Commercial drug compendium information: a First World/Third World comparison

The purpose of this study was to determine what differences exist in the content of commercial drug compendium monographs available in First World and Third World countries. A content model representing First World information was developed from monographs contained in the Physicians' Desk Reference, ABPI Data Sheet Compendium, and the Rote Liste. The content of the three First World compendia was found to be variable, with the Physicians' Desk Reference consistently more comprehensive than either the ABPI or Rote Liste. This result suggests that there is a lack of agreement among industrialized countries regarding what amount of information is necessary or appropriate for inclusion in a commercial drug compendium. A sample of 58 monographs was selected from four Third World compendia and evaluated in terms of comprehensiveness and accuracy. These monographs represented five commonly prescribed drugs from the World Health Organization's Essential Drugs List. The monographs were found to be less comprehensive than any of the three monographs contained in the First World compendia. Approximately 5 percent of the information contained in the sampled monographs was determined to be inaccurate. The sampled monographs for drugs supplied by multi-national pharmaceutical firms were found to contain the same amount of information as those for drugs supplied by domestic firms.     

Globalization, pharmaceutical pricing, and South African health policy: managing confrontation with U.S. firms and politicians.

Brewing since the advent of South African democracy in 1994 and promises of health sector transformation, an extraordinary drug war between President Nelson Mandela's African National Congress government and U.S. pharmaceutical manufacturers took on global proportions in 1998-1999. Within months of the passage of South African legislation aimed at lowering drug prices, the U.S. government quickly applied powerful pressure points to repeal a clause allowing potential importation of generic substitutes and imposition of compulsory licensing. At stake were not only local interpretations of patent law and World Trade Organization rules on Trade in Intellectual Property, but international power relations between developing countries and the pharmaceutical industry. In reviewing the ongoing debate, this article considers post-apartheid public health policy, U.S. government pressure to change the law, and pharmaceutical industry interests and links to the U.S. government, and evaluates various kinds of resistance to U.S. corporate and government behavior. The case thus raises--not for the first time--concerns about contemporary imperialism ("globalization"), the role of the profit motive as an incentive in vital pharmaceutical products, and indeed the depth of "democracy" in a country where high-bidding international drug firms have sufficient clout to embarrass Vice President Al Gore by pitting him against the life-and-death interests of millions of consumers of essential drugs in South Africa and other developing countries.     

The World Bank and pharmaceuticals

Within less than a decade the World Bank has become the largest single source of finance (loans) for health in low and middle income countries as well as a major player in the field of pharmaceuticals. Often 20-50% of the recurrent government health budget in developing countries is used to procure drugs. Drugs are among the most salient and cost-effective elements of health care and often a key factor for the success of a health sector reform. However, pharmaceuticals are frequently being used irrationally, mainly due to market imperfections in health care, such as information asymmetries, leading to serious health problems and a heavy financial burden on the health system. Lending priorities set by the World Bank could be used to promote public health sector reform, leading to the rational use of affordable and available drugs of good quality in developing countries. This report provides the first analysis of World Bank activity in the pharmaceutical sector worldwide. The analysis of 77 staff appraisal reports, describing the planning phase of World Bank country projects, shows that 16% of the total World Bank health, nutrition and population budget, or approximately US$1.3 billion, has been committed to loans or credits supporting pharmaceutical activities in the programme countries between 1989-95. Roughly US$1.05 billion has been committed to procurement of drugs and medical equipment. Only 5% of the total pharmaceutical sector lending is committed to software components such as drug policy work and rational use of drugs. No more than 45% of the projects were developed in collaboration with pharmaceutical expertise. The World Bank is recommended to improve its pharmaceutical sector involvement by promoting drug policy research and development including national and international dialogue on pharmaceutical issues to ensure rational use of both drugs and loans. In this, the World Bank has an advantage given its experience from working with both the private and the public sector, its in-house expertise in health economics, and lastly its ability to be listened to by governments through its power.     

Generic drugs: an alternative for the Brazilian market

The analysis of the main characteristics of the pharmaceutical industry worldwide and market aspects of that industry in Brazil leads us to consider a high share of external dependency and oligopolization. This situation is not peculiar to our country, but is rather a global trend. Recent Government initiatives in Brazil, aiming at reducing that dependency, associated with the critical aspects regarding the prices and costs of drugs as compared to international prices, are the background that support the proposal of evaluating generic drugs as an alternative for Brazilian market. One of the most striking aspect is the verification of overpricing of raw materials as demonstrated by "transfer prices", a practice that has been observed in several countries. Analysing international concepts dealing with generic drugs, generic names and pharmaceutical equivalence, based on World Health Organization recommendations and evaluating the experiences of different countries, several actions are proposed in order to gradually enforce a policy of generic drugs, bioequivalent and interchangeable, as a possible regulatory mechanisms for Brazil.     

