|
Links: The links to the Bill,
its Explanatory Memorandum and second reading speech can be found on the
Bill’s home page, or through the Australian
Parliament website.
When Bills have been passed and have received Royal Assent,
they become Acts, which can be found at the Federal Register of Legislation
website.
All hyperlinks in this Bills Digest are correct as
at August 2018.
Purpose of
the Bill
The purpose of the Therapeutic Goods Amendment (2018
Measures No. 1) Bill 2018 (the Bill) is to amend the Therapeutic Goods
Act 1989 (the Act) to introduce a mandatory reporting scheme for
medicine shortages involving higher risk medicines in Australia, to impose
penalties for non-compliance with the scheme; and to make a number of
miscellaneous amendments to the Act.
Structure
of the Bill
The Bill is divided into two Schedules.
Schedule 1 of the Bill introduces the medicine
shortages and discontinuation of medicines reporting schemes.
Schedule 2 of the Bill makes amendments to the Act,
principally to improve, or to add to, administrative processes that are already
set out in the Act.
Background
Therapeutic goods regulation
Therapeutic goods are products that are used in humans to
manage illnesses or injuries, alter bodily processes, prevent or test for
pregnancy or replace or modify a part of the body.[1]
Types of therapeutic goods range from items that can be purchased in a
supermarket, such as bandages, condoms and vitamins, to over-the-counter and prescription
medicines, through to complex medical devices such as pacemakers.
In Australia, therapeutic goods are regulated by the
Therapeutic Goods Administration (TGA), which is part of the Australian
Government Department of Health (DoH). The TGA regulates the supply, import,
export, manufacturing and advertising of therapeutic goods.[2]
The TGA administers the Act to ensure that medicines and medical devices are
evaluated and regulated for safety, quality and (in some cases) efficacy before
they reach the market. The TGA also monitors therapeutic goods once they are
available on the market.[3]
Medicines shortages
Medicines shortages occur when there is a supply issue
with a medicine or medicines, which can impact patient care. Due to the
multinational nature of the pharmaceutical industry, medicines shortages are a
complex global issue. The International Pharmaceutical Federation reports that
medicines shortages may be worsening with time.[4]
Australia has experienced a number of high profile
medicines shortages in recent years. These include shortages of EpiPen (an
adrenalin auto-injector for life-threatening allergic reactions), oestrogen
patches (for menopausal symptoms), the antidepressant duloxetine, metformin
(for diabetes) and various vaccines.[5]
Global reasons for medicines shortages include
‘manufacturing problems, barriers to competition, business decisions, the
impact of new technologies, expensive medicines and fragmented markets’.[6]
In Australia, the TGA has listed reasons for shortages as including ‘the moving
or closing of manufacturing plants, raw material shortages, natural disasters,
logistical difficulties or a batch not meeting the required quality standards’.[7]
Regular price reductions for off-patent medicines on the Pharmaceutical
Benefits Scheme (PBS) have also been cited as a cause of medicines shortages in
Australia.[8]
Reporting of medicines shortages
Dr Bastian Seidel, President of the Royal Australian
College of General Practitioners (RACGP), notes that doctors often receive no
advanced warning of a medicine shortage, only finding out when the pharmacist
calls to say that they cannot supply the prescribed medicine.[9]
Similarly, pharmacists may not be made aware of a medicine shortage until they
attempt to order the medicine. A 2017 Society of Hospital Pharmacists of
Australia (SHPA) survey of hospital pharmacies found that, in 70 per cent of
cases, procurement officers only realised a medicine was in shortage when their
ordering system displayed ‘out of stock’ or ‘on back order’.[10]
The TGA acknowledges that reporting of medicines shortages
does not actually prevent them from occurring. However, the TGA considers that
timely reporting and communication can allow strategies to be put in place to
mitigate the impact on patients. These strategies can include sourcing
alternative supplies from overseas, rationing available stock and identifying
alternative medicines.[11]
The current National Medicines Shortage Information
Initiative (MSII) was launched in 2014. It was designed to ‘provide doctors,
pharmacists and consumers with essential, up-to-date information about
shortages of prescription medicines’.[12]
The current MSII consists of a protocol for the communication of shortages
agreed between the medicines industry and the TGA, an MSII website and a
subscription alert service.[13]
The MSII is currently a voluntary notification scheme, with most of the
information being provided by medicine sponsors.[14]
The TGA has the power to publish information about medicines shortages, whether
received from the pharmaceutical company or from other sources.[15]
The current MSII system of voluntary notification has
experienced a number of issues with the timeliness, accuracy and completeness
of the information published on the website. The TGA acknowledges:
... there was increasing frustration expressed by all parties
that the information available on the website is neither complete nor current
and it is no longer seen as a credible source of information by healthcare
professionals or those involved in stock management in healthcare facilities.
