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This is a Bill, not an Act. For current law, see the Acts databases.
2016-2017-2018
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Therapeutic Goods Amendment (2018
Measures No. 1) Bill 2018
No. , 2018
(Health)
A Bill for an Act to amend the Therapeutic Goods
Act 1989, and for related purposes
No. , 2018
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
i
Contents
1
Short title ........................................................................................... 1
2
Commencement ................................................................................. 1
3
Schedules ........................................................................................... 2
Schedule 1--Reporting medicine shortages and discontinuation
of supply of medicine
3
Therapeutic Goods Act 1989
3
Schedule 2--Other amendments
9
Part 1--Amendments commencing day after Royal Assent
9
Therapeutic Goods Act 1989
9
Part 2--Amendments commencing 28th day after Royal
Assent
13
Therapeutic Goods Act 1989
13
No. , 2018
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
1
A Bill for an Act to amend the Therapeutic Goods
1
Act 1989, and for related purposes
2
The Parliament of Australia enacts:
3
1 Short title
4
This Act is the Therapeutic Goods Amendment (2018 Measures
5
No. 1) Act 2018.
6
2 Commencement
7
(1) Each provision of this Act specified in column 1 of the table
8
commences, or is taken to have commenced, in accordance with
9
column 2 of the table. Any other statement in column 2 has effect
10
according to its terms.
11
12
2
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
No. , 2018
Commencement information
Column 1
Column 2
Column 3
Provisions
Commencement
Date/Details
1. Sections 1 to 3
and anything in
this Act not
elsewhere covered
by this table
The day this Act receives the Royal Assent.
2. Schedule 1
The later of:
(a) 1 January 2019; and
(b) the 28th day after this Act receives the
Royal Assent.
3. Schedule 2,
Part 1
The day after this Act receives the Royal
Assent.
4. Schedule 2,
Part 2
The 28th day after this Act receives the
Royal Assent.
Note:
This table relates only to the provisions of this Act as originally
1
enacted. It will not be amended to deal with any later amendments of
2
this Act.
3
(2) Any information in column 3 of the table is not part of this Act.
4
Information may be inserted in this column, or information in it
5
may be edited, in any published version of this Act.
6
3 Schedules
7
Legislation that is specified in a Schedule to this Act is amended or
8
repealed as set out in the applicable items in the Schedule
9
concerned, and any other item in a Schedule to this Act has effect
10
according to its terms.
11
Reporting medicine shortages and discontinuation of supply of medicine Schedule 1
No. , 2018
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
3
Schedule 1--Reporting medicine shortages
1
and discontinuation of supply of
2
medicine
3
4
Therapeutic Goods Act 1989
5
1 Subsection 3(1)
6
Insert:
7
reportable medicine has the meaning given by section 30EH.
8
shortage of a medicine in Australia has the meaning given by
9
section 30EI.
10
2 After Division 2A of Part 3-2
11
Insert:
12
Division 2B--Reporting medicine shortages and
13
discontinuation of supply of medicine
14
30EF Reporting medicine shortages
15
(1) A person in relation to whom a reportable medicine is included in
16
the Register must notify the Secretary of any shortage of the
17
medicine in Australia. The person must do so:
18
(a) for a shortage that has a critical impact--as soon as possible,
19
but no later than 2 working days, after the first day the person
20
knows, or ought reasonably to have known, of the shortage;
21
or
22
(b) in any other case--before the end of 10 working days
23
beginning on the first day the person knows, or ought
24
reasonably to have known, of the shortage.
25
Note:
For reportable medicine, see section 30EH. For shortage of a
26
medicine in Australia, see section 30EI.
27
Schedule 1 Reporting medicine shortages and discontinuation of supply of medicine
4
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
No. , 2018
Critical impact
1
(2) The shortage of a medicine in Australia at a particular time has a
2
critical impact if, at that time, the medicine is included in an
3
instrument under section 30EJ.
4
(3) The shortage of a medicine in Australia at a particular time also has
5
a critical impact if:
6
(a) either:
7
(i) at that time, there are no registered goods that could
8
reasonably be used as a substitute for the medicine; or
9
(ii) at that time, there are other registered goods that could
10
reasonably be used as a substitute for the medicine but
11
the other registered goods are not likely to be available
12
in sufficient quantities to meet the demand for the other
13
registered goods that is likely to arise because of the
14
shortage; and
15
(b) the shortage has the potential to have a life-threatening
16
impact on, or a serious impact on the physical or mental
17
health or functioning of, persons who take, or who may need
18
to take, the medicine.
