Tuesday, 3 June 2014

The Saatchi Bill - Silk Purse or Pig's Ear?

As I write Lord Saatchi is due to present a new draft of his Medical Innovation Bill to the House of Lords on 5 June. I believe this will be a second reading.

I am not a constitutional lawyer, but am mystified as to how a parliamentary process which sets up a public consultation on a particular draft (Draft X) can then proceed to debate and vote on a new draft (Draft Y) before the results of the consultation on Draft X are published and with no apparent intention to consult on Draft Y? Is this how a mature parliamentary democracy is meant to work? How can parliament vote without knowing what the responses were? I trust that at least one peer will ask Lord Saatchi what the responses were from the BMA, GMC, NHSLA, MPS, MDU, Royal Colleges etc.

We also now have a parliamentary process in which the government will allow a signature to a petition organised by an individual to be treated as a formal response to a formal governmental consultation. So Lord Saatchi claims 18,000 + positive responses and fewer than 100 against the Bill, yet we know some of those against, such as the BMA, represent thousands of doctors. The BMA's response counts as one response, but Lord Saatchi's team response counts as 18,000 responses. What an exciting precedent for future law-making!

To the new draft.

It is a slimmed down version of Draft X, and slightly fitter, but the essentials remain the same.

You can find it here if you scroll down the pages of briefing notes.

Clause 1(2) is almost as was - see previous posts. Clause 1(3) encapsulates the much more prolix provisions in the previous draft which were intended to ensure that any innovation was "responsible".
It should be noted that, aside from the requirement for the patient's consent, the other elements of 1(3) are still all subjective. A doctor must consult, but he can ignore the views of others. He or she must report the decision, but it does not have to be authorised. The doctor must give consideration to all the matters which the doctor considers to be relevant.

It cannot be over-emphasised that this bill would allow a doctor to decide to give treatment which no other doctor supports. Innovation is not defined and so the bill will sanction any decision to give treatment, whether innovative or not.

For example. Dr A firmly believes Vitamin Z capsules will cure a particular cancer. He consults with colleagues who warn him against it, but he believes it is the right course of action and he reports his decision to treat Patient Y in that way. Patient Y consents. Patient Y could have surgery and chemotherapy which would leave her with a 70% chance of surviving 5 years but she has faith in Dr A and wishes to undergo the vitamin treatment he will supply to her for a mere £5,000.

I believe Lord Saatchi's bill would support that doctor. Worse still, when Patient Y dies earlier than she needed to have died, her family would have have no redress - the bill is designed to stop them obtaining justice.

Please do not listen to the siren calls that this bill requires treatment to be agreed in advance by senior doctors. It does not require the agreement of any other doctor. Consultation is not the same as agreement. The whole purpose of the bill is to prevent a doctor being found negligent who acts without the support of other doctors.

As before this draft does contain a provision (now at 1(4)(a) that nothing in the section,

"permits a doctor to administer treatment for the purposes of research or for any purpose other than the best interests of the patient".

If this is an objective test - was the treatment actually in the best interests of the patient - then Dr A would be in trouble. If it is a subjective test - does Dr A believe the treatment is in the patient's best interests - then Patient Y is in trouble. However, if the former, then what is the point of having this bill? Treatment which is indeed in the best interests of the patient will not have caused additional harm to the patient and there will be no recourse to the common law of negligence. If it is in the patient's best interests then the decision to give the treatment cannot have been negligent. Also, this bill purports to "bring forward" the Bolam test to the point when treatment decisions are made, rather than when scrutinised in court years later. But, you cannot determine whether treatment was in fact in the best interests of the patient until the effects of that treatment have become clear. So, this must be intended to be a subjective test - what does the doctor believe is in the patient's best interests, in which case, it is the patient who is in trouble.

The new draft contains a new provision. Clause 1(4)(b) provides that nothing in it

"abolishes any rule of the common law in accordance with which a decision to innovate is not negligent if supported by a responsible body of medical opinion".

