Letter from WHO Director General Gro Harlem Brundtland to Ralph Nader

Mr. Ralph Nader
P.O. Box 19312
Washington, DC 20036

21 September, 2001

Dear Mr. Nader,

Thank you for your letter of 23 July, which I have read with care. Your positive remarks about WHO's work on TB, malaria and tobacco are much appreciated. I welcome your engagement on issues relating to equitable access to essential health care. These are of great concern to all our Member States. The WHO Secretariat gives highest priority to helping improve all people's access to the diagnostic, treatment and preventive requirements - including medicines - that are necessary for this essential health care.

We in the Secretariat recognize the size of the task which faces us in responding to the Resolutions on access to essential medicines adopted by the World Health Assembly and our Executive Board. We seek to do this in ways that reflect the mandate, technical capacity, and comparative strengths of the World Health Organization's country teams, regional offices and Geneva-based technical clusters. Most of the matters you raise are already being addressed.

As you know, the WHO Secretariat has systematic contact with public-interest and consumer organizations on issues that relate to essential health care, including medicines. The fourth of the round table meetings established in 1998 - in which I will participate - is due to take place in October 2001. Many of the points on which you comment in your letter are under discussion in that forum.

It seems that there are differences in our respective interpretations of the appropriateness and impact of WHO's work in this area. Let me touch briefly on the four areas you raise.

Access to medicines for HIV/AIDS WHO is scaling up its own efforts with a view to enabling millions more people to access effective care for HIV and related illnesses. We are:

The high price of HIV-related medicines has been a source of considerable concern to the WHO Secretariat and many WHO Member States. In 1999, the WHO Secretariat was requested by its Member States at the World Health Assembly to engage in dialogue with the private pharmaceutical industry on prices of medicines necessary to treat people with HIV infection and AIDS. To this end, WHO has collaborated with governments, non-governmental organizations (NGOs) and some companies on the Accelerating Access to HIV/AIDS-related Care Initiative (AAI). We judge that this Initiative has made a significant contribution to accelerating work on access to HIV/AIDS care and treatment, triggering substantial price reductions by several companies, and helping to put the financing of HIV/AIDS care into national and international health policy debates.

Since May 2000, nearly 60 countries have indicated to the UNAIDS secretariat and WHO an interest in accelerating access to HIV/AIDS care. At least 25 countries have revised their national plans for improving the care for people affected by HIV/AIDS. Thirteen have reached agreement with pharmaceutical companies on significantly reduced medicine prices (the companies involved are Boehringer-Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Hoffman La Roche and Merck). Both Pfizer and Abbott have already joined this endeavor.

The Executive Director of UNAIDS and I joined the UN Secretary-General in a meeting with pharmaceutical company CEOs in Amsterdam on 5 April this year. Companies agreed - in principle - to substantially lower prices for named anti-retroviral preparations within all the Least Developed Countries.

Further, in October 2000, UNAIDS, WHO, UNICEF,UNFPA and the World Bank initiated a process to engage a much wider range of manufacturers in discussions about HIV-related medicine and commodity supplies for developing countries. Expressions of interest have been received from over 30 manufacturers of generic and branded products, and producers of diagnostics and other HIV-related commodities. We have seen offers of low priced generic anti-retrovirals and combination therapies. WHO, with the other UN partners, expects to publish a list of qualified suppliers by the end of this year. Our effort to enable developing country producers to assess this process and to ensure product quality has meant developing country producers to assess this process and to ensure product quality has meant that the process has taken longer than we would have liked, but should contribute to a competitive market for HIV-related medicines and diagnostics.

The generics industry has been invited to at least one AAI Contact Group meeting and was represented at the most recent review of the AAI by WHO, UNAIDS and other UN Agencies.

As a result of the AAI, offers from generic manufacturers, and the efforts of public advocacy groups, prices for triple anti-retroviral therapy have fallen from thousands of dollars per treatment/year to a minimum of $500 per treatment/year. We hope that the drug cost will drop further as a result of competition, increased demand and grouped purchasing.

