03/04/06

Patent study urges R&D boost for neglected diseases

Research is needed to develop drugs for 'neglected diseases' Copyright: NOAA

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A two-year inquiry into how patenting affects research on health products for developing countries concluded today (3 April). Its final report outlines steps needed to promote such research.

Former Swiss president Ruth Dreifuss, who chaired the commission, says the report is a ‘road map’ of how to ensure that poor people in the developing world "have sustainable access to the medicines, vaccines and diagnostics they need now and, critically, in the future".

The World Health Organization (WHO) set up the commission in 2004 to analyse how protecting intellectual property rights could affect efforts to tackle the ‘neglected diseases’ of developing nations (see WHO launches intellectual property commission).

The report urges developing countries to ensure that they fully explore their options under international patent agreements. One option is to secure access to essential drugs at affordable prices by using their right to compulsory drug licensing (see Are generic drugs the answer?).

It also urges the WHO to produce a global action plan that will "secure enhanced and sustainable funding" to develop products for neglected diseases, and to make these products affordable to those who need them.

The commission has, however, stopped short of recommending any significant changes to the overall international patent system, emphasising the need and potential for action at a country level instead.

In particular, it did not criticise TRIPS, the controversial agreement on trade-related aspects of intellectual property, adherence to which is one of the main requirements of World Trade Organization membership.

The report focuses on relatively modest reforms, such as restricting the patenting of core ‘upstream’ technologies that are used to develop other products.

It suggests that the WHO and the World Intellectual Property Organization should do more to promote such arrangements, "particularly to address diseases that disproportionately affect developing countries".

The commission’s conclusions, which will be submitted to the WHO’s executive board later this month, and to the World Health Assembly in May, reflect the diverse backgrounds of its ten members and their struggle to reach a consensus.

Its members ranged from those sharply critical of the international patent system and keen to see significant changes, to representatives of the pharmaceutical industry, who in general want the system be maintained in its current form.

In a dissenting comment published in an annex to the report, for example, two commission members — Carlos Correa from Argentina and Pakdee Pothisiri from Thailand — argue that patents are "irrelevant" to products needed to address neglected diseases, as they simultaneously increase prices and raise obstacles to innovation.

They also criticise the report’s emphasis on the need to evaluate the overall effectiveness of health delivery systems, arguing that this has led "to the consideration of issues that are not central to the commission’s mandate".

Meanwhile, Trevor Jones from the United Kingdom, a former director-general of the Association of the British Pharmaceutical Industry, argues that "patents are not the issue" behind the lack of adequate health care in many developing countries.

"There is a need to improve the competence of patent agencies and enforcement procedures in developing world countries, but the basis for granting a patent and the TRIPS agreement do not need reform," writes Jones in his note of dissent.

Link to full report (available in six languages)