1. Responsibility and Surgical Innovation: Locating Ethics in Responsive Regulation. Professor Colin Thomson University of Wollongong

2. The issue All the great surgeons of our time and of generations gone by have been quintessential innovators, trailblazers who have sought to make meaningful differences in how we practice, teach, do research, and administrate. Surgeons are known for taking initiative, being decisive, and leading the way for others to follow; innovation, therefore, is very much part of the surgical phenotype. (Anees, 2011:642)

3. The issue: Ethical regulation of surgical innovation: the last frontier ?(Reitsma & Moreno 2001) When is an innovation a variation of current practice something new or research?

4. The context: innovation in surgery haemorrhagic occluder pin

5. Clinical practice: traditional and laparoscopic appendectomy

6. Ligation of the internal mammary artery Failed innovations

7. The DePuy ASR hip replacement At least 50 hip replacement products available At least 20 competitors in $2billion global industry

8. The ASR hip replacement 2003European device authority approval 2005Published concerns about toxicity of metal debris from metal-on-metal hip replacements. 2006 DePuy paper Setting the record straight on metal hypersensitivity 2006 UK agency considers toxicity & appoints expert panel to advise on risk-benefits of metal-on-metal hip replacements

9. The ASR hip replacement 2007 Fractures & joint/tissue erosion Australian National Joint Register notifies DePuy annual revision 5xnormal DePuy explains data away 2008 Reports of high metal ion in blood 100 x normal 2009 DePuy withdraws ASR in Australia 2010 DePuy withdraws ASR world wide 93,000 ASR replacements predicted 49% failure in 5 years

10. Regulatory challenge How promote innovation AND Minimize & manage risks to patients? Can responsive or smart regulation assist in resolving the regulatory dilemma?

11. What is regulation? the intentional activity of attempting to control, order or influence the behavior of others. (Black)

12. Smart regulation*: Principle 1 Prefer policy mixes incorporating instrument and institutional combinations Gunningham & Sinclair

13. Smart regulation: Principle 2 Prefer less interventionist measures Intervention = Prescription - inflexible & inefficient Coercion – ineffective (conscripts) BUT less interventionist measure must work Capacity to elevate response

14. Smart regulation: Principle 3 (incl. responsive regulation) Escalate up an instrument pyramid to the extent necessary to achieve policy goals

15. Responsive regulation Smart regulation varies this by: including non- government agents as quasi-regulators escalating, in event if failure, in multiple ways triggers: inspection, audits,reporting,etc buffer zones circuit breakers

16. Smart regulation: Principle 4 Empower participants which are in the best position to act as surrogate regulators More potent More legitimate Government resources limited Governments not omnipotent – but may be important facilitator via $, or mandating information to insurers

17. Smart regulation: Principle 5 Maximise opportunities for win/win outcomes Regulation achieves safety & enables surgeon benefit/incentive? Professional recognition for notification/auditing of innovations? Access to intellectual property profits only if safety standards met?

18. Objectives of regulation Responsive & smart regulation devised to regulate industry to prevent environmental harm Objective=risk management Regulating innovation in surgery needs to: minimize & manage risks to patients BUT ALSO promote innovation

19. Could ethics be an element of smart regulation? (Can ethics be smart?)

20. Ethics in regulation What role does or should ethics play in smart or responsive regulation of surgical innovation? Is innovation consistent with surgical professional ethics? Is innovation consistent with ethical obligations to patients? Is ethical self-regulation individual or professional?

21. Ethics in regulation Would any such role impair the function of professional ethics as a source of responsibility? E.g. if ethics becomes associated with (mere) conformity on reporting & auditing of innovation?

22. Re-examining ethical conduct What motivates ethical conduct?* Autonomy Mastery Purpose *(Drive, Dan Pink)

23. Acknowledgement