Bills Digest no. 83 2009–10
Therapeutic Goods Amendment (2009 Measures No. 3) Bill
2009
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage history
Purpose
Background
Main provisions
Concluding comments
Contact officer & copyright details
Passage history
Date
introduced: 25 November
2009
House: House of Representatives
Portfolio: Health and Ageing
Commencement:
Formal provisions: on Royal
Assent
Schedule 1: a day
fixed by Proclamation
Schedules 2 6: the day
after Royal Assent
Links: The
relevant links to the Bill, Explanatory Memorandum and second
reading speech can be accessed via BillsNet, which is at http://www.aph.gov.au/bills/.
When Bills have been passed they can be found at ComLaw, which is
at http://www.comlaw.gov.au/.
The primary purpose of the Therapeutic Goods Administration
(2009 Measures No. 3) Bill 2009 (the Bill) is to introduce a
framework for the regulation of biologicals, which is consistent
with the regulation of therapeutic goods and medical devices under
the Therapeutic Goods Act 1989 (the Act).[1] In addition, the Bill proposes
other amendments to the Act, many of which are largely
administrative in nature.
This Bill is part of the overall regulatory reform to the Act
undertaken by the Therapeutic Goods Administration (TGA). Most of
these reforms were agreed in the context of the proposed Australia
New Zealand Therapeutic Products Authority (ANZTPA). Although the
New Zealand Government ultimately decided to not proceed with the
ANZTPA, the Australian Government decided to implement the proposed
changes. This is the fourth Bill to be considered by Parliament.
The passage of the previous three Bills has been largely
uncontroversial.
Previously, the regulation of biologicals in Australia was not
consistent with other regulators around the world such as the
United States, Canada and the European Union. Biologicals are
cellular and tissue based therapy products, for example, skin
tissue for use in grafts. It is important to note that organs and
assistive reproductive issues will not be affected by the proposed
amendments and the current regulatory arrangements for these
products will remain.[2]
The proposed amendments are designed to ensure that the
regulation of biologicals is consistent with the regulation of
other therapeutic goods. A risk based approach has been adopted and
different levels of pre and post market regulation are applied
based on the relative risk of each biological. The amendments will
set out the classes of biologicals from low to high risk.
Consistent with a risk based approach, higher risk biologicals will
be subject to greater regulation. In addition, the criminal offence
and civil penalty provisions are consistent with the provisions for
other therapeutic goods.
In addition, a flexible approach has been built into the
legislation when dealing with urgent medical circumstances. For
example, biologicals which do not meet the legislative requirements
but are considered clinically appropriate would be able to be used
in treatment, with the consent of the patient.
To facilitate the implementation of the new regulatory framework
for biologicals, the legislation provides for delayed
implementation. This will enable further consultation with industry
and finalisation of product-specific standards.
The Bill also contains the following proposed amendments:
- Schedule 2 provides immunity to the Minister,
Secretary and the Secretary s delegate from civil action, providing
they did not act in bad faith. This is consistent with other
Commonwealth legislation and other regulatory agencies
- Schedule 3 allows for a more targeted approach
to product recalls. Currently, the legislation does not allow for a
recall of batches to occur. This can be excessive and expensive
where only small numbers of batches are affected. The proposed
amendments will enable specific batches to be recalled
- Schedule 4 gives the TGA power to seek
information from persons who have previously registered goods on
the Australian Register of Therapeutic Goods (the Register)
- Schedule 5 ensures that any unpaid charges are
considered to be a debt owed to the Commonwealth and able to be
recovered
- Schedule 6 is a series of administrative
amendments. For example, improvements to post-marketing
surveillance and clarification of what new information can be
provided in the context of a merits review.
This Bill was introduced into the House of Representatives and
read a second time on 25 November 2009. This was the second last
day of the Parliamentary sitting for 2009, and as such, a decision
on referral to a Committee has not yet been made.
With respect to the proposed regulatory framework for
biologicals, the Minister s Second Reading Speech notes that:
the government has undertaken extensive consultation with the
industry over the past year, including explaining the proposed
framework to sponsors and manufacturers and setting out the steps
they will need to take to comply with the framework.[3]
There does not appear to be any publicly available information
about the nature of this consultation process and what information
was provided. The regulatory reform section on the TGA s
website[4] only has
information about the consultation sessions that were conducted in
July/August 2008 and does not include the regulation of
biologicals. The only information provided on this Bill on the TGA
website is summary in nature.
