Further to our earlier post in relation to the introduction of the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011, the Bill has been passed unamended.
The effect of the amendment is to insert a new s44BA into the Copyright Act 1968 to provide that supplying, reproducing, publishing, communicating or adapting a product information will not amount to an infringement of copyright in the product information, where the otherwise infringing act is done for a purpose relating to the safe supply of medicines. The amendment will take effect once the legislation receives royal assent and will apply to conduct which would otherwise infringe going forward.
In practical terms the Therapeutic Goods Administration requires sponsors of generic medicines to provide the same product information as that which is provided with the equivalent originating product. The amendment ensures that allegations of copyright infringement do not impede the provision of accurate and consistent information to consumers.
We will let you know when the Governor General gives her royal assent (which we expect to be in the next 2 weeks).