The Therapeutic Goods Administration faces something of a shake-up if there is effective implementation of the recommendations of a review, released today, that is aimed at improving the agency’s transparency.

The review was conducted over seven months and makes 21 recommendations (a summary of these is reproduced below), including that the TGA implement a more proactive communications strategy that should be based in-house (in contrast to the current arrangements).

The report says: “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 notes that there is an international trend towards greater openness in governmental decision making and that comparable overseas bodies were moving in this direction: “Australia cannot afford to be left behind in this worldwide approach to the regulation of therapeutic goods.”

The Panel said their consultations had shown that the TGA and its work cannot be considered well known by the Australian community: “The role of the FDA, the United States regulator, seems better known in Australia, and its information is as likely to be relied upon as that from the TGA.”

The report includes a suggestion that appropriately qualified public servants should be allowed (shock, horror!) to deal directly with the media.

It says: “The Panel also noted that the overseas regulators equivalent to the TGA are recognising that the public’s need for accurate information is best met by permitting professionals with appropriate media training, to speak directly on public health issues and concerns.”

The Review team clearly thought this a novel idea – “the Panel appreciated that it has not been a traditional role of public servants to deal directly with the media” – but Croakey is old enough to remember the days when journalists routinely interacted with federal and state health bureaucrats, for eg by attending NHMRC meeetings. (This was before the corporatisation of government processes meant vibrant, open debate was seen as a threat “to brand” rather than something to be encouraged for its contribution to a more informed and engaged society – but I digress…)

The Panel believes the recent announcement of a merger of Australian and NZ therapeutic agencies (which was made too late to be taken into account in the report’s preparation) will not affect the implementation of their recommendations. Time will tell…

The review also notes some of the constraints on the TGA’s operations, including:

• that it serves multiple stakeholders (including the Department of Health and Ageing hierarchy, as the TGA is a Division of DoHA)

• that the TGA is entirely funded on a cost recovery basis by the therapeutic goods industry and receives no government funding for its functions

• that it does not receive any government budgetary support for its public information and education role.

While the review contains many damning criticisms of the TGA, it also notes that the agency has “done much in recent years to publicise its actions and to consult with stakeholders about its role and functions”.

Summary of the recommendations

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 KPIs 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.

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.

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.

The 13-member review panel was chaired by Professor Dennis Pearce, a former Commonwealth Ombudsman, former Chair of the Australian Press Council and Special Counsel, DLA Piper Lawyers.

The Government is yet to respond to the review’s recommendations.

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