Description: A series of proposals to the WHO to create a global framework committing states to contribute a certain level of funding into a pooled funding mechanism.
Start date: Proposed 2005.
Meta-point: this summary shall refer to the proposals in their most recent form unless otherwise stated.
A series of proposals were made to the World Health Organisation (WHO) concerning a binding international convention on medical R&D. It was proposed that all states should commit to spending 0.01% of GDP on medical R&D focused on the diseases of the developing world, via a binding convention. Developing states should contribute more, and developed states the most.
This spending would be pooled in a funding mechanism, and then disbursed to incentivise research and capacity building.
The convention would be supplementary to current R&D funding, rather than a replacement to it. A composite approach would be taken to the way that the funding was disbursed, incorporating elements of open approaches to research and development and innovation, pooled funds, direct grants to companies, milestone prizes and end prizes and patent pools.
Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) was set up in 2004.
In 2005, WHO Resolution (EB117.R13) was sponsored by Brazil and Kenya.
CIPIH reported in 2006.
This led to resolution WHA59.34 in 2006.
This set up the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).
This led in 2008 to resolution WHA61.21.
This agreed the Global strategy and plan of action on public health, innovation and intellectual property (GSPA-PHI).
It also led to the creation of The Expert Working Group (EWG) on R&D: Coordination and Financing.
The EWG reported in 2010.
This led to resolution WHA63.28 to set up the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG).
The CEWG reported in 2012.
It recommended that the WHO create a binding convention on the funding of medical R&D.
This was blocked by the US, the EU and Japan.3
Instead, WHA65.22 resolved to hold a meeting to discuss the report further.4
This was followed up at WHA66, leading to the passing of WHA66.22, which called for a further meeting prior to reporting at WHA69, endorsed a strategic work plan, and called for demonstration projects to be selected.5
WHA69.23 called for the expediting of this strategic plan, and also for the creation of operational proposals following on from the Health Product Research and Development Fund proposals.6
The 2006 resolution established a working group to create a global strategy on medical R&D (this became the IGWG).
The resolution stressed that the flexibilities contained in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement should be taken into account.
The EC blocked inclusion of explicit references to improving access and openness in this resolution.
The GSPA-PHI covered a wide range of proposals, often in quite general terms.
For the purposes of iMED, the key elements were:
Promote the sharing of information.
Explore and promote incentive schemes including delinkage.
Support the generic production of drugs.
Set up a working group to investigate funding mechanisms (this became the EWG).
The EWG report recommended a global funding mechanism of \$3-15 billion.
It advocated that the WHO should be active in creating such a mechanism.
Ways of creating funding that the EWG proposed are:
a new indirect tax
voluntary business and consumer contributions
taxation of repatriated pharmaceutical profits
new donor funds
The proposal was that all states should commit to spending 0.01% of GDP on medical R&D focused on the diseases of the developing world, via a binding convention. Developing states should contribute more, and developed states the most.
This spending would be pooled in a funding mechanism, and then disbursed to incentivise research and capacity building.
The convention would be supplementary to current R&D funding, rather than a replacement to it.
The CEWG Report identified Global Framework on Research and Development, Open approaches to research and development and innovation, Pooled funds, Direct grants to companies, Milestone prizes and end prizes and Patent pools as the most promising proposals. It recommended a composite approach.
Scope: The global framework would encompass all aspects of R&D and those health issues which primarily affect developing nations.
Access: At various stages these proposals included references to delinkage, which were blocked by the US and other actors. There is no distribution incentive.
Innovation: The global framework does not explicitly incentivise health impact.
Efficiency: The grants element of the global framework would not be market-based, though the demand side of prizes would be.
Governability: The global framework would require the establishment of a new body to manage the fund. This would be costly and potentially politically fraught. As a composite approach, various aspects of the proposal would require extensive specification and evaluation, such as prize elements. The system would need to be robust against political interference.
Political Feasibility: The global framework would be complementary to the current patent system, making its adoption more feasible.
Of all proposals, the global framework is most like the Health Product Research and Development Fund, save that the contributions would be compulsory rather than voluntary.
The global framework is also similar to the Medical Research and Development Treaty (MRDT), in that both represent a binding international commitment to a certain level of funding. However, MRDT did not include any pooled funding mechanism, unlike the global framework.
The global framework is somewhat like the Medical Innovation Prize Fund (MIPF), except on an international and complementary basis.
A number of other global frameworks relating to healthcare have been proposed or implemented:
The Multilateral Treaty on Health Technology Cost-Effectiveness Assessment and Competitive Tender is a proposal to create a treaty formalising basic principles for price negotiations between buyers and manufacturers. This is more conservative in scope than the global framework, concerning only governance and administration, rather than the creation of a fund.
The Pandemic Influenza Preparedness Framework was successfully adopted. It committed states to sharing information and viruses and industry to contributing to a fund. It is thus a disease limited version of the global framework.
The WHO Framework Convention on Tobacco Control (FCTC) was also successful, and committed parties to tobacco control strategies. It thus only concerned governance, rather than funding like the global framework.
The WHO global consortium differs from these biomedical convention proposals in that it would target antibiotics specifically and would make open access compulsory.
The Developing Economies\’ Fund for Essential New Drugs (DEFEND) is a geographically limited and license purchase limited version of the WHO biomedical convention proposals. Both would also require international agreement and state contributions, but the biomedical convention contributions would be spent on medical research in general via a variety of mechanisms.
Targeted at: WHO members
Stakeholders on board:
Various working groups
Meta-point: there is no good single source explaining the chronology and development of these proposals.
