EU Stakeholder – Press Releases 28/08/2020
BEAM Alliance and global partners call for urgent action on new reimbursement models for life-saving antibiotics
At the end of the 4th AMR Conference “Novel Antimicrobials & AMR Diagnostics”, the BEAM Alliance and global partners have released a paper calling for urgent action, at EU and national levels, on new reimbursement models for life-saving antibiotics.
As the world struggles with the challenges brought by COVID-19, the threat of the next pandemic, in the form of Antimicrobial Resistance (AMR), is already on our doorstep. AMR already causes an estimated 750,000 deaths worldwide on a yearly basis. In some countries, 35% of human infections are caused by bacteria that are resistant to commonly used antibiotics. Some estimates suggest that by 2050 mortality attributable to AMR could reach 10 million deaths globally per year.
While the co-signatories of the paper welcome recent funding initiatives aimed at supporting research and innovation for new antimicrobials (“PUSH” incentives), they also underline that these initiatives do not embrace the whole spectrum of actions required to create a viable economic environment in which companies developing lifesaving antibiotics can survive and prosper.
Because new antibiotics appropriately are held in reserve, developers of new medicines have struggled financially or have gone bankrupt. The remaining companies are at this point focusing their regulatory and commercial efforts on the U.S market. Consequently, Europe is now at risk of not having access to the newest life-saving antimicrobials.
Against this background, the co-signatories urge the EU and its Member States to urgently act by designing and implementing new economic incentive models (“PULL” incentives) for the development and commercialization of AMR products.
More specifically, the co-signatories call on:
The European Commission to:
– Propose a new PULL incentive framework, as part of the upcoming Pharmaceutical Strategy, to address critical factors leading to commercial non-viability of launching novel life-saving antimicrobials.
– Stimulate the sharing of information and best practices between Member States.
– Deliver concrete guidance to Member States regarding the magnitude of incentives required based on the Member States’ GDP share.
EU Member States to:
– Champion, as part of the upcoming European Pharmaceutical Strategy, the introduction of a new EU legislative framework to enable and encourage the development and commercial introduction of novel antibiotics and adopt it as soon as possible.
– Take advantage of the recently released mapping of incentives by the Global AMR Hub and of the coordination work performed by the EU-JAMRAI Joint Action to implement HTA and reimbursement reforms in their respective National Action Plans, similar to what the UK and Sweden have already done.
– Setup and implement their own model, compatible with their existing national requirements and including a set of appropriate guardrails, that would allow them to test alternate features:
-Reimbursement should capture the societal benefit of AMR products, while warranting best medical care.
-Sustainable use of and access to antibiotics should be aligned with appropriate market incentives covering minimal reimbursement targets. Such a delinked revenue model is paramount for the sector.
-Appropriate tools, like Market Entry Rewards, Subscription Agreements or Transferable Exclusivity Vouchers have been proposed and discussed. Countries should decide on the best-fitting option to their current Health Technology Assessment regulations, and implement it at national or European level.
Members of the European Parliament to:
– Drive Europe to play a leading role in the fight against AMR, and ensure the survival of this strategic industrial ecosystem, composed mainly of SMEs.
– Support, as part of the upcoming Pharmaceutical Strategy for Europe, the introduction of a new EU legislative framework to provide appropriate incentives for the development of novel antibiotics, and adopt it as soon as possible.
– Advocate for the necessary changes mentioned above to happen as soon as possible in their respective Member State.
The full paper is available on BEAM Alliance’s website.