EU Pharmaceutical Package: The start of the largest reform in over two decades

The reform of EU pharmaceutical law is nearing completion. Early, strategic planning can help companies prepare for the EU Pharmaceutical Package.

This article provides a concise and practical overview of the status of the legislative process and selected key changes.

Objectives of the EU Pharmaceutical Package

The EU Pharmaceutical Package represents the most comprehensive reform of EU pharmaceutical legislation in more than two decades. The drafts presented by the European Commission in April 2023 aim to foster innovation, strengthen security of supply, enhance patient access and affordability, ensure a well-functioning internal market, and modernise regulatory procedures. To this end, the long-standing framework under Directive 2001/83/EC and Regulation (EC) No. 726/2004 will be replaced by a new Directive and a new Regulation, which will also integrate the existing rules on orphan and paediatric medicines.

Legislative status and timeline

Following the provisional political agreement reached by the European Parliament and the Council in December 2025, the compromise texts of the new Directive and Regulation were formally confirmed by the Committee of Permanent Representatives of the Member States (COREPER I) in March 2026 and published on 6 March 2026. On 18 March, the European Parliament’s Public Health Committee (SANT) approved both the proposed Regulation and Directive, paving the way for the next stage of the legislative process. Formal adoption by the European Parliament and the Council is expected to take place in the summer of 2026, with publication in the Official Journal following shortly afterwards. The legislation will then enter into force, and the transitional periods will begin, with full applicability currently envisaged for 2028.

Core of the reform: Redesign of regulatory protection periods

A central element of the reform is the readjustment of regulatory protection periods for medicines. Regulatory data protection refers to the period during which applicants for generic, hybrid or biosimilar products may not rely on the preclinical and clinical data of an already authorized reference medicine. This phase is followed by a period of regulatory market protection during which applications may be submitted and assessed, but the medicine may not yet be placed on the market.

Under the current framework, an eight‑year data protection period applies, followed by two years of market protection, with the possibility of an additional one‑year extension for certain new indications. While previous proposals had planned to shorten the data protection to six years, the published compromise text maintains the baseline data protection of eight years but shortens market protection to one year. This period may be extended in certain narrowly defined circumstances, for example where an unmet medical need is addressed, where EU filing follows promptly after an initial approval outside the EU, or where a new indication demonstrates a significant added clinical benefit. An absolute cap limits the total duration of regulatory protection to a maximum of eleven years. According to the European Commission, this structure is intended to strike a better balance between incentives for innovation, timely availability of medicines across the EU and earlier market access for generics and biosimilars.

Extended and harmonised bolar exception

The so-called “Bolar exception” allows the use of medicines before the expiration of the patent or supplementary protection certificate to conduct necessary studies and trials for obtaining marketing authorisation for generic or biosimilar products. At present, the scope and implementation of the Bolar exception vary significantly across EU Member States.

Under the new framework, which seeks to harmonise the Bolar exception at EU level, its scope is broadened significantly to cover preparatory activities related to marketing authorisation, health technology assessment applications, pricing and reimbursement applications, and participation in public tenders. The changes aim to enable generic and biosimilar manufacturers to prepare earlier and more uniformly for market entry across the EU.

Preventing supply shortages: Enhanced planning, reporting, and coordination

To improve the availability of medicines in the European Union and to better prevent supply shortages, the reform introduces new and more detailed obligations for marketing authorisation holders. These obligations include supplying medicines upon request by individual Member States. To address shortages, the package introduces mandatory “shortage prevention plans”, expands reporting and information obligations, and strengthens coordination mechanisms at EU level. 

Streamlining marketing authorisation procedures

The new framework introduces shorter timelines, increased digitalisation, clearer procedural milestones and additional tools during the authorization process before the European Medicines Agency (EMA). Overall, these changes are designed to improve procedural efficiency, reduce regulatory burdens, and shorten the time to market.

Additional regulatory changes to watch

In addition to the core reform elements, the EU Pharmaceutical Package introduces a range of further changes that are relevant for companies and merit close attention. These include modifications to the rules on advertising and information relating to medicines, expanded environmental risk assessment obligations, and specific provisions affecting magistral and officinal preparations.

It is also worth monitoring if the UK will follow the EU’s lead as a matter of policy. The recent Opinion of the Regulatory Policy Committee, which was published on 23 March 2026, suggests that review of regulatory protections is not a current priority for the UK Government. As with all regulatory changes at EU level, the UK must consider whether divergence is in its commercial interests. In the case of regulatory protections, arguably a more generous offering will help it to remain competitive.

More broadly, the reforms need to be considered in the context of the tensions they create in light of the United States’ still evolving Most Favoured Nation (MFN) pricing policies. In practice, the EU’s effort to force better access through legal requirements may backfire and result in significant shifts in launching strategies for pharmaceutical companies – with the effect of making the EU market less attractive, as MFN-style initiatives create incentives for manufacturers to delay EU product launches in order to protect pricing positions on the US market. This complex conundrum is still developing – and will need to be carefully monitored by companies going forward as they prepare their EU pharma package implementation planning.

Practical implications for companies at this stage

With the publication of the compromise texts, the substantive regulatory content is essentially set, and significant substantive changes are unlikely. Companies should therefore start preparing for the implementation of the new framework. It is advisable to develop a comprehensive strategy for study and dossier planning, protection periods, and shortage prevention. In addition, a review of existing contractual and governance structures is recommended to carefully “future-proof” them and create sufficient flexibility for the upcoming regulatory changes.