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2002-2003
THE PARLIAMENT OF THE
COMMONWEALTH OF AUSTRALIA
SENATE
THERAPEUTIC
GOODS AMENDMENT BILL (NO. 1) 2003
REVISED EXPLANATORY
MEMORANDUM
(Circulated by authority of the Hon Trish Worth MP,
Parliamentary Secretary to Minister for Health and
Ageing)
THIS MEMORANDUM TAKES ACCOUNT OF AMENDMENTS MADE BY THE
HOUSE OF REPRESENATIVES TO THE BILL AS INTRODUCED
OUTLINE
The Therapeutic Goods Amendment Bill 2003 makes
changes to the Therapeutic Goods Act 1989 (the Act) and the
Broadcasting Services Act 1992 (the BSA). The main purposes of these
changes are to:
• clarify the definition of a therapeutic good at
the food-medicine interface,
• transfer the remaining advertising
offences from the Therapeutic Goods Regulations to the
Act;
• create new offences for publishing advertisements that
breach the Therapeutic Goods Advertising Code, and extend the coverage of
existing offences to broadcast media;
• make changes to the BSA to
remove the provisions that incorporate the administrative functions relating to
pre-approving advertisements about medicines intended for publication in
broadcast media. The removal of the provisions from the BSA will enable these
functions to be transferred to the Therapeutic Goods
Regulations.
• increase maximum penalties for a range of existing
offences under the Act including where there has been a failure to comply with
standards, false statements made in applications for entry of goods on the
Australian Register of Therapeutic Goods (the Register), breach of a condition
of a manufacturing licence (including failure to comply with the manufacturing
principles), false statements made in a conformity assessment declaration and
the counterfeiting of therapeutic goods;
• create new offences for
falsification of any document that has been created, retained or issued for the
purposes of the Act and for supplying goods originating from a manufacturer or
manufacturing site that has not been notified to the
Secretary;
• expand the compulsory public notification and recall
provisions which may be used where there is a problem with a product or its
manufacture;
• insert a “fit and proper person” test
into the provisions for granting a manufacturing licence or conformity
assessment certificate and suspending or revoking a manufacturing licence or
conformity assessment certificate;
• insert new statutory
conditions of licence to ensure compliance with the manufacturing principles and
reporting of adverse effects known to a manufacturer;
• require
sponsors of therapeutic goods to maintain records of all manufacturers involved
in the manufacture of each batch of therapeutic goods and have them available
for inspection at any time or risk cancellation of the goods from the Register,
as well as requiring them to notify the Secretary of any change of
manufacturer;
• provide for better identification of therapeutic
goods in the event of a recall or where a sponsor applies for re-entry of
previously cancelled goods on to the Register; and
• improve
adverse event reporting for listed goods.
The proposed amendment to the
definition of therapeutic goods in the Act (set out in Part 1 of Schedule 1)
will provide greater clarity and certainty for industry, consumers and
regulators at the food-medicine interface.
There are many occasions
where it can be difficult to ascertain whether certain goods, because of the way
they are presented, are “therapeutic goods” or “foods”.
Where a food standard exists in the Australia New Zealand Food Standards
Code which may apply to that good or class of goods, the current definition
of therapeutic goods does not allow for a determination to be made under section
7 of the Act to address uncertain cases by allowing the Secretary to declare the
goods to be or not to be therapeutic goods. This is the case even where all
stakeholders agree that the good or class of goods should be regulated as
therapeutic goods.
The effect of the current definition is to require
that any complementary medicine, presented as assisting sports people in this
way, be regulated as a food. This means the product (which may be in tablet or
capsule form, with dosage instructions and indications for use) is not subject
to any pre-market assessment, or any of the therapeutic model post-market
regulatory surveillance. Additionally, the product cannot be represented as
medicine or carry medicinal claims, as to do so would render it to be an illegal
food.
The reason for the need for a timely amendment to the definition of
“therapeutic goods” is to prevent further dissatisfaction and
confusion with the regulation around the food-medicine interface as the
status quo represents a gap in the risk management of certain
complementary medicines, which could in the future pose public health and safety
risks to consumers.
