Feature

Rx for the Third World

by Holley Knaus

APPROXIMATELY FOUR MILLION CHILDREN DIE each year from diarrhea-related causes, primarily dehydration, according to the World Health Organization (WHO). Many of these deaths can be prevented through oral rehydration therapy, which is simply the replacement of fluid and mineral losses caused by the diarrhea with a mixture of clean water, salt and sugar. Yet, according to a 1992 WHO report on the use of drugs in treating diarrhea, appropriate treatment "often remains the exception rather than the rule. In particular, studies of current patterns of diarrhea treatment have shown that a large number of pharmaceutical agents of dubious efficacy and potential toxicity are widely used."

 Other anomalies concerning pharmaceuticals are not uncommon in much of the Third World. Dr. Syed Rizwanuddin Ahmad, currently a clinical pharmacology fellow at Georgetown University and coordinator of Health Action International Pakistan, says Pakistani hospitals often suffer shortages of anti-malarials and vaccines for tuberculosis, even while they are stocked with "vitamins, cough syrups and iron pills."

 Malnutrition, infection and diarrhea are among the leading causes of death among children in developing countries. The best "cure" for these conditions is prevention through proper nutrition, hygiene and clean water. In much of the Third World, however, these preventative measures are overshadowed by the magical allure of drug therapies.

 Multinational pharmaceutical companies, which have targeted Third World countries as markets for thousands of drugs, many of which are ineffective, and some of which are harmful, are significantly responsible for these misplaced priorities. Compounding the problem, pharmaceuticals in many developing countries are sold without prescriptions, warnings or instructions for use, and often are taken improperly or for inappropriate uses.

The consequences of this widespread misuse of medications are devastating: reliance on curative pharmaceutical measures often means that appropriate preventative measures are not implemented; the inappropriate use of drugs often delays or replaces appropriate treatment; poorer countries waste limited currency on unnecessary drugs; and indiscriminate use of drugs can lead to resistance to their effects - chloroquine, for example, widely available and often used improperly throughout the late 1950s and 1960s, is no longer effective as an anti-malarial in several countries because the disease has become resistant to the drug.

 Without question, certain drugs and vaccines can contribute greatly to the health of a population. In the late 1970s, as the United Nations recognized universal access to adequate health care as a fundamental human right, health activists and WHO officials began to identify pharmaceuticals that meet the basic health needs of the majority of people as "essential drugs." The idea behind the concept was primarily to broaden access to these essential drugs, but many health activists believe that stemming the flow of useless or harmful drugs into developing countries is equally important.

Making fewer mean more

 In 1977, WHO formulated a list of about 200 essential drugs to be used as a guideline by governments. The WHO Action Programme on Essential Drugs and Vaccines (APED) was formed in 1981 to provide training and to lend technical assistance and some financial support to countries implementing policies designed to ensure the widespread availability and affordability of essential drugs. According to WHO, more than 100 countries have formulated essential drug lists for the different levels of health care, and 50 have formulated or are formulating comprehensive national drug policies centered around the essential drugs concept.

The idea is that a country will look to the WHO list to identify those drugs most vital to its health needs. At a minimum, governments should give priority to essential drugs in areas such as foreign exchange allocations and should encourage their production by domestic enterprises. More comprehensive policies include provisions for withdrawing the registration of nonessential and harmful drugs, drawing up narrow selections of drugs for different categories of health workers (making different drugs available to a primary health care worker in a rural area than to a doctor in an urban hospital, for example), and educating doctors, nurses and other health-care workers on the proper use of available pharmaceuticals.

APED updates the model list every two years, which currently includes about 300 drugs and vaccines. Drugs and vaccines included in the list must meet a few broad requirements developed by APED: they must meet common health needs, have significant therapeutic value, be acceptably safe and offer satisfactory value. According to WHO, the drugs on the list meet about 90 percent of the pharmaceutical requirements of developing countries.

An APED report presented in March 1990 to the World Health Assembly states, "From a global perspective, access to essential drugs remains critical for reasons which include lack of resources, poor infrastructure, and shortage of trained technical and management national staff ... [It] must be recognized that a vast number of people - perhaps as many as 1,500 million - still lack regular access to the most-needed essential drugs, either because these are not available or because their cost is beyond the reach of most of the rural and urban poor."

 Economics is one of the primary motivations for the adoption of essential drugs lists. Philippa Saunders of OXFAM UK says that the lists are "mechanisms for rationalizing resources against needs." Saunders says that "financial restraints, [particularly] the availability of foreign exchange, govern" what resources a government can purchase. Limited lists ensure that funds are not wasted on useless or harmful pharmaceuticals.

 Additionally, almost every one of WHO's essential drugs is now off-patent and available in generic form. This lowers the price of a drug dramatically, while serving to lessen aggressive promotion of a particular brand through advertising or sales representatives.

