Generic drug equivalents – key to the availability of modern pharmacotherapy The generic products are equivalents of original pharmaceutical products; they may enter the market after the expiration of the patent coverage of the original products. The generic drugs contain the same active substance, fulfil the same exacting criteria during the development, production and safety assessment, and have the same quality, safety and efficacy as the original branded products. The generic products are either marketed as branded products, bearing their own trademark (e.g. Ibalgin®, containing the same active substance as ibuprofen), or unbranded products, using simplified names of the respective active substance (e.g. diclofenac, metformin).
What is the most principal importance of the generic equivalents? They are available at reduced prices, thus increasing the availability of modern drugs. The generic equivalents are available at prices which are by 20 – 80% lower than those of the original drugs. Their quality, efficacy and safety equal those of the original drugs. They support the process of innovation by forming competitive environment for the original products. Should the original drug have a permanent monopoly, there would be no reason to further innovation. There is no disagreement between the generic drugs and the original drugs. Broader use of the generic equivalents leads to savings, which may be used for broader use of more expensive original drugs where necessary..
Why are the generic equivalents cheaper than the original drugs? The original drug has a monopoly position, if covered by a patent; therefore, it is probable that its price will be somewhat higher. In case of a generic equivalent not all preclinical and clinical studies should be carried out again but a reference to clinical data of the original product can be made. Development of the product is therefore significantly cheaper.
The assurance of safety and efficacy of the generic equivalents Prior to marketing, every product must pass a registration procedure. Registration procedure in the Czech Republic is carried out by the State Institute for Drug Control, which is within the competency of the Health Ministry of the Czech Republic. In compliance with the Act No. 79/1997 Coll., as subsequently amended, safety, efficacy and quality of the product are assessed during the registration procedure. The registration of a drug means a legal confirmation of its safety, efficacy and quality. During the registration procedure identical criteria are applied to the generic equivalents and the original drugs.The registration decree is effective for 5 years. During this period the manufacturer is obliged to evaluate the product safety; this applies to both, its own product and all other products containing the same active pharmaceutical substance. Any renewal of the registration is based on a summary report on the product safety in the past period.
How is the generic equivalent formed? The drug development is controlled by strict international regulations, the so-called „good practices“. In case of drugs, Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice are applied. They represent a set of rules and only consistent adherence to such rules assures quality of all processes. The ability of a company to abide by those rules is verified by certificates issued by state authorities, i.e. in the Czech Republic by the State Institute for Drug Control in Prague. The first precondition of successful development is obtaining a pharmaceutically active substance fulfilling the highest quality standards. The quality requirements are high and are continuously increasing. Only traces of impurities are admissible, their maximum concentration depending on the administered drug dose. Development of pharmaceutical substances themselves becomes an important part of the development process. Another step consists in a development of a suitable pharmaceutical form, which brings drug into a human body in proper concentration and at proper rate. Along with the development of the pharmaceutical form, analytical methods for the quality control should be developed. The pharmaceutical forms are subject to very strict testing; they must show long-term stability, even under conditions of increased temperature and humidity. Therapeutic equivalence between the original drug and a generic equivalent is proven by a study of bioequivalence, comparing the rate/extent of absorption of the drug in the human body. The study is carried out in clinical conditions on healthy volunteers and is evaluated by objective statistical methods. All supportive documents obtained during the development of the drug are included in the registration documentation serving as the basis for the issue of the registration decree (sometimes called marketing authorisation) by the State Institute for Drug Control in Prague. The whole process of development is very exacting from time and cost viewpoints; it takes 2 to 5 years.
What is the rate of generic equivalents on the pharmaceutical market in the Czech Republic? According to the recent data of the IMS Company (an international company offering pharmaceutical market data), the rate of the generic equivalents in the Czech Republic amounts to 62% and 34% (from the viewpoint of volume and financial expression, respectively). Even such ratio signalizes that the generic drugs are substantially cheaper. The most extensive increase of the drug expenses is linked to the introduction of new and expensive original products.
What is the importance of the domestic drug manufacturers (the biggest Czech pharmaceutical company Zentiva may serve as an example)? They market modern drugs showing a high quality at reasonable prices. Domestic products are often considered reference products upon the stipulation of payment amounts. They supply drugs, which are well-known to both patients and physicians. They employ highly qualified experts. They support university research and research conducted by the Czech Academy of Sciences. They support cultural and sports events (Prague Autumn, Bridges between Cities, Olympic Committee, Czech Medical Society, and so on). They pay taxes in the Czech Republic. They significantly contribute to proper functioning of the economic environment.
The generic equivalents play an irreplaceable role in our health care system. | |  |