Thursday, 29 January 2015

The Medical Innovation Register

The new selling point for the Saatchi Bill is that it will lead to the creation of a new and important data base of innovative treatments. As seems often to be the case with the Bill, it pays to look behind the claims and check the reality.

At its Third Reading in the House of Lords, an amendment was made to the Medical Innovation Bill. The amendment was proposed by Lord Hunt of Kings Heath, Shadow Health Spokesman in conjunction with Lord Saatchi and others.

Lord Hunt hailed the amendment on twitter on 2.1.15: "Delighted the Lords accepted today my amendment to Lord Saatchi's medical innovation bill for a mandatory register to record innovation."


The amendment is now at section 1(3)(e) of the Bill. It requires the treating doctor to,


"comply with any professional requirements as to registration of the treatment under the provisions of this Act with a scheme for capturing the results of innovative treatment (including positive and negative results and information about small-scale treatment and patients' experiences)."


I asked Lord Hunt who has agreed to operate the register. On 24 January he replied on twitter: "No body as yet. The Bill specifies principle of mandatory registration. @DHgovuk Department of Health has been discussing with GMC."


I am grateful to Lord Hunt for his openness. He is right that the amendment establishes a principle of mandatory registration. But, as he notes, there is work to be done to convert this principle into a practical reality and there remain many questions about the usefulness of the register.


First, there has to be a professional requirement with which the doctor has to comply under the bill. The bill does not require registration, it requires compliance with a professional requirement to register. There is no existing professional requirement because the Bill is not enacted and this is a new amendment. A new professional requirement has to be created. I cannot think of any body other than the GMC that would have authority to impose such a professional requirement on doctors.


I contacted the GMC and David Buckle, Head of Public Affairs, wrote to me to say that there had been contact between the GMC and the Dept of Health prior to the 3rd Reading:


"Our contact was focused upon whether professional standards set by the GMC might be a suitable route to enforce the sharing of learning from innovation. As Earl Howe stated in response to the amendment, we informed the Department that we would be very happy to consider anything that might be helpful but advised that this may not be an effective route.



"We have statutory powers to provide advice and doctors must be prepared to justify their decisions and actions against the standards set out in our guidance. Serious or persistent failure to follow the guidance will put a doctor’s registration at risk. We confirmed to the Department that our initial view was that fitness to practise proceedings being brought against a doctor for not having recording information on an online database designed to foster the sharing of learning from innovation does not seem to be a proportionate response."

So, there has been no agreement from the GMC to create a professional requirement on doctors to register treatment under the Bill, and some expression of doubt as to whether they should do so. 

Without the GMC making registration a professional requirement there will be no mandatory register. A vote for the bill on the basis that it will create a mandatory register would be a vote for a chimera.

The Saatchi Bill website announced the new amendment with customary hyperbole:

"The open access Medical Innovation Register will record all treatments and their outcomes, both positive and negative which are received under the Medical Innovation Bill ... we are thrilled... the recording of this data is essential ... Lord Saatchi and the MIB team have been pushing for a means of data collection to be included on the face of the bill for two years.

Pushed whom? They drafted the bill. In another part of the Bill's website it is claimed that the register will be for innovative treatments, providing an essential data base for researchers and doctors alike.

The amendment does nothing of the kind. The Bill provides doctors with a defence to a claim for compensation. The defence applies when a doctor has "departed from the existing range of accepted treatments." Innovative treatment is not defined in the Bill. There is no register of accepted treatments and so identifying what is a departure from the existing range of accepted treatments will be a difficult task for anyone, let alone the individual doctor. 

Treatment under the bill is not necessarily innovative, and innovative treatment is not necessarily provided under the Bill.

Negligently deciding not to operate on a patient showing clear signs of a perforated bowel and peritonitis is a departure from the existing range of accepted treatments but it is not innovative. Using new technology developed to carry out surgery for a brain tumour is innovative, but it is not treatment under the Saatchi Bill.

Two doctors may provide the same innovative treatment. One may "choose" not to do so under the bill but be confident that he is not Bolam negligent. The other may seek protection under the Bill. Only the doctor who treats "under the bill" would have to register it. 

Let's not pretend that this will be a comprehensive register of innovative treatments. At best it would be a partial register of some treatments where doctors thought they were departing from accepted treatment. At worst it would be a register of doctors who had attempted to use the bill to avoid a negligence claim.

And what is treatment provided "under the bill"? First you have to identify whether the treatment was a departure from the existing range of accepted treatments. Remember that treatment under the bill includes inaction. Then, you have to determine whether the doctor met the requirements of section 1(3). Does every doctor who asks for a second opinion thereby provide treatment under the bill? And what if the court later determines, or the doctor later admits that he did not in fact comply with the requirements of the bill. Does the treatment then become de-registered? 

The Bill team says that Oxford University has offered to host the register. I asked the GMC about what would be included on the register, how many treatments would be expected to be registered in a year, who would pay for it, who would have access to it and how patient confidentiality would be secured. Mr Buckle answered:

"These are all important matters that would need consideration if the Bill was to become law with this new amendment included. We have not as of yet however been in discussion with the Department of Health or others with regard to who would operate such a register or how it would operate."

Since it would be the GMC that would have to make it mandatory for doctors to use the register, it would need to know the answers to these questions.

The Bill team has made great play of its partnership with the Dept of Health, but in the Lords, Earl Howe, for the government opposed this amendment. Will the government oppose it in the Commons? Is there time for the details of a register to be finalised and for a professional requirement to use it to be created?

To my mind the bill is fundamentally flawed and this amendment is a side issue. Nevertheless it is being treated as an important selling point, perhaps in particular to the medical community and to MPs. I very much hope they will examine the goods before buying.


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