WORLD HEALTH ORGANIZATION Reg io n a l O ffice for E uro pe Co pe n h a g en REGIONAL COMMITTEE FOR EUROPE Forty-eighth session, Copenhagen, 1 4 - 1 8 September 1998 Provisional agenda item 3(a) EUR/RC48/5 26 June 1998 04588 ORIGINAL: ENGLISH M a t t e r s A r i s i n g o u t o f D e c i s i o n s a n d R e s o l u t i o n s o f t h e W o r l d H e a l t h A s s e m b l y a n d t h e E x e c u t i v e B o a r d Part I o f this document provides an overview o f the discussions held and actions taken by the Executive Board and the World Health Assembly, during their January and May 1998 sessions, on matters of particular interest to Member States in the European Region. It should be noted that comments are requested from the Regional Committee on the issue of a revised drug strategy, and on a revised text for Article 2 o f the Constitution on the functions of WHO. It would be appreciated if comments on the revised text o f Article 2 of the WHO Constitution could be provided to the Secretariat no later than Friday 4 September 1998, so that they can be discussed by the SCRC at its meeting on 12 September 1998. The SCRC’s views on the matter will then be presented to the Regional Committee in document EUR/RC48/3 Add.l, which will be available at the start o f the session. In Part II o f this document, the Regional Director comments on those resolutions o f the Fifty-first World Health Assembly that are relevant to the regional programme. CONTENTS Page 101 st session of the Executive Board......................................................................................................................1 Fifty-first World Health Assembly.......................................................................................................................... 2 102nd session of the Executive Board.................................................................................................................... 4 PART I I ...................................................................................................................................................................... 6 WHA51.7 Health-for-all policy for the twenty-first century........................................................................ 6 WHA51.8 Concerted public health action on anti-personnel mines............................................................ 6 WHA51.9 Cross-border advertising, promotion and sale of medical products using the Internet.........6 WHA51.10 Ethical, scientific and social implications o f cloning in human health....................................6 WHA51.12 Health promotion...............................................................................................................................6 WHA51.13 Tuberculosis...................................................................................................................................... 6 WHA51.16 Promotion of horizontal technical cooperation in health sector reform in developing countries.......................................................................................................................7 WHA51.17 Emerging and other communicable diseases: antimicrobial resistance....................................7 WHA51.18 Noncommunicable disease prevention and control..................................................................... 7 WHA51.22 Collaboration within the United Nations system and with other intergovernmental organizations: health o f children and adolescents..................................................................... 8 WHA51.24 International Decade o f the World’s Indigenous People............................................................ 8 WHA51.28 Environmental matters: strategy on sanitation for high-risk communities.............................. 8 WHA51.29 The protection of human health from threats related to climate change and stratospheric ozone depletion....................................................................................................... 8 WHA51.30 Method of work o f the Health Assembly......................................................................................8 WHA51.31 Review o f the Constitution and regional arrangements of the World Health Organization: regular budget allocations to regions........................................9 Annex 1 ..................................................................................................................................................................... 10 Annex 2 ..................................................................................................................................................................... 14 PART 1.........................................................................................................................................................................1 EUR/RC48/5 page 1 P a r t I 101 ST SESSION OF THE EXECUTIVE BOARD 1. Two key issues dominated the Executive Board’s agenda at its session in January 1998, namely the nomination o f a new Director-General and WHO reform, particularly matters linked to the report o f the Executive Board special group dealing with regular budget allocations to regions. 2. Following her nomination as Director-General, Dr Gro Harlem Brundtland gave a presentation to the Board, in which she stated that one o f her priorities would be to raise the status of health on the international political agenda and to re-establish WHO as a respected lead agency in health. She also highlighted the need to strengthen WHO’s capacity to provide policy advice on health sector development, and called for a renewed effort to strengthen malaria control and the fight against tobacco. 3. The Board examined the nine issues contained in the report o f the Executive Board special group on the review o f the Constitution and regional arrangements, and most of the discussion under this item focused on the issue o f regular budget allocations to regions. In adopting resolution EB101 .RIO, the Board decided that future programme budgets should be guided by a model that drew upon UNDP’s Human Development Index, incorporated population statistics o f countries according to commonly accepted methods such as “logarithmic smoothing”, and could be implemented over three biennia starting from 2000-2001. 4. On the issue o f WHO’s country presence, the Board’s discussion coincided with the publication of the “Oslo Group Study”, which had been conducted by a group o f donor counties with WHO’s cooperation in 12 selected countries in 4 regions. Both this study and the report o f the Director-General focused on the need to provide better support to countries in greatest need, while at the same time adjusting WHO’s presence to the level o f health and socioeconomic development in the countries concerned. The concept o f “essential presence” was put forward, through which several types o f country representative might be foreseen. For countries in greatest need, a fully-fledged WHO Representative’s Office may be required; for countries with a higher “development index”, liaison offices would be preferable; and for developed countries the interface with WHO could be through national institutions or specially designated collaborating centres. (The Regional Office has suggested that, for groups of countries with similar development status and comparable cultural and linguistic conditions, an option could be to set up a central WHO Representative’s Office). The Board decided by decision EB101(6) to ask the Director-General to report to its 103rd session in January 1999 on the outcome of the pilot phase o f the United Nations Development Assistance Framework being conducted in 19 countries. 5. On the subject o f programme budget evaluation the Board adopted resolution EB101 .R1, which calls for the Director-General to present an interim report to the Board in January 1999, comparing expenditures and trends with budgetary allocations as a means o f complementing the Board’s discussion of the proposed programme budget for 2000-2001. The Committee will recall that a document comparing actual expenditures with budgetary provisions for the 1994-1995 biennium was presented to the forty- sixth session o f the Regional Committee in September 1996. A similar document for the 1996-1997 biennium will be presented to the Regional Committee this year. 6. In adopting resolution EB101 .R22, the Board recommended to the Health Assembly the adoption of a World Health Declaration on the promotion of health through relevant regional and national policies and strategies based on the health-for-all policy for the twenty-first century. 7. With a view to accelerating the procedure for the entry into force of amendments to the WHO Constitution (Article 73 of the Constitution) adopted by the Health Assembly, the Board, through EUR/RC48/5 page 2 decision EB101(2), asked the Director-General to present to the Board in May 1998 a study o f the situation in other international organizations and a proposal for accelerating the process. 8. By decision EB101(3), the Board asked the Director-General to ensure that the revised text of Article 2 o f the WHO Constitution be reviewed at all levels o f the Organization during the course o f 1998, so that a final draft could be submitted to the Board in January 1999. An extract from document EB101/7 is attached as Annex 1 and the Regional Committee is invited to comment on the revised text o f Article 2 (for ease o f reference the current text o f Article 2 is appended to the Annex). It would be appreciated if comments could be provided to the Secretariat in writing no later than Friday 4 September 1998, so that they can be discussed by the SCRC at its meeting on 12 September 1998. The SCRC’s view on this matter will then be presented to the Regional Committee in document EUR/RC48/3 Add.l, which will be available at the start o f the session. F if t y - f ir s t W o r l d H e a l t h A s s e m b l y 9. On its first day, the Assembly was called on to discuss a proposal from the Administration, Budget and Finance Committee of the Executive Board to restore, on a temporary basis, voting privileges to all Members whose voting privileges were currently suspended. The Health Assembly considered that it would be an appropriate gesture, on the occasion of the fiftieth anniversary o f the Organization, to restore voting privileges for the election of the new Director-General, and it accordingly adopted resolution WHA51.3 to that effect. 