E-DRUG: WHO report on essential medicines
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[WHO is having its annual Assembly in Geneva this week. One of the many
reports that is being discussed (see www.who.int/gb) is a report on the
medicines strategy (http://www.who.int/gb/EB_WHA/PDF/WHA56/ea5616.pdf ) For
those without Internet access here is the text. At the moment there is no
resolution planned on this topic. There is however a report and proposed
resolution on traditional medicines. Your E-drug team will be monitoring the
proceedings, and we hope to report later in the week on the outcome. WB]
WHO medicines strategy: progress report
Report by the Secretariat
BACKGROUND
1. In 1975, the Health Assembly introduced the concepts of �essential drugs�
and �national drug
policy� (see resolution WHA28.66). The Declaration of Alma-Ata in 1978
identified provision of
essential drugs as one of the eight elements of primary health care. On 21
October 2002, WHO
commemorated the twenty-fifth anniversary of the first WHO Model List of
Essential Drugs, which
stated that a limited range of medicines selected to meet priority health
needs would lead to better
health care, better drug management, better use of financial resources, and
thereby greater access to
care.
2. When the first Model List was produced in 1977, the national drug policy
concept was scarcely
known. Few countries had what would today be considered an essential
medicines list. The approach
to selection of medicines for health services was relatively informal.
Independent, unbiased
information on medicines was limited, with little attention paid to
systematic teaching about rational
prescribing and generic prescribing. Publicly available price information
was virtually non-existent,
and few countries encouraged generic substitution. Regulation of drug
promotion was haphazard, with
no international criteria for ethical promotion. A network of national
centres monitored the safety of
medicines, but it had limited membership and insufficient support
structures. Standards for good
manufacturing practices had been developed, but were rarely adhered to
outside industrialized
countries.
3. Today, more than 100 countries have national drug policies in place or
under development, and
156 Member States have national or provincial essential medicines lists.
More than 130 countries have
developed national treatment guidelines and/or formulary manuals to provide
objective guidance on
rational medicines use. More than 80 countries have introduced the essential
medicines concept into
curricula for medicine and pharmacy students. The WHO Guide to good
prescribing1 has been
translated into 18 languages. Generic competition is encouraged in scores of
countries. More than a
dozen countries provide price information on public web sites. WHO, with
other partners, maintains
pricing services for essential medicines, for active ingredients, and for
HIV-related medicines. The
WHO Programme for International Drug Monitoring now includes 76 Members and
Associate
Members, and a global effort has been mounted to assure the quality of
pharmaceutical production
worldwide.
4. WHO�s work on pharmaceuticals is guided primarily by the WHO medicines
strategy:
framework for action in essential drugs and medicines policy 2000-20031 (see
resolution WHA54.11).
The strategy aims to maximize the potential of essential medicines2 to save
lives and improve health
status and has four strategic objectives: to promote rational use; to
increase quality and safety of
pharmaceuticals; to improve access to essential medicines; and to provide
support for development
and implementation of national medicines policies. This report highlights
some of the key
developments and activities of 2002.
RATIONAL USE
5. The WHO Expert Committee on the selection and use of essential medicines
met in April 2002
to produce the twelfth WHO Model List of Essential Medicines.3 This was the
first meeting under new
procedures. These involve linking selection directly to treatment
guidelines, preparing systematic
reviews of the clinical evidence for proposed choices, making this evidence
publicly available before
decision-making meetings, allowing stakeholders to comment on proposed
changes in the list, making
final decisions in a closed meeting of independent experts, and publicly
documenting the reasons for
each decision.
6. The twelfth WHO Model List of Essential Medicines includes 12
antiretroviral medicines.
Information on antiretroviral agents appears in the first WHO Model
Formulary.4 Other efforts to
promote the most effective use of HIV/AIDS medicines included the
preparation and drafting of a
handbook on access to HIV-related treatments for use by nongovernmental
organizations and
community-based organizations, in collaboration with UNAIDS and the
International HIV/AIDS
Alliance.5 Also, the preparation of three training modules on the role of
pharmacists in HIV prevention
and care was in progress in collaboration with the International
Pharmaceutical Federation.
7. Promotion of rational use of medicines included developing guidelines for
national tuberculosis
programmes on use of fixed-dose combination antituberculosis medicines. A
new model for
containing antimicrobial resistance was piloted at four sites in India and
two sites in South Africa.
Work was also initiated to harmonize medicines for reprodutive health
included in the draft UNFPA
Interagency Reproductive Health Medicines and Commodities List, and those
included in the WHO
Model List of Essential Medicines. Cost-effectiveness analysis was
undertaken of HIV-related
interventions in Africa.
