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Revisiting Robust Regulation

Few can have missed media reports of the actions of Ian Stuart Paterson, the former breast surgeon who faced criminal charges on the basis that he had carried out “extensive, life-changing operations for no medically justifiable reason”. On Friday 28 April 2017, at Nottingham Crown Court, he was convicted of 10 counts of wounding with intent between 1997 and 2011, relating to nine women and one man, and three further wounding charges.  During the period in question Paterson was employed by Heart of England NHS Trust (as it was then) and also practised privately at Spire Healthcare. This blog considers some of the specific regulatory challenges that arise in this case, but also reflects upon the more fundamental question as to what might constitute “robust regulation” in these circumstances. 
review concerning Paterson’s surgical practice had previously been conducted in 2013, by Sir Ian Kennedy, at the request of the board of Heart of England NHS Foundation Trust.   At the outset of his report, he summarised the tragic story thus:
It is a story of women faced with a life threatening disease who have been harmed. It is a story of clinicians at their wits’ ends trying for years to get the Trust to address what was going on. It is a story of clinicians going along with what they knew to be poor performance. It is a story of weak and indecisive leadership from senior managers. It is a story of secrecy and containment. It is a story of a Board which did not carry out its responsibilities. It is a story of a surgeon who chose on occasions to operate on women in a way unrecognised by his peers and thereby exposed them to harm.”[1]

This highlights just some of the complex issues raised by the Paterson case.  Here also there are echoes of the organisational, cultural and regulatory failings that were identified in the 2013 report of the public inquiry chaired by Robert Francis QC into failings at Mid Staffordshire Foundation Trust (“the Mid Staffordshire Inquiry).
The lengthy background to Paterson’s recent criminal conviction makes difficult reading, in circumstances where it is reported that concerns had been raised by his colleagues as early as 2003 concerns had been raised by his colleagues as early as 2003[2]. The criminal conviction followed numerous investigations, with Paterson’s registration finally being suspended by the GMC in October 2012.[3]This had the effect that he restricted from practising as a doctor, either within the NHS or privately, in the UK.  This background prompts the same question asked of the Mid Staffordshire Inquiry, namely “why problems … were not identified sooner,and appropriate action taken?”[4]

A few weeks after the end of the criminal trial (17 May 2017), the Royal College of Surgeons (RCS) issued an open letter in response to the Paterson case, calling for a review of private sector transparency and safety standards. This letter also welcomed the Secretary of State for Health’s suggestion that an inquiry be conducted by the next Government to understand how Paterson was able to practise for so long.  In her introduction the President of the RCS, Miss Clare Marx, recognised improvements – such as appraisals and revalidation of doctors – that make the detection of “rogue doctors” more likely.  However, she further noted that: “…there are still a number of areas which require urgent improvements to protect patients from harm. Robust regulation remains an important way of protecting the public”.
Some of the regulatory challenges highlighted by the RCS include:
  • improving safety standards and data transparency in the private sector, and not just in the NHS.
  • scrutinising the private sector’s participation in clinical audits, and how this is enforced and monitored (for example by the Care Quality Commission).
  • examining better regulation of cosmetic surgery, which the RCS note happens almost entirely in the private sector.  In particular, they call for legislation to enable the General Medical Council to annotate the medical register with details of which surgeons are qualified to undertake cosmetic surgery.
However, leaving to one side for a moment these specific regulatory issues, Miss Marx’s statement raises the more fundamental question of what might constitute “robust regulation” in these circumstances.  In particular, does it simply mean more regulation? 
The report of the Mid Staffordshire Inquiry suggests not.  At the outset of that report Robert Francis QC listed the healthcare systems regulators and performance managers that had scrutinised the failing Trust in the relevant period.  This list included the Board, the local Strategic Health Authority, the Department of Health, Monitor and the Healthcare Commission.[5] The report went on to make the observation that: “It does not need a public inquiry to recognise that this elaborate system failed dramatically in the case of Stafford.”[6]  That Report’s recommendations were wide ranging and have shone a spotlight on issues of patient safety, quality of care, leadership, and creating positive organisational cultures. Thus, while regulation can provide a framework within which the practice of medicine takes place, it cannot necessary dictate or direct the culture of human practices that prevail over time.
As the RCS have stated:
 “The actions of Ian Paterson are beyond comprehension. Throughout the private and public health service, we must now try and understand what more we can do to prevent this from happening again and to take action to improve patient safety more generally.” 
How this learning will be delivered is beyond the scope of this blog post – as flagged above, there may be a public inquiry in due course.  However, if we are to move beyond a call for more regulation, this will require deep scrutiny around the roles and limits of the law in regulating health related issues, and the relationship between robust regulation, professional practices and ethics, and public protection as a matter of the central mission of all public health institutions. 

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