64—Declaration of authorised activities and authorised persons
(1) Subject to this
Part, the Minister may, by notice published in the Gazette—
(a)
declare an activity described in the declaration to be—
(i)
an authorised quality improvement activity; or
(ii)
an authorised research activity;
(b)
declare a person or group of persons (including a group formed as a committee)
described in the declaration to be an authorised entity for the purposes of
carrying out—
(i)
an authorised quality improvement activity; or
(ii)
an authorised research activity.
(2) The Minister
must—
(a) in
the case of a declaration under subsection (1)(a)(i)—relate the
declaration to any activity that involves—
(i)
an assessment or evaluation of the quality of services
provided by prescribed health-sector bodies, including by assessing or
evaluating clinical practices or by conducting studies of the incidence or
causes of conditions or circumstances that may affect the quality of any such
services; or
(ii)
the making of recommendations about the provision of
services provided by prescribed health-sector bodies after taking into account
the outcome of any activity of a kind described in paragraph (a); or
(iii)
the monitoring of the implementation of any
recommendations or other initiatives that are relevant to improving the
quality of services provided by prescribed health-sector bodies;
(b) in
the case of a declaration under subsection (1)(a)(ii)—relate the
declaration to research activities that relate to the causes of mortality or
morbidity;
(c) in
the case of a declaration under subsection (1)(b) that relates to a
person—ensure that the person holds an appropriate authorisation from
the governing body of the prescribed health-sector body and, if relevant, an
appropriate approval from a research ethics committee;
(d) in
the case of a declaration under subsection (1)(b) that relates to a group
of persons—ensure—
(i)
that the group is established in accordance with the
rules of the governing body of the prescribed health-sector body; and
(ii)
that the functions of the group include activities
involved in carrying out a quality improvement activity or research activity
within the contemplation of this Part; and
(iii)
that each member of the group will hold a qualification
or have experience or training that is relevant to the performance of its
functions in relation to a quality improvement activity or research activity;
and
(iv)
if the relevant rules so require—that the group
holds an appropriate authorisation from the governing body of the prescribed
health-sector body and, if relevant, an appropriate approval from a research
ethics committee.
(3) The Minister must,
in acting under this section, make the health and safety of the public the
primary consideration.
(4) In addition, the
Minister must not make a declaration under this section unless
satisfied—
(a) that
the performance of an activity within the ambit of the declaration, or the
functions or activities of a person or group of persons within the ambit of
the declaration, would be facilitated by the making of the declaration; and
(b) that
the making of the declaration is in the public interest.
(5) The Minister must
also take into account any criteria prescribed by the regulations for the
purposes of this section.
(6) To avoid doubt,
the Minister may—
(a) make
a declaration under subsection (1)(a) without specifying a particular
person or group of person as being an authorised entity to which the
declaration is to apply at that particular time;
(b) make
a declaration under subsection (1)(b)—
(i)
without specifying a particular authorised quality
improvement activity or authorised research activity that is to be carried out
by the authorised entity at any particular time;
(ii)
by defining the group rather than by specifying
particular members (on the basis that the constitution of the group may change
from time to time).
(7) A declaration
under this section does not confer authority on a person or group of persons
to conduct an investigation for the purpose of determining the competence of a
particular person in providing services.
(8) The Minister may,
by subsequent notice in the Gazette, vary or revoke a declaration under this
section.
(9) A declaration,
unless sooner revoked, ceases to be in force at the end of 3 years after
it is made, but this subsection does not prevent the Minister from making a
further declaration in respect of the same activity or person or group of
persons.
(10) The Minister may,
as the Minister thinks fit, determine various protocols or procedures that
must be complied with by a person or group of persons acting under this Part.