Regulation and risk
Editor – Your observations about the place for regulation (Evans TW, FHJ October 2014 pp 67–8) are well made. In 2010 the prime minister's Risk and Regulation Advisory Council, of which I was a member, mapped The risk landscape1 to demonstrate how challenging it is to ensure that regulation is proportionate to the risk against which such regulation aims to protect. It is not only the patients who stand to gain from regulation. There is an industry of ‘risk actors’, regulators, lawyers, insurers, standard setters and politicians who make a living from, or hope to gain re-election by, their participation. The direct costs of regulation include the salaries and expenses of those involved. There are also indirect costs, for instance for the time demanded of others to demonstrate compliance. Doctors are well aware of the effort that is needed to achieve revalidation but such costs are rarely considered, in part because they are difficult to quantify.
Those indirect costs may be very high indeed and bear little relation to the cost of the potential risks from which the regulation purports to protect. Even the best regulation cannot mitigate risk completely, while the obligation to comply with regulation takes precedence over other activity which may be of greater benefit to patients, for instance innovation. Professor Caldwell is correct in suggesting that regulatory processes can be over-engineered, unnecessarily cumbersome and expensive. I believe that it is beholden on Government and other responsible ‘risk actors’, including the Royal Colleges, to avoid the temptation to add to the regulatory burden. By all means let there be transparency on patient experience and outcomes. Let resources be used to improve both rather than to support a regulatory bureaucracy and the livelihoods of the ‘risk actors’ involved.
- © 2015 Royal College of Physicians
Reference
- 1. .↵
- Risk and Regulation Advisory Council
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