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1998-1999-2000
THE PARLIAMENT OF THE
COMMONWEALTH OF
AUSTRALIA
SENATE
THERAPEUTIC
GOODS AMENDMENT BILL (NO. 4) 2000
EXPLANATORY
MEMORANDUM
(Circulated
by authority of the Parliamentary Secretary to the Minister for
Health
and Aged Care, Senator the Hon Grant Tambling)
ISBN: 0642 464251
THERAPEUTIC GOODS AMENDMENT BILL (NO. 4)
2000
OUTLINE
The Bill makes a number of changes to allow the introduction of a redeveloped
system for electronically entering listable medicines on the Australian Register
of Therapeutic Goods (the Register). This new refined listing system seeks to
assure the safety and quality of and consumer confidence in listable
medicines whilst facilitating quicker market access by applicants
(sponsors). Listable, or listed, medicines are considered to be of low risk
based on their ingredients and therapeutic indications and claims. Most
complementary medicines (eg herbal, vitamin and mineral products) and sunscreens
fall into this category, and also some over-the-counter medicines.
Under
the changes introduced by the Bill sponsors of listable medicines will have
greater responsibilities in relation to pre-market assessment of the medicines
they wish to list on the Register and the Therapeutic Goods Administration (TGA)
will assume greater post-market monitoring responsibilities in relation to these
medicines. This shift in responsibilities emphasises the accountability of
sponsors to provide correct information in applications to list medicines. There
will be a corresponding increase in penalties for sponsors that provide false or
misleading information in any documentation, including applications to list
medicines. The changes will expand the Secretary’s power to take action
to cancel the listing of a medicine that does not comply with the listing
requirements or where the sponsor fails to comply with a request to supply
information.
Financial Impact Statement
The amendments to
the Therapeutic Goods Act 1989 have no significant financial
impact.
Clause 1: states that the short title of the legislation is
the Therapeutic Goods Amendment Act (No.4) 2000.
Clause 2:
sets out the commencement date for the changes set out in Schedule 1.
Schedule 1 will come into effect on a day to be fixed by Proclamation or, at the
latest, 6 months from the day the Bill receives Royal Assent.
Clause
3: has the effect of stating that the Therapeutic Goods Act 1989 (the
Act) will be amended in the manner specified in the Schedule.
SCHEDULE
1 - Electronic Lodgement Facility for listing medicines
Item 1:
inserts a definition of "export only medicine". An "export only medicine"
is one that is manufactured in Australia or imported into Australia for export
only and is required, under the regulations, to be included in the part of the
Register relating to listed goods only because it has been manufactured or
imported solely for that purpose. Where a medicine that is manufactured
or imported for export only can also be caught under another Item under Schedule
4 of the Regulations (which lists what goods are listable), then it is not an
“export only medicine”, and will be eligible for listing under
section 26A of the Act using the new electronic lodgement facility, whereas an
"export only medicine" will only be eligible for listing under section 26 of the
Act.
Items 2 and 3: insert definitions of "listable goods"
(those required to be included in the part of the Register for listed goods) and
"working day".
Items 4 and 5: amend subsection 16(1) of the Act
to provide for a new description of what constitutes separate and distinct
listable medicines. This description does not apply to export only medicines.
There are to be three features that will define what makes listable medicines
separate and distinct from other therapeutic goods. These are
different active ingredients, different quantities of active ingredients or
different dosage form. Other different characteristics may be set out in the
regulations.
Item 6: inserts a new offence in subsection 22(2A)
for the making of false or misleading statements in relation to certification of
matters for the listing of medicines under section 26A. The certification
includes statements regarding the safety of the medicine for the purposes for
which it is to be used, conformity with applicable standards, compliance with
prescribed quality or safety criteria and correctness of the information
provided with the application.
