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SETTING THE SCENE: THE ESSENTIAL DRUGS CONCEPT SESSION NOTES PURPOSE AND CONTENT A growing number of pharmaceutical products are available on the world market and there has been an increase, both in the consumption of drugs, and in expenditure on them. In spite of this, many people throughout the world cannot obtain the drugs they need. There are also many people who have access to drugs but who do not get the right drug, in the right dosage, when they need it. The essential drugs concept was developed in response to these problems and continues to be central to policies and strategies which aim to address them. The essential drugs concept is central to the development of a national drug policy. This session provides an introduction to the essential drugs concept. A short overview of the context in which it was developed and adopted is given. This includes a brief description of the main elements of primary health care (PHC) and the role of essential drugs. A short account of the current world drug situation follows, which includes problems relating to access to essential drugs and to irrational use. Current trends and challenges are discussed including the growing role of the private sector; changes in disease patterns; and the roles and interests of different actors. OBJECTIVES Upon completion of the module participants will be able to: 1. Understand the essential drugs concept in an historical perspective and in relation to primary health care. 2. Recognise the main components of national drug policy. 3. Identify the major actors in the pharmaceutical context and discuss the roles they play. 4. Recognise some of the main trends and challenges in the world drug situation today. PREPARATION 1. Read the Session Notes. © World Health Organization 2002 Setting the scene: the essential drugs concept Session Notes A. ESSENTIAL DRUGS – AN HISTORICAL PERSPECTIVE A1. Pharmaceuticals in history Pharmaceuticals are relatively new. Evidence-based medicine is even newer. The history of medicine goes back thousands of years and varies from continent to continent. But people have always (as long as records go back) attempted to influence their health and avoid or cure illness through the use of traditional medicine and herbal medicines. Many people all over the world turn to alternative, complementary and traditional medicine to maintain health or combat illness. However this course concentrates, to a large extent, on the use of pharmaceutical products – industrially produced medicines. Pharmaceuticals and pharmacotherapeutics are relatively new. If we go back just a hundred years we enter an age in which modern therapeutic medicine, as we know it, was in its infancy. When discussing drug use and drug policy today it is useful to have some idea of the historical development of the pharmaceutical industry and the place which pharmaceutical products have in health care. Current debates about drug policy and drug use are easiest to understand if we look at them in the context of: Changing ideas about health and health care services and systems; The development of the pharmaceutical industry from small beginnings at the start of the 20th century into one of the most powerful industrial sectors by its end. In the West, during the 19th century, there was an increasing concern with hygiene and a growing understanding of public health principles. However, the understanding of pharmacotherapy was very limited and there were few effective or safe medicines. Many common therapeutic interventions were hazardous and most were without any scientific basis. A2. The development of modern pharmacotherapy Before World War II there were relatively few effective medicines. Pharmaceuticals as we know them now hardly existed. Smallpox vaccination was one of few effective measures available before the turn of the century. Around that time aspirin became available and was mass-produced. The pharmaceutical industry has its origins in pharmacy, chemistry and microbiology (see Chetley (1990) A Healthy Business. Zed Books, London). Historically: Pharmacy started with herbal medicines and patent remedies. Chemical innovation during the 19th century (centred around the dye industry in Germany) led to the extraction of alkaloids and synthesis of organic compounds. 2 Setting the scene: the essential drugs concept Session Notes Increased understanding of germs and bacteria led to the development of compounds, which could kill bacteria and cure disease. (Salvarsan, an arsenic compound, was synthesised in 1910 and used to treat syphilis). Penicillin was identified in 1928 but not really recognised until 1939 when it ushered in the era of antibiotics. After World War II developments came rapidly. Early landmarks in drug development 1941 1943 1944 1948 1954 1955 - Penicillin Chloroquine Streptomycin Tetracycline and chloramphenicol Sulphonylureas (diabetes) First oral contraceptive trials A3. Problems in providing access The new breakthrough drugs were only available to a privileged minority. In spite of the rapid growth of the industry and the rapid proliferation of brand name drugs most people lacked the means to buy them. This led to the development of a market characterised by the following factors: Differences between rich and poor countries; Differences between urban and rural populations; Proliferation of brand name products; Lack of information/evidence about therapeutic value. A4. Miracles turn into disasters In addition to these elements there was almost no regulation of drugs, little understanding of how to measure their efficacy, and scant appreciation of potential risks. High expectations coupled with an optimistic view of possible benefits and ignorance about side effects created a dangerous situation. Lack of regulation and adequate safety measures resulted in a series of disasters, including: 1930s Sulphanilamide scandal resulted in the establishment of US Food and Drug Administration (FDA). In 1937 at least 73 people died as a result of taking a sulphanilamide elixir containing ethylene glycol. The resulting public outcry resulted in the establishment of the US Food and Drug Administration and to requirements for drug safety testing. (Only in 1962 were regulations tightened to require proof of efficacy) 1960s Thalidomide (8,000 children in 46 countries seriously handicapped) 1950 - 1970s Diethylstilbestrol (DES) tragedy 1970s Clioquinol caused widespread neurological disease in Japan. 