Medical Innovation Bill (HC Bill 162)

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.

(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,

(e) 25comply with any professional requirements as to registration of the
treatment under the provisions of this Act with a scheme for capturing
the results of innovative treatment (including positive and negative

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results and information about small-scale treatments and patients’
experiences), and

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

(4) 5For 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
the condition in question.

(5) The steps that must be taken by virtue of subsection (3)(f) include the recording
in the patient’s notes of details relating to—

(a) 10the views obtained under subsection (3)(a),

(b) the doctor’s decision to depart from the existing range of accepted
medical treatments for the patient’s condition, and

(c) the proposed treatment.

(6) Nothing in this section—

(a) 15applies in relation to treatment carried out for the purposes of medical
research;

(b) permits a doctor to carry out treatment for any purpose other than the
best interests of the patient.

(7) Nothing in this section applies in relation to treatment which is carried out
20solely for cosmetic purposes.

(8) In this Act—

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

(b) a reference to treatment of a condition includes a reference to its
management (and a reference to treatment includes a reference to
25inaction).

2 Effect on existing law

(1) Nothing in section 1—

(a) affects any rule of the common law to the effect that a departure from
the existing range of accepted medical treatments for a condition is not
30negligent if supported by a responsible body of medical opinion, or

(b) is to be read as limiting the circumstances in which any such rule of the
common law may be relied on (including, for example, where
emergency treatment is required).

(2) Accordingly—

(a) 35any decision by a doctor to depart from the existing range of accepted
medical treatments for a condition in accordance with section 1 does
not prejudice the doctor’s ability, in relation to the departure, to rely on
any rule of the common law referred to in subsection (1)(a);

(b) a departure from the existing range of accepted medical treatments for
40a condition is not negligent merely because the decision to depart from
that 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 2015.

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

(3) Regulations under subsection (2) may—

(a) appoint different days for different purposes;

(b) 5make transitional or saving provision.

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

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