Medical Innovation Bill [HL]

marshalled
list of Amendments
to be moved
in committee

[Amendments marked * are new or have been altered]

Before Clause 1

LORD TURNBERG

1

Insert the following new Clause—

“Provision of advice by registered medical practitioner

(1)     This Act applies only to decisions made by a registered medical
practitioner to advise a patient for whom he has assumed a professional
responsibility for the provision of advice with regard to the choice of
treatment for—

(a)   a cancer which in the reasonable opinion of the practitioner is
affecting the patient and is likely to cause the patient’s death
without the provision of effective treatment;

(b)   such other conditions as may be prescribed by regulations made by
the Secretary of State.

(2)     A condition to which this Act applies is referred to as a “relevant
condition”.”

Clause 1

LORD PANNICK

LORD WINSTON

LORD TURNBERG

2

Page 1, line 2, after “encourage” insert “reasonable and”

LORD TURNBERG

BARONESS FINLAY OF LLANDAFF

3

Page 1, line 3, after “treatment” insert “for relevant conditions”

LORD PANNICK

LORD WINSTON

LORD TURNBERG

4

Page 1, line 3, leave out “(and accordingly to deter reckless irresponsible
innovation)”

LORD TURNBERG

LORD SAATCHI

BARONESS FINLAY OF LLANDAFF

5

Page 1, line 3, leave out “reckless”

LORD WINSTON

LORD PANNICK

6

Page 1, line 3, at end insert—

“( )     For the purposes of this Act, “innovation in medical treatment” means—

(a)   the use of a medical procedure, treatment, therapy, device or
instrument which has not been subjected to a randomised clinical
trial or equivalent clinical validation, or for which there is no
published evidence of its risks or benefits in peer-review medical
journals;

(b)   the prescription of a drug which has not been licensed by the UK
Medicines and Healthcare Products Regulatory Agency and the
European Medicines Agency;

(c)   the prescription of a licensed drug for a treatment, condition or
therapy not recommended by the manufacturer; or

(d)   the use of a device or instrument which has not been regulated
under the Medical Devices Regulations 2002 (S.I. 2002/618) for the
purpose of that particular treatment.”

LORD TURNBERG

7

Page 1, line 4, leave out subsection (2) and insert—

“(2)     If, after assuming professional responsibility for advising a patient with
regard to the choice of treatment for a relevant condition, a doctor is
satisfied on reasonable grounds that there is no treatment accepted by a
responsible body of medical opinion which is known or likely to be
effective for the cure or palliative relief of a relevant condition from which
the patient suffers, it is not negligent for that doctor to advise the patient to
receive a treatment if the doctor—

(a)   has formed an honest and responsible opinion that—

(i)   there is a prospect of that treatment being more effective in
curing, alleviating or preventing a deterioration in the
relevant condition than any treatment which is supported
by a responsible body of medical opinion, and

(ii)   the provision of the treatment would be in the patient’s best
interests;

(b)   in reaching that opinion has had regard to—

(i)   the opinions of any other doctors who have responsibility
for the care and treatment of the patient for the relevant
condition;

(ii)   their views of the advice given of the patient or other person
with legal authority to consent to treatment on behalf of the
patient;

(iii)   the comparative risks and benefits for the patient of the
proposed treatment and any alternative treatments;

(iv)   any code of practice issued by the Secretary of State under
this Act;

(c)   has consulted with at least one other doctor who has expertise in the
relevant condition and is independent from him, and from any
other doctors or organisations with responsibility for the care and
treatment of the patient;

(d)   has obtained the agreement in writing of at least one doctor
consulted in accordance with paragraph (c) that the requirements of
this Act have been complied with and that in his opinion the advice
to be offered to the patient is responsible and in the patient’s best
interests;

(e)   has recorded in writing—

(i)   the advice given to the patient;

(ii)   his reasons for giving it; and

(iii)   the steps taken to comply with the requirements of this Act;

(f)   has given a copy of the record of his advice to the patient.”

LORD SAATCHI

8

Page 1, line 4, leave out “to decide”

9

Page 1, line 5, after “accepted” insert “medical”

LORD PANNICK

LORD WINSTON

LORD TURNBERG

10

Page 1, line 5, after “condition” insert “if the doctor acts in a manner which is
reasonable and proportionate and”

LORD SAATCHI

11

Page 1, line 5, leave out from “decision” to end of line 7 and insert “to do so is taken
responsibly.”

