Australia clears way for increased access to generic medicines

Australian consumers and health professionals will have more ready access to generic medicines following the passage of legislation through the Senate this week. Parliamentary Secretary for Health and Ageing Catherine King said the Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 will ensure originating pharmaceutical companies can no longer use copyright of product information to delay or prevent generic medicines entering the market.

The amendments are a response to an emerging practice of pharmaceutical companies arguing that the product information approved by the Therapeutic Goods Administration (TGA) of a generic version of a medicine breaches copyright by being essentially the same as the original.

“These amendments will ensure that product information documents for medicines continue to be consistent across different brands of the equivalent medicine without this constituting a breach of any copyright,” Ms King said, adding: “I welcome the passage of this Bill 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.”