19
Notification requirements
20
(4) A notification under subsection (1) must:
21
(a) be in accordance with a form that is approved, in writing, by
22
the Secretary; and
23
(b) contain the information required by that form.
24
(5) An approval of a form may require or permit information to be
25
given in accordance with specified software requirements:
26
(a) on a specified kind of data processing device; or
27
(b) by way of a specified kind of electronic transmission.
28
Civil penalty
29
(6) A person contravenes this subsection if:
30
(a) the person is subject to a requirement under subsection (1);
31
and
32
(b) the person contravenes the requirement.
33
Maximum civil penalty:
34
Reporting medicine shortages and discontinuation of supply of medicine Schedule 1
No. , 2018
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
5
(a) for an individual--100 penalty units; and
1
(b) for a body corporate--1,000 penalty units.
2
Exception
3
(7) Subsection (6) does not apply if:
4
(a) paragraph (1)(a) and subsection (3) apply in relation to the
5
shortage but subsection (2) does not; and
6
(b) as a result of steps taken by the person, it was reasonable for
7
the person to assume that paragraph (1)(b) applied in relation
8
to the shortage; and
9
(c) the person complied with paragraph (1)(b) in relation to the
10
shortage.
11
30EG Reporting discontinuation of supply of medicine
12
(1) A person in relation to whom a reportable medicine is included in
13
the Register must notify the Secretary of any decision (the
14
discontinuation decision) of the person to permanently discontinue
15
the supply of the medicine in Australia. The person must do so:
16
(a) if the discontinuation is likely to be of critical impact:
17
(i) at least 12 months before the discontinuation is
18
proposed to occur; or
19
(ii) if the person is unable to comply with
20
subparagraph (i)--as soon as practicable after the
21
decision is made; or
22
(b) in any other case:
23
(i) at least 6 months before the discontinuation is proposed
24
to occur; or
25
(ii) if the person is unable to comply with
26
subparagraph (i)--as soon as practicable after the
27
decision is made.
28
Note:
For reportable medicine, see section 30EH.
29
Critical impact
30
(2) The discontinuation of the supply of a medicine in Australia is
31
likely to be of critical impact if, when the discontinuation decision
32
is made, the medicine is included in an instrument under
33
section 30EJ.
34
Schedule 1 Reporting medicine shortages and discontinuation of supply of medicine
6
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
No. , 2018
(3) The discontinuation of the supply of a medicine in Australia is also
1
likely to be of critical impact if:
2
(a) either:
3
(i) when the discontinuation decision is made, there are no
4
registered goods that could reasonably be used as a
5
substitute for the medicine; or
6
(ii) when the discontinuation decision is made, there are
7
other registered goods that could reasonably be used as
8
a substitute for the medicine but the other registered
9
goods are not likely to be available in sufficient
10
quantities to meet the demand for the other registered
11
goods that is likely to arise because of the
12
discontinuation; and
13
(b) the discontinuation has the potential to have a life-threatening
14
impact on, or a serious impact on the physical or mental
15
health or functioning of, persons who take, or who may need
16
to take, the medicine.
17
Notification requirements
18
(4) A notification under subsection (1) must:
19
(a) be in accordance with a form that is approved, in writing, by
20
the Secretary; and
21
(b) contain the information required by that form.
22
(5) An approval of a form may require or permit information to be
23
given in accordance with specified software requirements:
24
(a) on a specified kind of data processing device; or
25
(b) by way of a specified kind of electronic transmission.
26
Civil penalty
27
(6) A person contravenes this subsection if:
28
(a) the person is subject to a requirement under subsection (1);
29
and
30
(b) the person contravenes the requirement.
31
Maximum civil penalty:
32
(a) for an individual--100 penalty units; and
33
(b) for a body corporate--1,000 penalty units.
34
Reporting medicine shortages and discontinuation of supply of medicine Schedule 1
No. , 2018
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
7
Exception
1
(7) Subsection (6) does not apply if:
2
(a) paragraph (1)(a) and subsection (3) apply in relation to the
3
discontinuation but subsection (2) does not; and
4
(b) as a result of steps taken by the person, it was reasonable for
5
the person to assume that paragraph (1)(b) applied in relation
6
to the discontinuation; and
7
(c) the person complied with paragraph (1)(b) in relation to the
8
discontinuation.
