Government officials and civil society representatives are meeting in Geneva this week to discuss ways to spark the development of affordable treatments for medical conditions that disproportionately affect people in poor countries.

The World Health Organization's Working Group on Public Health, Innovation and Intellectual Property (IGWG) is charged with developing a global strategy for the discovery, development, and delivery of medicines and other health products, as well as for encouraging pharmaceutical innovation in developing nations. In theory, this session of the committee, which runs through 10 November, is supposed to come up with an action plan to present to the WHO's 193 member states at the global health body's annual summit in May 2008.

Health campaigners see the deliberations as an opportunity to explore alternatives to the current intellectual property regime as a means of encouraging the development of new and affordable drugs. The patent-based model, they say, encourages high drug prices, since pharmaceutical companies have to use the time-limited sales monopoly to recoup all costs, from marketing expenditures to spending on unsuccessful inventions. Furthermore, the model does little to encourage innovation when the main market for a new medicine would be poor people who cannot afford to pay high prices.

One proposal under consideration at the WHO calls for a global medical research and development (R&D) treaty. Once conceivable way in which this might function would be to create biomedical R&D spending targets for governments, allowing drugs thus produced to be sold cheaply. Other proposed mechanisms include a 'prize fund' model, which would provide rewards for pharmaceutical innovation; 'advance market commitments', which guarantee future purchases of a health product to be developed at an agreed upon price; and, 'patent pools', which bundle together the technology in two or more patents so that they can be licensed out collectively to third parties.

However, intellectual property, particularly for medicines, is a controversial issue. Many industrialised countries and pharmaceutical companies are extremely reluctant to discuss changes to the status quo, suggesting it could threaten future innovation by making the rewards uncertain. The US, for instance, dissociated itself from a May agreement by member states that called on the WHO Secretariat to come up with proposals for addressing the links between R&D costs and the price of medicines and other healthcare products (World Health Assembly resolution 60.30; see BRIDGES Weekly, 23 May 2007).

WHO chief: innovation and affordability crucial

WHO Director-General Margaret Chan pointed to the imperative for both innovation and affordability while opening the gathering on 5 November. "Public health cannot move forward without innovation," she said. "Many diseases of the poor do not have good therapeutic drugs, or the prices are out of reach. Or diagnostic tools are outdated or too complicated for point-of-care use close to people's homes."

Chan chief drew particular attention to the "rise of chronic diseases," noting that they constitute the greatest burden for low- and middle-income countries. Such ailments, like heart disease, stroke, cancer, and diabetes, are responsible for 60 percent of deaths around the world, according to the WHO. Chan said that this, coupled with the long duration of treatment, made "the need for effective and affordable medicines all the more critical."

The WHO chief acknowledged some of the obstacles confronting attempts to promote both innovation and access. "The route to addressing these concerns passes through many other territories, including those where legal, economic, and trade issues have prominence. This is the reality," she said, alluding to critics' claims that attempts to address intellectual property treaded upon the terrain of the WTO and the World Intellectual Property Organization.

Ahmed Ogwell, the head of international relations at the Kenyan health ministry and a vice-chair of the IGWG, countered such claims head on at a press conference, reports Reuters. "If something is affecting public health, then the WHO is the proper place for it to be dealt with," he insisted.

US 'démarche' highlights differences

As the talks got underway, participants focused mainly on two documents: a draft strategy and action plan put together by the WHO Secretariat in July based on discussions at the previous IGWG session, and a paper produced by 14 Latin American countries at a September regional conference in Rio de Janeiro.

The Secretariat's draft global strategy and action plan contains a wide range of ideas for how to identify research needs, ramp up pharmaceutical development and innovative capacity, and improve access to medicines (see BRIDGES Weekly, 5 September 2007).

The so-called 'Rio text', though similar in format, is more emphatic about looking into new ways of de-linking R&D costs from drug prices, and underlines the need for sustainable funding for the implementation of an action plan on medical innovation. It sought to limit strict 'TRIPS-plus' intellectual property rules in bilateral and regional trade agreements, as well as to encourage the WHO to provide technical and policy support to countries seeking to take advantage of flexibilities in multilateral trade rules in order to promote public health. The Rio text set out several underlying 'principles' for a global strategy on health and innovation, among them the notions that the "right to health" trumps commercial interests, and that intellectual property rights should not become an obstacle to access to medicine.

