European Parliament Revamps Pharmaceutical Policy Framework

On Dec. 11, 2025, the European Parliament announced that it has reached an agreement with Council negotiators to move ahead with revising the pharmaceutical policy framework in the European Union (1), following a proposal in 2023 by the European Commission (EC) to revise pharmaceutical legislations to adapt to patient and industry needs to make drugs more accessible and affordable (2). The reform addresses the issues of market protection, antimicrobial resistance (AMR), market authorization, and drug availability. The Council is expected to formally adopt the agreement and Parliament is expected to endorse the agreement in a second reading.

“We need new, innovative therapies for unmet medical needs, for conditions currently without treatment, rare diseases, pediatric medicines, new antibiotics,” Adam Jarubas (EPP, PL), Chair of the Committee on Public Health (SANT), said in a press release (3). “We need equal access to medicines in all Member States, without delays, as differences in access between EU Member States can now reach up to two and more years. But equally importantly, we need medicines we can afford, meaning that competition of cheaper medicines begins immediately after an agreed deadline that protects innovation. I believe that for all these purposes, we have managed to achieve a balance in the regulations of this largest reform of the EU medicines market in over 20 years.”

What does this mean for market exclusivity?

As part of the reform, there will be a regulatory data and market protection period of eight years. During this time, other companies cannot access product data. An additional year will also be granted of market protection following market authorization in which generic or biosimilar products cannot be sold.

In addition, another year of market protection will be granted for the following drug types:

• medicines that meet unmet needs
• medicines that contain a new active substance that fulfill “a combination of conditions on comparative clinical trials, clinical trials carried out in several member states, and the obligation to apply for market authorization within 90 days after the submission of the application for the first marketing authorization outside the Union” (1)
• medicines that provide one or more new therapeutic indications that have a significant benefit compared to products already on the market.

Under the agreement, the combined regulatory protection period will have a cap of 11 years. Drugs for orphan diseases with no current treatment available would get up to 11 years of exclusivity.

“To support earlier market entry of generic and biosimilar medicinal products, the deal clarifies the scope of the ‘Bolar’ exemption (which allows manufacturers to conduct certain activities during the market protection period of the original product). Patent rights would not be infringed when necessary studies, trials and other activities are conducted for the purposes of obtaining marketing authorizations, conducting health technology assessments, obtaining pricing and reimbursement approvals, or submitting procurement tender applications,” the press release clarifies (1).

How will antimicrobial resistance be improved?

The deal introduces a ‘transferable data exclusivity voucher’ for priority antimicrobials. This voucher will give AMR drugs a year of additional data protection for one authorized product. The extension may only be used once for the priority drug or for another authorized drug of the same or different marketing authorization holder.

Stricter requirements, such as compulsory medical prescriptions, specific information in package leaflets, and an awareness card for package leaflets that are only available online will be put into place as part of the agreement. Companies will also need to provide an antimicrobial stewardship plan and a risk evaluation for AMR as part of a mandatory environmental risk assessment.

How will the agreement impact EMA?

The European Medicines Agency (EMA) will have their internal functioning simplified as part of the updated rules, with marketing authorization applications submitted electronically in a common format and drug approvals valid by default for an unlimited period. Regulatory sandboxes to allow for development and testing of innovative drugs may be set up by the EC under supervision of competent authorities.

References

1. European Parliament. Deal on Comprehensive Reform of EU Pharmaceutical Legislation. Press Release. Dec. 11, 2025. https://www.europarl.europa.eu/news/en/press-room/20251209IPR32110/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation
2. EC. European Health Union: Commission Proposes Pharmaceuticals Reform for More Accessible, Affordable, and Innovative Medicines. Press Release. April 25, 2023. https://ec.europa.eu/commission/presscorner/detail/en/ip_23_1843
3. European Parliament. Deal on EU Pharmaceutical Package–Statements. Dec. 11, 2025. https://www.europarl.europa.eu/news/en/press-room/20251209IPR32112/deal-on-eu-pharmaceutical-package-statements