The Therapeutic Goods Advertising Code and the
regulatory measures associated with the enforcement of the Code have been the
subject of a review, and changes to both the Code and the enforcement provisions
associated with giving effect to the Code are being made to increase its
effectiveness. Currently, some of the offences relating to advertising still
remain in the Therapeutic Goods Regulations, where the penalty for breaches of
advertising requirements is set at 10 penalty points. Other comparable
advertising offences have been included in the Act, where the penalty for
breaches of advertising offences is 50-100 penalty points. To ensure
consistency of penalties applying for all breaches of the Code, all advertising
offences that are included in the Therapeutic Goods Regulations, are to be
transferred to Part 5-1 of the Act, where other comparable advertising offences
are located (Part 2 of Schedule 1).
Based on recommendations from
previous reviews of the therapeutic goods advertising provisions, a new
requirement is for advertisements published in the different media described as
‘specified media’ to comply with the Code. This will ensure that
the principles of the Code in its entirety will be enforceable in relation to
advertisements published in all major forms of media, including broadcast
media.
The removal, in Schedule 2, of provisions in the BSA relating to
the administrative function to pre-approving advertising intended for broadcast
media will enable these functions to be transferred to the Therapeutic Goods
Legislation.
The purpose of the other amendments to the Act, set out in
Part 3 of Schedule 1, is to tighten the existing requirements placed on
manufacturers and sponsors of therapeutic goods to further ensure the quality,
safety and efficacy of therapeutic goods that are supplied in Australia or
exported from Australia. The need for these amendments arises from the recent
failure of the manufacturer, Pan Pharmaceuticals Ltd, to meet the requirements
of good manufacturing practice, and the difficulties encountered in quickly
identifying affected therapeutic goods for the purposes of recall.
That
case has highlighted the need to more clearly define the responsibilities and
obligations of both sponsors and manufacturers of therapeutic goods, and the
need for such persons to be held more accountable for their statutory
responsibilities and obligations. The offences and penalties require
strengthening to provide a more adequate deterrent to breaches of standards and
other statutory requirements designed to maintain the safety and quality of
therapeutic goods. However, penalty levels are higher than for similar offences
in the Criminal Code, such as falsifying documents, because of the potential to
expose the general public to an unacceptable level of risk.
The amendments have no significant financial impact.
Clause 1: Short Title
Clause 1 states that the short title of the
legislation is the Therapeutic Goods Amendment Act 2003.
Clause
2: Commencement
Clause 2 sets various commencement dates for the changes
set out in the Schedules.
Clause 3: Schedules
Clause 3 has the
effect of stating that the Act will be amended in the manner specified in the
Schedules.
SCHEDULE 1: AMENDMENTS TO THE THERAPEUTIC GOODS ACT 1989
(‘THE ACT’)
PART 1 – DEFINITION OF THERAPEUTIC
GOODS
Item 1: The amendment to the definition of therapeutic
goods in subsection 3(1) of the Act will provide greater clarity and certainty
for industry, consumers and regulators at the food-medicine interface.
The amendment to the definition of “therapeutic goods” will
allow the use of section 7 in the practical manner that the legislation and all
stakeholders always intended. Once a good has been or is declared to be, a
therapeutic good, no matter when this occurs, it will be regarded as a
therapeutic good, despite the fact that it is a good for which there is also a
prescribed food standard.
PART 2 – ADVERTISING OF THERAPEUTIC
GOODS
Item 2: Amends the definition of the ‘Therapeutic
Goods Advertising Code’, previously in the Regulations, to provide for its
notification in the Gazette.
Item 3: Clarifies the various
sections of the Act that require minor amendment to correctly refer to the
advertising provisions inserted in the Act by this Bill, and no longer in the
Regulations.
Item 5: Repeals existing section 42A.
Items 6-16
amend section 42B (Definitions)
Item 6: Inserts a definition
of a ‘broadcaster’ into the Act in relation to the advertising
provisions. A broadcaster is a person whose principal business is broadcasting
or the placement of advertisements for broadcasting (such as an advertising
agency). A sponsor of therapeutic goods cannot be a broadcaster.
Item
7: Inserts a definition of ‘broadcast media’ into the Act.
Provision is made for excluding particular means of electronic media (for
example, advertisements on the internet) from the definition of ‘broadcast
media’.
Items 8, 9, 12 and 13 transfer the
definitions of ‘generic information’, ‘prohibited
representations’, ‘required representation’ and
‘restricted representation’ from the Regulations to the
Act.
