WORLD HEALTH ORGANIZATION FIFTY-FOURTH WORLD HEALTH ASSEMBLY (Draft) A54/48 18 May 2001
Third report of Committee A (Draft)
Committee A held its fourth and fifth meetings on 17 May under the chairmanship of Professor S.K. Ongeri (Kenya). During the fifth meeting Dr Caleb Otto (Palau) later took the chair ad interim. The sixth and seventh meetings were held on 18 May under the chairmanship of Professor S.K. Ongeri (Kenya) and Dr M. Fikri (United Arab Emirates) as chair ad interim. It was decided to recommend to the Fifty-fourth World Health Assembly the adoption of the attached resolutions relating to the following agenda items: 13. Technical and health matters 13.6 HIV/AIDS One resolution entitled: – Scaling up the response to HIV/AIDS 13.8 Revised drug strategy One resolution entitled: – WHO medicines strategy
(Draft) A54/48
Agenda item 13.6
Scaling up the response to HIV/AIDS The Fifty-fourth World Health Assembly, Taking into consideration the report on HIV/AIDS; 1 Recognizing that AIDS is a crisis of unprecedented proportions that threatens development, social cohesion, political stability, life expectancy and places a devastating burden on many countries and regions; Recalling that the Constitution of the World Health Organization states that enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition, and considering that progressive realization of that right in the context of HIV/AIDS, should involve access, on a nondiscriminatory basis to health facilities, prevention, care, treatment and support; Considering that stigmatization, silence, discrimination and denial aggravate the impact of the pandemic; Acknowledging that all countries must continue to emphasize widespread and effective prevention, including education, nutrition, information and services, as well as access to, among other products, vaccines, condoms, microbiocides and drugs; Recognizing that prevention and care are inextricably linked, and that their effectiveness is increased when they are used together; Considering that HIV/AIDS affects women and children with special severity; Recognizing that inexpensive and effective drugs to prevent and treat opportunistic infections exist, are urgently needed, and can be made rapidly available; Acknowledging that the lack of affordable pharmaceuticals and of feasible supply structures and health systems continues to hinder an effective response to HIV/AIDS in many countries and especially for the poorest people; Recognizing that, where it has been available, antiretroviral therapy has reduced mortality and prolonged healthy lives, that recent reductions in prices create a new opportunity to extend this benefit to those that would otherwise not be able to afford them; Noting the critical role that health services and systems must play in delivering or scaling up delivery of these responses, and that the health systems in many developing countries are already overstretched by the existing burden of diseases and particularly by the added impact of HIV/AIDS; 1
Document A54/15.
2
(Draft) A54/48
Recognizing that in order to implement a comprehensive and multisectoral approach to combat HIV/AIDS, tuberculosis and other infectious diseases will require adequate human and financial resources at national and international levels; Taking into account the need to implement measures that incorporate HIV/AIDS prevention, care and awareness interventions in humanitarian assistance programmes to ensure that populations affected by conflict, and natural and human disasters – refugees, internally displaced persons and, in particular, women and children – are protected from and treated appropriately for HIV and related infections; Recalling efforts to make drugs available at lower prices for those in need; Welcoming the work in progress to develop a global AIDS and health fund; Bearing in mind various regional initiatives, including the Abuja Declaration on HIV/AIDS, Tuberculosis and Other Related Infectious Diseases of the African Heads of State and Government, which recognizes that those epidemics should be tackled as an integral part of the agenda for promoting poverty reduction and sustainable development and the Declaration of Quebec City of the Heads of State and Governments of the Americas, which emphasizes that good health and equal access to medical attention, health services and affordable medical drugs are vital for human development and for achievement of political, economic and social objectives; Noting resolutions 2001/33 and 2001/51 adopted by the Commission on Human Rights at its 57th session; Recognizing the role of UNAIDS in leading the global response to HIV/AIDS and its support to national AIDS programmes, the leadership of the United Nations Secretary-General, particularly in the context of the special session of the United Nations General Assembly on HIV/AIDS (June 2001); Recognizing also the key role that WHO plays in health promotion, prevention of disease, care and treatment, organization of services, dissemination of information to support the formulation of health policies, and the improvement of access to affordable drugs and commodities; 1. URGES Member States: (1) to ensure that HIV/AIDS is one of the highest priorities on the health and development agenda and to allocate sufficient resources for the response to HIV/AIDS; (2) to take effective measures, within a supportive environment, to ensure that people everywhere, particularly young people, know how to avoid infection, and to facilitate access to services and methods of prevention which should be the mainstay of programmes; (3) to scale up their responses to HIV/AIDS, with particular emphasis on building up partnerships across sectors, strengthening health care systems, nutritional programmes, education and information programmes and developing prevention, treatment and care interventions that involve people living with HIV/AIDS; (4) to recognize and act on the need for a society-wide response to reduce stigma and discrimination associated with HIV/AIDS;
