|Annual Report 2001 - Essential Drugs and Medicines Policy: Extending the Evidence Base
(2002; 12 pages) [French
Table of Contents
ACCESS: MORE MEDICINES FOR LESS MONEY
Essential medicines must be both available and affordable. Much has been done in recent years to ensure that they are. Price information for medicines is more widely available through WHO and other organizations (Box 3). Local production of some key pharmaceuticals has increased price-lowering competition. Experiences with improved public sector medicines management, contracting out of supply services, and growth of nongovernmental organizations' (NGO) medicines supply services, have shown that access to essential medicines can be improved. In 2001, progress continued, but especially in terms of helping governments to optimize use of financing for medicines.
To help governments investigate and respond to price variations for medicines, a manual for collecting data on drug prices and price composition in low- and middle-income countries was developed jointly by WHO and Health Action International. It will help governments in pharmaceutical policy-making, and offer a standard basis for developing more and better-quality information on drug price variation and trends across countries. Field-testing was 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.
While prices are important, calculating cost-benefit is also crucial since it can help policy-makers and clinicians to make the best use of available resources. An international course on pharmacoeconomic analysis and medicines selection (organized by WHO and the University of Newcastle, Australia) teaches how well-established cost-effectiveness and biostatistical methods can be adapted to help make better choices in medicines selection. Bringing together scientific evidence on clinical outcomes with information on cost, participants learn how to compare the potential health gain from any drug with the next best alternatives. In 2001, the course was held in Hungary, India and Latvia.
WHO medicines price information services
WHO works with several partners to make price information easily accessible to governments, nongovernmental organizations, donor agencies and any institution involved in medicines procurement.
International Drug Price Indicator Guide: Details 252 active ingredients in 448 dosage forms. Indicative prices of generic products on the international market and selected tender prices. Produced by Management Sciences for Health and WHO.
Sources and Prices of Selected Drugs and Diagnostics for People Living With HIV/AIDS: Details 73 active ingredients in 110 dosage forms. Issued by UNICEF, UNAIDS, Médecins Sans Frontières and WHO. Covers antiretroviral (ARV) medicines, HIV/AIDS test kits for diagnosis and ongoing monitoring, and medicines for treating opportunistic infections, for pain relief, for use in palliative care, for the treatment of HIV/AIDS-related cancers, and for managing drug dependence.
Pharmaceutical Starting Materials/Essential Drugs Report: Details over 262 active ingredients. Issued by WHO and the International Trade Centre, a joint WTO-UNCTAD centre.
AFRO Essential Drugs Price Indicator: Nearly 300 essential medicines and dosage forms listed - details provided by 24 Member States and 2 international low-cost essential drugs suppliers. Published by the Regional Office for Africa and the WHO Collaborating Centre for the Quality Assurance of Medicines, University of Potchefstroom, South Africa.
Average Prices of a One Year Treatment with Antiretrovirals in Countries of Latin America and the Caribbean: Survey by Pan American Health Organization of ARV therapy in Latin American countries.
Antiretrovirals in Latin America and the Caribbean: Details of prices and uses of ARV treatments, and access policies for these medicines. Also covers prices by country and by groups of countries.
New research into cost-effectiveness was also initiated, including an analysis of the cost-effectiveness of HIV-related interventions in Africa. This demonstrated the large variation in cost per life-year gained for various preventive and therapeutic interventions. In other words, cost-effectiveness analysis is an essential component of informed debate about priority setting for HIV/AIDS.1 Systematic examination of the evidence on cost-effectiveness of non-communicable disease interventions was undertaken too, with the focus on specific treatments for certain cardiovascular conditions, risk factors such as high blood lipids, chronic diseases such as diabetes, and cancer.
1 See: Creese A et al. Cost-effectiveness of HIV/AIDS interventions in Africa: a systematic review of the evidence. The Lancet, 2002, May 11, Vol 359(9262): 1635-1642.