Item 10: Replaces the definition of ‘publisher’
in the Act. A publisher is a person whose principal business is publishing or
the placement of advertisements for publication (such as an advertising agency).
A sponsor of therapeutic goods cannot be a publisher.
Item 11:
Inserts a definition of ‘publishing’ in the Act, to include in that
term the insertion of material (such as leaflets) within a magazine or
newspaper.
Item 14: Transfers the definition of ‘specified
media’ from the Regulations into the Act, and expands that definition to
include ‘broadcast media’.
Item 15: Inserts a
definition of ‘visual broadcast media’ into the Act. This
definition is used in the new subsection 42C(4) to limit to visual forms of
media the requirement to include approval numbers on advertisements in broadcast
media.
Item 16: Inserts a new heading and a new section 42BA
clarifying the application of section 42C to advertisements requiring
pre-approval under the Regulations.
Item 17: Replaces existing
section 42C and 42D with a new section 42C.
Subsection 42C(1) makes it an
offence to publish or broadcast, or cause to be published or broadcast, an
advertisement that has not been approved where pre-approval is required under
the Regulations. This offence applies to anyone undertaking these activities,
including publishers and broadcasters. The penalty for this offence is 60
penalty units.
Subsection 42C(2) makes it an offence to publish or
broadcast, or cause to be published or broadcast, an advertisement that differs
from the advertisement that was originally approved. The penalty for this
offence is 60 penalty units.
Subsection 42C(3) provides a defence for
prosecution under subsection (2) for publishers and broadcasters and where an
advertisement only differs in respect of the matters specified.
Subsection 42C(4) makes it an offence for advertisements not to display
an approval number, or to display a false approval number or an approval number
that has expired. The penalty for this offence is 30 penalty
units.
Subsection 42C(5) provides a defence to a prosecution under
subsection (4) for publishers and broadcasters.
Subsection 42C(6) makes
it an offence to publish or broadcast, or cause to be published or broadcast, an
advertisement that contravenes any conditions under which the advertisement was
approved. The penalty for this is 60 penalty units.
Subsection 42C(7)
provides a defence to prosecution under subsection (6) for publishers and
broadcasters.
Subsection 42C(8) makes an offence under section 42C an
offence of strict liability.
Section 42C of the Therapeutic Goods Act
currently contains four offence provisions relating to
advertising that are offences of strict liability. The proposed amendments
extend the coverage of section 42C to also include broadcast media, outdoor
displays and films so that all activities concerning the broadcasting and
publication of advertisements relating to therapeutic goods are treated in a
similar manner. The actual penalty for breaching these strict liability
offences is being reduced from 100 and 50 penalty units to 60 and 30 penalty
units respectively, in order to align with current Commonwealth criminal law
policy.
Where strict liability applies to an offence the prosecution does
not have to prove fault on the part of the defendant (see section 6.1 of the
Criminal Code). The prosecution need only prove that the physical element of
the offence did occur. However, there is a defence of mistake of fact under
section 9.2 of the Criminal Code. Section 9.2 provides that the person is not
criminally responsible for an offence of this nature if, at or before the time
of the conduct, the person considered whether or not a relevant fact existed and
is under a mistaken but reasonable belief about the fact and, had that fact
existed, the conduct would not constitute an offence. If there is a mistake of
fact, the evidential burden of proof is on the defendant who has to adduce or
point to the evidence that suggests a reasonable possibility that the fact
exists or does not exist. If the defendant is able to do this, the prosecution
is required to prove beyond a reasonable doubt that there was no such
mistake.
These section 42C offences are an integral part of the
regulation of advertising of therapeutic goods. It is appropriate that persons
responsible for the publication or broadcasting of such advertisements undertake
their activities in accordance with the requirements of the legislation. The
offences are summary in nature and are aimed at ensuring the responsible
advertising of therapeutic goods. It is important that consumers are not misled
and that they are able to make decisions about using therapeutic goods safely
and appropriately. The expansion of the offence in subsection 42C(1) to
broadcasters is also consistent with responsibilities under the Broadcasting
Services Act 1992 where it is a condition of a broadcasting licence that
unapproved advertisements about therapeutic goods are not
broadcast.
Item 18: Transfers the general provisions relating to
advertisements that do not require pre-approval from the Regulations to the Act,
and inserts them into a new Division 3 of Part 5-1. The item also transfers the
provisions relating to generic information and inserts them into a new Division
4 of Part 5-1.
