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.
“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?
[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.).
The Medical Innovation Bill, introduced into the House of Lords on June 5th, is the new, amended version following the feedback from many organisations, patients and doctors received as part of the Government-run public consultation.
The Medical Innovation Bill is explicit and clear – a doctor who wishes to innovate cannot claim protection under the Bill without using a transparent and accountable process to consult a range of expert colleagues, including the doctor’s responsible officer and any relevant multi-disciplinary team – only with a clear consensus from colleagues will a doctor feel safe in relying on the protection provided by the Bill. In addition the doctor must, of course, seek consent from the patient.
In addition the doctor must, of course, seek consent from the patient.
This legal analysis explains why the Bill protects patients and preserves the Bolam test and why the Bill uses the words ‘consent’ and ‘notify’.
This legal analysis on the Medical Innovation Bill has been prepared by Daniel Greenberg, who drafted the Bill.
MEDICAL INNOVATION BILL [HL] 2014 – 15
1. This legal analysis is produced by the Bill Team’s Parliamentary Counsel to assist in understanding the Bill. It should be read in conjunction with the Bill and the Explanatory Notes published with it.
Clause 1(1) – the purpose clause
The purpose of this Act is to encourage responsible innovation in medical treatment (and accordingly to deter reckless irresponsible innovation).
2. Purposes clauses are increasingly common in legislation. There has been much discussion about their use over the years (1) but there is consensus among modern judicial and other commentators that they can be helpful where appropriate; and the courts have shown willingness to have regard to them in applying or construing Acts.
3. In this case the purpose clause will enable the courts and other readers to set the provisions of the Bill in the context of a desire for responsible innovation: so that the provisions of the Bill will be applied and interpreted in a manner likely to provide encouragement to doctors who wish to innovate responsibly. Whether that encouragement is effective or significant will be tested by reference to the law as it was without the Bill.
4. The parenthetical words in the purpose clause are designed to encourage the courts to use the standards set by the Bill to determine what is irresponsible innovation, and to make it harder for a maverick doctor acting unilaterally and without a consensus of support to argue that he or she has behaved in a non-negligent manner.
Clause 1(2) – the central proposition – responsible innovation is not negligent per se
It is not negligent for a doctor to decide to depart from the existing range of accepted treatments for a condition if the decision is taken in accordance with a process which is accountable, transparent and allows full consideration of all relevant matters.
5. The policy at which the Bill is aimed is to remove the perception which appears to be held by some doctors and others, that a decision to depart from standard treatment for a condition is presumed to be negligent treatment unless the opposite is shown, and that it is therefore always safest to follow standard treatment even if it is known to be ineffective.
6. Clause 1(2) therefore states that a decision to innovate is not per se negligent, and that what matters is why and how that decision was taken.
7. The subsection establishes the general proposition that the process by which a decision is taken will not be negligent if it is accountable, transparent and allows full consideration of all relevant matters.
8. The concepts of “accountable” and “transparent” are left to be determined by the reader (including, but not limited to, the courts). They are non-technical words which will fall to be given a natural meaning in the context of medical practice. They are glossed in an expressly non-exhaustive way by subsection (3).
9. In essence, transparency will require the compilation and maintenance of an audit-trail showing how different components of the decision-process were conducted, including details of consultations and other discussions. There is no reason why that should impose a procedural or bureaucratic burden that exceeds existing good clinical practice.
10. (In extreme emergency situations where there is no time to put any process into place at all, the Bill will not apply and the doctor will rely on his or her judgment and the application of the existing common law Bolam test; but there will be emergency situations where a serviceable modified form of procedure can still be deployed.)
11. The essence of accountability is that the doctor should be able to show that there is some person or group to whom he or she has to account, on some appropriate basis, for professional decisions in general, and that the decision to innovate is part of that process. This might mean that a doctor who operates outside the NHS and who operates without clear oversight arrangements might feel unable to rely with certainty on the Bill, in which case he or she would have to rely on the existing common-law Bolam test and be satisfied that their conduct was defensible by reference to it.