10. On 13 May, in private session, the Health Assembly adopted resolution WHA 51.4 appointing Dr Gro Harlem Brundtland as Director-General for a period o f five years starting on 21 July 1998. Following her appointment, Dr Brundtland delivered a stirring and memorable speech to the Health Assembly. In paying tribute to Dr Hiroshi Nakajima, the Health Assembly declared him Director-General Emeritus. 11. On the morning o f 14 May, the Health Assembly observed the fiftieth anniversary o f WHO, with a forum of heads of state on the theme “Health for all in the twenty-first century”. Those who participated were Ruth Dreifuss, Vice-President o f Switzerland; Fidel Castro, President o f Cuba; Henri Konan Bedie, President of Cote d’Ivoire; and Tofilau Eti Alesana, Prime Minister o f Samoa. The Director-General presented Health for All medals to the heads of state. 12. The United Arab Emirates Health Foundation Prize was awarded to Mrs Hillary Rodham Clinton, and on the afternoon of 14 May 1998 she delivered a skilful and wide-ranging acceptance speech to the Health Assembly. 13. The release of World Health Report 1998 received wide coverage in the media and served to unite delegates’ statements in the general debate around the theme “Life in the 21st century: a vision for all”. While a trend towards a healthier, longer life is emerging, poverty remains the main item on the health agenda. 14. A major concern throughout the Health Assembly was to find an acceptable solution to the Executive Board’s proposal concerning the reallocation o f resources to the different regions, especially as alternative proposals were made by Japan and the SEARO Member States. The European Member States met twice, and the SCRC four times, to discuss the issue. Long hours o f informal consultations were held between representatives o f all the regions (the European Region was represented by Professor V. Grabauskas (SCRC Chair), Mr C. Ortendahl (Sweden) and Professor J. Leowski (Poland)), and everyone made considerable efforts to reach an agreement. Finally, resolution WHA51.31 was adopted by consensus during the last session of Committee B, and the very last plenary session. The outcome fo r the European Region will be around US $16 million, in increments o f some US $3 million per biennium for the next five biennia. Document EUR/RC48/9 Add.l makes proposals on how this will be used for the countries in greatest need in the Region. This issue, which has caused considerable concern and given rise to repeated resolutions in the Regional Committee, has now been finally resolved. EUR/RC48/5 page 3 15. The debate on health for all in the twenty-first century, was particularly lively and constructive. Delegations expressed appreciation of the policy document, its ethical principles, its clear and reasonable targets and its vision for the future. Resolution WHA51.7 adopting a World Health Declaration was approved by consensus. 16. The Health Assembly considered 11 progress reports on the implementation o f resolutions and decisions on technical matters, and 8 resolutions recommended by the Executive Board. Although the debates were often constrained by time, the Health Assembly managed to reach consensus. Resolutions were adopted on concerted public health action on anti-personnel mines, on cross-border advertising, on the promotion and sale o f medical products through the Internet, on the ethical, scientific and social implications o f cloning in human health, on health promotion, on tuberculosis and on the global elimination of blinding trachoma. The Health Assembly also considered and adopted a new resolution on the promotion of horizontal technical cooperation in health sector reform in developing countries. 17. Another very difficult and divisive resolution was EB101 .R24 on the revised drug strategy, which was considered after many hours o f work by a drafting group chaired by Professor Jean-Franfois Girard (France). In view o f the many complex issues addressed in this resolution - and its vital importance to almost every country - full agreement was not reached on all points. It was therefore decided, on the basis of a vote, to ask the Executive Board to consider this complex issue at its 103rd session in January 1999, and to prepare a draft resolution for adoption by the Fifty-second World Health Assembly in May 1999. It was decided to establish an ad hoc working group to meet during the 102nd session of the Board, in May 1998, to come up with an innovative mechanism to deal with the matter. (Please see below for the outcome o f the Board’s discussion.) 18. Under the item concerned with disease prevention and control, the Health Assembly discussed progress in the important revision o f the International Health Regulations (IHR), noting that the draft text o f the revised IHR had been sent to all Member States in February 1998 and that evaluation would take place in a pilot study in a limited number of countries in each WHO region. However, reactions to the draft text are still awaited from many Member States. Consensus was reached on resolutions on the control o f tropical diseases, on antimicrobial resistance and on noncommunicable diseases, and other resolutions were adopted on eliminating the transmission of Chagas disease and the elimination of leprosy as a public health problem. 19. The Health Assembly considered financial matters, including the financial report, the report o f the External Auditor and, for the first time, a report by the Internal Auditor. Other routine financial matters discussed were the status of collection o f assessed contributions, the use of casual income, and the Real Estate Fund. A resolution recommended by the Executive Board amending the Financial Regulations was adopted. A new scale of assessments was considered and adopted. Matters related to the programme budget were discussed, such as the efficiency plan for the financial period 1998-1999 and programme budget evaluation. 20. On the status o f collection o f assessed contributions, outstanding contributions for 1997 totalled US $91.1 million, with a group of countries previously forming part o f the former Soviet Union owing just over US $27 million. 21. The issue of WHO reform continued to appear on the Health Assembly’s agenda, and this year attention was devoted to the review of the Constitution, a process that has been going on since 1995. A recommendation of the Executive Board concerning the amendment o f Articles 24 and 25 of the Constitution was considered and resolution WHA51.23, increasing the total number o f seats on the Board to 34, was adopted. This allows for an additional seat each fo r the European and Western Pacific regions. Resolution WHA51.26, clarifying the interpretation o f Article 24 o f the Constitution concerning the status o f members of the Board, was adopted. It was decided that Member States entitled to designate a representative on the Executive Board should designate them as government representatives technically qualified in the field o f health. EUR/RC48/5 page 4 22. Collaboration within the United Nations system and with other intergovernmental organizations covered a range of issues of global concern. There was considerable support for resolution WHA51.22 on the health o f children and adolescents, which urges the Director-General to give high priority to this issue, and to contribute to the collective efforts of the international community to promote the effective implementation o f the Convention on the Rights o f the Child. The International Decade o f the World’s Indigenous People (resolution WHA51.24) continues to receive special attention in WHO, as it does in all specialized agencies of the United Nations system and other international agencies. 23. Two environmental matters were debated: the strategy on sanitation for high-risk communities and the protection of human health from threats related to climate change and stratospheric ozone depletion; a resolution was adopted on each. 24. The method of work o f the Health Assembly was discussed, and more particularly the availability o f governing body documents on the Internet. A resolution was adopted requesting the Director-General to ensure that documents are despatched and made available on the Internet not less than 30 days before the date fixed for the opening of the session. The Regional Office has this year, fo r the first time, placed Regional Committee documents on the Internet as they became available in the four working languages (English, French, German and Russian). 102n d SESSION OF THE EXECUTIVE BOARD 25. Dr Brundtland addressed the Board and told the members that it constituted a unique resource, bringing together experience from all comers o f the world. She would take full advantage o f the Board’s knowledge, which she would draw on for the entire Organization. She informed the Board on the four main areas o f focus in WHO’s future work: • to help monitor, roll back and where possible eradicate communicable diseases; • to help fight and reduce the burden of noncommunicable diseases; • to help countries build sustainable health systems; and • to speak out for health and back WHO’s case with solid evidence. 