Building a more robust medicine supply: proposals to help prevent, mitigate and manage medicine shortages

Closes 17 May 2021

Opened 29 Mar 2021

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on proposals to help ensure ongoing, reliable supply of important medicines.

Medicine shortages have been of particular concern during the COVID-19 pandemic. We have been reviewing the ways in which we can better assist affected Australian patients and their healthcare providers. Specifically, we are seeking feedback on possible reforms that would:

  • prioritise the evaluation and registration process for certain important generic prescription medicines, to reduce the risk of shortages
  • encourage registration of more generic versions of medicines known to be affected by shortages, to mitigate the impact of those shortages
  • support a more reliable supply of overseas-registered medicines imported into Australia as substitutes when the Australian medicine is in longstanding or repeated shortage.

Consultation Paper

The consultation paper gives further details about proposed mechanisms to prevent and mitigate medicine shortages.

Consultation paper - Building a more robust medicine supply

Why we are consulting

 

We have an important role in managing medicine shortages, to assist patients when they cannot access their usual medicines. While we have mechanisms to allow supply of overseas products to assist with a shortage in Australia, patients still experience difficulties and uncertainty using these options.

There are currently no specific regulatory pathways designed explicity to facilitate registration on the Australian Register of Therapeutic Goods (the ARTG) of medicines with the aim of supporting on-going supply or reducing the likelihood of shortages.

In this consultation paper we have identified four approaches incorporating various administrative, regulatory and legislative mechanisms to reduce regulatory burden on applicants, as possible medicine shortage mitigation or management strategies. 

Consultation Scope

We are unable to compel sponsors to make an application for registration and the TGA has no powers to compel ongoing supply of any approved goods. Inclusion on the ARTG often doesn’t equate to supply in the market and stakeholders have raised this with us as a concern. Possible alignment with Pharmaceutical Benefits Scheme (PBS) processes may be required to achieve the full benefits of our proposals; however, consideration of alignment of ARTG registration and PBS listing is outside the scope of this consultation.

Give us your views

Audiences

  • Aboriginal and Torres Strait Islander People
  • Seniors
  • Men
  • Women
  • Carers and guardians
  • Families
  • Parents
  • Young people
  • Academics
  • Non-government organisations
  • Health professionals
  • Health workforce
  • General public
  • Aged care professionals
  • Health staff
  • HPRG (TGA) Staff
  • Prescription medicines
  • Complementary medicines
  • Over-the-counter medicines
  • Biogicals
  • Other

Interests

  • Regulatory policy
  • Aboriginal and Torres Strait Islander health
  • Prescription drugs
  • Preventative health
  • Dental health