Medicines Australia calls for legislation change and transparency to address drug shortages

Pharma News: Australia grapples with a persistent challenge of medicines shortages. At any given time, the Therapeutic Goods Administration’s (TGA) website reveals over 400 medicines out of stock, signalling a pressing issue.

Earlier this year, in response to the concerning trend, the TGA initiated a consultation to delve into the root causes of these shortages and explore avenues for reform.

One of the key voices in this dialogue is Medicines Australia, advocating for a streamlined approach to the S19 process, labeling the current legislation as “inflexible” and the process itself as a “regulatory burden.”

According to Medicines Australia’s submission, there’s a clarion call for a review aimed at developing a patient-centric shortage management framework. This framework, they argue, should facilitate swifter access to the global supply chain, particularly for products where packaging is the sole point of differentiation from the registered product.

While acknowledging the collaboration between the TGA and sponsors in addressing shortages of medicines with significant public health implications, concerns persist regarding certain cases.

“Where an application appears to be ‘deprioritised’ the process is untransparent and can create major challenges in procuring overseas supplies due to the lack of standard review timelines and lengthy delays in getting feedback,” the peak body said in its submission.

The Royal Australasian College of Physicians (RACP) President Professor Jennifer Martin said Australia needs an effective strategy for managing medicine shortages and it is patients who are paying the price.

“Medicine shortages are becoming more of a problem in Australia, and we need to see a comprehensive strategy from Government about how to prevent shortages and how to manage them better when they do occur. Australia is particularly vulnerable because we import around 90% of our medicines,” Professor Martin said.

“Physicians across specialties continue to see shortages of key medicines for our most vulnerable patients: children with neurodevelopmental disorders, children and adults with obesity, diabetes or endocrine issues, palliative care patients, patients with cardiac conditions, sexually transmitted and other infections, and patients with substance use disorders.”

Delays in the review processes often stem from a disconnect between internal TGA clinical advice and the real-world impact on patients, amplifying the workload for sponsors and exacerbating the delay in resolving shortages. In light of this, proponents suggest a more contemporary approach, grounded in a comprehensive review of the existing framework.

The disruptions caused by events like the COVID-19 pandemic underscore the fragility of the supply chain. Manufacturers grappling with capacity constraints may prioritise other markets during demand surges, despite the efforts of local affiliates.

“Collaboration between entities such as the TGA and the Department of Health is crucial, supplemented by the inclusion of industry submissions and consultations with other government departments,” said Medicines Australia in its submission.

Professor Martin emphasised, “Government needs a better strategy to redirect existing critical medicines supplies within the country to priority groups and patients. Current approaches often get very difficult for both patient and physician and need to be fixed, urgently.

“Physicians are left to navigate the maze without a compass to find and source substitutes for complex patients, with varying levels of success. This can leave patients with the same health conditions in dramatically different positions and is a major national health equity concern.”

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