Regulatory and ethical challenges in offering innovative salvage treatments to patients
Sumytra Menon1, Centre For Biomedical Ethics, National University Of Singapore 1Centre For Biomedical Ethics, National University Of Singapore Singapore
Abstract
It is desirable to innovate and develop new treatments if it advances the health of humans. Innovative treatments offered and administered to patients in a clinical setting by doctors engages the doctor’s duty to act in the patient’s best interests because clinical treatment is primarily to benefit the patient’s health. In Singapore, the treatment and care of patients by doctors is governed under a paradigm that includes medical negligence and professional misconduct. A doctor’s departure from the standards in the Singapore Ethical Code and Ethical Guidelines (ECEG) (issued by the Singapore Medical Council), when read with the provisions of the Medical Registration Act, may constitute professional misconduct. The ECEG (2016) states that doctors should treat patients using generally accepted methods, which means time-tested or well-documented methods, or treatments supported by a responsible body of medical opinion, which are logically held. It further adds that doctors may consider innovative therapy for their patients if certain conditions are met. In recent legislative developments, additional governance for such therapies have been provided for by licensing terms and conditions and directives, which have been promulgated under the Healthcare Services Act 2020. In this paper, the author will discuss Singapore’s regulatory framework on innovative treatments administered to patients in a clinical setting, focusing on in-house manufactured cell, tissue, gene therapy products used for innovative salvage therapy. Challenges regarding the consent process, potential conflicts of interest, and the approvals required to proceed with such therapy will be examined, and the author will reflect on whether the right balance has been struck between protecting patients and giving them a chance of a better outcome.
Biography
Dr Sumytra Menon is Deputy Director of the Centre for Biomedical Ethics, Co-Director of the CENTRES initiative instituted to develop educational activities in clinical and transplant ethics and enhance ethics committees’ capabilities. A lawyer by training, her particular research interests are in healthcare decision-making, mental capacity law, and end-of-life issues.