Section 42DA limits the Division to advertisements about
therapeutic goods other than those for which approval is required under Part 2
of the Therapeutic Goods Regulations. Examples of forms of advertising that do
not require approval where the goods being advertised are designated therapeutic
goods would include flyers, letter box drops, internet advertising, shelf
talkers and other forms of point of sale advertising, not falling within the
definition of ‘specified media’.
Section 42DB defines the
terms ‘applicant’ and ‘approval holder’ for the purposes
of Division 3.
Section 42DC does not allow advertisements for
representations in an advertisement about therapeutic goods to be false or
misleading. The Secretary may prevent publication or broadcast of the offending
advertisement by notifying the person apparently responsible for the
advertisement.
Section 42DD does not allow advertisements to refer to a
serious form of disease that is not appropriate for a consumer to self diagnose
or treat (for example, heart disease) unless the person has approval from the
Secretary or it is permitted under subsection 42DK(1). These types of
representations are termed ‘restricted
representations’.
Section 42DE specifies that applications for
approval to use a restricted representation must be made in writing to the
Secretary.
Section 42DF sets out the process for approving the use of
restricted representations. The representation must be accurate and balanced
and not misleading or likely to mislead.
Section 42DG specifies that the
Secretary must provide notice in writing of whether approval to use a restricted
representation has been granted or refused, and sets out other requirements
relating to the notification, including conditions to which the approval is
subject.
Section 42DH specifies that the Secretary may, in writing, vary
conditions of approval of a restricted representation provided the applicant is
informed of the reasons for the variation and is provided details of how to
appeal the Secretary’s decision.
Section 42DI specifies how and on
what grounds the Secretary may withdraw approval of a restricted
representation.
Section 42DJ specifies that for the purpose of Part 5-1,
the Regulations may further specify representations which are prohibited or
required representations.
Section 42DK specifies that the Secretary may
by notice in the Gazette or on the Department of Health and Ageing’s
website permit the use of a restricted or a prohibited
representation.
Section 42DL specifies the general advertising offences
being transferred from the Regulations. The offences include publishing or
broadcasting an advertisement containing a prohibited representation, use of an
unapproved restricted representation and an advertisement about goods not
entered on the Australian Register of Therapeutic Goods (the Register).
Provision has been made for strict liability to apply to certain physical
elements of these offences.
Section 42DM specifies that it is an offence
for advertisements for therapeutic goods to be either published or broadcast
that do not comply with the Therapeutic Goods Advertising Code.
Section
42DN limits the effect of Division 4 to apply to generic information about
ingredients or components of therapeutic goods.
Subsection 42DO specifies
that generic information must comply with the principles of the Therapeutic
Goods Advertising Code.
Section 42DP makes it an offence to publish or
broadcast generic information that does not comply with the Therapeutic Goods
Advertising Code.
Section 42DP replaces the more specific offence
provisions relating to particular breaches of the Advertising Code with a
general offence for breaching the Code in relation to the advertising of generic
information. The effective administrative sanction of removing a product from
the Register is not available in the case of information about substances that,
by their nature, are not on the Register. In these circumstances it is
appropriate to transfer the offence provisions to the Act in order that an
adequate penalty be available.
The new offences in sections 42DM and 42DP
are also an integral part of the regulation of advertising of therapeutic goods
and hence are offences of strict liability. It is appropriate that persons
responsible for the publication or broadcasting of such advertisements undertake
their activities in accordance with the requirements of the legislation. The
offences are summary in nature and are aimed at ensuring the responsible
advertising of therapeutic goods, so that consumers are not mislead but rather
are able to make rational decisions about using therapeutic goods safely and
appropriately. The penalty provided is 60 penalty units, which is consistent
with Commonwealth criminal law policy relating to offences of strict
liability.
Item 19: Effectively transfers the appeal rights
available under the Regulations to the Act by amending the subsection 60(1)
definition of ‘initial decision’. Review rights are available in
respect of decisions made under new sections 42DF, 42DH and 42DI.
Items 20 and 21: insert into subsection 3(1) in the definition of
‘authorised person’ a reference to ‘a Customs officer
exercising powers in a Customs Place’ and define those
terms.
