Legal and regulatory responses to innovative treatment.
Developments in medical technology, healthcare delivery, and commercial interests in medicine have increased both the potential for conflicts of interest on the part of physicians, and doubts over the sufficiency of patient autonomy as a justification for administering innovative therapy. The legal and regulatory treatment of innovative therapy is therefore an important question, on which there is a current lack of consensus on a number of issues. This paper discusses recent developments in Singapore and uses them as a springboard to flesh out basic regulatory issues that arise from the deployment of innovative treatment: the distinction between innovative treatment and clinical research, the adequacy of the current post hoc scrutiny of innovative therapy under existing legal principles and the need for further specialised regulatory oversight.
Faculty of Law, National University of Singapore. lawchant@nus.edu.sg
Tracey Evans
TE
Chan
D035843:Biomedical Research / Q000331:legislation & jurisprudence; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans; D008318:Malpractice / Q000331:legislation & jurisprudence; D056687:Off-Label Use; D061214:Patient Safety; D035703:Therapies, Investigational / Q000941:ethics