E-DRUG: WHO Revised Drug Strategy report
-------------------------------------------------
[Next week, 15-19 May, the World Health Assembly discusses (inter alia) a
progress report on the WHO Revised Drug Strategy.
The following report is taken from
http://www.who.int/wha-1998/WH00/anglais.htm Copied as fair use; WB]
WORLD HEALTH ORGANIZATION
FIFTY-THIRD WORLD HEALTH ASSEMBLY A53/10
Revised drug strategy; Report by the Secretariat
1. Resolution WHA52.19 (1999) on the revised drug strategy addresses
challenges in the areas of international trade agreements, access to
essential drugs, drug quality, and rational use of medicines.
The resolution builds on the original revised drug strategy, adopted by the
Health Assembly in resolution WHA39.27 (1986), and updated at successive
Health Assemblies. This strategy identified principles and goals for WHO's
work in the pharmaceutical sector. Current work on key areas highlighted in
resolution WHA52.19 are summarized in the following paragraphs.
2. National drug policies. By the end of 1999 nearly 106 Member States had
framed national drug policies and 146 had drawn up national lists of
essential drugs. Support continues to be provided for policy development,
implementation and monitoring, with a particular focus on moving from
policy to implementation and on evaluating policy impact. The document
entitled Indicators for monitoring national drug policies has been revised
and issued as a second edition. Meanwhile, core indicators for monitoring
national drug policies are being field-tested. They will constitute a
highly practical tool for monitoring not only implementation of drug
policy, but also the impact of WHO's work in this area. Additionally, new
Guidelines for developing national drug policies will be published shortly.
Tools and strategies to ensure the introduction of a gender perspective
into national drug policies are also being developed. Support for
implementation of national drug policy also extends to collaboration on
drug financing, and drug management and supply. At global level, a database
on the world drug situation has been compiled.
3. Pharmaceuticals and trade. Advice is being provided to countries on the
new international economic environment, within the framework of national
drug policies. Guidance is being prepared in response to queries from
Member States about the relationship between international agreements and
such subjects as drug prices, innovation and local production, the use of
exceptions, transfer of technology, licensing arrangements, and the
transition period for least developed countries. An updated bibliography on
globalization, patents and drugs - of use to countries in researching such
issues themselves - has been finalized. Simultaneously, methods for
monitoring the pharmaceutical and public health implications of new
agreements are being developed together with WHO collaborating centres in
Brazil, Thailand and the United Kingdom of Great Britain and Northern
Ireland. Cooperative work is also proceeding with UNAIDS on trade
agreements and access to HIV-related drugs. A contact group has been set up
of interested parties from WHO, WIPO, UNCTAD and WTO.
4. Drug quality. Mechanisms are being devised to extend the WHO
Certification Scheme on the Quality of Pharmaceutical Products Moving in
International Commerce to cover control of starting materials and to
provide guidance on quality issues related to trade. At the same time,
monographs are being drafted for inclusion in The international
pharmacopoeia for drugs listed in the Model List of Essential Drugs,
including antimalarial and antituberculosis drugs. Basic tests are also
being developed for these drugs. More recent work has involved assembling
screening tests for antimalarial and antituberculosis drugs. These
activities accord with a step-by-step approach to quality control.
5. A major training and technical cooperation project to strengthen WHO
good manufacturing practices (GMP) is well under way. GMP basic training
modules and a model inspection certificate for national inspection of
pharmaceutical manufacturing sites of starting materials and finished
pharmaceutical products are being drafted. The aim is to ensure compliance
with WHO's GMP. Implementation is being planned in collaboration with
Member States.
6. Drug information and drug promotion. The eleventh Model List of
Essential Drugs was
published in WHO drug information in late 1999 and the full report of the
Expert Committee on the Use of Essential Drugs (held in November 1999) will
be produced late in 2000. Publication of the WHO Model Formulary is also
expected in 2000. Meanwhile, WHO and interested parties are working on ways
to operationalize WHO's Ethical criteria for medicinal drug promotion and
develop tools to monitor their implementation. A project to examine
critically evidence of inappropriate drug promotion worldwide is also
moving ahead.
7. Drug donations. WHO continues actively to promote implementation of good
donation practices as the basis of its strategy to improve drug donations.
Good practices are described in the revised Guidelines for drug donations
issued in August 1999 and cosponsored by 15 organizations with experience
in emergency humanitarian relief. (Document WHO/EDM/PAR/99.4)
A scheme has been launched for organizations and pharmaceutical companies
to endorse the guidelines publicly. The WHO website lists 11 pharmaceutical
companies, three pharmaceutical umbrella organizations and eight
nongovernmental organizations which have endorsed the guidelines, and
provides information on how unhelpful donations can be reported to WHO.
Infringements of good donation practices will be treated on a case-by-case
basis and repeated infringements publicized.
8. Expanding partnerships. WHO is increasingly working in collaboration
with bodies such as
UNICEF, the World Bank, other organizations of the United Nations system,
M�decins sans
Fronti�res, and nongovernmental organizations and with the private sector
on access to essential
drugs. This work should maximize the impact of WHO pharmaceutical policies
and programmes and broaden support for the revised drug strategy.
9. Looking to the future. WHO areas of responsibility outlined in
resolution WHA52.19 will be reflected in the broader WHO strategic plan for
essential drugs and medicines policy, 2000-2003, which is being prepared at
all levels of WHO and with a wide range of development partners. In
particular, the strategy outlines work to be undertaken to increase access
to drugs for treating priority health problems: malaria, childhood illness,
HIV/AIDS and tuberculosis - diseases that particularly affect poor and
vulnerable populations, keep them entrapped in poverty, and substantially
slow development. Emphasis is being placed on securing adequate financing
for essential drugs (through government revenues and social health
insurance), making essential drugs affordable (for governments and
consumers), and establishing reliable supply systems for essential drugs
(through a mix of public and private services). Indeed, the competing
demands that many Member States face for medicines for priority health
problems mean that national essential drugs programmes are needed more than
ever before.
ACTION BY THE HEALTH ASSEMBLY
10. The Health Assembly is invited to note the report.
[ A bigger review of the WHO Essential Drug Programme is available at
WHO/EDM Website:
http://www.who.int/medicines
WB]
--
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'.