26. Dr Brundtland said she would need to make some changes in the current budget and to elaborate further on these new directions in the 2000-2001 budget. She believed that the way the budget was presented would need to be changed so that it was more clear and transparent to the outside world, was easy to grasp and would motivate all who served WHO. She spoke o f her dilemma in assuming office mid-way through a biennium, when the budget for the following biennium was already being prepared, and said that she would be speaking to the Regional Committees on how priority issues could best be reflected in the regional contributions to the consolidated global budget. The addendum (document EUR/RC48/8 Add.1) to the draft Programme Budget document fo r 2000-2001 (document EUR/RC48/8) will include both proposals fo r using the additional regular budget allocation to the Region and the suggested regional response to the new policy direction. 27. She invited the members of the Board to join her for an informal two-day retreat in October to focus on the main directions to be pursued. In closing, she said that the Executive Board was one o f WHO’s prime resources for reaching out, collecting experiences and translating them into new and enriched policies for world health. After her address she met the Board in private session. 28. The Board adopted resolution EB102.R1 deciding that Regional Directors shall be appointed for five years and be eligible for reappointment once only (i.e. a total of ten years). This brings the rules regarding the appointment o f Regional Directors into line with the resolution adopted by the Health Assembly last year on the appointment o f the Director-General. Document EUR/RC48/Conf.Doc./4 proposes such a change to the Rules of Procedure for the Regional Committee fo r Europe. EUR/RC48/5 page 5 29. The working group on the revised drug strategy decided to appoint a task force comprising two members from each region (one o f whom would be a member of the Board), and to make available to regional committees for comment a concise and comprehensive document on the revised drug strategy (see Annex 2, document EB/RDS/RC/1), so that eventually the task force would be able to come up with a draft resolution that would be transparent and responsive to the views and wishes o f all Member States. This document is being prepared by WHO headquarters, and will hopefully be despatched to Member States together with all Regional Committee documents at the end of July; if it is not received by then it will be sent to Member States separately during August. The SCRC’s views on this matter will be presented to the Regional Committee in document EUR/RC48/3 Add.l, which will be available at the start o f the session. 30. The Board reviewed proposals to accelerate the procedure for the entry into force o f amendments to the WHO Constitution (Article 73 o f the Constitution), and asked the Director-General to convene a working group to develop a text around the three options proposed - either one o f which might be put into effect depending on the nature of the amendment - for submission to the Board in January 1999. EUR/RC48/5 page 6 P a r t II WHA51.7 Health-for-all policy for the twenty-first century 31. It is encouraging that the Health Assembly, through this resolution, fully adopted the World Health Declaration. Article II o f the Declaration acknowledges the need for regional and national policies and strategies to give effect to the new global health for all policy (EUR/RC48/10). In the European Region this will be effected by the Regional Committee in September 1998 through the new European health for all policy, which will also refer to the Declaration. WHA51.8 Concerted public health action on anti-personnel mines 32. This resolution will be brought to the attention of WHO staff in Bosnia and Herzegovina. WHA51.9 Cross-border advertising, promotion and sale of medical products using the Internet 33. This resolution is very important. Regulatory authorities in Member States are urged to review their legislation to ensure adequate legislative means for regulation, surveillance and enforcement. The issue is also being taken up at European Union (EU) level through its regulatory framework, and it has been brought to the attention o f the European Parliament. Internet sales o f medical products have already been established in several European countries. 34. Unregulated sale o f medical products through the Internet raises safety concerns, since people would be able to obtain, without prescription, products that require, under national law, medical prescription, information and supervision. Provision of information on medical products through the Internet should be in line with national and regional (EU) legislation on advertising; legislation needs to be adapted so that it will cover Internet communication. 35. Most importantly, Member States are asked to use the Internet to their advantage and to provide - through the appropriate national structures and institutions - objective, updated and unbiased information on medical products that encourages their appropriate use. Several countries have already developed initiatives in this area. In that respect, discussions have also begun on a European Medicines Information Network. WHA51.10 Ethical, scientific and social implications o f cloning in human health 36. This resolution will be used as a reference document for relevant meetings and forums on human rights, ethics, etc. It is very important for Member States, especially regarding research and capacity- building in medical legislation and bioethics. WHA51.12 Health promotion 37. The work of the Regional Office is already in line with this resolution. For example, the Office has a structured network o f Health Promoting Schools, and has been able to link health promotion issues to social and economic development in Member States. 38. While the efforts o f ten countries to promote the establishment of a network for health promotion among the most populous countries are noted with satisfaction, WHO could also provide specific services to assist all Member States in policy-making in this crucial area. WHA51.13 Tuberculosis 39. This resolution fully reflects the situation and needs in those Member States of the European Region where tuberculosis is a priority disease, particularly in eastern Europe. In close cooperation with Member States, international partners and WHO headquarters, the Office is currently developing and implementing plans for accelerated tuberculosis control in these countries. EUR/RC48/5 page 7 WHA51.16 Promotion of horizontal technical cooperation in health sector reform in developing countries 40. This resolution is important as it widens the scope o f technical cooperation beyond the previous concept of TCDC (technical cooperation among developing countries). It provides a role for all Member States. 41. The resolution emphasizes the use of the capacity and resources in countries when health care systems are being improved or reformed. The Office’s health care reform networks (MIDNET, EASTNET and CARNET) operate precisely on this principle. The networks are functioning well in the current biennium and will continue operating into the next biennium. The networks facilitate cooperation and the sharing of experience among network members. One of the future aims is to strengthen the management of change by expanding in-depth work in individual countries and strengthening network activities. 42. Country programmes, such as the MANAS programme in Kyrgyzstan and the LUKMAN programme in Turkmenistan, are also examples o f intensified support to countries in their efforts towards the achievement o f equitable, affordable, accessible and sustainable health care systems. Such programmes assist countries to develop their national health care policies in line with health for all principles. The experience and capacity gained in such programmes will be used in similar projects in other countries. WHA51.17 Emerging and other communicable diseases: antimicrobial resistance 43. The emergence o f antimicrobial resistance (AMR) is a global problem and can only be addressed effectively in Europe through European-wide coordination and cooperation. A first step was taken in December 1997 when a workshop was organized with the aim o f gaining an overview of AMR surveillance in Europe, the conclusions o f which were to strengthen the existing networks and to harmonize quality assurance standards. This concerted effort would be used to actively reverse the development of resistance through more appropriate use o f antibiotics, such as by introducing the DOTS strategy for tuberculosis. WHA51.18 Noncommunicable disease prevention and control 44. This resolution has been very positively received by health professionals in this field. 45. The recommendations of the resolution will be implemented in the following areas. • The CINDI programme will be further developed, with emphasis on expanding the programme to more countries in the Region, strengthening collaboration with primary health care, providing a stronger position for health promotion and disease prevention in health care reform, and developing and implementing national/regional noncommunicable disease prevention and control policies. Special attention will be paid to the CCEE and NIS, but the problem affects all Member States. • The Regional Office will participate actively in developing a global strategy for noncommunicable disease prevention and control (through collaboration with other regional networks such as CARMEN in the American Region, participation in the INTERHEALTH programme and continuous coordination with WHO headquarters). • Standards will be developed to ensure appropriate case detection and management (e.g. the implementation of the Helsingborg Declaration on stroke management, multidisciplinary prevention and control o f hypertension, and therapeutic education of patients with cardiovascular disease). • The Office is particularly active in tobacco control policy through the third Action Plan for a Tobacco-free Europe. The resolution endorses and strengthens the implementation of the Action Plan, which includes measures to protect young people. The resolution does not imply any change in strategic direction or programme implementation. It is noted that the resolution urges Member States to exert a concerted effort against the use o f tobacco as part o f noncommunicable disease prevention and control. EUR/RC48/5 page 8 WHA51.22 Collaboration within the United Nations system and with other intergovernmental organizations: health of children and adolescents 46. This resolution is very relevant to the Office’s child health development programme, which addresses the child’s rights by identifying and promoting preventive and curative interventions in harmful situations for infants, children and adolescents, and by strengthening and upgrading health and social services to improve their condition and wellbeing. 