3 Setting the scene: the essential drugs concept Session Notes A5. Major challenges became evident This situation brought out a number of distinct challenges to be met. The first was to make useful drugs widely available. Secondly to make sure that drugs were properly used in such a way that their benefits can be maximised and risks minimised. Thirdly to harness drug development to serve the needs of public health and the people who need them most. These challenges have stayed with us and are at the core of the drug policy debates occurring during the last three decades. “Thirty years ago modern health technology had just awakened and was full of promise. Since then its expansion has surpassed all dreams, only to become a nightmare. For it has become over sophisticated and over costly. It is dictating our health policies unwisely; and what is useful is being applied to too few.” Halfden Mahler, then WHO Director-General addressing the World Health Assembly in 1978. Frustration about proliferation of pharmaceutical products and inequitable access led to the development of the Essential Drugs Policy. A6. Essential drugs Essential drugs are those that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms (WHO). The essential drugs concept was not any one person’s discovery but was developed out of a number of experiences in countries seeking to meet the challenges described above. 1940s Norway defined a list of priority drugs which should be made available to everyone by state health services. 1960s and early 70s Sri Lanka, Cuba, and Costa Rica experimented with lists of essential drugs and bulk procurement. 1974 The UN adopted a resolution and programme of action of a New International Economic Order which introduced a new concept of, and commitment to development. The International Labour Organization (ILO) adopted the idea of defining basic needs. This concept provided a focus for countries trying to ensure equitable access to essential goods and services. 4 Setting the scene: the essential drugs concept Session Notes 1975 WHO defined ‘essential drugs’ – this was a response to the ILO challenge to multilateral organisations and countries to prioritise basic needs. 1976 First Model List of Essential Drugs produced and promoted by WHO. 1978 Declaration of Alma Ata – calling for focus on Primary Health Care. This was a logical progression. The focus on basic needs drew on the experience of countries such as China that had tried to promote access to health care through community involvement and barefoot doctors. WHO called for “a virtual revolution to bring about changes in the distribution of power, in the pattern of political decision-making, in the attitude and commitment of health professionals and administrators in ministries of health and universities and in people's awareness of what they are entitled to”. Primary health care was defined as including (at least): education about prevailing health problems and how to control and prevent them; promotion of food supply and proper nutrition; adequate supply of safe water and basic sanitation; maternal and child health care (including family planning); immunisation against major infectious diseases; prevention and control of locally endemic diseases; appropriate treatment of common diseases and injuries; provision of essential drugs. 1981 WHO Action Programme on Essential Drugs is established. This action is a result of the recognition within WHO that the essential drugs concept could revolutionise access and use of drugs. There was also the understanding at WHO that it was an idea that would need support and promotion at the international level and at the national level to assist countries in implementing it. 1982 Bangladesh adopted a national drug policy. One of the poorest countries in the world embarked on a bold experiment to tackle the double problems of irrational use and lack of access to essential drugs. 1985 Rational Use of Drugs - WHO Conference of Experts in Nairobi. At this meeting the need for both prescribers and consumers to know about and use drugs appropriately was the central theme - an important shift given that, until Nairobi, attention had gone mainly to strengthening selection, supply and distribution systems. 5 Setting the scene: the essential drugs concept Session Notes Gaining ground Since the beginning of the 1980s the essential drugs concept has become one of the cornerstones of international and national health policy - influencing decisionmaking in not only developing but also industrialised countries. The selection and rational use of drugs is accepted as a key principle of health service quality and management in both the public and private sectors. WHO has vigorously promoted the essential drugs concept and the rational use of drugs - at first through the Action Programme on Essential Drugs which became a powerful advocate for the new policies. National Drug Policies were promoted by WHO and others as a guide to action and a key framework within which to coordinate the various policy components needed to guarantee access to and rational use of drugs. The next section of this module deals in more detail with National Drug Policies and looks at some country examples. Figure 1. Access to essential drugs Percentage of population with regula access to essential drugs (1997) Access to essential drugs 1 = <50% 2 = 50-80% 3 = 80-95% 4 = >95% 5 = No data available (36) (68) (33) (41) (1) B. NATIONAL DRUG POLICY Some of the early attempts to implement the essential drugs concept focused on supply and technical aspects such as procurement, storage and distribution. At the same time, there was a growing awareness of the problems of rational use. These involved their complexity, the need for an integrated approach and for a comprehensive national drug policy as part of health policy. A drug policy is needed to: determine standards and values which will guide actions in the drug sector; define global objectives which should be met; identify which strategies will be pursued to meet these objectives. 