"The regulatory challenges in regards to clinical innovation” Talk by Professor Mette Hartlev, Director of Centre for Legal Studies in Welfare and Market, Faculty of Law, University of Copenhagen, Denmark. From the session "What is the legal and regulatory environment concerning clinical innovations in medicine?" at the NCBio conference Bioethics of clinical innovation and unproven methods, Copenhagen, 9 April 2019.
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Abstract: Development of new and better products and methods in health care is generally welcomed by both patients, health care professionals, and society. Consequently, there is a common interest among these actors and innovators in clinical innovation. However, innovation always implies a certain degree of uncertainty regarding benefits and risks – and this is particularly true in regards to radical innovation. Consequently, development and testing of new drugs, technologies and methods in health care takes place in a landscape of uncertainties, which calls for regulatory considerations. This paper explores the role of regulation in regards to clinical innovation. It explores whether (and how) regulators can stimulate and promote innovations to the benefit of society, while at the same time mitigating the potential risks affiliated with clinical innovation. It also discusses the regulatory challenges facing regulators when dealing with new technologies which does not fit into the existing legal and ethical regulatory regime. Consequently, innovation also calls for innovative regulation.
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