3
(Draft) A54/48
(5) to make every effort to provide, progressively and in a sustainable manner, the highest standard of treatment for HIV/AIDS, including the prophylaxis and treatment of opportunistic infections, and effective use of quality-controlled antiretroviral therapy in a careful and monitored manner to improve adherence and effectiveness and reduce the risk of development of resistance; (6) to strive to include participation of people living with HIV/AIDS in the formulation of national policies on HIV/AIDS; (7) while taking into account differences of health care systems, to develop appropriate modalities of care such as outpatient services, home-based care, day care in the context of a true continuum of care, so as to ensure sustainable and high-quality diagnosis, counselling, testing, care, treatment and support; (8) to support, encourage and provide incentives for increased investment in research related to HIV/AIDS, including social and behavioural research, and in the development of new preventive and therapeutic approaches and technologies, including in particular HIV/AIDS vaccines and microbiocides; (9) to make every effort to provide financial support and technical cooperation to enable Member States to expand their response to the pandemic; (10) in order to increase access to medicines, to cooperate constructively in strengthening pharmaceutical policies and practices, including those applicable to generic drugs and intellectual property regimes, in order further to promote innovation and the development of domestic industries consistent with international law; (11) to support the establishment of a global AIDS and health fund; 2. URGES the Director-General: (1) to provide Member States and other health and development partners with high-quality, normative, health-related guidance and sustained and comprehensive technical support that will enable countries to intensify their national responses to HIV/AIDS in line with their particular circumstances and priorities; (2) to assist in the development and implementation of integrated and comprehensive prevention and care strategies; (3) to expand with urgency support for the development of necessary health system capacities and structures, and to provide normative guidance and technical cooperation in order to enhance prevention, clinical management, nursing care, counselling, and social and psychological support to people living with HIV; (4) to foster research, including ethical, controlled, clinical trials, on HIV vaccines, microbiocides, and new antiretroviral therapies, and on necessary commodities such as testing kits; (5) to give guidance and support the building of national capacity for surveillance of adverse drug reactions and emergence of resistance in connection with antiretroviral medicines;
4
(Draft) A54/48
(6) to maintain close collaboration with the international community and the private sector with the aim of improving the availability of medicines for HIV/AIDS, including antiretroviral therapy; (7) to take an active part, together with other international actors, in the development and establishment of a global HIV/AIDS and health fund, including promoting mechanisms for a transparent and participatory governance structure including representation of civil society.
5
(Draft) A54/48
Agenda item 13.8
WHO medicines strategy The Fifty-fourth World Health Assembly, Recalling resolutions, nominally WHA39.27, WHA41.16, WHA47.12, WHA47.16, WHA47.17, WHA49.14 and WHA52.19; WHA43.20, WHA45.27,
Having considered the report on the revised drug strategy,1 and bearing in mind the previous report on the subject,2 that highlight challenges related to international trade agreements, access to essential drugs, drug quality and rational use of medicines, together with the urgent need to improve access to drugs for treating priority health problems such as malaria, childhood illnesses, HIV/AIDS and tuberculosis, among others; Acknowledging the four main objectives of WHO’s medicines strategy, namely, to frame and implement policy; to ensure access; to ensure quality, safety and efficacy; and to promote rational use of medicines; Taking into account that the aforementioned health problems are particularly acute among poor and vulnerable populations, entrapping them in poverty, and substantially inhibiting the growth of national and international economies to the detriment of all humanity; Recalling that the Constitution of the World Health Organization provides that the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition, and considering that progressive realization of that right should involve access, on a non-discriminatory basis, to health facilities, prevention, care, treatment and support in the context of access to medicines; Bearing in mind the WHO global framework for expanding access to essential drugs, and its four components: the rational selection and use of medicines, reliable health and supply systems, sustainable financing, and affordable prices; Taking into account that access to medicines is particularly price sensitive, since most people in developing countries have to pay personally for health care, and that the commitment of governments, organizations of the United Nations system, the private sector, and the civil society is necessary in order to achieve universal access;3
1 2 3
Document A54/17. Document A53/10.