In response to requests from Member States, we are exploring options, for further action to ensure that those who receive care for their HIV infection and AIDS can access all the medicines and commodities they need. This means work to improve the operation and financing of health systems for communities affected by HIV/AIDS, with a view to ensuring equitable and sustained access to care. This work involves Ministries of Finance as well as those of Health and Development. At the same time we are investigating options at regional or sub-regional levels for the organization of negotiations on essential commodity prices, as well as for encouraging pooled and bulk procurement of HIV-related drugs, diagnostics and testing.

Finally, from the WHO's perspective, the participation of countries in the AAI should in no way stop countries from pursuing compulsory licensing, adopting national intellectual property rules, or, indeed, doing anything that is consistent with international agreements in this area.

Hosbjor Meeting

Your letter comments on the meeting held in Hosbjor, Norway in April 2001, which was explicitly designed to explore the extent to which the use of differential pricing can improve people's access to essential medicines. It is envisaged that through adapting medicine prices to purchasing power, households in low income countries are better enabled to obtain life-saving medicines. We wanted to explore the extent of support for a systematic approach to medicine pricing which favours poor countries. We see this as preferable to the use of occasional and/or intermittent discounts (or donations) by individual manufacturers.

The meeting included 84 participants who came from industry (both research-based and generics manufacturers, the latter from Africa, Asia and Latin America), governments (north and south), NGOs consumer groups and intergovernmental agencies (World Bank, European Union, UNFPA, UNICEF, in addition to WHO, UNAIDS and WTO). It was deliberately designed to include a mix of interests and to provide a forum for debate. The WHO Secretariat's contributions were designed to reflect the range of viewpoints and to encourage participation by the different groups - whatever their affliliation. The meeting was certainly not established as a decision-making forum.

The consensus of the meeting was that the more widespread use of different medicine pricing is - from an economic, legal, and clinical perspective - a feasible means to increase equity of access. Contrary to the understanding in your letter, the report of the meeting specifically includes compulsory licensing as an option for achieving differential pricing, along with the options of leaving it to the market, negotiation, bulk purchasing, and voluntary licensing. The report also makes specific mention of the role of generic competition. The task of the WHO Secretariat is now to define more precisely the options and mechanisms to ensure sustained and dependable implementation, clarifying the scope of differential pricing in terms of who participates and benefits, and pursuing mechanisms to achieve the most favourable prices for poorer people.

For differential pricing to work it is clear that consumers in high price markets have to accept that the same products are sold for much lower prices elsewhere. Measures are needed to prevent the diversion of low-priced products into high-income markets. It is also evident that countries benefiting from differential pricing should not be asked to forego any rights they have under international agreements. The WHO Secretariat is helping countries to handle these political and technical issues.

Implementation of Revised Drug Strategy

On behalf of consumer and other public health advocates, you comment on the work of the WHO Secretariat as a follow-up to the Revised Drug Strategy discussions in the World Health Assembly during 1998. During the last 18 months, substantial progress has been made on helping Member States with selection and pricing issues. A careful review of WHO treatment guidelines has been conducted and a process started to update procedures for the WHO Model List of Essential Drugs. Much emphasis has been placed on our normative, standard-setting and guidance functions. In conjunction with several interested parties, including both pharmaceutical companies and organizations like Medicines sans Frontieres, WHO price information services have expanded, differential prices have been achieved on some drugs for HIV/AIDS, malaria, tuberculosis and sleeping sickness, and plans for more widespread differential pricing are being developed.

Member States have mandated the Secretariat to monitor the public health impact of TRIPS in four areas (medicine price, timing of the introduction of generics, share of market taken by generics, and investment in research and development). We are undertaking this task with the assistance of WHO collaborating centers. Trade negotiations have led to the incorporation of flexibility within the TRIPS Agreement with a view to "safeguarding" public health. We see a need to examine further the extent to which this flexibility functions in the real world context.

