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June 2001
Vol. 4, No. 6, pp 47–48, 54.
the timeline

Pharmaceuticals for all

The story of WHO and the “essential drugs”

In 1978, delegates from governments around the world met at Alma-Ata in the then-U.S.S.R. to embark on a bold plan. Under the auspices of the United Nations World Health Organization (WHO), the delegates created the Health For All program, with the goal that all people would have access to basic health care by the year 2000. An important part of this program was the list of essential drugs, those medicines that could be easily and inexpensively manufactured and that would make a real difference in people’s lives. Although the year 2000 goal has not been met, the essential drug concept and its attendant controversies mark an important milestone in the history of public health.

WHO are you?

In the aftermath of World War II, the United Nations was founded in San Francisco in 1945. At that time, China and Brazil made a motion that the new international body form an autonomous international health organization. The International Health Conference of 1946 approved a constitution for WHO. Within a year of its formation, the fledgling body faced its first test, when the WHO Interim Commission fought a cholera outbreak in Egypt.

On April 7, 1948, a day now celebrated as World Health Day, the WHO constitution was ratified by the requisite number of nations.Later, delegations from the 53 member nations met in Geneva for the first World Health Conference.

In 1978, WHO, in conjunction with another U.N. body, the United Nations Children’s Fund, met in Alma-Ata to formulate the Health For All (HFA) plan for universal health care for the world’s population by 2000.In 1981, WHO adopted a global strategy for the HFA program, and the U.N. General Assembly endorsed the plan. The General Assembly also urged other concerned organizations to cooperate with WHO.

WHO and the HFA

In 1978, the Alma-Ata conference tried to address what many saw as widespread inequities in medical care. Although most residents of the industrialized nations of the West enjoy good health care, residents of less-developed countries by and large do not, and the conference called for changes to the content and design of health care in an attempt to redress these inequalities. The result was the HFA program.

WHO did not mean that disease would be eradicated by 2000 (although some maladies have, in fact, been vanquished), but instead that all people would have access to primary health care. This goal required a multipronged strategy combining not only health services and community action, but also personal education and responsibility about matters of health.

The Alma-Ata Declaration called for education about hygiene, health, and prophylaxis;education about nutrition, food supply, and water supply; child and maternal health care, including family planning; immunization against major diseases and prevention of endemic local maladies; treatment of disease appropriate to the local conditions; and the provision of essential drugs.

The essential concept

One of the most important parts of the HFA campaign has also been the most controversial: the essential drug concept (EDC). The “essential drugs” are the relatively few pharmaceuticals necessary for the preservation of health. Panels of experts convened by WHO have determined that 200–250 drugs and vaccines are truly necessary to relieve most health problems. The cost of drugs in developed and less-developed countries wasand is high, and many drugs were either useless or harmful, such as the administration of a tonic for malnutrition. There are also “irrational combinations”, drugs that separately are beneficial but have no use in combination. Also, some drugs, such as dipyrone, have been withdrawn in the West but continue to be marketed in the developing world, while others are tightly controlled in the developed world but not in less-developed regions.

In less-developed countries, many drugs were,through tradition, education, or economics, restricted to a narrow segment of the population, unavailable to those who needed them the most.Inexpensive and readily available pharmaceuticals, then, would be a cornerstone of the HFA program.Without them, health care for everyone would remain a dream.

The concept of essential drugs can be traced to the 1976 Non-Aligned Summit Conference in Sri Lanka. The conference adopted a special resolution on drugs, which included the idea that a list of the most essential compounds be compiled. In 1977, WHO published its first list. The choice of an “essential” drug depended on several factors. First, only generic drugs would be considered. In addition, the following selection criteria are used for inclusion of drugs on the list:

  • sound and adequate data supporting efficacy and safety from clinical studies;
  • evidence of performance under different health care settings;
  • availability in a form in which quality, including adequate bioavailability, can be assured;
  • stability under anticipated conditions of storage and use;
  • total cost and relative cost-effectiveness of the treatment; and
  • preference for single compounds.

When drugs appear to be similar in the above respects, comparative pharmacokinetic properties and the availability of facilities for manufacture or storage are used as secondary criteria.

The drugs were chosen by disease patterns. For example, tropical countries included the antimalarial chloroquine. However, Great Britain has malaria (most often in tourists), yet its essential drug formulary lacks the antimalarial. More critically, Africa is currently wrackedby astronomically high rates of HIV transmission, but many antivirals are not included. Zidovudine and nevirapine, which are used to prevent mother-to-child transmission, are on the current list; however, antivirals for the treatment of HIV and AIDS are not included because there isinsufficient evidence that they can be used safely and effectively in the conditions found in less-developed countries. The issue will be considered again at the next revisionof the EDC listin autumn 2001.

Reactions to the EDC

While drugs are necessary to the preservation of health in the face of disease and injury, the manufacture of drugs is a business. Many pharmaceutical manufacturers felt threatened by the EDC, which, after all, called into question some of their most lucrative preparations.For their part, doctors, often educated about drugs by drug manufacturers, resented the imagined interference with their autonomy. Both groups have opposed the adoption of the EDC in many less-developed countries.

