Generic medical drugs

A generic drug is a novel medication alternative. It contains the same active substance and quantity as the original medication, has the same dosage form and is used for the treatment of the same disease. The patient can be sure that the medication he receives is effective and safe. The generic may vary from the original in its name, appearance, and the excipients may also differ.

A generic drug enters the market after the patent or the supplementary protection certificates have expired. A standard patent protection in the European Union lasts 20 years and can be extended by a supplementary protection certificate. This certificate is intended to compensate for the period between the filing of a patent application for a new product and the authorization to place it on the market. It is valid for a maximum of five years.

Affordable treatment for more patients

The registration of generics is carried out by national drug agencies, or by the European Medicines Agency (EMA). During registration, a generic (unlike an original) does not have to submit clinical study results and must demonstrate the reputed bioequivalence, i.e. the rate and extent of absorption of the active substance is within the specified range as for the original product.

Generally, this means that a generic and the original product are equally effective.

The registration of a generic drug usually lasts between one and two years but can be delayed for numerous reasons. For example, similar to the original preparations, generics are also subject to pricing and reimbursement regulations.

Generics can enter the Czech pricing and reimbursement system in an accelerated procedure, following the path of the correspondent similar product, when the medication requests a maximum pricing and reimbursement of a medicinal product that is already on the market. Provided the original product is the only one in the system, the law requires a 40% reduction of the maximum pricing and reimbursement compared to the original. The following generics will then have a reimbursement set in the same (reduced) amount in the reimbursement review.

Therefore, generics ensure that the medicinal products entering the system are effective and safe for a significantly lower pricing and reimbursement. This means that with the same number of finances, more patients can be treated, and the treatment becomes significantly more accessible.