The information is also not being published in a timeframe to allow alternative
supplies, where available, to be accessed and/or to otherwise mitigate serious
effects on patients when no alternative supply is available.[16]
The TGA also notes that a number of high impact shortages
have not been reported to the TGA by pharmaceutical companies, but rather by
concerned patients who cannot access their medication.[17]
The above issues are borne out by the SHPA survey. Of the
365 medicine products reported as unavailable in the survey, only 54 (14.8 per
cent) were listed on the TGA’s MSII website on the day of the survey. Even
where medicines were listed, the information was often neither current nor
accurate.[18]
Proposal for mandatory notification of shortages
In August 2017, the Health Minister Greg Hunt met
representative peak bodies for the pharmaceutical industry, pharmacy owners and
pharmacists. A working group was formed to develop a better process for
managing medicines shortages. The Australian Medical Association (AMA) and the
SHPA subsequently joined the working group. The working group unanimously
endorsed a revised MSII Protocol which includes mandatory reporting of all
shortages to the TGA. State and territory health departments also unanimously
endorsed the revised protocol.[19]
The Bill amends the Act to provide for mandatory reporting
of medicines shortages and discontinuations to the TGA by pharmaceutical
companies.
Therapeutic goods reforms
The regulation of therapeutic goods in Australia has been
significantly reformed in recent years. In 2014 the Government announced a
review into medicines and medical devices regulation.[20]
The review was designed to identify areas where ineffective regulation could be
streamlined, as well as opportunities to enhance regulation to respond to
global trends. The Expert Panel Review of Medicines and Medical Devices
Regulation (Sansom Review) reported in 2015.[21]
Its recommendations included expanding pathways for sponsors to seek marketing
approvals, enhanced monitoring for therapeutic goods already on the market, and
changes to therapeutic goods advertising.[22]
The Government accepted the majority of the
recommendations made by the Sansom Review.[23]
The reforms were legislated in two tranches by the Therapeutic Goods
Amendment (2016 Measures No. 1) Act 2017 (the 2016 Measures Act)
and the Therapeutic
Goods Amendment (2017 Measures No. 1) Act 2018 (the 2017 Measures
Act).[24]
The Bill makes minor amendments to some of the reforms
legislated by the 2016 Measures Act to:
- clarify
that the Regulations may allow the Secretary to require pharmaceutical
companies using the new priority review pathway (which gives faster assessment
for important new medicines)[25]
to provide supporting information about their application
- allow
notifications under the new Special Access Scheme (SAS) Category C pathway
(which allows supply of unapproved goods with a history of therapeutic use)[26]
to be made by other health practitioners on the treating practitioner’s behalf
and
- expand
the range of minor, low-risk variations that can be made to registered
medicines[27]
without triggering a new application for marketing approval.[28]
Committee
consideration
Senate Selection
of Bills Committee
In its Report 7 of 2018 the Committee noted that it had
deferred consideration of the Bill until its next meeting.
Senate
Standing Committee for the Scrutiny of Bills
At the time of writing, the Committee has not commented on
the Bill.
Policy
position of non-government parties/independents
At the time of writing, no comment by non-government
parties or independents specifically relating to the Bill had been identified.
