Medical Innovation Bill [HL]

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.”

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.”

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.”

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”

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.”