Political agreement reached in the fourth trilogue.

During the night of 10–11 December, the Council and the European Parliament reached a political agreement in the fourth trilogue on a comprehensive reform of EU pharmaceutical legislation. The European Commission had presented its reform proposals back in April 2023, followed by more than one and a half years of intensive negotiations in the Council and the Parliament. The reform aims to fundamentally modernise key rules on marketing authorisation, regulatory protection periods, medicine availability and access to medicines. It represents the first comprehensive reform of EU pharmaceutical legislation in more than twenty years. The agreement reached highlights the considerable technical and political effort involved and is regarded as one of the most important health policy initiatives of this legislative term.

Regulatory protection periods, Bolar exemption and orphan provisions

At the heart of the political compromise is a new, uniform system of regulatory protection periods. In future, eight years of data protection and one year of market exclusivity are foreseen, with clearly limited extension possibilities up to a maximum total duration of eleven years. Additional protection periods may be granted in cases of unmet medical need or for new active substances, subject to clearly defined conditions.

At the same time, the so-called Bolar exemption is significantly strengthened and clarified. It will in future also cover preparatory activities for authorisation, HTA, pricing and reimbursement as well as procurement procedures. The objective is to enable the market entry of generics and biosimilars immediately after the expiry of protection periods and to avoid delays.

For medicines for the treatment of rare diseases (“orphan medicines”), the agreement continues to provide for extensive exclusivity periods. Nine years of market exclusivity will become the standard. An extension to eleven years is foreseen exclusively for so-called “breakthrough orphan medicines”, i.e. medicines for which no therapeutic alternatives currently exist.

Supply shortages

The agreement also introduces new rules to improve the supply of medicines and to prevent shortages at an early stage. These include mandatory early warning notifications in the event of impending shortages, concrete measures to prevent shortages, and a stronger coordinating role for the European Medicines Agency (EMA).

Antimicrobial resistance

To combat antimicrobial resistance, the reform relies on a package of governance and incentive measures. These include requirements for the responsible use of antibiotics (antimicrobial stewardship) as well as new, narrowly targeted incentive instruments. One such instrument is a transferable data-exclusivity voucher for priority antimicrobial products, which, under strict conditions, allows a one-off extension of data protection by twelve months. In addition, Member States may introduce voluntary subscription models and jointly conclude multi-year contracts for antimicrobial medicines, in which remuneration is partially delinked from sales volumes.

Electronic product information

The reform is complemented by provisions on electronic product information. In future, patients will have easier digital access to package leaflets, while retaining the right to receive a free printed version.

Payer perspective – affordable access is key

The trilogue agreement on the EU pharmaceutical reform addresses key weaknesses of the existing system and has the potential to strengthen transparency, coordination and legal certainty at EU level. From the perspective of the German Social Insurance (DSV), particularly positive elements include the cap on regulatory protection periods at a maximum of eleven years, the strengthening of the Bolar exemption, and the improved framework for medicine availability and shortage prevention.

At the same time, the reform falls short of expectations where a more consistent strengthening of affordability, access and the financial sustainability of solidarity-based healthcare systems would have been required – in particular due to the abandonment of the Commission’s proposal to reduce data protection to six years and the continued high exclusivity periods for orphan medicines. New incentive instruments such as the voucher for antimicrobial medicines also entail risks from a payer perspective and require particularly careful implementation and oversight. Whether the stated ambition of putting patients at the centre will be fulfilled will ultimately depend on practical implementation.

The DSV set out this assessment in a statement.

Next steps

The political agreement will now undergo legal-linguistic revision. Once this process is completed, the European Parliament and the Council must formally adopt the reform.