12. The subsection also requires the process used to allow for full consideration of all relevant matters. The Bill does not attempt to specify what those matters might be. The policy of the Bill is to leave substantive regulation of doctors to the existing medical regulatory bodies and to the medical profession as a whole.
Clause 1(3)(a) – mandatory consultation
That process must include— (a) consultation with appropriately qualified colleagues, including any relevant multi-disciplinary team
13. Clause 1(3)(a) provides that a doctor will not be able to rely on the Bill for validation and protection of a decision to innovate unless he or she has consulted appropriately qualified colleagues, including the Multi-Disciplinary Team if there is one.
14. This is a duty to consult – it does not give colleagues a veto. But a legal duty to consult sets a high threshold (2) . In particular, it requires full communication, allowance of proper time to respond, and through and open-minded consideration of any responses received.
15. A doctor who does not receive consensus support from colleagues consulted under the Bill is unlikely to feel confident in relying on the protection of clause 1(2) – and that is precisely the policy of the Bill.
16. The Bill does not give any particular set of colleagues an express veto because it is not possible to be dogmatic about whose support and concerns will be most relevant in a particular case. For example, although the Multi-Disciplinary Team is always to be involved in any decision to innovate, so that the broadest range of cross-discipline expertise can be brought to bear, in some cases the doctor will feel that the MDT lacks significant experience or expertise in the context and that he or she needs to seek also, and attach particular importance to, the opinions of others with specialist clinical knowledge.
17. (As described above, in extreme emergency situations where there is no time to consult anyone at all, any process into place at all, the Bill will not apply and the doctor will rely on his or her judgment and the application of the existing common law Bolam test.)
Clause 1(3)(b) – mandatory notification of the responsible officer
That process must include—
… (b) notification in advance to the doctor’s responsible officer
18. The post of responsible officer is provided for by Part 5A of the Medical Act 1983, as inserted by the Health and Social Care Act 2008. The Government’s Explanatory Notes to the 2008 Act explain that the intended purpose for the responsible officer system is to ensure that they have responsibilities which can “include the evaluation of the fitness to practise of medical practitioners … and a duty to co-operate with the GMC in connection with its responsibilities … It is intended that this co-operation will include making recommendations to the GMC (with whom the final decision rests) on relicensing of medical practitioners based on individuals’ records.”
19. The Bill makes it an express condition precedent of its protection for innovation that the doctor has given advance notice to his or her responsible officer.
20. In accordance with the policy that it is for the medical profession to determine its methods of self-regulation, the Bill leaves it to individual responsible officers, in accordance with their hospital and local procedures, to determine what methods of control to apply in relation to notifications under the Bill.
21. A doctor who is concerned that in the ordinary course of events his or her responsible officer may not have the time to consider a routine notification with particular care, will be able to request whatever level of additional scrutiny is given to the notification in a particular case to give the doctor the confidence that the notification and its results will form part of the transparent and accountable procedure required by subsection (2).
Clause 1(3)(c) – patients’ opinions and requests
That process must include— … (c) consideration of any opinions or requests expressed by or on behalf of the patient
22. A key part of the policy of the Bill is patient empowerment: that patients must feel able to ask their doctor to consider a possible innovative form of treatment, knowing that their request will be taken seriously and that the doctor will not be able to dismiss it on the grounds that it is necessarily safer for everybody (including the doctor) to rely on standard procedure.
23. The Bill makes the patients’ opinions and requests central to the process and requires the doctor to include their consideration in the process for deciding whether to innovate.
24. That does not mean that a doctor necessarily has to accede to a request to innovate; the Bill expressly requires the doctor to treat the patient only in what the doctor believes are the patient’s best interests (clause 1(4)(a)). Where a patient passionately believes in the possible efficacy of a new treatment which the doctor considers likely to be either ineffective or harmful, the doctor will refuse the request and will explain why.
