E-DRUG: WHO Assembly essential drug paper + resolution
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[The WHO Assembly ("parliament" of WHO, all countries represented by their
Minister of Health, one vote per country) will start its meeting monday.
See http://www.who.int/gb/ for all papers.
On Essential drugs (or essential medicines, as WHO calls them now) there is
a report
from the secretariat (WHO/EDM). See
http://www.who.int/gb/EB_WHA/PDF/WHA55/ea5512.pdf
The Assembly is asked to approve a draft resolution from the WHO Executive
Board, see http://www.who.int/gb/EB_WHA/PDF/EB109/eeb109r17.pdf
Both reproduced below for E-druggers without Internet access. WB]
WORLD HEALTH ORGANIZATION
FIFTY-FIFTH WORLD HEALTH ASSEMBLY A55/12
Provisional agenda item 13.8 28 March 2002
WHO medicines strategy
Expanding access to essential drugs
Report by the Secretariat
1. WHO's work on pharmaceuticals is guided primarily by the WHO medicines
strategy (WHO medicines strategy: framework for action in essential drugs
and medicines policy 2000-2003. Geneva, WHO,
2000 (document WHO/EDM/2000.1)) which was adopted by the Fifty-fourth World
Health Assembly (resolution WHA54.11). The strategy aims to
help to save lives and improve health by closing the huge gap between the
potential that essential drugs have to offer and the reality for millions
of people that medicines are unavailable, unaffordable, unsafe, of poor
quality or improperly used.
2. Within the strategy, four factors are crucial to securing and expanding
access to essential drugs: (1) rational selection and use of essential
drugs; (2) affordable prices; (3) adequate and sustainable financing; and
(4) reliable health and supply systems. The priority areas for 2000-2003
are the major
diseases of poverty, such as HIV/AIDS, tuberculosis, malaria and childhood
illnesses.
3. Overall, considerable progress was made in 2000-2001 on selection and
pricing of essential drugs. This work is being consolidated in 2002-2003,
but more attention will be paid to drug financing, reliable supply systems,
financial sustainability of national drug supply systems, analysis of
options for public financing for drugs, expansion of drug benefits in
health insurance, development of financing sources, and support for access
to medicines in new global mechanisms to address highpriority health
problems such as AIDS, tuberculosis and malaria.
SELECTION
4. The first WHO Model List of Essential Drugs was prepared by a WHO expert
committee in 1977 and revised every two years thereafter. By the end of
1999, 156 Member States had official essential drugs lists. In 1999 the
Expert Committee on the Use of Essential Drugs noted that the
methods for updating and disseminating the Model List needed to be revised.
Hence, following extensive consultations, a revised procedure for updating
the Model List has been drawn up (See document EB109/8).
5. The twelfth meeting of the WHO Expert Committee on the Use of Essential
Drugs, to be held in April 2002, will be the first meeting of the Committee
since the new procedures to update and disseminate the list were discussed
at the 109th session of the Executive Board in January 2002. It is already
possible to follow most of the new procedures. The meeting will receive an
update on the current situation of the new procedures, and discuss the
current status of the WHO Essential
Medicines Library, WHO Model Formulary and the identification of priority
needs for systematic review. Proposed changes to the list and the sections
to be reviewed can be found on the WHO web site
(http://www.who.int/medicines/).
6. WHO clinical guidelines for prevention, diagnosis, and treatment
continue to be regularly updated. During 2000-2001, clinical guidelines for
malaria, sexually transmitted infections, tuberculosis, some
noncommunicable diseases and antiretroviral treatment for HIV/AIDS were
issued.
These guidelines will eventually constitute the basis of the WHO Model List
of Essential Medicines.
7. Creation of a WHO essential medicines library is under way. This
collection is intended to link various sources of information on essential
medicines in an electronic setting. For each essential medicine electronic
links will be made to various elements such as the WHO Model Formulary
(available by end of 2002), WHO clinical guidelines, Management Sciences
for Health/WHO's International drug price indicator guide, the
International Nonproprietary Name database and other information on quality
(basic tests and The international pharmacopoeia).
