On 20 July 2011 the Australian Government released a report that could be the catalyst for greater transparency in the operation and regulation of the therapeutic goods industry.
On 16 November 2010 Parliamentary Secretary for Health and Ageing, Catherine King, announced that a review was to be commissioned in response to community concern about the lack of information made available by the Therapeutic Goods Administration (TGA). The focus of the review was to improve the TGA's transparency to ensure that the public is better informed about the TGA's regulatory processes and the benefits and risk of therapeutic goods.
The review was undertaken by the Therapeutic Goods Administration Transparency Review Panel (the Panel), chaired by Professor Dennis Pearce. There were 13 members on the Panel; each member representing the main stakeholder groups of consumers, health practitioners, the rural health sector and the therapeutic goods industry. The five members representing the therapeutic goods industry represented the following sectors: prescription medicines; generic prescription medicines; over-the-counter medicines; complementary medicines; and medical devices.
The Panel commenced operation on 10 December 2010 with a view to providing a report by 29 April 2011. That date was extended to 30 June 2011 when the size of the task, and the extent of the public interest in the review, was realised.
Executive summary: key recommendations of the Panel
The consultations carried out by the Panel during the review highlighted the need for the TGA to devise and implement strategies to improve communications between the TGA and its key stakeholders.
A copy of the Review Report, which contains detailed information regarding each recommendation, is available here. An executive summary of the unanimous recommendations of the Panel are contained in the Final Report titled 'Review to improve the transparency of the Therapeutic Goods Administration' (the Report) and are as follows.
Recommendations for raising stakeholder involvement in the TGA
1. The TGA establish an Australian Therapeutic Goods Advisory Council made up of representatives of major stakeholder groups that holds an oversight role in the implementation, ongoing monitoring and evaluation of the recommendations of the Report.
2. The TGA develop, implement and publish consultation principles to ensure regulatory transparency and accountability.
3. The TGA develop and implement a comprehensive communication strategy geared to inform and educate the community and stakeholders. The establishment of a TGA communications team was recommended to achieve this objective.
4. The TGA work transparently with other key providers of information to enhance the information available to stakeholders and members of the community.
5. The TGA develop a plan to ensure information on the key public access portal, the TGA website, is current, accurate and relevant and meets the needs of its audiences.
6. The TGA provide user-friendly information on the risk based framework under which it operates; particularly information on the difference between registered and listed therapeutic goods and their processes of evaluation.
7. The TGA implement mechanisms to inform the public that listed medicines are not evaluated for effectiveness by the TGA prior to market.
8. The TGA provide clear information on the role of its statutory advisory committees, and adopt a consistent and transparent approach to the publication of information from those committees.
9. The TGA improve access to and quality of information on the regulation of advertising of therapeutic goods. This is to include information on the complaint process and the outcomes of complaints.
10. The TGA, in conjunction with key stakeholders, develop and publish agreed key performance indicators on the TGA's organisational effectiveness and operational efficiency.
Recommendations for improving market authorisation processes
11. The TGA develop and publish a policy on the disclosure of commercially confidential information, noting significant issues for each therapeutic product type. The policy is to take into account the practices followed by comparable international regulators.
12. The TGA explore ways of explaining its various regulatory processes to the public and adopt publication principles on the outcomes of application assessments using as an exemplar the Australian Public Assessment Reports.
13. The TGA assess and report on the feasibility of developing an online system for the submission and tracking of all applications for assessment. This system is to include a means of allowing the sponsor to track the progress of an application.
14. The TGA work with stakeholders to improve labelling and packaging requirements. The purpose of implementing this recommendation will be to educate consumers and health practitioners so they may make informed decisions about the quality use of therapeutic goods.
Recommendations to improve monitoring and compliance
15. The TGA conduct, and report on, a feasibility study into the development of an early post marketing risk communication scheme for therapeutic goods. International models are to be considered when devising the scheme.
16. The TGA actively promote the distribution of therapeutic goods safety information and consider ways of improving the timely communication of alerts and recalls to health practitioners and consumers.
17. The TGA explore ways of maintaining the currency of Consumer Medicine Information and Approved Product Information.
18. The TGA progressively develop and implement a system to publish the outcomes of investigations and compliance actions taken.
19. The TGA more effectively facilitate the recognition and reporting of adverse events by health practitioners and consumers, and promote the adverse event reporting system.
20. The TGA make its Adverse Events Database available to, and searchable by, the public in a manner that supports the quality use of therapeutic goods.
21. The TGA work with State and Territory Governments, stakeholders, and other relevant agencies, to improve the visible management of adverse event reporting in support of consumer safety and consistent with the finding of the Horvath Review into Immunisation.
The Government will now consider the Review Panel Report and provide a formal response to these recommendations.
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