EXECUTIVE BOARD                                        EB103/4
103RD SESSION			                     25 NOVEMBER 1998
Provisional agenda item 3


                       Revised drug Strategy

           Report by the Chairman of the ad hoc working group


1. In January 1998 the Executive Board at its 101st sessionconsidered the 
Director-General s report on the revised drug strategy. The Board recognized 
progress made and commended WHO on its work in promoting the essential 
drugs concept and national drug policies, and in improving drug regulation. 
In order to address specific constraints on access to drugs, rational use 
of 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. Views differed on a number of 
points in the resolution and the Health Assembly therefore agreed to 
establish a drafting group.

2. The drafting group was chaired by Professor J-F Girard (France). 
Despite many hours of discussion in the drafting group, no consensus was 
reached on language for the resolution and the Health Assembly decided to 
refer the resolution back to the Executive Board for further consideration 
at its 103rdsession[1].

3. At its 102nd session, immediately after the Health Assembly,the Executive 
Board decided to establish a two-tier method of work, in order to draft 
an ad hoc working group open to all Member States wishing to participate, 
which included a subgroup to assist WHO in its contacts with relevant 
interested partners[2]. The Board 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 were invited to nominate 
their representatives to the subgroup. Those nominated were Cape Verde, 
China, Indonesia, Islamic Republic of Iran, Jamaica, Japan, Poland, South 
Africa, Switzerland, Thailand, United States of America and Yemen.

4. The ad hoc working group and the subgroup met from 12 to 16 October 
1998 (list of participants attached at Annex). The meetings were chaired 
by Professor J-F Girard (France). The ad hoc working group elected Ms S 
Kizildeli (turkey) and Dr TJ Stamps (Zimbabwe) as Vice-Chairmen. A total 
of 59 Member States, including subgroup members, participated in the meeting.


5. In order to assist the ad hoc working group in exploring the complex 
issues raised by resolution EB101.R24, one full day was devoted to a 
technical briefing in which relevant interested partners were invited to 
participate. The technical briefing covered globalization and 
pharmaceutical, including the question of how trade agreements could 
interfere with or support public health, and strategies for ensuring 
access to pharmaceutical.

6. Presentations on globalization and pharmaceuticals were made by 
representatives of WIPO, WTO, The South Center, Health Action 
International, the International Federation of Pharmaceutical 
Manufacturer s Association, and the International Pharmaceutical Generic 
Alliance. A presentation on strategies for ensuring access to 
pharmaceuticals was made by the WHO Secretariat and reactions were 
invited from members of the ad hoc working group, including  the 
subgroup, and from those who had made presentations on the globalization and
pharmaceuticals issue.

7. The ad hoc working group identified a number of new topics not covered 
by resolution EB101.R24, which it felt should be the subject of further 
work by the Secretariat, in particular on access to drugs, transfer of 
technology and local production, new drugs, counterfeit drugs, human 
resources, and gender issues. Issues discussed under the topic of access to
drugs included supply systems, drugs financing, drug insurance, price 
information and pricing policies, generic drugs, procurement methods, and 
related matters. However, in order to conclude on the issues in 
resolution EB101.R24 on which there had been diverging views at the 
Health Assembly, the ad hoc group decided to concentrate on those topics 
currently included in the resolution.

8. By the last day of the meeting the ad hoc working group had reached 
consensus on the text of a resolution to be forwarded to the Executive 
Board, although, because of lack of time, certain points raised during 
the deliberations were not included in the text (e.g. the addition of  
transitional countries  in preambular paragraph 10, the addition of 
preambular paragraphs concerning gender inequalities in health care, and 
the need to improve access for vulnerable groups). The Secretariat was 
requested to provide information on the financial implications of the 
resolution, which will be provided separately.


9. The Board is invited to consider the following draft resolution as 
proposed by the ad hoc working group:

The Executive Board

RECOMMENDS to the Fifty-second World Health Assembly the adoption of the 
following resolution:

