Consumers

Generic medicine offers pharmaceutical products of the same quantitative and qualitative make up as branded pharmaceutical products, at a lower cost.  Generic products do not attract any brand price premiums and are sold to consumers at the lowest price stipulated by the Pharmaceutical Benefits Scheme (PBS) for that category of product.  They provide an economic benefit to consumers, whilst still ensuring that the quality of the medicine is of highest possible standard.

"I have often heard confusion from consumers and doctors about generic medicines. In this country they are of excellent quality assured by the Therapeutic Goods Administration."

Media release on 10th May 2005 by
Tony Abbott (minister for health and ageing) and
Ian Macfarlane (minister for Industry, Tourism and Resources).

Whilst some generic medicines have cosmetic differences compared to their brand counterparts, these differences have no impact on safety of effectiveness and are purely for brand identification purposed.

A generic medicine is defined in the Therapeutic Goods Regulations as a medicine that, in comparison to a registered medicine:

• has the same quantitative composition of therapeutically active substances, being substances of similar quality to those used in the registered medicine;
• has the same pharmaceutical form;
• is bioequivalent;
• has the same safety and efficacy properties.

In order for a generic drug to be considered bioequivalent, a clinical study must be conducted (often involving around 40 patients) where the generic drug is compared to the originator drug. For a generic drug to be registered in Australia, a bioequivalence study must be conducted and the results must be considered acceptable by the Australian Authorities.