47. Through its integrated management o f childhood illness (IMCI) and perinatal care activities, the Office aims to ensure the highest standards o f care. Interventions on the social determinants o f child and adolescent health are addressed in programmes to combat child abuse and neglect, and accidents and injuries involving children. The approach is holistic, covering not only the physical and biological needs of children and adolescents but also their emotional and psychological needs. WHA51.24 International Decade of the World’s Indigenous People 48. Issues related to the access of indigenous people to health care are dealt with in the same way as those related to other minority groups. WHA51.28 Environmental matters: strategy on sanitation for high-risk communities 49. This resolution is very supportive to the Regional Office’s water and sanitation programme in general and, in particular, to the protocol on “Prevention, control and reduction o f water-related diseases” being drafted for adoption at the third Ministerial Conference on Environment and Health in London in 1999. The protocol covers inter alia the areas mentioned in the resolution and requests Member States to establish targets for the performance o f water supply and sanitation services. 50. However, neither our work in general nor the draft text o f the protocol focuses on “high-risk communities”. This terminology relates primarily to conditions in developing countries, but it could also be used in some of the Member States o f this Region. There will always be communities in all countries that are “high-risk” compared to other communities, and it would be simple to amend the protocol to take this into account. WHA51.29 The protection of human health from threats related to climate change and stratospheric ozone depletion 51. Human health effects due to climate change have so far not been a programme activity o f the Office, although some aspects have been covered under the air pollution programme. 52. However, as a result o f growing concern, and as a consequence o f the Kyoto Conference last year, it was decided that “health effects o f climate change” could be one o f the new challenges for the Office in the twenty-first century and should therefore be discussed at the London Conference in 1999. A document is being prepared for discussion at the Conference. 53. It is intended to use the London Conference document as a starting point for developing a programme on human health related to climate change. In this light, the resolution is warmly welcomed as giving strong support to our work and strategy. WHA51.30 Method of work of the Health Assembly 54. Documents for the forty-eighth session of the Regional Committee will be placed on the Internet (http://who.dk) in the four working languages (English, French, German and Russian) after despatch to all Member States, i.e. by the end of July 1998. EUR/RC48/5 page 9 WHA51.31 Review of the Constitution and regional arrangements of the World Health Organization: regular budget allocations to regions 55. An addendum to the draft Programme Budget for 2000-2001 - which will set out some options for the use o f the additional regular budget allocation - will be presented to the Regional Committee together with the comments o f the SCRC, which will review the addendum at its meeting on 12 September 1998. Annex 1 EUR/RC48/5 page 10 EB101/7 Article 2: Functions of WHO 5. In its report to the Executive Board at its ninety-ninth session (January 1997),‘ the special group noted that if it is determined that the functions defined in Article 2 of the Constitution need to be revised, revision should take account of the following points, in conformity with the future mission: • wide range of functions to ensure flexibility and effective implementation • generic grouping of functions • organization of functions by priority • functions that reflect the evolution in health policy since 1948 and the prospect of health for all in the twenty-first century • functions defined in terms of general principles rather than specific activities. 6. The group expressed strong support for the framework of the following revised text of Article 2. It felt that the revised text should be proposed to the governing bodies of WHO and that the details should be reviewed at all levels of the Organization during the course of 1998. A final text, reflecting this broad consultative process, should then be submitted to the Executive Board at its 103rd session in January 1999. Article 2 In order to achieve its objectives the functions of the Organization shall be: 1. TO ACT AS THE DIRECTING AND COORDINATING AUTHORITY ON INTERNATIONAL HEALTH AND, IN SO DOING, (a) to provide leadership in health; (b) to develop an effective partnership with Member States in pursuit of global health; (c) to support Member States in formulating, implementing and evaluating their health policies; 1 D o c u m e n t E B 9 9 /1 4 . EUR/RC48/5 page 11 EB101/7 (d) to establish and maintain effective collaboration with the United Nations, the specialized agencies, and other intergovernmental bodies; (e) to work with, and promote cooperation between, professional groups and nongovernmental organizations active in the field of health, and where necessary to mobilize them for international health action. 2. TO LEAD INTERNATIONAL HEALTH POLICY DEVELOPMENT BY (a) providing global surveillance and early warning systems for transnational threats to health; (b) collating and disseminating data and assessments of disease treatments; (c) identifying and testing strategies to eradicate or control communicable diseases; (d) identifying determinants of health status as a basis for health programmes and resource allocations; (e) designing preventive programmes to combat other threats to health, including lifestyle diseases, mental illness and substance abuse; (f) designing programmes for the prevention and management, including rehabilitative aspects, of noncommunicable diseases; (g) advancing health research through stimulation and, where necessary, coordination of research activities; (h) collating and disseminating data on desirable and appropriate methods of teaching and training in the health professions. 3. TO SERVE AS THE INTERNATIONAL AGENCY FOR SETTING AND MONITORING NORMS AND STANDARDS IN HEALTH BY (a) proposing conventions, agreements and regulations, and making recommendations with respect to international health matters, and to perform such duties as may be assigned thereby to the Organization and are consistent with its objectives; (b) establishing and revising as necessary international nomenclatures for diseases, of causes of death, and of public health practices; (c) developing, establishing and promoting international standards with respect to food, biological, pharmaceutical and similar products and for health devices and health technologies; (d) developing, establishing and promoting international ethical standards in all aspects of health practice and research. 4. TO COOPERATE WITH MEMBER STATES, PRIMARILY THROUGH NATIONAL HEALTH ADMINISTRATIONS, AND UPON REQUEST, BY PROVIDING ADVICE AND TECHNICAL COOPERATION (a) on ways to strengthen and improve sustainable health systems and resources; EB101/7________ _________________________________________________________________________ __ (b) on enhancing policy-making, management capability and accountability within their health systems; (c) on disease eradication and prevention strategies; (d) in explicit health emergencies, on a short-term basis; (e) on other areas of the Organization’s functions. 5. TO ACT AS THE INTERNATIONAL ADVOCATE FOR HEALTH FOR ALL BY PROMOTING PARTICULARLY (a) the pursuit of equity in health outcomes, and the equitable international mobilization and management of health resources; (b) the centrality of primary health care within health systems; (c) intersectoral responses to health challenges; (d) health promotion and prevention, with particular reference to environmental, occupational and nutritional health, and combating of violence and substance abuse; (e) attention to the most vulnerable health stages of the life cycle (childhood; maternity, old age); (/) development of an informed public opinion on health among all peoples; (g) resource mobilization for health. EUR/RC48/5 page 12 2 BASIC DOCUMENTS establish the World Health Organization as a specialized agency within the terms of Article 57 of the Charter of the United Nations. C h a pt e r I - O b je c t iv e Article 1 The objective of the World Health Organization (hereinafter called the Organization) shall be the attainment by all peoples of the highest possible level of health. C h a pt e r II - F u n c t io n s Article 2 In order to achieve its objective, the functions of the Organization shall be: (a) to act as the directing and co-ordinating authority on international health work; (b) to establish and maintain effective collaboration with the United Nations, specialized agencies, governmental health administrations, professional groups and such other organizations as may be deemed appropriate; (c) to assist Governments, upon request, in strengthening health services; (d) to fumish appropriate technical assistance and, in emergencies, neces sary aid upon the request or acceptance