|February 2005 - Medical Research and Development Treaty Proposal|
Medical R&D Treaty Concept
The proposed draft R&D treaty provides new obligations and economic incentives to invest in priority research projects, and addresses several other important topics such as open access publishing. It includes agreements that member countries reduce intellectual property protection in certain areas, such as to permit research exceptions for patents, and exceptions to patentability relating to certain open source medical databases.
The core country obligation is to support medical R&D. The mechanisms to support R&D are flexible, and include traditional approaches such as national NIH style public sector funding, tax credits, or purchases of patented medicines (measured by the R&D stimulated by such purchases), as well as newer methods, such as medical innovation prize funds, competitive Intermediaries, or various open source collaborative research projects. Country obligations are pegged to a fraction of GDP, under a progressive rate, with minimum investments for priority research projects, such as investment in neglected diseases or global infectious diseases.
The proposal also creates a novel system of credits to reward and stimulate investments in research projects considered socially important. Member countries could use these credits to satisfy treaty obligations. Similar to the Kyoto climate treaty, credits could be traded across borders -- and countries that exceed the benchmark obligations can sell excess credits. The credits cover a variety of projects including:
R&D for neglected diseases and other priority research projects,
"Open public goods", such as free and open source public
Projects that involve the transfer of technology and capacity to
The preservation and dissemination of traditional medical
Exceptionally useful public goods.
At the core of the draft treaty is the proposal that a country meeting the treaty obligation for R&D would not be subject to other trade agreements on patents or drug prices:
"Members agree that in creating a global framework for minimum levels of investment in medical research and development it is possible and appropriate to rely less upon other, indirect mechanisms. Members thus agree to forgo certain WTO TRIPS dispute resolution cases, or bilateral or regional trade sanctions, in areas where compliance with the terms of the Treaty provides an alternative and superior framework for supporting innovation."
The treaty provides a strategy for rolling back intellectual property agreements on medicine. It does this by offering an alternative solution to the need for a global framework to support medical innovation.
On February 24, 2005, some 162 leading medical researchers, NGOs, parliamentarians, government officials, and other stakeholders submitted a letter to the World Health Organization (WHO) asking that it evaluate a proposal for a new global treaty to support medical R&D. The letter proposes to deal with higher drug prices for consumers in developed and developing countries by introducing a Medical R&D Treaty Framework that could ultimately replace existing or planned trade agreements that focus on patents or drug prices. A copy of this letter with a full list of signatories can be found here.
The project to develop a proposed treaty on medical R&D began in 2002, and has been discussed at numerous workshops, conferences, meetings and collaborative discourses and consultations. This effort has produced a working draft (available in English, Spanish, and French).
In late 2005, Kenya formally submitted a resolution to the WHO's Executive Board (WHO EB) asking for the creation of a group of member states to discuss a new global framework on medical R&D. In January 2006, Brazil became a co-sponsor of that resolution. The WHO EB approved a highly bracketed version of a draft resolution on this topic, which was debated at the World Health Organization's World Health Assembly (WHA) in late May 2006. And in late April, Brazil asked a committee of the WHO EB to begin discussions specifically on a framework convention on medical R&D.
In December 2006, the WHO Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property convened in Geneva to discuss Elements of a Global Strategy and Plan of Action to enhance innovation, research and development to address diseases predominantly affecting poor populations. The working group included governments as well as a number of observers and invited experts and stakeholders, in order to create a medium-term framework to identify R&D priorities, including methods and sources of funding. Further decisions have yet to be made. Public health groups and some experts will be pushing for new open source methods of conducting research, and new incentive systems that reward innovations that improve health outcomes in developing countries without imposing marketing monopolies or high drug prices. Big drug companies will lobby for measures that link high prices for blockbuster drugs to R&D for neglected diseases.
In the United States, there is considerable interest and support for the R&D treaty approach by certain high-ranking officials in NIH, the USTR, and among members of both political parties in the Congress. The treaty proposal is closely related to new thinking about how a country would meet its R&D obligations. Domestically, the most important new proposal is in the US -- HR 417, the Medical Innovation Prize Fund.