Medical innovation laws: an unnecessary innovation

Abstract

Objective This paper aims to demonstrate that any suggestion that there is a need for specific innovation laws is flawed. Innovation is central to good medical practice and is adequately supported by current law. Methods The paper reviews the nature of medical innovation and outlines recent attempts in the UK to introduce specific laws aimed at 'encouraging' and 'supporting' innovation. The current legal framework is outlined and the role of the law in relation to medical innovation explored. Results The analysis demonstrates the cyclic relationship between medical advancement and the law and concludes that there is no requirement for specific innovation laws. Conclusions The law not only supports innovation and development in medical treatment but encourages it as central to a functioning medical system. There is no need to introduce specific laws aimed at medical innovation; to do so represents an unnecessary legal innovation and serves to complicate matters. What is known about the topic? Over recent months, there has been a great deal of discussion surrounding the law in the context of medical innovation. This was driven by the attempts in the UK to introduce specific laws in the Medical Innovation Bill. The general subject matter - negligence and the expected standard of care in the provision of treatment - is very well understood, but not in cases where the treatment can be described as innovative. The general rhetoric in both the UK and Australia around the Medical Innovation Bill demonstrates a lack of understanding of the position of the law with regards to innovative treatment. What does this paper add? This paper adds clarity to the debate. It presents the law and explains the manner in which the law can operate around innovative treatment. The paper asserts that medical innovation is both supported and encouraged by existing legal principles. What are the implications for practitioners? The paper presents an argument that can guide the policy position in this area. It also provides clarity around the legal position and expected standard of care for those who are introducing innovative medical treatment.

When Doctors and Parents Don’t Agree: The story of Charlie Gard

“…These value-laden terms pointed to hope and cure but Charlie's interests would have been better served with the more accurate description of Bexperimental.^2 The extensive testing, research ethics, and protocols that are in place for new treatments, medicines, and devices have been designed to ensure that treatments are safe and effective when they reach patients. Accusations of the law preventing innovative medical treatment are not justified (Richards 2016), and terming experimental treatments as Binnovative^sug-gests that it is new but tried and tested; nucleoside therapy had not even been tested on mice. Charlie's case has been aired extensively in the media across the world over the last few months; the media spin put on Charlie's case did not help his medical situation, and it has been argued by at least one commentator that the inaccurate reporting in the United States on the situation Breinforced the parental refusal to accept this tragic situation^ (Phillips 2017).…”