E-drug: WHA: EBl0l.R24, Revised drug strategy
---------------------------------------------
The following document is an Executive Board resolution which will be
considered at the World Health Assembly in May. According to persons
in U.S. health care and trade related agencies, the Pharmaceutical
industry has asked for meetings with the US FDA, Department of
Commerce, United States Trade Representative and the United States
Patent and Trademark Office, asking that the U.S. government oppose
the resolution. I believe that PhRMA has expressed oppositions to
sections of the resolution which concern the WTO and TRIPS and they
relate to essential drugs.
We have asked that the U.S. Delegation also meet with persons from
the public health and consumer groups. Persons who are interested in
participating in such a meeting with US officials to discuss this
resolution should contact me. I would also be interested in hearing
comments from persons about the substance of the resolution, either
privately, or through posting to email discussion lists such as
ip-health@cptech.org, pharm-policy@cptech.org, or
e-drug@usa.healthnet.org. I also expect that this will be one of
(several) topics discussed during the May 7-8 meetings in Washington,
DC on Health Care and Intellectual Property.
James Love
love@cptech.org
http://www.cptech.org
The resolution is on the WTO Web page at:
http://www.who.ch/gb/pdfangl/angr24.pdf
The following is a version I scanned using Optical Character
Recognition Software.
101st Session EBl0l.R24
Agenda item 9 27 January 1998
Revised drug strategy
The Executive Board
RECOMMENDS to the Fifty-first World Health Assembly the adoption of
the following resolution:
The Fifty-first 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;
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 were based on the interagency
guidelines issued by WHO, but concerned that inappropriate drug
donations, such as donations of expired, mislabelled, in essential
products, continue to be common;
Concerned about the situation in which one third of the world's
population has no guaranteed access to essential drugs, in which new
world trade agreements may have a negative impact on local
manufacturing capacity and the access to and prices of pharmaceuticals
in developing countries, and in which poor quality pharmaceutical raw
materials and finished products continue to move in international trade;
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 abuses,
URGES Member States:
(1) to reaffirm their commitment to develop, implement and monitor
national drug policies to ensure equitable access to essential drugs;
(2) to ensure that public health rather than commercial interests have
primacy in pharmaceutical and health policies and to review their
options under the Agreement on Trade Related Aspects of Intellectual
Property Rights to safeguard access to essential drugs;
(3) to establish and enforce regulations that ensure good uniform
quality assurance standards for all pharmaceutical materials and
products manufactured in, imported to, exported from, or in transit
through their countries; :
(4) to enact and enforce legislation or regulations in accordance with
the principles of the WHO Ethical Criteria for Medicinal Drug Promotion,
and to monitor drug promotion in collaboration with interested parties;
(5) 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;
(6) 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;
(7) to promote and support consumer education on the rational use of
drugs and its inclusion into school curricula;
(8) to evaluate progress regularly, making use of indicators developed
by WHO or other suitable mechanisms;
(9) to continue their funding and material support for the revised
drug strategy especially by the provision of extra budgetary 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
methodologies 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;
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 raw materials;
(4) to strengthen and expand the provision of independent information
on market prices of raw materials of assured quality for production of
essential drugs;
(5) to continue the development and dissemination, also using electronic
media such as the Internet, of independent information on
pharmaceutical product safety and instances of counterfeit drugs or
medicines, on drug selection and on rational prescribing;
(6) to assist Member States to analyse the pharmaceutical and public
health implications of agreements overseen by the World Trade
Organization and to develop appropriate policies and regulatory
measures;
(7) 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;
(8) to report comprehensively 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.
Sixteenth meeting, 27 January
1998 EB
101/SR/16
--
James Love
Consumer Project on Technology
P.O. Box 19367, Washington, DC 20036
love@cptech.org | http://www.cptech.org
voice 202.387.8030, fax 202.234.5176
--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.