Bills Digest no. 163 2005–06
Therapeutic Goods Amendment
Bill (No. 3) 2006
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
Endnotes
Contact Officer & Copyright Details
Passage History
Therapeutic
Goods Amendment Bill (No. 3)
2006
Date introduced: 11 May 2006
House: House of
Representatives
Portfolio: Health and Ageing
Commencement: On the day of Royal Assent
The Bill proposes amendments to the Therapeutic Goods Act
1989 (the Act) to allow for applications for licences to
manufacture medicines, blood and tissues, to be lodged
electronically with the Therapeutic Goods Administration (TGA).
In Australia the Therapeutic Goods Act 1989 requires, with
certain exceptions, that manufacturers of therapeutic goods hold a
licence.(1) A therapeutic good is broadly defined as a
good which is represented in any way to be, or is likely to be
taken to be, for therapeutic use (unless specifically excluded or
included under Section 7 of the Therapeutic Goods Act
1989).(2)
In order to obtain a licence a manufacturer must demonstrate
compliance with manufacturing principles including relevant Codes
of Good Manufacturing Practice (GMP) and Quality Systems.
Compliance is ascertained by regular onsite audits undertaken by
the TGA.(3)
Under subsection 37(1) of the Therapeutic Goods Act
1989, an application for a manufacturing licence must be made
in writing in accordance with a form approved by the Secretary.
The proposed amendments will remove the requirement for an
application for a manufacturing licence to be made in writing, and
instead permit the electronic lodgement of an application. The
amendments will make section 37 consistent with other provisions in
the Act that permit the electronic lodgement of applications or
information, using software that is compatible with the systems
used by the Department of Health and Ageing.(4)
On October 11 2004 the TGA implemented a new computerised system
called the Manufacturer Information System (MIS) to provide for
more efficient processing of the different types of applications
made to the various areas of the TGA.(5) This was part
of a broader process to convert TGA information systems to an
e-business format, and was in line with the Government s
e-government strategy.(6) The new MIS is designed to
eliminate paper forms and allow for electronic application of:
- manufacturing licences for medicinal products,
- certification by audit of overseas medicines
manufacturers,
- variations to each of the above, and
- clearance certification of overseas medicines manufacturers by
assessment of GMP evidence provided by an overseas regulatory
body.(7)
The benefits associated with the electronic lodgement of
manufacturing licence applications were highlighted in the second
reading speech of the Bill; in particular, that the amendments will
allow manufacturer s to monitor progress with their licence
applications and electronically submit requests for amendments to
their licences.(8) Further, the second reading speech
makes clear that an electronic licence application will not require
any additional information beyond that already required by the
current paper application process.(9)
The introduction of the MIS in October 2004 preceded the release
of an Australian National Audit Office (ANAO) audit report into the
Regulation of Non-Prescription Medicinal Products by the TGA, in
December 2004.(10) The audit assessed the TGA s
regulation of non-prescription medicine products, and in
particular, the systems, procedures and resources used to manage,
monitor and confirm compliance with requirements for manufacture of
non-prescription medicine products. The audit report was critical
of the information management systems and processes employed by the
TGA, including its data management, documentation and recordkeeping
procedures, and recommended that these systems be
improved.(11)
As noted above, the TGA had been progressively implementing a
major information systems project in support of its regulatory
activities. Consequently, the Department of Health and Ageing in
its response to the audit, argued that many of the issues raised by
the ANAO in the audit were being addressed.(12)
Nevertheless, the Department agreed to all the recommendations made
in the audit report and engaged the consultants Deloitte s to
review implementation progress.(13) The subsequent
Deloitte s report, issued in June 2005, found that although the TGA
had planned activities to address all the audit recommendations,
none had been fully implemented at that time.(14)
There is no financial impact, according to the Explanatory
Memorandum.
Item 1 amends paragraph 37(1)(a) of the Act,
which currently requires a manufacturer of medicines, blood or
tissues to lodge an application in writing on an approved form, by
omitting the words in writing .
Item 2 inserts a new subsection 37(3) to allow
or require an application or information lodged by a manufacturer,
to be given in accordance with specified software requirements, on
a specified data processing device or by a specified kind of
electronic transmission.
Concluding comments
According to the government, the amendments proposed in the Bill
are expected to facilitate the speedy submission of licence
applications from manufacturers and the efficient handling of these
applications by the TGA.(15) The amendments address the
audit report recommendations that the TGA improve the integration
of its information management systems, and strengthen its
documentation procedures. However, in light of the Deloitte s
report, Parliament may want to confirm that implementation of all
the ANAO s recommendations has materially progressed since June
2005.
- Good
Manufacturing practice for therapeutic goods . It is an
offence, carrying heavy penalties, to manufacture therapeutic goods
for human use without a licence unless the manufacturer or goods
are exempt from this requirement. TGA website: http://www.tga.gov.au/docs/html/webgmp.htm
accessed 5 June 2006. Products exempt from manufacturer licensing
are listed in Schedule 7 of the Therapeutic Goods Regulations and
similarly persons exempt from licensing are listed in Schedule
8.
- Regulation of
therapeutic goods in Australia . TGA website: http://www.tga.gov.au/docs/html/tga/tgaginfo.htm
accessed 5 June 2006.
- Australia has Codes of GMP and Quality System requirements for
the manufacture of medicinal products, sunscreen products, human
blood and tissues, active pharmaceutical ingredients and medical
devices. See Good Manufacturing
practice for therapeutic goods , TGA website: http://www.tga.gov.au/docs/html/webgmp.htm
accessed 5 June 2006.
- Examples of where the Act already allows for the electronic
lodgement of information include, among others, provisions
contained in paragraphs 8 (1A), 23 (3), 26BA, 31 (3), 31A (4), 31B
(5), 41JB (2), and 41JD (4).
- Manufacturer information system , TGA News issue 45,
November 2004, p.1, URL: http://www.tga.gov.au/docs/html/tganews/news45/cover.htm#mis
accessed 5 June 2006.
- Department of Health and Ageing, Annual Report
2003-04, Canberra, The Department, 2004, p. 87.
- Manufacturer information system , op. cit.
- Hon. Christopher Pyne, Therapeutic Goods Amendment
Bill (No. 3) 2006, Second Reading Speech, House
of Representatives Hansard, 11 May 2006, p. 7.
- ibid.
- Australian National Audit Office, Regulation of
Non-prescription medicinal products : Department of Health and
Ageing, Therapeutic Goods Administration Audit Report no. 18,
2004-05 Performance Audit, ANAO, December 2004.
- ibid, in particular, see audit Recommendation No. 23 and
Recommendation No. 24, pp 119-120.
- ibid, p. 153.
- Department of Health and Ageing, Annual Report
2004-05, op. cit, p. 62.
- Deloitte, Therapeutic Goods Administration: consultancy
findings prepared for the Department of Health and Ageing,
June 2005, p 27. The report was issued in June but not made public
until December 2005. See Lisa Allen, Deloitte tells TGA to improve
procedures Australian Financial Review, 8 December 2005,
p. 7.
- Hon. Christopher Pyne, op.cit.
Amanda Biggs
Social Policy Section
22 June 2006
Bills Digest Service
Information and Research Services
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ISSN 1328-8091
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