Last month, the Parliamentary Secretary for Health & Ageing, the Hon Catherine King MP, released a Report into ways of improving the transparency of the Therapeutic Goods Administration. The Review Panel held public consultations and received 118 submissions from a variety of stakeholders representing consumers, healthcare practitioners and industry, following “community concern about the lack of information made available by the TGA.”
The Review Panel found that the TGA could improve the way it communicates with industry, consumers and healthcare practitioners. The Final Report makes 21 recommendations, centring on ways to improve access to information, educate stakeholders and communicate more effectively about the TGA’s role and the decisions it makes.
Recommendations 11 and 13 are of particular interest to industry.
Recommendation 11 proposes that “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.”
It is understandable that there is industry concern about how commercial-in-confidence information will be treated after it is provided to the TGA. In submissions, sponsors were eager for the TGA to develop a comprehensive policy explaining what the regulator recognises to be commercially sensitive information, as well as guidance on how, and when, this information will be released.
Recommendation 13 proposes that “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.”
Another industry concern is the lack of information provided to sponsors regarding the status of their applications to include products on the ARTG. The Review Panel agreed that the implementation of an online tracking system that would allow sponsors to track their applications would be useful. The Review Panel refused, however, to take this recommendation further so as to enable the identification of products being assessed by the TGA.
One of the reasons given by the Review Panel for refusing to extend the ‘tracking system’ was that it “is not aware of this practice being adopted by comparable overseas regulators.” It’s true the EMA and FDA do not have an open online tracking system. However, interestingly, New Zealand’s Medsafe - with whom the TGA recently announced a joint effort to streamline the regulation of therapeutic goods in both countries - does have a system that allows members of the public to track the progress of applications filed with the authority. It will be interesting to see what happens in this area once the joint authority is established.
The Government is yet to respond to the Review Panel’s Report.