Positron emission tomography (PET) is a new nuclear medicine technique that has recently entered the clinical realm of medicine. Although it is a technique that can be utilized for assessment of biochemical and physiological parameters of any organ in the body, it has particular utility in the investigation of the brain. PET poses unique advantages over previous imaging devices. For the first time, it is feasible to investigate directly various biological parameters of the brain in a noninvasive way. PET allows for investigating the functional, biochemical, physiological, and pharmacological characteristics of various areas within the brains of normal and psychiatric or neurological patients. Although it has already started to give promising results, it is too new a technique to obtain an accurate appraisal of its true potentials. This is a problem that seems always to surface when one tries to evaluate the utility of a new technique in a new area of research. The problem is accentuated in the case of PET where there is no other technique available with which to compare results. This paper will discuss the basic principles of PET, its relationship to other existing imaging devices, and the issues to be considered when making a technological assessment of positron emission tomography.

During the last 12 years, most Middle Eastern countries, particularly those focused upon in this study (Algeria, Egypt, prerevolutionary Iran, Iraq, Kuwait, and Saudi Arabia), have placed increasing emphasis on improved health care. This emphasis has been reflected in both budgetary and public policy plans. The strides made in medical care during this period have been enormous, but much remains to be done. Some of the major health problems today involve diseases that have largely been conquered in industrialized countries, such as infectious and parasitic diseases, respiratory infections, problems related to childbirth, and diarrheal disease. Chronic diseases, such as heart disease, which have become common in industrialized countries and to which much of the newer medical technology is addressed, are, by many accounts, far down on the list of health problems in the Middle East. Many Middle Eastern countries need comprehensive public health programs to help meet their goals.

The articles in this issue of the International Journal of Technology Assessment in Health Care are intended to give the reader a bird's-eye view of the ways that different countries approach the regulation of pharmaceuticals.

Drug regulation in the United States has been the subject of extensive public literature and has been studied more thoroughly than any other aspect of American governmental regulation. Yet it remains mired in criticism and debate that, over the years, have threatened not only the existing regulatory system but also the stability of the American drug industry itself. This article summarizes the history of drug regulation in the United States, discusses the basic structure of the American regulatory system as it exists today, and relates some of the more important controversies that continue to surround this subject.

It is difficult to determine when drug regulation began. The idea that some kind of control is necessary is very old indeed; it was many centuries ago that apothecaries were first accused of paternalism and secrecy, and it was just as long ago that they found arguments to present their case as guardians of the public interest. It was at least three centuries ago that regulations on the sale of opiates were first devised in order to protect the ignorant, the reckless, and the exploited.

French drug policy is closely controlled by the government to achieve two main purposes: to ensure therapeutic efficacy and safety, and to control pricing. Manufacturers usually price new drugs at the amount the French Sécurité Sociale (Social Security) agrees to reimburse the consumer. The specific steps a new ethical drug must go through in order to be released on the French market, and the process of negotiation between the government and the manufacturer are discussed in this paper.

All drug evaluation and regulation policy in the Federal Republic of Germany is based on the Drug Law of 1976. In accordance with the pharmaceutical directives of the European Community, this law provided that all drug products must be of good pharmaceutic quality, therapeutically effective, and safe according to the current state of knowledge. It is aimed at guaranteeing safety in the use of drugs without hindering the plurality of thought in medical science.

At about the time of national confederation in Canada, in the 1860s, profound changes had begun to take place in the field of chemical science, although most of these had not yet been translated into any advances in drug treatment. This was the era of chemical brilliance in Germany. Paul Ehrlich (1854–1915), often referred to as the father of modern pharmacology, had applied, with great foresight and considerable courage, the 1865 insights of August Kekulé, the chemist who had accomplished the difficult transition between inorganic and organic chemistry. Indeed, it was Kekulé who made possible the chemical –magic bullet— that could reach body organs to effect therapeutic changes, a realistic goal for Ehrlich, especially in his work associated with the treatment of syphilis.

The basic aim of a drug policy is to ensure that effective and safe drugs of good quality are available to cover the health needs of a country. A national drug policy should be considered an integral part of any comprehensive health-care policy. The formulation of national drug policies varies even between similar countries because of conflicting interests and different political, economic, and social pressures. It is influenced by such factors as:

the health situation of the country;

the medical care system;

the education and training of health personnel;

the social security and health-insurance schemes;

drug research and development possibilities;

the domestic production of drugs;

the determination of the demand for drugs;

the system of drug distribution;

the possibilities for evaluation and control of drugs; and

international policies on medicinal products.

The assessment of drugs in Sweden has a long tradition that goes back to the seventeenth century when the Collegium Medicorum was established in 1663. One of its duties was to control the production of drugs in pharmacies. In 1688, Sweden got its first pharmacopoeia. In 1917, the Pharmaceutical Laboratory was founded as an advisory body of the National Board of Health and Welfare. The laboratory, now called the Department of Drugs, became responsible for evaluating drug applications, including information on their pharmaceutical and chemical properties, pharmacological actions, and clinical effects.

The release of prescription drugs in Australia for use by the medical profession is complicated because in practice there is a two-tier system determining availability. The first tier, for new drugs, involves evaluation for safety and efficacy prior to marketing. The final decision is made by the Australian Drug Evaluation Committee (ADEC) serviced by the Department of Health. In the second, much more unusual step, a decision is made by a different committee on whether the now-approved drug is to be included on the government-subsidized drug list (Pharmaceutical Benefits Scheme—PBS). Because the PBS list is unusually extensive for a country without a nationalized health service (1,184 items, including all forms and strengths of over 600 drugs) and because a large proportion of prescriptions are written for drugs on the PBS, the PBS Committee making the listing decisions has a major influence on prescribing patterns. In addition, the government is able to exert considerable pressure on drug prices.

The intensity with which the United States and the European Community (EC) are reviewing their trade difficulties with Japan makes examination of the Japanese pharmaceutical regulatory environment particularly appropriate at this time. One of the four topics identified for focused discussion between the U.S. and Japanese governments in last year's Market Oriented Sector Selective (MOSS) talks was pharmaceuticals, a $13 billion industry (at 1985 exchange rates), in which Japan is the world's second largest market for pharmaceuticals.

The circumstances and conditions bounding the use of drugs in developing countries are not, as many commentators on this subject assume, similar to those in industrialized countries. Appropriate solutions to the issues of quality control, price, and distribution present major quandaries (1). But they can be addressed if governments exhibit adequate political will and set realistic policy objectives.