8. Cost-effectiveness analysis helps to expand access to essential drugs by
enabling policymakers and clinicians to make the best use of available
resources. Such an analysis of HIV-related interventions in Africa, for
example, demonstrated the large variations in cost per life year gained for
various preventive and therapeutic interventions. Systematic examination of
the evidence on the cost effectiveness of noncommunicable disease
interventions has been initiated, with the focus on specific treatment for
certain cardiovascular conditions, risk factors such as high blood lipids,
chronic diseases such as diabetes, and cancer.
9. International, regional and national courses have been held since 2000
on promoting rational drug use (in China, Indonesia, Islamic Republic of
Iran, Kyrgyzstan, Nigeria, Papua New Guinea, Philippines, Tajikistan and
Zimbabwe), on drug and therapeutics committees (in Cambodia, Kenya,
Lao People's Democratic Republic, Nepal and South Africa), on
pharmacoeconomics and drug selection (in Hungary, India and Latvia), and on
promoting rational drug use in the community (in Thailand and Uganda). In
November 2000, health professionals from ministries of health and
healthinsurance institutions from 20 European countries met in Copenhagen
to discuss the promotion of rational drug use. In October 2001 an
intercountry meeting of drugs and therapeutics committees for
the Western Pacific Region was held in Malaysia to evaluate ongoing
interventions and to design innovative ones for rational drug use in
hospitals.
10. Misuse of antimicrobials and unsafe injections contribute significantly
to irrational drug use.In 2001 WHO issued its global strategy for the
containment of antimicrobial resistance (Document WHO/CDS/CSR/DRS/2001.2).
The document summarized the evidence on interventions to promote rational
use of antimicrobials and the
roles of international organizations, national governments, the public,
industry and other important stakeholders. WHO also hosts a secretariat for
the Safe Injection Global Network, which inter alia addresses problems
caused by unsafe and excessive use of therapeutic injections.
PRICES
11. WHO is working with partners to maintain three international price
information services: the International drug price indicator guide covering
over 300 essential drugs (International drug price indicator guide,
Arlington, Virginia, United States of America, Management Sciences for
Health, published annually) ; Sources and prices of selected drugs and
diagnostics for people living with HIV/AIDS (UNICEF, UNAIDS, WHO and
M�decins sans Fronti�res, Sources and prices of selected drugs and
diagnostics for people living with HIV/AIDS, Copenhagen, UNICEF, published
twice a year); and Pharmaceutical starting materials/essential drugs report
(Pharmaceutical starting materials/essential drugs report, Geneva,
International Trade Centre/UNCTAD/WTO, published irregularly). WHO has
initiated a review of the feasibility and effectiveness of
implementing additional systems for voluntary monitoring of drug prices and
reporting global drug prices.
12. In response to requests from Member States, regional price information
services continue to be supported. They include the AFRO essential drugs
price indicator, which compares national tender prices for essential drugs
(AFRO essential drugs price indicator, Brazzaville, WHO, published every
two years) and Antiretrovirals in Latin America and the Caribbean, which
provides information on prices, uses and access policies (Available on the
PAHO web site:
http://www.paho.org/English/HCP/HCA/antiretrovirals_HP.htm)). The Regional
Office for Europe has established a pricing and reimbursement information
network on medicines in Europe and initiated discussions with
countries about systematically linking national drug price information
services for the European Region.
13. Price survey methods. A manual for collecting data on drug prices and
price composition in low- and middle-income countries, developed jointly by
WHO and Health Action International is being prepared. It should support
national policy-making by offering a global standard for producing
more and better-quality information on drug price variations and trends.
Field-testing has been completed in Armenia, Brazil, Kenya, South Africa
and Sri Lanka. Further country studies, and publication and distribution of
the manual, will take place in 2002.