25. Equally, a doctor will not be able to insist on innovating against a patient’s request or opinion: the Bill does not alter the law on informed consent and requires the innovation process to include the process by which informed consent is obtained – subsection (3)(d).
26. What will be possible, however, is for a doctor to take into account the strength of a patient’s desire to try an innovative treatment when balancing the potential efficacy of the treatment against its risks.
27. The reference to opinions or requests expressed on behalf of the patient deals with the case where the patient is unable to communicate direct. Doctors already have principles that they apply in determining how much weight to give to expressions by family and friends of opinions on behalf of the patient.
Clause 1(3)(d) – requirement for consent
That process must include—
… (d) obtaining any consents required by law
28. The Bill does not alter the law on informed consent and requires the innovation process to include the process by which informed consent is obtained.
Clause 1(3)(e) – substantive factors to be considered
That process must include—
… (e) consideration of all matters that appear to the doctor to be reasonably necessary to be considered in order to reach a clinical judgment, including assessment and comparison of the actual or probable risks and consequences of different treatments.
29. The Bill leaves it to the medical profession to determine what substantive factors require to be considered when determining the appropriate treatment for a patient.
30. So clause 1(3)(e) does not attempt to prescribe what factors a doctor should consider; but it requires the doctor to ensure that the process followed in determining whether to innovate allows all the appropriate substantive matters to be considered.
31. The provision mentions risk-assessment and risk-comparison as examples of the factors for which the process must make allowance: these are singled out because of their inevitable relevance to a decision whether or not to depart from standard practice. Where the standard practice is relatively effective it will require more to persuade a doctor to depart from it for the purposes of attracting what may be marginal benefits of an innovation. Similarly, in a context where risk of harm from side-effects is set against a probable non-terminal outcome of the patient’s condition, the doctor will require more in the way of evidence or outcome to support a decision to innovate. Equally, where the condition is such that the condition as treated by standard methods is expected to result in imminent death, relatively marginal prospects of success with an innovative treatment might be thought to justify departure from standard practice. The balancing exercise will be carried out by the doctor in his or her clinical judgment, with the aid of the consultation and other processes already referred to.
Clause 1(4)(a) – no experimentation on patients
Nothing in this section— (a) permits a doctor to administer treatment for the purposes of research or for any purpose other than the best interests of the patient
32. The policy of the Bill is to support innovative treatment where the doctor is satisfied that it is likely to be in the best interests of the individual patient receiving treatment.
33. This provision clarifies that a decision to experiment on a patient, not for their own good but for the possible benefit of others in the future, will never be protected by the Bill.
34. The law on the undertaking of clinical research trials is set out elsewhere, and by this provision the Bill expressly leaves that law untouched.
35. A number of commentators on the Bill have suggested that data acquired from the use of innovative treatments in reliance on the Bill should be shared with the medical community so as to inform future decisions (including the decision to run a formal clinical research trial). This provision would not prevent that. But it prevents the acquisition of useful information from being used as the justification for subjecting a patient to treatment which is not likely to be in their own medical interests.
Clause 1(4)(b) – preservation of Bolam
Nothing in this section—
… (b) 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.
36. Some commentators on earlier drafts of the Bill were worried that it would be construed as replacing the existing law of medical negligence in its entirety. Although other commentators were satisfied that it did not, the opportunity has been taken in this draft to avoid the possibility of confusion.
37. Clause 1(4)(b) therefore expressly preserves the existing common law rule that looks at whether a decision is supported by a responsible body of medical opinion .
Clause 1(5)(a) – “doctor”
“doctor” means a person listed in the register of medical practitioners under section 2 of the Medical Act 1983 38. The protection provided by the Bill is only in relation to registered doctors, whose professional standards and behaviour are regulated by the General Medical Council and other components of professional self-regulation.
39. The Bill will not protect anyone who while not a registered medical practitioner purports to offer any kind of medical treatment or healing.