Furthermore, there does not appear to be any stakeholder or
media commentary on this Bill or its introduction.
As previously mentioned, there are six Schedules in the Bill,
which deal with matters including:
- a new separate framework for dealing with biologicals
- immunity of the Commonwealth and certain people acting for the
Commonwealth from civil and criminal actions
- recall of therapeutic goods without suspension or cancellation
of the listing of the therapeutic goods in the Register
- gathering information from previous sponsors of therapeutic
goods
- classifying annual charges as debts due to the Commonwealth and
recoverable as such
- advertising statements, and
- review of decisions and remittance of matters for
reconsideration.
As mentioned previously, Schedule 1 of the Bill
provides for biologicals to be regulated separately from other
therapeutic goods and medical devices.
Item 25 proposes to insert a new Part
3-2A into the Act, specifically related to the regulation
of biologicals.
Proposed section 32A provides that biological
means something which:
- either comprises, contains or derives from human cells or
tissues; or is specified as such by the Secretary by legislative
instrument under proposed subsection 32A(2),
and
- is either represented to be; or because of how it is
represented or for any other reason is likely to be taken as being
for use in:
- treating or preventing a disease, ailment, defect or injury
affecting a person
- medically diagnosing a person s condition
- influencing, inhibiting or modifying a physiological process in
people
- testing people s susceptibility to a disease or ailment,
or
- replacing or modifying parts of people s anatomies.
The Secretary may also specify, by legislative instrument, that
something is not a biological (proposed subsection
32A(3)).
Proposed section 32AA provides that the
regulations may prescribe different classes of biologicals.
According to the Government:
This reflects the policy intent that regulation of these goods
is correlated to the relative risk of each biological, that is,
biologicals of a lower risk level would be subject to less rigorous
evaluation and regulation compared with higher risk biologicals. It
is expected that the regulations will specify four classes of
biologicals ranging from lower risk (Class 1) to higher risk (Class
4).[5]
There is a tiered criminal offence regime, as well as civil
penalties, proposed in relation to dealing with biologicals, which
are set out in proposed Division 2 of Part
3-2A, as well as in other parts of the Bill.[6] So the more serious
offences resulting in, or likely to cause, harm or injury would
attract heavier sanctions. It is stated in the Explanatory
Memorandum that:
There is a tiered offence regime for a number of criminal
offences, encompassing higher level penalties within a structure
that usually includes:
- a fault-based offence with an aggravating element (conduct that
results or will result in harm or injury to a person or persons),
generally attracting a maximum penalty of 4,000 penalty units
(presently $440,000) or 5 years imprisonment or both;
- a strict liability offence with an aggravating element (conduct
likely to result in harm or injury to a person or persons),
generally attracting a maximum penalty of 2,000 penalty units
(presently $220,000) with no term of imprisonment; and
- a fault-based offence, with no aggravating element, generally
attracting a maximum penalty of 1,000 penalty units (presently
$110,000) or imprisonment for 12 months or both.[7]
It is noted that the Bill proposes certain strict liability
offences in relation to the import, export, manufacture or supply,
by a person, of biologicals not included in the Register in
relation to that person, for potentially harmful use in
humans.[8]
The Government explains that:
The strict liability offences are necessary and appropriate in
maintaining the integrity of the regulatory scheme to ensure the
safety, quality, and efficacy or performance of therapeutic goods
supplied in Australia or exported from Australia.
The inclusion of strict liability offences takes into
consideration statements made in the Senate Standing Committee for
the Scrutiny of Bills Sixth Report of 2002 titled Application
of Absolute and Strict Liability Offences in Commonwealth
Legislation, and the Guide to Framing Commonwealth
Offences, Civil Penalties and Enforcement Powers (the Guide),
issued by authority of the Minister for Home Affairs in December
2007.
According to the above Guides, strict liability may be
appropriate where it is necessary to ensure the integrity of a
regulatory regime such as, for instance, those relating to public
health, the environment, or financial or corporate regulation
.
The strict liability offences proposed in the Bill are
considered to be similar in application to the strict liability
offences existing elsewhere in the Act.
