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Medicines in Developing Countries: A Global Health Concern
Policy Date: 1/1/1990
Policy Number: 9022(PP)
I. Statement of the Problem
Production, marketing, sales, distribution, regulation, and education about medicines and their uses is problematic in most parts of the world, but is most acute in developing countries where resources are most scarce. It is especially unfortunate when scarce resources are used for medicines that are known to be ineffective, or inappropriately administered, or peripheral to a nation's health problems. The American Public Health Association (APHA), through its affiliation with the World Federation of Public Health Associations (WFPHA) and its national and international influence, can help remedy this problem.
A. Relevance of the Problem to the APHA
The APHA is a highly supportive member of the WFPHA1 which has a formal relationship with the World Health Organization (WHO) that confers privileges and responsibilities upon its members. Among the responsibilities are: 1) implementation of "the mutually agreed programs of collaboration," 2) utilization of "the opportunities available to them through their normal work to disseminate information on WHO policies and programs," and 3) collaboration "individually or collectively in WHO programs to further health-for-all goals."2 The WFPHA is collaborating with the WHO Program, National Health Systems and Policies.
The Declaration of Alma Ata, adopted in 1978 by the International Conference on Primary Health Care sponsored jointly by the WHO and United Nations Children's Fund (UNICEF), stated that primary health care is the mechanism for attaining the WHO target of "Health for All by the Year 2000."3 The Declaration stated that at least the following should be included in primary health care: education concerning prevailing health problems and the methods of their prevention and control, promotion of food supply and proper nutrition, an adequate supply of safe water and basic sanitation, maternal and child health care including family planning, immunization against the major infectious diseases, prevention and control of locally endemic diseases, appropriate treatment of common diseases and injuries, and provision of essential drugs. The Eighth General Program of Work, covering the period 1990-95, describes the approaches WHO will follow to "promote, coordinate and support the collective and individual efforts by the countries of the world to attain the goal of health for all by the year 2000." The WHO has included among its targets, "By 1995, all countries will have: 1) formulated national drug policies and legislation and strengthened national capability for their implementation to ensure quantification of need, procurement, production as feasible, regular distribution, and improved rationality in the use of essential drugs and vaccines; and 2) ensured availability at the primary health care level of the most needed and affordable essential drugs and vaccines."4 Within WHO, the primary responsibility for achieving this target falls to the Action Program on Essential Drugs and Vaccines.
B. Drug Problems in Developing Countries
Inadequate access to essential drugs and inappropriate use are major problems in developing countries. Inadequate access is a function of inadequate resources and a failure of production and distribution. Inappropriate use is a function of drug promotion practices and inadequate education of health professionals and consumers.
Inadequate Access: Forty percent or more of a developing country's health expenditure may be spent on pharmaceuticals.5,6 Nevertheless, a 1988 WHO analysis indicated that between 1.3 and 2.5 billion people still have no regular access to essential drugs and in many countries the health budget is decreasing because of economic crises.7 If drugs are not produced internally, they must be imported. Drug importation requires foreign exchange and this is increasingly scarce in countries already deeply in debt. Without import controls, the number of drugs imported is usually in the thousands. In Bangladesh, legislation requiring the removal of useless and harmful drugs resulted in the reduction of the number of drugs imported from 4,000 to 2,700 with a basic list of 250 generic drugs recommended for public hospitals and clinics.8 From 10,000 to 15,000 drugs authorized in 1964, Algeria reduced its number to 1,800 of which 534 were termed "strategic."9 In the early 1970s, Sri Lanka reduced the number of imported drugs from 2,100 to 600.10 However, the lesson learned in Sri Lanka, as its socialist government moved to the right, was that regulatory reforms can be overturned without a stable committed government.11
To help meet their drug needs, control drug costs, and increase access of all the population to essential drugs, developing countries need to rationalize their supply, procurement, and distribution systems.12 It helps little to have an essential drugs list if the drugs are not available when and where they are need.
Inadequate access to drugs is partly due to failure to rationalize limited drug budgets. Rationalization means removal of unsafe, out of date, and ineffective drugs, use of drug formularies, extended use of generic names, bulk purchasing, adequate supply and distribution, control of drug diversion, local and/or regional drug production, development of schemes to finance drug costs, and local and/or regional drug production.12 Achieving rationalization is complex and difficult. For example, local production does not guarantee the lowest price, or that only essential, safe, and efficacious drugs will be produced, or that distribution will be adequate.
Inappropriate Use: There is an expanding literature documenting extensive misuse of medicines in developing countries.13-24 Drug promotion is often uncontrolled. Drug prescribers, sellers, and users are poorly educated about medicines.
