Australian copyright law amended to benefit generic medicines

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Australian copyright law amended to benefit generic medicines

INICIO/Políticas y legislación | Posted 18/03/2011 0 Post your comment

On 22 February 2011 the Australian Senate Legal and Constitutional Committee introduced into Federal Parliament the Therapeutic Goods Legislation Amendment (Copyright) Bill.

The bill will amend the Copyright Act of 1968 enabling generic manufacturers to reproduce, with a clear conscience, essential information which is provided to patients with their medicines.

This right to reproduce the information has been challenged by an originator company via the claim of alleged copyright infringement.

Any successful infringement of copyright case would mean that suppliers of generic medicines would be unable to provide information substantially similar to the originator information. This would then prevent generic companies from supplying the essential information that must accompany medicines, thereby preventing them from supplying generic medicines to the Australian market.

This bill will introduce an amendment specifically related to ‘certain medicines’ and states that there is no infringement of copyright when the supply, reproduction, publishing, communicating or adapting of the information is ‘for a purpose related to the safe and effective use of the medicine’.

The Australian Generic Medicines industry Association (GMiA) welcomed the amendment stated that this was ‘important public policy that is designed to ensure the continued supply of generic medicines to the Australian public’.

Efficient and timely market entry of generic medicines brings the public and government important benefits of more affordable medicines and contributes significantly to the sustainability of the Pharmaceutical Benefits Scheme (PBS). In the last four years the presence of a generic medicines sector has saved the PBS in excess of Aus$1.4 billion.

Source: Australian Government ComLaw, GMiA