They form an integral part of the full suite of alternative
sanctions proposed for biologicals in relation to breaches of key
regulatory requirements that will underpin the regulatory
arrangements for biologicals. This is to protect public health and
safety in respect of biologicals in a manner that is consistent
with the existing schemes applying to medicines, therapeutic
devices and medical devices, as currently set out in the
Act.[9]
In addition, it is stated that the main criminal offence
provisions and penalty levels are consistent with other provisions
in the Act (please refer to the Appendix to this Digest).[10]
There are four types of exemptions from the TGA s regulatory
framework relating to biologicals proposed in the Bill:
- exemptions under regulations (proposed section
32CA)
- exemptions to deal with potential and actual emergencies
(proposed section 32CB)
- exemptions for special and experimental uses (proposed
sections 32CK-32CN), and
- exemptions where substitutes are not available
(proposed section 32CO).
It is noted that exemptions may be subject to conditions
(proposed subsections 32CA(3), 32CK(6)
(8) and 32CO(7); proposed
sections 32CC and 32CL)
and that conditions relating to exemptions for biologicals in
emergency situations may be varied or revoked (proposed
subsections 32CD(3)).
In all cases, a breach of these conditions constitutes an
offence with varying penalty units (for example, proposed
subsections 32CA(4), 32CK(9),
32CL(2), 32CO(8) and
proposed section 32CI), and in some cases, tiered
terms of imprisonment (for example, proposed sections
32CH and 32CN).
There are also criminal offences and civil penalties relating to
situations where biologicals do not conform to applicable standards or are otherwise
unfit to be used for their intended purpose (proposed
subsections 32CJ(6) (11)). Where a person supplies a batch
of biologicals and the Secretary is satisfied that biologicals in
that batch do not conform to applicable standards or are otherwise
unfit to be used for their intended purpose, the Secretary has
discretionary power to require that person, by written notice, to
take steps to recover such biologicals unless the biologicals have
been administered to or used in treating a person and consequently,
cannot be recovered. Failure to comply with that requirement would
constitute a criminal offence or civil contravention, depending on
the circumstances and consequences of such failure to comply.
Application and assessment procedures relating to biologicals
would be different for Class 1 biologicals considered to be of
low risk and other classes of biologicals with increasing levels of
risk.[11]
Under proposed subsection 32DB(1), the
Secretary must include the Class 1 biological in the Register, in
relation to a particular person, if that person makes an
application to include the Class 1 biological in the Register in
accordance with proposed section 32DA. Under
proposed subsections 32DA(2) and
(3), an application must be accompanied by a
statement from the applicant in which the applicant must certify
several things about the Class 1 biological including that the
biological:
- is in fact a Class 1 biological and is safe for its intended
use
- conforms to applicable standards
- complies with applicable advertising requirements; as well as
prescribed quality and safety criteria (if any), and
- does not contain any substances that are prohibited imports
under the Customs Act 1901.
Under proposed subsection 32DE(1), where an
application is made to include a biological other than a Class 1
biological in the Register, the Secretary must evaluate the
biological with regard to matters including:
- satisfactory establishment of the biological s quality, safety
and efficacy in relation to its intended use
- acceptability of the biological s presentation, as well as of
the quality control and manufacturing procedures followed in its
manufacture
- the biological s conformity with applicable standards
- the biological s compliance with applicable advertising
requirements, and
- whether the biological contains any substances prohibited under
the Customs Act 1901.
Proposed sections 32DI 32DM set out provisions
relating to an evaluation fee, which is payable for evaluation of
the non-Class 1 biological and may be recovered by the Commonwealth
as a debt due to it. Such a fee would be specified in the
regulations or its method of calculation would be prescribed in the
regulations. The amount may be reduced if the evaluation is
incomplete within a prescribed period of time.
Note that where the Secretary refuses an application to include
a biological in the Register, the Secretary must give the person
notice of the refusal and reasons thereof as soon as practicable
(proposed sections 32DC and
32DG).
As mentioned above, the Bill proposes a tiered regime of
criminal offences and civil penalties, which are consistent with
other parts of the Act, in relation to:
- false statements made in applications to include biologicals in
the Register (proposed section 32DO), and
- failure to notify various matters, such as adverse effects of a
biological, while it is included in the Register or where the
application is withdrawn or lapses (proposed sections
32DQ and 32DR).
It is noted that, under proposed
subsection 32DR(1), where an application to have a
biological included in the Register is withdrawn or lapses, the
Secretary would have discretionary power to give the applicant
written notice within 14 days of the application being withdrawn
or lapsing requiring the applicant to:
- inform the Secretary of whether he or she knows of information
specified in proposed subsection 32DR(2), and
- if so, to give such information to the Secretary.
However, given the 14 day time limit in
particular, it is unlikely that this requirement would pose an
unreasonably heavy onus on such applicants.
