Medical Innovation Bill [HL]

to be moved
in committee

Before Clause 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

Clause 1



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


Page 1, line 3, leave out “reckless”


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

(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

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

(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

(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.”


Page 1, line 18, at end insert—

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


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”


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

After Clause 1



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.”


Insert the following new Clause—


Nothing in this Act will conflict with any other act or regulation governing
the conduct of research clinical trials of new treatments and will not obviate
such acts or regulations nor obstruct such activities.”


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.”

Clause 2



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

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

Prepared 4th August 2014