Intellectual property and access to medicines: an analysis of legislation in Central America

Globalization of intellectual property (IP) protection for medicines has been advancing during the past decade. Countries are obliged to adapt their legislation as a requirement of their membership to the World Trade Organization or as a condition of being part of international trade agreements. There is a growing recognition that, in low-income countries, stronger IP protection is a barrier to access to medicines. At the same time, the number of low-income countries writing national legislation to protect IP for pharmaceutical products is growing worldwide, but little research has been done on the ways in which this process is happening at the national level.This paper aims to contribute to the understanding of the implementation of IP legislation at the national level by providing a comparative analysis of the countries that are part of the United States–Dominican Republic–Central America Free Trade Agreement (DR-CAFTA). The analysis shows three trends. First, countries have often implemented stronger IP protection than required by trade agreements. Second, some countries have adopted IP protection before signing the trade agreements. Third, the process of ratification of DR-CAFTA increased public debate around these issues, which in some cases led to IP legislation that considers public health needs. These trends suggest that industrialized countries and the pharmaceutical industry are using more tactics than just trade agreements to push for increased IP protection and that the process of national legislation is a valid arena for confronting public health needs to those of the industry.     

The economics of essential drug programmes

Public health measures are still the most important factor in improving Third World health. However, medicines have an important part to play, and it is now generally agreed that for the very poor populations medicines should be restricted to those on an 'essential drugs list' and should be made available as cheaply as possible. A major problem arises, however, in trying to stop these very cheap supplies 'leaking' back into the private sector, and being sold to the public at high prices. This is particularly true as many countries have a large rich urban elite as well as a much larger poor rural population. It is also important to recognise that research into Third World diseases must be financed by profits on the sale of medicines in advanced countries. A 'cheap drug' policy in rich countries can be very harmful to the long-term health even of the less developed countries.     

Impact of the World Trade Organization TRIPS agreement on the pharmaceutical industry in Thailand.

The 1994 World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) established minimum universal standards in all areas of intellectual property. It is intended to implement these standards globally through a WTO enforcement mechanism. The present article proposes a strategy for alleviating the potentially negative impact of TRIPS in Thailand in relation to the following: purchasers; prescribers and dispensers; producers; products; price control; patent-to-third-party; parallel imports; power of the customer; patentable new drugs; personnel; and prevention policies. The following TRIPS provisions are pertinent to the pharmaceutical industry in Thailand: the limited term of product and process patents; the conditions of protection; and the broad scope for compulsory licensing and enforcement procedures in the national patent system.     

Expanding drug access in Brazil: lessons for Latin America and Canada

This paper discusses Brazil's efforts to provide essential medicines for its population while meeting international trade obligations. In the 1950s and 1960s, Brazil's pharmaceutical industry was largely overtaken by foreign companies. To counteract this, Brazil enacted a law in 1971 that allowed the production of patented drugs in order to provide affordable medicines, encourage research and development, and reduce dependency on imports. Eventually, pressure from the United States government (through tariffs and sanctions) drove Brazil to introduce pharmaceutical patent laws. Local interests prevailed, however, through Brazil's liberal interpretation of the TRIPS Agreement, which included a provision that pharmaceutical products must be "worked" or manufactured locally or the government could turn to the use of compulsory licensing. Brazil's willingness to use the threat of compulsory licensing compelled drug companies to lower HIV/AIDS drug prices substantially. Finally, the paper discusses how Canada can facilitate improving drug access in Latin America through helping Brazil expand its role as a manufacturer and providing medicines to countries without manufacturing capabilities.     

Drug discovery and developments in developing countries: bottlenecks and way forward

Infectious and parasitic diseases continue to threaten the health of million of people throughout the world, with the major burden being in developing countries. Many of the currently available drugs for the treatment of these diseases face setbacks such as insufficient efficacy, increasing loss of effectiveness due to emergence of resistance, high levels of toxicity, inaccessibility and/or high costs. The driving force for drug discovery and development by pharmaceutical firms has been the foreseeable profit from drug sells. Since most infectious diseases prevail in developing countries and the fact that people living in these countries have poor purchasing power, the market for such drugs are unattractive to these firms. Thus, there has been reluctance for the pharmaceutical companies to engage in the development of drugs addressing diseases that mainly affect developing countries. Although a lot of research to discover new effective and cheap drugs is in progress in the disease endemic countries, it is not yet possible to fully develop leads and drug candidates from natural products, hence people in these countries continue to rely on traditional medicines. Poor economies and technological capabilities, lack of human resources and good management in these countries are the major constraints to progress in research and development work for new drugs. This paper discusses these major bottlenecks in drug discovery and development and suggests the way forward.     