Clause 1(5)(b) – “responsible officer”
“responsible officer” has the same meaning as in Part 5A of [the Medical Act 1983]
40. The post of responsible officer is provided for by Part 5A of the Medical Act 1983, as inserted by the Health and Social Care Act 2008.
41. The Government’s Explanatory Notes to the 2008 Act explain that the intended purpose for the responsible officer system is to ensure that they have responsibilities which can “include the evaluation of the fitness to practise of medical practitioners … and a duty to co-operate with the GMC in connection with its responsibilities … It is intended that this co-operation will include making recommendations to the GMC (with whom the final decision rests) on relicensing of medical practitioners based on individuals’ records.”
Clause 1(5)(c) – “treatment”
a reference to treatment of a condition includes a reference to its management (and a reference to treatment includes a reference to inaction).
42. This provision is included for two reasons.
43. In policy discussions senior doctors explained that treatment can be thought to be confined to the application of particular surgical procedures or the prescription of medicines, whereas it can include components which consist of neither. The term “management” is understood to be used in the profession to be capable of including the broadest possible aspects of the process.
44. A decision to do nothing may be as innovative as a decision to do something, and may require equal protection. Where the standard practice is to treat a condition with surgical intervention, a doctor who believes that in the circumstances of his or her patient the risks of surgery outweigh the likely benefits, that inaction is a form of treatment that requires to be protected by the Bill in accordance with the same safeguards that apply to active treatment.
Clause 2(1) – short title This Act may be cited as the Medical Innovation Act 2014.
45. This provision gives the Bill its short title and has no other effect.
46. If the Bill is given Royal Assent in 2015, the title will be changed editorially to refer to the correct year.
Clause 2(2) – commencement This Act comes into force on the day on which it is passed.
47. This provision ensures that the Act comes into immediate effect. It will not need to be brought into force by a commencement order made by the Government.
Clause 2(3) – extent This Act extends only to England and Wales.
48. This provision makes the Bill part of the law of England and Wales (which share a single jurisdiction).
49. The law of medical negligence is not devolved to the National Assembly for Wales, and it is therefore not necessary for the National Assembly to pass a Legislative Consent Motion allowing this Bill to be made by the Westminster Parliament for the whole of England and Wales.
50. Should the legal jurisdictions operating in Scotland and Northern Ireland wish in due course to make similar provision, they will pass their own legislation that reflects their local legal and medical arrangements.
 For an overview see Craies on Legislation, D Greenberg, 10th Edition, 2012, paras.8.1.20 – 18.104.22.168.
. “The common law duty of consultation is well-established: consultation must be undertaken at a time when proposals are still at a formative stage; it must include sufficient reasons for particular proposals to allow those consulted to give intelligent consideration and an intelligent response; adequate time must be given for this purpose; and the product of consultation must be conscientiously taken into account when the ultimate decision is taken: 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.); “The essence of consultation is the communication of a genuine invitation, extended with a receptive mind, to give advice … without communication and the consequent opportunity of responding, there can be no consultation.” (Agricultural, Horticultural and Forestry Industry Training Board v Aylesbury Mushrooms  1 W.L.R. 190 per Donaldson J.).
I am a barrister who specialises in legislation. For 20 years I wrote laws as a member of the Office of the Parliamentary Counsel in 36 Whitehall, London.
Now I consult as in-house Parliamentary Counsel in the Parliamentary Team at Berwin Leighton Paisner BLP, where I advise on statutory interpretation, the legislative process and machinery of government.
I also have a legislative drafting and training practice in the UK and abroad. I have published and edited a number of books and articles including Craies on Legislation, and I am the General Editor of Westlaw UK Annotated Statutes and Insight Encyclopaedia. I am also the Editor of OUP’s Statute Law Review, the editor of two legal dictionaries and an adviser to the Oxford English Dictionary.
The Medical Innovation Bill will help doctors to innovate new treatments and cures safely and responsibly for cancer and other diseases.