One problem is that the demarcation between traditional and Western medicines is disappearing. Western medicines are becoming "indigenized" into local traditional medicine practices,25 but efficacy is frequently perceived to be based on color, consistency, taste, shape, size, cost, packaging, and reputed success in treating similar symptoms or in treating problems in similar parts of the body.13,15,23,26 The misuse of antibiotics and perceived superiority of medicines administered by injection is extensively documented22 Polypharmacy is endemic.17,19,23 Many countries have shortages in health manpower and physicians trained in different countries with different therapeutic environments have different diagnostic and treatment practices.27 The pharmaceutical industry has a disproportionate influence in consumption through advertising and sales representatives and through the confusing profusion of brand name products.15,16,21,28-34
Unfortunately, there is rarely an organized system of drug information.28 The public lacks information on the proper use of medicines and is not protected by an adequate drug distribution, regulatory, and enforcement system, and prescribers and drug sellers often lack training in appropriate medicine use.16,20,31-33,35 Thus, antibiotics may be bought freely over-the-counter in units as low as a single capsule. Medicines are often sold unlabeled and without information on how they should be taken.16 Impoverished parents buying worthless "growth" tonics for their children would more profitably buy them food.24,36,37
The problem of antibiotic resistance is now widely recognized and perceived as a global health problem.38,39 The misplaced belief in the superior efficacy of injections39,40 has taken on new importance since the advent of aquired immunodeficiency syndrome (AIDS) as a global health threat, and the recognition that needle sharing is one of the most common vectors of human immunodeficiency virus (HIV) transmission. The problem of injections is not limited to Africa but has been documented in El Salvador,29 the Dominican Republic,41 India,18 Vietnam,42 Taiwan,43 Indonesia,43 and Thailand.44
Despite more than a decade of criticism,33 promotional practices to both doctors and consumers in developing countries remain of great concern.39 For example, in Tanzania there is one manufacturer's representative for every four clinicians, six times the number in Great Britain.44 Moreover, doctors often both prescribe and dispense, a system which encourages the prescription of those drugs providing the biggest profit margin rather than those that are most appropriate in view of the patient's condition.
In summary, irrational, wasteful, and even dangerous medicine use is a serious problem in developing countries, and it is important to work to solve it through the drug regulatory systems. However, because the majority of developing countries import most of their drugs but lack the infrastructure for effective regulation, international standards are needed relative to safety, efficacy, labeling, and promotion. Such standards should be encouraged for drugs manufactured internally as well. Education of health care providers and the public is very important. There is a substantial communications gap among the public which uses medicines and those involved in prescribing, dispensing, administering, and regulating, and there are few opportunities for the public to become educated about medicines.
C. Solutions to the Problems
Programs supported by the WHO's Action Program on Essential Drugs and Vaccines (WHO/DAP) are a primary mechanism promoting access of the world's people to essential drugs at an affordable cost. Other efforts include promoting ethical criteria for drug marketing and promotion, local or regional drug production, and cost recovery. WHO/DAP assists countries that request help if funds are available. Transnational problems require global cooperation.
Action Program on Essential Drugs and Vaccines (WHO/DAP): A model essential drugs list, first produced in 1977 by a WHO Expert Committee on the Selection of Essential Drugs, identified about 220 drugs "proven to be therapeutically effective, to have acceptable safety and to satisfy the health needs of the population."5 The essential drugs list, updated biennially, serves as a guide to countries who use it to create their own lists depending on their morbidity patterns. In 1981, WHO established the Action Program on Essential Drugs and Vaccines (WHO/DAP) to help developing countries select, procure, distribute and rationally use essential drugs. WHO/DAP also assists developing countries to develop comprehensive drug policies. Currently, in addition to internal management and communications, WHO/DAP has activities in three areas: country support, development, and operational research, with country support predominating.27
Country support has been received by 90 countries in five regions which have components of an Essential Drugs Program (EDP).27 In addition to an essential drugs list, a fully operational Essential Drugs Program includes the following elements: drug policy formulation, personnel training, drug procurement and distribution mechanisms, quality assurance, financial resource generation, technical cooperation with other developing countries, and operational research to evaluate and improve program impact. In the African Region, 37 countries have adopted an essential drugs list and, of these, 20 are considered to have completely operational EDPs. In the Region of the Americas, 28 countries have essential drugs lists with 13 having operational EDPs. In the Eastern Mediterranean Region, 21 countries have essential drugs lists and of these, eight have operational EDPs. In the Western Pacific Region the comparable numbers are 14 and three respectively and in the Southeast Asian Region they are 11 and eight.
