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Medical Innovation Bill update 3 – not moved #SaatchiBill

For those concerned about the Medical Innovation Bill being put through the House of Commons without any proper debate or scrutiny, you will be relieved to know that it wasn’t moved at 2.30pm. As this was the last Friday on which Private Member’s Bills could be considered, it will not become law in this Parliament.

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Medical Innovations Bill update 2 – Wellcome Trust flags concerns #SaatchiBill

Charities have banded together under the banner of the Wellcome Trust to send MPs the following briefing on the Medical Innovations Bill. The bill is due to come in front of the House of Commons tomorrow and they are calling for its progress to be halted unless there is adequate scrutiny and debate:

wellcomecharities

Briefing on the Medical Innovation Bill

House of Commons Second Reading – 6 March 2015

Summary

We, as a coalition of medical research charities, non-commercial organisations and patient groups, believe that the Medical Innovation Bill will not achieve its aim of encouraging medical innovation, and could result in potentially harmful unintended consequences. We believe that this legislation is unnecessary, and, far from protecting doctors from litigation, it could actually increase the risk of litigation faced by doctors by introducing greater complexity into the legal framework.  These complex issues need careful consideration, and we call on MPs to object to any motion to pass the Bill without adequate scrutiny and debate.

Background

The Medical Innovation Bill is a Private Members Bill introduced by Lord Saatchi, which aims to encourage innovation in medical treatment by clarifying the circumstances under which a doctor may pursue an innovative treatment without fear of litigation. The Bill is currently scheduled to have its second reading in the House of Commons on Friday 6th March.

Key points

Is the Bill necessary?

  • The Bill aims to make it easier for doctors to pursue innovative treatments without fear of litigation. However, we are not aware of significant recorded evidence that doctors are being deterred from medical innovation due to the fear of litigation.
  • We are not convinced that legislation is the best way to address this issue, given this lack of evidence. There are significant other barriers to medical innovation that the Bill does not address – including funding, regulatory complexity, and clinical training and development. We believe efforts are better focused on understanding and tackling these wider barriers.

What are the risks?

  • The Bill risks subverting the frameworks currently in place to preserve patient safety. There may be unintended consequences for patients who could be at risk when receiving treatments for which the evidence base is not fully established, including treatments which could prove ineffective or harmful.
  • The Bill may discourage patients and their clinicians from participating in clinical trials by encouraging the provision of novel treatments on an ad hoc basis. Without properly controlled studies, it is not possible to develop the evidence of efficacy necessary to support wider adoption of new treatments in the NHS.
  • The Bill could introduce a degree of ambiguity to the law governing clinical negligence, potentially placing doctors at risk of further litigation.

What are the alternatives?

  • We believe that the best way to assess the efficacy and safety of treatments is through robust research studies with appropriate clinical monitoring and collection of data and other evidence.
  • It is essential that provision is made for collecting and sharing data in order to ensure that information of both beneficial and harmful effects of treatment is captured for the benefit of subsequent patients.

Other mechanisms already exist to increase access to innovative treatments. We believe efforts are better directed through existing mechanisms, with proportionate regulation and evidence review.

Further information and background:

Aims and rationale of the Bill

  • The main premise of the Bill is that doctors are being deterred from medical innovation due to the fear of litigation. We are not aware of significant recorded evidence that doctors are currently being deterred.  We believe there is a need for a better evidence base to support this premise, and to provide greater clarity on the best way to address this issue.
  • The Bill does not address other highly significant barriers to medical innovation within the structural and organisational levels of clinical service.  Without addressing these barriers we believe that the Bill cannot achieve its overall aim. They include:-
  • the complexity of the current regulatory system which can make it time-consuming and expensive to set up clinical trials;
    • the lack of financial incentives, clinical engagement and training for the development, adoption and diffusion of innovative approaches and treatments.
  • We support other mechanisms that currently exist to increase access to innovative medicines, and believe that efforts are better focused to build upon existing mechanisms such as:-
    • The Medicines and Healthcare Products Regulatory Agency’s recent announcement of the Early Access to Medicines Scheme  to provide a rapid approval mechanism for innovative medicines when there is a clear unmet medical need and before phase III trials;
    • The European Medicines Agency’s decision to provide adaptive licensing through its ‘adaptive pathways’ pilot project;
    • The ‘named patient’ provisions of Section 9 of the Medicines Act 1968 also allow doctors to prescribe unlicensed medicinal products; ensuring widespread information about these provisions could also provide a stronger basis for innovation.