6 Setting the scene: the essential drugs concept Session Notes B1. Goals of a national drug policy The general goals of a national drug policy are to ensure: Access: Quality: Rational use equitable availability and affordability of essential drugs the quality, safety and efficacy of all medicines the promotion of therapeutically sound and cost-effective use of drugs by health professionals and consumers. The more specific goals and objectives of a national policy will depend upon the country situation, the national health policy, and political priorities set by the government. In addition to health-related goals there may be others, such as economic goals. For example, an additional objective may be to increase national pharmaceutical production capacity. The policy should be concerned with efficiency, equity and sustainability. Objectives of the South African National Drug Policy Health objectives availability of essential drugs ensure the safety, efficacy, and quality of drugs ensure good dispensing and prescribing promote rational use through the provision of necessary training, education and information promote the concept of individual responsibility for health, preventive care and informed decision-making Economic objectives lower cost of drugs in private and public sectors promote the cost-effective and rational use of drugs establish a partnership between government bodies and private providers optimise the use of scarce resources Development objectives improve knowledge, efficiency and management skills reorient medical, pharmacy and paramedical education support the development of local industry and local production of essential drugs promote the acquisition, documentation and sharing of knowledge and experience. Source: National drug policy for South Africa, Department of Health, 1996 B2. Components of national drug policy Selection of essential drugs Drug selection, preferably linked to national clinical guidelines, is a crucial step in ensuring access to essential drugs and in promoting rational drug use, because no public sector or health insurance system can afford to supply or reimburse all drugs that are available on the market. Key policy issues are: 7 Setting the scene: the essential drugs concept Session Notes the adoption of the essential drugs concept to identify priorities for government involvement in the pharmaceutical sector, and especially for drug supply in the public sector and for reimbursement schemes; procedures to define and update the national list(s) of essential drugs; selection mechanisms for traditional and herbal medicines. Affordability Affordable prices are an important prerequisite for ensuring access to essential drugs in the public and private sectors. Key policy issues are: government commitment to ensuring access through increased affordability; for all drugs: reduction of drug taxes, tariffs and distribution margins; pricing policy; for multi-source products: promotion of competition through generic policies, generic substitution and good procurement practices; for single-source products: price negotiations, competition through price information and therapeutic substitution, and Trade-related aspects of intellectual property rights (TRIPS) compliant measures such as compulsory licensing, “early workings” of patented drugs for generic manufacturers and parallel imports. Drug financing Drug financing is another essential component of policies to improve access to essential drugs. Key policy issues are: commitment to measures to improve efficiency and reduce waste; increased government funding for priority diseases, and the poor and disadvantaged; promotion of drug reimbursement as part of public and private health insurance schemes; use and scope of user charges as a (temporary) drug financing option; use of and limits of development loans for drug financing; guidelines for drug donations. Supply systems The fourth essential component of strategies to increase access to essential drugs is a reliable supply system. Key policy issues are: public-private mix in drug supply and distribution systems; commitment to good pharmaceutical procurement practices in the public sector; publication of price information on raw materials and finished products; drug supply systems in acute emergencies; inventory control, prevention of theft and waste; disposal of unwanted or expired drugs. Regulation and quality assurance The drug regulatory authority is the agency that develops and implements most of the legislation and regulations on pharmaceuticals, to ensure the quality, safety and efficacy of drugs, and the accuracy of product information. Key policy issues are: 8 Setting the scene: the essential drugs concept Session Notes government commitment to drug regulation, including the need to ensure a sound legal basis and adequate human and financial resources; independence and transparency of the drug regulatory agency; relations between the drug regulatory agency and the ministry of health (MoH); stepwise approach to drug evaluation and registration; definition of current and medium-term registration procedures; commitment to good