In addition, drug manufacturers are often large, multinational corporations with tremendous influence in the electedassemblies of various Western countries, and they have used this influence to threaten developing countries that adopt the EDC with economic or political sanctions. Doctors have also mobilized to oppose the EDC.

The Bangladesh policy
Many questions
Questions were raised both by pharmaceutical companies opposed to the essential drug concept and by health advocates. These included:
  • What was the pattern of endemic disease in a given region? What treatment facilities existed?
  • What were the levels of training of health care providers? Were providers village technicians or university-trained physicians?
  • What were the financial resources of the country?
  • What environmental and demographic factors affected health care?
  • What percentage of the population would a given essential drug cover?
  • Were essential drugs proven safe in clinical trials, and was there sound data for their efficacy?
  • What if an essential drug covered only a percentage of the population?
  • What if there were only one drug per class, and some patients proved intolerant to it but would respond to others in that class?

In 1971, Sri Lanka instituted pioneering drug regulation: All imports of drugs and related material were to be funneled through a state agency, generics were to replace branded drugs, local companies were encouraged to make necessary drugs, and patent law was to be amended to remove the price incentive. Afghanistan, India, and Canada made similar efforts.

With these models, and inspired by WHO’s HFA program, in 1982 Bangladesh implemented its National Drug Policy (NDP). An expert committee assembled a list of recommendations based on WHO’s EDC, and the NDP aimed to ensure that procurement, local production, quality control, distribution, and use of pharmaceuticals came under the control of a single government body. This was to be a major part of national health policy.

No sooner had a form of the NDP been implemented than foreign-owned drug companies mobilized a campaign of misinformation, threats, and intimidation. For example, on June 1, 1982, the Bangladesh Times publicized the NDP. That same morning, the U.S. ambassador made an unscheduled call on the government to deliver the message that the policy was not acceptable to the U.S. government. Although the U.S. government had no overt interest in the NDP, drug companies, which had made considerable donations to the election campaigns of members of the U.S. government, assuredly did. They mobilized the influence their money had purchased against the NDP, which is why a superpower became involved in the internal health affairs of a small country on the other side of the globe.

Other controversies

Good intentions aside, the EDC has also proven to be controversial because of its disparities. By WHO’s own estimates, almost half of the world’s people have no reliable access to even a pared-down form of the EDC. This lack of accessis due in part to the fact that WHO has targeted only the public sector in its campaigns.Yet the private sector, as in Bangladesh, controls most—from 60% to 90%—of the drug market in underdeveloped countries.

Then there is the lack of uniformity. For example, Fluconazole, a treatment for AIDS-related meningitis, costs around U.S. $20 per day in Kenya but roughly U.S. $0.20 in Thailand, where it is produced locally. Yet Kenya needs the drug. Why is the drug not priced universally? Such inequalities, critics such as Oxfam charge, are the result of excessive influence of vested interests in updating the EDC.

Prices for essential drugs continue to skyrocket, often beyond all relation to the costs incurred by pharmaceutical companies to manufacture them. Until this inequity is addressed, critics charge, the EDC—and HFA—will not fulfill their goals.

To the present

Although the goal of universal health care by 2000 has not been met, the HFA initiativehas made significant gains. In wealthy lands, at least, life expectancies had already increased by several decades from the beginning of the 19th century to the end of the 20th.Poorer countries have also made significant gains due in some part to the WHO efforts. Smallpox has been eradicated, and a substantial part of the world’s burgeoning population faces a comparatively low risk of contracting infectious disease. Fecundityhas declined, as has infant and maternal mortality. Even if health for all has not been achieved, WHO’s HFA plan and its EDC have surely achieved health care for many who might not have otherwise had it.

Selected reading

  • Chowdhury, Z. The Politics of Essential Drugs: The Makings of a Successful Health Strategy. Lessons from Bangladesh. Zed Books: London and Atlantic Highlands, NJ, 1995.
  • Oxfam International. World Trade Rules and Poor People’s Access to Essential Drugs. www.oxfam.org.uk/ (accessed May 2001).
  • Implementation of the Global Strategy for Health for All by the Year 2000: Eighth Report on the World Health Situation, Volume 1: Global Review. World Health Organization: Geneva, 1993.
  • Four Decades of Achievement: Highlights of the Work of WHO. World Health Organization: Geneva, 1988.
  • World Health Organization. The WHO Model List of Essential Drugs. www.who.int/medicines/ (accessed May 2001).
  • The World Health Report, 2000. Health Systems: Improving Performance. World Health Organization: Geneva, 2000.

Christopher S. W. Koehler holds a Ph.D. in the history of science. He writes and teaches in northern California. Send your comments or questions regarding this article to mdd@acs.org or the Editorial Office by fax at 202-776-8166 or by post at 1155 16th Street, NW; Washington, DC 20036.

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