Expanding access to essential medicines in India
India's population - in 6 territories and 26 states - is around 1200 trillion. Many of the states are larger than most other countries in Asia. So the potential for creating positive pharmaceutical impact is immense. All the more so given that most health care spending is out of pocket and mostly for medicines. (Only a few states, such as Delhi and Himachal Pradesh, distribute the majority of essential medicines free of charge in public facilities. And health insurance coverage is very low at about 3%)
In 1997, WHO expanded its support to the WHO India Essential Drugs Programme. This was so that the Programme could replicate the success of its Delhi Capital Territory essential drugs programme, largely operated by the Delhi Society for the Promotion of Rational Use of Drugs (DSPRUD), in other states. Evidence shows that Delhi's essential drugs programme has had substantial impacts, including a 30-40% reduction in drug prices, as a result of central bulk procurement for 31 hospitals and 150 primary health care centres.
By the end of 2001, the WHO India Essential Drugs Programme was operating comprehensive programmes in 6 states and partial programmes in a further 8 states. Combined, these 11 states have 580 million inhabitants. The bar graphs summarize progress up to the end of 2001 in nine states (Delhi, Maharashtra, Andhra Pradesh, Himachal Pradesh, Karnataka, Punjab, Rajasthan, Uttar Pradesh, West Bengal)
Progress in the WHO-India Essential Drugs Programme 1997-2001: number of, states implementing specific components of an essential drugs programme
As a result of success at state level, changes are now occurring at national level. For the first time, the National Health Policy for India (2001) incorporated rational drug use principles - to promote more equitable access to health care needs - and clinical guidelines for the conduct of clinical practice and delivery of medical services. The Tenth National Five Year Plan, and several national policy-making bodies (the Planning Commission of India, the National Commission on Population and the Indian Council for Research on International Economic Relations) have recognized the value of the Delhi model, and recommended that similar models be adopted by every state government and the national government.
Additionally, DSPRUD has advised on preparation of an essential medicines list, preparation of standard treatment guidelines, and quantification of drug needs for the Uttar Pradesh Health Systems Development Project, funded by the World Bank. Meanwhile, in Delhi, over 70 senior prescribes from the public sector are collaborating on developing standard treatment guidelines for all levels of health care. Many more initiatives for further expansion to other states are planned.
Other work focused on developing medicines financing strategies as part of overall health financing. In 2000-2001 this included work undertaken in more than 35 countries, contribution to a publication on medicines benefits in Latin American social security systems (see Box 6), a regional workshop on medicines reimbursement in the European Region, and country support for quantification of medicines needs and managing medicines benefits in health insurance programmes.
Additionally, a regional consultation was held in the Eastern Mediterranean Region to consider how best its middle-income countries can make the transition from out-of-pocket expenditure to public health insurance. In Kathmandu, a workshop for Indonesia, Myanmar, Nepal and Thailand examined prepayment schemes, particularly in light of the South-East Asian financial crisis of 1997. Myanmar and Nepal have relatively little in the way of public health insurance. But as a result of this workshop, Nepal is now actively exploring the possibility of significantly extending such insurance.
In the Americas, a strategic fund for purchasing medicines and insecticides for targeted diseases (HIV/AIDS, leishmaniasis, malaria and tuberculosis) was established with WHO assistance. It provides for supplier prequalification, standardized criteria for inspection, harmonized medicines specifications, medicines quality surveillance and technical cooperation with countries. These are helping to strengthen medicines selection, distribution and rational use. Eight countries participate in the fund, and many others are expected to participate once they have reviewed and met administrative requirements. In the Caribbean, development of bulk procurement capacity facilitated development of regional antiretroviral (ARV) treatment and care plans.
In the Western Pacific Region, WHO supported collaborative pharmaceutical procurement involving small Pacific island countries through a pharmaceutical bulk purchasing scheme based in Fiji. In 2001, the scheme was extended to include the Cook Islands, Kiribati and the Marshall Islands.
