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WHO unduly influenced by large pharma companies, complains Nader

by Chakravarthi Raghavan

Geneva, 29 July 2001 - - The World Health Organisation has permitted a handful of large pharmaceutical companies to exercise undue influence over its polices and programs and intimidate and deter the WHO from exercising leadership on a wide range of trade-related health issues, particularly in the area of access to medicines and in promoting use of generic drugs, noted consumer advocate, Dr. Ralph Nader has complained in a letter to Dr. Gro Harlem Brundtland.

In a letter, a copy of which has been obtained by the SUNS, Nader says it is encouraging in recent years to see the WHO revive itself and begin to elevate its institutional profile and, more importantly, the international attention devoted to the horrific costs of worldwide under-investment in public health in the developing world. While commending the WHO role in congealing a ‘global mission’ to eradicate the scourges of malaria and tuberculosis and, under the Tobacco-Free Initiative, to aggressively take on an industry devoted to spreading death and disease, Nader says it has been disappointing to see that the WHO, under Mrs. Brundtland’s tenure, “has not matched the toughness and certainty of purpose it has displayed with respect to malaria, TB and tobacco in the area of access to medicines, and more generally, the expanded use of generic drugs. “

Many are concerned that the WHO has permitted a handful of large pharmaceutical companies to exercise undue influence over its polices and programs, and that in particular, the WHO has been intimidated and deterred from exercising leadership on a wide range of trade related issues, and has shrunk from its traditional role in promoting the use of generic drugs in poor countries.

In the area of AIDS, Nader complains, the WHO has been collaborating with big pharma companies on an ill-advised public relations effort, called the “Accelerating Access Initiative”, which is designed to: (a) undermine the legitimacy of national campaigns for compulsory licensing of patents on HIV drugs, (b) pressure poor countries to adopt overly restrictive intellectual property policies in return for extremely limited and unsustainable donation strategies, and ) undermine the success of Southern generics producers, who have been the most effective agents in bringing down the prices of HIV drugs.

In some cases, the WHO has shown a lack of sensitivity, creating problems, even when the putative intentions were good, such as Mrs. Brundtland’s efforts to push down the prices of branded patented medicines.

The Nader letter cites in this connection “highly publicized meeting”, on the eve of the April trial in South Africa over its medicines act, that the WHO and WTO held a in Hosbjor, Norway, where the central message of the WTO/WHO press communications was to endorse a model of restrictions on parallel imports on medicines and negotiated discounted prices by big pharma companies—the IFPMA alternative to the approach taken in the South Africa Medicines Act.

Whether intended or not, this meeting undermined the notion that broader use of parallel imports of medicines and compulsory licensing were sound policy goals.  This provided a public relations boost to the IFPMA companies at a time when their opposition to the South Africa law was coming under increasing scrutiny.

While WTO secretariat’s role in promoting pharmaceutical corporate views at Hosbjor and in WTO background documents for that meeting (and its website) have been known and the subject of critical comments from developing country trade negotiators, the Nader letter has thrown the spotlight on the WHO role too.

At the Hosbjor meeting, Nader complained, the WHO did not present an objective analysis of the factors that actually drove down the prices of HIV drugs in poor countries, and if it had, the WHO would have emphasized much more the role of efficient procurement and competition from generic suppliers. Also troubling (about the Hosbjor meeting) was the decision to feature as experts persons such as Professor Patricia Danzon and Richard Wilder, who posed as disinterested experts and failed to disclose to the participants in the meeting their professional ties to the big pharma companies, while presenting one-sided briefs for industry positions. Had these individuals been plainly identified as industry consultants, participants would have been better able to evaluate their views, Nader said.

On the implementation of the World Health Assembly Resolution on the WHO Revised Drug Strategy, Nader complains about the extremely limited response by the WHO secretariat to this resolution.

