The leaves are turning rusty brown, the weather turning crisper. John Lewis are selling ghostly tinsel for Halloween. But something rather more scary is on the horizon.
Lord Saatchi’s Medical Innovation Bill reappeared after its demise in the last parliament. The legislative zombie crept back to the Lords and a motion was scheduled for it to be fast-tracked. In the meantime, Lord Saatchi heralded Chris Heaton-Harris MP’s private members ballot win as the next carrier of the Bill’s baton before Mr Heaton-Harris admitted this himself. It is now very clear that Saatchi was correct.
This next Saatchi Bill, be it Saatchi (No.9 3/4), Mambo (No.5), was ‘won’ by Chris Heaton Harris MP when his name came up in the draw and the Saatchi lobby were in. It has just been published in draft form and it would appear that Mr Heaton-Harris sat back and thought of England while it was being drafted. Nurtured through the medium of cut and paste by the Department of Health, it is an almost identical replica of the much-criticised Saatchi horror, with some clangers thrown in to spin it in a better light without any substantive change to the concerning aspects of the original(s).
As Sir Robert Francis QC observed in his comments over a year ago on Saatchi’s Bill;
‘The evidence relied on by Lord Saatchi…does not provide the convincing support claimed. The difficulties that have caused so many drafts to be produced suggest that if there is to be legislation a more considered and less rushed approach is called for if we are to be satisfied that the patients who are intended to be benefit from this Bill, and patients generally, are not exposed to increased danger and risk.’
‘The number of attempts at this Bill suggest it is not the right answer… the deficiencies all versions show indicate that it would be quite wrong to rush legislation through… Considered scrutiny is required … calm assessment of the evidence of what are the real problems in practice.’
Despite evidence, reports, and meetings with concerned parties and expert organisations at the Heaton-Harris fingertips it seems that none of what made Saatchi’s originals awful has been removed. Indeed it is a reproduction of the original, with a database. Everything that made the originals terrible still stands. And despite the alluring title of Access to Medical Treatments (Innovation) Bill, it contains nothing at all about access to medical treatments or innovation for patients, and nothing at all to address such access issues for their doctors.
Indeed what it does is: preserve a complete defence to negligence for doctors who are actually so bad, so irresponsible, so irrational, so illogical in their treatment decisions, that they would be classed as negligent. These are the only doctors it helps. Not the majority of doctors, but the very minority that should not be protected by the law.
It does not preserve the common law tests of Bolam/Bolitho but jumbles concepts into nonsense. It would prevent people who are injured from obtaining compensation to help them live or help them pay for the carers they need after sustaining injuries from negligent treatment decisions – all this despite there being no evidence that innovative treatment forms the basis of such claims. It does nothing to ensure a patient is in the driving seat and improve communication and informed decision making, and nothing to address any barriers to accessing treatments that may actually help patients.
It applies squarely to those decisions which no other doctor would support or which are so indefensibly irrational that they are negligent.
It does not limit the scope of the Bill in the patients it can apply to or in what is classed as innovation, and thus does not limit the scope of this defence. Homeopathic remedies for childhood leukaemia would be a-okay under this defence if the process was followed when deciding to give a dying child a homeopathic tincture, rather than chemotherapy or another proven treatment and rather than include them in a global trial for a promising drug for their precise diagnosis. A wildly experimental drug from a pharmaceutical company the prescriber is a shareholder in, one that shortens lives and removes all quality of life for those who take it and inflicts a terminal suffering, sold as hope in a capsule- well, yeah that wouldn’t be a problem either.
It adds a completely separate concept of a database – ignoring the fact that such results are meaningless without clear methodology in data collection, reporting and conduct and patient selection, ignoring swathes of data security concerns, confidentiality factors, EU regulatory and even insurance issues; all the while missing the entire point of such initiatives as the AllTrials campaign which are very worthy of support. Nevertheless any such database could operate without the firmly refuted Saatchi Bill proforma defence for negligence. The ‘that sounds good let’s say that’ hooks added for selling points are completely meaningless, confused, soundbites that demonstrate a lack of understanding and substance. Patients deserve better care than that.
For excellent analysis please see:
Chris Heaton-Harris Resurrects Lord Saatchi’s Zombie Quacks’ Charter
Learned Friend: Access to Medical Treatments (Innovation) Bill 2015
this paper: Bye Bye Bolitho? The Curious Case of the Medical Innovation Bill
More Trick than Treat
Lord Saatchi’s PMB has tortuously rattled around despite loud criticism from all key experts, medical organisations, research and patient charities. Unusually, a No.2 bill procedure was used to introduce it into the Lords and the Commons simultaneously in 2012. Much criticism led to its withdrawal from the Commons and a second draft, the Medical Innovation (No.2) Bill, in the Lords. A Department of Health consultations as issued on the second version of this, and this consultation closed in April 2014. Before the responses were published, a new, third draft had been written and announced as improved and an answer to all criticism. Its first reading in the Lords, a formality, was on 5 June 2014 and its second took place on 27 June 2014. It was amended again following the second reading, and it entered committee stage as its fourth version, with 39 amendments tabled. It was amended again prior to Report stage, and again thereafter, and again (v7, mark 2). Once to the Commons Saatchi thought he’d get extra time in the last parliament to push it through and into law before the general election – despite legislative consent being unanimously rejected by a country. Indeed, if no MP objected and no amendments were tabled it could have been rushed through to Royal Assent in a day. Sarah Wollaston and Julian Huppert arranged a rota so that one of them, at least, would be around to object. When debating time and special deals were hanging in the balance the coalition government parted ways when someone said hang on, all the stakeholders say this is dangerous – let’s not do this.
Despite the ongoing opposition from across the board: medical organisations, patient charities and groups, research charities, academics, legal and patient safety experts, Lord Saatchi reintroduced his Bill in 2015/16 in the configuration it had left the Lords – and a motion to set aside SO46 (Standing Order 46 of the House of Lords, a rule that no two stages of a Bill shall be taken in one day) was scheduled which would allow a fast tracked passing back to the Commons and even passing its stages in one day, averting the proper scrutiny of the chambers. The motion to set aside SO46 is still scheduled for November and would allow the original Medical Innovation (No.2) Bill to pass. But Lord Saatchi has now confirmed that Chris Heaton-Harris’s private members bill IS the Medical Innovation Bill handed over, and thus given more time to run.
The second reading of the Access to Medical Treatments (Innovation) Bill is now scheduled for 16 October 2015 in the House of Commons.