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Second report of Committee B: (draft)

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SIXTIETH WORLD HEALTH ASSEMBLY

(Draft) A60/57 21 May 2007

Second report of Committee B (Draft)

Committee B held its fourth and fifth meetings on 18 May 2007 under the chairmanship of Mr Thomas Zeltner (Switzerland) and Dr Abdul Azeez Yoosuf (Maldives). It was decided to recommend to the Sixtieth World Health Assembly the adoption of the attached two resolutions relating to the following agenda items: 12. Technical and health matters 12.16 WHO’s role and responsibilities in health research One resolution, as amended 12.17 Progress in the rational use of medicines One resolution

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Agenda item 12.16

WHO’s role and responsibilities in health research The Sixtieth World Health Assembly, Recalling resolution WHA58.34 on the Ministerial Summit on Health Research; Having considered the report on WHO’s role and responsibilities in health research; Acknowledging the critical role of the entire spectrum of health and medical research in improving human health; Recognizing that research into poverty and inequity in health is limited, and that the ensuing evidence is important to guide policy in order to minimize gaps; Reaffirming that research to strengthen health systems is fundamental for achieving internationally agreed health-related development goals, including those contained in the United Nations Millennium Declaration; Recognizing that a wide gap exists between developed and developing countries in the capacity for health research, that it may hamper efforts to achieve better health results, and that it may contribute to worsening the brain drain; Noting in particular the work of IARC, the WHO Centre for Health Development, the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, and the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction; Convinced that research findings and data derived from effective health-information systems should be used to inform decisions about the delivery of interventions to those who need them most; Mindful that the Organization should lead by example in the use of research findings to inform decisions about health; Reaffirming the role of WHO’s cosponsored research programmes in support of neglected areas of research relevant to poor and disadvantaged populations, particularly poverty-related diseases, tuberculosis, malaria and AIDS, and recognizing the contributions of WHO to strengthening research capacity; Committed to ensuring ethical standards in the conduct of health research supported by the Organization; Recognizing the need to evaluate progress in health research since 2004 and to discuss the future needs of all Member States with regard to the promotion of evidence-based health research and policies,

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1.

URGES Member States: (1) to consider implementing the recommendation made by the Commission on Health Research for Development in 1990 that “developing countries should invest at least 2% of national health expenditures in research and research capacity strengthening, and at least 5% of project and programme aid for the health sector from development aid agencies should be earmarked for research and research capacity strengthening”;1 (2) to consider the development and strengthening of resource-tracking tools in order to monitor expenditure on health research from government and donor sources, and to disseminate relevant research findings to policy-makers, civil-society entities and the general public; (3) to integrate research in the mainstream of national programme activities and plans, and to promote wider access to research findings; (4) to strengthen the capacity of national and institutional ethics committees that review health-research proposals, as appropriate; (5) to draw up or strengthen health-research policies and health-research legislative documents, as appropriate; (6) to create a sustained training programme for research managers and to facilitate a cadre of trained professionals to manage health research, where necessary; (7) to improve the career management of researchers who do not necessarily come under the authority of the ministry responsible for research, as appropriate; (8) to consider strengthening national research capacities in the following complementary areas: generation of new knowledge, human and financial resources, research institutes and use of research findings in policy decisions, and to foster national and international networks for research collaboration; (9) to develop and strengthen a participatory mechanism, as appropriate, for all stakeholders in order to prioritize the health-research agenda on the basis of dynamic changes in health systems, disease burden, and emerging health-related issues.

2. CALLS UPON the health-research community, other international organizations, the private sector, civil society and other concerned stakeholders to provide strong, sustained support to research activities across the entire spectrum of health, medical and behavioural research, especially research into communicable diseases and poverty and inequity in health, with the participation of communities and in keeping with national priorities, and to maintain support of activities that promote the use of research findings to inform policy, practice and public opinion;

In Commission on Health Research for Development. Health research: essential link to equity in development. New York, Oxford University Press, 1990.

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3.

REQUESTS the Director-General: (1) to promote and advocate research in neglected areas of importance for better health, in particular on diseases that disproportionally affect developing countries and for poor and disadvantaged groups; (2) to strengthen the culture of research for evidence-based decision-making in the Organization and to ensure that research informs its technical activities; (3) to develop a reporting system on WHO’s activities in health research;

(4) to improve significantly coordination of relevant research activities, including integration of research into disease control and prevention, and designate one focal point within the Organization who has the overview of all WHO’s research activities; (5) to review the use of research evidence for major policy decisions and recommendations within WHO; (6) to establish transparent mechanisms for prioritization of research activities and projects within WHO, including independent peer-review mechanisms, and selection criteria such as relevance and scientific quality; (7) to establish standard procedures and mechanisms for the conduct of research and use of findings by the Organization, including registration of its research proposals in a publicly accessible database, peer review of proposals, and dissemination of findings; (8) to advise Member States, when requested, on ways to organize systems for research for better health; (9) to promote better access to relevant research findings, including by supporting the movement towards open access to scientific journals; (10) to provide support to Member States in order to develop capacities for health-systems and health-policy research, where necessary; (11) to provide technical support to Member States for strengthening the capacity of national and institutional health-research ethics committees, reviewing complex research protocols, and drafting national health policies and health-research legislative documents; (12) to identify and implement mechanisms to provide better support to countries and regions in recognizing and maximizing health research as a key factor in the development of health systems, in particular in developing countries; (13) to formulate simple priority-setting strategies for health research for use by national governments, where appropriate; (14) to institute appropriate systems and mechanisms for greater interaction and convergence among researchers and users of relevant research in order to improve use of research findings and to enhance framing of health policy;

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(15) to provide capacity-building opportunities in health economics, assessment of health technology, economic impact of disease, and costing of various interventions in order for a country to optimize its health-system delivery; (16) to build up capacity in order to monitor and report to Member States on total expenditure on health research by country and region, by public and donor sources, and by type of expenditure; (17) to submit to the Sixty-second World Health Assembly a strategy for the management and organization of research activities within WHO; (18) to convene a ministerial conference on health research, open to all Member States, in Bamako, November 2008.