Position of
major interest groups
As noted earlier, the revised MSII Protocol (including mandatory
reporting of all medicines shortages to the TGA) was unanimously endorsed by a
working group. The group included representatives from the National
Pharmaceutical Services Association (representing wholesalers), Medicines
Australia (MA, representing the innovative medicines industry), Generic and
Biosimilar Medicines Association (representing the generic and biosimilar
medicines industry), the Pharmacy Guild of Australia (representing pharmacy
owners), the Pharmaceutical Society of Australia (representing pharmacists),
the Australian Self Medication Industry (representing the non-prescription
pharmaceutical industry), the AMA (representing doctors) and the SHPA
(representing hospital pharmacists).[29]
The TGA undertook public consultation between 28 March and
30 April 2018 on the revised MSII Protocol and the accompanying consultation
paper. The TGA reports that ‘[v]irtually all stakeholders supported the need
for better management and timely communication of medicine shortages’.[30]
Health professional bodies generally supported the option of stricter
(criminal) penalties for failing to report a medicine shortage, whereas
industry stakeholders ‘were not convinced a penalty scheme was necessary; and
unanimously stated that criminal sanctions were too severe’.[31]
The Bill as introduced reflects the revisions that were made to the proposed
mandatory reporting scheme following the public consultation.[32]
For example, the Bill provides for civil, but not criminal penalties for
failing to report a medicine shortage.
A number of consumer health groups also made submissions
to the public consultation process. Asthma Australia supported the mandatory
reporting of medicines shortages to the TGA, and welcomed the inclusion of
emergency non-prescription medicines such as salbutamol inhalers on the
proposed watch list.[33]
Allergy & Anaphylaxis Australia and Hepatitis Australia proposed additional
medicines that should be included on the watch list.[34]
All three of these organisations stressed the importance of consumer groups
being notified of all medicines shortages that affect their membership, not
just those of extreme or high impact.[35]
MA, the Pharmacy Guild and the SHPA have all welcomed the
introduction of the Bill. MA believes the Bill takes a ‘balanced approach’ and
will ‘go a long way to ensuring there is timely and relevant information
available on the supply of medicines’ to assist patients and their doctors.[36]
The Pharmacy Guild supports the move to mandatory reporting of shortages, and
believes the Bill will ‘significantly reduce the likelihood of sub-standard
patient care arising from unforeseen and un-notified medicine shortages’.[37]
The SHPA believes the Bill will improve patient outcomes as timely notification
of shortages (particularly for medicines on the watch list) allows pharmacy
teams to manage and resolve them before they adversely affect patients.[38]
Financial
implications
According to the Explanatory Memorandum, the implementation
of the Bill’s measures will have no financial implications for the Government’s
budget, because the TGA operates on a cost recovery basis.[39]
The TGA charges fees for services such as product evaluations, and taxes are
also imposed on regulated industries.[40]
Statement of Compatibility with Human Rights
As required under Part 3 of the Human Rights
(Parliamentary Scrutiny) Act 2011 (Cth), the Government has assessed
the Bill’s compatibility with the human rights and freedoms recognised or
declared in the international instruments listed in section 3 of that Act. The
Government considers that the Bill is compatible.[41]
Parliamentary
Joint Committee on Human Rights
At the time of writing, the Committee has not commented on
the Bill.
Key issues
and provisions
Schedule 1
Schedule 1 of the Bill inserts new provisions into
the Act, which will have the effect of mandating a scheme for reporting
medicine shortages and the discontinuation of supply of medicine. To achieve
this, proposed Division 2B—Reporting medicine shortages and discontinuation
of supply of medicine is inserted into Part 3-2 of Chapter 3 (‘Medicines
and other therapeutic goods that are not medical devices’) of the Act by item
2 of Schedule 1 to the Bill. The new Division contains proposed sections
30EF to 30EJ.
Reportable
medicines
Proposed section 30EF requires a person in relation
to whom a reportable medicine is included in the Australian
Register of Therapeutic Goods (the Register) to notify the Secretary of any
shortage of a medicine in Australia.[42]
Proposed section 30EH of the Act describes what is
a reportable medicine for the purposes of the Act. This is a
medicine which includes either one or more substances included in Schedule 4 or
8 to the Poisons
Standard that is current at any point of time or a medicine determined by
the Minister in a legislative instrument. [43]
However, the Minister must not determine a medicine unless
satisfied:
- the
medicine is critical to the health of patients in Australia and/or
- the
notification to the Secretary of any shortage of the medicine, or of any
decision to permanently discontinue the supply of the medicine, in Australia
would be in the interests of public health.[44]
Shortages
Proposed section 30EI of the Act describes what is meant
by the expression shortage. There is a shortage of a medicine at
a particular time, if at any time in the six months after that time, there will
not be (or it is likely that there will not be) enough of the medicine
available to meet the demand for the medicine for all of the patients in
Australia who take, or who may need to take, the medicine.
