Today, BEAM Alliance releases an analysis of the recently released HaDEA study on the medical countermeasures (MCM) against antimicrobial resistance (AMR). The study aimed to develop a roadmap for DG HERA to help bring new medicines to the market to combat AMR.
The report represents an important step towards the implementation of a tangible solution to fix the AMR market. Although the overall approach of the study is thought-provoking, our analysis revealed some pitfalls that may prevent the proposed solutions from properly fixing the problem in a sustainable manner.
Firstly, the study suggests that the total sufficient costs of the PULL mechanisms are ranging from USD 700 million to 1.5 billion, which is too low. The expected EU fair share for the development of one novel antimicrobial agent should be around €1 billion. The chosen figures used to calculate the costs of development per phase should be questioned and compared to the now available accumulated deficits of different AMR biotech companies at the time of market approval.
Secondly, beyond the size of the reward, the PULL mechanisms should be designed to incentivise the development of clinically useful products addressing unmet medical needs. We do need novel antibiotics, but we also need improvements of existing ones to overcome the AMR crisis. Halting the development of many useful for patients products because of a race to market authorization could lead to a tremendous disruption of the whole innovation ecosystem.
Finally, the Joint Procurement Agreement (JPA) is proposed as a possible legal framework. There is a valid concern that such instrument is at risk of ‘free riding’ with detrimental consequences in terms of predictability and magnitude of the incentive unless proper guardrails are set.
Considering these factors, we continue to believe the TEE vouchers remain to be a most straightforward option. If the track of the joint procurement is pursued, we would strongly urge the establishment of efficient guardrails to ensure predictability and an appropriate size of the mechanism.
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