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A

BILL

TO

Make provision about innovation in medical treatment.

Be it enacted by the Queen’s most Excellent Majesty, by and with the advice and
consent of the Lords Spiritual and Temporal, and Commons, in this present
Parliament assembled, and by the authority of the same, as follows:—

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 judgment,

(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 judgment.

(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;

Medical Innovation (No. 2) BillPage 2

(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 Commencement, extent and short title

(1) This Act comes into force on Royal Assent.

(2) This Act extends only to England and Wales, and applies in relation to England
20only.

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

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