Bills Digest no. 67, 2016–17
PDF version [671KB]
Jonathan Mills
Law and Bills Digest Section
Alex Grove
Social Policy Section
27
February 2017
Contents
Purpose of the Bill
Structure of the Bill
Background
Therapeutic goods
Therapeutic Goods Administration
(TGA)
Sansom Review
2016–17 Budget
Government response
Recommendations supported by the Bill
Inquiry into the availability of new,
innovative and specialist cancer drugs in Australia
Committee consideration
Senate Community Affairs Legislation
Committee
Senate Standing Committee for the
Scrutiny of Bills
Policy position of non-government
parties/independents
Position of major interest groups
Industry
Consumers
Pharmacists
Financial implications
Statement of Compatibility with Human
Rights
Parliamentary Joint Committee on
Human Rights
Key issues and provisions
Review recommendations
3 and 15, faster approval of medicines and devices
Issue—faster approval
of medical devices
Review recommendations 13 and
42—variations to medicines through notification
Review recommendation 15—enabling
Australian ‘notified bodies’ to undertake conformity assessment of medical
devices
Review recommendation 24—enabling
health practitioners to supply certain therapeutic goods not on the Register to
patients under a notification scheme
Review recommendation 47—review and
appeal rights for persons applying to include new ingredients as permissible
ingredients in listed complementary medicines
Review recommendation 41—setting
timeframes for regulatory decisions in relation to listed complementary
medicines
Review recommendation 27—strengthening
post-marketing activity
Other provisions
Amendments to TGA statutory advisory
committees
Miscellaneous amendments
Concluding comments
Date introduced: 1
December 2016
House: House of
Representatives
Portfolio: Health
and Aged Care
Commencement: Schedules
1 and 9 commence on a day to be fixed by proclamation or six months after
Royal Assent. Schedules 2-8 and 10-12 commence the day after Royal Assent.
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 February 2017.
Purpose of
the Bill
The purpose of the Therapeutic Goods Amendment (2016
Measures No. 1) Bill 2016 (the Bill) is to amend the Therapeutic Goods
Act 1989 (the Act) to implement several recommendations from the Expert
Panel Review of Medicines and Medical Devices Regulation (Sansom Review)[1]
relating to the streamlining of the regulation of medicines and medical
devices. The Bill also introduces other amendments to the Act to simplify some
other aspects of the regulation of therapeutic goods and to reflect recent changes
to advisory committees.
Structure
of the Bill
This Bill is divided into 12 Schedules.
- Schedule
1 amends the Act to allow sponsors of therapeutic goods to vary the entry relating
to those goods on the Australian Register of Therapeutic Goods (the Register) in
certain circumstances
- Schedule
2 allows the Secretary to designate Australian corporations to undertake
conformity assessment of medical devices and their manufacture
- Schedule
3 enables health practitioners to supply certain unregistered therapeutic goods
to patients under a notification scheme. The Schedule also makes a
consequential amendment to the A New Tax System
(Goods and Services Tax) Act 1999
- Schedule
4 removes the requirement for the Minister to consult with the Therapeutic
Goods Committee, which ceased to exist at the start of 2017 (the Minister may
still consult with one of the new committees)
- Schedule
5 provides review and appeal rights for persons who apply to have new
ingredients permitted in listed complementary medicines
- Schedule
6 establishes regulation-making powers to allow for the priority approval of
medicines, medical devices and biologicals
- Schedule
7 enables regulations to be made setting timeframes within which regulatory
functions or decisions must be completed or made under the Act
- Schedule
8 sets out a number of amendments in relation to developing a more
comprehensive post-market monitoring scheme for medicines, including record
keeping requirements and rights of entry for authorised persons
- Schedule
9 enables the Secretary to determine the information that must accompany an
application to vary an entry in the Register
- Schedule
10 amends the powers of the Secretary to set requirements around the public
notification and recall of therapeutic goods, biologicals and medical devices
- Schedule
11 broadens the matters about which the Secretary may obtain information from
sponsors of listed medicines and
- Schedule
12 contains several miscellaneous amendments, including new powers for the
Secretary to approve unapproved goods in the event of a shortage.
Background
Therapeutic
goods
Therapeutic goods are products that are used in humans in
connection with:
- preventing,
diagnosing or treating an illness or injury
- altering
a physiological process
- testing
a person’s susceptibility to an illness
- affecting
conception
- testing
for pregnancy or
- replacing
or modifying part of someone’s anatomy.[2]
Therapeutic goods include a wide range of items, from
items that could 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.
Therapeutic
Goods Administration (TGA)
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.[3]
The TGA administers the Act to ensure that medicines and medical devices are
evaluated and regulated before they reach the market, and monitored once they
are in use.
