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Review to Improve the Transparency of the Therapeutic Goods Administration Panel to Review the Transparency of the Therapeutic Goods Administration Review to improve the transparency of the Therapeutic Goods Administration Final Report June 2011 Historical document Review to improve the transparency of the Therapeutic Goods Administration ISBN: 978-1-74241-523-9 Online ISBN: 978-1-74241-524-6 Publications Approval Number-D0482 Copyright © Commonwealth of Australia, 2011 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney General’s Department, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca Historical document Review to improve the transparency of the Therapeutic Goods Page i Administration (TGA) – Final Report FOREWORD The Review Panel began its work on 7 December 2010. The Panel comprised persons representing a range of interests and holding a diversity of views. It is pleasing therefore that the recommendations of the Review are unanimous. The Report reflects seven months of consultation and deliberation by the Panel. It makes 21 recommendations which the Panel believes will enable the TGA to better communicate its regulatory processes and decision to the community. The Panel anticipates that some recommendations will have an immediate impact, while others will take time to implement. The Panel recognises that the effective implementation of its recommendations will, in some cases, be dependent upon the availability of resources over and above those presently available to the TGA. It does not seem likely that the proposals could be implemented within the TGA’s present budget without a reduction in the functions presently being performed. The Panel is strongly of the view that the work of the TGA should not be diminished in any way. Accordingly, if the government is to accept and give effect to the Panel’s recommendations, it will be necessary for resources additional to those currently available to be found. The Panel has indicated where it considers that urgent attention needs to be given to changes in TGA’s procedures. However, it recognises that implementing some recommendations will only be able to be done over a longer term. The Panel suggests that, on receipt of this Report, the government request the TGA to develop and cost an implementation plan for the recommendations. The Australian Therapeutic Goods Advisory Council that the Panel recommends should be appointed, should be involved in the finalising and monitoring of this plan. On 20 June 2011 it was announced that the Australian and New Zealand Governments have agreed to proceed with a joint scheme for regulation of therapeutic goods. The announcement said that the creation of a joint regulatory scheme across both countries will safeguard public health and safety, while encouraging economic integration and benefitting industry in both countries. Over time, the joint arrangements will be administered by a single regulatory agency, the Australia New Zealand Therapeutic Products Agency, which will absorb the current regulators - Australia's Therapeutic Goods Administration and New Zealand's Medsafe. This announcement was made too late for the Panel to take it into account in the preparation of its Report. However the Panel believes that the implementation of its recommendations will not be affected by these new arrangements. I acknowledge the Panel’s commitment to this Review and the important contributions of the many people who took the time to provide insight into their expectations of the TGA. The unstinting commitment and contribution of the Review Secretariat to the management of the Review, the content of the Report and the completion by the required date deserves particular commendation. HistoricalProfessor Dennis Pearce AO document Chair, Transparency Review Panel Review to improve the transparency of the Therapeutic Goods Page ii Administration (TGA) – Final Report Review to improve the transparency of the Therapeutic Goods Administration Contents FOREWORD i EXECUTIVE SUMMARY 3 Recommendations ________________________________________________________________________ 4 CHAPTER 1: INTRODUCTION TO THE REVIEW 7 Transparency Review _____________________________________________________________________ 7 Objective of the Review ___________________________________________________________________ 7 Terms of Reference _______________________________________________________________________ 7 The Review Panel _________________________________________________________________________ 8 Context for the Review ___________________________________________________________________ 9 Transparency ____________________________________________________________________________ 11 TGA’s Recognition of its Role and Responsibilities ___________________________________ 11 Previous Reviews _______________________________________________________________________ 12 CHAPTER 2: REVIEW METHODOLOGY 13 Call for Submissions ____________________________________________________________________ 13 Consultations ____________________________________________________________________________ 13 Report Structure ________________________________________________________________________ 15 CHAPTER 3: SUMMARY OF ISSUES RAISED AGAINST THE TERMS OF REFERENCE 16 CHAPTER 4: DISCUSSION AND RECOMMENDATIONS 29 Raise Stakeholder Involvement in the TGA ___________________________________________ 29 Market Authorisation Process _________________________________________________________ 42 Post Market (Monitoring & Compliance) ______________________________________________ 46 CHAPTER 5: RELATED ISSUES THAT AROSE IN THE CONSULTATIONS 52 HistoricalAPPENDIX 1 - ACRONYMS document56 APPENDIX 2 - GLOSSARY 58 June 2011 Page 1 of 100 Review to improve the transparency of the Therapeutic Goods Administration APPENDIX 3 - BACKGROUND: THERAPEUTIC GOODS ADMINISTRATION 62 Establishment and role _________________________________________________________________ 62 TGA Facts and Figures __________________________________________________________________ 63 TGA Reform Program ___________________________________________________________________ 64 What legislation governs the TGA? ____________________________________________________ 65 Decision Making _________________________________________________________________________ 65 TGA Advisory Committees _____________________________________________________________ 66 What information is currently available to the public? ______________________________ 66 Creation of an Australia New Zealand Therapeutic Products Agency (ANZTPA) __ 68 APPENDIX 4 - TRENDS IN PUBLIC DISCLOSURE BY COMPARABLE INTERNATIONAL REGULATORS 69 United Kingdom: Medicines and Healthcare Products Regulatory Agency _________ 69 European Union: European Medicines Agency _______________________________________ 73 United States of America: Food and Drug Administration ___________________________ 76 Health Canada ___________________________________________________________________________ 80 APPENDIX 5 - PUBLIC SUBMISSIONS TO THE TGA TRANSPARENCY REVIEW 82 APPENDIX 6 - COPY: ADVERTISEMENT FOR NATIONAL DAILY PAPERS 87 APPENDIX 7 – LETTER OF INVITATION TO STAKEHOLDERS 88 APPENDIX 8 – PUBLIC MEETING ADVERTISEMENTS 91 APPENDIX 9 – GROUP DISCUSSION QUESTIONS 95 Historical document June 2011 Page 2 of 100 Review to improve the transparency of the Therapeutic Goods Administration EXECUTIVE SUMMARY The Therapeutic Goods Act 1989 states as its principal object ‘to provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods’ that are used in Australia or exported from Australia. This system is achieved through the operation of the Therapeutic Goods Administration (TGA), a Division of the Department of Health and Ageing. A perception has arisen in the community that the TGA does not provide the public with sufficient information about its activities and about the therapeutic goods that it regulates. This perception led the Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, to establish a panel of consumer, health practitioners and therapeutic goods industry representatives to review and report on the transparency of the TGA. In the performance of its task, the Panel consulted widely with persons and organisations affected by the TGA’s activities. It also took into account the requirements of the Australian Government’s Declaration of Open Government which determines a whole of government context directing agencies towards enhanced transparency and a consumer focus in their activities. Coincident with this, the Panel noted that action has been taken by a number of the overseas regulators that have functions equivalent with those of the TGA to increase the transparency of their activities. In the course of the Review it became apparent to the Panel that the TGA had done much in recent years to increase knowledge by stakeholders of the role and the functions that it performs. However, it was also apparent that the expectations of the public are not being met and there is more that the TGA can do. In this Report the Panel proposes means by which the TGA can provide greater transparency in the understanding by the public of its role and functions and can better inform stakeholders on the issues that are
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