Proposed sections 32DS 32DU enable the
Secretary to consult with the Gene Technology Regulator when an
application is made for inclusion of a biological in the Register
and the biological is or contains a genetically modified product or
organism. If the Gene Technology Regulator s advice has been sought
and received under the relevant provision, the Secretary must
consider such advice in making a decision about the
application.
Proposed Division 5 sets out provisions
relating to various types of conditions that would apply to
biologicals included in the Register under proposed Part
3-2A.[12]
Some conditions would apply automatically and others would be
imposed by a legislative instrument made by the Minister. In order
to prevent imminent risk of death, serious illness or injury,
additional conditions can also be imposed at or after the time the
biological is included in the Register. Those conditions may also
be varied or removed from the Register either at the request of the
Secretary or the person concerned (proposed sections
32ED and 32EE respectively).
A breach of a condition would constitute an
offence/contravention, incurring either criminal
penalties/imprisonment or civil penalties, depending on the
circumstances such as the seriousness/likelihood of harm to people
resulting from the breach (proposed sections 32EF
and 32EG).
There are certain conditions that apply automatically to the
inclusion of a biological in the Register, as set out in
proposed section 32EA:
- entry and inspection powers
- delivery of samples
- specific information with respect to the manufacture of the
biological
- expiry date, and
- advertising the biological only for accepted indications.
The Minister may, by legislative instrument, impose conditions
that relate to matters including:
- manufacture of the biological
- custody, use, supply, disposal and destruction of the
biological, and
- record keeping.
It is noted that different conditions may be imposed on
different classes of biologicals, for example:
different record keeping requirements may be applied under this
section where additional tests are required to be undertaken on a
class of biologicals, as prescribed by the standard applicable to
that class of biologicals (section 10 of the Act refers).[13]
The Secretary has discretionary power to suspend a biological
from the Register in particular circumstances, including:
- if the Secretary is satisfied that:
- there is a potential risk of death; or serious illness or
injury, if the biological remained in the Register, and
- during the time of suspension, it is likely that the person (in
relation to whom the biological is included in the Register) will
be able to take necessary action to prevent such potential risk,
or
- if the Secretary is satisfied that there are likely grounds for
cancelling the entry of the biological in the Register under
proposed Division 7.
However, before suspending a biological, the Secretary must
provide that person with written notice about the proposal to
suspend, setting out reasons for the proposed suspension and
inviting the person to make written submissions regarding the
suspension within a specific period of time (no less than 28 days
after the day the notice is given). The Secretary cannot make any
decision about the suspension without considering such
submissions.
The Secretary must revoke a suspension if he or she is satisfied
that the reason for which the biological was suspended from the
Register no longer applies and there are no other grounds for its
suspension (proposed subsection 32FC(1)).
Suspension of a biological from the Register would have the
effect of the biological being taken to generally not be included
in the Register for the purposes of the Act.[14] It is noted that dealing in a
biological that is not included in the Register may be a criminal
offence or civil penalty contravention under proposed
Division 2 (Main criminal offences and civil
penalties).
Under proposed Division 7, the Secretary may
immediately cancel the entry of biologicals in the Register in
particular circumstances. These include where:
- the Secretary is satisfied there would be imminent risk of
death, serious illness or serious injury if the biological remains
in the Register
- the biological either stops being a biological or is declared
by order under section 7 of the Act not to be therapeutic
goods
- the person requests the cancellation in writing (see also
proposed section 32GD)
- the biological contains substances that are prohibited imports
under the Customs Act 1901
- the Secretary is satisfied that a statement made in connection
with the application to include the biological in the Register was
false or misleading in a material particular
- there has been failure to comply with conditions relating to
entry and inspection of premises or to deliver relevant samples,
or
- there has been a breach of advertising requirements
(proposed section 32GA).
It is noted that in such circumstances:
The Secretary is not required to give the person who is
adversely affected by the decision (the person who is given a
notice of the decision), a prior opportunity to respond to the
cancellation. This is because the circumstances set out in
subsection (1) are either very serious and require an
immediate response to prevent or reduce the risk to public health
or are such that inclusion in the Register is no longer appropriate
or necessary.[15]
The Secretary may also immediately cancel the entry of a
biological in the Register due to a failure to comply with an
information gathering notice under proposed section
32JA within a particular period of time (proposed
section 32GB).