Therapeutic goods must be assessed by the TGA and entered
in the Australian Register of Therapeutic Goods (the Register) before they can
be sold in Australia.[4]
The TGA takes a risk-based approach to regulation, which
means that lower risk products will receive less assessment than higher risk
products.[5]
Higher risk medicines (including all prescription medicines and most over-the-counter
medicines) must be assessed by the TGA for quality, safety and effectiveness
before they can be registered on the Register. Lower risk medicines such
as vitamins, sunscreens and herbal complementary medicines can be listed
on the Register if the applicant certifies that claims about the effectiveness
of the product are accurate, the medicine contains only approved ingredients,
and relevant quality, labelling, packaging and manufacturing standards have
been followed.[6]
Similarly to medicines, lower risk medical devices (such
as bandages) rely on the applicant's certification of compliance with
regulatory requirements for inclusion on the Register, whereas higher risk
devices (such as pacemakers) require a direct evaluation of the available evidence
by TGA officers before they can be included on the Register.[7]
The TGA manages a number of programs to allow patients to
access therapeutic goods that are not on the Register. For example, the Special
Access Scheme (SAS) allows for ‘the import and/or supply of an unapproved
therapeutic good for a single patient, on a case by case basis.’[8]
Doctors apply under the SAS on behalf of the patient. If the patient is a
Category A patient (seriously ill and likely to die without treatment) the
doctor need only notify the TGA of the supply of the good. For other (Category
B) patients, the doctor must seek approval from the TGA to supply the
unapproved good to the patient.[9]
The TGA also has a role in monitoring therapeutic goods
after they have been approved and are on the market. Depending on the type of
good and the degree of risk involved, post-market monitoring activities may
include risk management plans, collecting reports of adverse events and
reactions, reviewing worldwide complaints data, auditing manufacturers and
environmental scanning for safety issues.[10]
The TGA operates on a cost recovery basis. Fees are
charged for services such as product evaluations, and taxes are also imposed on
regulated industries.[11]
Sansom Review
On 24 October 2014 the Australian Government announced an Expert
Panel Review of Medicines and Medical Devices Regulation (Sansom Review).[12]
This Reviewwas designed to identify:
- Areas
of unnecessary, duplicative, or ineffective regulation that could be removed or
streamlined without undermining the safety or quality of therapeutic goods
available in Australia
- Opportunities
to enhance the regulatory framework so that Australia continues to be well
positioned to respond effectively to global trends in the development,
manufacture, marketing and regulation of therapeutic goods.[13]
The Sansom Review provided two reports to the Government
in 2015. The first report, dealing with the regulation of medicines and medical
devices, as well as access to unapproved goods, made 32 recommendations. The
first report recommended expanding the pathways for sponsors to seek approval
for a medicine or medical device; enhancing post-market monitoring of goods and
streamlining post-market requirements; and improving transparency and
predictability of processes and decisions.[14]
The second report, dealing with the regulation of
complementary medicines and the advertising of therapeutic goods, made a
further 26 recommendations. The second report recommended expanding pathways
for sponsors to seek approval for a listed complementary medicine or for an
ingredient for use in a listed medicine; enhancing the transparency and
predictability of processes and evidence for such approvals; improving the
interface between market approval of goods and advertising requirements; and
enhancing and streamlining the therapeutic goods advertising framework.[15]
2016–17
Budget
In response to the Sansom Review, the Government provided
$20.4 million over four years (including $9.5 million in capital funding)
from 2016–17 to improve the regulation of therapeutic goods in Australia. The
ongoing cost of the measure from 2017–18 is to be met by the TGA’s cost
recovery arrangements.[16]
The objectives of the Budget measure are to bring
medicines and medical devices onto the Australian market faster, reduce costs
and administrative burden for industry, make some product assessments shorter
and simpler, consider removing regulation for some low risk products, improve
information about complementary medicines, simplify advertising for therapeutic
goods and reduce the number of committees advising the TGA.[17]
Government
response
The formal Australian Government Response to the Review
of Medicines and Medical Devices Regulation (the Government Response) was
released by Minister Ley on 15 September 2016.[18]
The Government accepted 43 of the 58 recommendations made by the Sansom Review.
A further six were accepted in principle, the Government supported the intent
of another five, and two were deferred. Only two recommendations relating to
delegation and committee structures within the TGA were rejected.
The stated aim of the Government Response is to strike a
balance between improving access to therapeutic goods for consumers and
removing unnecessary red tape for industry, while also maintaining the safety
of therapeutic goods in Australia.[19]
The Government is proposing to implement the reforms in a staged approach over
three years, with costs to be recovered from industry where necessary. DoH will
consult with government, consumers, health professionals and industry to
progress the reforms.[20]
A timetable for the release of public consultation papers is available on the
TGA website.[21]
Some of the accepted recommendations represent the status
quo and require no action, some can be implemented administratively, and some
require legislative amendments. The Government has indicated that the Bill
supports the implementation of eight key recommendations of the Sansom review:
recommendations 3, 13, 15, 24, 27, 41, 42 and 47.[22]
These eight recommendations are briefly described below.
Recommendations
supported by the Bill
Recommendations 3, 13, 41, 42 and 47 all relate to the
assessment and inclusion of medicines on the Register.
