Intended for healthcare professionals


Hazardous drugs in developing countries

BMJ 1997; 315 doi: (Published 13 December 1997) Cite this as: BMJ 1997;315:1557

The market may be healthier than the people

  1. David B Menkes, Senior lecturera (david.menkes{at}
  1. a Dunedin School of Medicine, University of Otago, PO Box 913, Dunedin, New Zealand

    The international pharmaceutical market shows substantial regional differences in availability and promotion of drugs.1 This variation depends on affluence, health requirements, capacity for local manufacture, and the restrictions which countries may impose to control dangerous or inappropriate use of drugs.2 3 Because of their limited industrial base, most developing countries import most of their drugs, and transnational corporations are adept at exploiting variations in such markets.1 Commercial interests may conflict with public health needs in developing countries,4 5 6 particularly when people are poisoned due to inadequate restriction of pharmaceutical use, misleading advertising or labelling, or frankly bogus products.

    Promotion of unsafe drugs in the developing world has long attracted criticism, particularly when products have been banned or restricted in the country of manufacture.3 5 Pharmaceutical adverts, labelling, and package inserts in developing countries often show the twin problems of exaggerated indications and minimised adverse effects.1 5 6 Drug exports from the United States to developing countries were reviewed independently in 1993 and found to have “severe labelling deficiencies,” in many cases posing life threatening risks.7 Locally produced drugs have labelling problems which may exceed even those of imports.5

    A further problem arises from unscrupulous entrepreneurs whose bogus merchandise mimics acceptable drugs. Whether manufactured locally or imported from the West, such counterfeit drugs can be dangerous,8 particularly when contaminated. Unethical promotion and counterfeiting are compounded by several factors: inconsistent import, export, and quality controls3; the dominance of private pharmacies and self medication9; direct advertising to pharmacies and consumers5 6; and the fact that promotional material may be the main information available to prescribers.1 3

    Promotion of expensive brand names increases apparent choice but can also hobble developing countries' efforts to meet pharmaceutical needs by bulk purchase or manufacture of essential generics.1 3 6 Ironically, “humanitarian” drug donations may serve donor companies (through brand awareness and tax incentives) more than recipient countries, which commonly suffer disposal costs (or toxic consequences) from inappropriate or poorly labeled drugs.10

    The health impacts of inappropriate pharmaceutical exports have included multiple fatal poisoning,3 1112 the spread of antibiotic resistant infections,3 13 and a host of problems arising from the mismanagement of diarrhoea in children.4 14 Women and children appear particularly susceptible to the health problems associated with the unrestricted use of particular pharmaceuticals.3 11 12 Inappropriate promotion of some products (such as stimulants to treat “lethargy” in children) is also lamentable, as it diverts attention and resources away from fundamental public health needs.1 13

    Control of hazardous drugs is an international imperative. Threats to public health posed by inconsistent control of various chemical hazards have prompted the United Nations to publicise existing regulations, ostensibly to encourage international consensus.2 A compendium of restricted pharmaceutical, agricultural, industrial, and domestic products has been systematically updated since 1982.2 Analysis of the pharmaceutical section indicates that a country's capacity to restrict dangerous drugs depends heavily on its wealth, as illustrated by the strong correlation of restrictions with per capita gross national product (r=0.65, n=162, P<0.001). This dismal picture may underestimate the true extent of the disparity, since poor countries with notable restrictions (including Bangladesh, Ethiopia) lack administrative machinery to police these.3 13

    The gravity of the situation has prompted resolutions from the World Health Organisation, the United Nations, and other corporations against inappropriate export and promotion of drugs. But whether such non-binding agreements help is debatable,3 5 and an enforceable code is lacking. Despite evidence of progress since the 1970s, some transnationals continue to promote irresponsibly, exploit frail national restrictions on imports, and behave in other unethical ways, for example offering doctors “commissions”for prescribing.1 6

    Inappropriate pharmaceutical promotion has also been challenged by non-governmental organisations. For example, lobbies such as Health Action International3 and the Medical Lobby for Appropriate Marketing1 monitor and publicise improper marketing and use of drugs. These lobbies also encourage governments and industry to invest in the development and appropriate use of antibiotics, contraceptives, and other (generally unprofitable) essentials for developing countries.13

    With pharmaceuticals as with other technologies, unrestricted market forces do not always work in favour of public health, particularly in countries with the most urgent needs. While sustainable economic development will be necessary finally to relieve the excess burden of illness in poor countries,13 steps can be taken now to use available resources more appropriately. Rational use of cost-effective pharmaceuticals is an achievable priority, and enforceable agreements are required to control promotion of inessential and hazardous agents.1 3 The medical community has a role to play in this effort, as it can influence both industry and government policy. Whatever their political leanings, doctors inevitably have a stake both in the control of hazardous technology and in the appropriate use of medicines.


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    View Abstract