Services: Intellectual Property & Technology
Industry Focus: Life Sciences & Healthcare

On 15 September 2016, the Federal Government released its response to the Expert Review of Medicines and Medical Devices Regulation (Sansom Review).1 The Sansom Review was tasked with reviewing Australia's medicines and medical devices regulatory framework and processes in order to identify areas of unnecessary, duplicative, or ineffective regulation that could be removed or streamlined, and to pinpoint opportunities to enhance the regulatory framework for medicines and medical devices.

Of the 58 recommendations made by the Sansom Review, 56 have been supported by the Federal Government in its response. Key recommendations include:

  • greater use by the Therapeutic Goods Administration (TGA) of assessments of medicines already made by comparable overseas regulators
  • provision for expedited and provisional approval of medicines
  • a risk-based approach to variations to medicines, medical devices and access to products not included in the Australian Register of Therapeutic Goods
  • enhancing post-market monitoring
  • simplifying the regulatory processes in respect of therapeutic goods advertising, including a greater capacity for self-regulation.

The Government proposes to implement the recommendations in a staged manner over the next three years.

As a result of implementation, access to new medicines and medical devices will be expedited which will reduce the estimated delay between approval overseas and approval in Australia (currently estimated to be in excess of 15 months or more).

So could this type of change have an impact on Australia's patent landscape?

For patentees, the reduction in time from application to marketing approval will mean that a greater portion of the term of the relevant patent can be used to exploit the patent commercially. This may reduce the need to apply for an extension of the term of the patent (a matter which is not always straightforward).

There may also be closer temporal alignment of patent infringement proceedings between an overseas jurisdiction, such as the United States, and Australia where a generic competitor has sought registration of its products in Australia immediately following registration in the overseas jurisdiction. This may have implications for the timing and conduct of infringement proceedings in each of those jurisdictions.

More detail about how the recommendations are to be implemented and their likely effects is expected to emerge later this year.

Footnote

1 Details about the Sansom Review including the terms of reference are available at http://www.health.gov.au/internet/main/publishing.nsf/Content/Expert-Review-of-Medicines-and-Medical-Devices-Regulation.

This article is intended to provide commentary and general information. It should not be relied upon as legal advice. Formal legal advice should be sought in particular transactions or on matters of interest arising from this article. Authors listed may not be admitted in all states and territories