Medical Innovation Bill [HL]

Page 1, line 3, at end insert—

“( )     The provisions of this Act shall not apply where a doctor, in the pursuit of
a treatment, is required to take action where time or place does not allow
the required consultation.”

Page 1, line 5, at end insert—

“( )     This Act shall not apply where the body of responsible medical opinion
considers that the innovative treatment being considered is likely seriously
or unreasonably to compromise patient safety.”

Page 1, line 9, leave out “views” and insert “support”

Page 1, line 15, at end insert “(based on explanation to the patient of the views and
other matters considered, and steps taken, under this subsection)”

Page 1, line 24, at end insert—

“( )   comply with any professional requirements as to registration of the
innovation with a scheme for capturing the results of innovative
treatment (including positive and negative results and information
about small-scale treatments and patients’ experiences),”

Page 2, line 2, at end insert—

“( )     For the purposes of this Act, an “innovation” means—

(a)   any medical treatment, the results of which have not been reported
in peer-reviewed medical publications or have not been subject to
the scrutiny of a published clinical trial;

(b)   the use of any drug, vaccine or pharmaceutical agent which has not
undergone appropriate clinical trials required by UK or EU
legislation;

(c)   the use of any drug, vaccine or pharmaceutical agent for a purpose
other than that stipulated by the manufacturer;

(d)   the insertion or application of a device or instrument for which
approval has not been given by the relevant EU regulatory
authority; or

(e)   the application of a monitoring device or biosensor for which
approval has not yet been sought or given.”

Page 2, line 5, at end insert—

“( )     The steps that must be taken by virtue of subsection (3)(e) include the
recording in the patient’s notes of details relating to—

(a)   the views obtained under subsection (3)(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.”

Page 2, line 6, after “section” insert—

“(a)   applies in relation to treatment carried out for the purposes of
medical research;”

Page 2, line 6, leave out “for the purposes of research or”

Page 2, line 7, at end insert—

“( )     Nothing in this section applies in relation to treatment which is carried out
solely for cosmetic purposes.”

Page 2, line 9, at end insert “or registered dental practitioner”

Page 2, line 13, at end insert—

“( )     The provisions of this Act shall not apply to practitioners or health workers
who are not registered by the General Medical Council or General Dental
Council.”

Page 2, line 13, at end insert—

“( )     The provisions of this Act shall not apply to the insertion or injection of
cells or tissues or other biologically derived material into the body of a
patient.”

Page 2, line 17, at end insert “, 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).”

Page 2, line 19, leave out paragraph (a) and insert—

“( )   any decision by a doctor to depart from the existing range of
accepted medical treatments for a condition in accordance with
section 1 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);”