 |
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
This paper has been prepared to support the work of the Australian Parliament
using information available at the time of production. The views expressed
do not reflect an official position of the Information and Research Service,
nor do they constitute professional legal opinion.
IRS staff are available to discuss the paper's contents
with Senators and Members and their staff but not with members of the
public.
ISSN 1328-8091
© Commonwealth of Australia 2006
Except to the extent of the uses permitted under the Copyright Act
1968, no part of this publication may be reproduced or transmitted
in any form or by any means, including information storage and retrieval
systems, without the prior written consent of the Parliamentary Library,
other than by members of the Australian Parliament in the course of their
official duties.
Published by the Parliamentary Library, 2006.
|
 |