The Bill provides that there are two ways in which a
shortage will have a critical impact:
- first,
the Minister has specified that the medicine should be listed on the Medicines
Watch List (a legislative instrument made by the Minister) [45]
and
- second,
at the particular time:
- there
are no registered goods that could reasonably be used as a substitute for the
medicine or in the event that other registered goods could reasonably be used
as a substitute—they are not likely to be available in sufficient quantities to
meet the demand[46]
and
- the
shortage has the potential to have a life-threatening impact on, or a serious
impact on the physical or mental health or functioning of, persons who take, or
who may need to take, the medicine.[47]
Time for
reporting—shortages
Proposed subsection 30EF(1) of the Act sets two
time limits for notification that there is a shortage of a reportable medicine–being
two working days in the case of a shortage with critical impact;
and ten working days otherwise.
The day count starts from when the person in relation to
whom a reportable medicine is included on the Register, ‘knows, or ought
reasonably to have known’ of the shortage. Notification of the shortage must
meet the relevant manner and form requirements.[48]
Penalties
for non-compliance
The proposed maximum penalties for non-compliance with the
requirement to notify are 100 penalty units for an individual and 1,000 penalty
units for a body corporate.[49]
The details of any penalties, and the names of non-compliant sponsors and
affected products, will also be published on the TGA’s website.[50]
These penalties reflect that this offence is regarded as serious,
but involving considerably less culpability than, for example, not complying
with a recall of therapeutic goods, for which the maximum penalties are 5,000
penalty units for an individual or 50,000 for a body corporate.[51]
Importantly the Explanatory Memorandum makes clear:
... section 42YCA of the Act provides for daily penalties for
continuing contraventions of civil penalty provisions and will apply to
subsection 30EF(6). This will have the effect that the obligation of the sponsor
to report a medicine shortage will continue until a report has been made, and
is not discharged upon expiration of the deadline. A separate contravention of
the civil penalty provision will be incurred for every day the obligation is
not met.[52]
In addition, section 42YK of the Act allows the Secretary
to issue an infringement notice where he, or she, has reasonable grounds to
believe that there has been a contravention of a civil penalty provision of the
Act. In that case, a sponsor would be able to choose to pay an infringement
notice amount as an alternative to having court proceedings brought against
them for the contravention.
The penalty provisions are not strict liability. Proposed
subsection 30EF(7) of the Bill operates so that penalties will not apply
where the person has taken reasonable steps–for example for reporting within 10
days rather than two when they reasonably believed that the shortage did not
have critical impact.
Time for reporting—discontinuation
Proposed section 30EG of the Act relates to the
discontinuation of the supply of a reportable medicine. In the case of
discontinuation the person in relation to whom a reportable medicine is
included in the Register:
- must
advise of the discontinuation 12 months before it is to occur (or as soon as
practicable after the decision is made) if the discontinuation is likely to be
of critical impact [53]and
- six
months in other cases—or as soon as practicable after the decision is made.[54]
The definition of critical impact is in
equivalent terms to those relating to medicine shortages,[55]
as are the notification requirements[56]
and the civil penalties.[57]
Other
provisions
Subsection 31(1) of the Act currently allows the Secretary
to give a notice to a person requiring them to give the Secretary, within a
reasonable time and in a specified form, information or documents about a
variety of subjects. Item 3 of Schedule 1 to the Bill adds proposed paragraph
31(1)(ja) which will add medicine shortages or discontinuation of supply to
the subjects about which the Secretary can require that information or
documents be provided.
Item 4 of Schedule 1 to the Bill contains
application provisions, which specify the date of effect of the new scheme. Proposed
sections 30EF and 30EG will apply to shortages or discontinuations which
occur after the commencement of the new provisions. However, they will apply to
medicines that were on the Register either before or after the commencement
date.
