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2010 - 2011
THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA
HOUSE OF REPRESENTATIVES
THERAPEUTIC GOODS LEGISLATION AMENDMENT (COPYRIGHT) BILL 2011
EXPLANATORY MEMORANDUM
(The Hon Catherine King, Parliamentary Secretary for Health and Ageing)
THERAPEUTIC GOODS LEGISLATION AMENDMENT (COPYRIGHT) BILL 2011
OUTLINE
Generally, therapeutic goods are required to be approved for inclusion in
the Australian Register of Therapeutic Goods (the Register) before they can
be lawfully marketed and supplied in Australia. Inclusion of prescription
and other higher risk medicines in the Register signifies they have
undergone a high level of scrutiny before they are approved.
A draft Product Information document ("PI") is lodged as part of the
application process for registration of these medicines under the
Therapeutic Goods Act 1989. The PI is approved by a delegate of the
Secretary to the Department of Health and Ageing as part of the
registration process. Any subsequent variation to a PI must also be
approved.
The purpose of the approved PI for a medicine is to assist medical
practitioners, pharmacists and other health professionals to prescribe and
dispense the medicine appropriately and safely and to assist them to
provide patient education so as to support high quality and safe clinical
care.
The PI contains technical information about the medicine such as the
characteristics of the active ingredient, its indications and
contraindications, a description of clinical trials that support the
indications, precautions, possible adverse reactions, dosages and storage,
and other information relating to the medicine's safe and effective use.
It has been a long-standing practice in the Therapeutic Goods
Administration (TGA) for delegates to approve the text of the PI of generic
versions of a prescription medicine that is essentially the same as the
approved PI of the "original" medicine. It is important for the safe and
effective use of the medicine that doctors, pharmacists and other health
professionals receive the same information about a medicine regardless of
the brand, thus avoiding any perception that differences in the text of the
PIs reflect clinical and/or pharmacological differences.
Recently a number of pharmaceutical companies that have prescription
medicines on the Register ("originator companies") have taken, or
threatened to take, legal action on the basis that they own the copyright
in the approved PI for their medicines.
In 2008, the Federal Court granted an interlocutory injunction to a
pharmaceutical company sponsor of a registered medicine partly on the basis
of an argument that copyright in the approved PI for that medicine would be
infringed by a competitor's use of the approved PI for a generic version of
the medicine.
The Federal Court hearing in this matter is scheduled for March 2011 and
the issue of copyright in the approved PI of a registered medicine will be
considered by an Australian court for the first time.
The Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 (the
Bill) provides an exemption to the infringement of copyright that may
subsist under the Copyright Act 1968 where a person uses the relevant text
for the purposes of applying to register a medicine, or for the purpose of
varying the approved PI of a medicine, or any incidental or ancillary acts.
The exemption applies to these acts irrespective of when the PI was
approved. The exemption will also apply to third parties supplying,
reproducing, publishing, communicating or adapting an approved PI for a
medicine where such acts are for purposes related to the safe and effective
use of the medicine.
The amendments are intended to prevent companies commencing legal action
asserting copyright in the text of an approved PI where it is used in the
PI of another version of the same medicine. They will enable the sound
public health objectives underlying the TGA's practice in relation to the
approval of the PIs of generic medicines to continue to be met.
FINANCIAL IMPACT STATEMENT
This measure would ensure that the Commonwealth is not subject to
additional costs resulting from any delays in generic medicines being
listed under the Pharmaceutical Benefits Scheme (thus triggering a
statutory price reduction) and ensure that generic medicines are not
subject to unnecessary additional costs in gaining access to the Australian
market. No additional administrative costs to the TGA will result as it
operates on full cost recovery.
THERAPEUTIC GOODS LEGISLATION AMENDMENT (COPYRIGHT) BILL 2011
NOTES ON CLAUSES
Clause 1: Short Title
Clause 1 is a formal provision specifying the short title of the Bill.
Once enacted, its title will be the Therapeutic Goods Legislation Amendment
(Copyright) Act 2011.
Clause 2: Commencement
This clause provides that the Act commences on the day after it receives
Royal Assent.
Clause 3: Schedules
This clause provides that each Act specified in a Schedule to the Bill is
amended or repealed as set out in the applicable items in the Schedule, and
any other item in a Schedule to the Bill will, once enacted, have effect
according to its terms.
Schedule 1 - Amendments
Copyright Act 1968
Item 1
This item inserts new section 44BA in Part III of the Copyright Act 1968.
Proposed section 44BA provides that certain acts are not an infringement of
copyright subsisting in a work that is Product Information (PI) approved
under the under the Therapeutic Goods Act 1989 (the TG Act) in relation to
particular medicines.