Globalization, TRIPS and access to pharmaceuticals. WHO Policy Perspectives on Medicines, No. 3, March, 2001. Geneva: WHO (document WHO/EDM/2001.2).
6
(Draft) A54/48
Taking into account the urgency of implementing the WHO medicines strategy in order fully to realize the enormous health benefits that essential drugs can offer to the one-third of the human population now lacking them; Taking into account the need to increase the current levels of international technical and economic assistance channeled to implementation of the WHO medicines strategy; Recognizing the importance of national drug policies established in accordance with WHO guidelines; Commending the strong leadership that WHO has shown in re-emphasizing the essential drugs concept, and the contribution of nongovernmental organizations working in public health to attaining such objectives as the framing of national drug policies and related aspects; Noting that the impact of international trade agreements on access to, or local manufacturing of, essential drugs and on the development of new drugs needs to be further evaluated; Recognizing that well-functioning and equitable health systems, including reliable supply systems, are key elements in any framework for expanding access to essential drugs; Noting resolution 2001/33 on access to medication in the context of pandemics such as HIV/AIDS adopted by the United Nations Commission on Human Rights at its 57th session; 1. URGES Member States: (1) to reaffirm their commitment to ensuring public health interests and to make every effort to promote equitable access to medicines, and to undertake the necessary action within their national health policies, including for priority diseases and pandemics, as an important element for progressively achieving the highest attainable standard of health; (2) to take effective measures in accordance with international law and international agreements acceded to in order to ensure improved access to medicines; (3) to cooperate with respect to resolution 2001/33 of the United Nations Commission on Human Rights; (4) to pursue measures directed to expanding access of their populations to essential drugs, including the implementation of resolution WHA52.19 taking into account the costeffectiveness of rational drug use as well as affordability; (5) in order to increase access to medicines, and in accordance with the health needs of people, especially those who can least afford the costs, and recognizing the efforts of Member States to expand access to drugs and promote domestic industry, cooperate constructively in strengthening pharmaceutical policies and practices, including those applicable to generic drugs, and intellectual property regimes in order further to promote innovation and the development of domestic industries, consistent with applicable international law; (6) to provide financial support and technical cooperation to enable Member States in need to expand access of their populations to essential drugs;
7
(Draft) A54/48
2.
REQUESTS the Director-General: (1) jointly with Member States, nongovernmental organizations and other partners involved in public health, to keep under review the effectiveness of the current strategy for essential drugs, and to stimulate the development of drugs for diseases whose burden lies predominantly in poor countries; (2) to explore the feasibility and effectiveness of implementing, in collaboration with nongovernmental organizations and other concerned partners, systems for voluntary monitoring drug prices and reporting global drug prices with a view to improving equity in access to essential drugs in health systems, and to provide support to Member States in that regard; (3) to provide support for implementation of drug monitoring systems in order better to identify development of resistance, adverse reactions and misuse of drugs within health systems, thus promoting rational use of drugs; (4) to continue and to enhance efforts to study and report on existing and future health implications of international trade agreements in close cooperation with relevant intergovernmental organizations; (5) to provide enhanced support to Member States that need and request support in achieving the priorities set out in the WHO medicines strategy; (6) to provide support to Member States to set up efficient national regulatory mechanisms for quality assurance that will help ensure compliance with good manufacturing practices, bioavailability and bioequivalence; (7) to continue WHO’s work in the field of traditional medicines;
(8) to report to the Fifty-fifth World Health Assembly on the progress of initiatives taken, globally or regionally, to expand access to essential drugs.
=
=
=
8