Incentives for R&D
This webpage summarizes key reports (just below) and newsletters about ways to fund the antibiotic ecosystem. For summaries of needed types of antibiotics and analyses of the state of the global pipeline, go to this webpage.
Key Reports on Ways to Fund the Antibiotic Ecosystem
- 2009: Held on 17 Sep 2009 in Stockholm during Sweden’s 2nd term as President of the EU, the workshop entitled “Innovative incentives for Effective Antibacterials” was the key starting point for all the discussions on ensuring we have adequate antibiotics. Limited materials are available online but we do have a pre-meeting report on policy options, a brief post-meeting report, a complete post-meeting report, and the post-meeting 1 Dec 2009 European Council Resolution that concluded with the call to the commission to “within 24 months, develop a comprehensive action-plan, with concrete proposals concerning incentives to develop new effective antibiotics…” and thus catalyzed TATFAR, the ND4BB project, and so much more.
- 2014: Eastern Research Group for the US Department of Health and Human Services: link
- 2015: Chatham House in London: link
- 2016: UK AMR Review led by Lord Jim O’Neill: link
- 2017: Duke-Margolis Center for Health Policy (11): link
- 2018: DRIVE-AB for the European Union: link
- 2019: “When Antibiotics Fail”, a report from the Canadian Council of Academies. It doesn’t directly discuss ways to fund the antibiotic ecosystem, but it does provide good material on the cost of AMR: link
- 2020: United States Government Accountability Office: link
- 2020: WHO-sponsored survey: Gotham et al. Reimbursement models to tackle market failures for antimicrobials: Approaches taken in France, Germany, Sweden, the UK, and the US. Health Policy, 2020 (https://doi.org/10.1016/j.healthpol.2020.11.015)
- 2021: EU-JAMRAI-sponsored survey of interest in incentives by policymakers in 13 countries (10 from EU plus Canada, South Africa, and Japan)
- 15 Feb 2021 position paper from IFPMA entitled “Global Principles on Incentivizing Antibiotic R&D
- 24 Mar 2021: the AMR Alliance Japan and the Nikkei FT Communicable Diseases Conference Asia Africa Medical Innovation Consortium (AMIC) AMR Consortium released calls for pull incentives in Japan that suggest delinked rewards of 20-80 billion yen (~$200-800m) over ten years. Go here and here for documents in English, here and here for Japanese. Also of interest are an 11 Jan 2020 newsletter giving some of the history of antibiotics in Japan, multiple prior documents from the Japanese Pharmaceutical Manufacturers Association (JPMA) on the need for Pull incentives (link), and the calls for Pull incentives in the report from the Nikkei FT 7th Communicable Diseases Conference (6 Nov 2020).
- Jan 2022: “Reflection Paper on the Pull Incentive Mechanisms Suitable For SMEs Developing AMR Products in Europe” from the BEAM Alliance. This paper makes a strong case for the use of transferrable exclusivity mechanisms.
- Feb 2022: “The Case for a Subscription Model to Tackle Antimicrobial Resistance” is a paper commissioned by Wellcome Trust and the Novo Nordisk Foundation in advance of the 2022 World Economic Forum. This paper makes a strong case for a subscription model as a component of any system of Pull incentives.
- Mar 2022: “Models for Financing Antibiotic Development to Address Antimicrobial Resistance.” This paper shows that the existence of Pull models would create a path for private capital to further invest and thereby multiple the effect of the Pull incentive. See also this 26 Mar 2022 newsletter.
- June 2022: Global AMR R&D Hub and the WHO AMR Team: “Incentivising the development of new antibacterial treatments“. This report is a response to a 2021 request by the G7 Finance Ministers for a report on the state of play for AMR incentives. It provides an excellent summary of models currently being explored globally.
- June 2022: Center for Global Development: “Leveraging Purchasing Systems to Ensure Access, Stewardship, and Innovation: A Landscape Review of Current and Potential Market Structures for Antimicrobials.” This excellent survey of procurement models is good to read back-to-back with the report just above from WHO and the AMR R&D Hub — very detailed, very well balanced. See also this 28 June 2022 newsletter.