Proposed subsection 44BA(1) provides that the following acts are not an
infringement of any copyright subsisting under Part III of the Copyright
Act (copyright in original literary, dramatic, musical and artistic works)
in a work that is approved PI under section 25AA of the TG Act:
a) acts done under the TG Act in respect of PI for any restricted
medicine, for any other medicine in respect of which the Secretary
has, under subparagraph 25(1)(da)(ii) of the TG Act, required a PI
document to be provided, and for any medicine in respect of which the
Secretary has otherwise approved PI under section 25(4) of the TG
Act; and
b) acts ancillary or incidental to an act referred to in paragraph (a).
PI approved under section 25AA of the TG Act is the following:
a) PI approved by the Secretary in relation to a medicine included in the
Register under subparagrapah 25(4)(d)(ii) after the legislative
instrument made under subsection 3(2A) and 3(2B) of the TG Act comes
into effect (subsections 25AA(1) and (3) of the TG Act);
b) PI in relation to a medicine included in the Register before the
commencement of that legislative instrument, that was approved by the
Secretary in a notice given under subsection 25(4) of the TG Act,
including that PI as varied before that time (subsection 25AA(2) of
the TG Act); and
c) PI approved in relation to a medicine before or after the commencement
of section 44BA, and subsequently varied under section 25AA of the TG
Act (subsections 25AA(4) and (5) of the TG Act).
The exemption in proposed subsection (1) will only apply to acts done after
the commencement of the amendments.
The effect of proposed subsection (1) is to enable any person applying to
register a medicine who is required to lodge a PI for approval as part of
the registration process, or a sponsor of a registered medicine seeking to
vary an approved PI, to lodge PI without infringing any copyright if the
lodged PI contains text in PI previously approved by the TGA under section
25AA of the TG Act (as described above).
The requirements for lodging a PI in relation to the registration of a
medicine under section 25 of the TG Act are set out in paragraph 23(2)(ba)
and subparagraph 25(1)(da)(ii) of the TG Act.
If the application is made under section 23 of the TG Act to register a
restricted medicine in the Register, the application is required to be
accompanied by PI for that medicine using a form approved by the Secretary.
A restricted medicine is a medicine, or class of medicines, specified by
the Minister in a legislative instrument made under the TG Act. Restricted
medicines include medicines that must be prescribed by a medical
practitioner and medicines that are "pharmacist only" medicines (substances
the safe use of which requires professional advice and are available from a
pharmacist without a prescription).
The requirement for PI to be provided in relation to an application to
register a medicine that is not a restricted medicine applies where the
Secretary notifies the applicant for the registration of a medicine to give
to the Secretary, in an approved form, PI for that medicine (refer to
subparagraph 25(1)(da)(ii) of the TG Act).
Variations to approved PI can be made by the Secretary under section 25AA
of the TG Act, including as a result of a request under section 9D of the
TG Act for a variation to the entry of a registered medicine.
Proposed subsection 44BA(2) provides that the supplying, reproducing,
publishing, communicating or adapting in Australia of any, or any part of,
PI that has been approved under section 25AA of the TG Act in relation to
medicine is not an infringement of any copyright subsisting under Part III
of the Copyright Act in a work that is PI approved under section 25AA of
the TG Act, providing that any such act is undertaken for a purpose related
to the safe and effective use of the medicine.
The use by pharmaceutical companies and their employees and agents of
approved PI in presentations about the relevant medicine and the making
available online of approved PI for the use of health professionals are
instances of acts that would be covered by the exemption set out in
proposed subsection (2).
Proposed subsection 44BA(3) provides that any act that is ancillary or
incidental to an act set out under proposed subsection (2) is not an
infringement of any copyright subsisting in the relevant work.
Proposed subsection 44BA(4) provides that for the purposes of the section,
medicine, approved product information and restricted medicine, have the
same meaning as in the TG Act.
Item 2
This item provides that new subsections 44BA(1), (2) and (3) inserted by
item 1 apply in relation to acts done on or after the day on which the
provisions commence.
The acts done after commencement may relate to PI approved under section
25AA after the commencement of these provisions but also to PI approved by
the Secretary before that commencement, that is, approved or taken to be
approved under section 25AA as described above.
Item 3
Sub-item (1) provides that where the operation of the amendments set out in
Schedule 1 to the Bill result in an acquisition of property from a person
otherwise than on just terms, the Commonwealth is liable to pay a
reasonable amount of compensation to the person. The inclusion of this
provision ensures the constitutional validity of the proposed amendments.
Sub-item (2) provides that if the Commonwealth and the person claiming
compensation do not agree on the amount of the compensation the person may
institute legal proceedings in a court of competent jurisdiction for the
recovery from the Commonwealth of a reasonable amount of compensation as
determined by the court.
Sub-item (3) provides that for the purposes of this item the terms
acquisition of property and just terms are to have the same meaning as in
paragraph 51(xxxi) of the Constitution.