Medical Innovation Bill (HL Bill 48)

1 Responsible innovation

(1) The purpose of this Act is to encourage responsible innovation in medical
treatment.

(2) It is not negligent for a doctor to depart from the existing range of accepted
5medical treatments for a condition if the decision to do so is taken responsibly.

(3) For the purposes of taking a responsible decision to depart from the existing
range of accepted medical treatments for a condition, the doctor must in
particular—

(a) obtain the views of one or more appropriately qualified doctors in
10relation to the proposed treatment,

(b) take full account of the views obtained under paragraph (a) (and do so
in a way in which any responsible doctor would be expected to take
account of such views),

(c) obtain any consents required by law to the carrying out of the proposed
15treatment,

(d) consider—

(i) any opinions or requests expressed by or in relation to the
patient,

(ii) the risks and benefits that are, or can reasonably be expected to
20be, associated with the proposed treatment, the treatments that
fall within the existing range of accepted medical treatments for
the condition, and not carrying out any of those treatments, and

(iii) any other matter that it is necessary for the doctor to consider in
order to reach a clinical judgement, and

(e) take such other steps as are necessary to secure that the decision is
made in a way which is accountable and transparent.

(4) For the purposes of subsection (3)(a), a doctor is appropriately qualified if he
or she has appropriate expertise and experience in dealing with patients with
5the condition in question.

(5) Nothing in this section permits a doctor to carry out treatment for the purposes
of research or for any purpose other than the best interests of the patient.

(6) In this Act—

(a) “doctor” means a registered medical practitioner;

(b) 10a reference to treatment of a condition includes a reference to its
management (and a reference to treatment includes a reference to
inaction).

2 Effect on existing law

(1) Nothing in section 1 affects any rule of the common law to the effect that a
15departure from the existing range of accepted medical treatments for a
condition is not negligent if supported by a responsible body of medical
opinion.

(2) Accordingly—

(a) where a doctor departs from the existing range of accepted medical
20treatments for a condition, it is for the doctor to decide whether to do
so in accordance with section 1 or in reliance on any rule of the common
law referred to in subsection (1);

(b) a departure from the existing range of accepted medical treatments for
a condition is not negligent merely because the decision to depart from
25that range of treatments was taken otherwise than in accordance with
section 1.

3 Short title, commencement and extent

(1) This Act may be cited as the Medical Innovation Act 2014.

(2) Sections 1 and 2 come into force on such day or days as the Secretary of State
30may by regulations made by statutory instrument appoint.

(3) Regulations under subsection (2) may—

(a) appoint different days for different purposes;

(b) make transitional or saving provision.

(4) This section comes into force on the day on which this Act is passed.

(5) 35This Act extends only to England and Wales.