Saatchi Bill Consultation Response
The Medical Innovation Bill, otherwise known as the Saatchi Bill after its proposer, is a bill which seeks to introduce more freedom for doctors to innovate. Important advance, or Quacks' Charter?
The public consultation for the bill ended on 25 April 2014. Here is my response, in case the responses don't get published.
Name: Sean Ellis
Phone number: [Redacted]
Are you responding as an individual or on behalf of an organisation? Individual
If as an individual, are you responding as: A patient (NHS user)
If you are responding on behalf of an organisation, please give the name of the organisation and say who it represents: N/A
The questions posed in the consultation paper are as follows:
Question 1: Do you have experience or evidence to suggest that the possibility of litigation sometimes deters doctors from innovation?
Question 2: Do you have experience or evidence to suggest that there is currently a lack of clarity and certainty about the circumstances in which a doctor can safely innovate without fear of litigation?
Question 3: Do you agree with the circumstances in which the Bill applies, as outlined in clause 1(3)? If not, please identify any changes you suggest, and give your reasons for them.
No. The circumstances appear to be counterproductive. There are usually good reasons why particular treatments do not gain support from health professionals, and this bill seems to explicitly designed to allow discredited or fringe treatments to be used.
Question 4: Do you have any comments on the matters listed in clause 1(4)-(5) on which the doctor’s decision must be based for it to be responsible? Are there any that should be removed, or changed, or added, and if so why? For example, should the Bill explicitly indicate that the other treatments mentioned in 1(5) (a)-(c) include treatments offered as part of research studies?
Where treatments are part of a research study, then the study must be registered in advance, including protocol, outcome measures, and timescale for publication. I would suggest following the guidelines laid down by the AllTrials initiative. In fact, I think that this should be the only circumstance in which unproven treatments should be available to the public. If a new, unproven treatment is given to a patient without then making the data about the patient's response and reactions available for study, then this does not serve to advance the state of medical knowledge. The reliance on the professional opinion and assessment of a single physician is a worrying point of failure. Single physicians can have opinions which range from fancy to fringe to fraud. The wording of the bill seems to offer no distinction between them. This seems to me to open a large loophole in the necessary process of clinical regulation. As examples, the cases of Errol Denton in the UK, Stanislaw Burzynski in the USA, and Gloria Thomas in Australia are instructive as the the kind of adverse outcomes that can occur when a single physician is in charge of all aspects of patient selection, monitoring, and reporting when using unproven (or disproven) treatments. I can see no wording in the bill to prevent this kind of abuse from occurring.
Question 5: Do you have any comments on the process set out in clause 1(6)-(7)? Are there any provisions that should be removed, changed or added – and if so, why?
The provisions here seem very woolly. Too much is left to opinion, and too much seems optional. For example, the wording does not make it clear whether cross- disciplinary consultation is a requirement, or a request. This appears to leave considerable leeway to skip important consultations and still comply with the letter of the bill.
Question 6: If the draft Bill becomes law, do you have any views on the best way to communicate its existence to doctors?
In its current form, if the bill became law I would urge that its existence be communicated to patients, rather than doctors, so that they can protect themselves from its consequences.
Question 7: To reinforce the Bill, are there other things that need to happen to encourage responsible innovation?
This bill is not required. Innovation should be encouraged within a framework of fully-disclosed and properly regulated clinical trials.
Question 8: Do you have any comments and suggestions for inclusion in the draft impact assessment and equality analysis?
The impact assessment should include an assessment of: Use of the law by unscrupulous doctors to cover themselves when offering dubious or fraudulent services. I think it would be instructive to arrange a role-play session, where one group make up a clearly fraudulent treatment (I favour “percussive cranial ligno-therapy”) and use this legislation to defend their practice against another group attempting a mock prosecution. What is the outcome? Unreported negative outcomes and positive reporting bias as a result of not having to register treatments in advance will lead to a skewed view of the effectiveness of any particular treatment.
Question 9: Overall, should the draft Bill become law?
No. The bill as it stands opens a huge loophole in the system of clinical regulation, seriously undermining the provision of safe and effective treatment on the NHS, and therefore the confidence of the public in their health practitioners. The amount of change required to make the bill a workable piece of legislation would be equivalent to starting again. In my view, a replacement bill should be introduced in which innovation is encouraged within a framework of fully-disclosed and properly regulated clinical trials.
We also welcome any other comments you wish to make.