On April 26, the European Commission released its proposals to revise the EU General Pharmaceutical Legislation. Antimicrobial resistance (AMR) and the need for innovation against it are given a prominent place in this reform. In particular, articles 40 to 43 of the proposed Regulation support the implementation of Transferable Exclusivity Extension (TEE) vouchers.
We already explained in a recently released reflection paper that a proper design would help lift most if not all concerns about the TEE.
In a first paper (link), we detailed 2 improved design options that follow 4 principles:
#1. A tiered approach to reflect the possible value of different antimicrobials
#2. A reward system linked to the value
#3. The definition of eligibility criteria for “priority antimicrobials”
#4. A set of guardrails to govern the TEE market.
We believe these 2 options represent balanced, yet sound, proposals to fix the AMR market failure in the EU. And above all, the TEE remains a concrete and implementable solution.
In a second paper (link), we express our concern about the fact that the proposed amendments introduced by the Rapporteur in the Committee on the Environment, Public Health and Food Safety of the European Parliament (ENVI Committee) fail to provide concrete incentives for innovation and lack a clear roadmap able to support European small and medium-sized enterprises (SMEs) developing novel antimicrobials.
In particular, the proposal to totally remove TEEs from the Regulation, made by the Rapporteur, and its replacement by a not-yet-defined PUSH and PULL scheme is very frustrating.
We call on policymakers to stop postponing decisions and either propose a clear incentive package now or reintroduce the TEE as a workable solution, possibly with some adjustments.