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The Fifty-second World Health Assembly,
Recalling resolutions 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 of Member States have adopted guidelines
for drug donations that are 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
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 that unethical promotion in developed and developing
countries and a lack of access to independent, scientifically validated drug
information contribute to such abuse,
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URGES Member States:
(1) to reaffirm their commitment to 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 issued 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 of other suitable mechanisms;
(10)to continue their funding and material support for the revised drug strategy,
especially through the provision of extrabudgetary resources to WHO;
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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 Scheme on
the Quality of Pharmaceutical Products Moving in International Commerce
to cover pharmaceutical starting materials; to develop and disseminate
uniform guidelines on the regulatory control, export, import and transit conditions of pharmaceutical
products; and to 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 in
order 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 the 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 analysing 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 recommendations
for action.
Ninth plenary meeting, 24 May 1999
A52/VR/9
(1) Document EB101/10, section VII and Corr.1
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