Item 22: amends the description of what constitutes
unacceptable presentation of therapeutic goods in subsection 3(5) to also
include the presentation of goods capable of being misleading or confusing at to
their identification. Regulations can be made under paragraph 3(5)(e) to the
effect that presentation is unacceptable if the name applied to the goods is not
sufficiently unique to allow identification for the purposes of
recall.
Items 23, 24, 25, 27 and 28: increase the maximum penalty
for a failure to comply with standards, unapproved supply and false statements
in applications for entry of goods on the Register, to imprisonment for 12
months or 1,000 penalty units, or both.
Given the recent experience with
the suspension of Pan Pharmaceuticals Ltd’s manufacturing licence and, as
a consequence the necessity to recall large numbers of therapeutic goods, it has
become clear that the current levels of penalties provided under the Act are an
inadequate deterrent to suppliers of therapeutic goods placing commercial
interests over and above public health and safety. Many goods are supplied at
high volume, high profit margins making current penalties for breaches of
regulatory provisions insignificant in a commercial sense. The supply of unsafe
or poor quality therapeutic goods represents a very serious risk to public
health and there is a need for strong deterrents against illegal, and
potentially dangerous, supply of these goods. For this reason, a message needs
to be sent to the industry that an unacceptable level of risk to public health
will not be tolerated. Also for this reason, a level of penalty commensurate
with the dire consequences to consumers of a failure to comply with a range of
safety issues must be included in the legislation.
As these are
regulatory style offences they need to be dealt with in a timely fashion. This
is why the period of imprisonment has been limited to a maximum of 12 months to
enable the offences to be dealt with in a summary jurisdiction. For lower level
breaches of offences of this kind it is also appropriate that a case not be
required to go to trial.
Item 26: inserts a new offence into
section 20 to cover situations where a sponsor changes the manufacturer of goods
on the Register, or the manufacturing site of those goods, without notifying the
Secretary of that change. Such conduct not only causes difficulties for tracing
the goods in the event of a recall but also increases the level of risk to the
public that the goods may not be manufactured in accordance with appropriate
standards. The maximum penalty for this new offence is to be 12 months
imprisonment or 1,000 penalty units, or both. This level of penalty is
necessary for the same reasons given in respect of items 23, 24, 25, 27 and 28
described above.
Items 29 and 30: insert into the registration
and listing provisions of the Act (sections 25 and 26) a requirement that
applicants nominate all manufacturers that will be used in the manufacture of
the therapeutic goods that are the subject of the application.
Item
31: provides that where a medicine has been previously cancelled from the
Register it cannot be the subject of an automatic listing application under
section 26A of the Act. Applications for listing of such goods must be dealt
with under section 26 of the Act.
Item 32: inserts new statutory
conditions of registration or listing under subsection 28(5) of the Act. These
new conditions require a sponsor of therapeutic goods (i) to keep a record of
all the manufacturers involved in the manufacture of each batch of goods
supplied. These records are to be kept at least until the end of 12 months
after the expiry date for the goods and are to be made available for inspection
by an authorised person at any time; (ii) to notify the Secretary of any change
of manufacturer or manufacturing site; and (iii) to comply with any other
reporting requirements prescribed in the regulations.
Items 33 to 36:
extend the requirement under sections 29A and 29B to notify adverse effects
of therapeutic goods to listed goods and add a requirement to provide
information to the Secretary that indicates that the quality, safety or efficacy
of the goods is no longer acceptable.
Item 37: inserts an
additional ground for immediate cancellation of a registration or listing of
therapeutic goods where a sponsor fails to provide records containing details of
manufacturers involved in the manufacture of each batch of goods supplied, as
required under the new statutory condition inserted into subsection 28(5),
within the specified time.
Item 38: removes a breach of the new
condition under subsection 28(5) relating to provision of details of
manufacturers involved in the manufacture of each batch of goods supplied from
the grounds for cancellation of a registration or listing after notice to the
sponsor. A breach of this condition is to be a ground for immediate
cancellation, as set out in item 37.
Items 39, 40 and 41: repeal
existing public notification and recovery provisions which are in sections 30,
30A and 30B as these are to be replaced by more comprehensive provisions, new
sections 30EA to 30ED. Requirements already imposed under these provisions are
not affected.
Item 42: Inserts new sections 30EA to 30ED into
Part 3-2 of the Act.