Under proposed section 32GC, the Secretary also
has discretionary power to cancel an entry of a biological in the
Register, after notice is given of the proposed cancellation, in
various circumstances including where:
- it appears to the Secretary that the quality, safety, efficacy
or presentation of the biological is not acceptable
- the biological has changed to the extent that it has become
separate and distinct from that which was included in the
Register
- the person has breached conditions to which the inclusion of
the biological was subject (apart from conditions under
proposed subsection 32EA(1) or
(3))
- the person contravenes proposed subsection
32DQ(1) or (2) by failing to notify of
adverse effects of the biological while it is included in the
Register, or
- the biological does not conform to an applicable standard.
In such circumstances, before cancelling the entry of the
biological in the Register, the Secretary must, in writing, notify
the person that the Secretary proposes the cancellation, set out
the reasons for the proposed cancellation and invite the person to
make submissions about it within a specified period of time (not
less than 28 days after the day the notice was given). It is noted
that the Secretary cannot make a final decision without considering
those submissions.
Importantly, it is noted that decisions to cancel an entry of a
biological in the Register are initial decisions and are
consequently reviewable under the Act.[16]
Under proposed subsection 32HA, the Secretary
may require certain people in certain circumstances to recover
biologicals or to inform the public about biologicals that do not
comply with requirements or that have not been lawfully
supplied.
Failure to comply with such requirements may constitute a
criminal offence or a contravention of a civil penalty under
proposed sections 32HC and 32HD
respectively.
The Explanatory Memorandum states that a decision made under
proposed section 32HA would also be a reviewable
decision under the Act.[17]
Under proposed section 32JA, the Secretary may,
by written notice, request certain information or documents
where:
- an application has been made to include a biological in the
Register
- the biological is already in the Register, or
- the person (applying to have the biological included in the
Register) is someone in relation to whom the biological had been,
at any time during the preceding five years, included in the
Register.
There is a tiered regime of criminal offences for failure to
comply with such a notice and for giving false and misleading
information under proposed section 32JB.
Provision of false and misleading information may also result in
a civil penalty under proposed section 32JC.
Importantly, it is noted that proposed section
32JD provides that a person cannot rely on the right to
avoid self-incrimination to avoid complying with such requirements.
However, where information relates to an individual, that person is
protected as information obtained is inadmissible as evidence
against that person, except in certain proceedings for offences
such as failing to comply with a notice etc (proposed
subsections 32JB(1) (3) and (5)); and
proceedings under section 42Y for contravention of provisions
relating to providing false and misleading information
(proposed section 32JC). It is stated in the
Explanatory Memorandum that:
This provision is necessary to ensure compliance with the
necessary requirements and the monitoring of biologicals that will
be supplied to the public or have been supplied to the public. It
is important the Secretary is able to request and obtain the
necessary safety, quality and safety information about biologicals
and that the relevant person requested to provide the information
complies with the request. The receipt of this information about
the biologicals will enable the Secretary to make informed and
timely decisions about biologicals that adversely affect public
health and safety.[18]
The Secretary may, by written notice, also require certain
information or documents about biologicals exempt under the
regulations (proposed section 32JE) and
biologicals exempt to deal with emergencies (proposed
section 32JF). Such information or documents would relate
to one or more of the following:
- the supply of the biological
- the handling of the biological
- monitoring of the supply of the biological
- results of the supply of the biological, and
- any other matter prescribed in the regulations for these
purposes.
The Secretary may, by written notice, also require similar
information or documents about biologicals that are exempt for
special or experimental uses from people approved or authorised to
import, export or supply such biologicals (see proposed
subsections 32JG(1) and (3)). However, a
request for information can also be made to an experimenter using a
biological subject to approval held by another person and covering
the importation into, or supply in, Australia of the biological
only for experimental use in people (proposed subsections
32JG(2)).
Under proposed section 32JH, the Secretary may
require information or documents about biologicals exempted because
substitutes are not available or are in short supply and the
biologicals are necessary for public health interests.
Note that proposed subsection 32JI(1) sets out
criminal offences for failing to comply with such notices. Giving
false and misleading information or documents would constitute
either a criminal offence or a civil contravention under
proposed subsection 32JI(2) and proposed
section 32JJ respectively.
Proposed section 32JK has a similar effect as
proposed section 32JD with respect to
self-incrimination (see above).