Recommendation 3 proposes three pathways for registering a
new medicine on the Register: the existing TGA assessment pathway (but with the
possibility of work-sharing with comparable overseas regulators); registration
via assessment by the TGA of a submission dossier and evaluation report from a
comparable overseas regulator, together with Australian-specific information;
and expedited approval of a medicine via either of these two pathways.[23]
Recommendation 13 is that the TGA should adopt a
risk-based approach to variations to medicines registered in the Register, with
assessment by the TGA only required where there is a potential impact on
safety, quality or effectiveness of the medicine, and any such assessment to be
abridged in scope and limited to these three areas.[24]
Recommendation 42 proposes the same risk-based approach for variations to
complementary medicines listed in the Register.[25]
Legislative timeframes already apply for the assessment of
prescription medicines and higher risk medical devices by the TGA.[26]
Recommendation 41 is that legislative timeframes should also be developed for
the assessment of complementary and other listed (lower risk) medicines and
ingredients.[27]
Recommendation 47 is that a sponsor who applies for
approval of a new ingredient for a listed medicine should have review and
appeal rights regarding the TGA’s decision on the application.[28]
Recommendation 15 relates to the assessment and inclusion
of medical devices on the Register. Similarly to recommendation 3 for
medicines, it is recommended that there should be three pathways to seek
approval for the inclusion of most medical devices on the Register: assessment
within Australia by either the TGA or a body designated by the TGA; utilisation
of an overseas marketing approval; and expedited approval in certain
circumstances.[29]
Recommendation 24 relates to the SAS for access to unapproved
therapeutic goods. It is proposed that certain low risk Category B applications
should be subject to automatic approval, but that higher risk applications
should continue to require individual assessment and approval.[30]
Recommendation 27 proposes that the Government develop a
more comprehensive post-market monitoring scheme for medicines and medical
devices, including better integration and analysis of information from data
sets such as the Medical Benefits Scheme, establishment of registries for all
high-risk implantable devices, implementation of an alert scheme for newly
registered medicines to encourage reporting of adverse events, allowing
electronic reporting of adverse events, and improving collaboration with
overseas regulators.[31]
Of the eight recommendations listed above, six were fully accepted
in the Government Response. The Commonwealth accepted recommendation 27, except
for the establishment of registries for all high-risk implantable devices.[32]
The Commonwealth supported the intent of recommendation 47, noting that ‘the
design of potential review and appeal rights requires careful consideration of
the application of administrative law principles in this context’.[33]
Inquiry
into the availability of new, innovative and specialist cancer drugs in
Australia
Shortly after the Sansom Review was announced in 2014, the
Senate referred an inquiry into the ‘availability of new, innovative and
specialist cancer drugs in Australia’ to the Senate Community Affairs
References Committee (the Community Affairs Committee).[34]
The Community Affairs Committee examined both the TGA process for registering
medicines, and the Pharmaceutical Benefits Advisory Committee (PBAC) process
for listing medicines for subsidy on the Pharmaceutical Benefits Scheme (PBS).
Generally speaking, only the former is relevant to this Bill, although
medicines cannot be listed on the PBS until they have been registered by the
TGA on the Register.[35]
The Community Affairs Committee noted that the TGA and
PBAC processes were ‘appropriately rigorous’, but also that some pharmaceutical
companies and other stakeholders had concerns about the ‘potential for
inefficiency and uncertainty in the system.’ The Community Affairs Committee
considered that Australia should maintain ‘continuous improvement of its
assessment processes’, while also acknowledging the role of the pharmaceutical
industry in ‘achieving timely listing of cancer medicines.’ The Community
Affairs Committee acknowledged the evidence it had received regarding ‘fast
track processes used by overseas regulators’.[36]
The Community Affairs Committee acknowledged the work of
the Sansom Review, including that the Review had produced findings consistent
with the evidence received by the Committee.[37]
The Community Affairs Committee, did, however, make recommendations of its own.
Of particular relevance to the Bill, the Community Affairs Committee
recommended that ‘the Australian Government initiate a comprehensive review of
the system for the registration and subsidisation of medicines’, to examine
topics such as pathways for the registration and listing of medicines
(including the use of assessments by comparable overseas regulators), options
for improving the operation of assessment processes, and options for expanding
post-market review of medicines.[38]
At the time of writing of this Digest, the Australian
Government had not given a final response to the Community Affairs Committee’s
report, but had advised that it was considering the implications of the Sansom
Review for its final response.[39]
While the focus of the Community Affairs Committee’s inquiry
was on improving access to cancer medicines in Australia, some stakeholders did
point out that providing earlier access to medicines was not without risk. For
example, the Department of Health submitted the example of ponatinib, a cancer
medicine that was ‘given accelerated regulatory approval in the USA’ and was
‘subsequently found to cause adverse events, such as heart attacks and deep
vein thrombosis, in 27% of patients. Without this information up-front,
prescribers and patients took on unknown risks’.[40]
Similarly, researchers from the University of Sydney, writing in response to
the Community Affairs Committee’s report, advised caution about demands from
stakeholders to radically overhaul TGA and PBAC assessment processes ‘that
might actually be working quite well’.[41]
Committee
consideration
Senate Community
Affairs Legislation Committee
The Senate Standing Committee for Selection of Bills
recommended that the Bill be referred to the Community Affairs Legislation
Committee for inquiry and report by 27 March 2017.[42]
Details of the inquiry, its terms of reference and report (when released) can
be found on the inquiry
homepage.[43]
No submissions had been published at the time of writing this Digest.
Senate
Standing Committee for the Scrutiny of Bills
The Senate Standing Committee for the Scrutiny of Bills
has raised a number of issues with the Bill. Many of these concerns relate to
the breadth and significance of the matters to be dealt with in regulations
rather than the primary legislation. The Committee has also raised concerns
around strict liability offences, reversal of the evidential burden of proof in
relation to some offences and abrogation of the privilege against
self-incrimination for manufacturers of therapeutic goods who have been asked
to provide information or documents to the Secretary.[44]
The Committee’s specific concerns are briefly outlined below in the section
‘Key issues and provisions’.
Policy
position of non-government parties/independents
At the time of writing this Digest, few statements by
non-government parties or independents specifically relating to the Bill had
been identified.
