Generic Medicines: Equivalent versions of trusted medicines
Generic medicines are the main copies of pharmaceutical products that are no longer protected by patent. They are more attractive, because they are generally less expensive than branded medicines. Their manufacturers do not incur the significant risks and costs associated with the research and development of innovative medicines.

A generic medicine contains the same active ingredient as a branded medicine that is no longer protected by patent. It is likely to have similar, but not necessarily identical, formulations to the original medicine. However, all generic products have to go through the same stringent and quality requirements demanded of the original product.

High-quality generic medicines from reliable authenticated sources are a valuable component of overall healthcare expenditure, but because they are by definition therapies which are at least 20 years old, they cannot be a substitute for advances in medical science arising from recent research and development by the innovative research-based industry.

A generic medicine is marketed in compliance with international patent law. It is identified either by its internationally approved non-proprietary scientific name (INN) or by its own brand name. Generic medicines are widely used in many developed countries in cost-effective treatment programmes, and are increasingly prescribed by doctors as effective alternatives to higher-priced branded (originator) pharmaceuticals.

Generic Medicines: Quality medicines at affordable prices
A generic medicine provides the same quality, safety and efficacy as the original branded medicine and undergoes strict scrutiny before it is licensed and given market approval by the various medicines authorities.

A generic medicine is typically 20% to 90% less expensive than the brand-name original. In addition, the availability of lower-priced generic medicines brings down the price of originator drugs (branded medicines) through market competition, producing even further savings to patients. The use of generic medicines saves European patients and healthcare systems an estimated €25 billion each year.

Generic Medicines: A tradition of excellence
In order to maintain strict national, European and international regulations, the production of pharmaceutical ingredients and medicinal products to the highest standards of excellence is encouraged. All the individual companies producing generic medicines produce in accordance with the rules of Good Manufacturing Practice (GMP) in approved and regularly inspected plants. Once a generic medicine has been approved for use by patients, its use continues to be monitored closely by the manufacturer and the health authorities. In short, generic medicines comply with the same strict standards of quality, safety and efficacy as original pharmaceutical products (branded medicines).

Generic Medicines: Strict observance of 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 (brand) 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 be equally effective.

Generic Medicines: Benefiting society
In an era when increasing demands are being made on 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. The estimated €25 billion in savings each year help provide national healthcare systems with the budget headroom needed to deliver more expensive medical treatments and services that patients often need.

Generic Medicines: Bringing economic sense to pharmaceutical care
Increasing the availability and range of generic medicines on the 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.

Generic Medicines: Committed to the future
Ageing populations and rapidly rising treatment costs are causing governments throughout the world to look again at the sustainability of their healthcare provision. Economically priced generic medicines provide a cost-effective means of controlling the fastest growing budget item in healthcare: pharmaceuticals.