The GMC: There is still no convincing argument

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).



This Side of the Truth: Wales and the Medical Innovation Bill

Baroness Ilora Finlay, a crossbench peer in the Lords and a very experienced consultant in palliative medicine,  moved an amendment in the House of Lords Committee debate on 24th October:

39: Clause 2, page 2, line 11, at end insert “but shall only come into force in Wales following legislative consent from the Assembly”

She explained that ‘health and healthcare provision is completely devolved’ in Wales, and ‘the experience of patients under the Welsh NHS falls completely within the legislative competence of the Assembly.’  She acknowledged that the Bill amends the law of negligence, however related concern from Wales about the use of resources, and ‘the possibility of practitioners being answerable as regards legislation that covers England and Wales, when the provision of healthcare is something for which they are answerable to the National Assembly.’

‘Sadly, we have had experience of extremely strange medical practices sometimes being put forward in the past. The Assembly is particularly concerned that, with its move toward prudent healthcare, which is a whole policy direction for NHS Wales, the Bill should not inadvertently cut across the principles of prudent healthcare, the first of which is, of course, to do no harm. ‘

The effect of this amendment would have been that the Bill would apply in Wales only once a legislative consent Motion had been passed in the Assembly, but this was rejected by the government, per Earl Howe:

 ‘the operative provisions of the Bill relate entirely to modifying the law of tort, which is a reserved matter. The Bill can fairly and realistically be classified as relating to a non-devolved subject, and therefore not within the competence of the National Assembly for Wales.’

Now, on one side  Earl Howe raised some valid points. The Bill does fundamentally destroy change the law of negligence, and it certainly provides no new access rights to a treatment for any patients in Wales, nor any new powers for them to be funded.   This is no more the truth than declaring a huge bouncy castle to be a flat line after measuring an inch of tarpaulin (insert varying analogies and units of choice) and actually, it’s worse.    The government’s statement clearly ignores the Bill’s obvious stated purpose, its effect and implications, while riding roughshod over the concept of devolution. It would be laughable if it were not such a serious topic.

The Government of Wales Act 2006 extended its predecessor and the remit of the Assembly, with s103 establishing that the Welsh Assembly Government, known as the Welsh Government since 2011, may pass primary legislation in accordance with Part 4, Schedule 7 and s108 if such power were to be approved through a referendum. This referendum took place in March 2011, and the Assembly can now pass legislation without the consent of UK Parliament, within the 20 specified areas of legislative competence listed in Sch.7  GoWA 2006

One of these areas happens to be, as pointed out by Baroness Finlay, health and health care provision under para 9, Pt 1 Sch.7.   Indeed in Wales there are perceptible differences in priorities, agendas, governance, even legislation in relation to the Welsh health service.  The AWMSG can make commissioning decisions and is not bound by NICE, NHS England et al.  Wales approves and pays for drugs not approved by or faster than England where assessed as appropriate, and has its own policies and consultations regarding access to treatment and responsible approaches to orphan drugs. Its decisions are not undermined for political purposes by schemes such as a cancer drugs fund, but it has appropriate schemes in place which conduct evidence reviews and consider individual circumstances. Wales even decided to legislate for presumed consent in relation to organ donation  (rather than continuing the UK system or introducing any alternative such as my preferred one, mandated choice): agree or disagree, this was done.

It’s therefore somewhat specious to assert that the Medical Innovation Bill would have no bearing on an area which is devolved, for it relates to medical practice, commissioning, resources, budgets, treatment, policies, oversight structures and patient care that are all, subject to any exceptions provided, entirely within the legislative, executive and administrative competence of the Welsh Assembly.  A quick glance at the Department of Health’s consultation document from 2014  provides p30:

Who will be affected?

Potentially doctors and patients, both in the NHS and more widely, in England and Wales.