- October 2022: Ministry of Foreign Affairs of Denmark and the Danish Health Authority, with support of the Novo Nordisk Foundation: A report calling for Pull incentives: “Both push and pull-factors are being discussed, and especially two models are of interest and are currently being tested in UK, Sweden and the US. A subscription model, with a fixed annual payment or minimum revenues in return for an antimicrobial product supply guarantee, delinked from the volumes sold. And exclusivity extension, where patent extensions are granted to the successful antimicrobial innovator with transferability to already approved drugs.”
- February 2023: The Ministry of Health, Labour and Welfare of Japan shared their vision for a delinked incentive during during the the 6th Meeting of the Global Leaders Group on AMR (GLG6) in Barbados (6-7 Feb 2023). See also this 13 Feb 2023 newsletter.
Newsletters about value, incentives, and funding
- 29 Nov 2022 (link): “Impact Of PASTEUR: 9.9m Lives Saved, ROI Of 125:1”. An estimate of the 30-year value of PASTEUR in terms of lives saved and financial return yields impressive results based on a very simple calculation. Highly recommended as a technical introduction to the AMR paradox and the fire extinguisher value of new antibiotics.
- 6 Nov 2022 (link): “Pull! Excellent 4-Part OHE Blog + BEAM Support For TEE-Based Pull.” OHE have produced an excellent 4-part blog on the paradoxical economics and antibiotics and how the UK’s subscription model is such an innovative solution.
- 4 Jun 2022 (link): “Notable Reports: Incentives (WHO, AMR Hub); Strategy (BARDA); Capacity Building (UK Fleming Fund, US CDC)” – Taken together, these 4 reports point to ways to diverse efforts needed to (re)build the antibiotic ecosystem.
- 26 Mar 2022 (link): “Pull Mechanisms: Private Capital Can Multiply Subscription (Netflix) And TEV Models!” – Three papers describe the best Pull models and how these could lead private capital to further invest.
- 20 Jan 2022 (link): “#AMRSOS! GRAM Report: “At Least 1.27m Deaths/Year Directly Attributable To AMR” – This is the most comprehensive estimate to date of the global burden of AMR. The title of the newsletter is a great summary!
- 18 Jan 2022 (link): “ARPEGE: New €17m French Consortium Tackles Economics, Diagnostics, And Therapeutics” – This project will use ideas from Jean Tirole’s Nobel-winning work on game theory and the problem of free-riding to advance our collective thinking on the economic challenge(s) of new antibiotics.
- 1 Nov 2021 (link): “Appropriate Pull Incentive For New Antibacterials: $2.2-4.8b For Full Delinkage” – An open-source modeling exercise has amended oversights in prior models. The UK’s “Netflix” model and the US PASTEUR Act are right on target for each country’s fair share.
- 14 Sep 2021 (link): “Outstanding Discussions Of Pull, The NHS Pilot, And Antibiotic Value” — A review of the 26-28 Aug 2021 annual BEAM Alliance meeting. Lots of good video discussions.
- 20 Aug 2021 (link): “‘Astonishing Mismatch’: Market Potential Of AMR Tools Vs. Patient Needs” – A report from the Global AMR R&D Hub documents (again) the value of new antibiotics. There is also a fascinating discussion of the very different challenge for diagnostics.
- 16 June 2021 (link): “PASTEUR Act Re-Introduced And Levels Up Antimicrobial Economics For Strong Innovation!” — The title of this one is the message!
- 11 Feb 2021 (link): “UK Antibiotic Subscription Pilot: Updates from a webinar” — the ground-breaking antibiotic subscription model being piloted by the UK’s NHS and NICE was discussed in a recent webinar. We need more countries to commit to this!
- [GOOD QUICK INTRODUCTION] Feb 2021 (link): “Brilliant 5-minute video explainer of the AMR problem!” — Andrew Jack of the Financial Times has produced an excellent brief video on how Netflix-like models can address the difficult economics of antibiotics. Highly recommended.
- [WHY IT COSTS WHAT IT COSTS] 11 Jan 2021 (link): “All-In Cost Of A New Antibiotic From Discovery To 10 Years On Market” — An integrated update on everything we know at present about the real cost ($ and time) bringing a new antibiotic to market and keeping it there.