of Governments; (e) to provide or assist in providing, upon the request of the United Nations, health services and facilities to special groups, such as the peoples of trust territories; <J) to establish and maintain such administrative and technical services as may be required, including epidemiological and statistical services; (g) to stimulate and advance work to eradicate epidemic, endemic and other diseases; (/i) to promote, in co-operation with other specialized agencies where necessary, the prevention of accidental injuries; (/) to promote, in co-operation with other specialized agencies where necessary, the improvement of nutrition, housing, sanitation, recreation, economic or working conditions and other aspects of environmental hygiene; {j) to promote co-operation among scientific and professional groups which contribute to the advancement of health; (k) to propose conventions, agreements and regulations, and make recom mendations with respect to international health matters and to perform CONSTITUTION OF WHO 3 such duties as may be assigned thereby to the Organization and are consistent with its objective; (/) to promote maternal and child health and welfare and to foster the ability to live harmoniously in a changing total environment; (m) to foster activities in the field of mental health, especially those affec ting the harmony of human relations; (/i) to promote and conduct research in the field of health; (o) to promote improved standards of teaching and training in the health, medical and related professions; (p) to study and report on, in co-operation with other specialized agencies where necessary, administrative and social techniques affecting public health and medical care from preventive and curative points of view, including hospital services and social security; (<7) to provide information, counsel and assistance in the field of health; (r) to assist in developing an informed public opinion among all peoples on matters of health; (s) to establish and revise as necessary international nomenclatures of diseases, of causes of death and of public health practices; (/) to standardize diagnostic procedures as necessary; («) to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products; (v) generally to take all necessary action to attain the objective of the Organization. C h a p t e r III - M e m b e r s h i p a n d A s s o c i a t e M e m b e r s h i p Article 3 Membership in the Organization shall be open to all Slates. Article 4 Members of the United Nations may become Members of the Organization by signing or otherwise accepting this Constitution in accor dance with the provisions of Chapter XIX and in accordance with their constitutional processes. Article 5 The States whose Governments have been invited to send observers to the International Health Conference held in New York, 1946, may become EUR/RC48/5 page 14 EB/RDS/RC/1 10 July 1998 Annex 2 Revised drug strategy WHO’s work in pharmaceuticals and essential drugs The Fifty-first World Health Assembly decided to refer resolution EB101.R24 on the revised drug strategy back to the Executive Board for further consideration at its 103rd session, taking into account discussions on the matter in Committee A and in a drafting group of the Assembly. At its 102nd session, the Executive Board decided by decision EB102(14) to establish a two-tier method of working to explore the complex issues raised, in order to draft a resolution f consideration at its 103rd session in January 1999. An ad hoc working group would be opL.. to all Member States wishing to participate and a subgroup would assist W H O in its contacts with relevant interested partners. It also decided that the subgroup would comprise the chairman of the drafting group established during the Fifty-first World Health Assembly, and two Member States from each region, of which at least one would be currently entitled to designate a person to serve on the Executive Board. The regional committees are invited to nominate their representatives to the subgroup. INTRODUCTION 1. Since its inception in 1948, WHO has been involved in worldwide public health efforts to improve quality assurance, safety, and efficacy o f medicinal products. Examples o f these activities include The International Pharmacopoeia for quality assurance (resolution WHA1.27, 1948), specifications for safety and efficacy ol vaccines and other biologicals (resolution W H A 1.26,1948), designation o f International Nonproprietary Na (INN) (resolution W H A3.11, 1950), and drug evaluation and monitoring (resolution W HA15.41, 1962). 2. In i 975, the Health Assembly responded to serious problems o f availability, cost, and use o f drugs facing developing countries, by adopting resolution WHA28.66. This resolution requested the Director-General tc provide greater direct assistance to Member States in the “formulation o f national drug policies” and in “advising on the selection and procurement, at reasonable cost, o f essential drugs o f established quality corresponding tc their national health needs.” This resolution built on the early, practical experiences o f countries such a: Norway, Peru, and Sri Lanka. 3. During the following 10 years, WHO prepared the first WHO Model List o f Essential Drugs (1977) undertook a rapid series o f 25 country assessments (from 1976 to 1978), formed an Executive Board Ad Hoi Committee on Drug Policies (1978), established the Action Programme on Essential Drugs (1981), and begai to provide direct operational support to countries (1983). 4. In light o f this work, WHO convened a major conference o f experts on the rational use o f drugs (Nairobi 1985). The Nairobi conference resulted in the formulation o f WHO’s revised drug strategy, which was adoptei by the Health Assembly in 1986 (resolution WHA39.27). The strategy called for WHO to support government in formulating and implementing national drug policies and action programmes on essential drugs; to cxpan< normative functions and support for drug regulation and quality assurance; and to intensify dissemination o drug information, improve training o f health personnel, and promote collaborative research. 10/07 ’ 98 MON 1 4 :3 5 FAX +4122 791 41 67 BBmDS/RC/1 WHO DAP GENEVA 5. Since 1986, WHO has carried forward and expanded implementation of the revised drug strategy, with frequent Health Assembly resolutions commenting on progress and constraints in implementation. TWENTY YEARS OF ESSENTIAL DRUGS 6. Essential drugs are those that satisfy the health care needs o f the majority o f the population; they should therefore be available at all tim es in adequate amounts and in the appropriate dosage form s.1 The essential drugs concept does not exclude all other drugs, but should focus therapeutic decisions, professional training, public information, and financial resources on those drugs which have the greatest public health impact. 7. Essential drugs have a substantial health impact: they save lives and improve health by combating a wide range o f com m unicable and noncommunicable diseases. Within health systems, pharmaceuticals also have a major econom ic impact: in m any developing countries spending on m edicines accounts for the ;est share o f household health spending and is the largest public expenditure for health after salaries. - ..armaceuticals spending as a share o f total health spending is greatest in developing countries, accounting for 25% to 66% o f total public and private health expenditures (Figure 1). FIGURE 1. PHARMACEUTICAL SPENDING, AS PERCENTAGE OF TO TAL HEALTH SPENDING The proportion of total expenditure used for pharmaceuticals is highest in developing countries. 1 The use of essential drugs. Third report o f the WHO Expert Committee. Geneva, World Health Organization, 1988. "echnical Report Series No. 770. E8/RDS/RC/1 8. Since the first WHO Model List o f Essential Drugs was introduced in 1977, Member States, with the support o f WHO and other organizations, have achieved a great deal. These achievements have contributed to narrowing the immense gap between the health benefits which pharmaceuticals could bring to the world’s population and the much smaller benefit that was actually being realized in 1977.' Achievem ents 9. In 1977 perhaps a dozen countries had what would now be considered an essential drugs list or an essential drugs programme. Today, three out o f four countries - over 140 countries in total - have adopted national essential drugs lists. National essential drugs lists are widely used for public procurement systems, reimbursement schemes, training, public education, and other national health activities. Sixty per cent o f countries have recently updated their list and WHO itself has updated the Model List o f Essential Drugs on average every two years for the past two decades. 10. In 1977 the concept o f a national drug policy was barely known. Today, nearly 90 countries have national drug policies in place or in preparation. From 1996 to 1997 alone, 30 countries adopted or substantially revis their national drug policies - most with WHO cooperation. National drug policies are being introduced at a growing pace in every region (Figure 2). More importantly, a growing number o f countries are now moving directly from policy to action through coordinated masterplans for implementation. The national drug policy process is increasingly serving as a framework, bringing together interested parties for pharmaceutical sector reform within countries. FIGURE 2. CUMULATIVE NUMBER OF NATIONAL DRUG POLICIES* AFR AMR EMR 1=11989 B H 1991 EUR SEAR WPR 1993 H S 1995 M 1 9 9 7 * Includes 51 countries with current national drug policies, 36 with draft policies or policies more than 10 years old. N ational drug policies are being introduced at a growing pace in every region • increasingly these policies become plans o f action for pharm aceutical sector reform s. 1 Action Programme on Essential Drugs. Report of the Biennium 1996-1997. Document WHO/DAP/MAC( l0)/98.4. 