In its support for the Saatchi bill, opposed by the majority of the medical establishment, the Department of Health is playing with patient safety.
“Let me take this opportunity, on the question of the government’s support, to reiterate that this is a Private Member’s Bill. This is not a Government Bill.”
George Freeman MP, Adjournment Debate on Medical Innovation Bill, 9th December 2014
To the casual observer, it may seem as though Lord Saatchi’s Medical Innovation Bill (the “Saatchi bill”), which met with widespread opposition in the last parliament, was not a Private Member’s Bill, but was in all but name a Government Bill. It had the benefit of a Department of Health consultation (even if Lord Saatchi did not wait for its conclusions to be published before driving the bill through the Lords). Government ministers turned up to speak on its behalf in both Houses. The Department of Health and Lord Saatchi operated as a tag team in the Lords debate, working together to shepherd through the amendments Saatchi wanted, while deflecting those he didn’t. The Saatchi bill team’s own website even described their relationship with the Department of Health as a “one-team philosophy.”
As the bill returns in this parliament, both in its original form as Lord Saatchi’s “Medical Innovation Bill”, and simultaneously as the near-identical “Access to Treatments (Innovation) Bill”, sponsored by Chris Heaton-Harris, the relationship is as close as ever. The Department of Health drafted Heaton-Harris’ new bill, though given its substantial similarity to Saatchi’s it cannot have overly taxed their draftspeople, and wrote the explanatory notes now published on the parliament website. They don’t seem to find it at all odd that there are now two near-identical bills working their way through parliament in opposite directions. George Freeman MP defended the new bill on behalf of the government at its Second Reading on 16th October, responding in a manner which was enthusiastic if not well-informed.
The Saatchi Bill received strong opposition in the last parliament, from medical organisations, patient protection groups, legal experts and medical charities. The National Assembly for Wales unanimously voted against it. The opponents are once again united in condemning Heaton-Harris’ latest version. The Royal College of Paediatrics and Child Health have called it “disastrous” and “a real danger to the safety of infants, children and young people in England and Wales.” The Royal College of Surgeons of Edinburgh, representing more than 11,000 members in England and Wales, say that it “is likely to be of primary interest to those practitioners seeking respectability for their unethical treatments.” The Royal College of Surgeons say they “unequivocally oppose” it. The BMA “strongly question the necessity & desirability of introducing statute to clarify or change the law in this area.” The chief executive of the Patients Association calls it “ill-judged, dangerous and unnecessary.”
Put simply, the bill attempts to armour-plate a doctor’s treatment decisions so they cannot be sued for negligence, and the supposed safeguards are ineffective at making sure those treatment decisions are sound.
So why would the Department of Health lend such assistance to this bill, when it is so widely opposed? If the medical and legal professions are united in saying something is a bad idea, one would normally expect that opposition to be listened to, but the Department of Health are sailing blithely on. Why? It’s clear even to outsiders that the Department of Health’s relationship with the medical profession is less that of inspiring leader and more that of angry, abusive jailer, but this is in itself perhaps not sufficient to explain their riding roughshod over the objections of medical experts.
The cost of negligence
The answer can perhaps be found in the original document that was published when the Department of Health launched its consultation on the bill last spring. This document devoted a section to discussing the cost of negligence litigation. The Saatchi bill campaign team tweeted on the subject, drawing a clear link between innovation and litigation, and along the way creatively inflated the litigation bill from £1.24bn to £24bn. The clear implication of all this is that here there is an opportunity to reduce the NHS’ legal costs.
Consulting on a bill whose purpose is to prevent patients harmed by experimental treatment from suing their doctors is one thing, but what the Department of Health did not attempt to do was describe how much litigation arose from such experimental treatment. Without knowing this, it’s impossible to know if the bill could save money. Dr Sarah Wollaston MP asked this very question at the bill’s Second Reading. George Freeman, speaking on behalf of the government, did not know. How can the government not know this key piece of supporting evidence for a bill to which they are lending their weight?
