Are equivalent versions of trusted medicine

A generic medicine is an equivalent of an originator pharmaceutical product. It contains the same active ingredient as the originator product and is therefore interchangeable with that product. It is identified by either its generic name (medicine name) or by its own brand name.

Are quality medicines at affordable prices

A generic medicine provides the same quality, safety and efficacy as the original brand name product and undergoes strict scrutiny before it is given marketing approval by the Therapeutic Goods Administration (TGA). Generic medicines have, to date, saved the PBS substantially over $3 billion since 1995. This will increase over the next few years as many patents expire on original products.

Have a tradition of excellence

In order to maintain strict national and international regulations, the GMiA encourages the production of pharmaceutical ingredients and medicinal products to the highest standards of excellence. All the individual companies represented by the GMiA produce in accordance with the rules of Good Manufacturing Practice (GMP) in approved and regularly inspected plants. In short, generic medicines comply with the same strict standards of quality, safety and efficacy as original pharmaceutical products.

Strictly observe bioequivalence

The key factor in creating a generic medicine is establishing bioequivalence. Bioequivalence means that, when compared scientifically, the generic medicine and the originator product
demonstrate essentially the same rate and extent of biological availability of the active substance in the body when administered in the same dose. In simple terms, the generic medicine and the original product must have the same effect on the body.

Benefit society

In an era when increasing demands are being made on Australia’s healthcare services, generic medicines provide a major benefit to society by ensuring patient access to quality, safe and effective medicines while reducing the cost of pharmaceutical care. In fact, generic medicines have saved the PBS substantially over $3 billion since 1995.

Bring economic sense to pharmaceutical care

Increasing the availability and range of generic medicines on the Australian market is essential for pharmaceutical care. Allowing effective competition between generic medicines and patent-expired original brands is crucial to lowering pharmaceutical costs and stimulating innovation.

GMiA members contribute to growth and employment

GMiA members supply over 30% of all prescriptions dispensed under the PBS and employ around 5,000 people (1,700 of these are employed in manufacturing), a significant number being tertiary qualified. They manufacture in Australia 80% of all generics dispensed, export generic medicines to Asia, Europe, Canada, USA and New Zealand and are significant investors in R&D in Australia.

GMiA supports intellectual property rights

The GMiA supports intellectual property rights in the pharmaceutical sector that enable timely access to generic medicines. In Australia, intellectual property laws allow up to 25 years patent protection for new medicines. When the patent expires, companies can apply to bring another brand of that medicine to the market. These new generic brands trigger savings to the PBS and provide consumers with the opportunity to choose not to pay the manufacturer’s premium on the original brand.