Tony Zappia, Shadow Assistant Minister for Medicare,
stated that Labor welcomed the Government Response to the Sansom Review. He
indicated that Labor would consider the details of the Government Response, but
that ‘any measures which provide faster access to medicines whilst maintaining
Australia's high regulatory standards are welcome.’[45]
However, Labor was one of the parties that proposed the
referral of the Bill to the Senate Community Affairs Legislation Committee, due
to concerns that many of the changes to the regulatory system will be made by regulations
that have not been drafted.[46]
The Nick Xenophon Team also proposed a referral of the
Bill to the Senate Community Affairs Legislation Committee, citing ‘concerns
about process proposed in the Bill’.[47]
The Liberal Democratic Party (LDP) supports ‘an approvals
sharing system’ for medicines with ‘other nations having similar standards to
avoid duplicate testing and approval processes (for example, with the US Food
and Drug Administration)’. However, the LDP also believes that approval of
medicines by the TGA should be a voluntary measure, and that unapproved
medicines (clearly labelled as such) should be available for sale in Australia.[48]
Medicines Australia (representing the patented
pharmaceutical industry) claims that the measures in the Bill have
‘widespread-cross political support’.[49]
Position of
major interest groups
At the time of writing, there had been little stakeholder
comment on the Bill itself. However, a number of stakeholders had commented on
the Government Response to the Sansom Review. Selected comments which are
relevant to the Bill are presented below.
Industry
Industry peak bodies have expressed their support for the
measures in the Bill. Medicines Australia believes the Bill ‘will enable faster
access to certain new medicines for Australian patients and help to cut
unnecessary red tape for industry too.’ In particular, Chief Executive Milton
Catelin has praised the ‘changes to approval, registration and listing times’.[50]
The Generic and Biosimilar Medicines Association (representing the off-patent
pharmaceutical industry) has also welcomed the prospect of faster approval
times for medicines, as well as the streamlining of post-market requirements and
a simpler process for making changes to products already on the Register.[51]
The peak body for the biotechnology industry, AusBiotech,
welcomed the Government Response to the Sansom Review. Chief Executive Officer
(CEO) Glenn Cross said ‘AusBiotech and its members have repeatedly expressed
support for third party conformity assessment and the expedited pathway for
assessment of novel medical devices for inclusion on the Register.’ Mr Cross expects
the measures to reduce time-to-market and improve the commercial viability of
innovative products.[52]
Consumers
The CEO of the Consumers Health Forum of Australia (the
peak body for health consumer organisations), Leanne Wells, has welcomed the
fast tracking of assessments for medicines and medical devices. However, she
has also pointed out that, while new medicines may come to market sooner under
the changes, they may still be too expensive for many consumers until they are
listed on the PBS. She has encouraged the Government to ‘develop more timely
assessment processes so that approvals for use in Australia and the separate
decisions over subsidising the new drugs are better coordinated’.[53]
Pharmacists
The Society of Hospital Pharmacists of Australia (the
national professional body for pharmacists working in the hospital sector)
welcomed the 2016–17 Budget announcement to fast-track access to new therapeutic
goods. CEO Kristin Michaels believes that ‘[c]ollaborating and sharing
information with international trusted regulators is a logical step to improve
the efficiency of medicine and medical device regulation’.[54]
Financial
implications
As noted earlier, the Government provided $20.4 million
over four years (including $9.5 million in capital funding) in the 2016–17 Budget
to improve the regulation of therapeutic goods in Australia, with the ongoing
cost of the measure from 2017–18 to be met by the TGA’s cost recovery
arrangements.[55]
The Explanatory Memorandum states that the ‘Government allocated $13.5 million
in both operating and capital expenses from the Budget in 2016–2017 to improve
the regulation of therapeutic goods in Australia.’[56]It
appears that the $13.5 million figure may only relate to the 2016–17
financial year.
The TGA operates on a cost recovery basis and is largely
self-funding. The Explanatory Memorandum states that ‘TGA special account
reserves (comprised of revenue from industry fees and charges)’ will be used to
fund the $13.5 million allocation.[57]
The opening balance of the TGA special account at 1 July 2016 was budgeted to
be $63.2 million, and the closing balance at 30 June 2017 is budgeted to be
$49.9 million.[58]
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.[59]
Parliamentary
Joint Committee on Human Rights
At the time of writing this committee had not reported on
the Bill.[60]
Key issues
and provisions
Review recommendations 3 and 15—faster approval of medicines and
devices
Items 1, 2 and 4
of Schedule 6 address these recommendations by introducing new sections
of the Act to establish regulation-making powers to allow the Secretary to make
determinations relating to priority applicants for purposes of the approval of therapeutic
goods, biologicals and medical devices respectively.[61] Item 3
similarly provides for the making of priority applicant determinations for
conformity assessment determinations.
In each case a determination that an
applicant is a priority applicant for the purposes of the respective existing
application provisions means that the evaluation period for the therapeutic
goods or biologicals may be shorter than would otherwise be required by the Act,[62] and the priority for the
conformity assessment or medical devices application may be determined by the
regulations.[63]
Proposed sections 25AAA, 32DEA, 41ECA and 41FKA
provide that further details regarding the operation of the priority
application schemes may be provided by regulations. These further details
include the applications, forms, fees, required information and publication of
decisions, as well as providing for the revocation of priority determinations
and the consequences of doing so.
The Government has stated that the proposed
changes support a risk-based approach and that medicines and devices will still
be ‘fully evaluated for safety- quality and efficacy or performance’.[64]
Issue—faster approval of medical devices
A study of 309 medical devices approved in the EU between
2005 and 2010 found that, while the majority of these devices were eventually
approved in both the EU and the US, most were approved in the EU first. The
difference between the two regulatory systems was described as follows:
In the European Union, medical devices are
approved by private notified bodies if they meet performance criteria and are
likely to be safe, but notified bodies generally do not require evidence of
effectiveness for most devices.
