Australian consumers and health professionals will have more ready access to generic drugs following the federal parliament's passage of new amendments to the Copyright Act this week, says the government.
The newly-approved Therapeutic Goods Legislation Amendment (Copyright) Bill 2011 was introduced as a result of increasing claims by originator drugmakers that product information approved by the Therapeutic Goods Administration (TGA) for generic versions of their products was essentially the same as the original and therefore constituted a breach of copyright.
Brand-name pharmaceutical manufacturers have sought to use this argument to delay or prevent generic versions of their products from entering the market, but the new amendments will ensure that product information is consistent across different versions of equivalent medicines without constituting any breach of copyright, according to Ministers.
The TGA requires pharmaceutical manufacturers to submit a product information document providing advice to health professionals and consumers about the medicine, and this information must be the same for all brands of the same medicine to ensure that they are used appropriately, said Catherine King, Parliamentary Secretary for Health and Ageing.
This consistency is critical, because any difference in the text of product information "could be misinterpreted as reflecting differences between the brands where in fact none exists," she added.
Ms King said she welcomed the passage of the amendments because any delay in generic medicines entering the market means a delay in their listing on the Pharmaceutical Benefits Scheme (PBS), "leading to higher costs for consumers and the government."
She also emphasised that the government has ensured that the amendments "go no further than is absolutely necessary," and that it believes they will "restore the appropriate balance between ensuring safe and timely access to medicines and encouraging R&D in the pharmaceutical industry through appropriate protection of intellectual property."
The bill's passage was welcomed by the Generic Medicines industry Association of Australia (GMiA) as "important public policy." If parliament had done nothing about the allegations of copyright infringement, generics firms could not only have been prevented from providing the information that accompanies their products but also from supplying generics to the Australian market, the industry group claimed.