Global AMR Action: EU Pharmaceutical Strategy; One Health Global Leaders Group on AMR

Dear All (and note the related 29 Apr 2021 newsletter),

As was discussed at length in the recent Wellcome Trust-sponsored analysis of the AMR-related needs for the coming decades (see this newsletter), it is critical that we build and maintain momentum around AMR-focused work. As a big part of that revolves around being visible in high-level political discussions, two recent events are very exciting: (i) An EU Pharmaceutical Strategy that includes pull incentives and a BARDA-like facility for Europe and (ii) the launch of a high-level political Global Leaders Group for AMR. Here we go…

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First, the EU has announced a Pharmaceutical Strategy for Europe. Go here for the main webpage, here for the .pdf of the strategy, and here for brief factsheet. Addendum: There was a prior newsletter about the call for comments on the strategy;  Kevin Outterson and I submitted these comments (.pdf).

This substantial initiative was triggered by a 10 Sep 2019 letter from Ursula von der Leyen (EC President) to Stella Kyriakides, Commissioner for Health and Food Safety in which Dr. von der Leyen said, “I want you to look at ways to help ensure Europe has the supply of affordable medicines to meet its needs. In doing so, you should support the European pharmaceutical industry to ensure that it remains an innovator and world leader.”

The comprehensive strategy encompasses access, unmet medical needs, competitiveness, innovation, sustainability of the EU’s pharmaceutical industry, medicine quality, and crisis preparedness and response. The proposed actions are called out as a series of topics for Flagship Initiatives:

• Antimicrobial Resistance
• Enhancing Europe’s Health Crisis Response mechanisms by creation of an EU Health Emergency Response Authority
  • In the document, this is actually the next-to-last initiative … I moved it up for convenience.
• Unmet Needs (pediatrics and rare diseases)
• Access to Medicines (includes an analysis of the root causes of deferred market launches)
  • Relatedly, you might be interested in a prior newsletter on delayed antibiotic launches
• Affordability
• Competitiveness (efforts around intellectual property and building the workforce)
• Innovation (lots of high-tech digital ideas here)
• Regulatory Efficiency
• Open Strategy Autonomy (lots of work on the security of drug manufacturing supply chains)
• Quality and Environmental Sustainability (good manufacturing practices)
• International Cooperation

Looking in detail at the AMR-focused topics, here are some relevant text excerpts:

• On AMR itself, specific initiatives are:
  • “Pilot innovative approaches to EU R&D and public procurement for antimicrobials and their alternatives aiming to provide pull incentives for novel antimicrobials.”
    • Wow! The text commentary notes that “Current incentive models do not provide a sustainable solution; new business approaches are required, including new incentives to develop antimicrobials as well as new pricing systems.”
  • “Promote investment and coordinate research, development, manufacturing, deployment and use for novel antibiotics as part of the new EU Health Emergency Response Authority (HERA), prior to the start of the authority’s operations preparatory action on AMR.”
    • Is this Europe’s equivalent of BARDA? Sure sounds like it … see also below.
  • “Consider in the review of the pharmaceutical legislation to introduce measures to restrict and optimise the use of antimicrobial medicines. Explore new types of incentives for innovative antimicrobials.”
    • These two items appear in one bullet point. Good stewardship is of course a good idea and it is great to see the need for incentives stated twice.
• On enhancing Europe’s health crisis response mechanisms, we have Creation of an EU Health Emergency Response Authority (HERA):
  • “HERA fills a major structural gap in the EU’s crisis preparedness and response infrastructure, and will strengthen the coordination of operations across the whole value chain and develop strategic investments for research, development, manufacturing, deployment, distribution and use of medical countermeasures.
    • “This will require the assembly of ecosystems of public and private capabilities that jointly enable a rapid response when the need arises.
  • “HERA will anticipate specific threats and enable technologies through horizon scanning and foresight.
    • “It will identify and address investment gaps in key countermeasures including the development of innovative antimicrobials.
    • “It will monitor and pool production capacity, raw material requirements and availability, thus addressing supply chain vulnerabilities.
    • “It will support the development of crosscutting technological solutions (e.g. vaccine platform technologies) that sustain preparedness and response planning for future public health threats and development of specific countermeasures, including through research, clinical trials and data infrastructure.”

Wow! Wow! Wow! A specific shout-out for incentives and new business approaches? Creation of a BARDA-like authority for Europe? Fantastic!

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Relatedly, there was a thoughtful commentary in the 28 Nov 2020 issue of The Lancet on the recently created One Health Global Leaders Group on Antimicrobial Resistance (OH-GLG-AMR, OK, I couldn’t resist that acronym!).This is the kind of high-level leadership that will keep AMR on the global political agenda:

• The GLG was created in response to the 2019 “No Time to Wait: Securing the Future from Drug-Resistant Infections” report to the UN Secretary-General (UNSG) from the Interagency Coordination Group (IACG) on Antimicrobial Resistance.
• The GLG is a 20-member group that is co-chaired by the Prime Ministers of Bangladesh and Barbados and includes ministerial leadership from Bhutan, Iraq, Sweden, Australia, Saudi Arabia, and Singapore as well as leaders from academia, the private sector, and civil society.

All good stuff that is so very exciting to see! And I now confess that I’m going to return to the Thanksgiving pie … cheers! –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.