WHO continues to support countries in formulating their own approaches to health and trade. In June 2000, Ministers of Health of the Southern African Developmental Community (SADC) were briefed on the implications for African countries of international trade agreements. WHO has helped to determine the impact of the Bangui Agreement (a TRIPS-plus Agreement) on access to essential drugs in francophone Africa (with United Nations and other partners). In May 2000, a joint ASEAN-WHO workshop took place in Jakarta on the TRIPS Agreement and its impact on pharmaceuticals. Concurrently, WHO has initiated monitoring and analysis of the impact of trade agreements on access to essential drugs in partnership with four WHO collaborating centres (in Brazil, Spain, Thailand and the United Kingdom of Great Britain and Northern Ireland), partly with the financial assistance of the Government of Norway.

WHO also provides technical expertise in drafting model legislation for incorporating the public health safeguards of the TRIPS Agreement into national legislation. In this context, WHO provided policy guidance on patent issues and revision of national pharmaceutical legislation in response to individual country requests (China, Costa Rica, Islamic Republic of Iran, and South Africa). WHO also conducted a "Workshop on TRIPS and the implementation of its safeguards in relation to pharmaceuticals in the WHO Africa Region" in Harare, Zimbabwe, 21-23 August 2001.

Additionally, WHO will continue to provide drug price information as a means to help make medicines more affordable and accessible. Currently WHO provides price information in collaboration with key partners on essential drugs, starting materials, and selected drugs and diagnostics for HIV/AIDS. WHO will also further strengthen the UN-wide project for pre-qualification of suppliers of essential drugs for priority communicable diseases such as tuberculosis and HIV/AIDS.

Despite these many efforts, we would agree that there is still much to be done to achieve full implementation of the new WHO Medicines Strategy, which incorporates all elements of the Revised Drug Strategy Resolution. Nonetheless, as indicated above, many of the specific issues raised in your letter have been actively addressed by the WHO Secretariat.

WHO role in managing patent rights

You suggest that WHO acquires patent rights from the US government under the US Bayh-Dole act. In the past, WHO has occasionally been involved in facilitating the transfer of patent rights (Intellectual Property Rights - IPR) between manufacturers and will continue to do so. The extent to which WHO adopts a more active role in managing IPR systematically (for example transferred from publicly funded research institutions) has been studied.

If IPR transfer agreements between WHO and the publicly funded research institutions existed, WHO would need either to conduct pharmaceutical research to develop the substances (which are generally in pre-clinical or early stage development) into final products, or sub-license the rights for development to another R&D-based pharmaceutical company. WHO's general role in drug R&D is to facilitate and coordinate research, but not to carry it out. In many cases, publicly funded research institutes have the necessary capacity (technology transfer departments) to out-license their patents to appropriate companies.

Your refer to a letter written on 6 July 2001 by US Secretary for Health and Human Services Tommy Thompson. The US government currently holds non-transferable rights to patents for products for which the IPR is already out-licensed to one or more pharmaceutical companies, as referred to in Secretary Thompson's letter. WHO therefore is exploring alternative strategies for handling intellectual property funded by public grants - strategies that are designed to encourage better access to the medicines needed for equitable health outcomes.

I appreciate the careful and clear way in which you have presented your thoughts to the WHO Secretariat and hope that this letter offers some clarification of the issues you raise. I sense that we differ in our assessment of the WHO Secretariat's performance in the essential medicines area. I would encourage you to maintain your advocacy for equitable and sustained access to essential medicines through dialogue with WHO Member States. We subscribe whole-heartedly to this goal, and anticipate continued dialogue on the options available to the international community in helping to ensure that the goal is fully achieved.

Yours sincerely,

Gro Harlem Brundtland, MD,MPH

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