Responsibility and Surgical Innovation: Locating Ethics in Responsive Regulation.

Professor Colin ThomsonUniversity of Wollongong

The issueAll 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) 

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?

The context: innovation in surgery

haemorrhagic occluder pin

Clinical practice: traditional and laparoscopic appendectomy

Ligation of the internal mammary artery

Failed innovations

The DePuy ASR hip replacement

At least 50 hip replacement products availableAt least 20 competitors in $2billion global industry

The ASR hip replacement2003 European device authority approval

2005 Published 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

The ASR hip replacement2007 Fractures & joint/tissue erosion

Australian National Joint Register notifies DePuy annual revision 5xnormalDePuy explains data away

2008 Reports of high metal ion in blood 100 x normal

2009 DePuy withdraws ASR in Australia2010 DePuy withdraws ASR world wide

93,000 ASR replacementspredicted 49% failure in 5 years

Regulatory challenge How promote innovation AND Minimize & manage risks to patients? Can responsive or smart regulation

assist in resolving the regulatory dilemma?

What is regulation?

the intentional activity of attempting to control, order or influence the

behavior of others.(Black)

Smart regulation*: Principle 1Prefer policy mixes incorporating instrument and institutional combinations

• Gunningham& Sinclair

Smart regulation: Principle 2 Prefer less interventionist

measuresIntervention = Prescription - inflexible & inefficient Coercion – ineffective (conscripts)BUT less interventionist measure must

workCapacity to elevate response

Smart regulation: Principle 3 (incl. responsive regulation)

Escalate up an instrument pyramid to the extent necessary to achieve policy goals

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

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

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?

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 patientsBUT ALSO promote innovation

Could ethics be an element of smart regulation?

(Can ethics be smart?)

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?

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?

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

Acknowledgement