8. International, regional and national courses were held in 2002 on:
promoting rational medicines
use (Manila, 4-15 March; Tehran, 14-17 June); promoting rational medicines
use in the community
(Bangkok, 3-16 November); promoting drugs and therapeutics committees (East
London, South
Africa, 5-13 February; Mumbai, India, 23 September � 2 October; Amman, 10-19
December);
application of pharmacoeconomics (Antalya, Turkey, 2-13 September; Bali,
Indonesia,
24-26 September; Vilnius, 15-19 October); and rational medicines selection
(Algiers,
16-27 September).
9. In 2001, the Pharmacy-based Hypertension Management Model, elaborated by
the EuroPharm
Forum Network of pharmaceutical associations and the Regional Office for
Europe, was tested and
implemented in Estonia, Latvia, Lithuania, Portugal, Slovenia and Spain.
Evaluation in 2002 showed
that pharmacists can contribute to improved use of health care services by
screening patients for high
blood pressure, undertaking regular measurement of blood pressure and
counselling patients. Also in
the European Region, a survey funded by the European Union to ascertain
pharmacists� smoking
habits and their interest in smoking cessation activities was carried out in
12 countries of the European
Union. Results were published in February 2002 in a research report, which
shows that community
pharmacies are increasingly involved in smoking cessation activities.1
QUALITY AND SAFETY
10. The Tenth International Conference of Drug Regulatory Authorities took
place in Hong Kong
Special Administrative Region, China, in June 2002. Recommendations covered
herbal medicines,
homeopathy, regulatory reform, medicines safety, counterfeiting, access to
medicines and vaccines,
regulation of clinical trials, harmonization, new technologies and
e-commerce. The document on the
impact of implementation of International Conference on Harmonisation (ICH)
guidelines in non-ICH
countries was distributed at the meeting.
11. Several activities were undertaken to enhance the impact of the work of
medicines regulatory
authorities. This included support to medicines regulatory authorities on
computer-assisted medicines
registration, and field-testing of a common data collection tool (to assess
medicines regulatory
functions) in Bhutan, Brazil, Bulgaria, India, Islamic Republic of Iran,
Japan, Malaysia, Morocco,
Poland, South Africa, Sri Lanka, Tunisia, Ukraine and Viet Nam. An
International Comparative Study
on Regulatory Drug Information to compare information on medicines approved
by national
authorities, was completed in 26 countries.
12. A project to increase access to HIV/AIDS medicines of assured quality,
including antiretroviral
agents, is creating a unified pre-qualification programme for organizations
of the United Nations
system. A list of pre-qualified suppliers was issued in March 2002.3 The
project has been expanded to
first-line medicines for the treatment of tuberculosis (on behalf of the
Global Drug Facility) and
antimalarial agents (on behalf of Roll Back Malaria). Three training
workshops were held in 2002 to
assist drug regulatory authorities: in Africa (on generics, South Africa,
June), the Americas (United
States of America, April) and Asia (India, September), which concentrated on
the evaluation and
registration of antiretroviral agents.
13. Work to promote quality of multiple-drug, fixed-dose combination
antituberculosis medicines
included collection of samples, collation of technical information and
testing of draft monographs.
Screening tests for antituberculosis medicines and all single-dose
antimalarial medicines were also
prepared. Phamacopoeial monographs are being drafted for antiretroviral
agents and collaboration
with the IAEA was initiated on developing specifications for
radiopharmaceutical materials.
14. Training in good manufacturing practices was held in Viet Nam (20-27
July 2002). A national
training course for inspectors and manufacturers of medicines on
implementation of good
manufacturing practices and inspection was held in Addis Ababa (3-7 June
2002) and also in Harare
(27-29 October 2002). Efforts to improve medicines safety also focused on
producing a multicountry
plan to fight counterfeits in the Greater Mekong subregion, at a meeting in
Thailand (11-13 November
2002).
15. Pharmacovigilance was promoted through issue of a document on safety of
medicines: a guide
to detecting and reporting adverse drug reactions � why health professionals
need to take action1 and a
publication on the importance of pharmacovigilance.2 A workshop in Australia
on pharmacovigilance,
in November 2002, attended by 28 participants from 16 countries, was held to
increase understanding
among Western Pacific countries of matters related to the reporting of
medicines safety. Three more
countries � Latvia, Peru and Ukraine � became full members of the WHO
Programme on International
Drug Monitoring (established in 1968 in the wake of the thalidomide disaster
and formalized into a
WHO programme in 1970), bringing the total number of Member countries to 68.