14. WHO actively promotes the concept of differential pricing to increase
access to essential drugs. A WHO/WTO workshop on differential pricing
(WHO/WTO workshop on differential pricing and financing of essential drugs
(jointly organized by WHO, WTO, Norwegian Foreign Affairs Ministry and
Global Health Council), H�sbj�r, Norway, 8-11 April 2001) has been much
cited in subsequent work by Member States, nongovernmental organizations
and the Commission on Macroeconomics and Health.
Participants noted that reductions of up to 95% have been achieved for some
products; that best prices are obtained through bulk purchasing,
competition, skilful negotiation and sound supply management;
and that more widespread differential pricing is feasible. They also
suggested that mechanisms for differential pricing could include: (1)
leaving it to the market; (2) bilaterally negotiated discounts; (3)
regional or global bulk purchasing; (4) voluntary licensing with transfer
of technology;
(5) compulsory licensing; and (6) flexible global systems. Subsequent
discussions in international and national forums have highlighted the need
for differential pricing arrangements to be closely monitored, sustainable
and transparent.
INTERNATIONAL TRADE AGREEMENTS AND ACCESS TO DRUGS
15. WHO will continue to provide independent data and technical assistance
to countries in order to develop informed approaches to dealing with the
health implications of trade issues. WHO has provided up-to-date policy and
technical support to 50 Member States through regional briefings and direct
country support. Between May 2000 and January 2002, six regional briefings
on the Agreement on Trade-Related Aspects of Intellectual Property Rights
(TRIPS) were held in China, Costa Rica,
Indonesia, Poland, South Africa and Zimbabwe. These meetings brought
together, often for the first time, representatives of health ministries,
trade ministries, patent offices, nongovernmental organizations, WTO and
WIPO. The briefings covered: the background to the TRIPS agreement; its
relevance to access to medicines; the role of intellectual property rights
in stimulating innovation; principles of model legislation; and a proposed
framework for implementing safeguards in the TRIPS agreement at national
level and the type of support that this would require. Direct technical
support to countries has been provided on request, for example to China,
Islamic Republic of Iran, South Africa and Thailand. A network of legal
experts with specialized knowledge and understanding of public health and
pharmaceutical impact of international trade agreements is being built as a
resource for developing countries.
16. In June 2000 WHO was granted observer status at the WTO Council for
Trade-Related Aspects of Intellectual Property Rights. In her statement on
the declaration on intellectual property rights and public health adopted
by the WTO Ministerial Conference, in Doha in November 2001, the Director-
General welcomed the conclusion that the TRIPS agreement "can and should be
interpreted and implemented in a manner supportive of WTO members' right to
protect public health and, in particular, promote access to medicines for
all". As instructed in the Doha Declaration, that WTO
Council is to find an expeditious solution to the problem of WTO Members
with insufficient or no manufacturing capacity in the pharmaceutical sector
which could face difficulties in making effective use of compulsory
licensing under the TRIPS agreement. The Council must report to the WTO
General Council before the end of 2002.
17. The network for monitoring the impact of globalization and TRIPS on
access to essential drugs (consisting of WHO collaborating centres in
Brazil, Spain, Thailand and the United Kingdom of Great Britain and
Northern Ireland) formulated draft model indicators for use in studies
measuring the
impact of globalization and the TRIPS agreement on access to essential
drugs. These indicators cover changes in pricing, generic competition,
investment in research and development, and technology
transfer. Case studies on trends in drug patenting have also been
undertaken by the University of Buenos Aires.
18. Cooperation with other international organizations has been
strengthened. Trade issues are systematically discussed with other agencies
besides WTO, such as UNAIDS, UNCTAD and WIPO, and in the Director-General's
round-table process with public-interest nongovernmental organizations and
the research-based industry.
FINANCING
19. Published studies and national health accounts confirm that
pharmaceutical expenditure in developing countries constitutes 25% to 65%
of total public and private health expenditure, and 60% to 90% of
out-of-pocket household spending on health. Because of the magnitude of
drug expenditure and the unique aspects of managing this critical health
resource, WHO devotes considerable attention to drug financing, treating it
as an integral component of overall health care financing.
