Regulating innovative treatments: information, risk allocation and redress

This special issue features papers culminating from a six seminar ESRC series ‘Liability versus innovation: Unpacking Key Connections,’ convened between December 2015 and September 2017 at Keele, QUT (Brisbane, Australia) and Durham universities.11 See: ‘Liability v Innovation: Unpacking Key Connections, An ESRC Seminar Series’. The support of ESRC towards this research is acknowledged. The seminar series was conceived in response to perceptions of scientists and clinicians that, despite the pro innovation rhetoric in Government policy documents,the threat of malpractice liability might stifle innovative treatment (IT). Such perceptions are supported by two related claims common in medico-legal literature – that the threat of legal liability following adverse outcomes causes defensive medicine, and that the threat of legal liability stifles innovation. The extent of these problems remains disputed. In particular, the Bolam-Bolitho test of clinical negligence in England – which excludes liability for clinical decisions accepted as proper by a responsible body of skilled medical peers unless such practice is illogical – is arguably problematic in terms of incentives to engage in IT. An IT is by definition less likely to accord with accepted practice. So, while policy-makers encourage and pay considerable lip service to innovation, tort law might give the opposite incentive to clinicians. Or so goes the argument