Penalties for drug companies who fail to report shortages, now made law

Drug manufacturers who fail to report their inability to supply important medications to the Australian market will now face legal penalties – fines of up to $210,000 per infringement – with the passing of one of the first pieces of legislation under the new Morrison Government.

Minister for Health, Greg Hunt MP, made the announcement last week saying in a statement, “This new law protects patients who rely on vital medicines. They also give the community, medicine company and patients the opportunity to take action to mitigate against a medicine shortage.”

Pharmacist, Matthew Bellgrove from National Custom Compounding on the Gold Coast said the legislation was significant and would address the very real problem of drug shortages world-wide.

“There have been cases in the past where a manufacturer has had manufacturing problems and expected shipments have not been made – with no warning,” Matthew said, “This has caught health professionals by surprise and they’ve had to scramble to find other alternatives in very little time so the health of their patients was not adversely affected.”

“If they have at least some warning of a looming shortage, health professionals can research what their alternatives might be, or arrange for a compounding pharmacist – a qualified chemist who makes up medications from scratch in a local laboratory –  to make up supplies for their most at-need patients until supplies return to normal.”

Under the new laws, due to come into effect on 1 January 2019, drug manufacturers will have to report shortages of important medicines as soon as they occur, and no later than two working days, after the drug manufacturer first becomes aware of the issue. Important medications are those whose shortage would have a ‘severe impact on a patient health.

Drug companies will have up to 10 working days to report shortages of medicines deemed not to have a severe impact on patient’s health should they become unavailable.

The new mandatory reporting legislation will apply to all prescription medicines as well as important over-the-counter medications such as EpiPens and inhalers.

Earlier this year, Australia was one of several countries hit by a shortage of EpiPens, which provide life-saving adrenalin for people who have had an acute allergic response.

In this and a number of other cases, the shortages were not reported in advance to the Department of Health through the TGA. As a result, patients and doctors were not alerted in time for them to make alternative arrangements.
In addition to new laws around the reporting of shortages, if a critical drug is being removed from the market altogether, as happens when a drug is no longer profitable to manufacture, the drug company must notify the Department of Health at least 12 months in advance.

Matthew Bellgrove applauded this decision.

“Discontinued medication can be very problematic for some patients on long term treatment plans who’ve been using a medication for many years. They’re forced to find an alternative that may not be as effective for their particular condition or may react adversely with other medication they’re taking.”

“Compounding pharmacies can again help in this situation by stepping in and making medications when the commercial manufacturer ceases production.”

For more information on the important contribution compounding pharmacies make to the health care sector during drug shortages contact Matthew Bellgrove at National Custom Compounding on 1300 731 755 or [email protected]