Item 26 proposes to insert new section
33B into the Act, providing that Part 3-3 of the Act would
not apply to Class 1 biologicals. According to the Government:
This is because Class 1 biologicals will have a low risk level
and have minimal manufacturing involved in their production. This
also means that manufacturers of class 1 biologicals will not be
required to hold a manufacturing licence.[19]
Items 27 29 propose to amend paragraphs
35(1)(a), 35(2)(a),
35(4)(a), 35(5)(c),
35(7)(c), 35(9)(c),
35A(1)(c) and 35A(2)(c),
effectively exempting biologicals, already exempt for the purposes
of dealing with emergencies, from the respective criminal offences
and civil penalty provisions in those paragraphs. Those offences
and penalties relate to the manufacturing of therapeutic goods and
are consistent with how they apply to other therapeutic goods
exempted the purposes of dealing with emergencies under section
18A.
Item 31 proposes to substitute
paragraph 40(4)(a) in the Act. Section 40 relates
to conditions that may be placed on manufacturing licences of
therapeutic goods. Proposed subparagraphs
40(4)(a)(i) and (ii) provide that in
addition to any condition imposed on a manufacturing licence under
subsections 40(1) and (2), the licensee may also be subject to a
condition that the therapeutic goods conform to applicable
standards and the licensee observes the manufacturing principles
when carrying out steps in the manufacturing process. However,
under proposed subparagraphs 40(4)(a)(iii) and
(iv), this would not apply to biologicals for
supply in circumstances prescribed by the regulations:
because under exceptional release the biologicals may not meet
the applicable standards for the biologicals or their manufacture
[20]
Importantly, item 49 proposes to amend
subsection 60(1) of the Act, so as to include
decisions made under proposed Part 3-2A
(Biologicals) in the definition of initial decision that
would be reviewable under the Act.
Schedule 2 contains proposed amendments
relating to immunity from civil actions generally under the
Act.
Item 14 proposes to insert new section
61A into the Act, which would provide that the
Commonwealth and protected persons would be immune from civil
actions, suits and proceedings, for any loss, damage or injury
resulting from anything done (or omitted to be done) by a protected
person in relation to the performance or exercise of a protected
person s functions, duties or powers under the Act or
regulations.[21]
Omissions would include a failure to make a decision.
It is noted that there would be no immunity for anything done in
bad faith.
Currently, the Act does contain several provisions conferring
similar immunity. However, these provisions differ in terms of the
breadth of immunity conferred and to whom such immunity is
conferred.[22]
Schedule 3 contains proposed amendments to
enable recall of therapeutic goods or a medical device, where the
Secretary believes either that the quality, safety or efficacy of
the goods/device or that the presentation of the goods/device is
unacceptable.
Currently, the Act only enables the Secretary to recall in other
specific circumstances, without being able to do so for
unacceptable quality, safety or efficacy of the goods/device or
presentation of the goods/device.[23]
Schedule 4 sets out proposed amendments to
section 31 of the Act, relating to information gathering.
The amendments proposed in items 1 5 would
enable the Secretary to request information from people who used to
be persons in relation to whom therapeutic goods were included in
the Register but who no longer are in that category of people.
Currently, section 31 does not allow for this to happen. It is
stated in the Explanatory Memorandum that:
A sponsor of therapeutic goods may decide to seek the
cancellation of registered or listed goods in relation to that
sponsor as there may be some safety or quality issues in relation
to those goods. Without the additional power to require sponsors of
cancelled goods to provide relevant information or documents, the
Secretary could be impeded in obtaining information as part of an
investigation into a safety issue if, for example, a person who was
responsible for a registered or listed product had relinquished
that responsibility before the investigation began. These
amendments extend the Secretary s power to obtain information to
such persons for a period of five years.[24]
This could be regarded as being relevant to regulating
biologicals under Schedule 1 of the Bill, as a former registrant
could be required to give certain information under
proposed sections 32DQ and
32DR.
Schedule 5 contains provisions relating to
unpaid annual charges.
Under the Act, annual charges are payable with respect to the
registration, listing or inclusion of therapeutic goods in the
Register, as well as manufacturing licences issued under the
Act.
Part 6 1 of Chapter 6 of the Act deals with payment of charges.
Item 1 proposes to insert new section
44B into the Act, providing that unpaid amounts of:
- annual registration charges
- annual listing charges
- annual charges for inclusion in the Register, and
- annual licensing charges
are recoverable as debts due to the Commonwealth if such amounts
are unpaid at the end of a 28 day period of time commencing after
the day on which such a charge becomes payable.[25]
Schedule 6 contains provisions proposing
various amendments to the Act.
