- in India
- with readers working within the Law Firm industries
- within Intellectual Property, Environment, Media, Telecoms, IT and Entertainment topic(s)
The European Union's landmark pharmaceutical reform is here. After nearly three years of negotiations, the Council and European Parliament reached agreement on 11 December 2025. For pharmaceutical companies, the question is no longer whether change is coming, it is how to prepare for it.
Key Changes
Regulatory Data Protection: 8+1(+1+1) Instead of 8+2(+1)
The reform introduces a new "8+1(+1+1)" framework replacing the existing "8+2(+1)" structure. New medicines will receive eight years of data protection, followed by one year of market protection, a reduction from the previous two-year period. Companies can secure additional one-year extensions if their product addresses an unmet medical need or contains a new active substance meeting requirements for comparative clinical trials conducted across several Member States, with marketing authorisation applied for within 90 days of the first application outside the EU. Market protection can also be extended once by a further year if, during the data protection period, the product is granted authorisation for one or more new therapeutic indications demonstrating significant clinical benefit compared to existing therapies.
Expanded Bolar Exemption
The reform broadens the Bolar exemption, allowing generic and biosimilar manufacturers to undertake preparatory activities before patent and supplementary protection certificate (SPC) expiration without infringing intellectual property rights.
The revised text confirms that patent and SPC rights are not infringed when studies, trials, and other activities are undertaken to obtain marketing authorisation. Significantly, this extends to health technology assessments, pricing and reimbursement applications, and procurement tender submissions.
Whilst promoting consistent application across Member States, this raises enforcement questions for originator companies. Activities such as pricing and reimbursement applications or tender participation have historically supported preliminary injunction applications. Their explicit inclusion within the exemption may reduce the success rate of such applications and alter at-risk launch dynamics.
Generic and biosimilar manufacturers can now complete all regulatory, pricing, reimbursement, and procurement preparations during the protection period, enabling immediate market entry upon expiry.
Streamlined Authorisation Process
The reform modernises the EMA's 210-day assessment timeline and paper-based processes, which have resulted in delayed patient access compared to the US FDA. The assessment period for the Committee for Medicinal Products for Human Use (CHMP) to issue a scientific opinion under the centralised procedure is reduced from 210 to 180 days. Following this, Commission Implementing Decisions must now be completed within 46 days, down from the previous 67-day timeframe.
Beyond faster timelines, the reform modernises the EMA's operational framework. Marketing authorisation applications will be submitted electronically in a standardised format common to all Member States, enabling more efficient processing under the centralised procedure. The reform also strengthens stakeholder participation by securing membership and voting rights for patient organisations and healthcare professionals in EMA committees.
Additionally, regulatory sandboxes will be introduced to facilitate the development and testing of innovative therapies. Perhaps most significantly for administrative efficiency, marketing authorisations will now be valid indefinitely, eliminating the requirement for five-year renewals.
Mandatory Shortage Prevention Plans
Member States may require manufacturers to supply sufficient quantities of medicines benefiting from regulatory data protection. Plans are mandatory for prescription medicines and Commission-identified products. The EMA will maintain a regularly updated list of critical medicines facing shortage risks.
The reform also adopts the controversial "access conditionality" provision originally proposed by the Council. This mechanism grants Member States the power to require pharmaceutical companies to bring a medicinal product to market within their territory. Non-compliance results in forfeiture of market protection, enabling early generic or biosimilar entry. This provision represents a fundamental shift in the balance between commercial freedom and public health obligations.
Antimicrobial Resistance Incentives
The reform introduces transferable exclusivity vouchers (TEVs) as a key incentive for development of priority antimicrobials. A TEV grants a 12-month extension to the data exclusivity period, applicable to the antimicrobial product itself or transferable to any other centrally authorised medicinal product, whether held by the same or a different marketing authorisation holder.
To protect healthcare budgets, the Parliament maintained the Council's "anti-blockbuster" limitation, preventing TEVs from being applied to products with average annual gross sales exceeding EUR 490 million over the preceding four years. This restriction ensures that the incentive benefits innovative antimicrobial development without extending monopolies on already highly profitable medicines.
Beyond financial incentives, the reform introduces enhanced stewardship measures. All antimicrobials will require a prescription, with limited exceptions. Products must carry clear warnings about the risks of misuse, and companies must submit an antimicrobial study plan with an AMR risk evaluation as part of the mandatory environmental risk assessment.
Timeline and Next Steps
The political agreement reached on 11 December 2025 is now subject to formal approval by the European Parliament and the Council. The complete text of the new pharmaceutical legislation will be published in 2026, with entry into force expected shortly thereafter upon publication in the Official Journal of the European Union.
A two-year transition period will run from 2026 to 2028. During this time, all EU Member States must transpose the new rules into national law. The European Commission, EMA, and Member States will issue implementation guidance to support stakeholders in understanding and complying with the new requirements.
Although the final legislative text is not yet published, companies should not wait to begin strategic planning. The reforms will fundamentally alter the regulatory and commercial landscape for pharmaceutical products in Europe. Early preparation will be critical to maintaining competitive advantage and ensuring compliance from day one.
How We Can Help
Hannes Snellman advises pharmaceutical companies on regulatory strategy, intellectual property protection, and commercial positioning under the new EU pharmaceutical framework. Contact us to discuss how these changes affect your business and what steps to take now.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
