The Lancet 2006 -Historic opportunity for WHO to re-assert leadership

When countries gather for WHO's Executive Board meeting next month, to appoint a new Director-General, they must select a candidate with the courage and political leadership necessary to address the most critical challenges the UN agency is facing today.

The recent appearance of extensively drug-resistant tuberculosis illustrates the scale of the work ahead. The health threat posed by this microbe in settings with a high prevalence of HIV highlights the urgent need for action for WHO to set the agenda for the fast-tracked development of new drugs and better and easier-to-use tests to diagnose tuberculosis and detect drug resistance, to replace today's increasingly ineffective tools.

WHO will need to lead a process involving health ministries, regulatory agencies, drug companies, product-development partnerships, funding bodies, and non-governmental organisations, and it will need to deliver.

HIV/AIDS is another immediate issue. With the end of the 3 by 5 programme, WHO today lacks any strategic plan for the coming years, despite ambitiously calling for universal access to AIDS treatment. Now that newer compounds are increasingly needed to deal with resistance, the cost of treating AIDS is set to skyrocket. How does the agency plan to respond?

Research and development needs are also pressing in AIDS. These needs include the development of new fixed-dose combinations of second-line drugs and formulations for children, and simpler field-adapted diagnostics. Drugs in research must be specifically developed to answer the needs of resource-poor settings—and not only cater for populations of patients in rich countries.

On a programme level, WHO will need to address more forcefully the crying need for greater human resources in medicine, which has become a critical bottleneck preventing further scale-up. It will also need to think of the longer term and make sure that more patients are not only started on treatment but are also kept alive by making second-line drugs available. A sufficient quality of country programmes must also be assured.

Malaria is another priority. The painfully slow implementation at country level of artesunate combination therapies (ACTs) must receive urgent attention. Although many countries have changed their treatment protocols to ACTs, these newer life-saving drugs are still not reaching patients who need them. Drugs are becoming available from an increasing number of suppliers but production costs are decreasing slowly. Will WHO play its role in ensuring the sustainable funding of ACTs, and challenge governmental complacency on this issue?

Possibly the greatest challenge facing the UN health agency today is the need to reverse the erosion of WHO's mandate, adapt to new international environments, and re-assert its leadership on health issues. WHO must now deal with new stakeholders: large contributions to international health are made by the Bill & Melinda Gates Foundation and, not surprisingly, the influence of this single private philanthropic organisation on the international health agenda is unprecedented. How will WHO assert leadership in view of new independent actors that come with vast resources?

Recent years have seen life-saving products become indistinguishable from any other tradable commodity, and actual health concerns relegated to the point of being superfluous during trade negotiations. WHO has become a follower rather than a leader while other agencies have promoted their respective agendas. Not least of these agendas is the standardisation of patent regimens by the World Trade Organization and assaults on flexibilities in patent law by the World Intellectual Property Organization.

Ensuring access to medicines for those in need now depends more than ever on the use of flexibilities in the Trade and Intellectual Property Rights (TRIPS) scheme enshrined in the Doha Declaration.(8) But Novartis' legal challenge to section 3d of the Indian Patents Act is the most recent in a series of developments that goes against the spirit of the Declaration. This challenge has far-reaching consequences that extend across the globe, threatening access to essential generic medicines not only in India but also in developing countries that import Indian generic medicines. Will WHO take bold steps to defend health over competing interests, for example by promoting implementation of TRIPS flexibilities in developing countries, or will it again choose to stay silent? Worse, will it continue to stifle dissenting voices from its staff, as it has done in the past? 

In April, WHO's Commission on Intellectual Property, Innovation and Public Health outlined many of the key problems in research and development, intellectual property, and access to medicines, and made several recommendations. Mandated by the 2006 World Health Assembly to follow up these conclusions, will the agency and its new leader have the resolve necessary to seize this historic opportunity, and develop a global framework for research and development driven by health needs and not by commercial concerns?

Our questions can be rephrased more simply: will the WHO's Executive Board choose a leader who is courageous enough to set the right health policies, even if that requires standing up to vested interests, including those of other international agencies, certain member states, and powerful lobbies?

We declare that we have no conflict of interest.

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Affiliations

a. Médecins Sans Frontières, Geneva, Switzerland
b. MSF Campaign for Access to Essential Medicines, Geneva 1211, Switzerland
c. MSF Campaign for Access to Essential Medicines, Paris, France