manufacturing practices (GMP), inspection and law enforcement; access to drug control facilities; commitment to regulation of drug promotion; regulation of traditional and herbal medicines; need and potential for systems of adverse drug reaction monitoring; international exchange of information. Rational use The rational use of drugs means that patients receive medicines appropriate for their clinical needs, in doses that meet their individual requirements, for an adequate period of time, and at the lowest cost to them and their community. Irrational drug use by prescribers and consumers is a very complex problem, which calls for the implementation of many different interventions at the same time. Efforts to promote rational drug use should also cover the use of traditional and herbal medicines. Key policy issues are: development of evidence-based clinical guidelines, as the basis for training, prescribing, drug utilisation review, drug supply and drug reimbursement; establishment and support of drugs and therapeutics committees; promotion of the concepts of essential drugs, rational drug use and generic prescribing in basic and in-service training of health professionals; the need and potential for training informal drug sellers; continuing education of health care providers and independent, unbiased drug information; consumer education, and ways to deliver it; financial incentives to promote rational drug use; regulatory and managerial strategies to promote rational drug use. Research Operational research facilitates the implementation, monitoring and evaluation of different aspects of drug policy. It is an essential tool in assessing the drug policy's impact on national health service systems and delivery, in studying the economics of drug supply, in identifying problems related to prescribing and dispensing, and in understanding the sociocultural aspects of drug use. Key policy issues are: the need for operational research in drug access, quality and rational use; the need and potential for involvement in clinical drug research and development. 9 Setting the scene: the essential drugs concept Session Notes Human resources development Human resources development includes the policies and strategies chosen to ensure that there are enough trained and motivated personnel available to implement the components of the national drug policy. Lack of motivation and appropriate expertise has been a decisive factor in the failure to achieve national drug policy objectives. Key policy issues are: government responsibility for planning and overseeing the development and training of the human resources needed for the pharmaceutical sector; definition of minimum education and training requirements for each category of staff; career planning and team building in government service; the need for external assistance (national and international). Monitoring and evaluation Monitoring and evaluation are essential components of a national drug policy, and the necessary provisions need to be included in the policy. Key policy issues are: explicit government commitment to the principles of monitoring and evaluation; monitoring of the pharmaceutical sector through regular indicator-based surveys; independent external evaluation of the impact of the national drug policy on all sectors of the community and the economy. C. INTERESTS OF DIFFERENT STAKEHOLDERS The development and implementation of drug policies is a complex and difficult process. It is also a process that is highly political and can become very polarised. Enormous stakes are involved in the pharmaceuticals arena. The financial interests are huge but there are also other factors that make the area a difficult one in which to work. People’s beliefs, traditions and cultural preferences can be a major determinant of how they treat drugs and make health care choices. These are not necessarily factors that can be changed. The medical profession has, over the centuries, developed a system of power and authority that can exert a powerful influence on society and the organisation of health care. There are a variety of factors such as these that cannot easily be ignored when developing pharmaceutical policy or when planning interventions to change drug use. The main actors in the pharmaceutical field include: C1. National governments The Ministry of Health will of course be very important, but other ministries such as the Ministry of Finance and the ministry responsible for industrial development are likely to have strong views on developments in the pharmaceuticals area. Often they will have objectives that are hard to reconcile. 10 Setting the scene: the essential drugs concept Session Notes C2. Pharmaceutical industry Drugs are big business. The global pharmaceutical market is expected to be worth US$400 billion by 2002. The ten largest drug companies control over a third of this market, several of them have sales of more than US$10 billion per year and profit margins of approximately thirty percent. Six of these giants are based in the US and four in Europe (Panos, Health and the New Millennium). The pharmaceutical industry is itself far from homogeneous. While multinational companies have been generally unsupportive of the essential drugs concept and maintain that it is only relevant to the least developed countries, generic companies and local producers may be supportive. C3. International organisations WHO has been the most important international advocate of the essential drugs concept and continues to give support to many countries. Other international agencies such as the World Bank and UNICEF also play an important role. The World Bank finances many country programmes and it is also a major voice in national and international health policy. UNICEF has been a major actor in developing cost recovery systems for essential drugs. Drug selection and essential drugs The need