The Cyprus presidency of the EU Council has reached a provisional agreement with the European Parliament on a new regulation that seeks to strengthen the EU’s resilience in addressing ongoing challenges to security of supply of critical medicines in Europe.
The critical medicines act (CMA) aims to tackle shortages of key medicines such as antibiotics, insulin and painkillers by improving security of supply and availability of critical medicines, and medicines of common interest in the EU. The new rules seek to diversify supply chains of critical medicines, make it easier for EU countries to join forces to procure critical medicines, and strengthen the manufacturing capacity for critical medicines and their active ingredients within the EU.
| “Patients should not have to worry about whether critical medicines such as antibiotics will be available at their pharmacy or hospital. With today’s agreement, we are taking practical action to reduce our vulnerabilities, diversify supply chains and strengthen Europe’s capacity to produce critical medicines and their ingredients closer to home.” |
| — Neophytos Charalambides, Minister of Health of the Republic of Cyprus |
Elements of the agreement
Public procurement procedures
One of the key objectives of the CMA is to strengthen the resilience of critical medicine supply chains in the EU. To this end, the provisional agreement between the Council and the Parliament introduces an obligation for contracting authorities to apply resilience-related requirements in public procurement procedures for critical medicines.
The new rules also seek to incentivise EU-based manufacturing of critical medicines and their active ingredients, thus reducing the EU’s dependency on non-EU countries. In this context, the agreement between the co-legislators provides flexibility for contracting authorities in implementing the ‘EU preference’ approach.
Collaborative procurement
The new regulation will allow EU countries to join forces when procuring critical medicines and medicines of common interest, thereby strengthening their collective leverage.
The co-legislators reduced the threshold of member states (from nine to five) required to submit a request to the Commission to procure on their behalf.
Contingency stocks safeguards
In its original proposal, the Commission aimed to safeguard security of supply by ensuring that any contingency stock requirements applied in one member state would not negatively affect other member states or the EU’s internal market. The co-legislators have maintained this ambition by stipulating that any contingency stock requirements should be transparent and respect the principles of solidarity and proportionality.
The Council and the Parliament have also introduced new measures allowing member states to share relevant information about contingency stock requirements. Moreover, the agreement clarifies the use of the existing voluntary solidarity mechanism (VSM) in ensuring that data on contingency stocks is exchanged between member states, and providing the means for countries to reallocate critical medicine products, if needed, on a voluntary basis.
Orphan medicines
The scope of the act was expanded to include orphan medicinal products in certain key areas, including strategic projects and collaborative procurement. Orphan medicinal products are used to treat life-threatening or very serious conditions that affect no more than 5 in 10,000 people in the EU.
Next steps
The provisional agreement will now have to be endorsed by the Council and the Parliament. It will then formally be adopted by both institutions following legal-linguistic revision.
Background
In recent years, the EU has increasingly faced severe shortages of critical medicines such as antibiotics, insulin and painkillers.
The critical medicines act complements the proposals to revise the EU’s pharmaceutical legislation (the ‘pharmaceutical package’), which also contain provisions on shortages and management of supply of medicinal products.