MSF letter to WHO Executive Board - MSF's concerns and suggestions related to the EB 2004 agenda; in particular, to HIV/AIDS and WHO's 3 by 5 initiative, the Commission on intellectual property rights, innovation and public health, and neglected diseases.
Dear WHO Executive Board Member,
Médecins Sans Frontières (MSF), an international medical humanitarian organization with field operations in nearly 80 countries, would like to take the opportunity of the WHO Executive Board meeting to share with you some concerns and suggestions related to the EB 2004 agenda; in particular, to HIV/AIDS and WHO's 3 by 5 initiative, the Commission on intellectual property rights, innovation and public health, and neglected diseases.
1. HIV/AIDS - the WHO 3 by 5 initiative
While long overdue, the WHO 3 by 5 project signals a positive change in WHO's policy on AIDS. It conveys a sense of urgency that was painfully lacking in earlier years.
MSF currently provides ARV treatment as part of a comprehensive continuum of care for approximately 10,000 people living with HIV/AIDS in 42 projects in 19 countries in Africa, Asia, Latin America, and Eastern Europe. We have learned important lessons about both the benefits and challenges of providing ARV treatment in resource-limited settings and are in the process of adapting our approach to AIDS treatment to better fit the real-life conditions faced in developing countries.
Based on our experiences, we believe the WHO will need to address the following issues in order to achieve its ambitious 3 by 5 goals:
Use of fixed dose combinations (three-in-one pills)
WHO should continue to support the use of fixed dose combinations of antiretroviral (ARV) therapy. Adhering to treatment must be made as easy as possible. Taking a smaller number of pills per day facilitates adherence, which encourages better clinical results and also lessens the risk of drug resistance, as it is impossible to take partial doses. The vast majority of HIV patients in MSF programs are on FDCs. The FDCs MSF uses have been pre-qualified by WHO and they are also the most affordable combinations available worldwide and have significant distribution advantages (procurement and stock management).
Decentralise and adapt
WHO should lead and support the development of adapted HIV/AIDS treatment models. In order for treatment to be expanded to larger number of people, treatment protocols must be designed in a way that facilitates access even for the poorest and most vulnerable people in remote settings where there are few hospitals, few doctors and even fewer laboratories. In Chiradzulu, Malawi, for example, MSF has set up mobile treatment clinics at each of the 10 local health centres, making treatment more accessible. Basic patient care and follow-up is delegated to nurses and health workers (for medical monitoring) and community counsellors (for education, adherence support and treatment literacy). MSF follows uniform guidelines for treatment minimizing use of laboratory tests; in many cases, treatment begins after a positive HIV test and clinical assessment by trained staff. More difficult cases are referred to the district hospital. This has allowed the number of patients under treatment in the district to rise quickly, to a rate of approximately 250 new patients each month.
Decrease the price of medicines and ensure availability even for the poorest
WHO should support countries' implementation of the WTO Doha Declaration on TRIPS and Public Health in a way that encourages efforts to make drugs affordable. WHO should also continue to make drug pricing information available. The lower the price of medicines, the more patients can be treated and the more sustainable treatment is in the long term. Globally, the prices of AIDS drugs have dropped by over 98% in less than three years. In MSF projects, the price of first-line treatment has ranged from $270 to $593 per person per year, and we now have access to WHO pre-qualified FDCs that cost less than $140 per person per year. The recommended first-line FDCs are available only from generic manufacturers because of patent barriers. In MSF's experience, crucial factors in bringing about lower prices for ARVs include government commitment to centralised procurement, overcoming patent barriers when necessary, and fostering generic competition. The cost of treatment for the patient should never be a barrier: this means treatment will have to be free for the majority of patients.
Involve the community
WHO should support the meaningful participation of people living with HIV/AIDS in treatment programmes. At its HIV clinics in Khayelitsha, South Africa, MSF and grassroots treatment advocates have fostered community-based education programs. Through carefully designed patient-centred adherence programs (not directly observed therapy), people on ARVs in MSF programs have the support of their peers and of trained counsellors. Community mobilization, in partnership with medical services, has had a powerful effect on the community, decreasing stigma and discrimination, and supporting prevention efforts. In Khayelitsha, there have been significant increases in the distribution and use of condoms, the number of sites providing voluntary counselling and testing, and the uptake rate of testing. According to a study conducted by the Centre for AIDS Development, Research and Evaluation (CADRE) and the South African Department of Health, the self-reported condom use at last sexual intercourse, willingness to use a female condom, and consent to an HIV test in the Khayelitsha community are the highest in South Africa.
Promote research and development of new tools
WHO should lead efforts to define a research agenda for new tools to tackle HIV/AIDS. There is also an urgent need for operational research, for example on management of HIV/TB co-infection, ideal second-line regimens, and structured treatment interruptions.
It will not be possible to solely base scaling-up efforts on existing tools. New tools will have to be developed to respond to specific needs in high-prevalence countries. For example, at present, ARVs are not well-suited for use by children, so fixed-dose liquid formulations for infants and low-dosage or breakable FDC tablets for children are needed. The pharmaceutical industry is not going to spontaneously fill existing and future gaps such as easy-to-use first-line treatments for children, simplified second-line treatments and simplified diagnostic tools (e.g. semi-quantitative tools to measure CD4 and viral load).
Support and expand the WHO project on pre-qualification of medicines.
MSF urges the WHO to reinforce the WHO pre-qualification of essential medicines project ensuring that it remains a fully-fledged permanent function of the WHO Essential Drugs and Medicines Policy Programme (EDM). Pre-qualification of ARVs, FDCs in particular, has been important in securing access to affordable medicines. However, the WHO pre-qualification process needs to be proactive and strengthened: additional technical, financial and human resources must be made available so that formulations that are recommended or desired (such as paediatric formulations) are developed and pre-qualified as soon as possible.
2. The WHO Commission on Intellectual property rights, innovation and public health
MSF believes that this Commission offers a unique opportunity to re-examine the way priorities in pharmaceutical R&D are set and how they are financed.
Society has failed to allocate sufficient resources to fight the diseases that cause high mortality and morbidity among people in developing countries. Research into neglected diseases, for example, human African trypanosomiasis, Chagas disease, leishmaniasis, TB and malaria does not translate into R&D for new and more effective therapies.
Health R&D is increasingly market driven, while needs-driven R&D activity is increasingly rare. There is a clear need for more public sector involvement in priority-setting and stimulating needs-oriented R&D, because the for-profit incentives provided by the patent system will not be sufficient to promote R&D into diseases in developing countries.
The WHO Commission should better examine the existing IPR-dominated R&D system and propose alternative and additional approaches. It should stimulate needs-driven R&D that responds to public health priorities. In our view, the Commission will have to explore the concept of drug and diagnostic tool innovation as a global public good for health both within and beyond the framework of the IPR regime.
3. Neglected diseases (Buruli ulcer, African trypanosomiasis, leishmaniasis etc)
Just as the WHO has finally become an active leader in tackling AIDS, TB and malaria, it needs to ensure that adequate attention is given to other diseases that the profit-based pharmaceutical industry and the public sector are ignoring, such as Buruli ulcer, African trypanosomiasis and leishmaniasis. It would be helpful if the discussions on some of the neglected diseases that are planned for this EB, such as Buruli ulcer and African trypanosomiasis, were linked to the agenda item on innovation and public health - in other words, focussing on what specific mechanisms can be put in place to stimulate R&D for these diseases.
Please do not hesitate to contact me or relevant MSF representatives in your country for further information.
Ellen 't Hoen
Campaign for Access to Essential Medicines
Médecins Sans Frontières
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