It is noted that items 8 18 propose to
amend section 60A, relating to when the Minister
(in reconsidering an initial decision) or the Administrative
Appeals Tribunal (in reviewing the Minister s reconsideration of an
initial decision) may consider additional information supplied by
the applicant.
It is stated in the Explanatory Memorandum that:
The policy intent of these amendments is that if new information
is provided to the Minister or the AAT, those decision-makers
should be able to remit the decision and the additional information
for consideration by the Secretary (or her delegate), unless the
additional information indicates that the quality, safety or
efficacy of the goods in unacceptable.
However, the way the current provisions operate means that in
some circumstances this may not be possible.
The amendments are intended to rectify this, mainly by drawing a
distinction between initial new information (relevant information
in existence at the time of the initial decision but not made
available to the Secretary or her delegate) and later new
information (relevant information in existence at the time of
Ministerial reconsideration but not made available to the
Minister).[26]
Item 19 proposes to repeal the existing
definition of new information in subsection
60A(8). Under the existing definition, new information is
information that:
- existed at the time the decision was made under sections 25 and
41EC
- was not made available to the Secretary or authorised delegate
for the purpose of making that decision
- is relevant to the decision, and
- includes opinions that are completely or substantially based on
such information, irrespective of whether those opinions were
formed before the decision was made.
Item 17 proposes to amend subsection
60A(8) by inserting a new definition of initial new
information , which essentially reflects the existing meaning of
new information in the Act.
Item 18 proposes to amend subsection
60A(8) by inserting a new definition of later new
information . Later new information would mean information
that:
- existed at the time the decision on reconsideration was
made
- was not made available to the Minister or the Minister s
delegate for the purpose of making that decision, and
- is relevant to the decision.
This would also include opinions that are
completely or substantially based on such information, irrespective
of whether those opinions were formed before the decision was
made.
Item 16 also proposes to amend
the definition of authorised delegate in subsection
60A(8), by adding to the functions of an authorised
delegate. The new function would require the delegate to exercise a
power to decide whether to issue a conformity certificate.
Item 10 proposes to substitute
subsection 60A(4) so that if:
- the appellant applies to the Administrative Appeals Tribunal
(AAT) for a review of a decision on reconsideration, lodging
initial new information in support of the application, and
- the appellant fails to lodge later new information in support
of the application,
the AAT must not remit the matter under
subsection 60A(3) if all of the initial new information was
considered by the Minister in making his or her decision on
reconsideration.[27]
It is stated in the Explanatory Memorandum
that:
This is because the Minister has been given the opportunity to
consider the initial new information in the reconsideration of the
initial decision and no additional later new information is lodged
which the Minister may not have had the opportunity to
consider.[28]
Items 11 14 propose to amend
subsection 60A(5) so that the AAT would be able to
consider initial new information already considered by the Minister
on reconsideration, but would not be able to consider any other new
initial information or later new information unless it is
information indicating that the quality, safety and efficacy of the
therapeutic goods are unacceptable.
This arrangement is designed to ensure that all
the relevant information is first put to the Minister for his or
her consideration before the matter is heard by the AAT on
appeal.
In the absence of any wider commentary, it is difficult to make
an assessment of the proposed amendments. However, the planned
changes for the regulation of biologicals seek to align Australia s
regulatory framework with other international regulatory agencies
such as the US, Canada and Europe. This will ensure that Australia
s regulatory framework remains consistent with those of other
pharmaceutical regulatory agencies and is also part of the broader
regulatory reform program currently being implemented by the TGA.
It appears that the proposed administrative amendments will enhance
the regulation of therapeutic goods in Australia.
