This morning the 62nd session World Health Assembly agreed to a resolution on public health, innovation and intellectual property that, among other things, settled outstanding issues regarding the “stakeholders” for various parts of the Global Strategy and Plan of Action. (GS/PoA). With regard to the issue of a possible medical R&D treaty, the outcome of the negotiation was something of a split decision. On the one hand, the WHA agreed that the WHO would not be a stakeholder, in terms of the specific element of the WHO Global Strategy document. On the other hand, it was also agreed that the proposal for an R&D treaty would legitimately be considered by the WHO Expert Working Group on R&D Financing (EWG), that is reporting to the WHA in 2010, and that any country could present a proposal for discussions on an R&D treaty at any future meeting on the WHA or WHO Executive Board (EB). So the R&D Treaty is out, but it is in the EWG, and it might be back at the WHA next year.
The dispute involves the following language in the global strategy document that was been adopted in by the 2008 WHA:
Element 2. Promoting research and development
(2.3) improving cooperation, participation and coordination of health and biomedical research and development
(c) encourage further exploratory discussions on the utility of possible instruments or mechanisms for essential health and biomedical R&D, including inter alia, an essential health and biomedical R&D treaty
Today the WHA kept the biomedical R&D treaty in the elements of the global strategy, but said the WHO would not be a stakeholder in those discussions. In the views of many NGOs, government negotiators and WHO staff, this was an absurd result. If discussions on a medical R&D treaty are supposed to take place, why would the WHO be excluded from the discussions? What does this say about the WHO? What does it mean for the future of an R&D treaty?
The primary opposition to the medical R&D treaty is coming from the pharmaceutical industry, which does not like where the conversation is headed, with demands for more transparency, ethical norms for research, and attention to priority setting and accessibility of products. (See, for example, the proposals here) The pharmaceutical industry also sees a medical R&D treaty as something that competes for policy space and paradigm framing with treaties and agreements that focus on strong IPR.
There is also opposition from some high income countries that fear new obligations to pay for R&D for priority projects, such as for treatments for neglected diseases, new antibiotics, open databases or materials libraries for medical research, or other public health priorities and public goods.
The debate this week showed how willing the WHO Secretariat is, under Dr. Chan’s leadership, to bow to pressure from the pharmaceutical companies and the US and the European Union.
Whether or not this is a victory or a defeat for the treaty opponents remains to be seen. Clearly it is a setback to remove the WHO as a stakeholder. But now that the treaty has become “forbidden” fruit, more countries and NGOs are interested, and in some unexpected ways, the debate about an R&D treaty may have moved forward. For example, today some countries have already indicated an interest in revisiting the issue at the January 2010 WHO Executive Board (EB) meeting, or pushing for a treaty in the EWG, and there is likely to be a more detailed review of the policy inside the Obama Administration, which was surprised by the controversy.
Background
Since last fall, there has been a push by the United States, the European Union and Canada, with close cooperation of the WHO DG Dr. Margaret Chan and Dr. Elil Renganathan (WHO Secretariat on Public Health, Innovation & Intellectual Property) to eliminate the WHO as a stakeholder for discussions about a possible medical R&D treaty, and to protect industry interests in other areas of policy. According to accounts, Chan wanted the medical R&D Treaty killed at the WHA 2009 meeting.
In January 2009, a few days before the Obama inauguration, a secret meeting was held to discuss the stakeholder issue involving the United States, the European Union, Canada, Norway, Thailand, Brazil, Chile and India. In the January 2009 meeting, the developed countries said they would accept the WHO as a stakeholder for the parts of the global strategy involving the management of intellectual property rights, on the condition that the WHO was eliminated as a stakeholder for the medical R&D treaty. The pressure on developing countries was described as very intense. The deal struck between these countries was then the basis for the resolution that was presented this week at the WHA.
As details emerged later about the green room negotiations, public health groups and a number of other countries were highly critical of both the process and the substance of the agreement. However, with Thailand and Brazil having agreed, and considerable pressure from the WHO Secretariat and rich country donor agencies, it was a quite difficult negotiation.