The most common steps taken when a country is at the initial stage of developing an EDP are: 1) prepare a situational analysis; 2) hold a national seminar to select priorities and identify constraints; 3) prepare an action plan; 4) secure funding.28 WHO/DAP staff is available to help with these steps. After implementation begins and upon request, staff members from WHO regional offices and from headquarters identify consultants, give technical and administrative support, monitor progress, report to funders, and initiate evaluations. These activities are coordinated with WHO regional offices.
The objective of the development area of WHO/DAP is to provide training, guiding principles, methodologies, publications and training materials for developing and implementing national drug policies and programs.28 These include technical support to estimate drug requirements, to secure financing, and to produce drugs locally. A current effort involves the compilation and distribution of recent international drug sales to assist countries in tendering bids. Another effort involves development and support of a computer system that will enable countries to get the most current information about individual drugs including any regulatory action taken in the country in which they are manufactured.
The objectives of the operational research area are to provide WHO/DAP with information on ways to achieve its goals, improve the performance of the national EDPs, and strengthen research capabilities in developing countries.
The Program on Essential Drugs and Vaccines is supported almost entirely by extrabudgetary contributions from outside donors, most of which are dedicated to specific countries and/or activities.27 For the years 1980-89, of a total budget of $36.1 million, 87.2 percent was supported by extrabudgetary funds to which the United States did not contribute. Therefore, although the United States is a major supporter of the regular WHO budget (estimates range to 25 percent) through the regular budget of the WHO,4 its support of WHO/DAP was no more than 3.2 percent during the last decade and no more than 1.2 percent in 1988-89. The major donors to the extrabudgetary funds have been Denmark, Finland, Italy, The Netherlands, Sweden, Switzerland, Norway, and the United Kingdom. The dependence of WHO/DAP on extrabudgetary sources means that funding is almost always uncertain and that WHO/DAP personnel must spend time seeking funding for projects they wish to support. It also means, however, that the failure of the United States to meet its financial obligations to the WHO (and the UN) in full and on time, as has happened in recent years, has had little financial impact on the Program.
Marketing Ethics: Although in 1988 the World Health Assembly endorsed ethical criteria by which drug promotion could be judged,45 and the pharmaceutical industry has its own code of ethics, without regulatory authority, drugs continue to be promoted that are either useless or harmful.46 The international pharmaceutical industry is represented by the International Federation of Pharmaceutical Manufacturing Associations (IFPMA). Since 1981, its constituent associations, and thereby their member companies, and by extension all of their subsidiaries, have been bound to a voluntary code of ethics47 which is intended to ensure that: 1) all products are manufactured according to adequate procedures and strict quality assurance; 2) qualities claimed for products are based on valid scientific evidence; 3) factual and honest information is provided about them to public health officials, health care professionals, and the public.
The major limitations of this code are that the IFPMA has no enforcement powers and it does not cover drugs licensed for sale without prescription. It is up to national authorities to punish code violators and for individual national associations to expel companies which fail to abide by the code. Adverse publicity is the major weapon used by consumer groups and the WHO to bring about changes in drug marketing practices by multinational drug companies.46 Progress has been made in removing dangerous drugs from the market and in bringing the labeling for contradictions in conformity with laws in developed countries, but very much less progress has been made in regard to efficacious drugs that are promoted inappropriately. Developing countries simply do not have the ability to enforce codes of ethics and regulations,48 or to control advertising that better protects consumers in developed countries.
Enforcement of the IFPMA code will not completely solve the problem. Similar enforced codes of ethics and regulations are needed for drug manufacturers operating within individual countries and regions.
Drug Production: Less than 10 percent of the world's drugs are produced in developing countries and, of these, six countries produce two-thirds.7 Seven developed countries, predominately the United States, produce 90 percent of the rest. Almost all drug exports (94 percent) come from developed countries and 36 percent of all imports are into developing countries. Production is in terms of finished products or raw materials. To increase local ownership and decrease their need for imports, developing countries are encouraging joint ventures between foreign and local companies, but often there is a conflict between health policy and economic policy.11,49 The same economic incentives driving multinational drug companies may also lead to the production and promotion of inefficacious, unsafe, or unneeded drugs by local companies.
The WHO/DAP supports a Production Advisory Group (PAG). The PAG hopes to be able to provide teams of production experts on small-scale pharmaceutical production, quality control, and assessment of technical and economic viability.
