Re-blogged with permission from The GMC: There is still no convincing argument by Sofia
The GMC tweeted a link yesterday highlighting its current position on the Medical Innovation Bill. This was a link to this month’s accountability hearing where the GMC provided oral evidence to the Health Committee in the House of Commons. At this hearing questions were asked about the Medical Innovation Bill and the responses given represent the official and continuing views of the GMC.
The full transcript of this hearing is available here, with the relevant paras at Q66 and 67 provided here in full.
Q66 Chair: Thank you for clarifying that. Another area of interest at the moment is Lord Saatchi’s proposed Medical Innovation Bill. A number of concerns have been expressed from various quarters about whether the Bill is necessary and whether it would have unintended consequences resulting in potential harm to patients. Some people have argued that we need the GMC to issue clearer guidance to doctors around the limits on when they can innovate and use unlicensed medicines. Is it your view that this should be a matter for the GMC and regulators, or do you feel that stand-alone legislation is necessary?
Professor Stephenson: One of the things the profession is struggling with on this Bill is the problem that it purports to solve. We have just had published in December the research excellence framework that looks at all the research done by UK universities over the last five years. In that report, UK biomedicine and UK medicine did extraordinarily well and probably punch above their weight; the quality and output of research per pound or per dollar probably even eclipses the United States’.
This is a country that has pioneered gene research, monoclonal antibodies, many new drugs and many new cancer treatments. I am a researcher, an academic; I have been researching throughout my career. Many of us are struggling to see that we would be inhibited in our research by fear of litigation. That is also what the Medical Protection Society and the Medical Defence Union say; they do not have records of cases of doctors being sued because of being inhibited from doing research or doing new things. The UK leads the way in high-quality biomedical research. It has a record that it should be justly proud of, so we are struggling a bit to see why the Bill is necessary.
Q67 Chair: So the GMC is opposed to the Bill.
Professor Stephenson: The GMC is waiting to see. There are a number of organisations in the public domain who are quite clearly opposed to the Bill — I was chair of the Academy of Medical Royal Colleges and this is in the public domain, so I am not saying anything new — the Academy of Medical Sciences, the Wellcome Trust and the Medical Research Council. The GMC’s position, up to now, has been that it needs to see the final draft of the Bill. It has undergone a huge number of amendments and the devil is in the detail. The GMC reserves judgment until it sees the final version.
Niall Dickson: Just to expand on that, we absolutely, first of all, come at this from, “Why is this Bill necessary?” We still have not heard a convincing argument about why. We had very serious concerns about some of the clauses inserted as so-called safeguards. For example, having to go to a responsible officer beforehand would seem to us absolutely counterproductive, in terms of both putting responsible officers in an impossible position and also being an inhibitor for innovation rather than something that would enhance it. So we were pleased when it seemed to indicate from Lord Saatchi’s amendments that they were going to drop those clauses. We still have concerns that the Bill, as currently drafted, talks about a doctor having another qualified doctor being enough for them to innovate. Our guidance is clear around people looking at expert opinion, people who are expert in that area and using that, of course, as one of the means by which you decide whether a particular treatment is to be taken forward. As Terence said, our position at the moment is, “Let’s see the next iteration of the Bill.” We still have concerns and there is still a question mark over the big picture, as it were: what is it trying to do? I suppose, in response to the final comment in your introduction, that if there is anything the GMC could do that would be helpful in terms of guidance, clarifying guidance or whatever, we would be absolutely happy to consider it.
The position put forward by the GMC is certainly not one of support at this stage. With countless revisions, amendments, references to the GMC by the Dept of Health and bill team, discussion of their involvement in ways that vary from ROs being responsible for innovative decision-making, to GMC policing non-Saatchi confirming doctors on the acute take and his mythical register; they are probably somewhat concerned, bemused and struggling to ascertain what their role is in all of this, and what all of this is anyway, let alone why. It’s absolutely fair and appropriate for the GMC to be supportive of the principles of encouraging innovation and best practice, yet reserve final comment until they have considered a final version.
When they had a finalised proposal in 2014 they duly responded to the Department of Health’s consultation.
The GMC response was thorough, carefully considered and clear.
We are…concerned that legislation which aims to clarify and encourage good practice in terms of when medical innovation is responsible could have the opposite effect as well as unintentionally weaken the principles which we regard as fundamental to safe, effective patient care. We take the view, therefore, that legislation is both unnecessary and undesirable.
The GMC raised a number of concerns and points – as discussed here in more detail. These include a lack of clarity in proposals, hindering responsible innovation, substantially changing roles and remits with ‘unwelcome layers of bureaucracy’. They noted that legislation as proposed would breach core GMC guidance and would be an unhelpful addition to current practice, adding new areas of uncertainty for doctors and others while removing important safeguards for patients.
Such ‘a lack of clarity in legislation of this kind can only serve to undermine any safeguards aimed at deterring dangerous practice or reducing the risk of exploitation.‘ And while the Lords were still stuck on what the difference is between innovation and research this month, the GMC raised this at the outset; concerned that the Bill fails to ‘provide a clear enough definition of medical innovation so as to define where the boundary lies between innovation and medical research. Our understanding is that this bill is aimed at doctors innovating to meet the needs of a particular patient. Whereas our understanding would be that innovation for a whole population of patients constitutes medical research.’
Now, following a fanciful passing-the-buck in the Lords at third reading the GMC are left in the frame over the latest amendment for a mandatory ‘register’. The Lords considered the options for this invisible database, including the GMC’s role on patrol as Saatchi’s FTP henchmen, and passed the Bill despite none of this having been agreed or scrutinised at all (but it sounds good, and capitalises through association on valid concerns about evidence – entirely unrelated to the Bill – and which it would serve to worsen -so scrutiny is the last thing Lord Saatchi would want). Of course, the workings of such a register, its parameters, applications, data laws and safeguards, operational capacity, everything, apparently haven’t appeared on the Bill team’s agenda, but the GMC have been squarely, potentially saddled with creating a new professional requirement, guidance, an invisible register and the witch from the wardrobe to Narnia.
Prior to the third reading however, the GMC and Dept of Health had been in communication as Nigel Poole QC has established, and the GMC communicated the view to the Dept of Health that fitness to practise proceedings being brought against a doctor for failing in an online recording requirement under Saatchi’s Bill ‘does not seem to be a proportionate response.’
Nigel Poole QC, cutting through the gaping voids of legal illiteracy, clinical implausibility and grim potential realities of the Bill, neatly illustrates that ‘perception is reality’ has struck once more. There has been no agreement from the GMC on any of these proposals, and as without making registration of treatment a professional requirement a mandatory register as per the latest amendment cannot exist: ‘A vote for the bill on the basis that it will create a mandatory register would be a vote for a chimera’.
The GMC are left questioning not only an unworkable amendment, but the entire premise behind the Bill.
‘What is the problem that it purports to solve?’ ‘What is it trying to do?’
“We had very serious concerns about some of the clauses inserted as so-called safeguards.” “We still have concerns and there is still a question mark over the big picture”
“Why is this Bill necessary?” “We still have not heard a convincing argument about why” (Niall Dickson, January 2015).