9
30EH What is a reportable medicine?
10
(1) For the purposes of this Act, registered goods are a reportable
11
medicine if:
12
(a) the goods are medicine; and
13
(b) either:
14
(i) the medicine contains one or more substances included
15
in Schedule 4 or 8 to the current Poisons Standard; or
16
(ii) the medicine is determined in an instrument under
17
subsection (2).
18
(2) The Minister may, by legislative instrument, determine medicine
19
for the purposes of subparagraph (1)(b)(ii).
20
(3) The Minister must not determine a medicine unless the Minister is
21
satisfied of either or both of the following:
22
(a) the medicine is critical to the health of patients in Australia;
23
(b) the notification to the Secretary of any shortage of the
24
medicine, or of any decision to permanently discontinue the
25
supply of the medicine, in Australia would be in the interests
26
of public health.
27
30EI When is there a medicine shortage?
28
For the purposes of this Act, there is a shortage of a medicine in
29
Australia at a particular time if, at any time in the 6 months after
30
that particular time, the supply of that medicine in Australia will
31
not, or will not be likely to, meet the demand for the medicine for
32
all of the patients in Australia who take, or who may need to take,
33
the medicine.
34
Schedule 1 Reporting medicine shortages and discontinuation of supply of medicine
8
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
No. , 2018
30EJ Medicines Watch List
1
(1) The Minister may, by legislative instrument, determine medicine
2
for the purposes of subsections 30EF(2) and 30EG(2).
3
(2) The Minister must not determine a medicine unless the Minister is
4
satisfied that any shortage of the medicine, or any permanent
5
discontinuation of the supply of the medicine, in Australia has the
6
potential to result in:
7
(a) significant morbidity in patients in Australia; or
8
(b) the death of one or more patients in Australia.
9
3 After paragraph 31(1)(j)
10
Insert:
11
(ja) if the goods are a reportable medicine and the medicine is
12
registered in relation to the person:
13
(i) whether or not there is a shortage of the medicine in
14
Australia; or
15
(ii) if there is a shortage of the medicine in Australia--the
16
shortage; or
17
(iii) any decision of the person to permanently discontinue
18
the supply of the medicine in Australia;
19
4 Application provisions
20
(1)
Section 30EF of the Therapeutic Goods Act 1989, as inserted by this
21
Schedule, applies in relation to a shortage of a medicine in Australia
22
that arises on or after the commencement of this item, whether the
23
medicine was included in the Register before, on or after that
24
commencement.
25
(2)
Section 30EG of the Therapeutic Goods Act 1989, as inserted by this
26
Schedule, applies in relation to a decision to permanently discontinue
27
the supply of a medicine in Australia that is made on or after the
28
commencement of this item, whether the medicine was included in the
29
Register before, on or after that commencement.
30
Other amendments Schedule 2
Amendments commencing day after Royal Assent Part 1
No. , 2018
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
9
Schedule 2--Other amendments
1
Part 1--Amendments commencing day after Royal
2
Assent
3
Therapeutic Goods Act 1989
4
1 After subsection 9D(2C)
5
Insert:
6
(2D) Subsection (2C), to the extent that it relates to therapeutic goods
7
that are registered, applies despite subsection 16(1).
8
2 At the end of section 10
9
Add:
10
(4) Despite subsection 14(2) of the Legislation Act 2003, an order
11
under subsection (1) of this section, or a variation of such an order,
12
may make provision in relation to a matter by applying, adopting
13
or incorporating, with or without modification, any matter
14
contained in an instrument or other writing as in force or existing
15
from time to time.
16
3 After subsection 19(7G)
17
Insert:
18
(7GA) Subsection (7F) does not apply in relation to a person and a
19
requirement to notify a supply of therapeutic goods if a health
20
practitioner, on behalf of the person, does the following:
21
(a) notifies the supply to the Secretary within 28 days after the
22
supply;
23
(b) makes the notification in accordance with the requirements
24
referred to in subsection (7D).
25
Note:
A defendant bears an evidential burden in relation to the matter in
26
subsection (7GA): see subsection 13.3(3) of the Criminal Code.
27
4 At the end of subsection 25AAA(3)
28
Add:
29
Schedule 2 Other amendments
Part 1 Amendments commencing day after Royal Assent
10
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
No. , 2018
; (e) empowering the Secretary to give the applicant a written
1
notice requiring the applicant to give to the Secretary
2
specified information or documents in connection with the
3
application within a specified period (which must be at least
4
10 working days after the notice is given to the applicant).
