The Council and European Parliament Reach Agreement on the Pharma Package

On 11 December 2025, after nearly three years have passed since the European Commission’s initial proposal in April 2023, the Council and European Parliament have reached an agreement on the so-called pharma package.

The pharma package is a significant new legislative framework for pharmaceuticals consisting of a new Directive and Regulation which are set to replace the current Human Medicines Directive 2001/83/EC and the Centralised Procedure Regulation (EC) No 726/2004. Its main objectives are to foster a fairer and more competitive European pharmaceutical sectoras well as toensure the availability of safe, effective, and affordable medicines across the EU, including critical new antibiotics, medicines for rare diseases, and more affordable generics.

Having seen no significant legislative updates in the pharmaceutical sector for over 20 years, the pharma package is a long-awaited reform.

Changes to regulatory data protection and market protection mechanisms – moving from the 8+2(+1) to the 8+1(+1+1) model. In line with the current legal framework, a data protection period of 8 years will continue to apply. During this period the developer retains the exclusive rights to data generated from pre-clinical tests and clinical trials. On the other hand, the standard market protection period, during which no generic or biosimilar versions of the medicinal product can enter the market, will be reduced from 2 years to 1 year. As a result, the baseline protection period granted under the pharma package to all companies placing a new medicine on the market will be 9 years.

On top of this, the new legislation seeks to incentivise pharmaceutical innovation by allowing a 1-year extension of market protection for companies that place on the market a new innovative medicinal product that addresses unmet medical needs. Alternatively, the 1-year extension may also be granted where the medicinal product meets certain conditions, such as where comparative clinical trials have been conducted in more than one Member State.

Finally, one further year of protection may be granted to medicines that demonstrate an additional therapeutic use beyond their original indication, bringing the maximum total protection period under the new legal framework up to 11 years.

Strengthening orphan market exclusivity. The pharma package seeks to encourage the development of orphan medicines which combat diseases that lack currently available medicinal treatment. In order to do this, the currently available 9-year-long protection period has been extended up to 11 years for developers of “breakthrough” orphan medicinal products.

Furthermore, companies which develop promising orphan medicines may enjoy early regulatory guidance potentially years before submitting an application for marketing authorisation.

Expansion of the “Bolar exemption”. The pharma package broadens this exemption to cover not only clinical trials and regulatory preparations but also pricing and reimbursement procedures. This enables generic and biosimilar manufacturers to enter the market quickly once a patent or supplementary protection certificate expires.

Combating antimicrobial resistance. The pharma package introduces a transferable exclusivity voucher for companies developing priority antibiotics. This grants one additional year of regulatory protection for one authorised product. However, a “blockbuster clause” stipulates that the voucher cannot be used on products with annual gross sales exceeding €490 million in the preceding four years. New measures to promote prudent use of antimicrobials include compulsory medical prescriptions, enhanced information requirements in package leaflets, and mandatory antimicrobial stewardship plans. Companies must also evaluate antimicrobial resistance risks as part of environmental risk assessments.

Enhanced EMA processes. The new legal framework will simplify the internal functions of the European Medicines Agency (EMA) by enabling faster handling of market authorisation requests. The standard assessment time will be reduced from 210 to 180 days. Applications need to be filed digitally using a standardised format and authorisations remain valid indefinitely by default. This represents a significant change from the current system, which requires renewals every five years.

Ensuring availability of medicinal products across the EU. As an attempt to ensure the availability and security of medicines, the pharma package requires companies that hold marketing authorisations for prescription medicinal products or other critical medicines to establish and regularly update shortage prevention plans. Medicine shortages shall be monitored at both national and EU levels, with the EMA establishing and updating an EU-wide list of critical shortages.

Moreover, Member States will have the power to require companies to supply medicines that are protected by regulatory measures, in order to ensure that patients’ needs are sufficiently met.

The final text remains unpublished at this stage. Consequently, a comprehensive assessment of how these changes will affect the pharmaceutical sector can only be conducted once the adopted version becomes publicly available.

Before this can occur, the provisional agreement requires endorsement from both the European Parliament and the Council. The legislation will enter into force upon its publication in the Official Journal of the European Union.

We are happy to answer any questions you may have regarding this reform.