The most favorable explanation for what is going on this week in Geneva is that Hillary Clinton and Obama are not following what key Bush hold-overs are about to do. The less favorable explanation is that Secretaries Clinton (State) and Sebelius (HHS) and the Obama White House are closely working with PhRMA to kill any further discussions of a medical R&D treaty at the WHO.
The medical R&D treaty has been discussed by many governments at the WHO, and supported by a very long list of health, consumer and development NGOs, including MSF, Oxfam, Health Action International, HealthGap, the 80 member TransAtlantic Consumer Dialogue, Knowledge Ecology International, Essential Action, and others. (See earlier expressions of support here, here, here, and here).
At present, the United States government is the leading source of government funded medical R&D, through agencies such as the National Institutes of Health. In both absolute terms and as a percentage of GDP, no other country comes close.
Health groups want more spent on priority medical R&D, particularly in areas such as the development of new antibiotics and vaccines, or treatments for neglected diseases. Given the dominant role of the U.S. in funding medical R&D now, this would largely result in increased obligations for other countries, particularly those with high incomes.
There are is also discussion about possible sharing of the costs of independent clinical trials for the development and evaluation of new medicines, greater transparency of the R&D resource flows and outputs, the use of new incentive systems like innovation inducement prizes that de-link R&D incentives from drug pricing, and many other topics (see below).
The efforts to discuss new trade and business models for R&D have delighted public health groups, but alarmed PhRMA.
The WHO is governed by World Health Assembly (WHA), which meets once a year, and an Executive Board, which meets twice a year. The annual WHA meeting began on Monday, and ends on Friday. The U.S. government delegation that is following this issue includes representatives from the Department of State, the Department of Health and Human Services, and the United States Trade Representative. State (Hillary's Department) seems to be taking the lead.
The U.S. position has now been incorporated in a draft resolution written by the WHO secretariat, which is highly responsive to US pressure. The US does not have its name on the resolution, which is sponsored by the Delegations of Canada, Chile, Iran (Islamic Republic), Japan, Libyan Arab Jamahiriya, Norway and Switzerland. (Distributed to the 62nd WHA as document A62/A/Conf.Paper No.4)
The deal the US has pushed is to force developing countries to choose between (a) the medical R&D treaty or (b) the ability of the WHO to look at other intellectual property issues relating to access to medicines. Basically the US delegation has conceded that it cannot block all efforts to deal with access to medicines, but it wants to stop any discussions that would be more transformative, in terms of trade or business models for medical R&D, that are opposed by PhRMA.
Negotiators say Obama is following the Bush game plan even more aggressively than was done when Bush was president.
For context about what a medical R&D treaty might do, consider this recent proposal by four countries for possible topics:
- Coordination and facilitation of periodic global priority assessments--including estimates of funding needs--for R&D to address public health needs.
- Norms and mechanisms to ensure sustainable financing for R&D.
- Measures to facilitate, encourage, and otherwise stimulate new incentive schemes for R&D (such as medical innovation inducement prizes, advanced market commitments, openness dividends, and other new innovative approaches), with special attention to measures that de-link R&D incentives from product prices, and reward innovations that improve health outcomes.
- Possible governmental agreement to contribute to the global cost of R&D, considering each nation's level of development, size of economy and capacity to pay, in order to establish global norms for R&D contributions. Contributions should be allowed through multiple means.
- Global norms and best practices to facilitate access to government funded research.
- Norms and measures regarding the transparency of global medical innovation.
- Mechanisms to develop and improve innovative capacity for research and development, particularly in developing countries.
- Measures to facilitate encourage or otherwise stimulate the transfer of technology between developed and developing countries as well as among developing countries.
- Norms promoting the management of intellectual property rights in a manner that reconciles the public interest in access to knowledge and health-related innovation, including the R&D needs of developing countries and that protects public health and promotes access to medicines.
- Relevant measures to improve the delivery of and access to health products and medical devices.
- Mechanisms to monitor and evaluate both the performance of global R&D efforts and the implementation of the treaty, including appropriate reporting systems.
- Measures to more effectively achieve compliance with appropriate ethical standards for medical research.
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