Transparency review of the TGA

20 July 2011

Report of the Review to improve the transparency of the Therapeutic Goods Administration

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Background to the Review

Introduction

On 16 November 2010, Parliamentary Secretary for Health and Ageing, Catherine King announced a comprehensive review of the way in which the Therapeutic Goods Administration (TGA) communicates its regulatory processes and decisions. The review will focus on improving the TGA's transparency.

The decision to establish the review reflects community concern about the lack of information made available by the TGA.

The purpose of the project is to improve public knowledge of regulatory decision-making and to enhance public understanding of the benefits and risks of therapeutic goods so that the Australian community can understand how the TGA operates and the reasons for its key decisions.

The review panel will be chaired by Professor Dennis Pearce AO.

Professor Pearce is a former Commonwealth Ombudsman, former Chair of the Australian Press Council and is Special Counsel, DLA Phillips Fox lawyers. He has conducted numerous reviews for both the Australian and ACT governments.

The other members of the panel were nominated by key consumer, health practitioner and industry bodies, and are listed below.

Consumers, health practitioners, industry and the public will all have the opportunity to provide input to the review.

The TGA will ensure that the review includes a careful and thorough consultation with all stakeholders to take into account any concerns associated with the publication of commercially sensitive information.

The TGA reforms are consistent with the Government's policy of reducing unnecessary regulatory burden, and its increased transparency agenda, particularly its changes to the Freedom of Information Act 1982 to improve public access to decision-making.

Panel membership

Name	Organisation
Pearce, Dennis	CHAIR - TGA Transparency Review
Aloizos, John	Australian Medical Association
Bennett, Carol	Consumers Health Forum of Australia
Carey, Karen	Consumers Health Forum of Australia
de Somer, Elizabeth	Medicines Australia
Harvey, Ken	Choice
Hughes, Clifford	New South Wales Clinical Excellence Commission
Lynch, Kate	Generic Medicines Industry Association
Marcus, Alison	Consumers Health Forum of Australia
McLachlan, Andrew	National Medicines Policy Committee
Morrow, Wendy	Complementary Healthcare Council of Australia - appointed 16/06/2011
Scarff, Steven	Australian Self Medication Industry
Smith, Janie Resigned 15/05/2011	National Rural Health Alliance
Tomas, Kristy Resigned 13/05/2011	Complementary Healthcare Council of Australia
Trimmer, Anne	Medical Technology Association of Australia

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Terms of reference

The panel will consider and report on:

• The current arrangements for disclosure of information or advice in relation to all therapeutic goods currently on the market in Australia or previously approved for marketing in Australia;
• Opportunities for increased provision of public information on therapeutic goods currently on the market in Australia or previously approved for marketing in Australia;
• Opportunities for improved public understanding of the procedures for ongoing monitoring of products already on the market and the evaluation, assessment and testing of new products;
• The timeliness of the provision to the public of information regarding the evaluation, assessment and testing of new products;
• Any constraints on the release of further information, including possible implications for public health or safety, which might influence future arrangements;
• Arrangements for the public disclosure of information utilised by other comparable international regulators;
• Opportunities to improve public access to information through enhancements to web-based and other information dissemination mechanisms; and
• The need to improve public awareness of, and access to, information on the arrangements for regulation of therapeutic goods advertising.
• Recommendation 6 in the Horvath Report which reads: Improvements to the transparency of TGA's vaccine safety monitoring processes should be considered by the independent Transparency Review of the TGA being chaired by Professor Dennis Pearce (added 25 May 2011)

Meeting reports & panel submissions

• TGA Transparency Review Panel, Meeting 6, 9 June 2011
• TGA Transparency Review Panel, Meeting 5 - cancelled
• TGA Transparency Review Panel, Meeting 4, 13 April 2011
• TGA Transparency Review Panel, Meeting 3, 23 March 2011
• TGA Transparency Review Panel, Meeting 2, 10 February 2011
• TGA Transparency Review Panel, Meeting 1 & Panel submissions, 7 December 2010

Consultation & public submissions

• Public submissions to the TGA Transparency Review
  Public submissions received by the TGA Transparency Review
• TGA Transparency Review public meetings
  The TGA Transparency Review Panel conducted public meetings in Sydney (23 February 2011), Melbourne (1 March 2011), Perth (4 March 2011)
• Call for input: Review to improve transparency of the Therapeutic Goods Administration (TGA)
  The purpose of this paper is to provide you with early information on the opportunity to contribute to the transparency Review of the TGA
• TGA Transparency Review consultation process outline
  The Panel undertaking the Review has agreed to seek input from the community by calling for written submissions, and holding a limited number of face-to-face meetings in metropolitan and rural locations

Media releases about the TGA transparency review

• TGA Transparency review released
• TGA transparency review extended at request of Review Panel
• Panel to review the transparency of the Therapeutic Goods Administration