Where Westminster chooses to legislate on an area of devolved competence, or if a Bill includes any provision that falls within or modifies an area of the Assembly’s legislative competence, by convention Ministers must gain the consent of the National Assembly via a Legislative Consent Motion (LCM) as set out within the Standing Orders of the Fourth Assembly.  A Legislative Consent Memorandum must be issued for an LCM to be considered, debated and passed in the National Assembly. A motion may seek to include a relevant provision in the Bill, and if provided in the legislation Wales may subordinately adopt, amend or annul its application.

Such a Legislative Consent Memorandum was laid down under SO 29.2(ii) on 10 December 2014. A consultation ran from 16 Dec 2014 until 9 Jan 2015, albeit rather quietly. Saatchi‘s close to the wire response contained somewhat misleading and truth-contorting PR, although submissions from the MDU, Patients Association and other organisations provide a more accurate perspective.

It was referred to the Health and Social Care Committee which met 21st January, and their report shall inform the debate in Plenary on Tuesday 3rd February.

The Health and Social Care Committee Report– released today- states:

‘It is important that patients are able to benefit from appropriate innovative treatments where it is in their best interests to do so, but on the basis of the evidence available to date, the Committee is not yet persuaded that this Bill would achieve its stated aim of encouraging such innovation. The Committee is therefore not yet persuaded that the Bill is an appropriate legislative vehicle to achieve its stated aims.’

On the subject of legislative competence it confirms:

‘The Supreme Court in its judgment on  Agricultural Sector (Wales) Bill in July 2014, clarified that the test of whether the provisions of a Bill fall within the legislative competence of the Assembly is simply whether those provisions relate to a devolved subject.’

‘In the view of the Committee, the Bill relates to the devolved subject of health, specifically the treatment and alleviation of disease, illness, injury, disability and mental disorder; provision of health services; clinical governance and standards of health. Neither medical innovation nor the law of tort are exceptions under Schedule 7 to the Government of Wales Act 2006, and therefore no relevant exceptions apply.’

The Bill relates to and will serve to significantly impact on large areas within the Assembly’s legislative and administrative competence.  It will affect the provision of health services, clinical governance, standards of health care, authorisation and commissioning of services and resources, the treatment of any patient and patient safety with resultant un-quantified constraint on associated functions.    It would be an unacceptable violation of political, legal and constitutional obligations for the Welsh Assembly to be ignored by Westminster and the Department of Health, due to the far reach and influence of the noble Lord, on this extremely significant potential legislative change that certainly does pertain to areas within the Assembly’s competence.    It’s remarkable that the Bill team and DH were not in more appropriate dialogue with the Wales Office and Welsh Government in time to correctly consider Baroness Finlay’s concerns.

The overwhelming opposition across the UK has continued from all expert bodies and organisations: medical, legal, charitable, research and patient groups are united in opposing this very misguided, unnecessary, unscientific, botched, rushed and dangerous Bill and this opposition is maintained by all key organisations despite attempts to mislead, coerce and force through deeply illegitimate legislation with illusory amendments as political devices.   It would be unthinkably irresponsible for the Assembly to pass the LCM on the 3rd.   It is not in the interests of Wales at all for this rushed, unmandated and unnecessary Bill to go through, a point not lost on the Committee.

The National Assembly must now take heed of its consultation findings and the careful consideration and work of its Committee in Plenary next week and Ministers subsequently in the Commons.

Honestly? patients deserve better

Lord Saatchi, between referencing his bereavement as the motivator for his bill, writes in the Telegraph that honest opposition to his bill has dispersed contentedly. Not so.

I experienced a very bad bereavement, indeed more than 5 significant ones within around 18 months, and it certainly did influence my decisions post-hoc. I had intrusive flashbacks of drawn out and agonising deaths, I was plagued by second guessing what I could have done or said differently, what I could have done to have altered the outcome, did I let them down by allowing them to do that, did I let them down by not insisting on more?  I crumbled entirely, indeed so much that I can never apologise adequately for the extent to which I fell apart. The experiences I went through and the profound and haunting loss had such a detonating influence on me that I tore my previous life to shreds, annihilated my job in a place with good colleagues, polite receptionists, comfy chairs and sensible pension schemes which gave out free cake and drinks and went back to the beginning, to medical school, to become a doctor. I also teach students and health care professionals, help others who have experienced traumatic bereavements and give time I don’t have in my committed work for a national charity.