Section 30EA provides in subsection (1) that the
requirements set out in subsection (2) may be imposed on various specified
persons where therapeutic goods (including in some cases those to which
exemptions apply) have been supplied which do not comply with standards, where
manufacturing principles have not been observed or manufacture has been carried
out by a manufacturer who did not hold a current licence, where the goods are
not listed or registered nor the subject of an exemption from entry on the
Register, where the goods are counterfeit and where goods have been cancelled
from the Register.
Subsection 30EA(2) provides that the requirements are
recovery of distributed therapeutic goods (except those which have been
administered to or applied in the treatment of a patient) and public
notification of identified circumstances, or of specified information, in a
specified manner and period. One or more requirements may be imposed. Recovery
may be limited to particular batches that are affected by the identified
circumstances (subsection (3)).
Section 30EB provides that a
notice setting out any requirements under section 30EA is to be published in the
Gazette.
Section 30EC creates an offence for failure to comply
with the requirements imposed under section 30EA.
Section 30ED
provides that the Secretary may still cancel the goods from the Register
despite the imposition of a requirement under section 30EA.
Items 43
to 45: increase the maximum penalty for manufacture without a licence and
breach of condition of a licence under section 35 of the Act to imprisonment for
12 months or 1,000 penalty units, or both. The supply of therapeutic goods that
have not been produced in licensed premises or in accordance with the
manufacturing principles or other conditions of licence significantly increases
the risk that public health could be seriously jeopardised. As for the other
penalty increases provided in these amendments, there is a need for a strong
deterrent against illegal supply in these circumstances because of the
significant threat to public health and safety.
Items 46 to 53:
provide for a new ‘fit and proper person’ test to be inserted in
section 38 of the Act where the grant of a manufacturing licence is under
consideration.
In addition to the existing requirements that the
Secretary be satisfied an applicant for a manufacturing licence is in a position
to comply with the manufacturing principles and has satisfactory manufacturing
premises, the Secretary should also be satisfied that the applicant is a fit and
proper person to hold a licence. Further, the Secretary should be satisfied
that all the persons who participate in or are likely to participate in managing
the affairs of an applicant for a manufacturing licence or otherwise have
effective control over the applicant are also fit and proper persons.
New
subsection 38(1A) sets out matters which the Secretary must have regard
to in considering whether the applicant for a licence or persons of influence
are fit and proper persons. The Secretary must consider not only the business
record of the applicant or person in relation to the particular business which
is the subject of the application, but also the business record of any other
business controlled by the applicant or person, and the business record of any
other business or person who controls the applicant or person. Relevant matters
include any previous suspension or revocation of a manufacturing licence, any
conviction for an offence against a law of the Commonwealth or a State or
Territory, and any previous failure to comply with a condition of a
manufacturing licence. These matters are not the only matters to which the
Secretary may have regard in considering whether the applicant or person is a
fit and proper person.
Items 54 to 60: amend section 40 of the
Act to provide for the insertion of two new statutory conditions of licence and,
at the same time, saving existing conditions of licence and the ability of the
Secretary to impose any other conditions the Secretary thinks appropriate.
Authorised persons are also to be able to take photographs of manufacturing
premises, goods and processes without first getting the agreement of the licence
holder (item 58).
The first statutory condition set out in item 56
requires the licence holder to ensure that the goods manufactured conform to any
applicable standard and that manufacturing principles are observed in the
manufacture of the goods (paragraph 40(4)(a) of the Act). The second, set out
in items 57 and 59, requires the licence holder to provide any information the
holder becomes aware of relating to adverse effects (described in subsection
40(5)) of the goods to the Secretary (paragraph 40(4)(ab)). These new statutory
conditions apply to existing licences as well as those granted after
commencement of this amendment (item 60).
Items 61 to 64: amend
section 41 of the Act to expand the circumstances for suspending or revoking a
manufacturing licence where the holder of a licence or any of the persons who
participate in managing the affairs of, or otherwise have effective control
over, the licence holder cease to be considered fit and proper persons to hold a
licence. The circumstances that are to be considered in relation to ‘fit
and proper’ for the purposes of the suspension or revocation are similar
to those provided under section 38 in respect of the granting of a licence.
Item 65: provides for a new ‘fit and proper person’
test to be inserted in section 41EC of the Act where the issue of a conformity
assessment certificate is under consideration.