Many high risk devices are approved faster in
the EU than in the United States, where the Food and Drug Administration
usually requires prospective clinical trials of such devices.[65]
The study found that devices approved first
in the EU were associated with an increased risk of post-marketing safety
alerts and recalls. The authors suggest that ‘products introduced earlier in
their development cycle are also more likely to increase the risk of harm’.[66]
Review
recommendations 13 and 42—variations to medicines through notification
Schedule 1 addresses
these recommendations by amending the Act to allow sponsors of therapeutic
goods to vary the entry in relation to those goods on the Register in certain
circumstances.
Section 9D of the Act deals with variations to the
Register. Item 1 inserts proposed subsection 9D(2C) to provide
that, where a person who has registered therapeutic goods makes an appropriate
request to vary the entry on the Register, the Secretary must do so. Proposed
paragraphs 9D(2C)(b) and (c) provide that the kind of variation and
any conditions to be satisfied may be specified in regulations.
Items 3 and 5 make similar changes to permit
the varying of entries for biologicals and medical devices, respectively.
The Senate Standing Committee for the Scrutiny of Bills
has concerns about these items, as no detail has been provided in the Bill or
the Explanatory Memorandum regarding what kind of variation, or what type of
conditions, might be prescribed in the Regulations. Pending the provision of
this detail, the Committee believes that the items may be considered to delegate
legislative powers inappropriately.[67]
Review
recommendation 15—enabling Australian ‘notified bodies’ to undertake conformity
assessment of medical devices
Schedule 2 implements
this recommendation by allowing the Secretary to designate Australian corporations
as Australian conformity assessment bodies, thereby permitting these third
parties to undertake conformity assessment of medical devices and their
manufacture to ensure that the devices will comply with safety and performance
principles.
Item 4 introduces proposed section 41EWA
into the Act to establish regulation making powers to enable the Secretary to
determine that an Australian corporation is an Australian conformity assessment
body for the purposes of the Act. The proposed section provides that regulations
may provide for a wide range of conditions and administrative matters attaching
to such determinations.
The Senate Standing Committee for the Scrutiny of Bills
has two major concerns regarding proposed section 41EWA. The first
concern is that it provides a broad regulation-making power which leaves most
of the details of how Australian companies will be designated as ‘conformity
assessment bodies’ to delegated legislation. The second concern is that the
Secretary is not precluded from delegating their functions under this section
to a relatively large class of persons. This concern also applies to the
delegation of the Secretary’s powers in other parts of the Bill.[68]
Item 5 inserts proposed section 41FIA to
provide that a certificate issued by an Australian conformity assessment body
may be considered by the Secretary if an audit is carried out on an applicable
device.
Review
recommendation 24—enabling health practitioners to supply certain therapeutic
goods not on the Register to patients under a notification scheme
Schedule 3
enables health practitioners to supply certain unregistered therapeutic goods
to patients under a notification scheme.
Items 4, 12 and 24
of Schedule 3 provide for such a notification scheme for therapeutic
goods, biologicals, and medical devices, respectively. The Senate
Standing Committee for the Scrutiny of Bills is concerned by the inclusion of
strict liability offences subject to 10 penalty units for health practitioners
who do not comply with the notification requirements of the scheme.[69]
The key legal effect of strict liability is that no fault element applies to
these offences. That is, the prosecution only needs to prove the relevant
physical elements—in these offences that the person is a health practitioner
who is authorised by the rules to supply the relevant goods, biologicals or
medical devices, that the person supplied the authorised item in accordance
with the rules and that the person failed to notify the Secretary of the supply
within 28 days.[70]
Item 1 of Schedule
3 also makes a consequential amendment to the A New Tax System (Goods
and Services Tax) Act 1999 to ensure that unapproved therapeutic goods
supplied under proposed subsection 19(7A) of the Act will also attract the GST exemption that currently applies
to goods supplied under the Special Access and Authorised Prescriber Schemes.[71]
Review
recommendation 47—review and appeal rights for persons applying to include new
ingredients as permissible ingredients in listed complementary medicines
As noted above, in responding to the Sansom Review and supporting
the intent of recommendation 47, the Commonwealth noted that ‘the design of
potential review and appeal rights requires careful consideration of the
application of administrative law principles in this context’.[72]
Schedule 5 addresses
this issue by amending the Act to provide review and appeal rights for persons
who apply to have new ingredients permitted in listed complementary medicines.
A person seeking to have a medicine listed on the Register
must certify that the medicine contains only permissible ingredients (paragraph
26(2)(ca) and (cb)). Permissible ingredients are set out by the Minister in a
determination made under section 26BB.[73]
Current section 26BD provides that a person may apply for a variation of a
determination of permissible ingredients in a medicine. Application and
evaluation fees are able to be prescribed. If an application for variation of
the determination is made, section 26BD permits the Minister to require the
applicant to provide certain information, and requires the Minister to have
regard to the quality and safety of the ingredients, but does not contain any
mechanism for review or appeal of the variation decision. Existing section 60
contains review mechanisms for the review of various decisions of the Secretary
or delegate that are made under the Act.
Item 1 repeals section 26BD while item 2
inserts proposed section 26BE to perform a similar function but with the
initial decision on an application to vary a determination made by the
Secretary or a delegate, rather than the Minister. The section provides that
the Secretary may either make or refuse to make a recommendation that a
determination be varied by the Minister. The section provides for an
application for a variation to be accompanied by prescribed application and evaluation
fees.
