On 6 March 2026, the European Council published its “compromise texts of the provisional agreement” (the “Compromise Text”), setting out the EU Pharma Reform consisting of a:

1. proposal for a Directive on the Union code relating to medicinal products for human use; and
2. proposal for a Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (EMA).

Time to Act

Given the advanced stage of the legislative process, substantive changes to the legislative texts are now considered unlikely. Accordingly, the focus should shift from monitoring the legislative process to preparing for and operationalising the new framework.

Set out below are some of the key elements of the Compromise Text. A more detailed advisory will follow upon formal adoption.

Selected Key Elements:

Regulatory Exclusivities 

The regulatory data protection period is the timeframe during which applicants for a marketing authorisation ("MA") for generic, hybrid, or biosimilar medicinal products cannot reference the dossier of an already authorised reference medicinal product. The regulatory data protection period is followed by a market protection period, during which MA applications for generic, hybrid, or biosimilar products may be accepted, but such medicines cannot be placed on the market.

Under the current framework, the regulatory data protection period is eight (8) years, followed by a basic market protection period of two (2) years and a potential additional one (1) year of market protection for a significant new indication. This formula is known as “8+2(+1) years”.

The main rule on regulatory exclusivity periods in the Compromise Text is set out in Article 80 of the Directive, consistent with the Council's June 2025 proposal. The new standard protection period will be nine (9) years: eight (8) years of Regulatory Data Protection (“RDP”) and one (1) year of Market Protection (“MP”). In addition, medicinal products will be eligible for two additional one-year periods of MP. The new formula will thus be “8+1(+1)(+1) years”.

Compared to the Council's June 2025 proposal, the following are some notable changes in the Compromised Text:

• The Compromise Text sets out a new approach under Article 81 to obtaining the additional MP for medicinal products containing a new active substance (NAS). Whereas the Council's June 2025 proposal required a NAS applicant to satisfy three conditions simultaneously to obtain an additional MP, the Compromised Text expands the number of grounds for the 12-month extension from two to four and allows the extension to be obtained by satisfying any one of the three new NAS-specific grounds independently.
• The Compromise Text introduces an explicit sentence in Article 81(2a) stating that the one-year extension for new therapeutic indications with significant clinical benefit "may only be granted once." No such language was included in the Council's June 2025 proposal.

Supply obligations 

To mitigate shortages and improve the EU-wide availability of medicinal products, the new EU Pharma Reform introduces obligations for Marketing Authorisation Holders (MAHs) to supply medicinal products upon request from Member States. These obligations are set out in Article 5a of the draft Regulation and Article 56a of the draft Directive.

The Compromise Text is generally in line with the latest draft proposal set forth by the EU Council in June 2025. A notable change, however, concerns the MAH's compliance deadline under the draft Directive. Under the Council's June 2025 proposal, the MAH had four years from the grant of the MA to make the product available. The Compromise Text shortens this period to three years and changes the starting point to the date of the Member State's request, thereby tightening the obligation. Accordingly, both the time limit and the basis for its calculation have been amended.

Moreover, it is worth noting that the wording in the draft Regulation has generally been updated from the Council's June 2025 version to align more closely with the wording in the draft Directive. Importantly, non-compliance with a Member State request made in accordance with the Regulation still does not entail any penalties for the MAH. This is consistent with the Council’s June 2025 proposal, which rejected the European Parliament's earlier proposal to subject non-compliance to financial penalties. That said, the Compromise Text provides for a future Commission evaluation of whether penalties should be introduced.

Bolar exemption

The Bolar exemption allows the use of medicinal products before patent or SPC expiry to conduct “necessary studies and trials” for obtaining marketing authorisations for generic or biosimilar medicinal products. Today, the implementation of the Bolar exemption across EU Member States is variable, leading to uncertainty.

Under the new framework, which seeks to harmonise the Bolar exemption across the EU, the scope has been expanded to also cover HTA submissions, pricing and reimbursement approvals, and submissions for procurement tenders.

Compared to the earlier draft Reform proposals, the Compromise Text does not generally introduce any key changes to the Bolar exemption. The only notable addition is an explicit clarification that intellectual property rights in the reference medicinal product cannot serve as a ground to refuse, revoke or suspend decisions relating to Bolar-exempt activities (see Article 85(2) of the draft Directive).

Antimicrobial resistance

Antimicrobial resistance is a central focus of the new framework. A key innovation is the introduction of transferable data exclusivity vouchers for "priority" antimicrobials (Articles 40-43 of the draft Regulation). These vouchers allow MAHs to extend data protection by one year - either for the priority antimicrobial itself or for another authorised medicinal product held by the same or a different MAH.

The framework in the Compromise Text is generally consistent with the Council’s June 2025 proposal. Notably, the total number of vouchers remains capped at five. For background on the voucher framework, see our BioTalk newsletter of 4 August 2025: "Council adopts its position on EU pharmaceutical law reform: focus on antimicrobials and transferable data exclusivity vouchers" (Caroline Arrighi-Savoie, Nour Saab, Margot Pietri). The Compromise Text does, however, introduce the following notable changes in relation to transferable exclusivity vouchers:

• Eligibility (Art. 40(4)(c)): Under the Council’s previous version, the application for an MA of the priority antimicrobial had to be submitted to EMA before any other regulatory agency or, failing that, within 90 days of the initial submission outside the EU. The Compromised Text extends this deadline to 180 days after the submission of the application for the first MA outside the EU.
• Use of the voucher: Where the voucher is applied to a product other than the priority antimicrobial, it may now be used in the fifth or sixth year of the data protection period (previously the fifth year only), provided annual EU gross sales did not exceed EUR 490 million in any of the first four years after the MA was granted. This represents a recalculated reference period compared to the Council's earlier text, which referred to "any of the preceding four years”.

Final Next Steps

The next step is formal adoption by the European Parliament and the Council, which is expected soon. This may even be imminent: according to media reports, the Committee on Public Health (SANT) of the European Parliament is expected to vote on the proposals as early as 18 March 2026.

Once formally adopted, the legislative texts will be translated into all official EU languages and published in the Official Journal of the European Union. The new EU Pharma Package will enter into force 20 days after publication, triggering the agreed transitional periods.