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Source: Australian Department of Health

Between 27 March and 9 June 2020, the TGA sought comments from sponsors on the Prescription medicines transparency measures: Implementation of generic and biosimilar medicines early notification of an application to innovators and publication of innovator applications.

The TGA would like to thank respondents who provided submissions in response to the March 2020 targeted consultation paper. A total of 22 submissions were received from industry stakeholders. As this was a targeted and not a public consultation, the submissions have not been published.

TGA response

Submissions received in response to the consultation showed that the majority of stakeholders continue to support the earlier publication of major innovator medicine applications that are under evaluation by the TGA. Based on stakeholder feedback, changes have been made to the level of detail of the information published and publication will commence from January 2021, rather than June 2020 as originally planned (see table 1, below).

Views were mixed regarding earlier notification of generic and biosimilar medicine applications to the innovator. None of the options canvassed during consultation received consensus support and therefore the proposed measure (see table 2, below) addresses some of the concerns expressed by the generic/biosimilar sector and provides a better balance between innovator and generic interests.

This outcome follows almost 18 months of consultation, including public consultation and targeted stakeholder consultations on implementation options held between February 2019 and June 2020.

Further information on implementation arrangements will be included on the TGA website in the coming months.

Outcome summary

Table 1: Publication of prescription medicines under evaluation
Current situation Proposed changes Benefits

Presently, to the frustration of patients, carers, health practitioners and the innovator industry, information on market authorisation of a prescription medicine only becomes available to the public with registration in the Australian Register of Therapeutic Goods (ARTG).

The TGA neither confirms nor denies existence of an application under evaluation.

From January 2021, the TGA will start to publish a description of major innovator applications that are under evaluation by the TGA.

Information will be published on the TGA website for:

  • new medicines,
  • new uses for existing medicines and
  • new combinations

Biosimilar medicines, generic medicines and variations to existing medicines are excluded from publication.

The details that will be published are:

  • product sponsor; and
  • the product name; and
  • the active ingredient(s); and
  • a summary of the proposed indication (e.g. first-line treatment of non-small cell lung cancer expressing PD-L1); and
  • the application type

Provides patients and their carers with earlier information about the potential availability of new treatment options that may be considered as part of discussions with their medical practitioners.

Provides information on application types that are considered to be of the greatest value to consumers and healthcare professionals.

Table 2: Proposed changes to the patent notification scheme for generic and biosimilar medicines
Current situation Proposed changes Benefits

The current patent notification scheme requires provision of a patent certificate to the TGA after the evaluation of the application is completed, prior to registration of a generic or biosimilar medicine on the ARTG.

The sponsor may certify that it is either not intending to market the product in manner that will infringe a valid patent,


infringing a valid patent and the patentee has been notified. 

Late notification under the current system leaves little time to resolve patent disputes if the innovator company believes that the pharmaceutical patent would be infringed by a generic or biosimilar product.

This can result in protracted and costly litigation, pending resolution of the dispute over the existence of a valid patent.

Applicants for first generic and first biosimilar medicines, subject to proposed changes to the Therapeutic Goods Act 1989, will be required to notify the patent holder when their application is accepted for evaluation by the TGA, before the TGA commences the evaluation.

The notification would be based on the existing arrangements under section 26B of the Act, but:

  • will occur earlier in the process, following preliminary assessment
  • will be required to be to the patent holder and to the TGA
  • will be required where the applicant does not market or propose to market the medicine before the end of the term of the patent, AND

where the applicant proposes to market the medicine before the end of the patent term

The existing notification scheme under section 26B of the Act, will continue to apply to all other applications for generic and biosimilar medicines, prior to registration of a generic or biosimilar medicine on the ARTG.

Addresses pharmaceutical innovator company concerns that like other members of the public, they may only become aware of a generic or biosimilar competitor on the inclusion of the medicine in the Register.

This change is intended to provide greater opportunity for early negotiation and resolution of disputes on potential patent infringements and invalidity before inclusion of generic and biosimilar medicines on the Pharmaceutic Benefits Scheme (PBS). It should reduce the need for protracted and costly litigation.

Restricts the impact of the reform to those applications that are for a first generic or biosimilar medicine.