- 9 Dec 2020 (link): “Global Survey Of Novel Antibiotic Reimbursement Models / PASTEUR Act Introduced To US House.” — In parallel with PASTEUR moving from the Senate to the House, a WHO-based group has authored an excellent review of global efforts to find new ways to reimburse for the full value of antibiotics.
- 28 Nov 2020 (link): “Global AMR Action: EU Pharmaceutical Strategy; One Health Global Leaders Group On AMR” — EU has announced a pharmaceutical strategy that includes a specific call for “… new incentives to develop antimicrobials as well as new pricing systems.” The strategy also includes a call to create an EU Health Emergency Response Authority (HERA) that sounds very much like BARDA!
- 21 Oct 2020 (link): “Nature Outlook: Antimicrobial Resistance.” — As a supplement to Nature, this superb collection of brief outlook papers (2-4 pages each) provides a concise survey of pretty much everything relevant to the AMR problem: broken economics, new approaches to discovery, use of antibiotics in fish farming, and more. If you only have time for one paper, look at “No money for new drugs” by Plackett (link).
- 30 Sep 2020 (link): “PASTEUR Act (re)introduced: A delinked Pull award advances in the US!” — This is huge deal: bipartisan legislation that would create predictable subscription-based market entry rewards for new antibiotics.
- 9 July 2020 (link): “AMR Action Fund: A $1b Down Payment From Industry; A Call For Creation Of Strong Pull Incentives” — The announcement of the AMR Action Fund is the beginning of the next step towards a stable ecosystem for antibiotics!
- 12 June 2020 (link): “Perspectives on restoring the antibiotic ecosystem: ACS ID, June 2020 issue” — This newsletter surveys the excellent series of papers on AMR R&D in the June 2020 issue of ACS Infectious Diseases.
- 7 June 2020 (link): “Assessing antibiotic value: DTR, fire extinguishers, and a view from Australia” — This newsletter begins with a very succinct summary of the problem with antibiotics.
- [A KEY REVIEW OF THE DATA] 14 Apr 2020 (link): “Pull Incentives For Antibiotics: How Much And Why? — A literature survey” — A summary of papers approaching value from the diverse view points of scientific features at baseline, features that emerge, top-down value estimates, and bottom-up value estimates.
- 29 Mar 2020 (link, plus link to follow-up FAQ): “UK Antibiotic Subscription Pilot Implies Pull Incentive Of Up To $4b”
- 23 Mar 2020 (link): “Tetraphase Sold For $14m … And $600m Goes Up In Smoke!”
- 6 Mar 2020 (link): “What Does An Antibiotic Cost To Develop? What Is It Worth? How To Afford It?”
- 11 Jan 2020 (link): “Japan’s Antibacterial R&D Landscape / Japan Calls For Pull Incentives”
- 5 Jan 2020 (link and link, a 2-part series): “Melinta Goes Bankrupt / Never Let A Good Crisis Go To Waste” — Note that part 2 of this series contains the best estimate to date of the post-approval costs incurred by an antibiotic developer.
- 22 Apr 2019 (link and link, a 2-part series): “Scary, Scarier, Scariest: Achaogen bankruptcy”
- 17 Feb 2019 (link): “Modeling The Value Of An Effective Antibiotic: Megiddo et al.”
- 23 Jan 2018 (link): “Push! Pull! Push! Pull! / Highlights From Davos 2018”
- 11 Sep 2017 (link): “Incentives For Antibiotics: Summary of the insights from DRIVE-AB”
- 8 June 2017 (link): “Ardal et al. / Pull Incentives For Antibiotics – TATFAR Analysis Of 6 Models”the
Dear All, Along with more than 50 others, I spent Tuesday 12 Sep 2023 on Capitol Hill visiting offices of members of Congress (Senate and House) seeking support for the PASTEUR Act. If you’re a regular reader, you’ll know that we now have substantial bipartisan support for PASTEUR: it was re-introduced as The Pioneering Antimicrobial
Note: For those of you with an interest in developing bacterial vaccines, the results of Pfizer’s failed STRIVE S. aureus vaccine have now appeared in print along with an excellent editorial commentary. Deep sigh on this one — please see the updated prior newsletter for the links and the full story. Dear All, Today we