Can physicians regulate themselves?

The President of the CMA questions a recent CMAJ editorial (1) that raises concerns about professional self-regulation and a possible erosion of public confidence in Canadian physicians. Dr Schumacher criticizes the editorial for making a case that draws heavily on troubling events and reported shortcomings in UK medical governance. Implicit in his criticism is the view that it is best to stick to what is known about Canadian governance in order to have informed discussion and debate and to avoid unnecessary alarmism. This is sound and responsible public policy advice.

The editorial could have strengthened its case had it set its sights on the Canadian research regulatory terrain. Concerns about the self- regulating character of research ethics boards (REBs) and public confidence in physicians as researchers were key issues in a report on national research governance arrangements. (2) The report has been described in another CMAJ editorial as an expression of Canada playing a leading role in research ethics on the international stage. (3) REBs are charged to protect the rights and welfare of research subjects as independent ethics watchdogs. The report assessed the effectiveness and integrity of governance arrangements and called for reform. Dr. Bisby of the Canadian Institute of Health Research noted in a recent presentation at an annual conference that concerns raised in the report about REBs remain active. (4)

There are longstanding accountability concerns about REBs. They include: REBs dominated by physicians who are often research colleagues employed by an institution hosting an REB; a secretive regulatory culture; token public representation; an absence of REB accreditation; conflict of interest of a professional, institutional and commercial nature that threaten REB independence. REBs often report to the office in a research centre that promotes research. And this occurs in a very competitive, commercial and entrepreneurial research climate where researchers, hospitals and universities are taking out patens and testing their own medical devices and drugs for the market place.

There have been calls for greater REB transparency (5) and public representation in research governance (6) to help offset concerns about conflict of interest and to promote public trust and confidence in regulatory affairs. But they have yet to be heeded. These calls have been heightened by insider reports of troubling REB practices at leading research centres. (7) The U.S. Office of Health Research Protection recently reproached a Canadian REB at a leading research university for serious informed consent violations in a multi-centered clinical trial. (8) Health Canada recognizes the need for reform and a robust system of protection in light of ethics violations and different kinds of conflict of interest that may exist between researchers, REBs, and research institutions. (9)

Against this backdrop, concerns raised in the CMAJ editorial are not as alarmist as Dr. Schumacher suggests. But they would have been more on target and forceful had the editorial included the Canadian research regulatory terrain. The challenge that looms large on the research regulatory horizon is who is going to exercise the political and moral leadership to tackle long standing accountability issues - issues that have been approached too long at the speed of a slow drip.

References

1. Can physicians regulate themselves? [editorial] The Can Med Assoc J 2005;172(6):717.

2. Law Commission of Canada. The governance of health research involving human subjects. Ottawa: The Commission; 2000.

3. Dismantling the Helsinki accord [editorial]. Can Med Assoc J 2003;169:997.

4 National Council Ethics Human Research nation conference, Ottawa, March 5, 2005.

5. Freedman B, Lemmens T. Ethics Review for Sale? Conflict of Interest and Commercial Research Review Boards. Milbank Quarterly (2000) 78.

6 Weijer C. Placebo trials and tribulations [editorial]. Can Med Assoc J 2002;166:6034.

Waring D, Lemmens T. Integrating Values in Risk Analysis of Biomedical Research: The Case for Regulatory and Law Reform. University of Toronto Law Journal 54.3 (2004) 249-290.

7. Corman C, Blajchman M, Knight A. Placebo tribulations. Can Med Assoc J 2002;167:4456.

8. Office of Health Research Protection. http://www.hhs.gov/ohrp/detrm_letrs/YR03/jul03z.pdf

9. Health Canada. A Canadian system of oversight for the governance of research involving human subjects. www.hc-sc.gc.ca/sab- ccs/feb2002_governance_subject_e.pdf

Conflict of Interest:

None declared

Your editorial (1) on Physician self-regulation is a welcome call for Canadian physicians to scrutinise the evolution of our self-regulation systems in the context of international developments.

You are correct to emphasise that self-regulation is but one ingredient in what should be a closely integrated system of quality management, as stressed in the report ‘Building a Safer System’ (2). However it would be wrong to draw the conclusion from the editorial that clinical governance in the United Kingdom has been a complete failure.

Dame Janet Smith concentrated on the role of the General Medical Council in the Shipman Inquiry, and ironically has delayed implementation of their revalidation scheme due this Spring. However the UK Department of Health has implemented sweeping reforms in governance under the guidance of Dr. Donaldson, the Chief Medical Officer. ‘Maintaining High Professional Standards In The Modern NHS’ (3) published last month is the latest chapter of this process which is based on modern management and human resources theory and empirical psychological research. The reforms to the GMC were but a small part of this response to past crises. As you suggest the emphasis is on prevention rather than blame. Ultimately the success of these changes will be measured in improved quality of care.

Dr Burns in his reply correctly reminds us that there is a national initiative through his umbrella organization, the Federation of Medical Regulatory Authorities of Canada. We should also be aware that appraisal is starting to appear in some Canadian provinces, such as PAR in Alberta, and this is a welcome development.

Dr. Schumacher in his response is concerned that over emphasis on the wrongdoings of Dr. Shipman may be alarmist. I think he is partly right, because Shipman should be seen in the context of a long series of tragedies and our evolving understanding of how things go wrong in health care. Our health care systems have handled these events very poorly in the past, and have been largely reactive rather than proactive and we should look eagerly at lessons learnt in other jurisdictions to see how they might be applied in our own system.

Despite Dame Janet’s admonitions in the Shipman report, ultimately physicians, patients and society have the same goals, and concentrating on what we have in common is most likely to succeed in the long run. This is the basis of what has become to be known as ‘professionalism’.

(1) Editorial. Can physicians regulate themselves? The Canadian Medical Association Journal. 2005;172(6):717.

(2) Building a Safer System. National Steering Committee on Patient Safety. Ottawa 2002

(3) Maintaining High Professional Standards In The Modern NHS. February 2005. http://www.dh.gov.uk/assetRoot/04/10/33/44/04103344.pdf (accessed 2005 March 29)

Conflict of Interest:

None declared

We could not agree more with the statement in the recent CMAJ editorial to the effect that confidence in physicians is at the core of what we do. We also agree that we need strong licensing and regulatory bodies.

Long before the Shipman case came to light in the UK, medical regulatory authorities in Canada began making significant progress towards transparency and increased public accountability: there are more public representatives on councils, and most discipline hearings are open to the public and media.

Furthermore, the medical regulatory authorities recognize that performance may decline over time, and that the quality and safety of any individual physician’s practice need regular reaffirmation. The top priority for the Federation of Medical Regulatory Authorities of Canada is revalidation of licensure.

Many medical regulatory authorities around the world are examining the recommendations contained in the fifth report of the Shipman Inquiry, with a view to doing everything possible to prevent a similar occurrence in their jurisdiction. While it behooves our organizations to learn from this sad and appalling case, it is an extreme example of the failure of a multi-component system.

Bob Burns MD

President

Federation of Medical Regulatory Authorities of Canada

Conflict of Interest:

None declared