 Rizwanuddin says that one of the main reasons countries adopt essential drugs lists is to improve access to drugs for people in rural areas where it is hard to get modern medicine.

 He also points out that an important aspect of the essential drugs concept is to protect consumers from aggressive producers and marketers of useless pharmaceutical products.

 In the United States, Rizwanuddin says, "the FDA is very active in regulating the marketing and advertising" of drugs. In most developing countries, however, "there is no such mechanism to control" the marketing practices of drug producers, he says, and the regulatory bodies that do exist usually lack enforcement power. In many developing countries, consumers buy the same drug (without a prescription) marketed by several different producers under different brand names, not realizing that they are all the same product. Reducing the number of drugs available facilitates pharmaceutical regulation and makes it easier for health officials to educate consumers about the proper use of the available medications.

Lack of education and information about pharmaceuticals is a serious concern which leads to irrational use of drugs, according to the APED report. The report states, "Paradoxically, the ever-increasing demand for drugs is frequently associated with poor compliance [with directions for] their use, often because patients are dissatisfied with the drug, do not understand how to take it or are unable to pay for the full dose."

While most countries have adopted essential drugs lists, implementation and enforcement varies widely. Policies are often adapted to different levels of care - physicians in hospitals will have access to more drugs than primary health care workers in rural areas. Almost all lists are based on the WHO model list, but the lists vary from region to region, as Rizwanuddin points out, because "different countries have different disease patterns."

In most countries, essential drugs lists apply only to the public sector - government hospitals, clinics and health care programs - while non-essential drugs remain available on the private market.

A few developing countries have adopted more stringent national drug policies based around the essential drugs concept. Nigeria, for example, prohibits the import, manufacture, sale or distribution of any drug not on its list of about 200 essential drugs. Drugs must be advertised and sold under generic names. The drug policy applies to both the public and private sectors. The policy does allow doctors to request permits to import pharmaceuticals not on the list for special cases. Nigeria has been unable to strictly enforce the policy, however - over-the-counter drugs are still widely available at pharmacies and quality-control facilities are inadequate. According to a June 1991 report issued by the Amsterdam-based Working Group on Health and Development Issues, "It is estimated that 40-60 percent of the drugs on the market in Nigeria are counterfeit."

 In 1982, Bangladesh enacted a national drug policy that identified 150 most essential drugs, and about 100 other drugs required by hospital specialists. The policy banned over 1,700 drugs described as useless, non- essential or harmful. [see Bangladesh bans 1700 drugs; curbs foreign firms," Multinational Monitor, August 1982 ]. U.S. and European government officials and industry interests responded with strong-arm tactics against the Bangladesh government, and the country eventually rescinded the ban on about 40 products. The supply of essential drugs to health-care facilities is still far below requirements, in large part because of low government spending on health - the 1990 health budget was only 3 percent of the total budget, or $1 per head - and because of difficulty in distributing drugs in the rural areas where 85 percent of the populace resides. However, the policy has resulted in lower prices for the most important drugs and better control over dangerous drugs, and has sparked local production of pharmaceuticals. Multinationals' share of the market declined from 65 percent in 1981 to 41 percent in 1987, and four domestic drug companies were among the top 10 producers as of 1990. By 1987, 75 percent of Bangladesh's pharmaceutical production was devoted to the 45 drugs determined to be most essential for primary health care.

 Rizwanuddin says there are important advantages to drug policies that restrict the number of drugs available. When consumers have access to drugs through private pharmacies, he says, they often come to believe that drugs available for free or at a subsidized rate through government hospitals or programs are not as effective as those available only on the private market. A "general attitude develops," says Rizwanuddin, that if you have to pay more for a medication, "then it must be a better drug."

Business and essential drugs

 WHO has generally emphasized the importance of broadening access to essential drugs, rather than curbing the marketing of useless or harmful drugs. Some health activists criticized the organization in the 1980s for not taking a strong position against non- essential drugs and the industry that produces and aggressively markets them. WHO was very slow, for example, to voice support for Bangladesh's national drug policy, the first to put WHO's essential drugs concept into practice.

Rizwanuddin says, however, that, in practice, APED policies have worked to stem the flow of useless drugs into developing countries. He points out that numerous WHO publications, intended for use in formulating national drug policies, do advise against the use of certain drugs. Its recent publication on the treatment of diarrhea, for example, strongly recommends that antidiarrheals never be used and advises only very limited use of antibiotics, and those only for dysentary and cholera.

APED has also encouraged local production of pharmaceuticals while acknowledging the potential economic and political consequences of government efforts to promote self-sufficiency. The APED report to the World Health Assembly says, "One of the aims of essential drugs schemes to serve the whole population is to encourage self- reliance in local production, but this raises many economic, infrastructural and technical problems - even political problems, when it threatens the interests of the transnational companies." The same report points out that WHO has had only limited success in stimulating local production, most of it in Africa.

