Following approval of the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 by the Senate on 11th May 2011, Australian consumers and health professionals will have more ready access to generic drugs, but proprietary drug companies will have fewer options in the twilight years of patent protection for shutting down access to Australian markets by generic medicines.
Under the bill, it is no longer an infringement of copyright to reproduce (or supply, publish, communicate or adapt) product information which has been approved by the Therapeutic Goods Administration (TGA). According to the government, the amendments will ensure that product information is consistent across different versions of equivalent medicines without constituting any breach of copyright. Parliamentary Secretary for Health and Ageing Catherine King 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 misinterpreted as reflecting differences between the brands where in fact none exists".
The TGA requires pharmaceutical companies to submit a product information document providing advice about the medicine, and this information must be the same for all brands of the same medicine to ensure that they are used appropriately.
King welcomed the passage of the bill through Parliament because "any delay in generic medicines entering the market means a delay in their listing on the Pharmaceutical Benefits Scheme, leading to higher costs for consumers and the government".
The amendments have been made in response to litigation tactics employed by proprietary drug companies under the Copyright Act that effectively seek to slow access to Australian markets by generics that, at the time of the litigation, have not yet committed a patent infringing act.
A copy of the bill can be found at www.comlaw.gov.au/Details/C2011B00026.