Draft Manuscript – Please do not cite without permission 1 Legal and Regulatory Responses to Innovative Treatment Tracey Evans Chan * I. I NTRODUCTION Patients suffering from illness that has no standard medical therapy, 1 Innovative medical therapy has thus been a matter of increasing concern internationally in health care, particularly where market forces are at play in the health care system. The concern stems both from the particular features of innovative therapy and its differential regulatory treatment – as part of the traditional therapeutic pathway in healthcare rather than the research ethics pathway. or who have exhausted all current therapeutic options are often in a desperate situation. They press their doctors in search of something new in the hope that it can offer them some chance of recovery. Their doctors, in turn, are thus motivated to experiment or innovate in order to develop alternative treatments. This therapeutic motivation, however, comingles in modern healthcare with other professional and commercial considerations such as enhanced reputation and profit. In addition, there is the potential for innovative therapy to generate knowledge that will spur its development and eventual adoption by the profession. However, this desire to benefit future patients may be at odds with the interests of the particular patient offered innovative treatment. 2 Ongoing developments in medical technology, health care 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 therefore becomes an important question, on which there is a current lack of consensus on a number of issues. This paper proceeds as follows. Part II discusses the recent pertinent developments in Singapore and uses them as a springboard to flesh out basic regulatory issues that arise from the deployment of innovative treatment. Part III examines the question of how we should distinguish innovative treatment from research, and the significance of appropriate classification. Part IV examines the adequacy of the current post If innovative therapy continues to fall within the therapeutic paradigm, as it traditionally has, decision-making would remain subject to the confines of the physician-patient relationship and certain post hoc review processes such as medical negligence. Substantial faith is therefore placed on professional judgment and the informed consent process. Patients in such situations may, however, not be in the best position to size up the medical complexities and uncertain risks, and are thus more vulnerable to false hopes and overly optimistic assessments of the worth of innovative therapy. In contrast, activity that is classified as research stands on a significantly different ethical, legal and regulatory footing, where the need for prior ethical review is the current international best practice. * Faculty of Law, National University of Singapore. Comments on this paper are most welcome and can be sent to lawchant@nus.edu.sg 1 A working definition of “standard medical therapy” can be found in the U.S. National Commission, The Belmont Report: Ethical Principles and Guidelines for Protection of Human Subjects of Research (18 April 1979) , Part A, para 2; online: <http://ohsr.od.nih.gov/guidelines/belmont.html#goa>: “interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable chance of success.” 2 See A. Mastroianni, “Liability Regulation and Policy in Surgical Innovation: The Cutting Edge of Research and Therapy” (2006) 16 Health Matrix 351 at 370-371.