(revised October 25, 2013)
According to persons involved in the negotiations, PAHO will forward from four to seven R&D demonstration projects to the WHO, for consideration at the December meeting. The projects were selected from 29 that had been proposed. Some rough notes on the 29 projects are available here: http://goo.gl/8AiJQi. The projects were supposed to address new models for financing open innovation, delinking R&D costs from product price. The relevant WHO resolutions include WHA66.22 and the decision points in A66/Div/3, attached below.
If the WHO only accepts four proposals, they will be:
- [DNDi] Chagas R&D Accelerator Initiative: A Coordination Mechanism For Accelerating The Development Of New Health Tools For Chagas Disease
- [Doctors without Borders/MSF]. The Open Source Multiplex POC Fever Diagnostic Project
- [Oswaldo Cruz Foundation, Ministry of Health, Brazil] Development Of A Vaccine Against Schistosomiasis Based On The Recombinant Sm14 A Member Of The Fatty Acid Binding Protein: Controlling Transmission Of A Disease Of Poverty.
- [US FDA & others] Development Of Class D Cpg Odn (D35) As An Adjunct To Chemotherapy For Cutaneous Leishmaniasis And Post Kala- Azar Dermal Leishmaniasis (Pkdl)
In case more projects are accepted, PAHO Member States recommend that the next 3 projects should be included in this order:
- [Ministry of Health and Social Protection, Colombia, 2. Administrative Department of Science and Technology, Colombia, 3. Knowledge Ecology International] Affordable Diagnostic Tests For Cancer
- [Doctors without Borders/MSF] Accelerating Innovation And Access To Medicines For Tuberculosis Through Open Collaboration: A Push, Pull, Pool Approach
- [Ministry of Health, Brazil] Establishment Of Public-Private Partnership For The Development Of A Diagnostic Kit For Prenatal And Postpartum
According to persons involved in the negotiations, the United States, represented by Dr. Karl Western from NIH/NIAID and Peter Mamacos from DHHS, sought to block the Colombia/KEI open source cancer diagnostics prize fund proposal (attached here), as well as the MSF TB proposal.
The KEI/Colombia open source cancer diagnostics prize fund proposal had a good deal of support among the PAHO members, with the exception of the USA and Mexico, which both expressed concerns about the technical feasability of obtaining better technologies for cancer detection within a time period for the demonstration project.
Note that among the 29 R&D proposals under consideration, 9 addressed cancer.
Also worth noting is the fact that many proposals addressed the need for better diagnostics technologies that can be used in resource poor settings. This may reflect (1) the growing recognition that diagnostics are a key element of health systems, (2) there are opportunities for innovations in diagnostics, particularly as it relates to resource poor settings, and (3) that the R&D costs associated with diagnostics are generally lower than for drug development, and people are trying to be realistic about the resources available for the demonstration projects.
KEI has asked Karl Western of the NIH/NIAID to explain why the NIH strongly opposed the open source cancer diagnostics proposal. Since the NIH also opposed the MSF proposal on TB treatment regimes, it seems as though the NIH was basically trying to limit the proposals to “Type III” diseases only, excluding all Type 1 and Type 2 diseases. (See WHO disease definitions here)
Some of the other regional consultations are not yet finished. For example, the deadlines for submitting proposals are as follows: EMRO: October 30, EURO October 31, and WPRO November 1.
The WHO Geneva meetings in on the R&D demonstration projects are currently scheduled to take place from December 3 to December 5.