Access to Medical Treatments (Innovation) Bill (HC Bill 8)
Make provision for access to innovative medical treatments; and for connected
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 Access to innovative medical treatments
The purpose of this Act is to promote access to innovative medical treatments
providing for the establishment of a database of innovative medical
treatments, and for access to information contained in the database,
encouraging responsible innovation by doctors in relation to the
carrying out of medical treatment.
Database of innovative medical treatments
2 Database of innovative treatments
The Secretary of State may by regulations make provision conferring functions on the
Health and Social Care Information Centre (“the HSCIC”) in connection with the
establishment, maintenance and operation of a database containing information
(a) innovative medical treatments carried out by doctors in England, and
(b) the results of such treatments.
For the purposes of this section, medical treatment for a condition is
“innovative” if it involves a departure from the existing range of accepted
medical treatments for the condition.
(3) Regulations under subsection (1) may in particular—
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(a) confer power on the HSCIC to make provision about—
(i) the information to be recorded in the database, and
procedures relating to the recording of information in the
make provision for and in connection with access to information
recorded in the database.
The provision that may be made by virtue of subsection (3)(b) includes, in
(a) provision requiring or authorising the HSCIC to disclose information—
(i) to specified persons or descriptions of person, or
(ii) for use for specified purposes;
provision requiring or authorising the HSCIC to impose conditions to
be complied with by persons to whom information is disclosed by
virtue of paragraph (a) (which may include conditions restricting the
use or further disclosure of information).
Regulations under subsection (1) may be made in relation to innovative
medical treatments generally or innovative medical treatments falling within a
Before making regulations under subsection (1) the Secretary of State must
consult the HSCIC.
(7) In this section, “specified” means specified in regulations under subsection (1).
The power to make regulations under subsection (1) is exercisable by statutory
instrument; and an instrument containing such regulations is subject to
annulment in pursuance of a resolution of either House of Parliament.
3 Responsible innovation
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.
For the purposes of taking a responsible decision to depart from the existing
range of accepted medical treatments for a condition, a doctor must in
obtain the views of one or more appropriately qualified doctors in
relation to the proposed medical treatment, with a view to ascertaining
whether the treatment would have the support of a responsible body of
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),
obtain any consents required by law to the carrying out of the proposed
any opinions or requests expressed by or in relation to the
the risks and benefits that are, or can reasonably be expected to
be, associated with the proposed treatment, the treatments that
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fall within the existing range of accepted medical treatments for
the condition, and not carrying out any of those treatments, and
any other matter that it is necessary for the doctor to consider in
order to reach a clinical judgement, having regard in particular
to the requirements of patient safety, and
take such other steps as are necessary to secure that the decision is
made in a way that is accountable and transparent.
For the purposes of subsection (2)(a), a doctor is appropriately qualified if the
doctor has appropriate expertise and experience in dealing with patients with
the condition in question.
The steps that must be taken by virtue of subsection (2)(e) include the
recording in the patient’s notes of details relating to—
(a) the views obtained under subsection (2)(a),
the doctor’s decision to depart from the existing range of accepted
medical treatments for the patient’s condition, and
(c) the proposed treatment.
Nothing in this section permits a doctor to carry out treatment for any purpose
other than the best interests of the patient.
4 Effect on existing law
(1) Nothing in section 3—
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
negligent if supported by a responsible body of medical opinion, or
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).
any decision by a doctor to depart from the existing range of accepted
medical treatments for a condition in accordance with section 3 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);
a departure from the existing range of accepted medical treatments for
a condition is not negligent merely because the decision was taken
otherwise than in accordance with section 3.
Section 3 does not affect liability in respect of the negligent carrying out of
medical treatment, notwithstanding that the treatment is carried out pursuant
to a decision taken in accordance with that section.
5 Interpretation etc
(1) In this Act—
(a) “doctor” means a registered medical practitioner;
references to treatment of a condition include references to its
management (and references to treatment include references to
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Nothing in this Act applies in relation to treatment carried out for the purposes
of medical research.
Nothing in this Act applies in relation to treatment which is carried out solely
for cosmetic purposes.
6 Extent, commencement and short title
(1) This Act extends to England and Wales only.
Sections 1 to 5 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) make transitional or saving provision.
(4) This section comes into force on the day on which this Act is passed.
This Act may be cited as the Access to Medical Treatments (Innovation) Act