The importance of research in assessing novel treatments

  • The Bill does not make adequate provisions for follow-up or data collection.  This is a key aspect of innovation since new interventions require an evidence base to demonstrate safety and efficacy and to ensure effective uptake in practice.  A lack of data collection or follow-up could also lead to some practitioners continuing to provide untested and ineffective (or potentially harmful) treatments to patients.
  • We are also concerned that the Bill may discourage patients and their clinicians from participating in clinical trials by encouraging the provision of novel treatments on an ad hoc basis, leading to a failure to develop the robust evidence of efficacy necessary to support wider adoption of innovations in the NHS.
  • The Bill contains no specific provision for the testing of novel treatments in comparison with existing treatments, as is standard in many research studies. Without appropriate collection and sharing of results – locally and centrally – it would be impossible for the clinical community to learn from existing and new evidence.
  • We believe the best way to assess the efficacy and safety of treatments is through full and robust research studies with appropriate clinical monitoring and collection of data and other evidence, on a rigorous statistical basis and with appropriate ethical approval(s).
  • We welcomed the commitments made during the debates in the House of Lords about the importance of collecting data and recording the outcomes of innovative treatments.  We further welcome that this is now reflected in the draft Bill, in particular the requirement for doctors to comply “with a scheme for capturing the results of innovative treatment (including positive and negative results and information about small-scale treatments and patients’ experiences)” (Clause 1 (e)), and to record details of such treatments in the patient’s medical record.  However we consider there remains a need for greater clarity over how such a scheme will work in practice, and the professional requirements for doctors to comply with it.

 Relation of the Bill to existing law and regulation

  • Even with the safeguards provided in the Bill, we are concerned that the Bill risks subverting the appropriate frameworks currently in place to preserve patient safety. There may be unintended consequences for patients who could be at risk of receiving treatments for which the evidence base is not well established, including treatments which could prove ineffective or even harmful.

While we welcome provisions in the most recent amendments to clarify the Bill’s intersection with common law, (Clause 2), we feel that the Bill still risks introducing a degree of ambiguity to the law governing clinical negligence, potentially placing doctors at risk of further litigation.  We would welcome further clarification of how the Bill will work in practice in relation to, and without conflicting with, existing law or regulation, particularly in relation to research.

Medical Innovations Bill update #SaatchiBill

Contrary to the report in the Telegraph, which claimed that the bill was “pulled at the eleventh hour”, Lord Saatchi’s Medical Innovations Bill, sponsored in the Commons by Michael Ellis, is still listed for consideration tomorrow. You can see it in the Order Paper under Future Business at No. 37.

Whilst it won’t be debated, it is theoretically possible for the bill to pass all its stages at 2.30pm tomorrow.

As the Liberal Democrats have refused to back the bill, there should be no agreed government position and so the bill should be blocked by a government whip shouting ‘object’ (they seem to block all private member’s bills which the government don’t support).

I hope that opponents of the bill will be on hand to make sure that does happen – or to shout object themselves in the event that the whip forgets.

In the interests of good science and patient safety, please ensure the Medical Innovations Bill doesn’t make any further progress and instead throw support behind Lib Dem Health Minister Norman Lamb’s sensible proposition in the Telegraph report:

‘So, faced with this level of concern, but recognising the profound importance of innovation and of saving lives, the best way to proceed is surely to appoint an eminent person examine what the barriers to innovation really are and how best to overcome them.

“I am not interested in pushing this into the long grass. It should be given priority but we must get it right. Such an examination of the issue should involve patient organisations, legal bodies, royal colleges and medical unions.’

You can read more about the Medical Innovations Bill here on my earlier blog post.

Mistruths, grotesque insults and the Medical Innovation Bill

The Lib Dems have been the recipients of heavy criticism in recent days from The Telegraph, The Express and, bizarrely, Andy Burnham, for their decision to block Lord Saatchi’s Medical Innovation Bill. Even the normally sensible Guardian gave more column inches to Lord Saatchi than an explanation of why the Lib Dems vetoed his proposals.

