[Ip-health] KEI proposal for Antibiotics Innovation Funding Mechanism (AIFM), shortlisted for demonstration project by WHO's EURO region

Thiru Balasubramaniam thiru at keionline.org
Fri Nov 22 05:29:12 PST 2013


http://keionline.org/node/1832

http://keionline.org/sites/default/files/KEI-CEWG-EURO-antibiotics-31Oct2013-r21Nov.pdf

http://keionline.org/sites/default/files/Annex-AntibioticRD.pdf


KEI proposal for Antibiotics Innovation Funding Mechanism (AIFM),
shortlisted for demonstration project by WHO's EURO region

Submitted by James Love on 21. November 2013 - 18:29


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).

(5) Other

   - 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



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