Thus if a doctor is not negligent at common law, this Bill will not render him/her liable in negligence. If the treatment would be or is supported by a responsible body of medical opinion, it will not be negligent just because the doctor has not consulted or reported the decision to treat. However, the bill certainly does not preserve the Bolam test. It does bypass the rule of common law that a decision to treat is negligent if not supported by a responsible body of medical opinion.

Doctors' representative bodies which have published their responses to the consultation agreed that the current common law of negligence is no barrier to responsible innovation. The premise of this bill is that it is a barrier. The premise is wrong. The bill is not needed. Legislation directed to the resourcing and regulation of new treatments and research would be much more effective. Worse still, this bill remains potentially dangerous. It will provide a defence to doctors who harm patients by providing treatment which no other doctor supports. It will remove a right of redress to those patients and their loved ones. And for whose benefit?

That is a poor way of paying tribute to those who have died of cancer and other terminal conditions.


  1. Lord Saatchi now adds insult to injury by promoting his bill using selective citation and anecdotal evidence in the same way proponents of alternative medicine promote snake oil. We now have a new profession of "alternative law maker" as distinct from "democratic law maker"

  2. Your opening paragraphs seem to suggest that the Government is somehow subverting legitimate process or pre-judging the outcome of the consultation exercise. This is a misunderstanding of what seems to be happening. It is important to understand the distinction between Parliament and the Government.

    The Government consulted on the initial draft, not Parliament. The new version of the Bill is being introduced to Parliament by Lord Saatchi as an individual member of the House of Lords, not by the Government. The Government is still evaluating the input it received in its consultation exercise. It may be possible to draw inferences from Lord Saatchi’s decision to press ahead without waiting for the Government to complete this work.

    The Bill will be introduced on Thursday – this is not a second reading, which comes later (if at all).

    1. John,
      Thank you for that. As I said, I am not a constitutional lawyer and having read articles about Lord Saatchi pressing ahead, you might forgive my confusion about this being a second reading.
      So, although Lord Saatchi has said very publicly that the consultation generated huge support for his bill and very little opposition, he has decided to abandon it and will be starting afresh?
      Actually, this new draft is essentially the same as the old one, so I still do not understand why the consultation is to be treated as an irrelevance. How can the House of Lords debate and vote on the new bill without seeing the results of the consultation on the old one? What was the point of the consultation?
      Is it safe to assume that the government will not have shown Lord Saatchi the results of the consultation without showing them to us, the great British public?

    2. Nigel

      Thanks for that summary of the problems the new draft has still failed to address.

      The undue haste (to put it mildly) with which the Bill has been 're-drafted' is certainly interesting...

      I have asked the DoH whether the campaign have seen responses sent directly to the DoH and when they expect to publish their report on the consultation. I'll let you know when I get a reply.

  3. Regarding the consultation by the Department of Health: Lord Saatchi seems to have opted to uncouple his efforts from the Government's. So the consultation responses are still being considered by DH and we can expect a response to them. Given that Lord Saatchi has decided to press ahead in spite of that, it may be that he has been informally told that the DH decision will not be favourable. If so, there's the point of the consultation: the proposal was made publicly and on the basis of the feedback received the Government decided not to press ahead with it by introducing legislation to Parliament (remember, it was a consultation by the Government, and nothing to do with Parliament at all). If that's what turns out to have happened.

    All of that is now separate from Lord Saatchi's private bill. While it's possible he might have had informal indications of the Government's thinking, I very much doubt he or his team would be allowed access to the consultation responses submitted to the DH (though the responses submitted via the online widget his team developed appear to be visible to both the DH and Saatchi's team, from what they say in the briefing attached to the new draft).

    There are other possibilities, however. Perhaps Lord Saatchi has been informally told that the Government will make time in the parliamentary schedule for his Bill, but isn't prepared to introduce it itself. That might explain why Saatchi needs to table it so quickly - for procedural reasons, to get it into the parliamentary schedule. In that scenario, the Government has the option of whipping its supporters to vote for it, or not doing so. Or it might be that he's received no such indication at all, and feels he needs to press on with it as a purely private measure.