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2004-2005
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS AMENDMENT BILL (No. 2) 2005
EXPLANATORY MEMORANDUM
(Circulated by authority of the Minister for Health and Ageing,
the Honourable Tony Abbott MP)
THERAPEUTIC GOODS AMENDMENT BILL (No. 2) 2005
OUTLINE
The purpose of this bill is to restrict patent certification requirements under subsection
26B(1) of the Therapeutic Goods Act 1989 (the Act) to only those applicants who have to
submit safety or efficacy data and who have relied on safety or efficacy data previously
submitted to the Therapeutic Goods Administration (TGA) by another person in relation to an
approved product, as part of the process for applying for the approval of that product.
Subject to certain exemptions or authorisations under the Act, before a medicine can be
imported into, manufactured in, supplied in, or exported from Australia it must be included in
the ARTG as either a listed or registered medicine. The two-tiered approach to the regulation
of medicines is based on risk with listed medicines being considered low risk and registered
medicines being considered higher risk.
Because of their low risk, listed medicines are not subjected to the same degree of evaluation
as registrable medicines. Listable medicines include most complementary medicines and a
minority of over-the-counter (OTC) products, for example, sunscreens. Applicants seeking to
list a medicine are not required to submit evidence to the TGA regarding the safety or
efficacy of the product. Applicants for listable medicines are required to hold evidence to
support the indications approved for marketing.
Registered medicines generally require full evaluation for quality, safety and effectiveness by
the TGA prior to being included in the ARTG. This group includes a small number of
complementary medicines, the majority of OTC medicines, and all prescription medicines.
A certificate in relation to patents (refer to subsection 26B(1) of the Act) is currently required
to be provided by all applicants seeking to include therapeutic goods (with the exception of
therapeutic and medical devices) in the ARTG on or after 1 January 2005.
The purpose of the certification requirements is to ensure that applicants seeking to include a
product in the ARTG certify either that they will not enter the market in a manner that would
infringe a patent on the product, or if they intend to enter the market before the expiry of any
applicable patent that they have notified the patent owner of their intention to do so.
Concerns have been raised that the current patent certification requirements under the Act are
broader than they need to be because they apply to products such as complementary
medicines that rely on readily accessible public data, and to originator medicines that submit
their own safety or efficacy data. It is considered that the application of the current
certification requirements to such products imposes an unnecessary burden on industry.
The amendments will:
Restrict the patent certification requirement under the Act to only those applicants who
have to submit safety or efficacy data of the goods as part of the process of applying for
inclusion of their product in the ARTG, and who rely on safety or efficacy data
previously submitted to the TGA by another person in relation to an approved product, as
part of the process of applying for approval of that product.
Now require that applicants for the registration or listing of goods either notify the
Secretary that the patent certification requirements under subsection 26B(1) do not apply,
or provide a certificate required under subsection 26B(1) in relation to patents.
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FINANCIAL IMPACT STATEMENT
There is no significant financial impact.
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THERAPEUTIC GOODS AMENDMENT BILL (No. 2) 2005
NOTES ON CLAUSES
Clause 1 - Short title
This clause provides for the Act to be cited as the Therapeutic Goods Amendment Act
(No. 2) 2005
Clause 2 - Commencement
The commencement date for the changes to the Therapeutic Goods Act 1989 (the Act)
contained in clause 3 is on a single day to be fixed by Proclamation. However, if the
amendments do not commence within the period of 6 months beginning on the day on which
this Act receives Royal Assent, they commence on the first day after the end of that period.
Clause 3 - Schedule(s)
Clause 3 has the effect of amending the Therapeutic Goods Act 1989 (the Act) in the manner
specified in Schedule 1.
Schedule 1 - Amendments
Therapeutic Goods Act 1989
From 1 January 2005 all applicants for registration or listing of therapeutic goods in the
Australian Register of Therapeutic Goods (ARTG) (except for therapeutic and medical
devices) have been required to provide a patent certificate required under subsection 26B(1)
of the Act prior to the inclusion of the goods in the ARTG. Proposed new subsection 26B
(1A) under item 12 now limits the circumstances in which a subsection 26B(1) certificate is
required to be provided by applicants for the registration or listing of goods under the Act.
Items 1-3 make changes to the process for registering therapeutic goods in the ARTG. These
changes have been inserted to accommodate new requirements under Item 12 allowing for
the provision of either a certificate required under subsection 26B(1) or a notice that a
certificate under subsection 26B(1) is not required in relation to the application for
registration.
Item 1 - Paragraph 25(4)(d)
Item 1 substitutes a new paragraph 25(4)(d). As a consequence of the inclusion of new
subsection 26B(1A), Item 1 substitutes a new paragraph 25(4)(d) to the effect that instead of
being required to provide a certificate required under subsection 26B(1), applicants for the
registration of therapeutic goods will now be required to provide either: a notification that a
subsection 26B(1) certificate is not required in relation to the application; or the required
certificate under subsection 26B(1) of the Act. The notice or certificate must be provided to
the Secretary of the Department of Health and Ageing (the Secretary) after notification from
the Secretary that (a) the goods are eligible for registration, and (b) that the goods will be
included in the ARTG if the applicant gives the certificate or the notice. The notice, that a
certificate under subsection 26B(1) is not required, must be provided in a form, approved in
writing, by the Secretary.
