Australian consumers, doctors, pharmacists, health professionals
and generic suppliers of medicine are set to benefit as originating
pharmaceutical companies can no longer use copyright of product
information to delay or prevent generic medicines entering into the
Pharmaceutical companies that invest significantly in the
research and development of medicines, including the creation of
product information, are no longer able to argue that the product
information approved by the Therapeutic Goods Administration
(TGA) of a generic version of a medicine breaches
copyright by essentially being the same as the original.
The introduction of the Therapeutic Goods Legislation Amendment
(Copyright) Bill 2011 (Bill) means that it is no
longer an infringement of copyright for generic pharmaceutical
companies to reproduce (or supply, publish, communicate or adapt)
product information that has been created by the originator and
approved by the TGA.
The amendments to the Copyright Act came into force on
27 May 2011.
Ms Catherine King, the Parliamentary Secretary for Health and
Ageing, stated that this is important because 'any difference
in text of product information used in relation to different brands
of the same medicine could be misrepresented as reflecting
differences between the brands where in fact none exists'.
Doctors, pharmacists and other health professionals will also
benefit because they are able to safely prescribe, dispense and
administer medicines and provide patients with consistent
information about the medicine they are being given.
A recent Federal Court decision highlights the need for employers to ensure that as well as clearly setting out the duties of employment, employment contracts also include a comprehensive assignment of all intellectual property rights, if the employer is to be assured that all rights in the intellectual property in materials created by employees are owned by the employe
The Government proposes to implement the Sansom Review recommendations in a staged manner over the next three years.
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