The Telegraph’s position should come as no surprise. They have acted as a mouthpiece for Lord Saatchi throughout. Then, a week ago, the Telegraph reported quite seriously on the complaints by David Tredinnick MP that we should use astrology to reduce pressure on the NHS. At least they had the good grace to admit that his claim that those opposed to astrology were ‘racist’ was ‘bizarre’. Strangely, the Telegraph report didn’t offer any comment from medical professionals as to whether using astrology to reduce pressure on the NHS was a good idea or not. The only criticism came from an unimpressed Liberal Democrat councillor, Michael Mullaney, who is challenging Tredinnick for his seat. Similarly, you would expect a right-wing populist paper like the Express to leap gleefully on another chance to indulge in another round of Clegg-bashing.

Burnham’s criticisms and the Guardian’s less than critical reporting of the bill are not so easily explained and are, frankly, disappointing.

There is no doubting the passion and commitment with which Lord Saatchi has committed himself to this cause. There is also no doubting the grief that has driven him, having lost his wife to cancer. However, the resultant headlines are an insult to the intelligence of most of us, who could all be struck down with these terrible conditions and illnesses (some of us suffering those conditions right now), and distract from the very real threat to patient safety that this bill presents. One might also hope that the Labour Party, and a national newspaper that prides itself on rational, critical journalism, might spend a bit more time scrutinising the details of the bill and, indeed, the processes around it.

First of all, the bill itself.

The Medical Innovation Bill’s innocuous-sounding purpose is to ‘Make provision about innovation in medical treatment.’ Lord Saatchi and his supporters are understandably most concerned about the highly emotive issue of horrendous, often painful, terminal illnesses for which the rate of development of new treatments often seems frustratingly and distressingly slow. Its basic premise is to protect doctors who try experimental treatments where conventional treatments have failed from claims of medical negligence.

And on the surface, it is very appealing.

The bill tries to do this by bringing forward an element of the four-fold test used to establish whether or not medical negligence has occurred to an earlier point. However, that is where the first problem lies. The test component it seeks to emulate is known as the Bolam Test and requires a doctor to find a responsible body of medical opinion to support the fact that another doctor night have made the same decision. The very purpose of the bill means this cannot happen, as the required body of medical opinion doesn’t exist. Instead, whilst misleading comparisons are drawn to Bolam, Lord Saatchi’s Bill actually redefines the test entirely (relying on the opinion of a single other doctor) – and then makes following that advice optional (presumably to protect the second doctor from any liability).

Despite securing passage through the House of Lords, the bill did not receive unanimous acclaim and indeed various amendments were suggested. One of these was for innovations to be registered. This was trumpeted by Lord Saatchi and his supporters as a response to critics and enough to allow the bill to progress. However, the Medical Innovation Bill doesn’t provide that register, doesn’t provide the means for creating it, provides no indication of who should administer it and provides no legal framework for the register’s operation and governance.

The public consultation on the bill conducted in 2014 is also worth reading. Not a single major organisation representing medical professionals or patients, and none of the leading charities, offered unqualified support for the bill. Almost all expressed reservations and some outright opposition, whilst appreciating and expressing sympathy with the motivations for wanting to accelerate innovation.

Surely, when people are at their most vulnerable, they need to be protected from potential treatments that could offer false hope or, worse, place them at increased risk? Reading David Hills writing on the campaign site for those opposed to the bill, it’s hard to avoid the conclusion that Lord Saatchi’s Bill risks becoming a ‘Quack’s Charter’. As I read it, a doctor with a pet theory (astrology?) could get the nod from a fellow doctor, perhaps who shares the view or who works in the same practise, and that would be deemed to be the required consultation (and which doesn’t even have to be taken into account), all with a view to preventing a future claim of medical negligence.

How can that be right?

Aside from the contents of the bill, it is worth pausing to consider exactly what is going on here in terms of making law.

Lord Saatchi’s bill was a private member’s bill. The Telegraph says that Norman Lamb told Jeremy Hunt that the Lib Dems could not support the bill, but there is scant evidence of Hunt championing the bill. Indeed, on the GOV.UK website, the only recent comment on the bill is from a PM spokesperson in 2014: “When asked about the Medical Innovation Bill, the PMOS said on the basis of a number of amendments to the Bill, the government was minded to support the Private Members Bill as it proceeds through Parliament.” That is not a ringing endorsement. Indeed, Hunt’s statement of 22nd November 2013 used very careful language. In announcing the public consultation that went on to draw out a large number of concerns, he said that “My second commitment is that the government will seek to legislate at the earliest opportunity, subject to the results of the consultation.” He did not commit the government to supporting Saatchi’s private member’s bill. He commited to legislating on the issue of medical innovation and working closely with Lord Saatchi in order to do so. They are not the same thing at all.

