This article is part of a series covering updates to the proposed European Union (EU) pharmaceutical legislation reform, known as the ‘pharmaceutical package’, made by the Council of the EU (the “Council”).

On 4 June 2025, the Council adopted its position on the European Commission’s proposals for revising EU pharmaceutical legislation. The Council introduced several key amendments to the proposed legislation, including some regarding transferable data exclusivity vouchers for antimicrobials. Antimicrobial resistance is one of the main focuses of this new legislative framework, as it has been identified as one of the main health challenges affecting the EU.

Context 

Following the initial proposals for a new pharmaceutical directive and regulation presented by the European Commission on 26 April 2023, the European Parliament adopted its position one year later, on 10 April 2024 (see our previous series of articles for more information regarding the European Parliament’s position). One year on, the Council has now proposed its own amendments.

One of the key elements of the pharmaceutical package is the introduction of a new voucher system for “priority” antimicrobials granting transferable data exclusivity rights (Chapter III of the draft regulation - articles 40 to 43). These vouchers would permit marketing authorisation holders to extend data protection by one year, either for the priority antimicrobial itself or for another authorised medicinal product of the same or different marketing authorisation holder.

The incentive scheme proposed by the European Commission has been revised by the Parliament and now by the Council, as described below. 

Proposed changes to the transferable data exclusivity voucher reward scheme

The amendments proposed by the Council introduce several significant changes relating to the transferable data exclusivity voucher system designed to encourage the development of priority antimicrobials. 

• Regarding the definition of “priority” antimicrobials 

The Council further specifies the definition of a priority antimicrobial. An antimicrobial shall be considered a ‘priority antimicrobial’ if it addresses multi-drug-resistant organisms causing a severe or a life-threatening infection (with the previous condition that the preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance retained); additional conditions requiring that its mechanism of action is distinctly different from that of any authorised antimicrobial in the Union and/or it contains a new active substance used either alone or in combination with other active substances remain, with some refinement.

• Regarding eligibility conditions for the voucher 

The Council has introduced an additional eligibility condition for the grant of the transferable exclusivity voucher. The application for marketing authorisation of the priority antimicrobial must be submitted to the European Medicines Agency before other regulatory agencies or failing that, within 90 days of the initial submission outside the EU.

• Regarding the duration of the voucher

The voucher entitles the holder to an additional 12 months of regulatory data protection. However, unlike the European Parliament, the Council has not provided for variable durations as envisaged in the version adopted by the Parliament, where extension periods of 6, 9 or 12 months were possible depending on the priority accorded to the pathogen.

• Regarding the transfer and use of the voucher

Under the revised terms, a voucher can be transferred at any time before its use. 

Additionally, if the voucher is used for a medicinal product other than the priority antimicrobial for which it was granted, it can only be used in the fifth year of the regulatory data protection period, provided that the marketing authorisation holder demonstrates that the product’s annual gross sales of the product in the EU have not exceeded 490 million euros during any of the preceding four years. This measure is intended to prevent the application of vouchers to high-revenue products.

• Reduction of the total number of vouchers 

As set out in the proposal, transferable data exclusivity vouchers are introduced as a temporary mechanism to be tested for a period of fifteen years after the Regulation enters into force or until the Commission has issued the maximum number of such vouchers. To minimize the potential burden on healthcare systems, the Commission initially capped the total number of vouchers at ten. However, the Council opted to reduce this number to five.

Next Steps

The Parliament, the Council, and the Commission have now all formalised their positions on the pharmaceutical package, paving the way for trilogue negotiations aimed at reaching a consensus on the final version of the legislation. 

These inter-institutional negotiations are expected to continue until at least the end of 2025, with a final vote anticipated in early 2026.