EMA Network Strategy to 2025: Action on AMR / Comments due 4 Sep

Dear All,

We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for comments on their draft Network Strategy to 2025 that considers how “the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies, globalisation as well as emerging health threats, such as the COVID-19 pandemic.”

The call for comments is here and I encourage you to take a look now … comments are due 4 Sep 2020. The strategy has 6 goals:

1. Availability and accessibility of medicines
2. Data analytics, digital tools and digital transformation
3. Innovation
4. Antimicrobial resistance and other emerging health threats
5. Supply chain challenges
6. Sustainability of the Network and operational excellence

All of the goals are obviously relevant to product innovation but you can see that goals 1 and 4 are particularly pertinent to the AMR community. The detailed elements of these two goals are found below my signature — please read the document for the full story. I’m pleased to see the call for Pull incentives and the call to streamline incentives, but I need to spend some time with nuance.

I’m pushing this out tonight because the deadline for comments is 4 Sep — please take a look at this! Follow-up note: Kevin Outterson and I submitted comments — here they are as a .pdf.

I hope to “see” you tomorrow at the BEAM meeting — the sessions feature an all-star cast! All best wishes, –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.

Goal 1: Availability and accessibility of medicines

• Strengthen the availability of medicines to protect the health of European citizens, via:
  • efficient and targeted regulatory measures, made possible through an in-depth understanding the root causes of unavailability of patented and off-patent products;
  • identification of possible challenges in implementing legislation, removal of national barriers, increased coordination of the EMRN, sharing and implementation of best practices including by thestakeholders and increased transparency are the essential steps towards this goal.
• Optimise the path from development, evaluation through to access for innovative and beneficial medicines through collaboration between medicines regulators and other decision makers in the areas of:
  • evidence planning, including post-licensing evidence;
  • engagement in review of evidence and methodologies, respecting remits of the various players;
  • collaboration on horizon scanning.
• As a result of this work, medicines that address unmet medical needs should have broader and earlier access coverage.

Goal 4: Antimicrobial resistance and other emerging health threats

1. Provide high quality information on antimicrobial consumption and surveillance data on antimicrobial resistance in animals and humans in support of policy development.
2. Contribute to responsible use of antibacterial agents and effective regulatory antimicrobial stewardship in human and veterinary sectors by putting in place strategies to improve their use by patients, healthcare professionals and national authorities
3. Ensure regulatory tools are available that guarantee therapeutic options (with a focus on veterinary medicines) while minimising impact of antimicrobial resistance on public health and the environment
4. Define pull incentives for new and old antibacterial agents, including investigating support for new business models and not-for-profit development
5. Foster dialogue with developers of new antibacterial agents and alternatives to traditional antimicrobials, to streamline their development and provide adequate guidance in both human and veterinary medicine
6. Improve regulatory preparedness for emerging health threats