Deepali Patel, AMR Action Fund’s director of international policy, joined AMR.Solution’s John Rex for a detailed discussion about the ongoing work in the European Union to develop and enact a pull incentive.
John: What is the state of play in Europe for Pull incentives?
Deepali: As you know, the G7 has committed to enacting policies to incentivise R&D of antimicrobials. For the European Union, including France, Italy and Germany, this is being approached through the General Pharmaceutical Legislation (GPL).
Under its policy framework, the EU has three decision-making bodies. The European Commission (EC or ‘the Commission’) is the executive that proposes laws, in this case the proposal for the revised GPL in April 2023. This proposal went to the European Parliament (EP), which represents the people, and the Council of the European Union (‘the Council’), which represents the member states. Each of them has their own process to review the legislation, make their amendments and adopt their version of the legislation.
The EP adopted their version in April 2024, and the Council adopted its version in June 2025.
This now triggers a negotiation between the three bodies (the EC, the EP, and the Council), through meetings called ‘trilogues’, which started this month. Through these meetings, the three parties come to a compromise on a single version of the legislation and then respectively undergo their formal approval procedures.
The GPL includes, amongst many things, an incentive for AMR R&D referred to as a ‘transferable data exclusivity voucher’ (TEV). Per the Commission’s proposal, the TEV provides for a 12-month extension of data exclusivity. When the developer of an antibiotic that meets certain conditions successfully obtains marketing authorisation, a TEV can be granted. The developer can choose to use the voucher on its own product or sell the voucher to someone else to use on a different product (again, under certain conditions).
Read the full Q&A here.