KEI proposal for Antibiotics Innovation Funding Mechanism (AIFM), shortlisted for demonstration project by WHO's EURO region
The WHO is considering potential projects that will demonstrate the feasibility and benefits of open innovation models, delinkage of R&D costs and product prices, and innovative finance mechanisms. The process for selection began at the regional level, as each of six WHO regions was allowed to shortlist four projects that will be considered at a December 3-4, 2013 meeting of experts in Geneva, where the list will be narrowed again, and then considered by the WHO Executive Board in January 2014 and the WHO World Health Assembly in May 2014. A couple of projects received endorsements from more than one region. The full list of the projects shortlisted at the regional level, and the text of the proposals, is now available from the WHO here: http://www.who.int/phi/implementation/phi_gtc_meeting/en/index2.html
KEI is a co-sponsor with the Government of Colombia of one project presented to the WHO which PAHO has ranked 5th, for open source affordable cancer diagnostics. (http://keionline.org/node/1819). Because the WHO is limiting the number of proposals to 4 per region, it may not be considered at the December 2013 meeting. If not, there will be no proposals address the special R&D needs of developing countries that relate to cancer.
KEI is separately the sponsor of a proposal for an Antibiotics Innovation Funding Mechanism (AIFM), which was short listed by the WHO EURO region. A copy of this proposal, including an Annex, is attached to the end of this blog. The WHO now has three proposals dealing with antibiotics, and a project on fever diagnostics, which is highly relevant to the issue of misuse of antibiotics, for consideration at the December meeting.
The two other antibiotics proposals were both sponsored by ReAct – Action on Antibiotic Resistance, and the Program on Global Health and Technology Access, of the Sanford School of Public Policy at Duke University. The titles of the proposals are: "Building a Diagnostic Innovation Platform to Address Antibiotic Resistance," and "Establishing a Drug Discovery Platform for Sourcing Novel Classes of Antibiotics as Public Goods."
The WHO experts and member states may at some point reshape and blend the various proposals.
The Annex to the KEI proposal (attached below) is 14 page paper titled "Approaches to simulating innovation for the development of new antibiotic drugs," and it provides a brief review of several approaches to funding innovation for antibiotics, including:
(1) R&D Subsidies.
(2) Policies regarding regulatory barriers for registering products.
(3) Extending terms for patents and other intellectual property rights
(4) Innovation inducement prize type incentives to reward innovation and/or conservation
- Innovation Inducement Prizes
- Antibiotic Conservation and Effectiveness (ACE) program
- Strategic Antibiotic Reserve (SAR)
- Pricing of antibiotics
- Antibiotics Health Impact Fund (aHIF)
- Antibiotics Innovation Funding Mechanism (AIFM).
- Pigouvian Taxes
- Antibiotic Innovation and Conservation (AIC) fee
- Transferable Patent Extensions
- Transferable Priority Review Vouchers
- Advanced Marketing Commitment (AMC), and Advanced Purchase Commitment (APC)
- Call options for antibiotics