The electronic listing of medicines under
section 26A relies heavily on information provided by applicants and is
predicated on self-assessment, rather than the TGA checking every detail to
establish whether the medicine meets statutory requirements for listing in the
listing process. An applicant could, on the basis of false or misleading
information, successfully list a medicine and place it on the market. This
would create potential risks to public health by the supply of potentially
dangerous medicines.
The penalty of 400 penalty units is designed to
discourage the provision of inaccurate information that could have serious
public health consequences. It also reflects the higher risk of false or
misleading information resulting in a successful listing under a fully
electronic lodgement process. A lesser penalty for provision of false or
misleading information is currently provided in subsection 22(2) of the Act
where listing is achieved through a combination of an electronic lodgement
process followed by an immediate review of the application by the TGA. This is
because, under current arrangements attracting the lower penalty, the TGA has a
much greater opportunity to assess the information upon which the application is
based at the time of the application.
Item 7: clarifies the
operation of paragraph 26(1)(j) of the Act which, in its previous form, was
unclear in its intent. This paragraph deals with the situation where the
Secretary refuses to list therapeutic goods that are manufactured or imported
solely for export because an importing country has not agreed to accept the
goods. The goods may not have been accepted for listing or registration
for supply in Australia or the Secretary may have required this agreement from
the importing country for some other reason.
Item 8: replaces the
words "therapeutic goods" in paragraph 26A(1)(a) with the word "medicine" to
reflect the fact that listing under section 26A is now to be restricted to
medicines that are listable goods. Listing of other therapeutic goods not
covered by section 26A will take place under section 26.
Item 9:
repeals paragraph 26A(1)(b). That paragraph required compliance with
requests by the Secretary for information in relation to therapeutic goods prior
to listing of the goods on the Register. This paragraph is redundant because
entry onto the Register will be largely automatic once an application has been
submitted by an applicant using the electronic lodgement facility and any
requests for information about the goods will be made after entry of the goods
on the Register, as part of the post-market monitoring.
Item 10:
provides for the exclusion of export only medicine from listing under section
26A.
Item 11: makes it clear that the Secretary must list a
medicine where the medicine meets the requirements of subsection
26A(1).
Item 12: replaces subsection 26A(2) with a new
certification requirement for applicants seeking listing of a medicine.
Paragraphs (h), (i), and (j) are matters which were not previously required to
be certified. These require the applicant to certify that the application
contains the names of all manufacturers of the medicine, that written agreements
are in place with prescribed manufacturers and that information or evidence is
held to support any claim made relating to the medicine. These additional
certifications emphasise the accountability of the applicant at the time of
listing of a medicine. The other certification requirements reflect those
previously contained in the repealed subsection 26A(2).
Items 13 to
17: make a number of changes to section 26A to restrict its operation to
the listing of medicines that are listable goods.
Item 18:
inserts a new matter to be taken into account under paragraph 26A(4)(c)
where the Secretary is certifying the manufacturing and quality control
procedures in respect of medicines manufactured overseas. The Secretary may
consider whether the applicant has complied with any request for information
that is made under section 31 of the Act relating to the manufacture or
preparation of the medicine. This amendment recognises that, whilst the power
to require information under section 31 will no longer be required for the
purpose of making a decision on the application for listing of the medicine, it
will be required for the purpose of certification of the acceptability of
manufacturing facilities of overseas manufacturers under subsection 26A(3).
This certification takes place prior to an application for listing being
made.
Items 19 to 26, and Item 28: make a number of further
changes to section 26A to restrict its operation to the listing of medicines
that are listable goods.
Item 27: removes the
requirement under subsection 26A to notify an applicant of a decision on the
application. This requirement is redundant as listing will be automatic
providing the requirements of section 26A are met.