Early WHO Framing of the work program for the Expert Working Group
In the same month of the secret green room meeting on the PS/PoA negotiation, Renganathan organized a meeting of the WHO Expert Working Group (EWG) on R&D Financing (January 12-14, 2009) that was also secret. The EWG is a forum for discussions about a possible R&D treaty, and the first meeting was quite important.
Among the groups invited to present at the EWG group meeting were: The IFPMA, the Bill and Melinda Gates Foundation, a Gates Foundation funded initiative at the George Institute for International Health, the Global Forum for Health Research, a group now chaired by Pfizer’s Jill Samuels, two PDPs (IAVI and Stop TB), and Essence, an initiative supported by the UK Department for International Development (DFID), Canada’s International Development Research Centre, the Ministry of Foreign Affairs of the Netherlands, the Norwegian Agency for Development Cooperation (NORAD), the Swedish International Development Cooperation Agency (Sida), the Bill and Melinda Gates Foundation, and the Wellcome Trust.
NGOs like MSF, Oxfam, Health Action International, KEI and others that supported the creation of the EWG or an R&D Treaty did not find out about the EWG meeting until after it was held.
Obama or Bush Administration Agenda?
Leading up to today’s decision, several efforts were made to change the US government position, which pre-dated Obama taking office. Unfortunately, during the WHA negotiations, it seemed as though the Obama Administration was even less flexible in substance than was the Bush administration a year ago, leading to jokes here about a “third term” for the Bush Administration on IP and health issues. The Obama Administration will have plenty of chances to distance itself from PhRMA on these issues in the next few months, and at the January 2010 WHO Executive Board meeting. Will the new Obama Administration continue to maintain the Bush Administration course, and coordinate their positions closely with PhRMA, or will we see some change in the direction of positions advocated by public health groups? No one really knows at this point.
Europe Represented by Private Sector
The U.S. has been criticized for the corrupting influence of the revolving door between the government and the private sector, but the European Union innovation on this front has taken things to a new level.
The European Union’s lead negotiator at the WHA this week Albert Tramposch, a citizen of the United States and Slovenia living in the United States. Tramposch is not a government official. Among other things, he is a principle of Romulus, a corporate “Global Issues Management Group.” See: http://www.gor omulus.com/profile/?sec=20&subsec=3&id=62. Romulus works on intellectual property issues for the National Foreign Trade Council. The NFTC board members are listed here: http://www.nftc.org/?id=232. Among NFTC members most active in the IP work are General Electric and Microsoft.
Gates Foundation views uncertain
The WHO gave both Microsoft and the Bill and Melinda Gates Foundation (BMGF) access to the drafting sessions during the IGWG negotiations. The BMGF played a very prominent role in the first meeting of the EWG, something that could certainly be justified in terms of its importance in funding global health projects. However, there is a tension, not often discussed, between the idea of a medical R&D treaty, and the role current filled by BMGF, in terms of setting global norms. There is an assumption by some that a treaty is currently opposed by Gates, but there is not much on the record one way or the other, and Gates advisors like Dick Wilder have not said much about it. In any event, it would have been useful if groups with other views, such as DNDi, MSF, HAI, TWN, IQSensato, KEI etc, would have also had an opportunity to address the EWG, or meet with the members of the EWG over the three day secret meeting.
Looking Ahead
Some NGOs and governments are optimistic about dealing with the medical R&D treaty at the WHO EWG, and there will certainly be an effort to do so, given the fact that there is already at least one proposal before the EWG (http://www.who.int/phi/Bangladesh_Barbados_Bolivia_Suriname_R_DTreaty.pdf) to discuss a treaty. Others are concerned about reports that the WHO has already lobbied the EWG and cautioned them against doing anything in this area. It it difficult to imagine the EWG doing something they think is entirely unwelcome by the WHO Secretariat, but it could happen, in theory. Perhaps more likely will be efforts to change the position of the Obama administration, or a new resolution at the 2010 EB or WHA, which is possible.
Clearly NGOs have to do a better job of influencing policy makers in Europe and the United States for things to have any real traction on the short run. In some ways, the current controversy has created an opening to have a conversation about this, as the current WHA resolution has created an absurd and embarrassing mandate to not discuss something that they agreed should be discussed, and is really needed to meet the objectives of the whole global strategy document.