An international
board was established for the WHO Collaborating Centre for International
Drug Monitoring (Uppsala,
Sweden).
ACCESS
16. WHO continues to promote differential pricing to improve affordability
of essential medicines.
An analysis of evidence on the effectiveness of a variety of alternative
mechanisms for achieving
prices related to purchasing power of individuals and countries was carried
out in cooperation with the
Department for International Development of the United Kingdom of Great
Britain and Northern
Ireland.
17. To provide support to countries in conducting their own price surveys
and improving the quality
and availability of price information, a manual for surveying medicines
prices, price composition and
the affordability of key treatments in low- and middle-income countries was
prepared in collaboration
with Health Action International. As a standard basis for monitoring
medicines price variation and
trends, it will contribute to national pharmaceutical policy-making.
18. Work on medicines financing included publication of case studies from
the Americas on health
insurance systems and access to medicines.1 In Europe, with the support of
the European Union Health
Monitoring Programme, a project started to map out patterns in medicines
consumption, expenditure
and pricing in 15 western European countries. Additionally, technical
support was provided to the
national country pharmaceuticals programmes of Bulgaria, Romania and Turkey
for review of
reimbursement policies.
19. With respect to international trade agreements and access to medicines,
WHO continues to
provide policy and technical support to Member States. A meeting was held in
Yaound� in May 2002
with member countries of the African Organization for Intellectual Property
to discuss the Doha
Declaration, the Revised Bangui Agreement, and the WTO Agreement on
Trade-Related Aspects of
Intellectual Property Rights (TRIPS).
20. WHO issued a document2 analysing the question of use of the TRIPS
agreement�s provisions on
compulsory licensing by countries with insufficient or no pharmaceutical
manufacturing capacity. The
underlying public health principle is that the people of a country that does
not have the capacity for
domestic production of a needed product should be no less protected by
compulsory licensing
provisions (or any other TRIPS safeguards), nor should they face any greater
procedural hurdles, than
people living in countries capable of producting the product. Other work
relating to international trade
agreements and health included a report on the network for monitoring the
impact of globalization and
TRIPS on access to medicines.3 This document outlines model indicators for
studying the impact of
globalization and TRIPS on access to essential medicines in relation to
changes in pricing, generic
competition, investment in research and development, and technology
transfer.
21. Considerable work was undertaken to improve medicines procurement.
International training
courses on procurement of antituberculosis medicines were held in Nairobi
(September 2002) and in
Jakarta (June 2002). Practical guidelines on pharmaceutical procurement for
countries with small
procurement agencies4 were published to demonstrate how such agencies can
minimize costs and
ensure product quality.
22. The initial phase of a multicountry study on best practices in public
sector medicines supply in
Africa was completed. Additionally, a tool was devised to study the
involvement of faith-based
nongovernmental organizations in medicines supply and distribution.
POLICY
23. Strengthening of human resources capacity in pharmaceuticals continued.
In Africa, by the end
of 2002, national programme officers had been recruited for Cameroon, Chad,
Ethiopia, Ghana, Mali,
Nigeria, Rwanda, Senegal, Uganda and the United Republic of Tanzania. In the
Eastern Mediterranean
Region, a national programme officer was recruited for Afghanistan.
24. In Africa, national programme officers are working with their ministry
of health counterparts on
pharmaceutical situation surveys to ascertain whether existing national drug
policies require
modification or reinforcement. By the end of 2002, surveys had been carried
out in Ethiopia, Ghana,
Mali, Nigeria, Uganda and the United Republic of Tanzania. Also in Africa,
WHO continues to work
with Health Action International on a six-year programme (2001-2006) to
improve national drug
policy implementation.
25. The joint WHO-India Essential Medicines Programme was started in 1997,
based on experience
with the medicines policy programme of Delhi State Capital Territory. By the
end of 2002, the
programme supported the public sector in 11 other states in India, with
intensive capacity-building
programmes. An essential medicines programme was launched in Afghanistan. It
is focusing on issues
relating to medicines donations, updating the national list of essential
medicines and developing the
pharmaceutical capacity of the Ministry of Health.
26. The 2002 WHO international drug policy course on tackling issues
relating to national drug
policy development and implementation was held in Tashkent, from 27 October
to 8 November. It was
organized in collaboration with the Ministry of Health of Uzbekistan, the
United States Agency for
International Development and Boston University School of Public Health
(United States of America)
and attended by 40 people, including participants from all the Newly
Independent States and several
countries of central and eastern Europe.
ACTION BY THE HEALTH ASSEMBLY
27. The Health Assembly is invited to note the information contained in this
report, which was
discussed and noted by the Executive Board at its 111th session in January
2003.
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