Item 29:
inserts a new condition of listing for medicines listed under section 26A
that the sponsor deliver samples requested by the Secretary within the period
specified (which must be at least 10 working days) and in accordance with any
other requirements specified by the Secretary. Subsection 23(2) gives
the Secretary the power to require samples to be delivered to the TGA before an
application is treated as effective. For goods that are automatically listed
under the electronic lodgement facility following self-assessment by the
applicant this power will be redundant. A key aspect of post-market monitoring
of listed medicines will be laboratory testing to determine the composition and
quality of medicines. This amendment will strengthen the post-market monitoring
system for listed medicines.
Item 30: This amendment makes it
clear that the grounds for cancelling goods under paragraph 30(1)(e) of the Act
applies to listed medicines that have been listed under section 26A of the
Act.
Item 31: inserts two new grounds in section 30 (subsections
(1A) and (1C)) for the cancellation of the listing of medicines that are listed
under section 26A. Firstly, where the medicine is not eligible for listing, is
exempt, or there is a serious breach of the advertising requirements which
results in the presentation of the medicine (except a medicine that is
manufactured or imported for export only) being misleading to a significant
extent, the listing may be cancelled by notice in writing. Secondly, the
listing may be cancelled by notice in writing where the sponsor fails to comply
within 20 working days with a request for information, made for the purpose of
determining whether the medicine should have been listed, for information or
documents relating to the medicine.
Listed medicines are required to
meet certain eligibility criteria for listing including that they may only
contain certain substances (considered to be low risk) and they may not make
claims in relation to serious diseases. A medicine that contains a non-listable
substance or makes a claim in relation to a serious disease, for which it has
not been evaluated, represents a risk to public health and safety and should not
be supplied without pre-market evaluation. Medicines that are exempt from the
operation of Part 3 of the Act should not be listed on the Register.
A
serious breach of the advertising requirements that results in the presentation
of the medicine being misleading to a serious extent may pose a risk to public
health. Misleading information may arouse unwarranted and unrealistic
expectations of the safety and effectiveness of the medicine. It may lead to
consumers self-diagnosing or inappropriately treating potentially serious
diseases without seeking appropriate medical advice. It may also encourage
inappropriate consumption of a medicine.
Post-market monitoring of listed
medicines will rely in part on the ability of the TGA to obtain information from
the applicant in order to determine whether the medicine meets the criteria for
listing. If an applicant fails to supply such information the TGA will be
unable to determine whether the medicine should have been listed. If the
medicine does not meet the criteria for listing there is a risk that a
potentially dangerous medicine will continue to be available for public
consumption.
Item 32: clarifies that the ground for cancellation
under paragraph 30(2(ba) of the Act applies to listed medicines that have been
listed under section 26A of the Act.
Item 33: provides for the
cancellation by notice in writing of medicines listed under section 26A where
certifications under paragraph 26A(2)(h), (i), (j) or (k) are incorrect. This
expands the cancellation power to incorporate the new certification requirements
described in Item 12.
Item 34: provides for the application of
the provision specifying the date of effect of cancellation to cancellations of
listings under new subsections 30(1A) and (1C).
Item 35: inserts
a new offence provision into section 31 in respect of medicines listed under
section 26A, where false or misleading information is provided in purported
compliance with a request for information relating to the medicine. A maximum
penalty of 400 penalty units is provided. This provision complements the new
offence provision described in Item 6. To undertake surveillance of medicines
listed under section 26A information about the medicine may be requested under
section 31. The content of this information may determine whether or not a
medicine is to remain listed on the Register and therefore available for public
consumption. If this information is false or misleading in a material
particular there is a risk that a potentially dangerous medicine will continue
to be available for public consumption. The high penalty is meant to be a
deterrent to sponsors of medicines for similar reasons to those described in
Item 6.
Item 36: provides for the application of the amendments
contained in this Bill to pre-existing applications or therapeutic goods that
are listed on the Register. Applications for listing made prior to commencement
of this Bill will continue to be dealt with under the Act as in force
immediately before commencement. However, new subsection 16(1A) will apply to
all medicines listed before commencement of the Bill and new subsections
30(1A-C) will apply to medicines listed under section 26A before commencement of
this Bill.