Medical innovation laws: an unnecessary innovation
Bernadette RichardsLaw School, University of Adelaide, North Tce, SA 5005, Australia. Email: bernadette.richards@adelaide.edu.au
Australian Health Review 40(3) 282-285 https://doi.org/10.1071/AH15081
Submitted: 3 May 2015 Accepted: 24 July 2015 Published: 14 September 2015
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.
References
[1] This language reflects the original professional standard of care test stated in Bolamv Friern Hospital Management Committee [1957] 1 WLR 582 and now reiterated in the Civil Liability Acts around the country, Civil Liability Act 2002 (NSW) s5O, Civil Liability Act 2003 (Qld) s22, Civil Liability Act 1936 (SA) s41, Civil Liability Act 2002 (TAS) s22, Wrongs Act 1958 (VIC) s59, Civil Liability Act 2002 (WA) s5PB.[2] Lord Saatchi, Second Reading of the ‘Medical Innovation Bill’ (HL) Hansard, 27 June 2014. The following summary is taken from Lord Saatchi’s speech, columns 1449–1454.
[3] The Telegraph. The Saatchi Bill. 5 March 2015. Available at: http://www.telegraph.co.uk/news/health/saatchi-bill/ [verified 7 August 2015].
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[6] Lord Saatchi, First Reading of the ‘Medical Innovation Bill’ (HL) Hansard, 27 16 January 2013, column 756.
[7] See for example, Lord Saatchi’s article, ‘The Law is Killing Patients’ (Health Services Journal, 30 September 2013. Available at: http://www.hsj.co.uk/comment/lord-saatchi-the-law-is-killing-patients/5063651.article# [verified 7 August 2015].
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[15] Mt Isa Mines v Pusey (1970) CLR 383, Windeyer J, 395.
[16] Civil Liability Act 2002 (NSW) s5O, Civil Liability Act 2003 (Qld) s22, Civil Liability Act 1936 (SA) s41, Civil Liability Act 2002 (TAS) s22, Wrongs Act 1958 (VIC) s59, Civil Liability Act 2002 (WA) s5PB.
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[19] Paterson R. Decision 08HDC20258 Wellington: New Zealand Health and Disability Commissioner. Available at: http://www.hdc.org.nz/decisions–case-notes/commissioner’s-decisions/2009/08hdc20258 [verified 7 August 2015].
[20] It is worth noting here that if this case was heard in Australia as opposed to New Zealand, where there is a different approach to cases such as this, there would have been a problem with the patient proving causation. In the process of delivering his findings, the Commissioner concluded that the patient had in fact already made his decision prior to the consultation and that he was less likely to be attentive to the information and unlikely to have heard the warnings. This conclusion was based upon his general approach to the treatment, which had included his earlier refusal to comply with his surgeon’s advice to wait until he returned from his trip to have the biopsy. Thus, it would be difficult for the patient to argue that more information would have made a difference to his decision-making process.
[21] Brus v ACT [2007] ACTSC 83.
[22] A detailed consideration of the HDC/ABMT treatment is beyond the scope of this discussion. For a detailed analysis and account, refer R. A. Rettig, P. D. Faruhar, C. Jacobsen. False hope: bone marrow transplantation for breast cancer. Cary, NC: Oxford University Press; 2007.
[23] Lord Saatchi, First Reading of the ‘Medical Innovation Bill’ (HL) Hansard, 27 16 January 2013, column 756.
[24] Kulakowski v Rochester Hospital Service Corporation 779 F.Supp. 710, 717.
