By Annie Sorbie
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.
A 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.