Schedule 2
Schedule 2 makes a number of amendments to existing
provisions in the Act.
Item 1 of Schedule 2 to the Bill inserts proposed subsection
9D(2D) into the Act to resolve a possible conflict between two current
provisions, subsection 9D(2C) and subsection 16(1). Currently Regulations
prescribe that certain minor variations can be made to product descriptions
without pre-approval. However, despite variations being minor, this can
sometimes create a separate product, which would then require a new application
for marketing approval. The proposed amendment dispenses with the need for new
marketing approval in such a case.
Items 2, 11 and 12 make amendments to sections 10
and 42BAA if the Act to allow references to other documents in legislative
instruments, such as documents published by recognised international field
leaders, to mean reference to those documents as they are published from time
to time. The Explanatory Memorandum argues that it would be in Australia’s
interests for such legislative instruments to refer to the most up-to-date
information.[58]
These amendments are necessary because subsection 14(2) of
the Legislation
Act 2003 does not allow a reference to another document in a
legislative instrument to mean a reference to amended or new versions of that
document unless the legislation underpinning the legislative instrument
specifically states that this is intended to be the case.
While there would appear to be a clear interest in
referencing up-to-date material, such provisions could be seen as creating
uncertainty about the meaning of a Regulation by outsourcing regulatory detail
to varying versions of external documents. This may particularly be the case
when the external document can only be accessed on the payment of a fee.[59]
Nevertheless, this approach has already been taken elsewhere in the Act—for
instance in relation to permissible ingredients.
Items 3 to 8 inclusive and 10 build
on amendments made by the 2016 Measures Act. That Act allowed the use of
some unapproved therapeutic goods in certain circumstances, provided that the
treating practitioner advised the Secretary within 28 days of having supplied
the product. Items 3, 5 and 10 allow another health professional, and not
necessarily the treating health professional, to make the notification (for
example, a hospital pharmacist rather than the treating doctor). However, under
the penalty provisions of the Act, the onus would remain on the treating health
professional to ensure that the notification had occurred.
Items 4, 6, 7 and 8 clarify amendments made by the 2016
Measures Act to allow Regulations to be made for the Secretary to make
determinations on applications for priority pathways for expedited assessment
of new medicines, biologicals and medical devices. The proposed amendments ensure
that Regulations can be made to give the Secretary the power to request further
information from applicants where necessary in certain circumstances.
Item 9 corrects a typographical error in subsection
41FN(1) of the Act. This does not change the substance of this section.
Item 13 is a date of application provision. There
is no retrospective effect of the amendments, except that certain existing
legislative instruments will be taken to fall under the new (reference to
another document as it appears from time to time) provision.
Other provisions
Part 2 of Schedule 2 makes a minor amendment to the
Act to remove the requirement for certain applications to the Secretary for
approval to use a ‘restricted representation’ in a therapeutic goods
advertisement to be signed. This amendment is made to ensure that electronic
lodgement of such applications complies with the requirements of the Act. This
will only apply to applications made after this provision takes effect (on the
28th day after Royal Assent).
Concluding comments
The current voluntary notification system for medicines
shortages, introduced in 2014, has proved ineffective. The main purpose of the
Bill is to introduce a mandatory reporting scheme for medicines shortages and
discontinuation of supply of medicine. The design and implementation of the
mandatory scheme was subject to detailed consultation, and appears to have
widespread support from industry, pharmacists, health professionals and
consumer groups. The position of non-government parties and independents is not
known at this time.
[1]. Department
of Health (DoH), ‘What
are “therapeutic goods”?’, Therapeutic Goods Administration (TGA) website; Therapeutic Goods
Act 1989, section 3.
[2]. DoH,
‘Who we are and what we
do’, TGA website.
[3]. DoH,
‘TGA regulatory
framework’, TGA website, version 1.0, 31 May 2012.
[4]. International
Pharmaceutical Federation (FIP), ‘FIP addressing global medicines
shortages’, FIP website, updated 20 February 2018.
[5]. See,
for example, A Dow, ‘EpiPen
crisis tip of iceberg for shortages’, The Canberra Times, 14 April
2018, p. 19; Z Efrat, ‘Drug
drought’, Medical Observer, September 2016, pp. 22–23.
