Description: A binding international treaty committing states to contribute a certain proportion of GDP to medical research.
Start date: Proposed in 2002.
Status: Proposed.
A Medical Research and Development Treaty (MRDT) would be a binding international treaty which commits participants to a certain level of funding on medical R&D. This funding could be discharged flexibly, through direct funding, tax incentives, remuneration rights or other means.1
Originally called the Medical Innovation Convention (MIC),2 the project to draft such a treaty began in 2002. A draft was produced in 2005 by the Consumer Project on Technology (CPTech), led by James Love.3
To incentivise innovation on neglected areas, credits would be offered on priority research which would then count towards a country’s minimum commitment.4
Participants in MRDT would not be subject to existing rules on intellectual property and patents, including the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.5
The MRDT would be administered by a governance body within the WHO called the Assembly for Medical Research and Development (AMRD). This would administer the treaty, set priorities and periodically reassess funding levels.6
Scope: The MRDT would cover all aspects of R&D and all areas of health.
Access: MRDT would increase the funding available for R&D, and it would sidestep international agreements on intellectual property rights. Medicines would probably get cheaper therefore. There is no explicit incentive for distribution in the MRDT (though as it allows for multiple kinds of funding, it is possible that some MRDT funding would include such provision.)
Innovation: Incentives are partially linked to health impact, in that credits are provided for priority diseases. However, there is no comprehensive link to health impact.
Efficiency: MRDT would be funded progressively through income-proportionate contributions by governments. It is not market-based.
Governability: The MRDT would be substantially decentralised, with a central governing assembly to set priorities and funding levels. It is unclear how the treaty would be enforced.
Political Feasibility: An MRDT would coexist with the patent system, making it easier to implement. However it would also sidestep TRIPS, which might be unpopular.
Because MRDT is neutral with regards to funding mechanisms, it could resemble many other kinds of proposal, depending on how it were implemented. For instance, governments could choose to spend their commitments through remuneration rights, or tax credits, or priority reviews.
The MRDT prefigures a number of other proposals, notably the Medical Innovation Prize Fund (MIPF) and the WHO discussions. Both of these proposals envisage government(s) contributing a set proportion of wealth to medical R&D, and are sometimes traced back to the MRDT proposals.
The MRDT is similar to MIPF, as both envisaged a comprehensive funding system provided by government. Differences are:
MRDT would be international, MIPF national.
MRDT focused on funding levels or input, rather than health impact or output.
MIPF specifies how the money should be spent (via a fund), whereas MRDT leaves this open.
MRDT is related to the global framework proposed to the WHO.
MRDT was proposed to Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) in 2005.7
The 2005 WHO Resolution (EB117.R13) supported by Kenya and Brazil was based on the MRDT.8
A core difference is that in the course of the WHO discussions, the idea of a pooled fund was added to the concept of proportionate and binding contributions.
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 much more conservative in scope than MRDT, 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 an MRDT.
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 MRDT.
The WHO global consortium differs from MRDT in that it would target antibiotics specifically and would make open access compulsory.
Developing Economies\’ Fund for Essential New Drugs (DEFEND) is a geographically limited and license purchase limited version of MRDT. Both would also require international agreement and state contributions, but MRDT contributions would be spent on medical research in general via a variety of mechanisms.
Targeted at:
The WHO
Governments
Stakeholders on board:
CPTech
James Love
Tim Hubbard
The proposal: “Medical Research and Development Treaty: Discussion Draft 4,” 2005. http://www.cptech.org/workingdrafts/rndtreaty4.pdf.
Further details on the proposal:
“Medical Research and Development Proposal.” Accessed July 7, 2017. http://www.cptech.org/workingdrafts/rndtreaty.html.
Hubbard, Tim, and James Love. “A New Trade Framework for Global Healthcare R&D (Global Healthcare R&D).” PLoS Biology 2, no. 2 (2004): e52. doi:10.1371/journal.pbio.0020052.
Resources: “Trade Framework for Funding Research and Development.” Accessed July 7, 2017. http://www.cptech.org/ip/health/rndtf/.
Commentary:
Dimasi, Joseph A., and Henry G. Grabowski. “Patents and R&D Incentives: Comments on the Hubbard and Love Trade Framework for Financing Pharmaceutical R&D,” 2004. http://www.who.int/intellectualproperty/news/en/Submission3.pdf.
Hubbard, Tim. “Reply to the Comments Requested by IPIH and WHO to the CPTech Proposal for a Medical Research and Development Treaty (MRDT),” 2005. http://www.who.int/intellectualproperty/submissions/SubmissionsHubbard.pdf.
“The Medical Innovation Convention: A New Global Framework for Healthcare Research and Development.” Open Knowledge International Blog, October 30, 2004. https://blog.okfn.org/2004/10/30/the-medical-innovation-convention-a-new-global-framework-for-healthcare-research-and-development/.
Reflection: James Love. “Prizes rather than Prices.” Le Monde Diplomatique, 2006. http://mondediplo.com/2006/06/20wha.
General information:
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.