0 /0 7 '9 8 MON 1 4 :4 0 FAX +4122 791 41 67 WHO DAP GENEVA EB/RDS/RC/1 ittj UU4 11. In 1977 objective information on rational use o f drugs was extremely limited - especially in developing countries. Today, nearly 100 governments and numerous national nongovernmental organizations have developed therapeutic manuals and formularies, which provide health professionals with current, accurate advice on the rational use o f drugs. 12. In 1977 medical training in prescribing was often based on brand names, and little attention was given to systematic teaching about rational drug use. Today, use o f generic names is the accepted standard for medical training and WHO’s Guide to Good Prescribing,' with translations in 15 languages completed or in process, is being adopted by leading medical universities in countries at all levels o f development. 13. Perhaps, m ost importantly, in 1977 less than half the world’s population had regular acccss to essential drugs. Today, through a combination o f public and private health systems, it is estimated that nearly two-thirds o f the world’s people have access to a full and effective treatment with the medicines they need. In absolute terms, the number o f people estimated to have access to essential drugs has grown from roughly 2.1 billion in 1977 to 3.8 billion in 1997. Developm ent o f national drug policies, formulation o f essential drugs lists, improvements in drug information, and increased access to essential drugs arc just a few examples o f what has been achieved over the past 20 years through the efforts o f Member States, WHO, and many other organizations. Unfinished agenda 15. Although much has been achieved, much remains to be done. Lack o f access to essential drugs, irrational use o f drugs, and poor drug quality remain serious global public health problems.2 16. Access to essential drugs. Availability and affordability o f medicines remains a major global challenge. Although two-thirds o f the world’s people now have access to essential drugs, literally hundreds o f millions still do not (Figure 3). For example, in the poorest parts o f Africa and Asia, over 50% o f the population still lacks access to essential drugs. Whereas in many developed countries over 70% o f pharmaceuticals are publicly funded through reimbursement plans and other mechanisms, in developing and transitional econom ics 50% to 90% o f drugs are paid for by the patients themselves. And it is the poor and disadvantaged who suffer the most from financial, social and geographic barriers to availability and affordability o f drugs. . . . Factors contributing to poor access to drugs includc lack o f clear national health policies, poorly functioning health services, inadequate financing, high drug prices relative to available funds, inefficient supply systems, and wasteful prescribing and dispensing practices. 18. R ational use o f drugs. Despite the progress made in drug selection, availability o f therapeutic information, and training, irrational use o f drugs continues. For example, up to 75% o f antibiotics are prescribed inappropriately, even in teaching hospitals. In poorer countries, studies find that 50% o f customers buy only jne day’s supply o f antibiotics and 90% buy three days’ supply or less. Dispensing time in some settings iverages less than 10 seconds per patient, allowing little time for counselling. Worldwide, an average o f only 50% o f patients take their medicines correctly. One o f several serious health consequences o f irrational drug Jse is the growth o f antimicrobial resistance for major infectious diseases, including bacterial diarrhoea, gonorrhoea, malaria, pneumonia, and tuberculosis. Also, the more potent new drugs arc usually between three ind 10 times more expensive. ' Document WHO/DAP/94.11. - 1 Document WHO/DAP/MAC(10y98.4. EB/RDS/RC/1 FIGURE 3. PERCENTAGE OF POPULATION ESTIMATED TO HAVE REG ULAR ACCESS TO ESSENTIAL DRUGS (1997) One-third of the world’s population still lacks access to essential drugs. 19. Factors contributing to irrational drug use include inadequacies in training o f health professionals, provision o f drug information, and public education. Economic factors, unethical drug promotion, and poor use o f diagnostic capacity are equally important. 20. D rug quality. Although global standards for drug quality are becoming more demanding, the actual quality o f drugs on the market in many countries remains a major public concern. Surveys from a number ol developing countries find that 10% to 20% o f sampled drugs fail quality control tests. It is estimated that fe than one in three developing countries have fully functioning drug regulatory authorities. Failure in gooc manufacturing practiccs too often results in toxic, sometimes lethal, products. And expanding world trade i: bringing fresh challenges to global quality assurance. 21. Assuring drug quality in local, national, and international markets requires sound regulatory norms an< standards. Nevertheless, failures in quality assurance and drug control arise most com m only from gaps in th( legislation, organization, financing, and human resources for drug regulation. WHO ACTIVITIES 22. WHO works globally, regionally, and at country level to address the challenge o f ensuring access t< essential drugs, rational use o f drugs, and drug quality. Activities focus on global norms and standards, polic; and technical development, and development o f country programmes. Currently, within WHO, these activitie are primarily the responsibility o f the Action Programme on Essential Drugs and the D ivision o f Dru; Management and Policies. Collaboration with countries is facilitated by programmes and advisers on essentia drugs and pharmaceuticals in each o f the six WHO regions. Several other WHO health promotion and diseas control programmes also have pharmaceutical components. 3/07 '9 8 MON 1 4 :4 1 FAX +4122 791 41 67 zB/RDS/RC/1 WHO DAP GENEVA Slobal norms and standards 23. WHO determines, establishes and promotes international standards for safety, quality and efficacy o f pharmaceutical products and biologicals, including vaccines and blood products, and disseminates drug regulatory information. 24. Quality control specifications for pharmaceutical substances and products included in the WHO Model List o f Essential Drugs continue to be drawn up and published in The International Pharmacopoeia (in English, French, and Spanish), and Basic tests for pharmaceutical substances and Basic tests for pharmaceutical dosage forms are published in Chinese, English, French and Spanish. WHO’s Good Manufacturing Practices for Pharmaceutical Products (GMP) have been supplemented with recommendations for inspection o f manufacturing locations, distribution channels and guidance for the establishment o f quality control laboratories. A compendium o f WHO guidelines and other materials relating to quality assurance o f pharmaceuticals was published in 1997.1 Special projects are ongoing to train trainers in GMP and to upgrade GMP in local production o f pharmaceuticals. Regulatory networks, information exchange, computer-assisted drug registration, etings for harmonization o f measures and other intercountry or country initiatives have been supported in i o f the six WHO regions. From 1996 to 1997 support for drug regulation and quality assurance was provided to more than 50 Member States. 25. WHO continues to assign and publish INNs for newly developed pharmaceutical substances. Some 150 INNS are published annually, making a total o f over 7000 since 1952. WHO has initiated a project for combating counterfeit drugs, and a reference guide on the subject is in the final stage o f preparation. 26. Countries participating in international drug safety monitoring have increased to 51, and a number o f countries, particularly in the Eastern Mediterranean, Latin America, and South-East Asia, receive support in establishing drug safety monitoring systems. 27. WHO continues to prepare and disseminate information on pharmaceutical products. An updated Model List o f Essential Drugs (ninth list) was published in 1997.2 Model prescribing information has been issued for HIV and associated infections, and for drugs used for anaesthesia, and for skin, parasitic, and mycobacterial diseases. Work is in progress on a WHO model formulary for essential drugs. The quarterly journal, IWHO Drug Information, and the monthly WHO Pharmaceutical Newsletter provide current information on drug safety, elopment, regulation, and regulatory decisions. Policy and technical development 28. The 1997 operational strategy for the essential drugs programme3 highlighted five areas for policy and technical development. WHO work is now organized around these five areas, namely national drug policies, health economics and drug financing, drug management and supply strategies, rational drug use, and regulation and quality assurance capacity. In each area WHO initiates necessary strategic and operational research, draws up practical guidelines, provides information and advocacy, and addresses the development o f human resources. 29. National drug policies. Although national drug policies have been formulated in nearly 90 countries, implementation varies considerably. Greater emphasis is now laid on policy implementation through national plans o f action and improved monitoring. WHO has prepared materials such as Guidelines for developing 1 Quality assurance ofpharmaceuticals: a compendium o f guidelines and related materials. Vol. 1. Geneva, World Health Organization, 1997. 1 The use ofessential drugs. Seventh report o f the WHO Expert Committee, Geneva, World Health Organization, 1997. WHO Technical Report Series No. 867. 1 Document DAP/MAC(9)/97.4. EB/RDS/RC/1 national drug policies and a manual o f indicators for monitoring national drug policies.1 ft also recently carried out a comparative analysis o f national drug policies in 12 countries. Current priorities include updating the World drug situation, which will contain global comparative information about national drug policies and pharmaceutical sector development, and establishing a network o f sentinel countries for monitoring implementation and impact o f national drug policies. 