The Senate Standing Committee for the Scrutiny of Bills would
like consideration to be given to providing greater legislative guidance as to
how the application and evaluation fee amounts in proposed section 26BE are
to be determined.[74]
There is currently no guidance in section 26BD about how the application and
evaluation fee amounts are to be determined. The Committee also sought advice
from the Minister as to why it is considered necessary to provide for two fees,
rather than a single fee.[75]
As the decision under proposed section 26BE (which
falls within Part 3-2 of the Act) will be made by the Secretary, it will be
reviewable by the Minister under existing paragraph 60(1)(c) and subsection
60(2) of the Act. Item 3 inserts proposed subsection 60(2B), which
will provide that an application for review of the Secretary’s decision under
proposed section 26BE may only be made by the person who made the application
for variation of the determination.
Review
recommendation 41—setting timeframes for regulatory decisions in relation to
listed complementary medicines
Section 63 of the Act provides a broad
regulation-making power. Item 1 of Schedule 7 addresses Recommendation 41 by inserting proposed
paragraphs 63(2)(de) and (df) to enable regulations to be made
setting timeframes within which regulatory functions or decisions must be
completed or made under the Act.
Review
recommendation 27—strengthening post-marketing activity
The aim of this recommendation is addressed
through various amendments in Schedules 8 to 11.
Schedule 8 sets
out a number of amendments in relation to developing a more comprehensive
post-market monitoring scheme for medicines, including record keeping
requirements and rights of entry for authorised persons.
Items 1 to 4 amend section 28 of the Act, dealing with conditions of registration or
listing of goods. This section, among other requirements, currently requires a
sponsor to permit an authorised person to enter premises at which sponsored
goods are dealt with, for inspection purposes. Item 1 will expand this
requirement so that sponsors of goods will also be obliged to allow authorised
persons to enter premises where record keeping requirements are undertaken or
documents stored. This will allow access to premises where sponsored goods are
not kept, but where record keeping requirements in relation to those goods are
undertaken. Item 2 will allow the inspection and copying of compliance
related records.
Item 3 inserts
an ability for additional recordkeeping requirements to be prescribed in regulations.
Item 5 amends
section 46A, dealing with the searching
of premises to monitor compliance with Act, to extend the application of that
section to premises related to compliance records.
Schedule 9 amends
section 9D, which deals with the variation of entries in the Register and
circumstances where applications for variations will not be considered effective.
Item 1 would provide further grounds where such applications would not
be effective – specifically where the application is not accompanied by
information that the Secretary has determined in a legislative instrument under
new subsection 9D(8) and where that information is not in a form approved in
writing by the Secretary.
Schedule 10
amends the powers of the Secretary to set requirements around the public
notification and recall of therapeutic goods, biologicals and medical devices.
Items 1 to 20 amend Part 3-2 of the Act, dealing with the public notification and
recovery of therapeutic goods, while items 21 to 53 make similar amendments relating to biologicals and
medical devices. The amendments include the substitution of the term ‘recall’
for the current term ‘recovery’, clarification of the grounds under which the
Secretary may require recall actions to be taken, and to allow the Secretary to
require a person to inform the public or specified persons of specified recall
information about the goods.
The Secretary’s power to release recall
information in relation to biologicals and devices is also amended by item 62
to bring it into line with that for therapeutic goods.
Schedule 11
broadens the matters about which the Secretary may obtain information from
sponsors of listed medicines.
Currently, paragraph 31(2)(fa) allows the Secretary to
require a sponsor to provide information or documents relating to any claim
that the applicant makes relating to a medicine. Item 1 amends this
paragraph to allow the Secretary to require a sponsor to provide information or
documents relating to any of the matters that a sponsor has certified at
application.[76]
Other provisions
Amendments
to TGA statutory advisory committees
Schedule 4
removes the requirement for the Minister to consult with the Therapeutic Goods
Committee, which ceased to exist at the start of 2017.
Item 1 repeals
subsection 10(4) which required the Minister to consult with a committee before
making or varying an order for a standard for therapeutic goods.
The Minister may still consult with one of
the remaining committees to obtain advice, but will not be required to do so.
The Senate Standing Committee for the Scrutiny of Bills has questioned
the removal of this requirement to consult, given that other committees will
still be available to provide advice to the Minister.[77]
Item 2 repeals
subsection 36(3), which stated that the Minister may obtain advice from a
committee before determining written principles to be observed in the
manufacture of therapeutic goods. The Senate Standing Committee for the
Scrutiny of Bills has similarly questioned the removal of this reference to the
Minister’s discretion to obtain advice from a committee.[78]
Miscellaneous
amendments
Schedule 12
contains several miscellaneous amendments to the regulation of therapeutic
goods, biologicals and medical devices.
Items 2, 4, 5, 11-22, 25-28, 30-33, 37-48,
50, 51, 53, 54, 56 and 57 introduce new
powers for the Secretary to approve the importation or supply of unapproved
goods in the event of a shortage or unavailability of equivalent registered
goods.
The Explanatory Memorandum explains that,
while the Secretary can currently approve the importation and supply of
unapproved goods where the goods in question are either registered or approved
for general marketing in a foreign country specified by the Secretary in a
legislative instrument:
There are instances, however, when the only
unapproved medicines that are available globally to address a shortage are not
available in any of the countries that the Secretary has specified.[79]
The proposed provisions will extend the
existing approvals so that the Secretary can approve goods from other countries
where they are not registered in any of the countries specified in the
legislative instrument or are registered in one of those countries, but are not
easily available. The Secretary must be satisfied that, among other things, the
approval is necessary for public health and the goods are registered in a
foreign country and have acceptable manufacturing and quality control
procedures.
