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 Medicare prospective payment system (PPS) for inpatient hopital service was enacted in 1983. It uses a classification based on diagnosis-related groups (DRGs) to determine payment for services provided.

Bone marrow transplantation has become an accepted treatment for severe aplastic anemia, acute myelogenous leukemia, and acute lymphocytic leukemia (20;35). Less commonly thalassemia (23), multiple myeloma (25), severe combined immune deficiencies (10), and chronic granulocytic leukemia (14) are also treated with marrow transplantation. Most donors are siblings whose HLA phenotype is identical to the patient's. Such donors, however, are available to only one third of patients (6;16;27;28;35). In the absence of an HLA-identical sibling, partially matched, haplo-identical, related donors (differing by only one major histocom-patibility antigen) can be found for another 7% of patients (1;6;27;37). A variety of lower quality matches also can be found but have not been used extensively. Advances in tissue typing and the treatment of graft versus host disease now allow physicians to consider matched unrelated individuals as potential donors when a suitable related donor is not available (11;12;13;15;17;22).

Over the past decade the Office of Medical Application of Research (OMAR) of the National Institutes of Health has developed the consensus development conference (18) to assess technologies in cases where the scientific community has been unable, or unwilling, to reach a firm position as to efficacy but which require some better form of assessment than expert opinion (8). Another paper in this issue describes the principles that underlie such conferences (9).

The Netherlands is a small country of about 15 million inhabitants. With 400 inhabitants per square kilometer, it is one of the most densely populated areas of the world (19). Here, government is not seen as negative, but as a tool to solve societal problems. Ordinarily, the public and private sectors work cooperatively together, but the government will step in when needed. (19, 20).

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.

In 1958 Joseph Murray and associates reported the first successful kidney transplantation between two identical twins at Peter Bent Brigham Hospital in Boston (14). Since then organ transplantation has advanced rapidly. Renal transplantation is now a standard treatment for irreversible renal failure, and liver transplantation is an accepted method for treating end-stage liver disease. A number of patients have survived more than 20 years after renal transplantation and more than 10 years after liver transplantation (20). Very few liver transplantations have been performed in Sweden but this method is expected to become more common in the near future.

“Technology assessment” is still a relatively new concept, and its application to the field of medicine is even more recent. This results not only from an important effort to develop the scientific basis for health care, but also as a consequence of the growing concern about medical care costs (19). The term refers basically to the evaluation of the costs and effects of a medical technology. The most important methodological approach in this area has been, and still is, the traditional clinical trial, defined by Bradford Hill as “A carefully and ethically designed experiment with the aim of answering some precisely framed question,” including random allocation of the subjects in the trial (4).

Since 1977, the Consensus Development Program of the Office of Medical Applications of Research (OMAR), part of the National Institutes of Health (NIH), has sponsored more than 50 consensus development conferences (CDCs) on the safety and efficacy of important biomedical technologies. The aim of these conferences, described fully elsewhere (4), is to inform the health care community, and to some extent the public, of the status of emerging biomedical technologies and the need for change in the use of existing health-related technologies. OMAR has therefore, worked diligently to publicize conference findings among these audiences. Further, OMAR has sought to improve the effectiveness of these transfer activities by conducting assessments of the impact of CDCs on their primary audience, U.S. physicians.

This article describes issues that are clinically significant when assessing quality of life of patients whose organ disease can be treated only through transplantation or reliance upon an artificial organ. Emphasis is placed on stresses that affect the family as well as the immediate patient, because, over time, these are inextricably interwoven. The transplant recipient who experiences a “good” medical outcome may perceive that he has little to live for if his family is severely disrupted or broken apart by the strain of the illness. The family of a patient who dies after unremitting complications while being sustained by an artificial organ may experience both relief at the lifting of an unmanageable burden, and continuing guilt that they were unable to provide unconditional love and support to a dying family member.

The economic, political, ethical, and medical issues surrounding organ transplantation are complex, and coverage policies for it vary considerably among insurers. Some insurers cover virtually all transplants, while others cover few or none (Wyoming Medicaid does not cover any transplants) (3;4;5;6;7). In the past, insurers have followed Medicare's lead regarding coverage of new technologies. This has not been the case with organ transplantation. Although Medicare does not cover heart transplants, almost all Blue Cross/Blue Shield plans and commercial health insurers, as well as one-half of the state Medicaid plans and one-third of the Health Maintenance Organizations (HMOs), do cover heart transplants. (See note, p. 570.) In addition, although Medicare does not cover heart–lung transplants, a substantial proportion of Blue Cross/Blue Shield plans, commercial health insurers, state Medicaid plans, and HMOs cover it. At present, Medicare covers kidney and cornea transplants, selected pediatric liver transplants, and selected bone marrow transplants.

The role and the place of technology assessment, in relation to health policy making, are gradually changing. These changes have implications for the transfer of assessment findings to the parties involved in the process of policy making.