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