[Ip-health] Text of the 1999 Revised Drug Strategy, WHA52.19

[James Love]

Some IGWG negotiators have asked for this resolution, and in particular,
the following text:

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Concerned about the situation in which (a) one-third of the world=E2=80=99s
population has no guaranteed access essential drugs, and (b) poor
quality pharmaceutical raw materials and finished products continue to
move in 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;  . . .

1. 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;

Here is the full resolution

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FIFTY-SECOND WORLD HEALTH ASSEMBLY WHA52.19

Agenda item 13 24 May 1999

Revised drug strategy

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=E2=80=99=
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 policies, which are contributing to the
rational use of resources in the pharmaceutical sector and to improved
care;

Noting with satisfaction that a number of Member States have adopted
guidelines for drug donations that based on the interagency guidelines
issued by WHO, but concerned that inappropriate drug donations, such
donations of expired, mislabelled, inessential products, continue to be
common, and further concerned that of the impact of the guidelines has
not yet been completed;

Concerned about the situation in which (a) one-third of the world=E2=80=99s
population has no guaranteed access essential drugs, and (b) poor
quality pharmaceutical raw materials and finished products continue to
move in trade;

Noting that there are trade issues which require a public health
perspective;

1 Document EB101/10, section VII and Corr.1.


WHA52.19

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, that unethical promotion
in developed and developing countries and a lack of access to
independent, validated drug information contribute to such abuse,

1. 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;

WHA52.19

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
Scheme on the Quality of 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 with
WHO Good Manufacturing Practices, and to collaborate with Member States,
at their, 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=E2=80=99s revised drug strategy, with recommendations for action.

Ninth plenary meeting, 24 May 1999
A52/VR/9