Key Takeaways
- The Council of the EU has adopted its position on Europe’s package of legislative reforms for medicines and is now ready to start negotiations with the European Parliament.
- The council has introduced more amendments to the package, including changes relating to regulatory data protection and the proposed transferrable exclusivity voucher.
The pharmaceutical package, which will constitute the biggest reform to the EU medicines legislation in over two decades once finalized, made significant progress today, after the Council of the EU, which represents the EU member states’ governments, agreed its position on the new rules.
The package was proposed by the European Commission around two years ago, and was subsequently amended by the European Parliament. It now comprises further amendments tabled by the council, which will soon negotiate with parliament.
While the council was anticipated to take a position on the package at around this time, there had been concerns that differences among member states could delay negotiations by another year (see sidebar).
The package comprises a regulation and a directive. Regarding the council’s key amendments, they are as follows:
- Regulatory data protection: under the council’s amendment, companies producing innovative medicines would be able to prevent competitors from accessing the data used to develop those medicines for eight years.
- Regulatory market protection: producers of innovative medicines would benefit from one year of regulatory market protection, extendable to two years if certain pre-defined key objectives were achieved.
- Obligation to supply: a new article (56a) has been added to the directive, giving member states the power to oblige the marketing authorization holder of a medicinal product to make that product available in sufficient quantities to cover the needs of patients in the member state.
- Transferrable exclusivity voucher: the council has introduced a new clause stipulating that a transferred voucher can only be used in the fifth year of the regulatory data protection period, and only if the marketing authorization holder demonstrates that the annual gross EU sales of the product have not exceeded €490m ($560m) in any of the preceding four years.
- Intellectual property exemption for generic medicines: in order to support earlier market entry of generic and biosimilar medicinal products, the council’s amendment clarifies the scope of the so-called Bolar exemption and expands it to include submissions for procurement tenders.
The pharma package was first proposed by the European Commission on 26 April 2023 and was significantly amended by the parliament on 10 April 2024.
While the aim of the package is to make medicines more available, accessible and affordable while supporting the competitiveness and attractiveness of the EU pharmaceutical industry, some of the proposals have come under fire over the past few years.
The council said on 4 June that it was “now ready to begin negotiations with the European Parliament with a view to reaching an agreement on the package. The new rules will then be adopted following legal-linguistic revision.”
Legal experts have predicted that a final agreement may not be reached until 2026, and that its provisions might not actually be implemented until 2028.
On 14 May, a policy officer at the commission’s health department, DG SANTE, said that a new legal framework could be adopted by the end of this year if negotiations by the council were completed later that month.