Item 6 amends section 30 of the Act, to extend the
grounds under which the Secretary may cancel the registration or listing of therapeutic
goods to include circumstances where a false or misleading statement was made
in an application. A minor amendment relating to the administration of
cancellations due to non-payment of fees brings the cancellation provision for
therapeutic goods into line with those for biologicals and devices.
Items 9, 29 and 36 amend the Act to allow sponsors
of goods whose registration was cancelled due to non-payment of annual charges
to apply to the Secretary for a revocation of that cancellation, within 90 days
of the cancellation, where the charges have been paid.
Item 34 amends the Act to enable the Secretary to
require manufacturing licence holders to provide information or documents about
a range of specified matters relating to the goods they are manufacturing and
the manufacturing process, as well as providing for further matters to be
specified in regulations. Offences are included for contravening such a
requirement or for providing false and misleading information.
The Senate Standing Committee for the Scrutiny of Bills
has sought the Minister’s justification for two aspects of this item: the
reversal of the evidential burden of proof in the offence-specific defences
relating to the provision of false or misleading information or documents, and
the abrogation of the privilege against self-incrimination when a person is
required by the Secretary to give information or produce a document.[80]
Item 35 inserts proposed subsection 41FN(5)
to provide a regulation making power to set out conditions for the inclusion of
kinds of medical devices in the Register, and also allows the Minister to determine
such conditions by legislative instrument.
For a summary of the operation of further specific items
included in the Bill readers are referred to the Explanatory Memorandum.
Concluding comments
While this Bill introduces many amendments to the Act, the
proposed changes to the regulation of therapeutic goods are in support of
recommendations made by the Sansom Review and are broadly supported by
stakeholders. However, the Bill is complex and leaves much of the detail of the
changes to delegated legislation. Concerns about the Bill have been raised by
the Senate Standing Committee for the Scrutiny of Bills, and it has been
referred to the Community Affairs Legislation Committee for further inquiry.
Specifically on the issue of faster approvals for
therapeutic goods, a note of caution is raised by the above-cited overseas
research that links the earlier approval of medical devices with an increased
risk of safety alerts and recalls.[81]
This of course must be weighed against the reasons laid out in the Sansom Review
in support of faster access to medicines and medical devices. The details of
the operation of the proposed approval pathways in Australia will not be known
until the relevant regulations have been introduced.
[1]. Department
of Health (DoH), ‘Expert
review of medicines and medical devices regulation’, DoH website, 15
September 2016.
[2]. DoH,
‘What are
'therapeutic goods'?’, Therapeutic Goods Administration (TGA) website; Therapeutic Goods
Act 1989, section 3.
[3]. DoH,
‘Who we are and what we
do’, TGA website.
[4]. DoH,
‘TGA basics’, TGA website.
[5]. DoH,
‘TGA regulatory
framework’, TGA website, May 2012.
[6]. DoH,
‘Product
regulation according to risk’, TGA website.
[7]. Ibid.
[8]. DoH,
‘Special access
scheme’, TGA website.
[9]. Ibid.;
DoH, ‘Special
access scheme applications’, TGA website, 8 April 2011.
[10]. DoH,
‘Product
regulation according to risk’, op. cit.
[11]. DoH,
‘Fees and
charges: summary—from 1 July 2016’, version 1.3, TGA website, 8 February
2017.
[12]. DoH,
‘Expert
review of medicines and medical devices regulation’, DoH website, 15
September 2016.
[13]. 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.
[14]. DoH,
‘Expert
review of medicines and medical devices regulation’, DoH website, 15
September 2016.
[15]. Ibid.
[16]. Australian Government, ‘Part 2: expense measures’ Budget measures:
budget paper no. 2: 2016–17, p. 106.
[17]. DoH,
Improving
the regulation of therapeutic goods in Australia, Budget 2016–17 fact
sheet, DoH, 2016.
[18]. DoH,
Australian
Government response to the review of medicines and medical devices regulation,
DoH, Canberra, 2016; S Ley (Minister for Health and Aged Care), Reform
of regulation of medicines and medical devices , media release, 15
September 2016.
[19]. DoH,
Australian
Government response to the review of medicines and medical devices regulation,
op. cit., p. 2.
[20]. Ibid.,
p. 5.
[21]. DoH,
‘Implementation
of reforms—public consultation forecast’, TGA website, 20 February 2017.
[22]. Explanatory
Memorandum, Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016,
p.1.
[23]. L
Sansom, W Delaat and J Hovarth, Review
of medicines and medical devices regulation: report on the regulatory framework
for medicines and medical devices, (Sansom Review [Stage One]),
Commonwealth of Australia, March 2015, p. ix.
[24]. Ibid.,
p. xv.
[25]. 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,
(Sansom Review Stage Two), Commonwealth of Australia, July 2015, p. xii.
[26]. DoH,
Annual
report 2015–16, DoH, Canberra, 2016, p. 150. For example, the TGA has
255 working days to assess an application for a new prescription medicine to be
registered—regulation 16C of the Therapeutic Goods
Regulations 1990.
[27]. (Sansom
Review Stage Two), p. xii.
[28]. Ibid.,
p. xiii.
[29]. Sansom
Review [Stage One], p. xvi.
[30]. Ibid.,
p. xx.
[31]. Ibid.,
p. xxii.
[32]. DoH,
Australian
Government response to the Review of medicines and medical devices regulation,
op. cit., p. 25.
[33]. Ibid.,
p .34.