The Fifty-second World Health Assembly, Recalling resolution WHA39.27, WHA41.16, WHA43.20, WHA45.27, WHA47.12, WHA47.13, WHA47.16, WHA47.17, and WHA49.14; Having considered the report of the Director-General on the revised drug strategy[1]; Noting the activities of WHO to further the implementation of the revised drug strategy, in particular through support to the development and implementation of national drug policies; the strategy to review and assess the effectiveness of the WHO Ethical Criteria for Medicinal Drug Promotion; the flow of market information; guidelines for drug donations; and model drug information; Recognizing with satisfaction the progress made, and approving WHO s comprehensive response to current and new challenges in the pharmaceutical sector; Commending the strong leadership shown by WHO in promoting the essential drugs concept and national drug policies, which are contributing to the rational use of resources in the pharmaceutical sector and to improved health care; Noting with satisfaction that a number a Member States have adopted guidelines for drug donations that were based on the interagency guidelines issued by WHO, but concerned that inappropriate drug donations, such as donations of expired, mislabelled, inessential products, continue to be common, and further concerned that the evaluation of the impact of the guidelines has not yet been completed; Concerned about the situation in which (a) one third of the world s population has no guaranteed access to essential drugs, and (b) poor quality pharmaceutical raw materials and finished products continue to move in international trade; Noting that there are trade issues which require a public health perspective; Recognizing that the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) provides scope for the protection of public health; Taking note of concerns of many Member States about the impact of relevant international agreements, including trade agreements, on local manufacturing capacity and on access to and prices of pharmaceuticals in developing and least developed countries; Concerned also that drugs continue to be irrationally used by prescribers, dispensers and the general public, and because unethical promotion in developed and developing countries and a lack of access to independent, scientifically validated drug information contribute to such abuse, 1. URGES Member States:
(1) to reaffirm their commitment of developing, implementing and monitoring national drug policies and to taking all necessary concrete measures in order to ensure equitable access to essential drugs; (2) to ensure that public health interests are paramount in pharmaceutical and health policies; (3) to explore and review their options under relevant international agreements, including trade agreements, to safeguard access to essential drugs; (4) to establish and enforce regulations that ensure good uniform standards of quality assurance for all pharmaceutical materials and products manufactured in, imported to, exported from, or in transit through their countries; (5) to enact and enforce legislation or regulations in accordance with the principles of the WHO Ethical Criteria for Medicinal Drug Promotion, to encourage the pharmaceutical industry and the health community to establish an ethical code, and to monitor drug promotion in collaboration with interested parties; (6) to develop or maintain national guidelines governing drug donations that are compatible with the interagency guidelines issues by WHO and to work with all interested parties to promote adherence to such guidelines; (7) to promote the rational use of drugs through the provision of independent, up-to-date and comparative drug information, and to integrate the rational use of drugs and information about commercial marketing strategies into training for health practitioners at all levels; (8) to promote and support education of consumers in the rational use of drugs and its inclusion into school curricula; (9) to evaluate progress regularly, making use of indicators developed by WHO or other suitable mechanisms; (10) to continue their funding and material support for the revised drug strategy especially by the provision of extrabudgetary resources to WHO;
2. REQUESTS the Director-General:
(1) to support Member States in their efforts to develop and implement policies and programmes that achieve the objectives of the revised drug strategy, including the development of tools, guidelines and methodology for evaluation and monitoring; (2) to adopt a comprehensive strategy to implement the WHO Ethical Criteria for Medicinal Drug Promotion and to continue to review its effectiveness with all interested parties; (3) to extend the guidelines incorporated in the WHO Certification Sheme on Quality of Pharmaceutical Products Moving in International Commerce to cover pharmaceutical starting materials; develop and disseminate uniform guidelines on the regulatory control, export, import and transit conditions of pharmaceutical products; and develop standards of practice for entities involved in international trade in pharmaceuticals and pharmaceutical starting materials; (4) to establish and develop a model inspection certificate for the national inspection of pharmaceutical manufacturing sites of starting materials and finished pharmaceutical products to ensure compliance with WHO Good Manufacturing Practices, and to collaborate with Member States, at their request, in implementation; (5) to strengthen and expand the provision of independent information on market prices of starting materials of assured quality for production of essential drugs; (6) to continue the development and dissemination, also using electronic media such as Internet, of independent information on safety of pharmaceutical products and instances of counterfeit drugs or medicines, on drug selection and on rational prescribing; (7) to cooperate with Member States, at their request, and with international organizations in monitoring and analyzing the pharmaceutical and public health implications of relevant international agreements, including trade agreements, so that Member States can effectively assess and subsequently develop pharmaceutical and health policies and regulatory measures that address their concerns and priorities, and are able to maximize the positive and mitigate the negative impact of those agreements; (8) to review and update the revised drug strategy to reflect current and continued challenges in the pharmaceutical sector and the principles articulated in the renewed health-for-all- policy; (9) to report to the Fifty-third World Health Assembly on progress achieved and problems encountered in the implementation and renewal of WHO s revised drug strategy, with recommendation for action.
---------------------------------------------- Footnotes In the preambular paragraphs: [1] Decision WHA51(10) [2] Decision WHA102(14) In the draft resolution [1] Document EB101/10, Chapter VII, and Corr 2.