KRIS WEERASURIYA, PASCALE BRUDON*
* Kris Weerasuriya is Professor, Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka, and Pascale Brudon is Chief, Development of Programme Evaluation, WHO and was formerly a Scientist in the Action Programme on Essential Drugs.
THE concept of essential drugs - first launched over 20 years ago - has been widely adopted today by countries throughout the world. But its implementation is proving a lot more difficult than envisaged.
The idea - providing priority drugs to meet the health care needs of the major ity of the population - was simple, socially just, and both technically and economically sound. By having a care fully designed, scientifically sound list of a limited number of drugs, procurement could be made easy, the drug storage problem simplified, prescribers would have safe and effective drugs, and costs could be reduced.
The system entailed no reductions in health services, and health administrators did not have to make difficult choices between the competing needs of different groups or assess the social and health implications of different strategies. The money allocated for pharmaceuticals 20% - 40% of limited health care budgets - could now be spent on less expensive, essential drugs, facilitating wider access to drugs without any increase in costs Rarely had administrators been offered such a clear, simple solution to so many problems. The essential drugs concept was an idea whose time had come.
But the simplicity was beguiling. Although the concept was well accepted by most countries, its implementation has proved a daunting task. More than two decades after it was conceived, the essential drugs concept has still to make the full impact that was anticipated - demonstrating that technical soundness and economic rationality do not necessarily ensure political viability1.
1 WHO/DAP. Comparative analysis of national drug policies. Second workshop, June 1996. Geneva: World Health Organization; 1997. DAP Research Series No.25. WHO/DAP/97.6.
ESSENTIAL DRUGS CONCEPT UNDER FIRE
At the outset, direct opposition to the essential drugs concept came mainly from the pharmaceutical industry - unconvinced by the argument that lost sales on more expensive drugs would be offset by the enlarged market for essential drugs. However, initial outright rejection of the concept was followed by grudging acceptance that it might be appropriate for poorer countries that cannot afford to have an unrestricted amount of pharmaceuticals available on the market. And with the increasing popularity of the essential drugs list, many manufacturers have seen its potential and sought to have their drugs included in the list.
Many doctors were also opposed at first - viewing the list as an unnecessary restriction on their freedom to prescribe. Concern was voiced mainly by doctors working in the private sector, who had a larger range of drugs to choose from than those employed in the public sector. However, this opposition has lessened, over time.
Another frequent criticism is that the essential drugs list is a “second class” list, determined on the basis of financial stringency rather than the effectiveness of the drugs. However, the belief that countries will abandon the list, once the economic situation improves, and switch to better drugs is based on a misconception. The list does not include less effective drugs simply because they are cheaper. The aim is to include more cost-effective drugs that can be used by the majority of the population. For example, among the H2 receptor blockers, ranitidine has an advantage over the much less expensive drug cimetidine, in that it can be used by the elderly and has fewer interactions with other drugs. However, cimetidine was chosen for the model list not only because it was cheaper but because it has similar efficacy to ranitidine, and because the majority of patients using it would be neither elderly nor receiving drugs which could interact with cimetidine. While a particular health technology may be superior in a few situations, another cheaper one may be equally effective in the majority of situations - making it more cost-effective.
The essential drugs list is also criticised for failing to include a drug for a particular disease. However, the list was never meant to cover all diseases. The aim was to ensure the availability of drugs to treat the majority of diseases that occurred in a specific country. The exclusion of a drug from the list does not prevent it from being purchased if needed. The fact that the essential drugs concept accommodates this should be seen as its strength.
IMPACT IN DEVELOPING COUNTRIES
Over 120 developing countries have now adopted the essential drugs concept and developed a national essential drugs list based on the WHO Model List2. The exclusive use of generic drugs in the list has contributed to increasing awareness of generic names. While some countries have closely followed the criteria for selection of drugs, others have lists that include over 350 products (Pakistan) or two or more similar drugs rather than the recommended single drug (Tanzania) from each therapeutic category. Some of these deviations may be due to attempts by doctors to get a particular drug included in the national essential drugs list - thereby enabling hospitals to buy the drug and ensuring its inclusion in reimbursement schemes.
