Liability v innovation: unpacking key connections

In this topical (see 'objectives' for detail) 6 seminar series we bring together jurists, economists, ethicists and medics from several jurisdictions, including the UK, Australia, the US and Israel, to explore from interdisciplinary and comparative perspectives the theoretical assumptions, empirical findings, and normative ramifications of the debates about the relationship between tort liability, disciplinary proceedings, defensive medicine and innovation, and the practical implications of legal reforms, as follows:

Seminar 1: The defensive medicine debate
This seminar will set the ground to the inquiry by examining the broader question of whether tort liability causes defensive medicine. The findings in the literature are inconclusive, and broadly speaking, are US focused. Participants will include both academics researching medical malpractice and defensive medicine and stakeholders, including medical and legal practitioners.

Seminar 2: Does liability stifle innovation?: economic models and anecdotal findings
This seminar has four related aims. First, to learn from anecdotal evidence brought forward by regenerative medicine and other clinicians and researchers suggesting that the problem exists. Second, to examine conflicting findings in the literature of whether liability stifles innovation or not. Third, to explore, mainly from a health economics perspective, the methodological difficulties involved in defining and measuring levels of innovation. Finally, to scrutinise assumptions, methodologies and findings on the effect of changes in malpractice liability rules on level of innovation.

Seminar 3: The Medical Innovation Bill: significant change, or much ado about nothing?
A major policy oriented response to the fear of stifled innovation is the introduction of the Medical Innovation Bill by Lord Saatchi. In its latest form the Bill would have added to the common law's common professional practice 'defence' a statutory defence which hinges on a pre-treatment peer review of the benefits and risks of the proposed treatment, alternative treatments, and no treatment. The seminar will explore the significance and desirability of the Bill, and the best way forward, by bringing together academics, representatives of the Bill's team, clinicians, patient rights' advocates and legal practitioners.

Seminar 4: The effect of disciplinary proceedings
Clinicians are likely to be more wary of disciplinary proceedings than of malpractice suits. Yet, curiously, much of the defensive medicine research focuses solely on tort liability to the neglect of disciplinary proceedings. Seminar 4 will begin to fill this void by looking into disciplinary proceedings in the context of innovative treatments and their supposed consequences, drawing on the experience of academics, clinicians, legal practitioners and regulators.

Seminar 5: Thinking outside the box: Strict liability and offsetting risks
The Medical Innovation Bill's solution still works within the confines of received wisdom: (a) fault-based liability, (b) full compensation and (c) the patient's best interest as a governing principle to determine whether offering the innovative treatment is negligent. Seminar 5 will question this received wisdom. It will examine, first, the case for strict liability towards patients injured from innovative treatments; and then, the case for and against determining (= standards of care) and reducing (= compensation) the physician's liability based on benefits to others.

Seminar 6: The regulation of research
This seminar will examine the relationship between the regulation of research, and of innovative treatments and the effects on innovation. Issues to be addressed include the distinction between innovative treatment and research; the relative threat of tort law and regulation on innovation in research; and whether the level of compensation to research subjects stifles innovation.

The seminar series will impact three main groups. First, policy makers and activists. Non-academic speakers and participants will be invited based on their expertise or interest in this subject as either regulators, policy makers or representatives of relevant interest groups (such as patients and physicians). These participants will benefit from the opportunity to develop their awareness and understanding of recent findings and legal developments in the area. They will also be able to draw on the insights of the academic participants in framing their own policy agendas. At the same time, the experience, views and concerns of stakeholders will inform the research agenda of academics in the field of law, ethics and health economics.

Second, the series will benefit legal practitioners who present or attend the seminars by providing opportunities to exchange knowledge with other practitioners, to be exposed to cutting edge research in this area, and to be able to inform academics, policy makers and regulators of their own experience. This will be done in an environment which is conducive to creative, theoretically informed and contextualised reflection. In addition to the lawyers invited to participate as speakers and discussants, we will reserve workshop places for practitioners interested in attending for Continuing Professional Development purposes.

Third, the series will have impact on medical practitioners by creating an environment in which both their views, insights, experiences and concerns could be voiced to policy makers, regulators and academics researching the subject, and they could be informed about recent studies and regulatory developments which might dispel some misbeliefs and misconceptions about the effect of liability on innovation. We will draw on our connections with the University Hospital of North Staffordshire and the Australian Centre for Health Services Innovation (AusHSI) to maximise the impact on medical practitioners by ways of attending the seminars, informing the discussion and being aware of its findings.

After each seminar, we will prepare a brief indicating the main discussions and their conclusions and publish it on the seminar series' website which forms part of this project. In addition to the brief, we will make materials generated by the seminar available online. These materials will be of interest to a wide range of policymakers, activists, practitioners, academics, and the general public. As explained in further detail in 'pathways to impact' policy-makers, legal- and medical practitioners who do not attend the series will have access to the series' findings, and an opportunity to feed in their views, through dissemination by participants via their own networks, the website (with its interactive module), the blog and other social media and the 'liability versus innovation' research and knowledge exchange network.

We will invite representatives from the following organisations to the following seminars:

NHS Legal Authority (2,5)
Australian Health Practitioner Regulation Agency (1, 4)
Australian Medical Association (1,4)
British Medical Association (2,3,5,6)
Avant Insurance (1, 4)
Australian Health Complaints Commissioner (1,4)
AusHSI (1,4)
Slater & Gordon (1, 2,3, 4, 5)
Tress Cox Lawyers (1,4)
Medico Legal Society of Qld (1,4)
Therapeutic Goods Administration (4)
Australasian Association of Bioethics and Health Law (1,4)
Australian Centre for Health Law Research (1,4)
Queensland Health (1,4)
Cancer Council (1,4)
Medical Defence Union (2,3,5)
National Institute for Health and Care Excellence (2,3)
Care Quality Commission (2)
General Medical Council (2,5,6).
Action against Medical Accidents (2,3)
Picker Institute Europe (2)
Patient Advice and Liaison Service (2,3)
Lord Saatchi's Medical Innovation Bill team (3,5)
Qld Health Ombudsman (4)
European Forum for Good Clinical Practice (2,3,5,6)
DoH (2,3,5,6).