12

Page 1, line 8, leave out subsection (3) and insert—

“(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
relation 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 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 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, and

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

LORD WINSTON

LORD PANNICK

13

Page 1, line 8, leave out subsection (3) and insert—

“(3)     That process must include—

(a)   the written agreement of a Clinical Ethics Committee;

(b)   notification in advance to the doctor’s responsible officer;

(c)   consideration of any opinions or requests expressed by or on behalf
of the patient following the open communication of all relevant
information to the patient or those acting legally on behalf of the
patient;

(d)   obtaining all consents required by law, both verbally and in
writing; and

(e)   consideration of all matters which are reasonably considered
necessary to reach a rational clinical judgement about the proposed
innovative treatment, together with an assessment of any probable
risks of that treatment, including transparent communication with
the patient or those acting legally on behalf of the patient about all
other reasonable treatments that are available to treat the
condition.”

BARONESS MASHAM OF ILTON

14

Page 1, leave out line 14 and insert—

“( )   providing the patient with a detailed explanation of the aims,
processes and risks associated with the proposed treatment;

( )   obtaining informed consent with reference to all relevant legislation
and professional guidance;

( )   providing the patient with a detailed asssessment of how the
proposed treatment may affect their condition;

( )   providing the patient with information about any factors that may
limit or discontinue their access to the proposed treatment; and”

LORD TURNBERG

LORD PANNICK

BARONESS EMERTON

BARONESS FINLAY OF LLANDAFF

15

Page 1, line 18, at end insert—

“(f)   recording the processes in paragraphs (a) to (e) in the patient’s
medical record; and

(g)   recording all results of such innovative treatments, whether
positive or negative—

(i)   in the patient’s medical record; and

(ii)   in a public record within six months of the treatment
ending.”

LORD SAATCHI

16

Page 1, line 18, at end insert—

“( )     For 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.”

LORD WINSTON

LORD PANNICK

17

Page 1, line 18, at end insert—

“( )     The provisions of this section shall not apply to—

(a)   the conduct of delivery during childbirth or medical care during
parturition;

(b)   neonatal or paediatric care;

(c)   treatments involving in vitro fertilisation or other treatments
currently regulated by the Human Fertilisation and Embryology
Authority;

(d)   the conduct of operative surgery;

(e)   emergency care;

(f)   treatments required as a result of acute trauma;

(g)   psychotherapeutic interventions for mental ill health; or

(h)   conditions that are not regarded as life-threatening or seriously
debilitating by the broad body of responsible medical opinion.”

BARONESS MASHAM OF ILTON

18

Page 1, line 18, at end insert—

“( )     The Secretary of State may issue additional guidance about the necessary
steps for obtaining informed consent under subsection (3).”

LORD TURNBERG

19

Page 1, line 18, at end insert—

“( )     There shall be a register of innovative treatments performed under this
Act.”

LORD SAATCHI

20

Page 1, line 20, leave out “administer” and insert “carry out”

LORD TURNBERG

21

Page 1, line 20, leave out from “treatment” to “, or” in line 21 and insert “without
any consent required by laws or abolishes the requirements of law for obtaining
such consent”

LORD WINSTON

LORD PANNICK

22

Page 1, line 21, after “patient” insert—

“( )   requires a doctor to institute an innovative medical treatment if he
or she does not consider it to be in the best interests of the patient;

( )   means that a doctor is negligent for failing to institute an innovative
medical treatment; or”

LORD SAATCHI

23

Page 1, line 22, leave out paragraph (b)

LORD TURNBERG

BARONESS MASHAM OF ILTON

24

Page 1, line 24, at end insert—

“( )     In an emergency, where there is insufficient time for full consultation and
approval, a doctor may use an innovative treatment or procedure that
appears to him to be necessary, appropriate and reasonable at the time.”

