Greg Hunt proposes changes to reporting scheme to help address medicine shortages

Amanda Lyons

29/06/2018 11:33:05 AM

The Federal Health Minister wants to make the reporting scheme mandatory rather than voluntary, with legal definitions of medicine shortage and penalties for non-compliance.

Federal Minister Greg Hunt wants to tighten requirements for reporting medicine shortages to the TGA. (Image: Mick Tsikas)
Federal Minister Greg Hunt wants to tighten requirements for reporting medicine shortages to the TGA. (Image: Mick Tsikas)

A proposed new law amending the scheme for reporting medicine shortage to drug regulator the Therapeutic Goods Administration (TGA) was tabled in Parliament yesterday.
Federal Health Minister Greg Hunt introduced the bill by explaining it had been written in response to increasing incidences of medicine shortage in Australia and around the world.
‘This Bill responds to concerns raised by patients, their carers and health professionals, as well as many representations from members of parliament on behalf of often-distressed patients seeking information about a shortage of a critical medicine,’ he said.
The existing reporting scheme, which has been in place since 2014, is voluntary and gives suppliers no obligation to report. As a result, the TGA is not always able to alert the public or practitioners in a timely way about upcoming medication shortages that can have an impact on people’s health and even their survival.
A recent example is the nationwide EpiPen shortage that occurred earlier this year. Australia’s only EpiPen supplier did not inform the TGA until January, despite having known of the issue since November 2017.
The proposed new law aims to fix this situation by making it mandatory for suppliers to report medicine shortage. The measure will be targeted to higher-risk medicines and will mostly apply to prescription medicines, but some non-prescription medicines registered under the TGA, such as EpiPens and Ventolin inhalers, may also be covered.
The proposed law defines ‘medicine shortage’ in order to facilitate the process, stating that shortage will exist if the supply of medicine ‘will not, or will not likely, meet the demand for it at any time in the next six months for all the patients in Australia who take it or who may need to take it’.
The law also outlines strict timeframes for reporting. Shortages of critical impact, which may place a patient’s life at risk, must be reported no later than two working days after they are known, while shortages of non-critical impact must be reported no later than 10 days after they are known.
Suppliers will also be required to report instances in which a medicine is to be discontinued – 12 months beforehand for a medicine of critical impact and six months for other medications.
There will be penalties for suppliers who do not comply with the reporting timeframes, with individuals potentially liable for a fine of $21,000 and corporates for $210,000. The names of these suppliers will also be published on the TGA website.
However, it is preferred that the TGA work with suppliers to ensure compliance and take a ‘graduated approach’ to instances of non-compliance.

“Federal “Legislation” “Medicine “Therapeutic Administration” Goods Government” shortage”

newsGP weekly poll Are you happy with the incoming changes to CPD?


Login to comment