From 1 January 2019, it will be mandatory for sponsors of ‘reportable medicines’ (prescription medicines and other medicines that the Minister determines) to report a shortage of, or a decision to permanently discontinue, medicines to the TGA in accordance with the following timeframes:
|Shortage of ‘critical impact’||as soon as possible, but no later than 2 working days after sponsor knows or ought to have reasonably known of the shortage|
|Any other shortage||within 10 working days after sponsor knows or ought to have reasonably known of the shortage|
|Discontinuation of ‘critical impact’||at least 12 months before the discontinuation would occur or, if this is not possible, as soon as practicable after the sponsor’s decision to discontinue|
|Any other discontinuation||at least 6 months before the discontinuation would occur or, if this is not possible, as soon as practicable after the decision to discontinue|
Yesterday, the Therapeutic Goods Amendment (2018 Measures No. 1) Act 2018 received Royal Assent, putting into effect the mandatory reporting scheme.
Under the new reporting scheme, a medicine is in ‘shortage’ if its supply in Australia will not, or will not likely, meet the demand for it at any time in the next 6 months, for all the patients in Australia who take it or who may need to take it. Shortages will be determined on a national level and instances of unavailability or short supply at particular locations or with particular wholesalers will not be shortages that require reporting under the new regime.
A shortage or discontinuation will have a ‘critical impact’, if either:
- there are no approved goods that could be used as a substitute or where a substitute good exists but is not available in sufficient quantities to meet demand, and the shortage or discontinuation will have the potential to have a life threatening impact on, or a serious impact on the physical or mental health or functioning of, patients who require the medicine; or
- the medicine is included in the Medicines Watch List by the Federal Health Minister on the basis that any shortage or permanent discontinuation of the medicine could potentially result in significant morbidity or death in relation to patients in Australia.
The current voluntary reporting scheme (the Medicine Shortages Information Initiative, which has been in place since 2014) encourages sponsors to notify the TGA of shortages of their products, however the Government decided it has not been effective in managing medicine shortages. The introduction of a mandatory reporting scheme for medicine shortages has been introduced in response to a number of recent shortages of critical patient impact e.g. the Epipen shortage earlier this year.
A civil penalty will now apply where sponsors fail to notify of a shortage or a decision to permanently discontinue a reportable medicine, the maximum civil penalty being AUD$210,000 for a body corporate. The Secretary has been given powers to request information from a sponsor about a shortage or permanent discontinuation.
Sponsors will need to review their mandatory reporting procedures to ensure that protocols are in place to identify and report shortages and discontinuances, assess whether they would be of “critical impact” and meet the (in some cases tight) reporting timeframes to the TGA.