Australia’s regulatory body proposes transparency reforms Posted 15/05/2020

Australia’s Therapeutic Goods Administration (TGA) has issued a number of proposed transparency reforms for feedback from industry stakeholders, including earlier notification of generics applications.

At present, the TGA only states it can ‘neither confirm nor deny’ receipt of an application.

In response to feedback from patients, carers and healthcare professionals that it is frustrating not knowing whether treatments are likely to be available in Australia, the TGA released a public consultation on whether they should start publishing information on medicines under evaluation [1]. This evaluation closed at the end of March 2019.

Now, the Administration has given approval to implement enhanced transparency measures and has published a paper to canvass opinion on different implementation options from industry stakeholders.

The proposals aim to increase public transparency about applications under evaluation, while also protecting the commercial value to the applicant. The TGA aims to do so by:

  • Only publishing information with the biggest impact on public health
  • Withholding information on generic medicines applications prior to registration
  • Providing the innovator company with earlier notification of generic medicines applications

The Administration outlines the proposed changes (which would require amendments to the 1989 Therapeutic Goods Act) in detail:

1) Early publication of major innovator medicine applications
Frome June 2020, the TGA could begin publishing earlier information on major innovator drugs accepted for evaluation, with details including the product sponsor, name, active ingredients and indications.

2) Earlier notification of generic medicine applications
The second proposed change relates to generic drugs; and is more complex. The TGA gives two different options for the implementation of this reform, which would begin from early 2021.

Early notification in addition to the existing scheme, only where a patent has not expired
Where the patent on the originator drug has not expired, the applicant would be required to notify the patent holder that their application has passed preliminary assessment.

This option would prevent the assessment of patent infringement claims being at the sole discretion of the applicant. It would also provide innovator manufacturers with the opportunity to resolve potential infringements before marketing; but does rely on the applicant on having ‘reasonable belief’ as to the existence of a patent. This means the patent holder might not always be notified of a generics application.

Early notification regardless of the existence of a patent
Under the alternative option, all generic drug applicants would be required to notify the innovator and the TGA, whether the patent has expired or not. Under this option, the TGA would not evaluate the generic medicine until the applicant notified the patent holder.

This option would provide more protection for the confidentiality and commercial value of a generic drug application and would mean the innovator is notified of all applications that rely on its information, whether or not the patent has expired.

However, it could impact the availability of generics applications by removing the option for applicants to avoid notifying the patent holder by declaring they are not infringing a patent, e.g. because marketing is not intended to start until after patent expiry.

The TGA is asking for feedback on these proposals from stakeholders, including what their preferred option is and the impact the different options might have on them, financial and otherwise.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Australia’s TGA considering whether to publish drugs under evaluation [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 May 15]. Available from: www.gabionline.net/Policies-Legislation/Australia-s-TGA-considering-whether-to-publish-drugs-under-evaluation

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Source: TGA

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