Tackling the Research Gap on Neglected Diseases

1 November 2007

Members of the World Health Organisation (WHO) have started negotiations for a global strategy to boost research on diseases that disproportionately affect developing countries.

At issue is how to respond to the international recognition of the need to improve research and development of new drugs to treat so-called ‘neglected’ tropical diseases that overwhelmingly, or exclusively, affect developing countries, i.e. malaria, dengue fever, leprosy, river blindness, Chagas disease, leishmaniasis, lymphatic filariasis (elephantiasis), schistosomiasis (bilharzia) and human African trypasomiasis. The negotiations also target access to, and improvement of, available treatments for diseases with a substantial proportion of sufferers in poor countries, such as HIV/AIDS and tuberculosis, as well as illnesses that are increasingly affecting developing country populations, including diabetes, cardiovascular diseases and cancer.

The WHO Intergovernmental Working Group (IGWG) on Public Health, Innovation and Intellectual Property, which held its second meeting in November, is charged with developing a global strategy and action plan to tackle these challenges.

Inching towards Consensus

While some were disappointed that a final draft document could not be agreed at the November meeting, most delegates seemed confident that one would be ready in time for adoption by the May 2008 World Health Assembly.

WHO members made some progress in further shaping the relatively vague draft they had discussed at the working group’s previous meeting (Bridges Year 11 No.5 page 11). Most notably, they incorporated to the text a paper produced by 14 Latin American countries at one of a series of regional conferences on the process worldwide. This so-called ‘Rio text’ was more emphatic than the Secretariat’s draft about the need to explore new ways of de-linking research and development costs from drug prices, as well as on the use of flexibilities in trade rules to promote public health.

Much of the discussion focused on a set of 11 principles outlined in the Rio text addressing issues such as the right to health, the relationship between intellectual property and access to medicines, and innovative capacity in developing countries. Members could not agree on two of the principles. One was whether to refer to international treaties in connection with the notion that the enjoyment of physical and mental health is a ‘fundamental human right’. The other concerned the relationship between trade and health. Two options remain bracketed in the draft document: the Rio text’s assertion that “the right to health takes precedence over commercial interests” and the phrase “the objectives of public health and the interests of trade should be appropriately balanced and co-ordinated,” reportedly proposed by the EU.

Another outstanding issue is whether the global strategy/action plan should focus on the 14 diseases outlined in the WHO Secretariat’s July draft (see para.1 above), or have a broader focus that would allow for adjustments to meet countries’ diverse health needs, as suggested by a number of governments – including those of Brazil and several African nations.

Intellectual Property Rights

The link between medical research and intellectual property rights (IPRs) also remains controversial. Agreed text under the heading Application and Management of Intellectual Property to Contribute to Innovation and Promote Public Health states that “there is a crucial need to strengthen innovative capacity as well as capacity to manage and apply intellectual property in developing countries including […] the use to the full of the provisions in the TRIPS Agreement.” In contrast, consensus is lacking on the actions to be taken under this heading, including the creation of “user-friendly global databases on the status of health-related patents.” Central to this discussion is how the WHO and World Intellectual Property Organisation (WIPO) should work together to manage such databases, and how the information they contain might be used.

Industry, Civil Society Reactions

Prior to the working group’s November meeting, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) slammed the draft text, arguing that it focused too much on intellectual property rights, which it considers to be the bailiwick of the WTO and WIPO.

IFPMA took issue with the text’s call for ensuring that bilateral trade agreements do not incorporate ‘TRIPS-plus’ protection that might reduce developing countries’ access to medicines, and to encourage trade agreements that recognise the flexibilities available to countries under the TRIPS Agreement. It was not within the WHO’s competence to advise governments on trade policy, the association argued.

Both negotiators and civil society observers highlighted delegations’ serious engagement in substantive discussions, as well as an underlying consensus that the challenges related to research on neglected diseases are real and change is necessary to tackle them effectively.

“We are getting a sense that countries are pushing the WHO to be more active in resolving the access to medicines crisis, and take a pro-health approach to intellectual property,” campaigner Michel Lotrowska of Médecins sans Frontières said. “And governments are taking steps to address the fundamental reasons why investment into innovation for diseases of the poor is lacking.”

Next Steps

The IGWG is set to pursue the drafting of the global strategy and action plan in January 2008, and will meet again from 28 April to 3 May. In preparation for the work, the WHO Secretariat is accepting comments from members on parts of the text that have not yet been discussed until 31 January.

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