Generic medicines are the therapeutic equivalent to original pharmaceutical products whose patent expired. They contain the same active substance as the original product, being their equivalent in dose, concentration, administration mean, safety, efficiency and therapeutic indications.
A generic medicine is marketed in accordance to international patent laws. The product is identified by Common International Denomination (DCI) or by its own name. Generic medicines are used on large scale in many EU countries for cost-efficient treatment programs. They are prescribed by doctors as efficient alternatives to more expensive innovative pharmaceutical products.
Generic medicines offer the same quality, safety and efficiency as the original products. European or national authorities strictly control them before issuing certificates and approving their marketing.
Usually, a generic medicine is 20% - 90% less expensive than the original one. In addition, the fact that generic medicines are available at lower prices decreases the price of the original medicines by creating competition on the market, which offers access to pharmaceutical treatment to patients.
Generic medicine producing companies meet the international criteria on quality, safety and efficiency of medicines. In fact, all the medicine producing plants are audited and certified with the quality norms Good Manufacturing Practices (GMP) by the National Agency of Medicines and Medical devices (ANMDM).
The key factor in creating a generic medicine is establishing bioequivalence. The bioequivalence implies that, from scientific point of view, the generic medicine and original product have the same rate and biological availability of the active substance in the body when the medicine is administrated in the same quantity. Therefore, the generic medicine and original product must be equally efficient.
Whereas all EU countries register more need for medical assistance, the generic medicines play a major role in the society by providing access to quality pharmaceutical treatment for patients at accessible costs.
A real competition between generic medicines and original products is crucial for decreasing the allocated costs for pharmaceutical treatment and also stimulate innovation.
The aging population and the accelerated increase of medical assistance costs are key factors forcing governments from all over the world to carefully analyze all aspects on supplying medical assistance services. Generic medicines offer a cost-efficient solution for controlling the segment with the largest cost growth–the pharmaceutical treatment.