[6]. Efrat,
‘Drug
drought’, op. cit., p. 23.
[7]. Ibid.
[8]. Ibid.,
p. 22. Many of these price reductions have been made under the price disclosure
policy, which aims to move the price paid by the Government for PBS medicines
closer to the price at which the medicines are supplied in the
market. For details of the policy see DoH, Pharmaceutical Benefits Scheme price disclosure arrangements:
procedural and operational guidelines, version 6,
DoH, Canberra, June 2016, p. 8.
[9]. Dow,
‘EpiPen
crisis tip of iceberg for shortages’, op. cit.
[10]. Society
of Hospital Pharmacists of Australia (SHPA), Medicine
shortages in Australia: a snapshot of shortages in Australian hospitals,
SHPA, Collingwood, Victoria, June 2017, p. 5.
[11]. DoH,
Management
and communication of medicines shortages – proposed implementation approach:
consultation paper, DoH, Canberra, Version 1.0, March 2018, p. 5.
[12]. F
Nash (Assistant Minister for Health), Improved
information on medicine shortages, media release, 26 May 2014.
[13]. Ibid.
See DoH, ‘Medicine
Shortages Information Initiative’, TGA website, 22 June 2018 for details of
the website, alert service and protocol.
[14]. DoH,
Management
and communication of medicine shortages In Australia – a new protocol,
DoH, Canberra, Version 1.0, March 2018, p. 4; DoH, ‘Medicine
Shortages Information Initiative’, op. cit. A medicine sponsor is
responsible for applying to the TGA for market authorisation for the medicine,
and for exporting, importing or manufacturing the medicine. Most medicine
sponsors are pharmaceutical companies. See DoH, ‘Role of the sponsor’, TGA
website, 31 March 2015.
[15]. DoH,
‘Medicine
Shortages Information Initiative’, op. cit.; Therapeutic Goods Act 1989,
subsections 61(5C) and 61(5D); Therapeutic Goods
Information (Medicine Shortages Information Initiative) Specification 2014.
[16]. DoH,
Management
and communication of medicines shortages in Australia – a new protocol,
op. cit., p. 4.
[17]. DoH,
Management
and communication of medicines shortages – proposed implementation approach:
consultation paper, op. cit., p. 5.
[18]. SHPA,
Medicine
shortages in Australia: a snapshot of shortages in Australian hospitals,
op. cit., p. 7.
[19]. DoH,
Management
and communication of medicines shortages – proposed implementation approach:
consultation paper, op. cit., p. 5. The revised protocol is DoH, Management
and communication of medicine shortages in Australia – a new protocol,
op. cit.
[20]. P
Dutton (Minister for Health) and F Nash (Assistant Minister for Health), Expert
Panel to review medicines and medical devices regulation, media
release, 24 October 2014.
[21]. L
Sansom, W Delaat and J Hovarth, Review of
medicines and medical devices regulation: report on the regulatory framework
for medicines and medical devices, Expert Panel: Review of Medicines
and Medical Devices Regulation, [Department of Health], [Canberra], March 2015;
L Sansom, W Delaat and J Hovarth, Review of
medicines and medical devices regulation: stage two: report on the regulatory
frameworks for complementary medicines and advertising of therapeutic goods,
Expert Panel: Review of Medicines and Medical Devices Regulation, [Department
of Health], [Canberra], July 2015.
[22]. DoH,
‘Expert
review of medicines and medical devices regulation’, DoH website, last
updated 16 March 2017.
[23]. DoH,
Australian
Government response to the Review of Medicines and Medical Devices Regulation,
DoH, Canberra, 2016.
[24]. Therapeutic Goods
Amendment (2016 Measures No. 1) Act 2017 and Therapeutic Goods
Amendment (2017 Measures No. 1) Act 2018. For an overview of the
changes made by these Acts, see J Mills and A Grove, Therapeutic
Goods Amendment (2016 Measures No. 1) Bill 2016, Bills digest, 67,
2016–17, Parliamentary Library, Canberra, 27 February 2017 and A Grove and
S Power, Therapeutic
Goods Amendment (2017 Measures No. 1) Bill 2017 [and] Therapeutic Goods
(Charges) Amendment Bill 2017, Bills digest, 56, 2017–18, Parliamentary
Library, Canberra, 6 December 2017.