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Agenda item 12.17

Progress in the rational use of medicines The Sixtieth World Health Assembly, Having considered the report on rational use of medicines: progress in implementing the WHO medicines strategy; Recalling the report on rational use of medicines by prescribers and patients, discussed at the Fifty-eighth World Health Assembly, and followed by adoption of resolution WHA58.27 on antimicrobial resistance; Recalling resolutions WHA39.27, WHA41.16 and WHA47.13 on the rational use of drugs, WHA41.17, WHA45.30 and WHA47.16 on ethical criteria for medicinal drug promotion, WHA43.20 and WHA45.27 on the WHO Action Programme on Essential Drugs, WHA47.12 on the role of the pharmacist, WHA49.14 and WHA52.19 on the revised drug strategy, WHA51.9 on cross-border advertising, promotion and sale of medical products using the Internet, and WHA54.11 on the WHO medicines strategy; Recognizing the efforts of WHO in collaboration with governments, universities, the private sector, and nongovernmental organizations, in areas related to health-care delivery systems and healthinsurance programmes in order to improve the use of medicines by prescribers, dispensers and patients; Aware of the core components of WHO’s strategy for promoting the rational use of medicines;1 Wishing to promote evidence-based rational use of medicines by providers and consumers and better access to essential medicines; Aware that irrational use of medicines continues to be an urgent and widespread problem in the public and private health sector in developed and developing countries with serious consequences in terms of poor patient outcome, adverse drug reactions, increasing antimicrobial resistance and wasted resources; Acknowledging that successful implementation of previous resolutions on antimicrobial resistance cannot be achieved without addressing the global problem of irrational use of medicines; Recognizing that many countries do not have a stringent drug-regulatory authority nor a full national programme or body to promote rational use of medicines; Emphasizing that global initiatives to increase access to essential medicines should adhere to the principle of rational use of medicines, and include adherence by patients;

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Document WHO/EDM/2004.5.

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Concerned that insufficient attention and resources are being directed towards tackling the problem of irrational use of medicines by prescribers, dispensers and consumers; Emphasizing the need for a comprehensive, sustainable, national and sector-wide approach to promote the rational use of medicines; Recognizing that financing of medicines and methods of arrangements for provider payments can have a major impact on rational use, and that appropriate policies on financing health care are required; Recognizing that there may be incentives for the irrational use of medicines throughout the health system, for example in some circumstances which give rise to conflict of interest; Concerned that direct-to-consumer or Internet sales may give rise to irrational use of medicines; Convinced that it is time for governments, the health professions, civil society, the private sector and the international community to pledge their commitment, including adequate resources, to promoting the rational use of medicines, 1. URGES Member States:1 (1) to invest sufficiently in human resources and provide adequate financing in order to strengthen institutional capacity in order to ensure more appropriate use of medicines in both the public and private sectors; (2) to consider establishing and/or strengthening, as appropriate, a national drug regulatory authority and a full national programme and/or multidisciplinary body, involving civil society and professional bodies, to monitor and promote the rational use of medicine; (3) to consider developing, strengthening and implementing, where appropriate, the application of an essential medicines list into the benefit package of the existing or new insurance funds; (4) to develop and strengthen existing training programmes on rational use of medicines and ensure that they are taken into account in the curricula for all health professionals and medical students, including their continuing education, where appropriate, and to promote programmes of public education in rational use of medicines; (5) to enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines, to monitor promotion of medicines, and to develop and implement programmes that will provide independent, nonpromotional information about medicines; (6) to develop and implement national policies and programmes for improving medicine use, including clinical guidelines and essential medicines lists, as appropriate, with an emphasis on multifaceted interventions targeting both the public and private health sectors, and involving providers and consumers;

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And regional economic integration organizations, where appropriate.

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(7) to consider developing, and strengthening where appropriate, the capacity of hospital drug and therapeutic committees to promote the rational use of medicines; (8) to expand to national level sustainable interventions successfully implemented at local level; 2. REQUESTS the Director-General: (1) to strengthen the leadership and evidence-based advocacy role of WHO in promoting rational use of medicines; (2) in collaboration with governments and civil society, to strengthen WHO’s technical support to Member States in their efforts to establish or strengthen, where appropriate, multidisciplinary national bodies for monitoring medicine use, and implementing national programmes for the rational use of medicines; (3) to strengthen the coordination of international financial and technical support for rational use of medicines; (4) to promote research, particularly on development of sustainable interventions for rational medicine use at all levels of the health sector, both public and private; (5) to promote discussion among health authorities, professionals and patients on the rational use of medicines; (6) to report to the Sixty-second World Health Assembly, and subsequently biennially, on progress achieved, problems encountered and further actions proposed in the implementation of WHO’s programmes to promote rational use of medicines.

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