How Can Europe Help Revitalise the Antimicrobial Pipeline?
European Antibiotic Awareness Day on November 18 should constitute a call for action.
New data [1] released on the same day by the European Centre for Disease Prevention and Control show that antimicrobial resistance (AMR) still represents what Stella Kyriakides, EU Commissioner for Health and Food Safety, calls a "silent pandemic" [2].
It reaffirms how vital it is to accelerate the fight against AMR and promote the development of novel antimicrobials as essential tools to combat infectious diseases. November 18 should act as a spur to action: a clarion call to create the conditions for developing new antimicrobials, through the adoption of novel incentives that will help reboot the pipeline.
MSD is one of the few companies still investing in R&D into new vaccines and medicines for preventing and treating infections and was a founder member of the AMR Industry Alliance. We've just celebrated the first anniversary of our Global Study for Monitoring Antimicrobial Resistance Trends (SMART) new website [3] - one of the largest AMR surveillance programs - launched during the World Antimicrobial Awareness Week 2020. MSD is also committed to a One Health approach: we're one of the largest manufacturers of animal health vaccines in the world [4].
While surveillance and appropriate stewardship for existing antimicrobials are important tools for fighting AMR, creating the right conditions to revitalise the antimicrobial pipeline is equally critical if we are to effectively address this global health crisis.
New antibiotics are urgently needed to keep pace with AMR. But, as the world knows (or should) all too well, there are relatively few in development. Major challenges – above all, economic [5]– discourage innovation in antimicrobials, with the inevitable result: a significant decline in the number of companies conducting antimicrobial R&D over the last two decades. And time is running out.
Europe's role
We support ambitious EU action to tackle AMR and effectively address the innovation challenge. We welcome the inclusion of AMR as a key area for action in the Pharmaceutical Strategy for Europe [6] as well as the new Health Emergency Preparedness and Response Authority (HERA).
However, more ambitious action is required if Europe is to successfully tackle the innovation challenge and ensure new antimicrobials reach the patients who need them. To revitalize antimicrobial R&D, it is essential to reward successful innovation at a level that is sufficient to attract the investment required and to incentivise companies to take on the substantial risks of antimicrobial R&D. This can happen through a package of incentives both at the EU and member states levels.
At the EU level, the upcoming review of the EU pharmaceutical legislation [7] provides a once-in-a-lifetime opportunity to introduce a novel pull incentive, in the form of a Transferable Exclusivity Extension (TEE). How would it work? A research-based company that succeeds in bringing an eligible priority antimicrobial to the market would be entitled to receive a transferable right to extend the exclusivity period of another product. This TEE could be applied either by the same company that developed the new antimicrobial within its own portfolio or sold to another company.
At the member state level, HTA and reimbursement reforms will also be needed if we are to fully recognise the societal value of antimicrobials, now undervalued, and to enable patients to access the most appropriate antibiotics to treat or prevent their infection.
Industry is an important part of the solution and takes its role seriously, as demonstrated by the AMR Action Fund [8] (MSD is a founding investor) and the AMR Industry Alliance. This message was reaffirmed at the recent EFPIA event on ‘Pandemic prevention: how Europe can lead the fight against AMR [9].
But industry cannot solve the entire AMR issue on its own. Ambitious action from European and national policy-makers and public health authorities is needed. We urge the European Commission to put forward a proposal for an EU TEE in 2022 and to become the world leader in establishing such a novel pull incentive. We cannot afford to be short-sighted or complacent. The time to act is now.
By Sophie Noya, Director Public Policy Europe, MSD