“WHO | Meeting the Need for Treatment: The Initiatives.” WHO. Accessed June 26, 2017. http://www.who.int/bulletin/volumes/84/5/news30506/en/.
Hollis, Adrian, and Thomas Pogge. The Health Impact Fund: Making New Medicines Accessible for All. Incentives for Global Health, 2008. http://healthimpactfund.org/wp-content/uploads/2015/12/hif_book.pdf.
Rufus Pollock, Open this Book.
“HOW A GLOBAL R&D CONVENTION COULD FILL THE GAPS LEFT BY TODAY’S MEDICAL INNOVATION SYSTEM.” MSF, 2012. https://www.msfaccess.org/sites/default/files/MSF_assets/Innovation/Docs/MedInno_Briefing_GlobalConventionRD_ENG_2012Update.pdf.
2006 CIPIH report: “Public Health, Innovation and Intellectual Property Rights.” Report of the Commission on Intellectual Property Rights, Innovation and Public Health. 2006, 2006. http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf?ua=1.
Executive Board, 117. “[Global Framework On] Essential Health Research and Development,” 2006. http://www.who.int/iris/handle/10665/20678.
World Health Assembly, 59. “[Global Framework On] Essential Health Research and Development,” 2006. http://www.who.int/iris/handle/10665/21107.
2006 resolution: “WHA59.24: Public Health, Innovation, Essential Health Research and Intellectual Property Rights: Towards a Global Strategy and Plan of Action,” 2006. http://trade.ec.europa.eu/doclib/docs/2006/october/tradoc_130884.pdf.
Commentary on the 2006 proposals:
Farlow, Andrew. “A Global Medical Research and Development Treaty: An Answer to Global Health Needs?” IPN Working Papers on Intellectual Property, Innovation and Health, 2007. http://www.andrewfarlow.com/global_medical_research_treaty.pdf.
James Love. “Prizes rather than Prices.” Le Monde Diplomatique, 2006.http://mondediplo.com/2006/06/20wha.
CPTech response to 2006 resolution - “Statement on WHA Passage of Historic Resolution on: Public Health, Innovation, Essential Health Research and Intellectual | On the Commons.” Accessed June 25, 2017. http://www.onthecommons.org/statement-wha-passage-historic-resolution-public-health-innovation-essential-health-research-and#sthash.xUXQ4qx1.dpbs.
Background on the IGWG: “WHO | Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG).” WHO. Accessed June 25, 2017. http://www.who.int/phi/igwg/en/.
2008 proposals: “GLOBAL STRATEGY ON PUBLIC HEALTH, INNOVATION AND INTELLECTUAL PROPERTY.” WHA, 2008. http://apps.who.int/gb/ebwha/pdf_files/WHA61-REC1/A61_Rec1-part2-en.pdf?ua=1.
2008 resolution: “WHA61.21: Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property.” WHA, 2008. http://www.wpro.who.int/health_research/policy_documents/global_strategy_may2008.pdf?ua=1.
Background on the EWG: “WHO | Proposals Considered and Evaluated by the Former Expert Working Group on R&D Financing and Coordination (EWG).” WHO. Accessed June 26, 2017. http://www.who.int/phi/news/cewg_proposals/en/.
2010 EWG report: “Research and Development - Coordination and Financing.” Report of the Expert Working Group on Research and Development Financing. WHO, 2010. http://www.who.int/phi/documents/RDFinancingEN.pdf?ua=1.
2010 resolution: “WHA63.28: Establishment of a Consultative Expert Working Group on Research and Development: Financing and Coordination.” WHA, 2010. http://www.who.int/phi/news/wha_A63_R28_en.pdf.
Background on the CEWG:
“WHO | CEWG Demonstration Projects: Background and Process.” WHO. Accessed June 26, 2017. http://www.who.int/phi/implementation/cewg_background_process/en/.
“WHO | Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG).” WHO. Accessed June 26, 2017. http://www.who.int/phi/implementation/research/cewg-consultation/en/.
“WHO | Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG).” WHO. Accessed July 7, 2017. http://www.who.int/phi/news/cewg_2011_background/en/.
2012 CEWG report: “Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination.” Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination. World Health Organisation, 2012. http://apps.who.int/iris/bitstream/10665/254706/1/9789241503457-eng.pdf?ua=1.
Commentary on the 2012 events:
“WHO | Towards a New Model for Pharmaceutical Research.” WHO. Accessed July 6, 2017. http://www.who.int/bulletin/volumes/90/11/12-113712/en/.
May 29, and 2012. “Officials At WHA Fail To Agree On Convention ToEncourage R&D Into Health Issues In Developing Countries.” The Henry J. Kaiser Family Foundation, 2012. http://www.kff.org/news-summary/officials-at-wha-fail-to-agree-on-convention-to-encourage-rd-into-health-issues-in-developing-countries/.
Røttingen, John-Arne, and Claudia Chamas. “A New Deal for Global Health R&D? The Recommendations of the Consultative Expert Working Group on Research and Development (CEWG).” PLOS Medicine 9, no. 5 (2012): e1001219. doi:10.1371/journal.pmed.1001219.
Moon, Suerie, Jorge Bermudez, and Ellen ’t Hoen. “Innovation and Access to Medicines for Neglected Populations: Could a Treaty Address a Broken Pharmaceutical R&D System?” PLOS Medicine 9, no. 5 (2012): e1001218. doi:10.1371/journal.pmed.1001218.
2006 proposals: “CPTech Page on the 59th World Health Assembly.” Accessed July 7, 2017. http://www.cptech.org/ip/health/who/59wha/.
2012 proposals: “Medical Research and Development.” Knowledge Ecology International. Accessed July 7, 2017. https://www.keionline.org/medical-rnd.