Professor Malcolm Sparrow of the Harvard Kennedy School of Government looks at how regulators can better anticipate risks and act to protect patients and reduce harm.

Prof Malcolm SparrowRoughly half the work that governments do involves the control of harms. Medical regulators, along with their counterparts in law enforcement, security, intelligence and other social regulatory agencies all exist primarily to protect citizens from harms of one type or another. True, they deliver services too, but their core task is to identify “bads” (hazards, risks, threats, problems, or harms) and to control them effectively, thereby making citizens safer, healthier, and more secure.

Citizens expect regulators to be:

(a) vigilant, so they can spot emerging threats early, pick up on precursors and warning signs, use their imaginations to work out what could happen, and to do these things even before much harm is done.
(b) nimble, flexible enough to organize themselves quickly and appropriately around each emerging risk, rather than being locked into patterns of practice constructed around the risks of a preceding decade, and
(c) skillful, masters of the entire intervention toolkit, and adept at creating new approaches when existing methods turn out to be irrelevant or insufficient to suppress a risk.

Little guidance has been available on the operational challenges peculiar to the risk-control business, even as a series of disasters (quickly dubbed “regulatory failures”) have unfolded in recent years. Regulators, and others with risk-control responsibilities, need practical help with a distinct set of issues: What does it mean to be vigilant with respect to novel or emerging risks? What is the relationship between enforcement discretion and effective risk control? How best can regulators modify behaviour and manage compliance, and at the same time remain minimally intrusive? How can executives organize established bureaucracies around specific harm-reduction objectives when the harms don’t align with any established piece of the organizational structure? How do we measure an organization’s contributions to risk reduction? How can policymakers justify a budget for preventive work on a long-term and sustainable basis, in the absence of a catastrophe? On these and many other issues, regulatory practitioners are hungry for guidance.

Many regulators, deeply dissatisfied with the traditional performance of their own agencies, have already begun inventing for themselves a truly risk-based approach to their business. They are explicitly acknowledging and embracing the expert model (focused on risks) as opposed to the legal model (focused on compliance) as the overarching framework for their operations. They are recognizing different types of discretion and becoming more comfortable exercising them as they carefully pick and choose what to work on, and how best to intervene. They are learning how to form constructive and appropriate relationships with regulated industries, centred on priority risk-control imperatives rather than misplaced notions of customer-service.

In the same way that epidemiologists study pathogens, regulators are learning how to scrutinize specific harms to uncover their dynamics and dependencies with a view to producing cleverly conceived acts of sabotage – tailor-made interventions that can substantially reduce or even eliminate specific problems altogether. These innovative practices deserve attention. The sabotage of harms is an emerging professional art-form, full of promise but surely in need of development, formalization and refinement.

These emerging ideas are as relevant and the associated challenges as pressing in the safe provision of medical care as they are in any other industry. I look forward to exploring how the many medical regulators, academics and government officials gathering in London for IAMRA 2014 might move toward a truly expert model of risk-based regulation as they seek to protect patients and support good medical practise.


 Adapted from an essay previously published by Professor Malcolm K. Sparrow in “The Sabotage of Harms: An Emerging Art Form for Public Managers,” ESADE Institute of Public Governance & Management, E-newsletter, March 2012.