Import laws for replacement meds ‘inflexible’ and cause delays

3 minute read

Medicines Australia has called for a revamp of Section 19A of the Therapeutic Goods Act to circumvent lengthy delays.

Section 19A of the Therapeutic Goods Act – which allows importation of replacement medicines in the case of short supply – needs a revamp, says Medicines Australia.

Australia has suffered several critical drug shortages in recent months – be that ADHD medication, drugs and devices for women’s health or diabetes medication.

Earlier this year, the TGA opened a consultation into the challenges contributing to drug shortages across the nation and opportunities for reform.

In its response to the TGA’s consultation, which was released yesterday, Medicines Australia has called for the simplification of the S19 process.

Section 19A of the Therapeutic Goods Act includes a provision allowing the import and supply of medicines not approved by the TGA in cases where a registered or previously registered medicine is unavailable or is in short supply.

But according to Medicines Australia, the current legislation is “inflexible” and the process, a “regulatory burden”.

“A review should be conducted to assess how to create a patient-centred  shortage management framework, to enable faster access to the global supply chain, especially for products where the only difference from the registered product is the packaging,” reads the organisation’s submission.

“For medicines in short supply with a critical public health impact, the S19 process usually operates with close collaboration between TGA and sponsors to find a rapid solution which is highly appreciated by sponsors.

“However, 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.”

According to Medicines Australia, drug manufacturers prioritise supply to countries with regulatory approval and often, will not allocate supply for Australia without TGA approval.

“Delays with review can occur where internal TGA clinical advice is not reflective of real-world patient impact due to lack of familiarity with the true disease burden, creating unnecessary work for sponsors and delays in addressing a shortage,” the submission reads.

“In cases where the risk of ongoing shortages is known, the need to reapply adds extra burden for sponsors and TGA and a more contemporary approach could be implemented based on review of the current framework.”

Medicines Australia listed incentives as an improvement opportunity.

“Australia is one market in a complex, global medicines ecosystem,” reads the submission.

“If manufacturers have capacity issues, as occurred during covid, demand spikes may see supply being prioritised to other markets, despite the best efforts of local affiliates.”

Ultimately, effective communication and collaboration would facilitate better management of shortages, added the organisation.

“For effective management of medicine shortages, seamless communication among government departments is essential,” reads the submission.

“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.

“This approach fosters cooperation, enhances our medicine supply chain resilience and ensures timely access for all Australians.”

While setting up a solid framework was a must, the organisation added that flexibility to allow for “case-by-case” approaches when necessary, allowing for “the unique operational methods of individual companies”, would also be necessary.

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