APPENDIX 4
Review to improve the transparency of the Therapeutic Goods Administration
Final Report–June 2011
Executive Summary & Recommendations
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 of concern to them.
The Panel considers that it is necessary for the TGA to
recognise that it serves multiple stakeholders and that it must adapt its
communication strategies accordingly. Consumers and health practitioners have
as much interest in therapeutic goods as the industry that produces and markets
those goods. It is important that the TGA recognise this when formulating the
communications strategy that is recommended by the Panel.
The Panel considers that the TGA should adopt a pro-active
stance to the many issues relating to therapeutic goods that are of concern to
the public that it serves. It should move away from the conservative approach
that has characterised its actions in the past and recognise that it has a duty
to collaborate with stakeholders to create a culture in which the community has
confidence in the therapeutic goods the TGA regulates.
The Panel recognises that the TGA provides a service to the
community by the timely registration, listing and inclusion of suitable
products onto the Australian Register of Therapeutic Goods (ARTG). The TGA also
has an ongoing responsibility to conduct post-marketing surveillance on these
products and to inform the community about new information that changes their
risk-benefit ratio. Post-marketing surveillance includes monitoring the
promotion of therapeutic goods and taking timely and effective action when
promotion is in breach of the Therapeutic Goods Advertising Code 2007 or when
self-regulation fails.
The Panel observes that, in order to maintain confidence in
the regulatory system and ensure that products beneficial to the Australian
community continue to be made available by sponsors, the performance of the
TGA's regulatory functions must be objective, consistent and timely. It is also
essential that the TGA's independence from sponsors and fairness in
decision-making be reinforced by openness in its dealings.
The Panel believes that the adoption of the following
recommendations will assist both the government and the TGA by increasing the
community's trust in therapeutic goods regulation and by showing that it is
possible to balance legislative obligations with the need to provide more and
better information to the Australian community.
Recommendations
Raise Stakeholder Involvement in the TGA
Recommendation 1
The TGA establish an Australian Therapeutic Goods Advisory
Council, with membership representative of major stakeholder groups, to enable
more effective stakeholder input into future directions and program
implementation. The Council will have an oversight role in the implementation,
ongoing monitoring, and evaluation of the recommendations of this review.
Recommendation 2
The TGA define, adopt and publish consultation principles to
guide regulatory transparency and accountability.
Recommendation 3
The TGA develop and implement a comprehensive communication
strategy to inform and educate. A dedicated communications team should be
established within TGA to implement that strategy.
Recommendation 4
The TGA work transparently with other key providers of
information to enhance the information available to the public (community and
stakeholders), consistent with the principles of the quality use of medicines.
Recommendation 5
The TGA develop a plan to ensure information on the key
public access portal, the TGA website, is current, accurate, relevant, timely
and up to date, and meets the needs of its audiences
Recommendation 6
The TGA provide user-friendly information on the risk based
framework under which it operates, including detailed explanations of how this
operates for different classes of therapeutic goods. As a priority, the
differences between registered and listed therapeutic goods, and their
processes of evaluation, should be explained.
Recommendation 7
The TGA implement mechanisms to educate and inform the
public that listed medicines are not evaluated for effectiveness by the TGA
prior to market.
Recommendation 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.
Recommendation 9
The TGA improve access and quality of information on the
processes for regulation of advertising of therapeutic goods, including the
complaint process and the outcomes of complaints.
Recommendation 10
The TGA, in conjunction with key stakeholders, develop and
publish agreed Key Performance Indicators to provide quantitative and
qualitative information on the TGA's organisational effectiveness and
operational efficiency. This may be achieved in conjunction with the proposed
Australian Therapeutic Goods Advisory Council.
Market Authorisation Process
Recommendation 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 should take into account the practices
followed by comparable international regulators.
Recommendation 12
The TGA explore mechanisms for providing explanations on its
various regulatory processes, and adopt publication principles on the outcomes
of application assessments using as an exemplar the Australian Public
Assessment Reports (AusPAR).
Recommendation 13
The TGA assess and report on the feasibility of developing
an on-line system for the submission and tracking of all applications for
assessment, which enables the sponsor to ascertain the progress of an
application.
Recommendation 14
The TGA work with stakeholders to improve labelling and
packaging requirements to educate and assist consumers and health practitioners
to make informed decisions about the quality use of therapeutic goods.
Post Market (Monitoring & Compliance)
Recommendation 15
The TGA conduct, and report on, a feasibility study into the
development of an early post marketing risk communication scheme for
therapeutic goods, with consideration of international models.
Recommendation 16
The TGA actively promote the distribution of therapeutic
goods safety information, and examine mechanisms for improving the timely
communication of alerts and recalls, to health practitioners and to consumers.
Recommendation 17
The TGA explore mechanisms to maintain the currency of
Consumer Medicines Information (CMI) and Approved Product Information (PI).
Recommendation 18
The TGA progressively develop and implement a system to
publish the outcomes of investigations and compliance actions taken.
Recommendation 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.
Recommendation 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.
Recommendation 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
findings of the Horvath Review into Immunisation.
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