A letter to the WHO
In a letter to Dr Gro Harlem Brundtland, the Director-General of the World Health Organisation, US consumer activist, Ralph Nader, has criticized the organization for failing to exercise effective leadership on the critical issue of access to medicines and, more generally, on the expanded use of generic drugs. We reproduce below the full text of the letter dated 23 July 2001.
Dear Dr Brundtland:
It has been 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. Your efforts to throw a spotlight on the scourges of malaria and tuberculosis have been important steps to congeal a global mission - including, hopefully, appropriate resources - to eradicate these diseases. And the Tobacco-Free Initiative is aggressively taking on an industry devoted to spreading death and disease.
However, it has been disappointing to see that the WHO under your 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 World Health Organisation has permitted a handful of large pharmaceutical companies to exercise undue influence over its policies and programmes, 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.
Accelerating Access Initiative
In the area of AIDS, the WHO has been collaborating with big pharma companies on an ill-advised public relations effort called the ‘Accelerating Access Initiative’, which, in our opinion, 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
(c) 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 lack of sensitivity shown by the WHO has created problems, even when the putative intentions were good, such as your efforts to push down the prices of branded patented medicines. For example, on the eve of the April trial in South Africa over its medicines act, the WHO and the WTO held a highly publicised meeting 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 (International Federation of Pharmaceutical Manufacturers Associations) companies at a time when their opposition to the South Africa law was coming under increasing scrutiny.
In our view, at the Hosbjor meeting on drug pricing, 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 emphasised much more the role of efficient procurement and competition from generic suppliers.
Also troubling 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 meeting participants 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.
Implementation of the WHO Revised Drug Strategy (RDS) resolution
As you know, we have long been supportive of a larger mandate for the World Health Organisation to investigate the impact of trade policies on public health, and worked on this issue during the 1998/1999 debate over the WHO Revised Drug Strategy (RDS). However, we are dismayed by 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:
1. 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).
2. 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.
3. The costs of ‘ever-greening’ strategies for patents (cases where companies seek endless extensions of market exclusivity by filing new patents on old drugs).
4. 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 licences or authorise 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.
5. 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).
6. 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).
7. 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.
8. The need to develop simplified and easier-to-administer systems for compulsory licensing of patents (and the development of model legislation).
9. New models for treatment of health care in trade agreements that focus on funding R&D rather than on the protection of property rights.
Will the WHO be able to produce such documents? It is the concern of many public health groups 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 healthcare-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.
US Bayh-Dole rights in patents
For two years, the WHO has hesitated when asked to make an official request to the US government for the right to use US government interests in patents, which is permitted under the US Bayh-Dole Act. WHO officials were reluctant to make this request on the grounds that it would anger 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 licences for use in poor countries. Also, the WHO has no mechanism to use US government-funded research tools.
We raised the US Bayh-Dole rights issue as a priority for the new Bush Administration, as did the Trans-Atlantic Consumer Dialogue and many public health groups. On 6 July 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-subsidised patents. This rejection was likely due in part to the lack of interest shown by your own staff in acquiring such rights.
While we appreciate 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, it falls far short of what was expected when in 1998 you took over the WHO leadership and the World Health Assembly began its debate on these topics. Facilitating developing country access to medicines is part of the WHO’s proud tradition. We hope that as you continue to energise the agency, you will also renew the WHO’s commitment to give priority to public health in matters concerning trade and pharmaceuticals.