[34]. Senate
Community Affairs References Committee, Availability
of new, innovative and specialist cancer drugs in Australia, The
Senate, Canberra, September 2015, p. 1.
[35]. NPS
MedicineWise, ‘What
is PBS listing?’, NPS MedicineWise website, 25 October 2012.
[36]. Senate
Community Affairs References Committee, Availability
of new, innovative and specialist cancer drugs in Australia, op. cit.,
p.33.
[37]. Ibid.,
p. 109.
[38]. Ibid.,
p. 111.
[39]. F
Nash (Minister representing the Minister for Health and Aged Care in the
Senate) and S Ley (Minister for Health and Aged Care), Interim
Government Response to the Senate Community Affairs References Committee, Inquiry
into availability of new, innovative and specialist cancer drugs in Australia,
10 October 2016.
[40]. Australian
Government Department of Health, Submission
to Senate Community Affairs References Committee, Inquiry into Availability
of new, innovative and specialist cancer drugs in Australia, submission
no.197, 17 March 2015, p. 20.
[41]. N
Ghinea and W Lipworth, ‘Affordable
access to innovative cancer medicines—don't forget the prices’, Medical
Journal of Australia, 204(6), 4 April 2016, pp. 214–215.
[42]. Senate
Standing Committee on Community Affairs, Report,
1, 2017, The Senate, 9 February 2017.
[43]. Senate
Standing Committee on Community Affairs, Therapeutic
Goods Amendment (2016 Measures No. 1) Bill 2016, The Senate, Canberra.
[44]. Senate
Standing Committee for the Scrutiny of Bills, Scrutiny
digest, 1, 2017, The Senate, 8 February 2017.
[45]. T
Zappia (Shadow Assistant Minister for Medicare), Sansom
review of medicine and medical device approvals, media release,
15 September 2016.
[46]. Senate
Standing Committee for Selection of Bills, Report,
op. cit.
[47]. Ibid.
[48]. Liberal
Democratic Party, ‘Pharmaceuticals’,
Liberal Democrats website.
[49]. Medicines
Australia, Legislation
will improve access to medicines and cut red-tape, media release, 2
December 2016.
[50]. Ibid.
[51]. Generic
and Biosimilar Medicines Association, ‘GBMA
welcomes Health Minister’s plans to streamline medicines regulation’, GBMA
website, 15 September 2016.
[52]. PharmaDispatch,
‘Government
congratulated for TGA review response’, PharmaDispatch website, 16
September 2016.
[53]. Consumers
Health Forum of Australia, Fast
track for new drugs will need faster subsidy decisions, media release,
15 September 2016.
[54]. Society
of Hospital Pharmacists of Australia, SHPA
supports Budget measure to fast-track medicine approvals, media
release, 4 May 2016.
[55]. Australian Government, Part 2: expense measures, Budget measures:
budget paper no. 2: 2016–17, p. 106.
[56]. Explanatory
Memorandum, Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, p.
6.
[57]. Ibid.
[58]. Australian
Government, Part
1: special appropriations table, Agency resourcing: budget paper no. 4:
2016–17, p. 117.
[59]. The
Statement of Compatibility with Human Rights can be found at page 7 of the
Explanatory Memorandum to the Bill.
[60]. Parliamentary
Joint Committee on Human Rights, Report,
1, 2017, The Senate, Canberra, 16 February 2017, p. 53.
[61]. Biologicals
are therapeutic products that are made from, or contain, human cells or human
tissues. See Therapeutic
Goods Act 1989, section 32A and DoH, ‘Products regulated
as biologicals’, TGA website, 8 January 2013.
[62]. Proposed
subsections 25AAA(6) and 32DEA(6), respectively.
[63]. Proposed
subsections 41ECA(6) and 41FKA(6), respectively.
[64]. Explanatory
Memorandum, op. cit., pp.1, 2.
[65]. T Hwang, E Sokolov, J Franklin and A Kesselheim, ‘Comparison of
rates of safety issues and reporting of trial outcomes for medical devices
approved in the European Union and United States: cohort study’, BMJ, 2(8), August 2016, pp. 50–57.
[66]. Ibid.
[67]. Senate
Standing Committee for the Scrutiny of Bills, Scrutiny
digest, op. cit., pp. 31–32.
[68]. Ibid.,
pp. 32–35.
[69]. Ibid.,
p. 35. Currently, 10 penalty units is equal to $1,800: Crimes Act 1914,
section 4AA.
[70]. Criminal Code Act
1995, section 6.1. A defence of mistake of fact is available to the
person—see section 9.2.
[71]. A New Tax System
(Goods and Services Tax) Act 1999.
[72]. DoH,
Australian
Government response to the Review of medicines and medical devices regulation,
op. cit., p. 34.
[73]. The
current determination made under section 26BB is the Therapeutic Goods
(Permissible Ingredients) Determination No. 1 of 2017.
[74]. Senate
Standing Committee for the Scrutiny of Bills, Scrutiny
digest, op. cit., pp. 37–38.
[75]. Ibid.
[76]. Such
matters are specified in subsections 26A(2) and (2A) of the Act.
[77]. Senate
Standing Committee for the Scrutiny of Bills, Scrutiny
digest, op. cit., pp. 35–36.
[78]. Ibid.
[79]. Explanatory
Memorandum, p. 36.
[80]. Senate
Standing Committee for the Scrutiny of Bills, Scrutiny
digest, op. cit., pp. 38–39.
[81]. Hwang
et al, Comparison
of rates of safety issues, op. cit.
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