G7 Finance Ministers call for Pull; US-specific text cites PASTEUR and a PASTEUR backup plan!

Dear All,

VERY exciting news on the Pull incentive front: The G7 Finance Ministers have released a statement on Actions to Support Antibiotic Development, aiming to strengthen G7 preparedness against the “silent pandemic” of antimicrobial resistance. Implicitly, this is a statement that is agreed and endorsed by the political leadership of each country — for the US, this means Treasury Secretary Yellen (and behind her, the White House). 

There’s some amazing language in the statement … let’s take a look. Here are the links you need:

• The webpage about the statement
• The statement itself
• An annex that summarizes actions by country
• A statement on Shared Principles for valuation of antimicrobials

From the statement, we have this key paragraph (I’ve added line breaks and emphasis):

• “All G7 members commit to expedite their implementation of existing strategies, outlined in our respective AMR Action Plans and related strategies, and to take additional specific and appropriate steps to address the antibiotic market failure and create the right economic conditions to preserve essential existing antibiotics and ensure their access, strengthen AMR antibiotic research and development, and bring new drugs to market where they meet identified public health needs (see annex A for examples of G7 action).  
• “Recognising country-specific circumstances and member state competences, possible steps could include exploring a range of market incentive options, with a particular emphasis on supporting relevant pull incentives, implementing new pilot projects, contributing to new national governance structures to develop economic strategies to strengthen antibiotic development, and exploring legislative and regulatory measures.”

Then in the Annex of ongoing by-country actions, we have of course mentions of the UK “Netflix” pilot as well as the EU’s call for Pull incentives, but the real stunner is the explicit endorsement of PASTEUR plus a statement that DHHS is preparing to simply implement the idea of PASTEUR by direct action if it doesn’t pass in Congress! Read for yourself:

• “Additionally, AMR-related legislation known as the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act was introduced in the U.S. Congress.
  • “This Act aims to address shortcomings in the antibiotic development market and increase public health preparedness by keeping novel antibiotics on the market and improving appropriate use across the health care system.
  • “While current contracts between the government and drug makers base payment on volume, the PASTEUR Act would establish a subscription-style model which would offer antibiotic developers an upfront payment in exchange for access to their antibiotics, encouraging innovation and ensuring the U.S. health care system is prepared to treat antibiotic resistant infections. 
• [READ CLOSELY — AMAZING] “In the event that the proposed Act is not enacted into law, HHS has begun the process required to establish a novel payment mechanism with the HHS FY23 proposed legislative program.”

Last but not least, the shared valuation framework includes mention of STEDI, the importance of stewardship and access plans (the Stewardship & Access Plan (SAP) Development Guide by CARB-X gets a shout-out), and how to de-link reimbursement and volume of sales. The list of guiding principles that would be required for recipients of delinked Pull rewards is a good read:

1. “publishing of global access and stewardship plans;
2. “promotion of product affordability and improvement in access, particularly for low- and middle-income markets
3. “maintenance of high manufacturing standards, including measures to reduce the risk of sub-standard and falsified medicines entering into circulation;
4. “adherence to high environmental standards, including the proper management of manufacturing waste and pollutants;
5. “maintenance of robust end-to-end supply chains and mitigation plans for supply disruption;
6. “reinforcement of appropriate promotional behaviours, including removing sales incentives;
7. “consideration of the other commitments made by the AMR Industry Alliance in its 2016 Davos Declaration.”

WOOT, WOOT! Stunning! I am all astonishment!

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.