Sources report that several public health groups that had criticised the WHO draft for being vague about funding and specific responsibilities were happier with the Rio text.

The US government, on the other hand, was not. In a paper reportedly sent to certain developing countries last week, Washington warned of a "push by Brazil or other like-minded countries to use the Latin American position paper as the basis of the negotiation." This so-called 'démarche' suggested that basing discussions on anything other than the WHO document would significantly delay progress.

The paper, a copy of which was seen by Bridges, warned that "there could be a push by some WHO member states during the second IGWG (November 2007) for a 'global framework' in the context of research and development relevant to diseases that particularly impact developing countries. This 'global framework' proposal has the potential to undermine existing research and development incentives and to harm the patent system and the incentives to innovation that it offers."

The US démarche also argued that the WHO should not take a more proactive role with regard to intellectual property for pharmaceutical products, warning of potentially negative trade implications. "The United States believes that the WHO Secretariat goes beyond its technical competence when it seeks to advise its member states on trade-related matters, including intellectual property," it said. "The WHO should not set parameters by which WTO member states can negotiate their trade agreements." The document urged governments to include trade, economic, and intellectual property officials in their IGWG delegations "in order to ensure trade issues are fully and appropriately considered."

The US state department and permanent mission in Geneva declined to confirm or deny the existence of the démarche.

Tensions within the IGWG

US opposition to the Rio text was plainly evident as the IGWG proceedings got underway, with delegates from the US and Brazil disagreeing on issues such as the importance of intellectual property protections to innovation, the WHO's role in facilitating the use of TRIPS flexibilities, and an R&D treaty.

Canada and Norway suggested that the Rio text's proposed principles for a global strategy may overstep the IGWG mandate. So did Mexico, even though it had signed on to the Rio text in September. Citing domestic decisions, Mexico explained that it could not accept the Rio text's statement that the right to health should always take precedence over commercial interests.

The US proposed three principles of its own for a global public health strategy, emphasising the importance of intellectual property rights to innovation.

While most sessions at the IGWG were open to both government officials and representatives from a range of industry groups and NGOs, the 'drafting committee' that is putting together a new text for the strategy and action plan is open only to governments and selected experts.

Countries spent a significant amount of time debating procedural issues. Questions arose over the difference between the open sessions and drafting sessions, as well as whether there should be concurrent drafting sessions. Several Latin American countries wanted a single drafting group, so as to give small delegations an equal voice. The African region argued that parallel drafting sessions working simultaneously on the strategy and the plan of action would be most effective. One official noted that while governments talk in Geneva, "children are dying."

Some developing country officials suggest that the week may not be enough time for governments to agree on a meaningful plan to address drug prices, intellectual property, and innovation. However, they say that WHO members might be able to use this session of the IGWG to set up some sort of process in which they will be able to continue to negotiate with each other on these issues.

Earlier this year, Bangladesh and Bolivia called for extending the IGWG's mandate by one year, particularly so that it could focus on a range of infectious or parasite diseases that heavily affect the poor (see BRIDGES Weekly, 7 March 2007).

Progress despite initial divisions

On 7 November, officials were in closed drafting groups attempting to come up with a new working draft for further negotiation. The chairs reported later in the day that the pace of progress was picking up, praising members for their "spirit of accommodation."

At time of writing, sources report that negotiators had accepted provisions in the text that would call on governments to "encourage further exploratory discussion on the utility of possible instruments or other mechanisms for essential health and biomedical R&D including, inter alia, an essential health and biomedical R&D treaty." This acceptance increases the likelihood that an eventual strategy and action plan would leave the door open to negotiations on such mechanisms. Countries including Brazil, China, Kenya, India, and even the US reportedly helped the EU and Switzerland overcome their initial opposition to the clause. Canada proposed the phrasing that ultimately became the compromise.

The conclusion of the WHO IGWG session will be covered in the next edition of BRIDGES Weekly.

ICTSD reporting; "WHO health chief urges fast action on cheap drugs," REUTERS, 5 November 2007.