Since 1998, the WHO staff has been asked by public health groups to publish staff papers on such items as:

·        the public health issues relating to WHO trademark provisions (an issue of very large importance in generic drugs, regulation of tobacco products and the marketing of food products to children);

·        the costs of patent litigation and the capacity of poor countries to resolve patent disputes, and the implications for poor countries if they lack the practical ability to reject overly broad or non-novel patent claims;

·        the costs of “ever-greening” strategies for patents (cases where companies seek endless extensions of market exclusivity by filing new patents on old drugs);

·        the implications of WTO TRIPS restrictions on the export of medicines produced without permission of a patent owner. Specifically, while the WTO TRIPS gives countries fairly broad authority to issue compulsory licenses or authorize government use of patents, for most cases this is predominantly for domestic use, making it problematic for smaller market countries to benefit from such measures, when economies of scale would make it impractical to produce drugs locally. The WHO has been asked to spell out in practical terms how a rigid interpretation of restrictions on such exports would affect the health care of the poor in smaller market countries.

·        Pro-consumer strategies for implementation of TRIPS, Article 39.3 obligations for protecting pharmaceutical drug registration data (a technical issue of very large importance that will soon be subject to a WTO dispute panel);

·        The public health concerns with respect to TRIPS Article 27.1, which requires that patent rights not discriminate on the basis of the “field of technology,” and in particular, the concerns that a “one size fits all” patent system will hamper efforts to protect public health interests. Specifically, the WHO has been asked to make the case that this provision in the WTO TRIPS accord should not be interpreted to restrict countries from adopting patent laws that specially address public health concerns (a reasonable request, given the widespread advocacy by IFPMA of “patent extensions” for pharmaceuticals);

·        The extent to which patent exceptions for research serve the public interest, and the policy instruments needed to address problems of excessive intellectual property claims on research tools.

·        The need to develop simplified and easier to administer systems for compulsory licensing of patents (and the development of model legislation).

·        New models for treatment of health care in trade agreements that focus on funding R&D rather than on the protection of property rights.

Would the WHO be able to produce such documents, Nader asks and says, many public health groups are concerned that the engagement of the WHO in the implementation of the RDS has been minor, and that the WHO has failed to provide the types of policy papers that are most useful in influencing the future WTO panels and regional trade agreements that are rapidly making global policy on trade and health care related issues.

Moreover, within the public health community, there is concern that more productive work on these topics has been discouraged at the highest levels of WHO management, undermining efforts by lower tier management or regional workers who seek to explore these topics.

Referring to the US statutory provision (the Bayh-Dole Act) enabling the WHO to request and obtain authorization from the US government for drugs invented and patented under a government research grant, Nader notes, WHO officials are reluctant to make this request on the grounds that it would anger the big pharma companies. As a consequence, the WHO has no mechanism to obtain inexpensive versions of many drugs that were invented under a government grant, for which the US government could grant licenses for use in poor countries. Nor has the WHO any mechanism to use US government funded research tools.

The US Consumer Project on Technology, the Trans-Atlantic Consumer Dialogue and many public health groups. had raised the US Bayh-Dole rights issue as a priority for the new Bush Administration. On July 6, 2001 US Secretary of Health and Human Services Tommy Thompson wrote to reject our request that the WHO and other UN agencies have access to US rights in government subsidized patents.  This rejection was due in part to the lack of interest shown by the WHO staff in acquiring such rights.

While commending the “modest” effort of the WHO to support some national efforts to study the public health consequences of trade agreements, and to provide some limited technical assistance in these areas, Nader notes that these fell far short of what was expected when in 1998 Mrs. Brundtland took over the WHO leadership and the World Health Assembly began its debate on these topics.

Nader hopes that as she continues to energize the WHO, she will also renew WHO’s commitment to give priority to public health in matters concerning trade and pharmaceuticals. – SUNS4947

The above article first appeared in the South-North Development Monitor (SUNS) of which Chakravarthi Raghavan is the Chief Editor.

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