2 WHO/DAP. WHO essential drugs strategy: objectives, priorities for action, approaches. Geneva: World Health Organization;1997. DAP/MAC(9)/97.4.
As countries have increasingly recognised the need for a national drug policy, the national list has provided the cornerstone for this policy development. Meanwhile, the knowledge that a limited list of drugs can meet the majority of health care needs has also created an awareness that “more is not necessarily better” and that “newer is not necessarily better”. The list has also enabled health administrators to assess whether appropriate drugs are being supplied.
Although the essential drugs concept has consistently focused on the importance not only of the selection but also the proper use of the drugs, progress in encouraging the rational use of drugs has been slow. Even where essential drugs are available, their full potential is not being realised. This is mainly due to the failure to provide unbiased drug information for prescribers. Whereas suppliers of other forms of goods routinely spend a proportion of sales revenue on evaluating how the goods are used, very few developing countries have access to independent drug information - let alone the capacity to spend a proportion of their drugs budget on providing information on the rational use of drugs. It is estimated that both developing and developed countries currently spend less than 1% of their drugs budget on rational drug use. However, the essential drugs concept has been influential in preventing the import of ineffective drugs.
In some developing countries, the implementation of the essential drugs concept has been hampered by efforts to industrialise. Many governments hoped that a vigorous and profitable pharmaceutical industry, producing drugs that were mainly outside the essential drugs list, would contribute to a general increase in both living standards and improved health. As a result, essential drugs were ignored and sometimes difficult to obtain, while more expensive, non essential drugs were freely available. Now, after finding that the impact on living standards is less than anticipated, some countries are rethinking their policy and are likely to place greater emphasis in future on essential drugs. This development should help increase the accessibility and affordability of essential drugs.
More expensive doesn’t necessarily mean better
Although the essential drugs concept was designed to meet the health care needs of the majority of the population, the private sector has tended to drag its feet in implementing the concept. This is largely due to fears that the resulting changes in the pharmaceutical sector might have an adverse effect on multinational corporations, the urban elite, and, to a lesser extent, physicians. In order to succeed, the concept should have broadly-based support which reaches to the highest political levels. However, with the exception of the Philippines and Sri Lanka, this has rarely occurred3.
3 Reich MR. The politics of health sector reform in developing countries: three cases of pharmaceutical policy. Health Policy. 1995; 32:47 - 77.
The lack of acceptance of the essential drugs concept within the private sector is also due to the fragmented nature of health care in this sector in developing countries. Patients pay for their drugs “out of pocket” and are individual buyers who purchase what the doctor prescribes. However, large health care providers such as insurance schemes, which are common in the developed world, can persuade prescribers to use a restricted list of drugs known to be effective. When such schemes are established in the developing world the same trend towards using known effective drugs would develop.
Essential drugs are not a poor man’s medicine, and the essential drugs concept is as important today as it was 20 years ago
A RESPONSE TO RISING PRICES
Acceptance of the essential drugs concept and the essential drugs list faced different hurdles in developed countries, due to the different socioeconomic and industrial circumstances. In the developed countries, governments saw the pharmaceutical industry as a vibrant one, providing useful products as well as contributing to the economy through the employment of skilled labour, the production of substantial export earnings, and a contribution to scientific and industrial research. Money was usually available to buy more expensive pharmaceutical products and it was believed that restricting access to these products would be counterproductive in the long run. Unlike the developing countries, health care providers in developed countries (either the state or state-sponsored social insurance schemes) had immense buying power and could negotiate a reduction in prices. However, these products are becoming increasingly expensive and are often beyond the reach of cash-strapped health service providers. As a result, both governments and health service providers in the private sector have now adopted the essential drugs concept - albeit by another name.
