TGA launches consultation into issues around medicine supply and shortages
The Therapeutic Goods Administration (TGA) is conducting a public consultation seeking feedback on reforms intended to help ensure ongoing, reliable supply of important medicines in Australia.
The TGA says it is “specifically seeking feedback” on four proposals it identified in a recent consultation paper as possible medicine shortage mitigation or management strategies.
“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,” the TGA said.
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 the consultation paper, the TGA identified four approaches incorporating various administrative, regulatory and legislative mechanisms to reduce regulatory burden on applicants, as possible medicine shortage mitigation or management strategies.
The proposals are:
- Prioritising evaluation of important generic medicines – giving ‘priority’ assessment of variations to existing medicines, which some stakeholders said would be of benefit in mitigating medicine shortages.
- Mitigating the effects of a medicine shortage – developing a new set of criteria be tailored to support medicines with limited commercial viability or in longstanding shortage.
- Improving reliability of supply for known shortages – with development of a transparent process to define medicines in very long-term (extended or repeated) shortage, for which there is a strong public health justification for encouraging their ongoing availability via Schedule 19A approvals.
- Managing alternative supply if medicines are discontinued – involving an amendment to regulations to include new criteria for waiving annual charges, tailored to support certain discontinued medicines
The paper identified the strategies 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.
The consultation opens on Monday 29 March 2021. Interested parties should respond by close of business, Monday 17 May 2021.
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