Medical Innovation Bill (HL Bill 21)

1 Responsible innovation

(1) The purpose of this Act is to encourage responsible innovation in medical
treatment and to deter reckless departure from standard practice.

(2) It is not negligent for a doctor to depart from the pre-existing range of accepted
5treatments for a condition (standard practice) if the decision to innovate is
taken responsibly.

(3) A responsible decision to innovate will, in particular, be based on
consideration of—

(a) the reasons why the available research or other evidence is insufficient
10or unclear including, in particular, whether it is referable to the nature
of the condition (as in, for example, a cancer that affects relatively few
patients),

(b) the relative risks that are, or can reasonably be expected to be,
associated with the treatment the doctor proposes to apply and other
15treatments,

(c) the relative likely success rates of the treatment the doctor proposes to
apply and other treatments, in the doctor’s reasonable judgement,

(d) the relative likely consequences of applying, or failing to apply, the
treatment the doctor proposes to apply, and other treatments,

(e) 20opinions or requests expressed by or in relation to the patient, and

(f) any other matter that appears to the doctor to be reasonably necessary
to be considered in order to reach a clinical judgement.

(4) A responsible decision to innovate must be made in accordance with a process
which is accountable, transparent and allows full consideration of all relevant
25matters; the process may include, in particular—

(a) decision-making within a multi-disciplinary team;

(b) notification in advance to the doctor’s responsible officer (within the
meaning of Part 5A of the Medical Act 1983);

(c) explanation to the patient of the doctor’s reasons for proposing to
depart from standard practice, including discussion of any contrary
5opinions expressed by the doctor’s colleagues.

(5) Nothing in this section permits a doctor—

(a) to provide treatment without consent that is otherwise required by law,
or

(b) to administer treatment for the purposes of research or for any purpose
10other than the best interests of the patient.

(6) In this section—

(a) “doctor” means a person listed in the register of medical practitioners
under section 2 of the Medical Act 1983, and

(b) a reference to treatment of a condition includes a reference to its
15management (and a reference to treatment includes a reference to
inaction).

2 Short title, commencement and extent

(1) This Act may be cited as the Medical Innovation Act 2013.

(2) This Act comes into force on the day on which it is passed.

(3) 20This Act extends to England and Wales, Scotland and Northern Ireland.