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Item 2 - Subsection 25(4) (second sentence)
Item 2 substitutes a new second sentence under subsection 25(4). This amendment follows
on from the amendment under Item 1 to the effect that if the applicant for the registration of
goods gives the Secretary a certificate required under subsection 26B(1) of the Act or a notice
that a certificate under that subsection is not required, the Secretary must include the goods in
the ARTG without inquiring into the correctness of the certificate or the notice.
Item 3 - At the end of subsection 25(4A)
Item 3 adds the phrase "or a notice given under subparagraph 25(4)(d) (ii)" at the end of
subsection 25(4A). Subsection 25(4A) provides that civil proceedings will not lie against the
Secretary, or his or her delegate, where the Secretary includes therapeutic goods in the ARTG
in reliance upon the certificate required under subsection 26B(1) which was given by an
applicant to the Secretary, and another party has or claims to have suffered loss, damage or
injury of any kind as a result of the inclusion of the goods in the ARTG. In view of the
amendments made to subsection 25(4) of the Act by Items 1-2 and 12, Item 3 amends
subsection 25(4A) to the effect that civil proceedings will also not lie against the Secretary, or
his or her delegate, in respect of loss, damage or injury of any kind, where the Secretary
includes therapeutic goods in the ARTG in reliance upon the notice under subparagraph
25(4)(d)(ii) that a certificate under subsection 26B(1) of the Act is not required in relation to
the application for registration.
Items 4-6 make changes to the process for including in the Register export only medicines.
These changes have been inserted to accommodate the new requirements under Item 12
allowing for a notice that a certificate under subsection 26B(1) is not required in relation to
the application for listing under section 26 of the Act.
Item 4 - Paragraph 26(1)(aa)
Item 4 substitutes a new paragraph 26(1)(aa). As new subsection 26B(1A) now limits the
circumstances in which applicants for registration or listing of therapeutic goods are required
to provide a subsection 26B(1) certificate, a consequential amendment is required in relation
to paragraph 26(1)(aa). Paragraph 26(1)(aa) is amended to the effect that it now allows an
applicant for listing of therapeutic goods (which are not therapeutic devices) under section 26
of the Act to provide either a certificate required under subsection 26B(1) or a notice that a
certificate under that subsection is not required in relation to the application for listing under
section 26 of the Act. The notice must be in a form approved in writing, by the Secretary.
Item 5 - Paragraph 26(1A)(b)
Item 5 substitutes a new paragraph 26(1A)(b). The current subsection 26(1A) provides that
the Secretary must list the goods if the requirements under paragraphs 26(1A)(a)-(c) are met
or complied with, without inquiring into the correctness of the certificate. As a consequence
of the amendments made under items 4 and 12, paragraph (b) is amended to allow the
applicant to either provide a certificate required under subsection 26B(1) or a notice that a
certificate under that subsection is not required in relation to the application for listing under
section 26 of the Act. And once all the requirements under paragraphs 26(1A)(a)-(c) are met
or complied with, the Secretary will list the therapeutic goods without inquiring into the
correctness of the certificate or the notice.
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Item 6 - At the end of subsection 26(1A)
Item 6 inserts the phrase "or the notice" at the end of subsection 26(1A). Item 6 is a
consequential amendment of Item 5.
Item 7 - At the end of subsection 26(1B)
Item 7 adds the phrase "or a notice given under subparagraph (1)(aa)(ii)" at the end of
subsection 26(1B). Subsection 26(1B) provides that civil proceedings will not lie against the
Secretary, or his or her delegate, where the Secretary list the therapeutic goods in the ARTG
in reliance upon the certificate required under subsection 26B(1) given by an applicant to the
Secretary as part of the application process, and another party has or claims to have suffered
loss, damage or injury of any kind as a result of the listing of the goods in the ARTG. In
view of the amendments made to section 26 of the Act by Items 4-6 and 12, Item 7 amends
subsection 26(1B) to the effect that civil proceedings will also not lie against the Secretary, or
his or her delegate, in respect of loss, damage or injury of any kind, where the Secretary list
therapeutic goods in the ARTG in reliance upon the notice under subparagraph 26(1)(aa)(ii)
that a certificate under subsection 26B(1) of the Act is not required in relation to the
application for listing under section 26.
Items 8, 9 and 10 amend the approval process for including listable medicines in the ARTG
under section 26A of the Act. Listable medicines are in the main, low risk therapeutic goods
that require a different assessment process for the purposes of being granted marketing
approval, than "high risk" registrable therapeutic goods such as prescription medicines that
are intended for use in the treatment of serious medical conditions. These changes have been
inserted to accommodate new requirements under Item 12 allowing for the provision of a
certificate required under subsection 26B(1) or a notice that a certificate under subsection
26B(1) is not required in relation to the application for listing under section 26A of the Act.
