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TGA's Consultation on Managing Medicine Shortages

The Australian Therapeutic Goods Administration (TGA) is currently conducting a public consultation on proposals to help prevent, mitigate and manage medicine shortages, a prevalent concern due to the pandemic.

The potential reforms aim to ensure that there is an ongoing and reliable supply of certain medicines with four potential approaches:

  • improving the reliability of supply for known shortages;
  • mitigating the effects of a medicine shortage by introducing a new set of criteria to reduce fees for medicines with limited commercial viability or in longstanding shortage;
  • prioritising the evaluation and registration process of certain generic medicines; or
  • managing alternative supply if medicines are discontinued.

Since 2019 with the amendment of the Therapeutic Goods Act 1989, sponsors are required to inform the TGA of shortages of prescription medicines and certain over-the-counter medicines.  This enables the TGA to notify the public via the medicine shortage reports database and manage such shortages.

Although there are mechanisms that allow for the supply of overseas-registered medicines (that are not registered on the Australian Register of Therapeutic Goods (ARTG)) when there are shortages in Australia, there are difficulties with using these options as there are no regulatory pathways that explicitly facilitate registration to support ongoing supply.  Further, the TGA has no avenue of forcing sponsors to apply for registration on the ARTG and there is no requirement for sponsors to guarantee ongoing supply (with the exception of certain bioequivalent or biosimilar medicines listed on the Pharmaceutical Benefits Scheme).

The Consultation Paper outlines questions that the TGA is interested in obtaining feedback on for each of the four proposals. Responses can be provided either through the online survey or by sending a submission to medicine.shortages@health.gov.au. The last day to submit a response is Monday 17 May 2021.

Tags

asiapac, pharmaceuticals, regulation-pharma