In addition to the
existing requirements that the Secretary must consider in deciding whether to
issue the certificate, the Secretary should also consider whether the applicant
is a fit and proper person to hold a certificate. The Secretary should also
consider whether all the persons who participate in or are likely to participate
in managing the affairs of an applicant for a conformity assessment certificate,
or otherwise have effective control over the applicant, are also fit and proper
persons.
New subsection 41EC(4) sets out matters which the
Secretary must have regard to in considering whether the applicant for a
conformity assessment certificate or persons of influence are fit and proper
persons. The Secretary must consider not only the business record of the
applicant or person in relation to the particular business which is the subject
of the application, but also the business record of any other business
controlled by the applicant or person, and the business record of any other
business or person who controls the applicant or person. Relevant matters
include any previous suspension or revocation of a conformity assessment
certificate, any conviction for an offence against a law of the Commonwealth or
a State or Territory, and any previous failure to comply with a condition of a
certificate. These matters are not the only matters to which the Secretary may
have regard in considering whether the applicant or person is a fit and proper
person.
Items 66 and 67: amend section 41ET of the Act to expand
the circumstances for suspending or revoking a conformity assessment certificate
where the holder of a certificate or any of the persons who participate in
managing the affairs of, or otherwise have effective control over, the
certificate holder cease to be considered fit and proper persons to hold a
certificate. The circumstances that are to be considered in relation to
‘fit and proper’ for the purposes of the suspension or revocation
are similar to those provided under section 41EC in respect of issuing a
certificate.
Items 68 to 77: increase the maximum penalty in
respect of offences for false statements in applications for inclusion of
medical devices on the Register (s41FE), non-compliance with the essential
principles (s41MA), failure to apply conformity assessment procedures (s41ME and
41MF), false statements in conformity assessment declarations (s41MH), and
unapproved supply of medical devices (s41MI) to imprisonment for 12 months or
1,000 penalty units, or both. The justification for the level of penalty for
these offences relating to medical devices is the same as for similar offences
relating to therapeutic goods dealt with above. The emphasis is on public
health and safety and the necessity to avoid serious harm or death to large
sections of the community.
Item 78: increases the maximum penalty
for counterfeiting of therapeutic goods (s42E) to imprisonment for 5 years or
2,000 penalty units, or both. Dishonesty offences such as counterfeiting and
deliberate falsification of records (see new section 54AB below) warrant even
higher penalties than other regulatory style offences because of the intentional
disregard of the risk to public health and safety and the malicious nature of
such actions. Hence the offences for counterfeiting and falsification of
records have been given high pecuniary penalties and are to be treated as
indictable offences.
Item 79: corrects a minor drafting error in
subsection 54AA(1).
Item 80: inserts a new offence provision,
section 54AB, where a person falsifies any document or otherwise damages,
destroys, alters or conceals any document that has been created, retained or
issued for the purposes of the Act, or for purposes that would include the Act.
The maximum penalty for this offence is imprisonment for 5 years or 2,000
penalty units, or both.
Item 1: Repeals the current definition of ‘medicine’
in Clause 1 of Schedule 2 of the BSA, as this definition will no longer be
required.
Item 2: Repeals subclauses 6(2) to (8) of Schedule 2 of
the BSA. A new subclause (2) retains the requirement for a broadcaster to only
broadcast approved advertisements where advertisements about therapeutic goods
are required to be approved under the Therapeutic Goods Act
1989.
The approval of advertisements under repealed subclauses 6(3)
to (8) of Schedule 2 of the BSA was granted by the Secretary to the Department
of Health and Ageing, or her delegates. Review of the Secretary’s
decisions to be undertaken by the Minister for Communications, Information
Technology and the Arts was available under these repealed subclauses.
By transferring the administrative functions relating to pre-approving
advertisements about medicines intended for publication in broadcast media from
the BSA to the Therapeutic Goods Regulations, inconsistencies regarding the
application of the Therapeutic Goods Advertising Code to advertisements in the
broadcast media will be resolved. The pre- approval and review of decisions in
relation to approval of all advertisements about therapeutic goods will be
undertaken in the same manner, irrespective of the media in which the
advertisement is to appear.
Item 3:
Provides transitional
arrangements for completion of appeals by either the Minister for Health and
Ageing or the Minister for Communications, Information Technology and the Arts
in relation to pre-approval (or non-approval) of an advertisement for medicines
to be published in the broadcast media, where the decision-making process has
not been finalised when these amendments come into operation.