The Council is ready to begin negotiations with the European Parliament, having agreed its position on new rules that aim to make the EU's pharmaceutical sector fairer and more competitive.

The pharma package

The proposals for a regulation and directive that make up the so-called 'pharma' package constitute the biggest reform to the EU's laws on medicines in over two decades. They aim to:

• ensure that patients across the EU have fair access to safe, effective and affordable medicines, regardless of where they live
• enhance the competitiveness of the EU's pharmaceutical industry by reducing the regulatory burden and simplifying the regulatory framework
• address issues relating to security of supply through measures aimed at monitoring and preventing shortages
• mitigate the environmental impact of medicines via better enforcement of environmental rules

The Council's position

The Council's mandate for negotiations with the European Parliament introduces several key amendments to the proposed legislation:

• regulatory data protection: under the Council's mandate, companies producing innovative medicines will be able to prevent competitors from accessing the data used to develop those medicines for eight years
• regulatory market protection: in addition, producers of innovative medicines will benefit from one year of regulatory market protection, extendable to two years if certain pre-defined key objectives are achieved
• obligation to supply: a new article (56a) has been added to the directive, giving member states the power to oblige the marketing authorisation 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 authorisation holder demonstrates that the annual gross EU sales of the product have not exceeded €490 million 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 mandate further clarifies the scope of the so-called 'Bolar exemption' and expands it to include submissions for procurement tenders

Next steps

The Council is 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.

Background

On 26 April 2023 the European Commission published proposals for a new regulation and directive aimed at revising the EU's pharmaceutical legislation. Taken together, these two legislative proposals seek to increase the availability of innovative medicines throughout the EU, while also boosting the competitiveness of the EU's pharmaceutical industry, promoting higher environmental standards, and reducing administrative burden.

In particular, the proposals:

• reduce the current standard period of regulatory data protection from eight years to six years and incentivise companies to make new medicines available in all EU countries by providing an additional two years of regulatory data protection (meaning that rival companies cannot sell generic versions of the medicine during that period)
• encourage research into rare diseases by providing an extended period of market exclusivity (9 years in the original proposal) and increasing this period by one year if the medicine in question addresses a high unmet medical need or is launched in all member states
• introduce a new 'transferable data exclusivity voucher' providing an extra year of data protection, which will be available to companies that develop 'game-changing' antimicrobials

• Mandate for negotiations (regulation)
• Mandate for negotiations (directive)

The pharma package: new EU rules on medicines