Ethical issues in clinical trials in developing countries

The vertical transmission trials conducted in a variety of developing countries by researchers from more developed countries illustrate a variety of crucial ethical issues. Three crucial issues are the injustice of the use of placebo control groups, the coerciveness of the offer to participate, and the exploitation of Third World countries. This paper examines each of these issues separately. It develops a new standard for when such control groups are acceptable. It concludes that the issue of coercive offers is not well founded. It also concludes that concerns about exploitation are better addressed by assurances about the future care of the subjects in the trial than by assurances of availability of the drugs in the country in general.     

Plundering the poor: the role of the World Bank in the Third World

The World Bank, the most important so-called development assistance agency, annually dispenses billions of dollars to Third World governments, ostensibly to "develop" their economics through a variety of loan projects. But even a superficial analysis reveals that the Bank is the perfect mechanism to help (i.e., subsidize) the large transnational corporations from the industrial countries to expand their industrial, commercial, and financial activities in the Third World, at the expense of the latter and particularly at the expense of the rural and urban proletariat. This article discusses Cheryl Payer's recent book, The World Bank: A Critical Analysis, in which she analyzes the Bank's role in the Third World and sets forth the major reasons why poverty, hunger, and malnutrition, as well as unemployment, and all the adverse social phenomena associated with them, are on the increase.     

Essential drugs and registration of pharmaceuticals: the Sri Lankan experience.

Many factors influence the regulation of pharmaceuticals in a country. The essential drugs concept, formulated by the World Health Organization to assist developing countries in selecting appropriate drugs, also provides a basis for regulation. Sri Lanka has long regulated pharmaceuticals as part of its health policy. Over 70% of 3436 pharmaceutical product registrations were found to be drugs (or alternatives) named in the country''s essential drugs list. This is despite the fact that product registrations are mainly for the private health care sector, and the list is for the state sector. The essential drugs concept therefore appears to have influenced the pharmaceuticals registered in Sri Lanka.     

Deficient information in developing countries: Internet alone is no solution

Health-care personnel in developing countries have poor access to information, partly because the books are out of date and journals and Internet access are lacking, and partly because the information that is available is not appropriate for the local situation. There is too little research aimed at the problems of the Third World. This is due to a lack of interest in Western countries and because local scientists have done too little research. Internet solves the problem of access to information for health-care personnel in large hospitals and institutes, but there is still a shortage of relevant information for them as well. The editorial boards of professional journals could make a contribution by facilitating the publication of relevant research. Health-care personnel in rural areas will remain dependent upon basic books. This basic component of the provision of information should continue to receive attention. For the time being, Internet will remain inaccessible for rural health-care personnel. One of the initiatives being undertaken in order to improve the provision of information to health-care personnel in developing countries is the distribution of the 'blue trunk library' of the WHO with a selection of more than 100 basic books in every trunk. A number of journals have also taken action: the BMJ Publishing Group offers access to its journals free of charge to the 118 poorest countries and the Canadian Medical Association Journal provides free copies to libraries in developing countries. Moreover, a number ofwebsites have been started with a view to enlarging the information for health-care personnel in the Third World.     

Accommodation for elderly persons in newly industrializing countries: the Hong Kong experience

The newly industrializing countries seem set to follow many developed countries with a rapid growth in numbers of elderly people. This will throw considerable strain on their resources, particularly in the provision of services and accommodation for this group in society. Hong Kong is a leader amongst the newly industrializing countries, both in terms of its aging population (more than 11 percent of its people are now over 60 years of age) and in terms of economic growth. It has, however, only relatively recently embarked upon a comprehensive and integrated program to provide a wide range of accommodation for the elderly. This includes sheltered housing within Hong Kong's well-known public housing schemes, old people's homes, care-and-attention homes, and infirmaries. The private sector has also been growing rapidly in the 1980s with a considerable recent increase of old people's homes. A voluntary code of conduct for this sector was introduced in late 1986, but concerns remain about the quality of care and the rapid growth of private homes in the territory. The approaches to the provision of accommodation for the elderly are set in the context of Hong Kong's overall social policy development. Whilst the experience of relatively wealthy Hong Kong may not prove to be of relevance for the majority of Third World countries, it is argued that it may provide a model for other newly industrializing countries.