European Pharmaceutical Reform: Council Approves Texts

Last Monday, September 28, 2026, the Council of the European Union approved the texts related to the European pharmaceutical reform, which consists of a new Regulation and a new Directive, which will now be sent to the European Parliament for approval in second reading. This is the first major revision of EU pharmaceutical legislation since 2004 (as explained in more detail in our previous posts “European Pharmaceutical Reform” and “Reform of EU Pharmaceutical Legislation”).

As previously noted, the main objectives of the pharmaceutical reform are to encourage innovation, improve patient access to treatments, prevent stockouts, and reduce the environmental impact, while preserving the competitiveness of the European pharmaceutical industry. Furthermore, the aim is to ensure equitable access to safe, effective, and affordable medicines throughout the European Union.

Set forth below is a brief overview of the key aspects contemplated by the pharmaceutical reform:

1.    Regulatory Protection: Data Protection

• The new framework establishes an 8+1(+1)(+1) protection period: eight years of regulatory data protection and one year of market protection, which can be extended for up to two more years. Through the use of a transferable data exclusivity voucher, the data protection period can be extended by an additional year.

2.    Access and Supply

•  Member States have new tools to ensure patient access to medicines and may, in particular: (i) require companies to supply sufficient quantities of medicines that benefit from regulatory protection; (ii) impose a range of obligations on marketing authorization holders, such as submitting a valid application for price and reimbursement, participating in public procurement procedures, or establishing a product launch plan.
• Furthermore, if market authorization holders fail to comply with these requirements within 3 years of the Member State’s request, the market protection period may cease to apply in the Member State in question. To prevent parallel trade, generics that have been authorized in a Member State as a consequence of the marketing authorization holder’s failure to comply with an access request may not be sold in other Member States where regulatory protection remains in effect.

3.    Expanded Bolar Exemption

• The reform expands the scope of the Bolar exemption, so that certain preparatory activities for the launch and marketing of medicines will not constitute an infringement of the protection conferred by the patent. These activities include health technology assessments, obtaining approvals for pricing and reimbursement, and submitting bids in public procurement procedures.
• The sale of the medicinal product remains prohibited, however, for the duration of the protection granted by the patent or supplementary protection certificate.

4.    Transferable Exclusivity Vouchers (Antimicrobial Resistance)

• To address the global challenge of antimicrobial resistance, the new regulation establishes the so-called Transferable Exclusivity Voucher (TEV), used for priority antimicrobials.
• This voucher, which is for single use and valid for five years, grants the right to twelve additional months of data protection for an authorized product —whether the priority antimicrobial itself or another medicinal product authorized through a centralized procedure—and can only be transferred only once to another holder. When used for a medicinal product other than the priority antimicrobial, the voucher may only be exercised in the fifth or sixth year of the data protection period.
• An anti-blockbuster clause applies: the voucher cannot be used for medicines whose annual gross sales in the EU have exceeded 490 million euros in any of the first four years following authorization.

5.    Orphan Medicinal Products

•  The current ten-year market exclusivity period is reduced to nine years, as a general rule. However, so-called “breakthrough orphan medicinal products”—those intended for diseases for which no available treatment and which result in a clinically relevant reduction in disease morbidity or mortality—may benefit from up to eleven years of exclusivity.
• Exclusivity may also be extended by 12 months for each new indication for a different orphan disease, up to two times, provided that the new indication is obtained at least two years before the end of the exclusivity period.

6.    Environmental Protection and Post-Authorisation Measures

• Competent authorities may impose post-authorisation environmental risk assessments studies, require the collection of monitoring data, or mandate appropriate risk mitigation measures when concerns about environmental or public health risks—including antimicrobial resistance—are identified after a product has been marketed.
• For a more detailed overview of the measures outlined in the pharmaceutical reform, please refer to our previous post “European Pharmaceutical Reform.”

The next milestone will be the European Parliament’s approval of the texts at second reading, scheduled for October 19, 2026. At this stage, although the European Parliament may still propose amendments, all indications are that the Council’s position will be accepted, as recommended by the Chair of the European Parliament’s Committee on Public Health (SANT).

Once approved, the legislation will officially enter into force upon publication in the Official Journal of the European Union. It should be noted, however, that Member States will have two years to adapt their national frameworks to these new rules. Thus, the new framework is not expected to take effect at the end of 2028 or start of 2029.

Given the industry’s criticism regarding the negative impact these measures may have on competitiveness in the European market, we must now monitor their practical implementation and assess how they will actually affect investment in innovation within the European Union.