Most countries have adopted a two-step procedure for introducing a new product into the health system. In Australia a new drug is scientifically evaluated for quality, safety and efficacy4. Once registered, a drug is then assessed for possible inclusion in the reimbursement scheme. Approval at this stage depends on evidence of cost-effectiveness. This two-stage process has resulted in the registration of drugs, such as finasteride, that are expensive but minimally effective - without their approval for reimbursement.
4 Murray M. Australian National Drug Policies: facilitating or fragmenting health? Dev. Dialogue. 1995;1:148 - 192.
Elsewhere, in the UK, where 17 benzodiazepines are available, the National Health Service supplies only five of these, each a generic drug. Although the other 12 benzodiazepines are equally effective, they are more expensive and not reimbursable. Although this is not a strict interpretation of the essential drugs concept (which allows only one drug from a therapeutic class) a focus exclusively on drugs that are known to be safe, effective, and cost-effective is in keeping with the spirit of the concept. However, both countries promote the export of these drugs - a clear example of industrial priorities overtaking health ones outside the country’s own borders.
INTERNATIONAL ORGANIZATIONS PROMOTE THE CONCEPT
Although, initially, a number of international organizations failed to appreciate the relevance or importance of the essential drugs concept, today most accept and promote it as a good tool for organizing the pharmaceutical sector and improving health care. The World Bank, which plays an increasing role in the health sector in the developing world, has based most of its activities in pharmaceuticals on the concept and national drug lists - mainly to facilitate managerial efficiency 5,6.
5 World Bank. World development report 1993: Investing in Health. New York: Oxford University Press; 1993.
6 World Bank. Better health in Africa. Experience and lessons learned. (Report No.12577 - AFR). Washington DC: The World Bank; 1994.
UNICEF’s activities involving pharmaceuticals have been guided by the essential drugs concept in order to ensure equity, and donor countries/institutions have focused on national lists when supplying drugs. Meanwhile, the guidelines for drug donations developed by WHO and other agencies have also stressed the importance of donating only drugs that are included in national lists7.
7 WHO/DAP. Guidelines for drug donations. Geneva: World Health Organization; 1996. WHO/DAP/96.2.
The Model List is revised regularly by WHO with the latest revision in 1997. The number of items included has risen from 208 in 1977 to 306 today - as new products are added and older, less effective products removed. Programmes covering malaria and cancer control have helped refine the selection of drugs included in the List. Meanwhile, the participation of the pharmaceutical industry associations provide an opportunity for them to discuss the List as well as propose products for inclusion. On several occasions, inclusion of a drug in the Model List has encouraged pharmaceutical companies to either continue manufacturing the drug or to start manufacturing it.
BETTER IMPLEMENTATION NEEDED
The essential drugs concept is today a key issue on the international health agenda. Together with the concept of primary health care, it is one of the major achievements of WHO over the last two decades, and its most durable pharmaceutical initiative. Other initiatives, such as promoting the local production of pharmaceuticals, have achieved neither the sustainability nor the prominence of the essential drugs concept.
Yet, while the concept’s scientific validity remains unchallenged, it has still to be implemented to its full potential. One of the problems is that it is a public health concept and not a curative intervention. When drugs are made available in this way it is taken for granted and not seen as a major advance. Because of this, it is a difficult concept to promote.
Another problem is the wide range of objectives involved: equity in the provision of basic health care needs, efficient use of available resources, and responsiveness to societies rather than to market forces. While this elicits widespread support, the involvement of numerous players with different strengths and objectives can hamper the concept’s implementation.
In developed countries, the weak implementation of the essential drugs concept has been driven by fears that the international pharmaceutical industry would suffer - a prospect that generated strong opposition from powerful groups and governments. Meanwhile, in some countries, implementation strategies have not been carefully thought through. Effective implementation of the concept requires careful planning, backed up by strong political commitment at country level, together with a clearer understanding of the role of the different players involved. Better implementation of the essential drugs concept could make all the difference between success and failure.