30. Health econom ics and drug financing. Access to drugs depends on adequate financing and efficient use o f available resources. Recent literature has included Health reform and drug financing,1 Public-private roles in the pharmaceutical sector,3 Pharmaceuticals and health sector reform in the Americas: an economic perspective, Global comparative pharmaceutical expenditures/ and Globalization and access to drugs.5 Areas o f current concern include the role o f public financing for drugs, gender and access to drugs, world trade agreements and access to drugs (see Annex), mechanisms for promoting generic drug use, and provision o f drugs through health insurance programmes. 31. WHO has completed reviews o f pricing policies in the Americas and in Europe, and is preparing a global summary analysis. In consultation with interested parties, it has initiated a study on prices, and sources o f information on prices, o f essential drugs. The African Region has already initiated a pilot service for region exchange o f price information. WHO continues to ensure that price information on raw materials for essential drugs is regularly made available, and recently commissioned an independent review o f this price information service. 32. Drug m anagem ent and supply strategies. Recent work in the area o f drug management and supply has included collaborative publication o f the second edition o f the standard reference work, Managing drug supply, revision o f the N ew emergency health kit,* completion o f a study on collaboration between WHO and nongovernmental organizations in drug supply, and development o f international and regional training programmes. Guidelines for drug donations were issued in 1996/ as an interagency document endorsed by eight international organizations. The guidelines have been widely distributed in English, French and Spanish, and adopted or adapted by 15 donor or recipient countries. By the end o f 1998, a major evaluation o f donor and recipient experience with the guidelines should be completed. 33. Current priorities include a multicountry assessment o f drug supply strategies in the context o f health reform, expanded international and regional drug management training, and support for review and revision o f pharmacy curricula. The assessment o f drug supply strategies will consider experiences with innovative di supply arrangements, including decentralized and privatized supply, and improvements in traditional central medical stores. 34. Rational drug use. Rational use o f drugs involves prescribers, dispensers, and the general public. Past efforts have emphasized training o f medical educators and prescribers through networks such as the International Network for Rational Use o f Drugs and through WHO collaborating centres in Australia, Indonesia, the Netherlands, and elsewhere. WHO also supports research into effective strategies to improve the use o f medicines, and development o f research methods for the study o f drug use in communities and health facilities. WHO co-sponsored a major international conference (Chiang Mai, Thailand, 1997) which brought together 270 1 Document WHO/DAP/94.12. 2 Document WHO/DAP/98.3. J Document WHO/DAP/97.12 4 In preparation. 5 Document WHO/DAP/98.9. ‘ Document WHO/DAP/90.1. 7 Document WHO/DAP/96 2. 9/07 '9 8 MON 1 4 :4 3 FAX +4122 791 41 67 WHO DAP GENEVA EB/RDS/RC/1 ifciuua researchers from the public sector, academia, nongovernmental organizations and industry to identify successful interventions to promote rational drug use.1 35. Current priorities include training in rational drugs use in the community; containment o f resistance through more rational use o f antimicrobial drugs; expansion o f training in promotion o f rational drug use in French-.and Spanish-speaking countries; and implementation o f WHO’s Ethical criteria for medicinal drug promotion. A draft strategy for review and assessment o f the effectiveness o f the ethical criteria was elaborated with contributions from a round table o f Member States and interested parties. The strategy seeks to achieve greater impact through intersectoral and international collaboration, stronger regulation, self-regulatoty codes, and measures to enable consumers and health professionals to assess drug promotion critically. 36. R egulation and quality assurance capacity. WHO is increasing its emphasis on country-level implementation o f effective drug regulation and quality assurance by focusing on organization, financing, and human resources for drug regulation. In addition to activities noted in paragraphs 9 to 14 above, WHO has initiated a multicountry working group on effective drug regulation. The group will define measures o f regulatory effectiveness, compare national approaches to drug regulation, and assess which approaches seem ;t effective in particular settings. Country programme development 37. WHO’s largest commitment o f regular budget and extrabudgetaiy resources for pharmaceuticals and essential drugs is for direct support to countries. WHO collaborates with countries to implement national drug policies and programmes which address each critical element in the pharmaceutical sector: legislative and regulatory framework, selection o f drugs, national supply strategies, quality assurance, rational use o f drugs, financing and economic strategies, human resources development, and monitoring. Work at country level often includes integration o f local experience and the various programme-specific WHO guidelines for standard treatment into a single national manual o f clinical guidelines. This becomes the basis for the national essential drugs list, training, and supply activities. 38. Country support may be for initial situation analysis, development o f policy and strategy, implementation of comprehensive national programmes, or specific technical activities. Priorities for regular budget support are set at national level as part o f the regional WHO budgeting process. Extrabudgetary support is based on criteria *ch include severity o f need, level o f development, national commitment, likelihood o f sustainable impact, —..lonstration value, value for development, and existence o f a window o f opportunity. In 1996-1997, regular budget support for work in pharmaceuticals and essential drugs was provided to over 80 countries and sxtrabudgetary support was provided to over 50 countries. 39. Increasingly, countries are supported through exchange o f information at regional and subregional level, letworks, working groups and research projects. Such initiatives provide a practical means to share experience md to solve collectively problems o f mutual concern related to the pharmaceutical sector. Recent regional initiatives have addressed such matters as pharmaceuticals in health reform, drug financing, pharmacy :urriculum reform, harmonization o f drug regulation, rational drug use, and improvements in good nanufacturing practices. 1 See Essential Drugs Monitor. 1997,23:6-12. EB/RDS/RC/1 RESOLUTION ON TH E REVISED DRUG STRATEGY 40. In January 1998, the Executive Board at its 101st session considered the Director-General’s report on the revised drug strategy.1 The Board recognized progress made, and commended the work o f WHO in promoting the essential drugs concept and national drug policies, and improving drug regulation. In order to address specific constraints on access to drugs, rational use o f drugs, and drug quality, it adopted resolution EB101 .R24 on the revised drug strategy. The Fifty-first World Health Assembly was invited to consider the resolution in May 1998. Since January 1998, several Member States indicated their concerns regarding some points in the resolution. Committee A o f the Fifty-first World Health Assembly therefore decided to establish a drafting group. 41. The following Member States participated in the drafting-group meetings which took place throughout the Assembly: Argentina, Australia, Belgium, Botswana, Brazil, Canada, Finland, France, Germany, Italy, Japan, Malawi, M exico, Namibia, N ew Zealand, Norway, South Africa, Swaziland, Sweden, Switzerland, United Kingdom o f Great Britain and Northern Ireland, United States o f America, Zambia and Zimbabwe. In addition, the Commonwealth Secretariat and the European Commission attended the drafting group. 42. The following three points in resolution E B 101 .R24 led to most discussion in the drafting group, and n« consensus was reached on language: ■ —(b) new world trade agreements may have a negative impact on local manufacturing capacity and the access to and prices ofpharmaceuticals in developing countries,... (seventh preambular paragraph). ■ 1. URGES Member States: (2) to ensure thatpublic-health interests rather than commercial interests have “primacy" in pharmaceutical and health policies... ■ 2. REQUESTS the Director-General: (6) to cooperate with Member States in analysing the pharmaceutical and public health implications o f agreements the application of which is overseen by the World Trade Organization and in developing appropriate policies and regulatory measures; 43. Final ly, the Health Assembly decided in decision W HA51 (10) to refer the resolution back to the Executive Board for further consideration at its 103rd session, taking into account the discussions o f the matter in Committee A and in the drafting group. 44. Subsequently the Executive Board at its 102nd session decided in decision EB 102(14) to establish an open-ended ad hoc group to explore the complex issues raised by resolution EB101.R24 on the revised drug strategy. The group will take note o f the outcome o f contacts pursued by WHO with other partners, including WTO, WIPO, industry and nongovernmental organizations, in order to draft a resolution for consideration by the Executive Board at its 103rd session in January 1999. 