New transparency measures for prescription medicines

The Australian Government has given approval to proceed with two measures to enhance transparency for prescription medicines. The changes follow almost 18 months of consultations and are in response to public demand for more information on prescription medicines that are under evaluation by the Therapeutic Goods Administration (TGA).

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

From January 2021, the TGA will publish a description of major innovator medicine applications that are under evaluation by the TGA. Information about the potential availability of new medicines, new uses for existing medicines and new combinations will be published on the TGA website.

This change will provide health practitioners and their patients the ability to discuss potential new treatment options for a wide range of conditions.

Legislative changes to introduce an earlier patent notification scheme for first generic and biosimilar medicines are planned to be introduced to Parliament in late 2020. The proposed changes would require applicants for the first generic and biosimilar form of an originator product to notify the patent holder when their application is accepted for evaluation by the TGA.

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.

Contact for members of the media:

• Email: news@health.gov.au;  Phone: 02 6289 7400