Item 8 - Paragraph 26A(1)(b)
Item 8 substitutes a new paragraph 26A(1)(b). The Secretary must list therapeutic goods in
the ARTG where the requirements under paragraphs 26A(1)(a)-(e) are met or complied with.
Currently, subsection 26A(1)(b) requires that the application be accompanied by the
certificate required under subsection 26B(1). As a consequence of the amendment under
Item 12, paragraph 26A(1)(b) now requires that the application be accompanied by either the
certificate required under subsection 26B(1) or a notice that a certificate under that subsection
is not required in relation to the application for listing under section 26A. The notice must be
in a form, approved in writing by the Secretary.
Item 9 - Paragraph 26A(1A)(b)
Item 9 substitutes a new paragraph 26A(1A)(b). Subsection 26A(1A) provides that the
Secretary must list the medicine if the requirements under paragraphs 26A(1)(a), (b) and (c)
are met or complied with, without inquiring into the correctness of the certificate. As a
consequence of the amendments under Item 8 and 12, subsection 26A(1A) now provides that
the Secretary must list the medicine if the requirements under paragraphs 26A(1)(a)-(c) are
met, including in circumstances where the applicant provides a notice under paragraph
26(1A)(b) that a certificate under that subsection is not required in relation to the application
for listing under section 26A of the Act, without inquiring into the correctness of the
certificate
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Item 10 - At the end of subsection 26A(1A)
Item 10 adds the phrase "or the notice" at the end of subsection 26A(1A). Item 10 is a
consequential amendment to Item 9.
Item 11 - At the end of subsection 26A(1B)
Item 11 adds the phrase "or a notice given under subparagraph (1)(b)(ii)" at the end of
subsection 26A(1B). Subsection 26A(1B) provides that civil proceedings will not lie against
the Secretary, or his or her delegate, where the Secretary lists a medicine in the ARTG in
relation to a person in reliance on the certificate required under subsection 26B(1) given by
that person to the Secretary under subsection 26B(1), and another party has or claims to have
suffered loss, damage or injury of any kind as a result of the listing of the goods in the
ARTG. In view of the amendments made to section 26A of the Act by Items 8-10 and 12,
Item 11 amends subsection 25(4A) to the effect that civil proceedings will also not lie against
the Secretary, or his or her delegate, in respect of loss, damage or injury of any kind, where
the Secretary includes therapeutic goods in the ARTG in reliance upon the notice under
subparagraph 26A(1)(b)(ii) that a certificate under subsection 26B(1) of the Act is not
required.
Item 12 - Before subsection 26B(1)
Item 12 inserts a new subsection 26B(1A) which restricts the patent certification requirement
under subsection 26B(1) of the Act to only apply to applications for registration or listing
when the following circumstances are satisfied:
(a) the applicant is required to submit evidence or information to establish the safety or
efficacy of their product as part of the process of applying for the registration or listing of
therapeutic goods in the ARTG; and
(b) in doing so, the applicant relies (in whole or in part) on evidence or information,
previously submitted to the TGA by another person to establish the safety or efficacy of other
therapeutic goods that have already been registered or listed; and
(c) the evidence or information was provided by that other person to the TGA as part of the
process of applying for registration or listing of those other goods.
The intent of this item is to only require the provision of a patent certificate required under
subsection 26B(1) by an applicant for the registration or listing of therapeutic goods where
that person (the second applicant) is required to submit evidence or information establishing
the safety or efficacy of therapeutic goods which are the subject of the application, relies on
evidence or information establishing the safety or efficacy of other goods that have already
been registered or listed, and the evidence or information has been given to the TGA by
another person as part of the process of applying for the registration or listing of those goods.
Item 13 - Subsection 26B(1)
Item 13 is a technical amendment.
Item 14 - After Section 26B
Item 14 inserts a new subsection 26B(1A) in relation to what type or form of a notice for the
purposes of including goods in the ARTG under subsection 25(4), 26(1) and 26A(1) can be
permitted or required by the Secretary. New subsection 26B(1A) provides that an approval
of a form for a notice (that a subsection 26B(1) certificate is not required in relation to the
application for listing or registration of therapeutic goods in the ARTG) by the Secretary,
may require or permit the notice to be given in accordance with specified software
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requirements, on a specified kind of data processing device, or by way of a specified kind of
electronic transmission. Permitting or requiring the approved form of the notices to be given
in an electronic form allows for the electronic lodgement of these notices.
Item 15 - Application
Item 15 makes it clear that the amendments to the Act only apply to applications for
registration or listing of therapeutic goods under section 23 of the Act that are lodged on or
after the day on which the amendments come into effect. Applications for registration of
therapeutic goods lodged prior to the commencement of these amendments and which have
not yet been evaluated under section 25 of the Act or have not yet been included in the ARTG
will not be affected by these amendments.
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