knowledge 15 December 2025 |

EU Agrees Landmark Reform of Pharmaceutical Legislation

A new pharmaceutical package, which aims to overhaul, modernise and streamline the EU’s existing legal framework for the pharmaceutical sector, was agreed between the EU Council and the European Parliament on 11 December 2025: ‘Pharma package’: Council and Parliament reach a deal on new rules for a fairer and more competitive EU pharmaceutical sector.

The package is part of the EU’s broader life sciences agenda, details of which were set out in the EU Life Sciences Strategy published by the European Commission in July 2025.

Underpinning the package are objectives such as ensuring fast, fair and safe access to medicines, easing regulatory burdens, streamlining the European Medicines Agency (EMA) and improving security of supply.  Key aspects of the new package are below (subject to sight of the final approved texts):

New medicines: regulatory protection period for data

• Companies that obtain marketing authorisations for new medicines will continue to benefit from an 8-year protection period during which only they can access the data from pre-clinical tests and clinical trials. The additional period of market exclusivity, where companies have the exclusive right to sell the medicine free of competition from generic or biosimilar medicines, will be reduced from a minimum of two years to one year, though now with the possibility of up to two years’ extension if certain conditions are met: an additional year’s protection will be available if the medicine addresses an unmet medical need; if it contains a new active substance and meets certain other conditions (e.g. comparative clinical trials and clinical trials in several EU states); and/or if it is approved for an additional indication that brings a significant clinical benefit in comparison with existing therapies.
• Breakthrough orphan medicinal products (for diseases without a currently available medicinal treatment) will get up to 11 years of regulatory protection.  Companies creating promising orphan medicines may also benefit from early regulatory guidance, long before they apply for marketing authorisation, with a view to maximising the speed at which new therapies will reach patients.

Availability of medicines

• Member States will be able to require companies whose medicines benefit from the above regulatory protections to supply adequate quantities of those medicines to meet patient needs.

Generic medicines and the ‘Bolar’ exemption

• The scope of the Bolar exemption will be clarified and extended such that patent rights would not be infringed by the taking of necessary steps, such as engaging in health technology assessments, obtaining pricing and reimbursement approvals and submitting procurement tender applications, to enable generics to launch immediately on patent expiry.

Antimicrobials

• Pharma companies that develop priority antibiotics for antimicrobial resistance will be able to obtain a ‘transferrable exclusivity voucher’ which will give them 1 extra year of market protection for a pharma product of their choice.  However, the voucher will not be available for any product with annual gross sales of > €490 million over the previous 4 years (known as the ‘blockbuster clause’).  
• Medical prescriptions for all antimicrobials will be compulsory, together with specific patient information requirements.
• Companies applying for a marketing authorisation for antimicrobials will be required to supply an ‘antimicrobial stewardship plan’.

Authorisation requests

• The package will streamline how the EMA processes marketing authorisation applications to make the process more efficient and less costly, and to facilitate speed-to-market.  EMA evaluation times will be cut from 210 days to 180 days.  Submissions will be online.
• Subject to some exceptions, marketing authorisations will be for an unlimited period.

Addressing shortages

• Companies with authorisations will need to have ‘shortage prevention plans’ for products that are on prescription or which the European Commission identifies as requiring such a plan.  The EMA will keep a list of critical shortages within the EU.
• There will be an EU-wide list of critical medicines, and supply chain vulnerabilities will be monitored – both steps aim to give a clear view of potential supply chain weaknesses which need to be managed.

Regulatory sandboxes

• The European Commission may set up regulatory sandboxes, supervised by competent authorities, for the development and testing of new and innovative therapies.

Next steps

• Once the texts of the directive and regulation that comprise the new EU pharma package are updated and approved to reflect the political agreement, we will get final confirmation on timing – the Commission originally suggested a transposition deadline of 18 months following publication in the Official Journal, but the EU Council then suggested 36 months.  We will update this briefing with further details of the agreed package once the final texts are published.

Comment

• While we will need to see the final texts before drawing any conclusions about what has been agreed, the agreement and proposed timelines for transposition reflect the Commission’s commitment to implement its strategy to position the EU as the world’s most attractive place for life sciences by 2030.
• As perhaps the most hotly debated aspect of the package, the pharma industry should take some comfort from the fact that the regulatory data protection period has been retained at 8 years, despite earlier suggestions of a more extensive revision, and that up to 11 years regulatory exclusivity will remain available at least for some medicines. Incentivising the spread of clinical trials across EU member states, and encouraging timely applications for marketing authorisations, seems sensible and it will be interesting to see to what extent the new conditional extensions will be satisfied and whether they will result in any changes in behaviour. Clarification of the scope of the Bolar exemption should also give certainty to generics (and originators seeking to enforce their rights) as to what activities can be freely undertaken irrespective of the patent infringement analysis, which may differ from jurisdiction to jurisdiction.
• McCann FitzGerald LLP’s Life Sciences team has expertise across the full life cycle of medicines and is happy to assist with any of your marketing authorisation, regulatory or enforcement needs.