding and role of EU funds
Alongside the regulatory push, the parliamentary position insists on the issue of resources. MEPs call for the EU and Member States to give priority to financial support for strategic projects, including through regional funds. Looking ahead, Parliament also proposes the establishment of a “fund for the safety of critical medicines” in the Union’s next multiannual financial framework.
The political indication is clear: the reduction of dependencies and the strengthening of production require structured financing instruments, not just coordination measures. MEPs also call for national governments and the EU to give priority, in the current budget and the next multiannual financial framework, to financial support for strategic industrial projects located in the EU to strengthen their production capacity.
Public procurement: supplier diversification and production in the EU
A second pillar concerns public purchasing. Parliament wants to orient procedures in order to reduce dependence on a few suppliers and limit the risks linked to production interruptions or bottlenecks along the supply chain.
The position proposes that procurement could lead to the awarding of contracts to multiple suppliers for the same product, precisely to encourage diversification and distribute production between different companies and geographical areas in the EU. Furthermore, it is requested that the administrations insert requirements capable of valorising the producers who produce a significant share of critical medicines within the Union. The text also introduces a “Buy European – Buy European” approach to support EU production. “This ‘Buy European’ approach ensures that public procurement supports reliable suppliers, strengthens the production of medicines in the EU and contributes to long-term security of supply,” Sokol explained.
Joint purchasing for innovative medicines
Parliament attaches particular importance to voluntary collaborative purchasing between Member States, indicating it as a tool to improve the supply of innovative, high-cost or highly specialized medicines. This framework explicitly includes drugs for rare diseases, but also antimicrobials and other treatments which, due to market characteristics and production complexity, may be more exposed to availability problems.
The logic is that by combining the demand of several countries and coordinating the procedures we can increase the contractual capacity and make the supply more stable. According to Parliament’s proposals, to launch the new cross-border joint procurement procedure, the participation of at least five EU countries will be necessary, less than the nine envisaged in the Commission’s proposal, with the aim of facilitating joint purchases and strengthening the capacity to respond to shortcomings.
National stocks
Parliament also intervenes on the issue of stocks, calling for the creation of a European coordination mechanism between national stocks and emergency stocks of critical medicines. The proposal aims to make the availability picture more transparent and improve the response to shortages.
In the event of supply disruptions or identified shortages, MEPs also expect the Commission to decide, as a last resort, to redistribute medicines from a national stockpile to one or more other countries. It is one of the most sensitive passages of the parliamentary position, because it touches the balance between national competences and European intervention in emergency situations.
The main differences with the EU Council line
The Council’s position, agreed at the beginning of December 2025, insists on some partly convergent priorities but with different emphases. On the one hand, governments are focusing on sharing information on emergency supplies and simplifying collaborative purchasing by lowering the minimum number of states needed to initiate a joint request. On the other hand, the Council introduces a criterion of principle in procurement: the resilience of supply must prevail over price in evaluations for the purchase of critical medicines.
Compared to this approach, Parliament’s line stands out above all for two elements. The first is the request for a dedicated fund in the next multiannual financial framework, which strengthens the industrial and investment policy dimension. The second is the emphasis on more incisive operational tools at EU level in managing stocks, up to the possibility of redistribution decided by the Commission as a measure of last resort. On the purchasing front, both institutions aim to make cooperation between states more effective, but Parliament insists more strongly on the diversification of suppliers and the valorisation of production carried out in the EU.
Towards negotiation between institutions
With the definition of the parliamentary position, the dossier enters the negotiation phase with the Council to arrive at a definitive text of the regulation. The discussion will likely focus on financial instruments, the degree of European intervention in stock management and how the criteria of resilience, diversification and production in the EU will be translated into procurement rules and collaborative purchasing mechanisms, with a particular focus on medicines for rare diseases and innovative and high-cost therapies.