Proposed new provision
|
Offence
|
Provision(s) in the Act upon which provision
based
|
|
Sections 32BA to 32BD
|
Importation, exportation,
manufacture or supply of unassessed or unapproved biologicals
|
Section 19B
|
|
Section 32BI
|
Using a biological in the
treatment of another person or solely for experimental purposes, in
circumstances where the biological has not been approved or
assessed or specifically exempted or approved for that purpose
|
Subsections 21A(12) to (14)
and subsection 22(8)
|
|
Section 32CH
|
Breaching a condition
attaching to the exemption of a biological from the requirement to
be included in the Register
|
Subsections 22(7AB) to
(7A)
|
|
Subsections
32CJ(6)-(10)
|
Supplying a biological that
does not conform with an applicable standard
|
Section 30F
|
|
Section 32CN
|
Supplying a biological
authorised by the Secretary under subsection 32CM(1) in a manner
other than in accordance with that authority
|
Subsections 21A(9) to (11)
and subsection 22(7A)
|
|
Section 32DO
|
Making a false or
misleading statement in an application for inclusion of a
biological in the Register
|
Section 22A
|
|
Section 32EF
|
Breaching a condition
attaching to the inclusion of a biological in the Register
|
Subsections 21A(5) to
(8)
|
|
Section 32HC
|
Non-compliance with a
requirement in relation to public notification and recovery of
biologicals
|
Section 30EC
|
|
Subsections 32JB(2)-(5)
|
Providing information or
documentation to the Secretary in purported compliance with a
notice issued by the Secretary if the information or documentation
provided is false or misleading in a material particular
|
Subsections 31(5A)
to (6)
|
|
Civil penalty provision
|
Relevant conduct to which provision relates
|
Maximum penalty
|
Corresponding criminal offence provision in the
Bill
|
Provision in the Act upon which civil penalty provision
based
|
|
Subsections 32BF(1) (5)
|
Importing into, exporting from, manufacturing in or supplying, in,
Australia, biologicals not included in the Register or in relation
to which, or the relevant person specified, exemptions, approvals
or authorities do not apply
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
Sections 32BA-32BD
|
Section
19D
|
|
Subsection 32BF(6)
|
Supplying a biological in Australia without the biological number
on the label
|
200
penalty units for an individual
2,000
penalty units for a body corporate
|
N/A
|
Subsection 19D(4)
|
|
Subsection 32BG(2)
|
Importing into, exporting from, manufacturing in or supplying in,
Australia, a biological if the sponsor has not notified the
Secretary of the manufacturer or manufacturing premises
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
Subsection 32BG(1)
|
Section
20A
|
|
Section
32BK
|
Making
a representation about specified matters that is false or
misleading
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
N/A
|
Subsection 21B(3)
|
|
Section
32CI
|
Breaching a condition of an exemption under proposed section 32CB
in relation to a biological
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
Section
32CH
|
Section
22AA
|
|
Subsection 32CJ(11)
|
Failing
to comply with a requirement to recover substandard or unfit
biologicals
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
Subsections 32CJ(6), (7) and (9)
|
Section
30FA
|
|
Subsection 32DP
|
Making
a false or misleading statement in or in connection with an
application for inclusion in the Register
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
Section
32DO
|
Section
22B
|
|
Subsection 32DQ(2)
|
Failing
to notify the Secretary of adverse effects of a biological
|
3,000
penalty units for an individual
30,000
penalty units for a body corporate
|
Subsection 32DQ(1)
|
Section
29AA
|
|
Subsection 32DR(5)
|
Failing
to notify the Secretary, if required, of adverse effects of a
biological after an application for inclusion of the biological in
the Register lapses or is withdrawn
|
3,000
penalty units for an individual
30,000
penalty units for a body corporate
|
Subsection 32DR(3)
|
Subsection 29C(1)
|
|
Subsection 32DR(6)
|
Giving
information to the Secretary on a lapsed or withdrawn application
for inclusion of a biological that is false or misleading
|
3,000
penalty units for an individual
30,000
penalty units for a body corporate
|
Subsection 32DR(4)
|
Subsection 29C(2)
|
|
Subsection 32EG
|
Breaching a condition of inclusion of a biological in the
Register
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
Subsection 32EF
|
Subsection 21B(2)
|
|
Section
32HD
|
Breaching a requirement relating to the public notification and
recovery of biologicals under section 32HA
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
Section
32HC
|
Sections 30ECA and 41KCA
|
|
Section
32JC
|
Giving
information to the Secretary on a range of matters such as
formulation and design of a biological that is false or
misleading
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
Section
32JB
|
NA
|
|
Section
32JJ
|
Giving
information to the Secretary on a biological exempt under the
regulations, as it is required to deal with an emergency, because
of unavailability, or for special and experimental purposes, that
is false or misleading
|
5,000
penalty units for an individual
50,000
penalty units for a body corporate
|
Section
32JI(2)J
|
N/A
|
|
These tables may be found
at Explanatory Memorandum, op. cit., pp. 33 (criminal offences) and
35 37 (civil offences).
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[8]. See
Therapeutic Goods Administration (2009 Measures No. 3) Bill 2009
Schedule 1, item 25 proposed subsections
32BA(3), 32BB(3),
32BC(3) and 32BD(3).
Rebecca de Boer
Sharon Scully
21 January 2010
Bills Digest Service
Parliamentary Library
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