This special section is the written record of the second National Institute for Clinical Excellence (NICE) conference, which drew together experts in the fields of health technology assessment (HTA) from around the world. It includes a significant perspective from the pharmaceutical industry, whose partnership with the manufacturers of technologies (pharmaceuticals, devices, etc.) is of paramount importance to the successful future of the input of HTA into healthcare delivery. The importance of HTA as the basis of clinical decision making has never been more apparent. All clinicians are aware of the requirement that they provide the most up-to-date health care for their patients, who in turn appropriately consider this as a right. The need to ensure that this care is based on reliable evidence of clinical effectiveness is paramount. In addition, the need for all healthcare systems to consider costs as well as benefits has led to a further imposition on those who provide care to take into account value for money when considering the implementation of a new technology.

In healthcare decision making, there is an important functional separation between assessment and appraisal. In the U.K. National Health Service (NHS), this distinction is illustrated by the separation of roles between the Health Technology Assessment Programme and the National Institute for Clinical Excellence. However, it can be seen at every level within the healthcare system. Assessment of a technology is a scientific task that synthesizes all relevant evidence on effectiveness and cost-effectiveness; its results are therefore generalizable. Appraisal of the technology is informed by the assessment but adds context-specific judgments on the applicability of the evidence, the feasibility and impact of alternative options, relative priorities, and wider social and ethical aspects. An explicit distinction between assessment and appraisal is helpful in achieving clarity, consistency, and consensus. It also makes clear the need for a wide range of assessment reviews to support decision making by commissioners, providers, and users of health services. Increasingly, the secondary research supported by the NHS R&D Programme is being distributed electronically. It is also being used to identify areas in which further primary research should be commissioned.

The technology appraisal program of the National Institute for Clinical Excellence (NICE) was established on April 1, 1999. Its role is to advise the NHS in England and Wales on the clinical effectiveness, cost-effectiveness, and service impact of new and emerging as well as established healthcare technologies. This paper describes the role of HTA in the NICE technology appraisal process, discusses some of the challenges of the use of HTA in national policy making, and considers some of the potential ways forward.

Health technology assessment (HTA) grew from a need recognized by researchers concerned about the effectiveness of health services. They were later joined by policy makers in search of valid information about the costs and benefits of investments in health care. The history of HTA shows that this need appeared in many countries at nearly the same time.

Increasingly, health technology assessment (HTA) is used to aid decisions on the reimbursement of pharmaceuticals or recommendations for their use. The pharmaceutical industry seeks to work in partnership with HTA agencies; however, this presents a number of challenges. Clinical trials will need to include appropriate measures that capture economic and patient benefits as well as relevant clinical endpoints, and the industry will want to seek international harmonization of the many guidelines for economic evaluation. The problem of demonstrating cost-effectiveness of a product before it is available for use must be addressed, possibly by conditional reimbursement to allow collection of real world evidence. It is also important that reimbursement decision makers minimize bias, play fair, and adhere to the written rules they issue. If the industry fairly demonstrates the value of a product using the best available evidence, HTA agencies should be transparent in the rationale for their recommendations.

Governments may perform health technology assessment (HTA) in their roles as a regulator in the public interest, as a source of information for decision makers in the public and private sectors, and/or as a purchaser or provider of healthcare services. The U.S. government's roles in the health sector as a regulator, source of information, and purchaser and provider of services are influenced both by characteristics of that sector and by its stakeholders' effectiveness in influencing national health policy debates.

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) was established by the Federal, Provincial, and Territorial Ministers of Health in 1989 for a 3-year trial period. In 1993 CCOHTA was made a permanent organization and in 1999 the Deputy Ministers of Health renewed CCOHTA's mandate and increased its funding. CCOHTA's role is to coordinate health technology assessment (HTA) priorities across jurisdictions, foster and undertake assessment activity, and function as a clearinghouse for technology assessment results while increasing healthcare system stakeholder awareness of HTA findings. The coordinated and collaborated approach adopted by CCOHTA minimizes duplication with other national and provincial organizations and contributes to the ability of the Canadian healthcare system to continue to deliver high-quality health care to its constituents.

More than 10 years ago, the Australian government took the bold and unprecedented step of announcing that it would request evidence on comparative cost-effectiveness of new pharmaceutical products, assess this evidence, and then use it to guide systematically the decisions as to whether to subsidize these new products. This paper summarizes the Australian drug subsidy scheme and the activities involved in making this announcement work in practice, assesses the impact these activities have had on broader policy actions, and examines whether these have resulted in any worthwhile achievements.

Health technology is an indispensable part of any nation's healthcare system. During the past 50 years, all member states that comprise the European Union have increased their technological base for health care, both in terms of knowledge and by investments in equipment, devices, and pharmaceuticals. Generally, this process has gone well. However, several problems have emerged related to the acquisition, diffusion, and use of modern health technology. Concerns have been also raised about the effectiveness and efficiency of already established procedures in health care.

Health technology assessment (HTA) seeks to inform health policy makers by using the best scientific evidence on the medical, social, economic, and ethical implications of investments in health care. Technology is broadly defined to include the drugs, devices, medical, and surgical procedures used in health care, as well as measures for prevention and rehabilitation of disease, and the organizational and support systems in which health care is provided.

The aim of Working Group 1 has been to assess health promotion and disease prevention activities in terms of benefits, risks, and economic, social, and ethical implications as a complement to community health indicators.

The aim of Working Group 2 has been to develop a system for routine exchange of information concerning ongoing or planned evaluations and their findings, priority setting, and emerging technology.

The aim of Working Group 3 has been to identify possible joint assessments and to coordinate findings and existing resources within the community to support joint assessments.

The aim of Working Group 4 has been to develop and disseminate best practice in undertaking and reporting assessments, and to identify needs for methodologic development.

The aim of Working Group 5 is to develop and coordinate education and support networks for individuals and organizations undertaking or using assessment of health interventions and to identify needs in the field and assist in the establishment of new provisions.

According to the HTA-Europe report, health technology assessment (HTA) has the potential to influence health policy in the fields of research and development, regulation of pharmaceuticals, devices, and services, quality assurance, reimbursement, education and training of healthcare providers, and consumer education (1). To identify and bridge the gaps between HTA production and implementation, the goal of Working Group 6 was to approach the use of HTA in policy and practice on the aggregate policy level as well as in the local context, such as in hospitals. Members of Working Group 6 included both users (e.g., members of decision-making bodies) and producers (e.g., members of HTA agencies) of HTA reports. The aim of the working group was to identify three types of information on HTA implementation and impact. These included identifying successful examples of the implementation of HTA results, examples of structures that require HTA information as part of the decision-making process, and finally, identifying groups and persons who use HTA frequently and are willing to share their experiences with other HTA users and producers.