Anthony Coates
Board Member, BEAM Alliance
The needs of small and medium-sized enterprises (SMEs) must be considered when reshaping the regulatory framework intended to incentivise AMR innovation. SMEs are keen to contribute to a dialogue with policymakers.
As we painfully enter a post COVID era, Europe is organising itself to ensure that it is not caught unawares in the event of a new pandemic. In this fight, antimicrobial resistance (AMR) is well positioned to take over the role of public enemy number one. While the last decade has been largely one of global reporting and political awareness, the time for action is now.
While the last decade has been largely one of global reporting and political awareness, the time for action is now.
Moving towards a regulatory big bang for AMR
This year, evidence of the European Commission’s (EC) action has been mounting. In 2021, the EC launched the HERA (European Health Emergency preparedness and Response Authority). At the moment, the focus of it is predominantly on preventing deterioration on the COVID front, but the hope is AMR will soon be in its scope.
In addition, 2022 will hopefully see a new consortium launching, funded by the Horizon Europe programme. The consortium will set the basis of the “Innovation Partnership” which is a legal framework created by the EC. The aim of the proposed partnership is to combine the support of R&D against AMR and the procurement of the antimicrobials that would come from this support.
Last but not least, the major manoeuvres around the recasting of pharmaceutical legislation have been launched, with a public consultation underway until December this year. At the heart of this review is how to better address unmet medical needs, in particular AMR. Even if it remains to be defined how all these initiatives will fit together, these major manoeuvres are clearly heading in the right direction, at least in intention.
No second chance to succeed
BEAM Alliance and its members are looking forward to these promising developments with enthusiasm and with a little concern, if the outcome is not suited to SMEs, it will not work. Access conditions to any type of market incentive must be transparent, predictable and recognised early, this includes eligibility criteria and size of the reward. Only then will an SME be able to raise the necessary funds to develop its product.
SMEs are in the best position to anticipate what investors expect, so their voice must be heard. As author and screenwriter Alan Bennett once said, “Sometimes there is no next time, no time-outs, no second chances. Sometimes it’s now or never.” This time is now for the AMR innovation ecosystem.