20. Work on drug financing, undertaken in more than 35 countries during
2000-2001, included contribution to a publication on drug benefits in Latin
American social security systems (Zerda A., Vel�squez G., Tobar F., Vargas
JE. Sistemes de Seguros de Salud y Acceso a Medicamentos, Buenos
Aires, ISALUD, 2001, ISBN 92 75 32353 4), a regional workshop on drug
reimbursement in the European Region, and country support for
quantification of drug needs and managing drug benefits in health insurance
programmes.
21. Drug donations are provided through WHO for the treatment of
onchocerciasis, leprosy, African trypanosomiasis and lymphatic filariasis.
These donations are managed according to specific WHO guidelines. In some
instances, special safety monitoring or other measures are being taken to
ensure safe and effective use of large drug donations.
RELIABLE HEALTH AND SUPPLY SYSTEMS
22. International, regional or national bulk procurement can dramatically
reduce costs and improve monitoring of drug quality. WHO has supported the
Stop TB Secretariat to establish the Global TB Drug Facility, which has led
to substantial reductions in prices for antitubercular drugs. In the Region
of the Americas, a strategic fund for purchasing medicines and insecticides
for targeted diseases (HIV/AIDS, leishmaniasis, tuberculosis and malaria)
has been established. The fund provides for supplier prequalification,
standardized criteria for inspection, harmonized drug specifications, drug
quality surveillance, and technical cooperation with countries to
strengthen drug selection, distribution and rational use. In the Western
Pacific Region, WHO supports collaborative pharmaceutical procurement
involving small Pacific island countries through a pharmaceutical bulk
purchasing
scheme based in Fiji.
23. A project to increase access to high-quality HIV/AIDS drugs, including
antiretroviral agents, will create a unified prequalification programme for
all United Nations organizations. The first list of prequalified innovator
and generic suppliers was published in March 2002 and is being updated
periodically. An analysis of measures needed to correct deficiencies will
help both regulatory authorities and manufacturers to improve product
quality.
24. Work on drug quality control has focused on medicines for high-priority
diseases. An eight country field study on the quality of antimalarials and
the use of rapid screening techniques for drug quality control is in its
final phases. A plan of action is being implemented on the quality, safety
and
efficacy of the four-drug fixed-dose combination for tuberculosis.
Screening tests and monographs for The international pharmacopoeia are
being prepared for antitubercular drugs (including fixed-dose
combinations), antimalarial agents and HIV/AIDS drugs.
25. Good manufacturing practices ensure that pharmaceuticals are produced
according to established standards. Strong, good manufacturing practices
are important for enhancing domestic production. Since the start of a major
initiative to improve such practices, 240 people from more than
40 countries have been trained; relevant training materials have been
translated into Spanish.
EXPANDING ACCESS TO OPIOID ANALGESICS
26. Overemphasis on the dependence-producing characteristics of opioid
analgesics can lead to excessive fear of addiction, underuse for legitimate
medical purposes, and enactment of unduly restrictive regulations on
distribution and use. In 2000, WHO issued a report entitled "Achieving
balance in national opioids control policy" which advocates balanced
control approaches (Document WHO/EDM/QSM/2000.4). A special
issue of the newsletter Cancer Pain Release was produced in collaboration
with the WHO Collaborating Centre for Policy and Communications in Cancer
Care, United States of America, to promote a more balanced approach (New
WHO opioid guidelines put into action, Cancer Pain Release, 2001, 14(1)).
Regulatory barriers to access to opioid analgesics have been lowered in
several countries, including China, India, Italy and Mexico.
27. Import-export controls can limit the efforts of humanitarian
organizations to supply countries in emergency situations with emergency
medical kits containing opioid analgesics. To help to overcome this
obstacle, WHO promotes the application of simplified controls in emergency
situations, by widely disseminating model guidelines for the international
provision of controlled medicines for emergency health care (See resolution
WHA49.18, also endorsed by the Commission on Narcotic Drugs in its
Resolution 7 (XXXIX)).
ACTION BY THE HEALTH ASSEMBLY
28. The Health Assembly is invited to consider adoption of the draft
resolution contained in resolution EB109.R17.