1 Document EB101/10, section VII. 9 EB/RDS/RC/1 D/07 '9 8 MON 1 4 :4 4 FAX +4122 791 41 67 WHO DAP GENEVA 1^3 oio ACTION BY THE REGIONAL COMMITTEES 45. In accordance with decision EBI 02(14) regional committees are requested to select two Member States to participate in the subgroup mentioned therein, o f which one Member State will be currently entitled to designate a person to serve on the Executive Board. The subgroup will meet in Geneva after the regional committees and before or during the 103rd session o f the Executive Board in order to finalize the resolution on the revised drug strategy. EB/RDS/RC/1 ANNEX WORLD TRADE AGREEMENTS AND PHARMACEUTICALS 1. In 1996 the Forty-ninth World Health Assembly, by resolution WHA49.14, requested the Director-General “to report on the impact o f the work o f the World Trade Organization (WTO) with respect to national drug policies and essential drugs”. N ew international trade agreements affect health care issues, including pharmaceuticals, and present new opportunities, challenges, and uncertainties, In particular, a number o f WHO Member States have expressed conccm about the possible impact o f WTO agreements on the health sector in developing countries. WORLD TRADE ORGANIZATION 2. WTO is the international body dealing with the rules o f trade between nations. The Agreemi establishing WTO came into force on 1 January 199S, but the multilateral trading system is half a century old-., as the General Agreement on Tariffs and Trade (GATT) had previously provided rules for international trade. WTO states that the basic principles that run through the WTO agreements are (i) nondiscrimination; (ii) progressive liberalization o f barriers to trade; (iii) predictable policies and transparency; (iv) encouragement o f competition; and (v) special provisions for developing countries.1 3. WTO has 132 Member governments, and a further 31 are in the process o f negotiating accession. The specific agreements annexed to the Agreement establishing WTO provide the legal groundrules for international commerce. Those o f greatest relevancc for the health sector are: the Agreement on Trade-Related Aspects o f Intellectual Property Rights (TRIPS); the Agreement on the Application o f Sanitary and Phytosanitary Measures (SPS); the Agreement on Technical Barriers to Trade (TBT); and the General Agreement on Trade in Services (GATS). The TRIPS Agreement may have the greatest impact in the pharmaceutical sector. 4. WTO aims to establish a rule o f law in international trade relations and, for this purpose, provides for a mechanism for the settlement o f disputes between Members. Members commit them selves to settle disputes about compliance with WTO obligations through and in conformity with the multilateral dispute settlemertt mechanism and not to take action unilaterally. THE AGREEM ENT ON TRADE-RELATED INTELLECTUAL PROPERTY RIGHTS 5. The TRIPS Agreement links intellectual property and trade issues and provides minimum global standards for the protection and enforcement o f intellectual property rights, including in relation to pharmaceuticals. All WTO Members are required to implement these standards by the end o f their respective transition periods. 6. Prior to the TRIPS Agreement, international conventions did not contain minimum standards for the protection o f patents, including in the area o f pharmaceuticals, in a number o f important respects. Although most countries, both developed and developing, protected pharmaceutical process and patent inventions, others did not, and the duration and scope o f protection also varied between countries. The provisions given below are the key requirements o f the TRIPS Agreement in regard to patents in the area o f pharmaceuticals. 1 Introduction to the WTO: Trading into the future. Geneva, World Trade Organization, 1998. Also available on the WTO web site: http:// www.wto.org/wto/about/facts2.htrn. 11 ) /0 7 '9 8 MON 1 4 :4 5 FAX +4122 791 41 67 WHO DAP GENEVA ZB/RDS/RC/1 ____ Annex (4)012 Patentability. The Agreement requires Member States to make available patent protection for a minimum o f 20 years for any invention, including o f a pharmaceutical product or process, that fulfils the criteria o f novelty, inventive step and usefulness (subject to permissible exceptions in regard to inventions that are contrary to ordre public or morality, methods o f diagnostic, therapeutic and surgical methods for the treatment o f humans or animals, and certain plant and animal inventions). Rights conferred. The Agreement specifies the rights conferred on a patent owner, but also allows for limited exceptions and compulsory licensing subject to specified conditions. Transitional arrangements. The Agreement provides transitional periods for countries to bring their national legislation and practices into conformity with its provisions. With respect to the substantive rules on patent protection, the latest dates for WTO Members are 1 January o f the following years: 1996 for developed countries; as a general rule, 2000 for developing countries; 2005 for the introduction o f product patent protection for pharmaceuticals in developing countries which have not done so by 2000; and 2006 for least- developed countries. er provisions. The Agreement also contains provisions on the protection o f undisclosed information, including test data; anticompetitive practices; trademarks (relevant to generic substitution and combating o f counterfeit drugs); and enforcement. WHO ACTIVITIES ON TRADE AGREEM ENTS AND ACCESS TO DRUGS 7. WHO programmes concerned with health services, pharmaceuticals, vaccines and food safety have each become involved in health-related aspects o f WTO agreements. In relation to pharmaceuticals and in response to resolution W HA49.14, WHO has initiated a series o f activities aimed at identifying issues in WTO agreements related to essential drugs and national drug policies, studying the implications o f these issues, and advising Member States on opportunities to promote public health through these agreements. This work has resulted in material included in the attached selected reading list, an Internet discussion group, consultations in some WHO regions, and initiation o f work on a practical document on “Frequently asked questions on trade agreements and drugs”. WHO’s approach in this area is based on its long-standing recognition (resolution W HA35.14) that intellectual property rights (patents) contribute to the development o f new health technologies, including drugs, and that the TRIPS Agreement has established standards for the protection o f intellectual property rights, including in respect o f pharmaceuticals, which are obligatory for all WTO Members. Among other things, WHO has been informing countries about TRIPS provisions which may help to ensure availability o f drugs and fair competition. Examples o f implementing legislation for these TRIPS provisions can be found in several industrialized and some developing countries. QUESTIONS A BO UT W TO AGREEMENTS AND PHARMACEUTICALS 9. The TRIPS Agreement has proven to be one o f the most controversial o f the WTO agreements. Many argue that TRIPS should lead to increased development o f drugs; increase in technology transfer and direct foreign investment in developing countries; increase in the resources devoted to research and development by developing country pharmaceutical companies and, linked to this, a reduction in the “brain drain” from developing to industrialized countries; and improvement in the welfare o f the population resulting from a wider range o f better quality products. 10. Others argue that the Agreement will result in higher drug prices in many developing countries; no significant increase in the number o f new drugs, at least for those problems specific to developing countries; •»o Annex EBfoD Sm c/1 further concentration o f research, development, and production in industrialized countries; and no increase in local research and development in developing countries. 11. These arguments have been put forward by various acadcmic and nonacademic sources, each drawing upon different theoretical and empirical evidence. From a health perspective, questions o f particular importance in implementing the TRIPS Agreement are: How can future access to newly patented essential drugs be guaranteed for the poorest populations in developing countries? and How can the discovery and development o f new and needed drugs for malaria, tuberculosis, and other conditions prevalent in developing countries be assured? SELECTED READING ON W TO AGREEMENTS AND PHARMACEUTICALS The following is a selected chronological listing o f some recent working papers and publications by WHO, other United Nations organizations, nongovernmental organizations, and other interested parties. V elisquez G, Boulet P. Globalization and access to drugs - the implications o f the WTO/TRIPS Agreemi Health Econom ics and Drugs DAP Series N o.7. Geneva, World Health Organization, 1998. Document. WHO/DAP/98.9. The question of patents. Geneva, International Federation o f Pharmaceutical Manufacturers Associations, 1998. The TRIPs Agreement - a guide for the South. Geneva, South Centre, 1997. Often A. The implications o f the TRIPS Agreement for the protection o f pharmaceutical inventions. WHO Drug Information, 1997,11: 1. Power, patents and pills - an examination of GA TT/WTO policies and essential drug policies. Seminar Report. Amsterdam, Health Action Intemational-Europe, 1997. The TRIPS Agreement and developing countries. Geneva, United Nations Conference on Trade and Development, 1996. Document UNCTAD/ITE/1. 1
Всемирная организация здравоохранения (ВОЗ / WHO) · Governing Bodies documents
Forty-eighth Regional Committee for Europe: Copenhagen, 14-18 September 1998: matters arising out of decisions and resolutions of the World Health Assembly and the Executive Board
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