 The multinational pharmaceutical industry was strongly opposed to the essential drugs concept when it was first introduced and implemented in the late 1970s, with the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) and the U.S. Pharmaceutical Manufacturers Association (PMA) arguing that limited lists would lower the standard of health care in developing countries and reduce competition, resulting in lower quality and higher priced drugs. A 1985 PMA report asserted that the national drug policy in Bangladesh scared off investors, that it had failed to make essential drugs more widely available and that banned drugs were still available in Bangladesh as a result of an increase in smuggling from India and the manufacture of low-quality imitation products within the country.

 The pharmaceutical industry seems less concerned today with issuing dire warnings about the impact limited lists will have on world health (as long as they do not attempt to restrict the private market). An IFPMA position paper on essential drugs says, "The international pharmaceutical industry represented by IFPMA supports the original concept of WHO's Model List of Essential Drugs for government-funded primary healthcare programs designed to serve the poorest populations in countries with limited resources."

The IFPMA paper does warn against any limits on the private sector: "In countries where a well-developed, private medical sector meets the needs of patients who can afford optimal care, subjective limits on the variety of drugs available can harm medical care. ... [Imposing] such limits on all sectors of the community will do nothing to raise the standard of treatment for the least privileged." The paper also states that restricting the number of available drugs may lead to reduced research and development and competition and to higher prices for drugs. Restricted drug lists, IFPMA contends, "limit the number of drugs available at a serious and unnecessary risk to public health."

 Multinational pharmaceutical companies have probably relaxed their rigid stance against the concept because in practice limited lists have had little impact on sales. Very few lists apply to private markets, which remain open to the pharmaceutical manufacturers.

An essential role

 Education must be a key component of an effective essential drug program, both OXFAM's Saunders and Rizwanuddin stress. "An unbiased source of information is an essential component" of a rational drug policy, says Rizwanuddin. Physicians, pharmacists, primary health-care workers and other prescribers must be given objective information (from a source other than a manufacturer) about medication, he says.

Health activists stress that prevention of disease should play as large a role in health care as curative measures. Still, the essential drugs concept is a useful mechanism for determining which medications really are vital to the health standard of developing countries, and which pharmaceuticals those countries should purchase with limited currency.

 

Sidebar

Pushing Poisonous Pills

PHARMACEUTICALS BANNED or withdrawn in Europe are widely available in the Third World, according to "Exposed Deadly Exports," a June 1991 report issued by the Amsterdam-based Working Group on Health and Development Issues (WEMOS).

The group determined that at least 47 drugs banned or withdrawn in Europe were on the market in the Third World in the second half of 1990. The WEMOS list contains both drugs exported from Europe and those produced in developing countries by subsidiaries of European companies. The majority of the drugs on the list are analgesics and antibacterials, for which there are several safer alternatives that appear on the World Health Organization essential drugs list.

Europe has much less stringent pharmaceutical export regulations than the United States, where the 1986 Drug Export Amendment Act severely restricts export to the Third World of any new drug that has failed to gain approval from the Food and Drug Administration, has had approval withdrawn or is otherwise restricted for safety reasons. According to WEMOS, discussions in the European Parliament over the issue of drug exports to the Third World ended in 1989 with the adoption of regulations that lack substantial export restrictions.

"Exposed Deadly Exports" lists numerous examples of "irresponsible industry response" to concerns about the safety and efficacy of a product. The WEMOS report charges many companies with: postponing the withdrawal of obsolete products in the Third World; selling out old stocks after voluntarily withdrawing a product for safety reasons; reformulating a product into a similar drug after a ban, but selling it under the same name and logo, making it almost impossible for consumers to distinguish between the old, unsafe product and the new, safer drug and enabling companies to continue selling their stock of the unsafe drug; and refusing to accept responsibility for the marketing of obsolete products by their subsidiaries outside the Community, even though the products are promoted under the company name and logo.

WEMOS recommends the EC take a number of steps to control the export of harmful or ineffective drugs to the Third World. These include: creating a consolidated list of banned drugs within all European countries; limiting the exports of banned, withdrawn or unlicensed drugs through application of a "prior informed consent" procedure which would allow for the export of a banned or restricted product only if it was specifically requested for import by a country and full information on its use in Europe was disclosed; and enacting a complete ban on the export of products that are considered too dangerous for use in any circumstance.

"The basic premise of export control is that the same standards should be applied for the domestic market as for the export of pharmaceuticals. ... [Most] products are banned because they are unreasonably hazardous no matter where they are used. The same standards should therefore be applied for their export as for the drugs we use in our own pharmacies," the report concludes.

 - H.K.