5
5 After subsection 32CM(7G)
6
Insert:
7
(7GA) Subsection (7F) does not apply in relation to a person and a
8
requirement to notify a supply of a biological if a health
9
practitioner, on behalf of the person, does the following:
10
(a) notifies the supply to the Secretary within 28 days after the
11
supply;
12
(b) makes the notification in accordance with the requirements
13
referred to in subsection (7D).
14
Note:
A defendant bears an evidential burden in relation to the matter in
15
subsection (7GA): see subsection 13.3(3) of the Criminal Code.
16
6 At the end of subsection 32DEA(3)
17
Add:
18
; (e) empowering the Secretary to give the applicant a written
19
notice requiring the applicant to give to the Secretary
20
specified information or documents in connection with the
21
application within a specified period (which must be at least
22
10 working days after the notice is given to the applicant).
23
7 At the end of subsection 41ECA(3)
24
Add:
25
; (e) empowering the Secretary to give the applicant a written
26
notice requiring the applicant to give to the Secretary
27
specified information or documents in connection with the
28
application within a specified period (which must be at least
29
10 working days after the notice is given to the applicant).
30
8 At the end of subsection 41FKA(3)
31
Add:
32
; (e) empowering the Secretary to give the applicant a written
33
notice requiring the applicant to give to the Secretary
34
specified information or documents in connection with the
35
Other amendments Schedule 2
Amendments commencing day after Royal Assent Part 1
No. , 2018
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
11
application within a specified period (which must be at least
1
10 working days after the notice is given to the applicant).
2
9 Subsection 41FN(1)
3
After "kind of device is included in the Register", insert "will".
4
10 After subsection 41HC(6F)
5
Insert:
6
(6FA) Subsection (6E) does not apply in relation to a person and a
7
requirement to notify a supply of a medical device if a health
8
practitioner, on behalf of the person, does the following:
9
(a) notifies the supply to the Secretary within 28 days after the
10
supply;
11
(b) makes the notification in accordance with the requirements
12
referred to in subsection (6C).
13
Note:
A defendant bears an evidential burden in relation to the matter in
14
subsection (6FA): see subsection 13.3(3) of the Criminal Code.
15
11 Section 42BAA
16
Before "The", insert "(1)".
17
12 At the end of section 42BAA
18
Add:
19
(2) Despite subsection 14(2) of the Legislation Act 2003, an instrument
20
under subsection (1) of this section may make provision in relation
21
to a matter by applying, adopting or incorporating, with or without
22
modification, any matter contained in an instrument or other
23
writing as in force or existing from time to time.
24
13 Application and transitional provisions
25
(1)
The amendment of section 19 of the Therapeutic Goods Act 1989 made
26
by this Part applies in relation to the supply of therapeutic goods on or
27
after the commencement of this item.
28
(2)
The amendment of section 32CM of the Therapeutic Goods Act 1989
29
made by this Part applies in relation to the supply of a biological on or
30
after the commencement of this item.
31
Schedule 2 Other amendments
Part 1 Amendments commencing day after Royal Assent
12
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
No. , 2018
(3)
The amendment of section 41HC of the Therapeutic Goods Act 1989
1
made by this Part applies in relation to the supply of a medical device
2
on or after the commencement of this item.
3
(4)
An instrument in force under section 42BAA of the Therapeutic Goods
4
Act 1989 immediately before the commencement of this item continues
5
in force on and after that commencement as if it were an instrument in
6
force under subsection 42BAA(1) of that Act.
7
Other amendments Schedule 2
Amendments commencing 28th day after Royal Assent Part 2
No. , 2018
Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018
13
Part 2--Amendments commencing 28th day after
1
Royal Assent
2
Therapeutic Goods Act 1989
3
14 Section 42DE
4
Repeal the section, substitute:
5
42DE Applications for approval of use of restricted representation
6
(1) An application for approval of the use of a restricted representation
7
must be made to the Secretary in accordance with a form approved,
8
in writing, by the Secretary.
9
(2) An approval of a form may require or permit an application to be
10
given in accordance with specified software requirements:
11
(a) on a specified kind of data processing device; or
12
(b) by way of a specified kind of electronic transmission.
13
15 Application provision
14
The repeal and substitution of section 42DE of the Therapeutic Goods
15
Act 1989 made by this Part applies in relation to applications made on
16
or after the commencement of this item.
17