This article is part of a series on the final agreement reached regarding the pharmaceutical package, which is currently awaiting formal adoption. 

Background and legislative process

The pharmaceutical package (comprising a new regulation and new directive) was proposed by the European Commission and subsequently amended by both the European Parliament (which adopted its position on 10 April 2024) and the Council of the EU (which adopted its position adopted on 4 June 2025), thereby triggering trilogue negotiations. A provisional political agreement was reached in December 2025. 

The final texts of the Directive and Regulation, published in September 2026 ahead of their formal adoption by the Council of the EU and European Parliament, form the basis of this article series. 

For further detail on the legislative process, please refer to our complete article series regarding European Parliament’s position and the Council’s position.

Status of the texts and implementation timeline

Once published in the EU Official Journal, the new framework will enter into force 20 days after publication. Certain provisions, notably the ones related to antimicrobial resistance (AMR), including transferable exclusivity vouchers (TEVs), will apply immediately, while most provisions will only take effect twenty-four months after publication. 

Companies developing antimicrobials could therefore apply for the voucher as early as December 2026 or shortly thereafter, depending on the exact date of adoption.

Antimicrobial resistance: measures retained in the provisional agreement

The pharmaceutical package comprises a new Regulation and a new Directive, each addressing antimicrobial resistance. 

The Regulation introduces a voucher scheme designed to incentivise the development of priority antimicrobials: manufacturers that meet the relevant criteria will be entitled to receive a voucher granting an additional year of data protection. This voucher can also be transferred to other pharmaceutical companies, giving it a commercial value that extends beyond the manufacturer of the priority antimicrobial.

The draft Directive focuses on promoting the prudent use of antimicrobials through a series of targeted measures. These include: the requirement to include an antimicrobial stewardship plan¹ in the marketing authorisation application; the default classification of antimicrobials as prescription-only medicines²; and the inclusion in the package leaflet of specific information on the antimicrobial, AMR and the appropriate use and disposal of antimicrobials.³

Focus on transferable exclusivity vouchers⁴

This incentive scheme originally proposed by the European Commission was subsequently revised, first by the European Parliament and then by the Council, each proposing their own amendments. The elements set out below reflect the final agreement reached. 

Eligibility conditions 

Under the retained scheme, and subject to strict eligibility criteria, the holder of a priority antimicrobial will be granted a TEV conferring an additional twelve months of regulatory data protection for a product authorised under the centralised procedure. 

Qualifying as a priority antimicrobial is itself subject to a series of demanding criteria. The medicine must, for instance, address a multi-drug-resistant organism. In addition, both preclinical and clinical data must demonstrate a significant clinical benefit with respect to antimicrobial resistance, and the medicine must have either a mechanism of action distinctly different from that of any antimicrobial already authorised in the Union or contain a new active substance that, whether used alone or in combination with other active substances, addresses a series of life-threatening infections.

Further conditions apply. In particular, the applicant must demonstrate that the application for a marketing authorization (MA) for the priority antimicrobial was submitted to the European medicines' agency before any other regulatory agency or, failing that, within 180 days after the submission of the first MA outside the EU. It is interesting to note that the final agreement extends this deadline, which had been set at 90 days in the Council’s position. 

A single period of 12 months

As regards the duration of the voucher, the final text settled on a single period of 12 months. The EU Parliament had originally proposed a modulated approach (under which extension periods of 6, 9 or 12 months were possible depending on the priority accorded to the relevant pathogen) which was ultimately not retained.

Conditions of use

The voucher may be used in one of three ways: (i) it may be applied to the priority antimicrobial itself, (ii) it may be applied to another product held by the same marketing authorisation holder, (iii) or it may be transferred to an entirely different marketing authorisation holder. 

The voucher must be used within five years from the date of grant, may only be used once, and may only be applied in relation to a single centrally authorised medicinal product.

Where the voucher is applied to a product other than the priority antimicrobial for which it was granted, additional conditions apply: it may only be used in the fifth or sixth year of the regulatory data protection period, and the marketing authorisation holder must demonstrate that the product’s annual gross sales in the EU did not exceed 490 million euros during any of the preceding four years.

Finally, it is worth noting that the TEV scheme is a temporary mechanism. It will apply from the date of entry into force of the Regulation for a period of fifteen years, or until the Commission has issued five vouchers, whichever occurs first. The initial commission proposal had capped the total number of vouchers at ten, the reduction to five in the provisional agreement signals a clear desire to limit the scope of this scheme for the time being.  

A review clause⁵ has also been built in at the midpoint: once two vouchers have been used, or five years from the date of application of the Regulation, whichever is the earlier, the effectiveness of the scheme will be evaluated and, depending on the outcome of that assessment, the Commission may present a legislative proposal to amend the Regulation if necessary.