Transferable Exclusivity Voucher for priority antimicrobials under the EU Pharma Law Package – What can innovators do now?

Recap

In 2023, the European Commission proposed the most significant reform in over 20 years, replacing Directive 2001/83/EC and Regulation (EC) 726/2004.

After the Parliament and Council adopted their positions and trilogue negotiations were concluded, the final text was agreed and published on 6 March 2026. The next step would be the formal adoption and entry into force of the text, which is expected in autumn 2026, with publication in the Official Journal of the European Union to follow. Generally, a transition period of 24 months will apply, except for the provisions on TEV that start to apply immediately upon entry into force (i.e., expected in Q4 2026. The agreed text is expected to be adopted unchanged. Therefore, companies can start planning now.

Antimicrobial resistance (AMR)

The pharmaceutical law package introduces incentives to develop novel antimicrobials and measures to mitigate the increasing antimicrobial resistance (AMR) in the EU, posing risks to public health globally. These incentives and measures are part of a greater strategy of the European Commission, the “One Health Approach,” which aims to integrate a unifying approach to sustainably balance and optimize health of people, animals and ecosystems.

To tackle the risk that antimicrobials pose for the environment, and ultimately human health, measures are introduced raising awareness among patients and healthcare professionals regarding the use and disposal of antimicrobials. The TEV is created as an incentive to reward the development of “priority antimicrobials."

Priority antimicrobials

A “priority antimicrobial” is an antimicrobial that addresses a multi-drug-resistant organism, of which the marketing authorisation applicant can demonstrate that the preclinical and clinical data have a significant clinical benefit with respect to AMR. It only qualifies as such when either its mechanism of action is distinctly different from that of any authorised antimicrobial in the EU; or it contains a new active substance that, when used either alone or in combination with other active substances, addresses a serious or life-threatening infection.

Extension of regulatory data protection (RDP)

Priority antimicrobials will be authorised by the European Commission via the centralised procedure. When submitting for a marketing authorisation for a priority antimicrobial, the applicant may also apply for a TEV.

In one of our previous Our Thinking articles, part of a series of articles regarding the revised pharmaceutical legislation, we explain that the most prominent and debated changes relate to regulatory data protection and market exclusivity. The TEV gives the right to its holder to an additional 12 months of regulatory data protection of one priority antimicrobial or of another centrally authorised medicinal product of the same or of a different marketing authorisation holder.

The EC decides on granting the TEV. When granted, the TEV must be used within 5 years from the date it is granted, otherwise the TEV ceases to be valid, and the TEV may only be used once.

The marketing authorisation holder to whom the TEV is granted may transfer it to another medicinal product of which it holds the marketing authorisation in the EU, or alternatively, it may transfer the TEV to another marketing authorisation holder of another medicinal product that is approved for the EU. The agreed transaction value – whether monetary or non-monetary – between the buyer and seller should be publicly disclosed to inform regulators and the public. In case of a medicinal product other than the priority antimicrobial concerned, the use of the voucher is to take place only in the 5th or 6th year of the regulatory data protection period. The marketing authorisation holder must show that EU annual gross sales of the medicinal product, to which the TEV is transferred, remained below €490 million in each of the first four years after authorisation.

Application criteria

Not only must the product tick all the boxes to qualify as a priority antimicrobial, the applicant of the TEV must also demonstrate that it has the capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the EU market. Also, in view of transparency, the applicant is required to make information on all direct financial support received for research related to the development of the priority antimicrobial publicly accessible within 30 days after the marketing authorisation is granted.

In respect of strategic planning, innovators of future priority antimicrobials should consider that they should demonstrate that the marketing authorisation of the priority antimicrobial was first submitted to the European Medicines Agency (EMA) or no later than 180 days after submission of the first application of a marketing authorisation outside the EU.

Temporary incentive

To ensure that funds paid by health systems go to the developers of the priority antimicrobials – and not the buyers of the TEVs and to limit the total costs of the incentive for EU member state’s health systems – the EU lawmaker sees the need to only grant a limited number of TEVs. Hence, the incentive is available only until a total of 5 TEVs are granted by the EC or until 15 years after the entry into force of the revised pharmaceutical legislation (which would be around autumn 2041), whichever is earliest.

This 15-year period and the 5-voucher cap may be extended by the European Parliament and the Council upon proposal by the EC because of the experience acquired.

What can innovators do now?

The provisions on the TEV incentive already apply as of the entry into force of the revised pharmaceutical legislation, which is expected for Q4 2026. Hence, innovators of priority antimicrobials may want to submit their TEV application as soon as possible, or at least start gathering relevant information and strategic planning.

Strategic steps for applications expected as of the transition period are:

• Communicating to sponsors that details of funding will be made public when securing funding for the development of the product and clinical trials.
• Assessment based on preclinical and clinical data showing the product has a significant clinical benefit with respect to AMR.
• If the product does not have a new active substance and/or does not address a serious or life-threatening infection, investigate whether its mechanism of action is distinctly different from that of any authorised antimicrobial in the EU.
• Planning of distribution of the product post approval to ensure capacity to supply the priority antimicrobial in sufficient quantities for the expected needs of the EU market.
• Apply for a marketing authorisation in the EU first or within 180 days in the EU after application for a marketing authorisation elsewhere.
• Assess possibilities of transferring the voucher (e.g., entering contact with potential candidates, eligibly criteria of potential candidates, pricing or other rewards etc.) and assess timing to ensure candidates available to whom the voucher could be transferred.
• Pay attention to progress of competitors once several TEVs have been granted, to still be able to (potentially) successfully apply for a TEV, given the 5-vouchers cap.

Strategy is highly dependent on the specific product and timelines at hand. Reach out to the authors of this article or the Hogan Lovells attorneys with whom you regularly work, to discuss what the new legislation means for your products and how to optimise incentives and timelines.

Authored by Hein van den Bos and Samantha van Dijk