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Dr Wendy Bonython School of Law and Justice Studies

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Presentation on theme: "Dr Wendy Bonython School of Law and Justice Studies"— Presentation transcript:

1 Does Australia’s ‘defensive medicine’ problem situation warrant a Medical Innovation Bill?
Dr Wendy Bonython School of Law and Justice Studies Faculty of Business Government and Law University of Canberra Do we have a ‘defensive medicine problem’ or a ‘situation’? Argue the latter- more complicated than a direct relationship btw negligent treatment and finding of liability, incompletely understood from both legal and medical practitioner perspectives That said, this paper is going to attempt to consider whether a Medical Innovation Bill, modelled on the type currently under consideration in the UK, is an appropriate solution to a poorly conceptualised problem that may or may not exist, either here or there… here goes!

2 Medical Innovation Bill
Innovation vs Litigation Medical Innovation Bills Protection from litigation for ‘responsible’ innovators Does regulation of innovation have a stifling effect? Is fear of litigation (defensive medicine) really the barrier? Saatchi Bill; The Medical Innovation Bills currently under consideration by the UK parliament are predicated on the belief that fear of litigation prevents practitioners from making ‘innovative’ medical treatments available to critically ill patients. Both Bills focus on patient access to innovative medical treatment, understandably - but incorrectly - identifying practitioner fear of litigation as an inhibitor of ‘responsible’ medical innovation, and proposing exemption from negligence for doctors providing innovative medical treatment. Critics of the Bills have pointed to a lack of evidence that this phenomenon actually occurs. (eg Miola, Colleges)

3 Innovation in Australia
The Myriad argument for patent protection (D’Arcy and Cancer Voices v Myriad Genetics) The ‘burden’ of regulation, cf the reason for regulation Clinical trials Ethics approvals Drug/device registration Innovation policy renewal Medical innovation – and innovation more broadly – is a policy focus of the current Australian government, requiring balancing of a number of competing interests, including those of commercial entities and patients. The tensions between those interests was recently highlighted in Australia by the High Court decision in D’Arcy and Cancer Voices v Myriad Genetics, which rejected a patent claim over the BRCA1 gene, used in diagnosis of breast and other cancers. Regulatory purpose: Risk MINIMISATION, not ELIMINATION Identified barriers occurring earlier in the innovation life-cycle, including access to funding, ethics and regulatory approval bottlenecks, and delays in dissemination of outcomes influences by intellectual property protection. Responses in Policy announced on Monday 8/12/15.

4 Medical negligence litigation in Australia
The ‘torts/insurance’ crisis Emergence of ‘defensive medicine’ United Medical Protection ‘landmark’ cases and their coverage The Ipp Review Targets for reform Standard of care (especially wrt ‘informed’ consent) Causation The post-Ipp reforms Defensive medicine –the phenomenon of practitioner behaviour modification driven by fear of litigation - has attracted much attention in Australia in recent decades, particularly during the torts crisis of the early 2000’s. Frequently mentioned by politicians and lobbyists in media circa Ipp Review; literature from the time -Rogers v Whitaker (standard of care regarding consent) -No of large damages awards ‘The courts expect the impossible’ Collapse of UMP Reform of standard of care (see eg s5O CLA (NSW)); Causation reform; damages

5 The data…negligence litigation outcomes
Based on a longitudinal study (25 years) of practitioner involvement before the courts, we have found the role of the courts in litigation as a driver of defensive medicine has been overstated, and that perceptions of court involvement in litigation, rather than reality, make a more significant contribution. Courts account for 4% of all matters notified to insurers 562 events, 711 judgments (some finals also had earlier judgements); mostly neg, a few had trespass as alternatives 404= procedural only 357= substantive- 150 (plaintiff); 157 (defendant)

6 The data… damages awards
Of the 150 findings for plaintiffs, 119 included an award for damages in the published judgement; the remainder were presumably settled confidentially once liability was resolved. The total value of damages awarded by the courts over the 25 year period was $123,225,516.00, an average of $1,035, when divided across the 119 cases which included damages. Split into the periods pre and post legislative reform, however, damages awards averaged $672, per judgement for published judgements with damages awards in the period , and $1,458, per judgement for published judgements with damages awards from

7 Will a Medical Innovation Bill solve the problem?
Probably not… No evidence to suggest that fears of defensive medicine are proportional Link between ‘innovation’ and ‘malpractice’ is poorly understood (and poorly explained!) Will the policy solve the problem… who knows?? In light of these observations, supplemented by analysis of the Australian case law on medical negligence, we conclude that a medical innovation bill based on those under consideration in the UK is unlikely to address the perceived problems of defensive practice in Australia, nor is it likely to have any real impact on the rate of innovation . The proposed reforms reflect a lack of understanding of UK law governing liability for medical treatment, disregarding empirical evidence indicating that litigation is not a significant factor in restricting access to medical innovation by patients. Reforms of the type proposed would be similarly inappropriate in Australia. Better targets for Australian legislative intervention may be identified barriers occurring earlier in the innovation life-cycle, including access to funding, ethics and regulatory approval bottlenecks, and delays in dissemination of outcomes influences by intellectual property protection.


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