Emily McQuilkin, in-house solicitor and medico-legal adviser for the Medical Malpractice team at Gallagher, has received confirmation from the General Medical Council (GMC) that they have – so far – issued Rule 7 letters to four registrants involving allegations under their 2019 “Decision Making and Consent” guidance (“the 2019 guidance”)1.
As registrants will be aware, the 2019 guidance came into force on 9 November 2020, and applies to clinical interactions from that date onwards. Given the time that is often taken for GMC complaints to arise, and the time then taken by the GMC to undertake their initial triage and investigation processes before a Rule 7 letter can be issued, the GMC’s response may come as a surprise to some – but is undoubtedly of interest to the wider medical and medico-legal professions.
The GMC has also supplied Gallagher with redacted copies of the allegations in each of the four cases. Our initial observations on these are as follows:-
- Two of the cases involve cosmetic procedures to the face and neck area, and both of these cases arguably have an added “sting” alongside the consent allegations - one procedure was alleged to be “not required” in the first place, and the other involves additional allegations regarding failure to appropriately document the consenting process and a potential CQC breach.
- The other two cases relate to cardiology and urology procedures, and also both appear to have an added “sting” alongside the consent allegations. The cardiology case appears to involve allegations surrounding the use of an unapproved cardiac device outside of a clinical trial setting in four separate patients (and the consent allegations themselves are fairly wide-ranging), and the urology case appears to involve an alleged failure to “record any discussions” with the patient on more than one occasion.
- Some of the consent allegations are being framed as we anticipated – i.e. with quite a high level of detail and a list of sub-allegations setting out the various specific elements of the alleged failure to consent. For example, one of the Rule 7 letters specifically lists out the various alternative options that the registrant allegedly failed to discuss (including the option of “doing nothing”), and another of the letters specifically lists out the various complications that the registrant allegedly failed to discuss. We anticipate that registrants will need to be prepared to meet detailed allegations in this format moving forward.
- Despite point 3, above, several of the Rule 7 letters contain allegations that are arguably still quite vague and limited to (for example) allegations surrounding failing to “adequately explain the procedure”, failing to “obtain Patient [x]’s consent to carry out the procedure” and failure to discuss “[the patient]’s expectations” with no corresponding sub-allegations giving further detail on these alleged failures. Clearly these allegations leave a lot to be desired in terms of identifying precisely what the GMC say the registrant should have done, but this may not necessarily be related to the new guidance and may simply reflect imperfect drafting on the GMC’s part.
Also highlighted by the GMC, quite logically, is the fact that “because the guidance was issued recently, there are cases that are currently ongoing in which no Rule 7 letter has been issued because the case hasn’t progressed to this stage yet.”
While it is still early days in terms of knowing how the GMC will frame allegations under the 2019 consent guidance moving forward, at this stage there seem to be discrepancies in the level of detail that registrants are being asked to respond to. No doubt we will start to see these discrepancies being ironed out over the coming years, and we expect that registrants should be ready to respond to very detailed lists of sub-allegations if they are unfortunate enough to receive a Rule 7 letter from the GMC.
In light of this, and as always, we would encourage registrants to immediately contact their medico-legal adviser upon receipt of any correspondence from the GMC, so they can help to guide you through the process as safely and appropriately as possible.
1. Email from the GMC’s Information Access Team to Emily McQuilkin dated 12 October 2021.
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