Today, 6 March 2026, the Council of the European Union (“Council”) published the provisional agreement on the reform of the EU pharmaceutical legislation and the new Directive [link] and Regulation [link]. Formal adoption by the European Parliament and the Council is expected in the coming months. 

The publication follows the provisional political agreement on the text reached by the European Union Institutions on 11 December 2025 (see our previous blog post). For fuller background, please see our advisory.

We set out below some of the key elements of the provisional text.  After formal adoption, a more detailed advisory will follow.

  • Regulatory data protection:  The new standard protection will be nine years: eight years of Regulatory Data Protection (“RDP”) and one year of Market Protection (“MP”). Medicines will be eligible for two additional one year periods of MP.

One year of MP may be obtained:

  • If the product addresses an unmet medical need; or
  • For products containing a new active substance, if comparative clinical trials have been conducted and either, the first application for a marketing authorisation (“MA”)  was submitted in the EU, or the MA application was submitted in the EU within 90 days of submission of the first application outside of the EU; or
  • For products containing a new active substance, if comparative clinical trials have been conducted, and clinical trials evaluating efficacy were conducted in more than one Member State; or
  • For products containing a new active substance, if comparative clinical trials are not possible or appropriate, (i) clinical trials evaluating efficacy of the medicinal product were conducted in more than one Member State, and (ii) the first application for a MA was submitted in the EU, or an MA application was submitted in the EU within 90 days of submission of the first application outside of the EU.

One additional year of MP may be obtained if during the first eight years, the marketing authorisation holder obtains an authorisation for one or more new therapeutic indications which bring a significant clinical benefit in comparison with existing therapies. This extension can be granted only once.

There will be a cap of eleven years on the overall protection periods.

  • Orphan market exclusivity: The period of market exclusivity available for an orphan medicinal product, which is currently ten years, will be nine years. However, orphan medicinal products addressing a disease with no current available medicinal treatment and which bring a clinically relevant reduction in morbidity or mortality, known as “breakthrough orphan medicinal products”, will benefit from up to eleven years of market exclusivity. The orphan market exclusivity granted to orphan medicinal products containing an active substance that have been in well-established medicinal use is limited to four years.
  • Global Orphan Market Authorisation: Very importantly, the new legislation introduces the concept of Global Orphan Market Authorisation i.e., new orphan indications for the same active substance will not benefit from an independent orphan exclusivity period (as currently) but only one additional year of orphan market exclusivity (up to two years in total). The applications for the additional orphan indications must be submitted at least two years before the end of the initial orphan exclusivity period.
  • Paediatric rewards: there will no longer be the option to obtain a two year extension of orphan market exclusivity for conducting research in compliance with a paediatric investigation plan. However, the six month SPC extension will remain.
  • Antimicrobial resistance: The new Regulation introduces the concept of a “transferable data exclusivity voucher” (known as “TEV”) for priority antimicrobials.  The one-use-only voucher, valid for five years, will give the right to 12 additional months of data protection for one authorised product, be that the priority antimicrobial or another centrally authorised medicinal product (subject to conditions relating to timing and annual gross sales volume) of the same or different marketing authorisation holder (can be transferred only once). Grant of the TEV by the European Commission would be subject to strict conditions – i.e., (i) capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the EU market; (ii) provide information on all direct financial support received for research related to the development of the priority antimicrobial; and (iii) demonstrate that the application for granting a marketing authorisation of the priority antimicrobial has been first submitted to the EMA or has been submitted no later than 180 days after the submission of the application for the first marketing authorisation outside the EU. Failure to supply the priority antimicrobial in sufficient quantity to the EU Member States’ markets may result in the revocation of the TEV by the European Commission. Other measures on antimicrobial resistance include that all antibiotics will become prescription-only, subject to limited exemptions, and must include a warning on misuse inside the packaging.
  • Bolar exemption: The scope of the so-called “Bolar” exemption will be broadened such that certain activities preliminary to launch and sale will not be an infringement of patent protection, including conducting health technology assessments, obtaining pricing and reimbursement approvals, or submitting procurement tender applications. The legislation also introduces a patent linkage ban.  This will make it easier for generics to enter the market immediately following expiry of patent protection.
  • Access and supply obligations: Member States will have the power to require companies to supply medicines benefiting from regulatory protection in sufficient quantities to meet patient needs.

Member States will be able to impose one or more of the following access requirements on marketing authorisation holders (“MAH”) within 1 year after the grant of the MA:

  •  Submit a valid pricing and reimbursement application;
  • Participate in procurement processes; or
  • Establish a ‘roll-out plan’ for the supply of the product in that Member State.

If a MAH does not comply within three years of the request, the MP period shall not apply in that EU Member State. Generic and biosimilar applications would be permitted 6 years after the start of the RDP period, but the MAs could only be granted at the end of the RDP period. The new Directive also includes provisions intended to prevent the parallel trade of such generics and biosimilars outside the EU Member State in question.

  • Shortage Prevention Plans: It has been confirmed that new measures requiring marketing authorisation holders to put in place and update shortage prevention plans will apply to all prescription only products.  The measures may also apply to other products identified by the Commission.
  • Procedural and structural amendments: The EMA’s Committee for Medicinal Products for Human Use (“CHMP”) timeline to issue a scientific opinion in centralised marketing authorisation procedures will be shortened from 210 to 180 days. The EMA structure will be streamlined to two high-level EMA committees, CHMP and the Pharmacovigilance Risk Assessment Committee (“PRAC”).
  • Comparative advertising: As a new requirement, any comparative safety and/or efficacy claims must be supported objectively by the summaries of product characteristics. The new legislation is also more explicit about the prohibition on disparaging other products, stating that “[a]ny form of advertising that aims to highlight negatively another medicinal product shall be prohibited”. The remaining conditions on comparative advertising remain the same i.e., the advertising must not mislead, and only presents objective and unbiased information.
  • Pharmacy compounding: “Magistral formula medicinal products” are prepared in pharmacies in accordance with a medical prescription, or, at the written instruction of a doctor, to meet the special needs of individual patients. “Officinal formulas”  are prepared in accordance with a pharmacopoeia and are intended to be supplied directly to the patients served by the pharmacies in question, but are not customised for a particular patient. Both are excluded from the scope of the new Directive and therefore do not require MAs to be placed on the market. Pharmacies are permitted to prepare stock of magistral formula medicinal products for up to three weeks in advance on the basis of the estimated medical prescription. However, they must document the justification for such advanced preparation in the event of an inspection.  The recitals note that purely financial interests should not be used as a justification. Finally, the EU Member States may allow the supply of officinal formula by the pharmacy to a hospital it serves upon the request of that hospital, subject to the approval of the competent authority concerned.

Next steps

The Directive and Regulation will undergo legal-linguistic review and translation by late May or early June 2026, before formal adoption and publication in the EU Official Journal.  This will trigger the implementation process and the start of the two year transition period.  The legislation is expected to apply around late-2028 or early 2029, although certain provisions may be subject to different transition dates as set out in the Directive and Regulation.

Ahead of application, the Commission and EMA are expected to publish a series of implementing and delegated acts, as well as guidelines, to support the implementation of the new EU pharmaceutical framework.