Public health after Doha: understanding the implications of trade issues
The Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health, adopted by the World Trade Organization (WTO) Ministerial Conference, in November 2001, affirmed that the Agreement (known as TRIPS) should be interpreted and implemented so as to protect public health and promote access to medicines for all. This was the first time in the 50-year history of the multilateral trading system that a separate Ministerial Declaration was considered on intellectual property and public health issues.
The declaration enshrines the principle publicly advocated and advanced by WHO over the last four years: namely, that WTO Members have the right to make full use of the safeguard provisions of the TRIPS Agreement, so as to protect public health and promote access to medicines.
Countries receiving technical support 2000-2001 from WHO on how international trade agreements, can influence access to medicines
WHO will continue to assess the public health implications of the Doha Declaration and advise Member States on how to implement the declaration through national legislation. In parallel, 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, is measuring the impact of TRIPS on access to essential medicines. Indicators used cover: changes in pricing; generic competition; investment in research and development; and technology transfer. They also cover use of TRIPS safeguards, such as: provision for use of transitional period; parallel imports; compulsory licensing; and early workings of generics ("Bolar" provisions).
"Ministers of trade, economy, industry and foreign affairs gave a great deal of attention to the issue of access to essential medicines in Doha. This demonstrates the growing appreciation of the importance of international trade agreements for people's lives and well-being."
Director-General Dr Gro Harlem Brundtland, statement after the World Trade Organization's Doha Ministerial Conference, November 2001.
Towards equitable medicines financing in the Americas
Health system reform, including pharmaceutical reform has been in progress throughout the Americas since the 1980s. Pharmaceutical reform has aimed at improving medicines selection, procurement and use. At the same time, more and more health insurance systems have been created in response to populations' health needs. They range from private for-profit organizations, to social security organizations financed with public resources. Between these two extremes, a large number of alternative arrangements have evolved - within the context of managed competition - including private, non-profit insurance companies and public insurance plans.
A WHO study* compared the health reform process and health insurance systems in Argentina, Colombia, Chile, Costa Rica, Guatemala and the United States. Data collected showed that:
• In Argentina, medicines prescribing has been rationalized and positive changes in consumption patterns achieved, resulting in improved control of expenditures and improved quality control.
• In Colombia, a medicines list has been included in the Compulsory Health Plan, experience with bulk purchasing schemes by cooperatives and groups of health service providers has been positive, and generic medicines have been introduced successfully.
• In Costa Rica, a universal health insurance system, based on solidarity, equity and obligation, has been established, together with a Pharmaceuticals policy based on the essential medicines concept. Additionally, a centralized purchasing system has been put in place leading to considerable savings on medicines purchases.
• In Chile, use of generic medicines has been a great success.
• In the USA, the Pharmaceuticals market is regulated effectively. Selective formularies which favour generic medicines are used by many US public health services and major private insurance programmes to establish which medicines must be available. Nevertheless, millions of people lack coverage for their medicines costs and patient co-payments may limit the access of some low-income patients who find it difficult to make the necessary immediate payment.
• In Guatemala, single-dose packaging and specification of dosage by therapeutics committees has been key to successful medicines management in hospitals. As in Costa Rica, centralized purchasing has enabled medicines to be bought at much lower prices than on the general market.
These country examples indicate that a combination of equitable financing arrangements, risk sharing through insurance and reimbursement schemes, wise medicines selection, reliable medicines management and rational medicines use, are all needed to ensure access to essential medicines.
"A health system is not good because of what it spends or because of who spends it. It is good because of the health results that it generates for each unit of money invested."
* Reported in Zerda A et al. Sistemas de Seguros de Salud y Acceso a Medicamentos (Health Insurance Systems and Access to Medicines). Buenos Aires, ISALUD, 2001, ISBN 92 75 32353 4 (ISBN 92 75 12353 5).