AbstractsEngineering

New health technologies offer both challenges and opportunities. Regulation is one mechanism to help balance the benefits and risks of new health technologies. This thesis examines the extent to which ‘good’ health technology regulation is achieved and the effectiveness of the policy measures regulators (and others) employ to meet such aims. To accomplish these objectives, a conceptual framework of ‘good regulation’ based on the academic and practitioner literatures was developed and its various dimensions considered and explored across eight different studies. Taken together, the studies provide an analysis of the roles, processes, policies, and performance of the regulators responsible for the market authorisation and coverage and reimbursement of pharmaceuticals and medical devices in Europe and the US; the role and use of technology assessment in health technology regulation and its impact on attaining good regulation; and, the factors that impact regulatory performance. The thesis demonstrates that attaining good health technology regulation is complex and challenging, because of the inherent uncertainty regarding the benefits and risks of new technologies, their growing diversity and complexity, the limitations of existing study designs and assessment methods, the increased demands placed on regulators to meet sometimes conflicting objectives, and the underlying political nature of making decisions about public access to and financing of new health technologies. Regulators have made progress on addressing these challenges. However, additional improvements are needed to improve health technology regulatory performance. Like much of health care policy, movement toward achieving the various criteria of good regulation will be incremental, especially considering the often step-wise nature of technological innovation.