Cost Recovery: Although external funding may be available to start an Essential Drugs Program in a developing country, mechanisms are needed to make the programs self-sufficient and to replenish drug supplies.50 The Bamako Initiative, sponsored by WHO/UNICEF, is designed to respond to the widespread concern about the long-term sustainability of health services, and aims to revive and expand peripheral health services for the delivery of maternal and child health care. It considers community financing with funds managed by the communities themselves as an essential contribution to the local costs of providing health services, covering some recurrent costs, including drugs and supplies, operating expenses of local facilities, and incentives for local health workers. This approach is intended to provide a means for community decision-making in the management of local health services.51-53 The funds received are to be used to replenish drug stocks with extra income used to pay for other health services. The objectives of the strategy are to: 1) strengthen local financing and management of primary health care through user-financing and cost recovery schemes; 2) strengthen the essential drug system; and 3) ensure the financing of recurrent costs. The proposed system of user charges has advantages and disadvantages.
The advantages are: 1) income can be used for other priority health services such as maternal and child health; 2) the availability of essential drugs is improved; 3) fees may decrease the use of health services for unnecessary services; 4) services may be better adapted to local needs.
The disadvantages are: 1) the poor may not be able to afford to pay; 2) people may only be willing to pay for curative rather than preventive services; 3) the revenue may be very little; 4) people may increase inappropriate self-care and use of traditional healers and unlicensed drug sellers; 5) some drugs may be less expensive from other sources; 6) the infrastructure needed to run the complex program may not be available at the community level; 7) overprescribing may result if the prescribers jobs are dependent upon the income generated from drug sales.
Communities throughout sub-Saharan Africa are assessing their capacity to implement the Bamako Initiative. The Bamako Initiative and other cost-recovery schemes will need monitoring and evaluation for their impact.
The purpose of this position paper is to build a consensus among a variety of public and private organizations on the need to provide strong support to the WHO to help it achieve its goal of ensuring that all the peoples of the world have access to essential drugs of acceptable quality and affordable cost, and have the information required for their rational prescription and use.
The goal of this initiative is to increase support both for Essential Drugs Programs and for the promotion of rational drug use as essential components of primary health care in developing countries, and to increase recognition of the central role of the WHO Program on Essential Drugs and Vaccines. This goal is consistent with policies urged by the APHA as early as 1979.54 The specific objectives are:
A. Relative to the Pharmaceutical Industry:
1. Ensure that the ethics code of the IFPMA is applied to exported drugs and that all possible pressures are brought to bear upon violators by both the IFPMA and the national authorities of all countries.
2. Support enforcement of codes of ethics and drug regulations for locally manufactured drugs.
B. Relative to the WHO Program on Essential Drugs and Vaccines:
1. Institutionalize financial support so that the Program is less dependent on the uncertainties and restrictions associated with donor funds to support its activities;
2. Ensure that the 1989 reorganization within WHO which resulted in the reduction in rank and authority of the Program Director will not adversely affect the vigor, initiative and creativity heretofor associated with the Program.
C. Relative to Member States of the WHO:
1. Ensure that exported drugs meet accepted standards of safety, efficacy, and labeling.
2. Support the WHO's commitment to guidelines on ethical criteria in drug promotion45 and ask all governments and pharmaceutical manufacturers to implement and enforce such criteria.
3. Provide technological and financial support for workshops in developing countries to train health personnel to implement and administer Essential Drugs Programs.
4. Provide technological and financial support for the routine collection of epidemiological data needed to estimate drug requirements and for systems of drug use review in developing countries.
5. Provide technical assistance for evaluation of drug cost recovery schemes, particularly the Bamako Initiative.
6. Provide technical assistance for development of local and regional drug production capabilities.
7. Assist developing countries to develop and disseminate drug education materials for health professionals and for the population especially relative to antibiotics, injections, immunizations, oral rehydration therapy, vitamins and tonics, drug storage, and compliance.
IV. Methods for Implementation by APHA
Each of the desired action areas represents an opportunity for APHA to fulfill its international responsibilities through the following:
A. Promote the desired actions through its formal association with the WFPHA and collaboration with the WHO Program, National Health Systems and Policies.
B. Use the resources at its disposal to establish an ad hoc advisory group which can formulate specific policies and mechanisms to assist APHA to promote the desired actions through the WFPHA, the WHO, other organizations, and the United States Congress.
C. Develop and clearly communicate APHA's position on the desired actions to international, national and local audiences. These include health-related international organizations, national organizations, trade associations and professional associations, pharmaceutical companies, the APHA membership, and the public.
D. Develop strategies to induce all transnational drug companies, especially those based in the US, to cooperate with the WHO to achieve its goals relative to Essential Drugs Programs in developing countries.
E. Educate the US Congress about APHA's position, encouraging legislation that would support the desired actions, especially relative to export controls, technical support, payment of the US contribution to the WHO in full and on time, and the extrabudgetary needs of the WHO/DAP.
F. Establish an ongoing mechanism to monitor the global drug situation and health impact relative to drug access and rational use.
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