WORLD HEALTH ORGANIZATION
EXECUTIVE BOARD EB103/4
103RD SESSION 25 NOVEMBER 1998
Provisional agenda item 3
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Revised drug Strategy
Report by the Chairman of the ad hoc working group
BACKGROUND
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.
ISSUES
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.
ACTION BY THE EXECUTIVE BOARD
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.
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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.