Access to Medical Treatments (Innovation) Bill

A
Access to Medical Treatments (Innovation) Bill Is this the answer.
Bill 8 56/1
Access to Medical Treatments (Innovation) Bill
CONTENTS
Introductory 
1 Access to innovative medical treatments
Database of innovative medical treatments 
2 Database of innovative treatments
Responsible innovation 
3 Responsible innovation 
4 Effect on existing law
Interpretation 
5 Interpretation etc
Final 
6 Extent, 

 Bill 8 56/1
Access to Medical Treatments (Innovation) Bill 1
A
BILL
TO
Make provision for access to innovative medical treatments; and for connected
purposes.
E 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:—
Introductory 
1 Access to innovative medical treatments
The purpose of this Act is to promote access to innovative medical treatments
by— 
(a) providing for the establishment of a database of innovative medical
treatments, and for access to information contained in the database,
and 
(b) encouraging responsible innovation by doctors in relation to the
carrying out of medical treatment.
Database of innovative medical treatments 
2 Database of innovative treatments 
(1) 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
about— 
(a) innovative medical treatments carried out by doctors in England, and 
(b) the results of such treatments. 
(2) 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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2 Access to Medical Treatments (Innovation) Bill
(a) confer power on the HSCIC to make provision about— 
(i) the information to be recorded in the database, and 
(ii) procedures relating to the recording of information in the
database; 
(b) make provision for and in connection with access to information
recorded in the database. 
(4) The provision that may be made by virtue of subsection (3)(b) includes, in
particular— 
(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; 
(b) 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). 
(5) Regulations under subsection (1) may be made in relation to innovative
medical treatments generally or innovative medical treatments falling within a
specified description. 
(6) 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). 
(8) 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.
Responsible innovation
3 Responsible innovation 
(1) 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. 
(2) 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
particular— 
(a) 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
medical opinion, 
(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
treatment, 
(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
be, associated with the proposed treatment, the treatments that
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Access to Medical Treatments (Innovation) Bill 3
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, having regard in particular
to the requirements of patient safety, and 
(e) take such other steps as are necessary to secure that the decision is
made in a way that is accountable and transparent. 
(3) 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. 
(4) 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),
(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. 
(5) 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— 
(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
negligent 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) 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); 
(b) 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. 
(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.
Interpretation 
5 Interpretation etc 
(1) In this Act— 
(a) “doctor” means a registered medical practitioner; 
(b) references to treatment of a condition include references to its
management (and references to treatment include references to
inaction).
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4 Access to Medical Treatments (Innovation) Bill 
(2) Nothing in this Act applies in relation to treatment carried out for the purposes
of medical research. 
(3) Nothing in this Act applies in relation to treatment which is carried out solely
for cosmetic purposes. 
Final
6 Extent, commencement and short title 
(1) This Act extends to England and Wales only. 
(2) 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. 
(5) This Act may be cited as the Access to Medical Treatments (Innovation) Act 
So the debate was made on friday.
You can read the debate  (CLICK)
1) The Secretary of State shall require the National Institute for Health Research to develop and introduce a mechanism for—
(a) gathering and recording existing evidence on off-patent, repurposed drugs, including clinical trial evidence, and
(b) passing this information to relevant bodies.
(2) The Secretary of State shall determine the relevant bodies under subsection (1) and may revise that determination from time to time.
New clause 3—Appraisal in new indications
(1) Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall direct theNational Institute for Health and Care Excellence (NICE) to conduct an appraisal in relation to the drug in its new indication.
(2) An appraisal under subsection (2) should include a cost-effectiveness analysis.
New clause 4—National commissioning policy for off-patent new drugs
Where there is an off-patent, repurposed drug with strong evidence of its effectiveness in a new indication, the Secretary of State shall require NHS England to produce and disseminate a national commissioning policy.
New clause 5—Accessibility of the licensing process
(1) The Secretary of State shall require the Medicines and Healthcare products Regulatory Agency to consult key stakeholders about steps to be taken to make the licensing process more accessible to organisations or individuals other than pharmaceutical companies.
(2) For the purposes of subsection (1), key stakeholders shall include, but not be limited to—
(a) patient organisations,
(b) medical research charities,
(c) relevant academics, and
(d) the British Generic Manufacturers Association.
New clause 6—British National Formulary: inclusion of off-patent drugs
The Secretary of State shall require NICE and the British National Formulary (BNF) to review their processes for registering off-label uses of repurposed drugs where there is strong evidence of their effectiveness.
Amendment 10, in clause 1, page 1, line 3, after “treatments” insert “(including treatments consisting in the off-label use of medicines or the use of unlicensed medicines)”
Amendment 13, in clause 5, page 3, line 44, at end insert—
“(1A) For the purposes of section 2(2), the kinds of medical treatment that may be innovative medical treatments include (amongst other things)—
(a) the off-label use of an authorised medicinal product, and
(b) the use of a medicinal product in respect of which no marketing authorisation is in force.
(1B) In subsection (1A)(a), the reference to the off-label use of an authorised medicinal product is a reference to the use of the product—
(a) for a purpose other than one for which its use is specified,
(b) in relation to a person who is not within a description of persons for whom its use is specified, or
(c) in any other way in which its use is not specified.
(1C) In this section—
(a) ‘authorised medicinal product’ means a medicinal product in respect of which a marketing authorisation is in force;
(b) ‘marketing authorisation’ and ‘medicinal product’ have the same meanings as in the Human Medicines Regulations 2012 (S.I. 2012/1916);
(c) ‘specified’, in relation to a medicinal product, means specified in its marketing authorisation.”

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