The Therapeutic Goods Legislation Amendment (Copyright) Act 2011 received Royal Assent on 27 May 2011 and commenced operation on 28 May 2011. The Act amends the Copyright Act 1968 to include a new section 44BA that allows the supply, reproduction, publication, communication and adaptation of production information pertaining to therapeutic goods without infringing copyright in the original product information (approved under section 25AA Therapeutic Goods Act 1989) where it is done “in relation to the safe and effective use of the medicine.”  

The rationale behind the Bill was to prevent originator pharmaceutical companies from arguing that the product information submitted by a generic sponsor for a generic medicine infringes copyright by being essentially the same as the original.