for drug selection is not restricted to developing countries. Health care costs in general, and drug costs in particular, are rising everywhere. Most of the increased drug cost is due to the use of new medicines, and many of these are for chronic diseases. In order to ensure an optimal use of limited resources a careful evaluation is needed of their cost-effectiveness in relation to existing treatment alternatives. Some industrialised countries have developed very detailed procedures for this difficult process. One example is the pharmaceutical benefit scheme in Australia, which requires proof that a drug is more cost-effective than existing treatments before it is approved for reimbursement. It is interesting to note that the list used in the Australian scheme contains approximately the same number of active ingredients as the national list of essential drugs in Zimbabwe. Another example is the Scottish Intercollegiate Guidelines Network, which is developing national treatment protocols entirely on the basis of evidence. For every treatment recommendation, the strength of the supporting scientific evidence is indicated according to four levels - the strength of the evidence defines the strength of the recommendation. The main objective of the Scottish guidelines is to attain the highest standards in health care, rather than cost-containment. Some of the recommendations lead to increased health care cost, for example, in the treatment of diseases which are generally known to be underdiagnosed and undertreated. These two examples show that essential drugs are not for poor countries only or for rural areas only. The concept of essential drugs is just as valid in developed countries, in teaching hospitals, and in health insurance schemes. It is as valid for the treatment of cancer, cardiovascular diseases and metabolic disorders as it is for malaria, acute diarrhoea and pneumonia. The World Health Report 1997. World Health Organization, Geneva, 1997. 11 Setting the scene: the essential drugs concept Session Notes C4. Health professionals The term “health professionals” covers a broad spectrum. The influence and the interests of health professionals will depend on their degree of organisation, on the resources available for health care and on how the system is divided between private and public sectors. C5. NGOs In many countries (most notably in Africa) NGOs have become important in health care delivery. NGOs often provide a way to stimulate community involvement and participation. C6. Consumers Consumers are themselves the users of drugs and health services. Consumer organisations are increasingly seen as important partners in the development of health and drug policy and in some countries have played an important role. However in many countries there is little in the way of an organised consumer movement. Over the last twenty years there has been considerable attention on the need to address irrational drug use by prescribers and dispensers but relatively little effort has been made to change drug use in communities and to alter the behaviour of consumers. The vast majority of drugs in developing countries are bought in the private sector by consumers without any medical consultation. This is an increasing trend. If we are to have a real impact on irrational drug use then it is essential that community drug use be addressed. C7. Insurers In countries with a high level of health insurance, health insurers have a major influence on drug policy. Decisions about whether or not a particular drug is reimbursed act effectively as a selection mechanism. 12 Setting the scene: the essential drugs concept Session Notes D. CURRENT TRENDS AND CHALLENGES In spite of the progress made during the last twenty years, a large proportion of the world’s population still lacks access to essential drugs. Estimates suggest that onethird of the world’s population lacks access to essential drugs. In developing countries the proportion is much higher; in Africa and many parts of Asia more than half the population does not have access to essential drugs. Essential drugs are not costly and their provision is a cost-effective intervention as well as one which is essential to maintain confidence in health services. In spite of this many people do not have access (geographical or financial) to drugs when they need them. Many of the drugs that are available are paid through private out-of-pocket expenditure. Many of the drugs that are prescribed or purchased over the counter are not used appropriately. Changing patterns of drug use is complex and time-consuming. D1. Reduced role of government Reductions in spending in the public sector make it difficult for governments to provide quality health care and the essential drugs which people need. It also becomes more difficult to control the way in which drugs are used. The current focus on private/public partnerships makes it much harder for governments (or international agencies) to promote policies which may not be consistent with the interests of major players in the private sector or with ‘free market’ philosophies. Social solidarity and support to the public sector is less of a priority and the solutions to lack of access are increasingly sought in terms of stimulating the private sector and partnership with the industry rather than in strengthening basic services and reallocation of resources. In some countries, particularly in Latin America, this move from public to private has been accompanied by reduced government regulatory control of pharmaceuticals. In fact, as WHO has pointed out, an increasing role of the private sector requires stronger not weaker central, i.e. government regulatory control. D2. Increased role of the private sector The reduction in public sector provision is matched by a growth in the private sector. The private sector includes private pharmacies and drug sellers, private