So, I give a nod of respect to Lord Saatchi’s stated vision and aim and feel protective of his tenacity and drive to make a difference, make it matter and continue his strongest bonds and meaning through these activities, effecting positive, meaningful change.  I am however a firmly opposed critic, which doesn’t sit easily with me.

Why am I critical?   I do not admire how he appears to choose to abuse his power, wealth and political influence to exert control over a legislative catastrophe in his name. I do not admire deliberately falsifying the law, misrepresenting medical practice and nasty spin on his opponents. I couldn’t bear his misuse of grieving and aggrieved relatives as a PR victory.  I find his total lack of mandate from those whose opinions should matter and the lack of legitimacy in the process simply unconstitutional, arrogant, hubristic, chilling, recklessly harmful and misleading.

I’m critical because, with such power and influence, such drive to make a change, I am left wondering just why Lord Saatchi ignores the views of the medical profession who tell him this is unnecessary and undesirable, repeatedly ignores esteemed medical law experts who unanimously tell him he’s wrong on the law, ignores the views of patient groups and charities who are fearful of the consequences and ignores defence unions- whose role is to defend doctors on the front line and provide guidance on best practice.  Overlooking the failure to consult before his bill was ever launched, I can’t get past the failure to listen to an overwhelming body of opinion saying his idea was not based on the right law, was not required and would not help doctors or patients.        For, under his proposal, nobody wins. Doctors aren’t entirely able to be protected from being sued, for such is the likelihood of satellite litigation that many more doctors and their colleagues may be dragged into the churning mill of the legal process. They will also be swamped by his procedural red tape and lose the remaining crumbs of clinical autonomy trying to follow a procedural hoop-athon. It’s written to provide a benefit for only those who are truly negligent or even exploitative of desperation and hope-in-hype, which is precisely why some have termed this a ‘quack’s charter’. This is not however inert for non-quacks. It will have procedural and practical consequences for the vast majority who are committed and excellent doctors,  rendering them handicapped, bureaucratised, pressured yet uncertain of potential liabilities in an array of legally creative and expensive ways; and possibly, if Friday’s musings are to be followed up, it may leave them wide open to GMC fitness to practice investigations, and all in the name of Maurice Saatchi, the PR and advertising legend with no legal or medical background at all.

Patients do not gain any rights of access to a drug under this bill.  All they stand to gain is the knowledge they will have immeasurable difficulty in ever obtaining any form of redress for serious harm and suffering, serious care needs unmet by the health service, caused by defective drugs; for who is liable for these under the bill?; or an entirely negligent decision or unreasonable basis to treat. Their relatives gain the comforting knowledge that they ‘tried everything’, against the best possible knowledge of science, that could easily end in death, suffering and the removal of any quality of life for the patient.  They gain the knowledge that the ‘results’ of such experimentation are meaningless, and will help no future patient. A dehumanising, agonising and barbaric accolade.

Indeed, the bill doesn’t even solely apply to those with cancer, or nearing the end of their lives. This allows full-on experimentation, expressly and entirely unscientifically, and attempts to act as a defence, while simultaneously adding bureaucratic mayhem and managerial mandates for the good doctor, that still don’t combine for any logical purpose.  It does not make sense.  If it made sense, I’d be supportive and the medical defence organisations would be supportive.

It trashes the law and trashes the importance and respect for any scientific integrity and for a patient’s quality of life.  Patients deserve better than this. It’s frustrating, as in his esteemed, powerful position I would listen and put my name to something that might genuinely help others.  I’m still not honestly sure why he won’t.