[25]. DoH,
‘Priority
review pathway: prescription medicines’, TGA website, 26 June 2017.
[26]. DoH,
‘Special Access
Scheme’, TGA website, 30 July 2018.
[27]. DoH,
‘Proposed
new notifications process: registered medicines’, TGA website, 19 January
2018.
[28]. Explanatory
Memorandum, Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018,
pp. 4–5.
[29]. DoH,
Management
and communication of medicines shortages – proposed implementation approach:
consultation paper, op. cit., p. 5.
[30]. DoH,
‘Submissions
received and next steps: management and communication of medicines shortages’,
TGA website, 27 June 2018.
[31]. Ibid.
[32]. Ibid.
[33]. Asthma
Australia, Submission
to the TGA consultation: management and communication of medicines shortages,
April 2018.
[34]. Allergy
& Anaphylaxis Australia, Submission
to the TGA consultation: management and communication of medicines shortages,
23 April 2018, p. 2; Hepatitis Australia, Submission
to the TGA consultation: management and communication of medicines shortages,
19 April 2018, p. 1. The Bill provides for a list of medicines to be determined
by legislative instrument which will automatically be considered to have a
critical impact if they are in short supply. A list of proposed medicines for
this ‘watch list’ is in DoH, Management
and communication of medicines shortages – proposed implementation approach:
consultation paper, op. cit., pp. 10–11.
[35]. Asthma
Australia, op. cit.; Allergy & Anaphylaxis Australia, op. cit., p. 2;
Hepatitis Australia, op. cit., p. 2.
[36]. Medicines
Australia, MA
welcomes shortages legislation, media release, 28 June 2018.
[37]. Pharmacy
Guild of Australia, Welcome
action on medicine shortages, media release, 28 June 2018.
[38]. SHPA,
From
coalface to Canberra: SHPA welcomes medicines shortages legislation,
media release, 29 June 2018.
[39]. Explanatory
Memorandum, op. cit., p. 5.
[40]. DoH,
‘Fees and payments’, TGA
website.
[41]. The
Statement of Compatibility with Human Rights can be found at page 6 of the Explanatory
Memorandum to the Bill.
[42]. ‘A
person in relation to whom a reportable medicine is included in the Register’
means a sponsor of the medicine on the Australian Register of Therapeutic
Goods. Item 1 of the Bill inserts a reference to a reportable
medicine into subsection 3(1) of the Therapeutic Goods Act.
[43]. Therapeutic
Goods Act, proposed paragraph 30EH(1)(b).
[44]. Therapeutic
Goods Act, proposed subsection 30EH(3).
[45]. Therapeutic
Goods Act, proposed subsection 30EF(2) and proposed subsection 30EJ(1).
[46]. Therapeutic
Goods Act, proposed paragraph 30EF(3)(a).
[47]. Therapeutic
Goods Act, proposed paragraph 30EF(3)(b).
[48]. Therapeutic
Goods Act, proposed subsections 30EF(4) and (5).
[49]. A
penalty unit is currently $210 – Crimes Act 1914
(Cth) subsection 4AA(1). This means the maximum penalties are equivalent to
$21,000 for an individual and $210,000 for a body corporate.
[50]. G
Hunt, ‘Second
reading speech: Therapeutic Goods Amendment (2018 Measures No. 1) Bill 2018’,
House of Representatives, Debates, (proof), 28 June 2018, p. 5.
[51]. Therapeutic
Goods Act, section 30ECA.
[52]. Explanatory
Memorandum, op. cit., p. 12.
[53]. Therapeutic
Goods Act, proposed paragraph 30EG(1)(a).
[54]. Therapeutic
Goods Act, proposed paragraph 30EG(1)(b).
[55]. Therapeutic
Goods Act, proposed subsections 30EG(2) and (3).
[56]. Therapeutic
Goods Act, proposed subsections 30EG(4) and (5).
[57]. Therapeutic
Goods Act, proposed subsections 30EG(6) and (7).
[58]. Explanatory
Memorandum, op. cit., p. 18.
[59]. Ibid.
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