We are very grateful for all the input we have received.
The Bill is going through the usual Parliamentary process and amendments are part of that process.
The following explanatory notes have been prepared by parliamentary draftsman Daniel Greenberg.
MEDICAL INNOVATION BILL [HL] EXPLANATORY NOTES TO AMENDMENTS FOR REPORT TABLED BY LORD SAATCHI
ON WEDNESDAY 3rd DECEMBER 2014
- On 3rd December 2014 Lord Saatchi tabled a set of amendments to his Medical Innovation Bill to be considered on Report on 12th December.
- The amendments were prepared by the Department for Health to respond to concerns raised by peers and others at and around the Committee Stage.
- These Notes explain the manner in which the amendments meet the concerns expressed.
Transparency: patients’ notes; and recording outcome of consultation
- Some peers wanted details of decisions to innovate to be recorded in patients’ notes.
- Peers and others have also expressed a wish to see greater transparency about the nature of responses received by the doctor when undertaking the consultation with colleagues required by clause 1(3)(a) and (b).
- Amendment 1 requires the results of the consultation to be recorded in the patient’s notes, together with details of the doctor’s decision to innovate.
- There has also been pressure to turn the requirement to consult colleagues into a requirement to obtain colleagues’ written consent. These amendments do not give effect to that suggestion. Senior doctors consulted by Lord Saatchi expressed concern about giving formal written consent to another doctor’s proposed course of treatment, without knowing the full history and other circumstances, while they would be relaxed about expressing a view of the soundness of the doctor’s proposal as described to them. Lawyers consulted were also concerned about a possible new form of legal liability for consenting doctors. The requirement to record views in the patient’s notes should introduce the necessary formality, transparency and accountability, while avoiding both of these objections.
Preservation of existing law about clinical trials and other forms of research
- It has always been the intention of the Bill to make no change of the law relating to research (see clause 1(5)). But concerns were expressed that this needs to be made even clearer.
- Amendments 2 and 3 are designed to put the point beyond possible doubt.
Exclusion of cosmetic surgery
- At the Committee Stage and elsewhere suggestions have been made that the Bill should be confined expressly to the principal kinds of case at which it is aimed, namely relatively rare terminal cancers and other terminal conditions.
- Lord Saatchi has reconsidered attempting to define the intended scope of the Bill, but has found it impossible to do so in a way that answers more questions than it raises.
- Much of the concern has centred around the potential use of the Bill in relation to cosmetic surgery, and it was suggested that it could at least be made clear that it is not the purpose of the Bill to apply to that.
13. Amendment 4 accordingly excludes cosmetic surgery from the Bill. (Cosmetic surgery can of course in some cases be crucial to life or quality of life – as in the case of severe burns; doctors wishing to innovate in such cases will be able to rely on the existing common law Bolam test.)
Emergency treatment; and preservation of common law
14. Concern has been expressed whether in emergency situations doctors will realise that they are not expected to follow the procedures set out in the Bill.
15. Amendment 5 accordingly introduces a reference to emergencies, as an example of a situation in which the existing common law Bolam test would apply and a doctor might not engage the procedures in the Bill.
16. Amendment 6 recasts the principle that the Bill does not force doctors to rely on its procedures and that they can simply rely on the existing Bolam test in all cases. The new form is designed to meet concerns expressed as to whether the intention of existing clause 2(2)(a) was sufficiently clear.
17. Amendment 7 is a consequential amendment to reflect the numbering changes effected by Amendment 5.
Daniel Greenberg 3rd December 2014