Bills Digest No. 127   1997-98 Therapeutic Goods Legislation Amendment Bill 1997


Numerical Index | Alphabetical Index

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

Endnotes

Contact Officer and Copyright Details

Passage History

Therapeutic Goods Legislation Amendment Bill 1997

Date Introduced: 3 December 1997
House: House of Representatives
Portfolio: Health and Family Services
Commencement: Royal Assent

Purpose

To establish a scheme under which confidential information about 'new chemical entities' registered in the Australian Register of Therapeutic Goods will have five years of data protection.

Background

 The Therapeutic Goods Act 1989 (the Act) provides for the compulsory listing of most drugs. High risk products are evaluated for quality, safety and efficacy and registered in the Australian Register of Therapeutic Goods (ARTG). Low risk products, such as those sold over the counter, are assessed for quality and safety and listed in the ARTG. The Act also provides for manufacturers to be licensed to produce various classes of products and for the setting of standards to regulate the quality of products and their advertising and labelling. The Act also establishes the Therapeutic Goods Administration (TGA), a division of the Department of Health and Family Services, to provide administrative support to the Australian Drug Evaluation Committee and to act as the national therapeutic goods control authority.

A new pharmaceutical product must pass through a number of regulatory steps before it can be made available to consumers. Manufacturers are required to submit test data to the Therapeutic Goods Administration in connection with their applications to register new products in the ARTG. At present this confidential information is protected against disclosure, unless release is in the public interest, and also against use by the TGA for its own commercial benefit.(1)

Australia is party to the Trade Related Intellectual Property Agreement (TRIPs) negotiated in 1994 as part of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT). Parties to the TRIPs agreement are required to protect 'trade secrets and knowledge' which have commercial value from 'breach of confidence and other acts contrary to honest commercial practices'. Test data submitted to governments in order to obtain marketing approval for pharmaceutical or agricultural chemicals must be protected against 'unfair commercial use'.(2)

Adequate protection of intellectual property is of fundamental importance to research based industries. Given the high risks and costs involved, pharmaceutical companies rely on a period of patent protection for successful products to secure sufficient return on their total investment in research and development.

In reviewing the Australian Pharmaceutical Industry in 1996 the Industry Commission commented that:

Protection of commercially sensitive data supplied in confidence is understandably a major concern to international businesses. ... Of particular concern is the potential for companies to withhold new drugs from the Australian market if commercial confidentiality cannot be assured.(3)

The Commission found that:

There is a potential for the availability of some important new drugs to be jeopardised in the event that Australia's current practice relating to the protection of confidential information does not meet its international obligations.(4)

This Bill introduces a new 'data protection' regime under which confidential data about a new chemical entity (referred to in this legislation as an 'active component') will have five years of data protection. The period of five years data protection is similar to that provided by several overseas countries, including the United States and New Zealand. In introducing the Bill, the Parliamentary Secretary to the Minister for Health and Family Services, Hon Trish Worth MP, explained the effect of the new regime by saying that:

During this time, any other company seeking to register a generic copy of a registered product containing, or consisting of, the active component will be required to seek the agreement of the originator company before the TGA can directly or indirectly access or reference the originator company's data relating to the same component.

Applicants seeking to register generic products containing protected active components may still do so. However, they must develop and lodge their own full data package, instead of lodging an abbreviated package that demonstrates bioequivalence with a new active component.(5)

Main Provisions

 Item 3 inserts a new definition of 'protected information' in relation to therapeutic goods and establishes a data protection regime for information about a new chemical entity that is lodged in an application to register a product in the Australian Register of Therapeutic Goods (ARTG).

Item 4 provides for the Secretary of the Department of Health and Family Services to cancel the registration of therapeutic goods that have been registered in the ARTG as a consequence of using protected information.

Item 5 enables the Secretary to seek additional information about the manufacturing processes and procedures used to produce goods which are listed (but not registered) in the ARTG.

The purpose of Items 6 and 7 is to stop people who have been convicted of an offence against the Act, or a State or Territory law relating to therapeutic goods, from continuing to manufacture goods through another corporation or entity.

Item 9 provides for the Governor-General to make regulations relating to the issue of permits to import or export therapeutic goods. The effect of this provision is to regulate these activities under the Therapeutic Goods Act 1989 as well as under Customs legislation.

Schedule 2 makes consequential amendments to the Customs Act 1901 to take account of the Governor-General's power to regulate the issue of import and export permits and licences under both Customs legislation and therapeutic goods legislation.

Endnotes

  1. Second Reading Speech, House of Representatives, Debates, 3 December 1997: 11472.
  2. Agreement on Trade-Related Aspects of Intellectual Property Rights, Article 39, Australian Treaty Series, 1995 No.8, Annex 1C: 358-9.
  3. The pharmaceutical industry, Industry Commission, Report, No. 51, AGPS, Canberra, 1996, Vol. 1: 452.
  4. ibid.
  5. Second Reading Speech, loc. cit.

Contact Officer and Copyright Details

Rosemary Bell
20 January 1998
Bills Digest Service
Information and Research Services

This paper has been prepared for general distribution to Senators and Members of the Australian Parliament. While great care is taken to ensure that the paper is accurate and balanced, the paper is written using information publicly available at the time of production. The views expressed are those of the author and should not be attributed to the Information and Research Services (IRS). Advice on legislation or legal policy issues contained in this paper is provided for use in parliamentary debate and for related parliamentary purposes. This paper is not professional legal opinion. Readers are reminded that the paper is not an official parliamentary or Australian government document.

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 1997

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 Department of the Parliamentary Library, 1997.



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