We can find out the answer for ourselves, because the bodies who have to indemnify and defend doctors when they are sued know exactly how much litigation arising from “innovative treatment” costs. It’s zero. £0.00. The Medical Protection Society, the Medical Defence Union, The British Medical Association and the Academy of Royal Medical Colleges, The NHS Litigation Authority and the Medical Research Council, Cancer Research UK and many other organisations cannot between them identify a single case of litigation arising from a doctor’s decision to try an innovative treatment.
So why should the Department of Health still look kindly upon this bill? Well, given that the bill is deliberately vague about what constitutes “innovative treatment”, and how much protection it could potentially give doctors at the expense of their patients, it is likely that a whole swathe of current practice could be recast as “innovative” in order to gain the protections of the bill. The majority of current paediatric prescribing, for example, is for medicine that is not licensed for use on children. The use of unlicensed medication is an area the bill campaign was clear on wanting the bill to cover. It is entirely possible, then, that the Department of Health are in favour of this bill because they see the opportunity to drive some treatments outside the reach of the law.
Let’s pause to think through the implications of this for a moment. The bill can only save on litigation costs by taking some current treatments outside the protection of the law.
The final piece of the jigsaw comes in the form of an article in the Times(£), which reveals there is a plan afoot to force the National Institute for Health and Care Excellence (NICE) to allow NHS patients to be used as guinea pigs by drug companies for experimental treatments. In effect it would bring drugs into use in the NHS that have not been shown to be effective and which could turn out to be harmful.
There is cause for concern here. One only needs to read Ben Goldacre’s Bad Pharma to see how pharmaceutical companies have captured regulatory bodies and run rings around any rules put in place to restrain them. A major growth area is in “orphan” drugs, many of which are of highly questionable effectiveness, and Lord Saatchi’s advertising agency has seen its profits rise along with the drug companies it represents. Now we see the UK government handing NHS patients to these companies on a plate. It is perhaps now clear why the Department of Health would support this bill, because it means they will be able to absolve themselves of responsibility for harm caused by potentially ineffective or dangerous experimental treatments – the same treatments that they now actively intend to foist upon the NHS.
The end result
You will have your own views on whether it is a good idea to prevent doctors being sued for bad practice, or to prevent anyone being able to stop them from repeating that bad practice. You will have your own views on whether it is appropriate for somebody who is harmed by the treatment they have received to be compensated with enough money to pay for the long-term care they may now need as a result of that harm. But there is a further problem with any plan to throw whole swathes of patients to the wolves in order to save on litigation costs. Because it may not even reduce the cost of litigation.
Sir Robert Francis QC says of the Department of Health’s consultation document, “The assessment suggests there will be a reduction in medical negligence claims. On the contrary there is likely to be protracted and complex litigation about the meaning of this bill.” The reason for this is simple. In future, in order to demonstrate negligence, a claimant would first have to show why the bill did not apply, and only then go on to show why the treatment was negligent. This is clearly a more protracted way of working, and runs the risk of denying people who have been harmed from seeking a remedy.
Whatever the end result, by ushering through these “Private Member’s Bills”, the Department of Health can absolve itself of any responsibility for the fall-out. When the bodies start piling up, the blame will fall on Saatchi and Heaton-Harris. Or so the Department of Health must hope.
However, the mask is slipping. The government yesterday issued a 3-line whip for its MPs to vote for a money resolution for the new bill. This in itself is surprising, since there has been no assessment of the likely cost of a database of innovative treatments, no assessment of the likely increased cost of litigation, no assessment of the increased cost that inevitably results from experimental treatment. It is effectively asking parliament to write a blank cheque. But it is astounding when one remembers that this is supposed to be a Private Member’s Bill about which the government claims to be neutral.
We’ll finish with the words of George Freeman MP once more, speaking on behalf of the government in the adjournment debate on the Saatchi Bill in the House of Commons last December:
I want to be clear that, as the bill completes its passage in the House of Lords, I hope it returns to this House in a form that the vast majority of medical opinion and respectable bodies in the medical field feel able to support. It is not our intention to have a bill that undermines public or patient trust in research medicine.
It is clear that the bill has not arrived in a form that lives up to Mr. Freeman’s hopes. It is now time for the government to make good on its stated aims and stop enabling this execrable bill.
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