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16 Feb 2017

Should new drugs with the potential to save lives be fast-tracked for sale in Australia, even if their safety and efficacy is not yet fully known? Should government vetting of advertisements for complementary medicines be dropped in favour of industry ‘self-regulation’?

These questions and more were considered in a review of medicines and medical devices regulations in 2015.

As doctors, we rely on the independence and expertise of the Therapeutic Goods Administration (TGA) to ensure that the medicines we prescribe and the medical devices we use to treat patients meet appropriate standards of quality, safety and efficacy.

This means we can focus on treating patients, confident that these medicines and devices have passed stringent and independent assessment processes, rather than undertake our own research to check the validity of data provided by industry.

So the AMA was fully engaged in the review, submitting three submissions based on advice from the Medical Practice Committee as well as meeting with the review panel.

In 2016, the Government announced it would go ahead with a raft of reforms recommended by the review, which made 58 separate recommendations aimed at improving and streamlining current regulatory processes.

The good news is that the reforms include many advocated for by the AMA, including improving post-market monitoring systems by establishing more device registries, increasing the transparency of medicines scheduling processes and decision-making, and strengthening the TGA’s powers to pursue advertising breaches.

The TGA is now moving quickly to implement the reforms. In the last three months it has released five consultation papers canvassing options on possible ways to proceed and seeking comments on the best way forward.

The AMA, with Medical Practice Committee advice, has focused on proposals most likely to impact on doctors and their patients.

The most significant consultation proposals and our key points are summarised below. All the AMA’s submissions to the TGA are available in full on our website. []

Expedited approval pathways for prescription medicines to bring new medicines to the Australian market more quickly without introducing unacceptable risks

The AMA supported a proposed ‘priority review pathway’which would reduce the time to process new medicine applications, because it would be limited to situations where the new medicine: treats a life threatening or seriously debilitating disease; addresses an unmet clinical need; and has a complete data dossier demonstrating substantial advantage over existing treatments.

The AMA also supported a proposed ‘provisional approval pathway’ for new medicines that also meets the above requirements, but rather than a complete data dossier, there is only promising evidence from early data.

We decided to support this proposal on the basis that the benefits to patients from earlier access would need to outweigh the risks, and provisional registration will be time limited and automatically lapse unless sponsors meet conditions imposed by the TGA, including additional post-market safety and efficacy data leading to full registration.

However, our submission raised questions about how the provisional status of a new medicine will be clearly communicated to patients and how the TGA proposes these medicines will be monitored given the higher risks.

Accelerated assessments for new medical devices which address life threatening or debilitating conditions

The AMA supported the TGA’s proposed approach because a full dossier of supporting data would still be required and the focus is on changes to the TGA's administrative processes to achieve faster approval times.

Improvements to over-the-counter medicines advertising regulations

The AMA supported most of the proposed changes to the regulations dealing with the advertising of over-the-counter (OTC) medicines (these do not apply to any S3, S4 or S8 medicines which cannot be advertised directly to patients). The changes will improve the complaints management system for reporting and dealing with advertising breaches and strengthen the powers of the TGA to apply and enforce sanctions and penalties.

However, the AMA opposed the replacement with an industry self-regulation model, of the current pre-vetting of OTC medicine advertisements by an independent committee administered by the TGA. We are not confident that a self-regulatory approach would sufficiently protect the public from misleading and fraudulent claims about the therapeutic benefits of (mainly) scientifically unproven products.

The Medical Practice Committee will continue to report on the AMA’s responses to further consultations on TGA reforms as they arise through 2017.




Published: 16 Feb 2017