The new draft of the Medical Innovation Bill, which has its second reading in the House of Lords on June 27th 2014, is a strong and robust version of the Bill that has been improved by public consultation.
As the discussion continues in the public domain and, of course now in Parliament, the Bill will continue to be tested and improved by the dialectic of debate.
Indeed, the Bill Team has heard and reacted to the call for an open database to register innovations that take place under the Bill.
This will have two results. First, it will allow clinicians to see what innovations have already been tried, which will help drive new data, support the gold standard of evidence-based medicine and provide evidence which can be fully tested in clinical trials.
Second, it will act as another safeguard. A doctor who wishes to innovate, under the Bill, will be obliged to register that innovation in advance for all to see.
The Department of Health also commissioned NHS chief Sir Bruce Keogh to formulate a practical proposal as to how the Bill’s safeguarding mechanism should work, which he has done.
At the same time, criticisms of the Bill are crystallising. One objection asserts it is not true that the Bill needs the clear consensus of support from a body of relevantly qualified medical experts.
This critical assertion is false.
The wording in the Bill – in clause 1(3)a is legally tight. It states that a clinician must, as part of the process to assure protection under the Bill, consult ‘…with appropriately qualified colleagues…’.
The clear requirement to consult is a legal definition and has a meaning within the legal sphere that differs from its common linguistic use. It is a definition derived from case law (see below example)[i].
It does not allow a doctor merely to consult colleagues (in the everyday sense of the word) and then to ignore their advice. It means that a doctor must genuinely carry the meeting with him or her in order for the doctor to derive protection under the Bill. Arguments for and against must be minuted and documented.
As both a former Lord Advocate & Lord Chancellor James MacKay put it in the House of Lords second reading debate (on June 27 2014) The Bill sets out a procedure by which an innovation must be done “….by a process which is accountable, transparent and allows for full consideration of all the relevant matters, says Lord MacKay.
“The first requirement is, ‘consultation with appropriately qualified colleagues, including any relevant multi-disciplinary team.’
“That implies consultation. I have read some opinions which suggest that it could be ignored without any consequences whatever. You can ask someone’s opinion, and if it goes against what you want to do, you just ignore it and carry on.
“That is not my understanding of the term “consultation” as it is used in the law. Consultation means that you have regard to the opinion.
“…and of course consultation would include looking at the relevant literature on the subject.”
In short there is a clear requirement to attempt to build consensus; and a doctor who cannot demonstrate consensus will not able to rely on the protection of the Bill.
To state otherwise is incorrect.
Those that insist this is not so misunderstand the law.
However, lest there be doubt, it is worth applying the Occam’s razor test. To the question: is the Medical Innovation Bill, as stated in the intention clause of the Bill, designed to ‘…encourage responsible innovation in medical treatment and to deter reckless departure from standard practice’?
Or, conversely, is it an incredibly complicated, deep, dark, cunning artifice and a conspiracy to in fact do the opposite of what the Bill actually says and to allow quackery and destroy empirical science?
Clearly, it is the former.
[i] See, for example: R v Brent London Borough Council, ex parte Gunning (1985) 84 LGR 168 ; R v North and East Devon Health Authority, ex parte Coughlan  QB 213, .” (R. (on the application of Compton) v Wiltshire Primary Care Trust  EWHC 1824 (Admin) at para.104.); Agricultural, Horticultural and Forestry Industry Training Board v Aylesbury Mushrooms  1 W.L.R. 190 per Donaldson J.).