On 11 December 2025, representatives of the Council of the European Union and the European Parliament reached a political agreement on a new framework for pharmaceutical legislation, the so-called EU Pharmaceutical Package.[1] This represents a comprehensive reform of EU pharmaceutical law and the most extensive revision of the rules governing medicinal products in more than twenty years. Its objectives are to improve patients’ access to medicines across the EU, strengthen security of supply, and at the same time preserve the competitiveness and innovative capacity of the EU pharmaceutical sector. The package will also have a significant impact on the field of rare diseases.
The reform builds on the European Commission’s legislative proposals of April 2023 and envisages the adoption of a new directive and a new regulation, replacing the current framework based primarily on Directive 2001/83/EC and Regulation (EC) No 726/2004. The aim is to modernise the rules on the authorisation, supervision and availability of medicinal products, simplify regulatory processes, and better address structural challenges such as unequal availability of medicines between Member States, recurrent medicine shortages, and insufficient development of new antibiotics.
Regulatory protection and incentives for innovation
One of the most debated elements of the agreement is the new configuration of the data protection system. Under the basic framework, companies placing new medicinal products on the market are guaranteed eight years of data protection, during which they will enjoy exclusive rights and access to data generated from pre-clinical and clinical studies. This is followed by one year of market exclusivity, during which no generic or biosimilar products may be placed on the market. This period may be extended by up to one additional year for innovative medicinal products that address unmet medical needs or meet certain conditions, such as conducting comparative clinical trials. A further third additional year of protection may be granted for medicinal products authorised for an additional therapeutic indication (for example, products that can be used to treat diseases other than those for which they were originally developed). Accordingly, the data protection model changes from the former 8+2(+1) system to 8+1(+1+1), with a maximum total protection period of up to eleven years.
Availability of medicines and prevention of shortages
Significant attention is also paid to the availability of medicinal products and the prevention of shortages. The agreement strengthens supply planning and monitoring mechanisms and introduces an obligation to prepare and regularly update shortage prevention plans for selected medicinal products. The European Medicines Agency (hereinafter the “EMA”) is to play a key role in monitoring the situation and identifying critical shortages. EU representatives are expected to establish a list of critically important medicinal products, for which availability will be subject to close monitoring.
At the same time, the provision allowing Member States to require pharmaceutical companies to supply certain medicinal products in sufficient quantities to meet the needs of patients within their territory remains in place. The agreed text also includes safeguards clarifying the obligations of pharmaceutical companies and Member States and preventing abuse of this mechanism for the purposes of parallel trade.
The bolar exemption and market entry of generics
The package further clarifies and, in certain respects, extends the scope of the Bolar exemption, with the aim of facilitating the timely market entry of generic and biosimilar medicines. The wording of the Bolar provision has been expanded to allow generic manufacturers not only to carry out the necessary studies, trials and other activities required to obtain a marketing authorisation, conduct health technology assessments, or secure pricing and reimbursement approval, but also to participate in public procurement procedures and tenders before the expiry of a patent or supplementary protection certificate, while the reference product remains protected. This change is intended to enable manufacturers to prepare generic products for market entry immediately upon expiry of the reference product’s patent, representing a further step towards ensuring timely availability of medicines.
Antimicrobial resistance and the transferable voucher
A separate part of the agreement introduces new measures addressing the growing problem of antimicrobial resistance. A key element is the introduction of a transferable voucher designed to incentivise the development of priority antibiotics and other antimicrobial agents. The voucher grants twelve months of additional regulatory protection and is designed to be transferable. The holder may apply it to another medicinal product of their choice or transfer or sell it to another pharmaceutical company.
The agreement also includes a significant limitation on the use of the voucher, the so-called “blockbuster clause”. The voucher may not be applied to medicinal products whose annual gross revenues exceeded EUR 490 million in any of the preceding four years. The purpose of this limitation is to mitigate the potential budgetary impact of extended protection on national public health insurance systems.
In addition to the voucher mechanism, the agreement contains further measures aimed at promoting the prudent use of antimicrobials. These include, in particular: a requirement that antimicrobial medicinal products be dispensed exclusively on prescription, enhanced information obligations in package leaflets, an obligation to provide patients with a paper information card where the package leaflet is available only in electronic form and the introduction of an antimicrobial stewardship plan. An assessment of the risk of antimicrobial resistance is also to become part of the mandatory environmental risk assessment for medicinal products.
Simplification of regulatory procedures
The package also seeks to simplify regulatory procedures and reduce the administrative burden associated with the authorisation and supervision of medicinal products. The reform aims to improve the internal functioning of the EMA and accelerate the processing of marketing authorisation applications. The standard assessment timeline is to be reduced from 210 days to 180 days.
One of the key changes is the introduction of marketing authorisations of unlimited duration as the default regime. Time-limited authorisations should remain possible only for safety reasons. This change is intended to eliminate the administrative burden associated with periodic renewals and to allow both regulatory authorities and marketing authorisation holders to focus more closely on continuous monitoring of the safety of medicinal products.
Next steps and practical implications
At this stage, the agreement remains a political agreement and must still be formally approved by the Council of the EU and the European Parliament. Only thereafter will the new legislation be published in the Official Journal of the European Union and enter into force. Nevertheless, it is already clear that the Pharmaceutical Package will have a substantial impact on the strategies of marketing authorisation holders, generic and originator manufacturers, and pharmaceutical distributors across the EU.
If you have any questions regarding the new Pharmaceutical Package and its implications for pharmaceutical and healthcare businesses, Jakub Málek and Kateřina Musilová at PEYTON Legal are at your disposal.
[1] Council of the European Union. (2025). ‘Pharma package’: Council and Parliament reach a deal on new rules for a fairer and more competitive EU pharmaceutical sector. https://www.consilium.europa.eu/en/press/press-releases/2025/12/11/pharma-package-council-and-parliament-reach-a-deal-on-new-rules-for-a-fairer-and-more-competitive-eu-pharmaceutical-sector/
European Parliament. (2025). Deal on comprehensive reform of EU pharmaceutical legislation.
https://www.europarl.europa.eu/news/en/press-room/20251209IPR32110/deal-on-comprehensive-reform-of-eu-pharmaceutical-legislation
Mgr. Jakub Málek, managing partner – malek@plegal.cz
Mgr. Kateřina Musilová, junior lawyer – musilova@plegal.cz
Anna Němcová, legal assistant – nemcova@plegal.cz
15. 1. 2026