After a two-year review process, the Australian Government has committed to enacting the recommendations of the Sansom Review, which will create a more streamlined and efficient system for the regulation of therapeutic goods in Australia.
The Government expects that the implementation of the recommendations (which are summarised below) will deliver significant benefits to the Australian public and to the Australian medicine and medical device industries.
In 2014, the Department of Health announced an independent review of medicines and medicinal devices regulation by Emeritus Professor Lloyd Sansom AO, Will Delaat AM and Professor John Horvath AO. Two reports on the review were delivered by the expert panel in March and July 2015 making 58 recommendations for reform of the regulation of medicines and medical devices in Australia (together known as the Sansom Review).
On 15 September 2016, the Australian Government released a response to the Sansom Review, and accepted 56 of 58 recommendations made by the review. These recommendations will be implemented in a staged approach over the next three years to limit disruption to industry. The Government has begun the implementation process by opening a series of industry consultations, which invite stakeholders to provide input on how the more complex Sansom Review recommendations should be implemented.
1. Workshare arrangements with overseas authorities
The Sansom Review recommended an overhaul of the registration system for new chemical entities, generic medicines, biosimilars and medical devices so that the review process could effectively be shared between the Therapeutic Goods Administration (TGA) and its overseas counterparts.
Under these recommendations, when a sponsor applies for registration of a new drug, rather than submitting a full application specifically for the Australian market, it can submit an evaluation report from a comparable overseas authority, such as the US Food and Drug Administration, along with an abbreviated Australian application. The TGA is currently seeking submissions from stakeholders regarding the criteria it will use to identify comparable overseas regulators.
The Sansom Review also suggested that the TGA engage in work-sharing arrangements with comparable overseas drug authorities to make the approval process faster and more efficient.
This new process could result in a decrease to the application and evaluation fees payable by sponsors. As of 1 July 2016, the total application and evaluation fees for a ‘new chemical entity’ in Australia was $231,200 – a reduction in these fees may encourage innovation from smaller market participants.
2. A “fast track” application process
Another significant recommendation made by the Sansom Review was to introduce an accelerated review stream. Although the circumstances under which products will be eligible for this expedited review are not clear from the Sansom Review – it aims to give patients faster access to cutting edge treatments.
3. Incentives for innovation in complementary medicines
The Sansom Review acknowledged that the current regulatory framework does not adequately incentivise innovation in complementary medicines.
As it stands, sponsors have little incentive to invest in research and development of complementary medicines, as they are not granted any form of market exclusivity period to recoup the R&D investment.
Although the Sansom Review concluded that it was ‘outside its terms of reference’ to make more specific recommendations on this point, it hinted that the data protection period available for some registered medicines could be extended to all complementary medicines as a mechanism to drive innovation.
Several other interesting recommendations were made in relation to complementary medicines, including:
where the product is listed on the Australian Register of Therapeutic Goods (the ARTG), the sponsor be required to publish on a website the evidence that it holds to support all the indications included on the ARTG entry (while supporting the intent of this recommendation, the Government will not require but will encourage self-publishing);
where the product is listed on the ARTG through the self-assessment route, the sponsor be required to include a prominent disclaimer on promotional materials to the effect that the efficacy claims have not been independently assessed (the Government support the intent of this recommendation but noted that further consultation was required); and
where the product is listed on the ARTG through TGA assessment, the sponsor is able to indicate on promotional materials that the efficacy of a product has been independently assessed (the Government accepted this recommendation in principle, noting that the permitted promotional statements will require further consideration).
4. Streamlined advertising regulation
The Sansom Review proposed a more streamlined system for advertising and specifically recommended that:
the vetting and pre-approval process for advertising should be scrapped and the industry should move to a self-regulation model;
all advertising complaints should be dealt with by the same body (the TGA is currently seeking stakeholder input on how this body should operate);
future advertising regulation should be consistent for all medicines and medical devices; and
the TGA should facilitate the development of sponsor educational programs and resources about therapeutic goods advertising.
The Australian Government accepted 56 out of the 58 recommendations in the Sansom Review.
The implementation of these changes will result in significant changes to the regulation of therapeutic goods in Australia. This reflects the Government’s desire, through the National Innovation and Science Agenda and the Industry, Innovation and Competitiveness Agenda, to boost competitiveness and innovation and lessen unnecessary regulatory burden.
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