not-forprofit NGOs (e.g. the Church is a major provider in many African countries) and the informal or illegal sector (many drugs exchange hands through market stalls or are sold again after being prescribed by a health worker). The private sector is harder to regulate/control and influence than the public sector. Improving drugs use and implementing the essential drugs concept in the informal and illegal sectors is very hard. 13 Setting the scene: the essential drugs concept Session Notes D3. Changing morbidity and mortality patterns People are living longer and this means that more people survive to experience ill health in old age. In 1955 average life expectancy was 48 years; in 1995 it was 65 years. Longer life expectancy is one of the reasons for the increase in chronic diseases that can be seen in both developing and industrialised countries. Additional reasons include the increase of smoking, changes in diet and reduction in exercise. Chronic diseases often require long-term drug therapy. Many of the drugs used in the treatment of chronic diseases are relatively expensive. New diseases have also emerged as major problems. HIV /AIDS This viral disease is the most important of these. The overwhelming majority of people living with HIV - some 95% of the global total – live in the developing world. That proportion is set to grow even further as infection rates continue to rise in countries where poverty, poor health systems and limited resources for prevention and care fuel the spread of the virus. As of June 2001, there were an estimated 36.1 million people living with HIV/AIDS. Sub-Saharan Africa continues to bear the brunt of HIV and AIDS and is home to nearly 70% of the global total of HIV-positive people. Providing good care for AIDS patients puts enormous economic pressure on health services and family budgets. Providing care and access to drugs (both basic essential drugs and new drugs such as antiretrovirals [ARVs]) for the care of people with AIDS is one of the most important challenges facing the health services in many countries. This single issue has enormous repercussions for all aspects of drug policy. Tuberculosis It is estimated that between now and 2020 nearly one billion people will be newly infected, 200 million will get sick and 70 million will die of tuberculosis (TB) if current trends continue. Treatment of TB can put great pressure on health budgets and multi drug resistent TB is a major potential public health threat. D4. Changing relationships between professionals and consumers In industrialised, and in some developing countries, the last fifty years have seen a revolution in consumer and patient expectations. People have more access to information about drugs and their health. They know more about treatment options and about new drugs on the market and expect to be involved in treatment choices. They have come to expect access to drugs and health care as a right. On the one hand this leads to a sense of assertiveness, a confidence and a feeling of responsibility for health. On the other hand these changes have fostered a tendency to look for technological solutions, to medicalise problems which are not purely medical, and to turn to new wonder drugs to solve these problems. Reconciling the divergent interests of these actors, channelling their strengths and involving them in decisions and their implementation can be crucial to the success of drug policy. 14 Setting the scene: the essential drugs concept Session Notes ADDITIONAL READING Essential Drugs Monitor (no. 27). Geneva, World Health Organization. Essential Drugs Monitor (no. 30). Geneva, World Health Organization. Chetley A (1990) A Healthy Business. London, Zed Books. WHO (2001) How to develop and implement a national drug policy 2 nd ed. Geneva, World Health Organization. World Pharmaceutical Situation. Geneva, World Health Organization (in preparation). 15 Setting the scene: the essential drugs concept Session Notes ACTIVITY 1 (1 HOUR) You are going to watch a video on Essential Drugs. You should make a note of every “drug problem” you see referred to in this video. There will be a considerable number – try to identify as many as possible. When the film is finished you will work in country/regional groups. You should try to sort the problems into types of problem. Then take the problems one by one and consider: 1. How they could be tackled, i.e. by legislation, by education, by improving distribution. 2. Whether resources and energy are being spent in their country primarily on efforts to ensure rational procurement and adequate supply of medicines or whether the rational use of drugs (RUD) is also given adequate attention. 3. If RUD is part of the national drug policy, are efforts directed at prescribers mainly or are programmes to promote rational use of drugs by consumers also implemented? If yes, what is being done? and 4. To what extent do the participants – in their country situation – have the potential to influence or have already some influence on rational use of drugs by consumers? What kind of influence do they have? 16 Setting the scene: the essential drugs concept Session Notes ACTIVITY 2 (40 MINUTES) A complicated range of actors - conflicting interests This is a short exercise, 15 minutes and 3 minutes report back per group. It is intended to encourage discussion rather than to be an in-depth discussion Discuss with each other (in country or regional groups) who are the important actors in their country in relation to pharmaceutical policy. Give the following actors marks out of 10 (for power and influence): National governments Pharmaceutical industry International organisations (WHO, World Bank, UNICEF etc) Health professionals (doctors, pharmacists, nurses etc) NGOs Consumers Insurers One rapporteur should feed back from each group and then groups should compare notes and comment on differences. 17