As a private member’s bill, the Medical Innovation Bill is one of a large number that was before the House of Commons. The Telegraph says that it was due to be debated 6th March but was pulled at the eleventh hour, presumably because the Lib Dems were blocking it. Interestingly, despite the report of it being pulled, it is still on today’s Agenda under Future Business and hasn’t been withdrawn at all.

But what does that mean?

Anyone who has any knowledge of how private members bills works will know that this is disingenuous. It is rare for the Commons to get past the first three or four private members bills on a sitting Friday. On the Summary Agenda for Thursday 26th February, two days before the Telegraph story, the Medical Innovation Bill was listed at number 45 for 6th March. It was never going to be debated on 6th March. Clearly, Lord Saatchi and his supporters were hoping that it would go through all its stages, on the nod, without any debate at all. Whatever your position on the bill, no-one can seriously believe that it would be good law-making to tackle such a controversial and emotive issue, where there are such strongly held and different views, without proper scrutiny.

All it takes to block a bill at 2.30pm on a Friday is for any member of the House of Commons to shout ‘Object’. The objector isn’t even identified in Hansard. As the Telegraph makes clear, Sarah Wollaston MP, the Tory chair of the Health Select Committee, was also opposed to the bill and so could have blocked the bill. It wouldn’t have to be a Lib Dem.

Rather, reports of blocking suggest that the Lib Dems have blocked some sort of deal inside government to give Lord Saatchi’s bill special treatment. Given that government doesn’t usually interfere in the order in which bills are considered on any given day, special treatment would have been – to use Lord Saatchi’s words – a grotesque insult to the House of Commons. Whilst it is a perfectly worthy bill, why should it take priority over the forty-four bills ahead of it on that day? What reason would government have to justify giving Lord Saatchi’s bill time but not giving time to Norman Baker for women’s refuges or Mark Garnier for road fuel pricing? Interestingly, there is also a footnote on the Agenda against the Medical Innovation Bill to say that “The National Assembly for Wales has not approved a Legislative Consent Motion in respect of this Bill”. This suggests that there may be a dispute between the UK government and the Welsh government as to whether or not the bill applies in Wales.

Lord Saatchi is a very well-connected and influential Conservative peer with access to all the political, scientific and medical advice that an eminent institution like the House of Lords (and being a prominent supporter of the Conservative Party) affords. He also cares passionately about this issue. But none of that justifies special treatment for a bill in the House of Commons and it is a credit to the Liberal Democrats that they have not bent to Tory pressure.

What this also shows is that the Telegraph and the Express are prepared to trade on people’s ignorance of the way that parliament makes law, as well as an understandable fear of serious illness and the suffering of those we love, to engage in appalling party-political attacks using disgusting and grotesque insults about Nick Clegg handing down death sentences. That Burnham joined in this ugly display shows how weak and contemptible the Labour Party is, too fearful to stand up for what is right when it might give rise to public criticism. That the Guardian’s coverage is so poor demonstrates how providing easy ‘balanced’ copy now trumps getting to the truth behind a story.

Disappointingly, none of the concerns about the bill are properly addressed by Saatchi or his supporters. Instead, those who raise concerns are criticised vehemently by those who believe their well-meaning motivation means the bill and its implementation should be taken on trust.

Medical innovation is something that all parties should champion. It is a more than worthy cause. Lord Saatchi is right to highlight the fact that progress is not fast enough. But medical innovation should be discussed in a considered and thorough way. It should not be rushed through in a badly-drafted and flawed private member’s bill on a poorly attended Friday.

Thankfully, in the interests of patient safety, sound science and proper parliamentary scrutiny, the Lib Dems seem to have their heads screwed on.

And if Michael Ellis, the person who is sponsoring the Medical Innovations Bill in the Commons, doesn’t withdraw it, I hope someone is present to shout object.

Supporters of the bill can find more information here.

Opponents of the bill can find more information here.