Commentary on provisions of Bill
Clause 1: Access to innovative medical treatments
14 Clause 1 provides that the purpose of the Bill is to promote access to innovative medical treatments by:
a. making provision for a database of innovative medical treatments, and for access to information contained in that database, and
b. encouraging responsible innovation by doctors in relation to the carrying out of medical treatment.
Clause 2: Database of innovative treatments
15 Subsection (1) gives the Secretary of State a power to make regulations conferring functions on the HSCIC in connection with the establishment, maintenance and operation of a database. The database will contain information about innovative medical treatments carried out by doctors in England, and the results of those treatments. Before making regulations the Secretary of State must consult the HSCIC (subsection (6)).
16 Subsection (2) provides that a treatment is "innovative" if it involves a departure from the existing range of accepted medical treatments for a condition. This will include the use of medicines and medical devices in innovative ways, and would include treatments where only part of the treatment is innovative.
17 Subsection (3)(a)(i) and (ii) provide that the regulations can confer on the HSCIC the power to make provision about the information to be recorded in the database and procedures relating to how it is recorded.
18 Subsections (3)(b) and (4) provide that the regulations can make provision about access to information recorded in the database, including provision requiring or authorising the HSCIC to disclose information, and to impose conditions on those to whom information is disclosed. It is intended that the regulations will make provision for other doctors to access information recorded in the database for the purpose of sharing knowledge about innovative medical treatments and encouraging learning.
19 Subsection (8) provides that the regulations are subject to the negative resolution procedure.
20 Information about treatments will only be able to be disclosed where this is in accordance with the law, in particular the common law duty of confidentiality and the Data Protection Act 1998.
Clause 3: Responsible innovation
21 Subsection (1) provides that it is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly. Subsection (2) sets out a series of steps that doctors must take to show that they have acted responsibly (and thus not negligently).
22 Subsections (2)(a) and (b) and (3) require the decision-making process to include consultation with appropriately qualified colleagues, who must have expertise and experience in dealing with patients with the relevant condition, with a view to ascertaining whether the proposed medical treatment would have the support of a responsible body of medical opinion.
23 Subsection (2)(c) requires the decision-making process to include obtaining any consents required by law; the Bill does not affect the legal requirement for a doctor to obtain a patient’s informed consent to any treatment proposed. 1
24 Subsection (2)(d)(i) requires the decision-making process to include consideration of opinions or requests expressed by the patient or on behalf of the patient (for example, by family members in the case of a patient who is unable to communicate his or her own opinions). This is intended to ensure that such views are taken into account by the doctor as part of making a responsible decision as to whether to offer an innovative medical treatment to a patient.
25 Subsection (2)(d)(ii) requires the decision-making process to include a risk-benefit analysis including comparison of the innovative medical treatment with the standard treatment for the condition, and with no treatment at all.
26 Subsections (2)(e) and (4) require the doctor to take any other steps necessary to ensure that decisions to innovate are accountable and transparent. Those steps expressly include recording in the patient’s notes details of the colleagues whose views were obtained, what those views were, and the proposed innovative treatment.
27 Subsection (5) is self-explanatory.
Clause 4: Effect on existing law
28 Clause 4(1) and (2) expressly preserve the common law Bolam test, so that a doctor who chooses to innovate in reliance on that rather than on clause 3 of the Bill is able to do so. They also confirm that the availability of the Bolam test is not limited by clause 3.
29 Clause 4(3) provides that compliance with clause 3 will not protect a doctor from liability in negligence if the way in which the medical treatment was actually provided was negligent.
Clause 5: Interpretation etc.
30 Subsection (1)(a) is self-explanatory.
31 Subsection (1)(b) provides that references in the Bill to treatment of a condition include references to its management (and references to treatment include references to inaction).
32 Subsection (2) confirms that nothing in the Bill applies to treatment carried out for the purposes of medical research (such as in the context of a clinical trial). This is because such research is subject to its own separate regulatory regime. Nor do the provisions extend to treatment which is carried out solely for cosmetic purposes (subsection (3)). This reflects debates in the House of Lords on the MIB, during which strong views were expressed in favour of limiting the clinical negligence provisions to medical treatments that offer clinical benefits for patients.
1 The Supreme Court have recently clarified the law of consent in the case of Montgomery v Lanarkshire Health Board  UKSC 11