LORD SAATCHI

25

Page 1, line 25, leave out “section” and insert “Act”

26

Page 2, line 1, leave out from “a” to end of line 2 and insert “registered medical
practitioner;”

LORD TURNBERG

LORD SAATCHI

27

Page 2, line 3, leave out paragraph (b)

LORD HUNT OF KINGS HEATH

BARONESS WHEELER

28

Page 2, line 7, at end insert—

“( )     The Secretary of State must exercise the functions of the Secretary of State
in relation to the health service with a view to supporting responsible
innovation in medical treatment, as encouraged by this section.

( )     The following bodies must exercise their functions in relation to the health
service with a view to supporting responsible innovation in medical
treatment, as encouraged by this section—

(a)   NHS Commmissioning Board;

(b)   Clinical Commissioning Groups;

(c)   NHS Trusts;

(d)   NHS Foundation Trusts;

(e)   Care Quality Commission;

(f)   Monitor;

(g)   NHS Trust Development Authority;

(h)   Health Education England; and

(i)   Health Research Authority.”

After Clause 1

LORD SAATCHI

29

Insert the following new Clause—

“Effect on existing law

(1)     Nothing in section 1 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.

(2)     Accordingly—

(a)   where a doctor departs from the existing range of accepted medical
treatments for a condition, it is for the doctor to decide whether to
do so in accordance with section 1 or in reliance on any rule of the
common law referred to in subsection (1);

(b)   a departure from the existing range of accepted medical treatments
for a condition is not negligent merely because the decision to
depart from that range of treatments was taken otherwise than in
accordance with section 1.”

LORD WINSTON

30

Insert the following new Clause—

“Clinical ethics committees

(1)     Every NHS trust must establish a Clinical Ethics Committee.

(2)     The Clinical Ethics Committee shall be composed of—

(a)   the Medical Director of the trust, as Chair;

(b)   three senior doctors;

(c)   a senior nurse; and

(d)   at least one lay member.

(3)     The Clinical Ethics Committee may at any time co-opt specialist doctors to
provide such detailed knowledge as the Committee requires.

(4)     The purpose of the Clinical Ethics Committee of a trust shall be to
determine any application to undertake an innovative medical treatment
made by—

(a)   a doctor working for that trust; or

(b)   a general practitioner who practises in the local area.”

LORD TURNBERG

BARONESS FINLAY OF LLANDAFF

31

Insert the following new Clause—

“Code of practice

(1)     The Secretary of State may issue one or more codes of practice in
connection with—

(a)   the process to be undertaken by a doctor before giving advice under
this Act;

(b)   the form in which the agreement required under section 1(2)(d) is
to be recorded;

(c)   the factors which the doctor should take into account in deciding to
offer advice under this Act;

(d)   requirements for making and keeping records required by the Act;

(e)   such other matters relating to the operation of the Act as the
Secretary of State thinks fit.

(2)     Before issuing a code under this section, the Secretary of State shall consult
such persons as he thinks appropriate.”

32

Insert the following new Clause—

“Other legislation governing clinical trials

Nothing in this Act will conflict with any other legislation governing the
conduct of research clinical trials of new treatments and will not override
such legislation nor obstruct such activities.”

33

Insert the following new Clause—

“Power to make regulations

(1)     Any power of the Secretary of State under this Act to make regulations is
exercisable by statutory instrument.

(2)     A statutory instrument containing regulations under this Act is subject to
annulment in pursuance of a resolution of either House of Parliament.”

BARONESS MASHAM OF ILTON

34

Insert the following new Clause—

“Availability of treatments

The Secretary of State must—

(a)   periodically publish an assessment of geographical variances in the
availability of innovative treatments; and

(b)   set out steps to promote uniform access to innovative treatments.”

Clause 2

LORD SAATCHI

35

Page 2, line 9, at end insert—

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

(1B)    Regulations under subsection (1A) may—

(a)   appoint different days for different purposes;

(b)   make transitional or saving provision.”

LORD TURNBERG

36

Page 2, line 10, leave out subsection (2) and insert—

“(2)     This Act will come into force on a day to be appointed by regulations.”

LORD SAATCHI

37

Page 2, line 10, leave out “Act” and insert “section”

38

Page 2, line 10, leave out “it” and insert “this Act”

BARONESS FINLAY OF LLANDAFF

39

Page 2, line 11, at end insert “but shall only come into force in Wales following
legislative consent from the Assembly”

Prepared 23rd October 2014