News and Analysis • Volume 13 • Number 2 • June 2009

23 - WHO Tackles Intellectual Property, R&D Treaty

The World Health Assembly held in May engaged in lively discussions on intellectual property, innovation and public health. A proposal for a treaty on biomedical research and development emerged as a particularly controversial issue.

Discuss this articleShare your views with other visitors, and read what they have to say

After intense debate, member states of the World Health Organisation adopted a final Plan of Action on Public Health, Innovation and Intellectual Property that includes an agreed list of stakeholders who will be involved in the process of implementation, as well as a time frame and progress indicators by which to monitor progress. The plan was approved after three years of deliberations by the WHO Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The group had been asked to draw up a global strategy and plan of action on ways to bring new thinking on innovation and access to medicines, as well as to provide a framework for essential health research and development relevant to diseases which disproportionately affect developing countries.

But the final approval was not without contention. A number of developing countries expressed concern over the lack of inclusiveness in the process in which the negotiating text on stakeholder participation was developed and presented to the assembly. In a joint intervention, Barbados, Bangladesh, Bolivia, and Suriname noted that “only a limited number of countries were invited to negotiate on the remaining bracketed text of the WHO plan of action leaving the majority of states with no real recourse or fora to engage in meaningful negotiations prior to the convening of the 62nd Assembly.”

Mixed Reactions to Possible R&D Treaty
Discussions focused extensively on a possible international treaty on biomedical research and development (R&D). The concept has been driven by civil society groups and supported by developing countries such as Bangladesh, Barbados, Bolivia and Suriname. The WHO’s Global Strategy on Public Health and Intellectual Property calls for “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.”

A 2007 discussion draft offers the following description of the purpose of the agreement: “The state parties to this treaty seek to create a new global framework for supporting medical research and development that is based upon equitable sharing of the costs of research and development, incentives to invest in useful research and development in the areas of need and public interest, and which recognises human rights and the goal of all sharing in the benefits of scientific advancement.”

Although the sponsors believe that such a treaty would considerably “transform the landscape of biomedical innovation to incorporate needs-driven health research and development,” several developed country members, primarily the US and the EU, said that the WHO was not an appropriate forum for discussing the treaty.

After informal negotiations, the WHO’s status as a stakeholder in the process was dropped. This change triggered concerns among non-governmental organisations and developing country members. Barbados stated that leaving the WHO out of the negotiations could leave the proposal without a forum for discussion or advancement once the Expert Group on R&D Financing concludes its time-limited mandate. Bolivia added that “much time, effort and hope may be lost if the WHO, which is in a position to support the needs of developing countries, is not allowed to participate in bringing it to fruition.”

Advocacy groups, such as Essential Action, Health Action International, Knowledge Ecology International and Médecins sans Frontières, also expressed concern on the matter. In an open letter to member states, they argued the WHO was the UN agency that had a mandate for global health, and said it was “unacceptable that there would be any opposition the WHO having a role in taking forward discussions on what global norms should be contained in a proposal for a biomedical treaty.”

The WHO secretariat assured members that the institution could consider the proposal, even though it would not be a formal stakeholder in the process. The WHO’s legal counsel reaffirmed that position. The “[d]ecision undertaken on agenda item 12.8 shall not prejudice the future consideration of a biomedical R&D treaty by the WHO Executive Board and the World Health Assembly,” the counsel said.

Worries Expressed over Counterfeiting in the WHO Context
Although initially on the agenda for this year’s Health Assembly, the controversial question of the WHO’s role in fighting sub-standard or counterfeit medicines was subsequently dropped as the meeting was cut short due to the recent H1N1 influenza outbreak.

Nevertheless, the issue arose during discussions on the organisation’s Mid-term Strategy Plan 2008-2019. Many member states object to the use of the term ‘counterfeit’ in the WHO context because of its association with intellectual property rights infringements rather than product safety and efficacy. They worry that work on ‘counterfeit’ drugs could shift the focus from protecting public health toward protecting the trademarks of pharmaceutical companies (see related article on page 19).

The medium-term plan allows the WHO to assist countries in implementing the International Medical Products Anti-counterfeiting Taskforce (IMPACT) strategy. The composition of this taskforce was met with much apprehension during the January meeting of the WHO Executive Board, as many developing countries raised concerns over the legitimacy of the body, arguing that it was not representative of all relevant stakeholders and perspectives. In light of these concerns, WHO Director General Margaret Chan agreed to replace the term ‘counterfeit’ in favour of other terms such as ‘sub-standard’.