What do generic medicinal products mean?
Patent-free or generic medicinal products are medicinal products equivalent to original medicinal products. It means that such medicinal products contain the same active substance as the original medicinal product; therefore for the same dose their therapeutic efficiency is equivalent or close to the one of the original medicinal product - they are completely fungible or bioequivalent. Such medicinal products can enter market upon the end of patent life for original pharmaceuticals. Although chemical content of generic medicinal products is identical to the original products usually the price is 20-90% less compared to the original medicinal products. Therefore generic medicinal products are widely used allowing saving costs for patients, governments and insurance companies at the same time providing patients as effective and qualitative treatment as the costly original medicinal products.
Is there any difference between generic and original medicinal products?
Generic medicinal products contain the same active substances as the original medicinal products and have the same effect on a patient. However generic medicinal products equivalent to original pharmaceuticals may contain diverse non-active substances (such as colour, starch etc.), those can be of different size, colour or shape, in individual cases due to salts and esters also active substances of the medicinal product may differ. But such differences do not affect therapeutic effect of particular pharmaceuticals.
What institutions control quality, safety and efficiency of generic medicinal products?
Just like original medicinal products also manufacturing of generic medicinal products and use for treatment of patients in the European Union requires licence issued by a responsible institution of the appropriate country (in Latvia - the State Agency of Medicines) or the European Medicines Agency verifying compliance of particular medicinal product with the set quality, safety and efficiency requirements and providing continuous control and monitoring. The said requirements are as strict as for original medicinal products.
Manufacturers of generic medicinal products have to prove that particular pharmaceuticals guarantee equivalent therapeutic effect as the original medicinal products. For that reason before registration and entry in the market the bioequivalence study must be carried out.
Patentbrīvo medikamentu ražotājiem ir jāspēj pierādīt, ka attiecīgās zāles nodrošina tādu pašu terapeitisko efektu kā oriģinālie preparāti. Tāpēc, pirms tie tiek reģistrēti un nonākt tirgū, ir jāveic tā sauktais bioekvivalences pētījums.
Are generic medicinal products really as good as the original medicinal products?
Yes. Chemical formula and effect of generic medicinal products is completely equivalent to original products. Those are subject to the same safety, quality and efficiency standards as the rest medicinal products. Production units of generic medicinal products are strictly monitored and meet the good manufacturing practice standards drawn up upon the initiative of World Health Organisation. Moreover manufacturers of generic medicinal products do not have to carry out initial clinical trails required for innovative products meeting strict medical standards (safety and efficiency of active substances of generic medicinal products are proved by bioequivalence with a original product); therefore a great amount of funds can be channelled to improvement of quality and efficiency of generic medicinal products as for products of other manufacturers, including original medicinal products.
Registration and control of all medicinal products in Latvia is provided by the State Agency of Medicines, thus guaranteeing compliance with the safety, quality and efficiency standards.
Are generic medicinal products and patent-free medicinal products one and the same?
Yes. In official documents, publications and daily life physicians and other professionals talking about patent-free medicinal products mostly use terms "generic medicinal products", "generic products" or "generic pharmaceuticals", which is derived from English word "generic", which directly translated into Latvian means "patent-free". In accordance with the State Language Centre statement in the information provided to the mass media term "patentbrīvie medikamenti" (generic medicinal products) or "patentbrīvās zāles" (generic pharmaceuticals) must be used. In individual cases referring to generic medicinal products concept "economic" and "completely fungiblemedicinal products" can be used.
Are really generic medicinal products cheaper?
Yes, and the difference is significant. Usually generic medicinal products are 20-90% cheaper compared to the original equivalents. Therefore by the end of patent life and upon entry of generic equivalent medicinal products in the market due to competition also manufacturers of original pharmaceuticals are forced to reduce pricess of their produce.
What is the benefit of generic medicinal products to patients and national healthcare system?
Use of generic medicinal products allows patients and national healthcare system save significant funds every year, and those can be used for other needs relating medical assistance, including research and development of new medicinal products. In the entire European Union the saved costs account for tens of billions of euro. Price of generic medicinal products is a major stimulus for manufacturers of original medicinal products to cut their selling prices. Thus availability of qualitative medicinal products and healthcare for patients is promoted.
When generic medicinal products become available to patients?
Just like in other spheres also the patent in pharmaceutical industry usually is set for 20 years. This term can be prolonged for 5 more years, if the manufacturer has been awarded the Supplementary Protection Certificate. By the end of this term medicinal products of the same formula can be manufactured by any certified manufacturer.
As regards intellectual property rights in the pharmaceutical industry European countries are very strictly protected, compared to the rest of the world. In accordance with the EU Directive No 2004/27/EC besides patents entry of generic medicinal products in the market is restricted by the Data Exclusivity. It is a period of 6 or 10 years during which manufacturers of generic medicinal products are prohibited to declare registration of its pharmaceuticals, basing on the bioequivalence studies with original medicinal products. (Refers to medicinal products declared for registration before 31 October 2005.) Generic medicinal products can enter the market 2 or 3 years after the end of the said period.
Within what time after the end of patent life of original medicinal products generic medicinal products can enter the market?
Just like manufacturers of original medicinal products also manufacturers of generic medicinal products invest large amount of money and time in production and development of their products. Also registration of generic medicinal resources takes a lot of time - in the EU Member States this process takes about 1-2 years, sometimes even more. Entry in the market depends also on the procedure of acquisition of the status of compensated medicinal product. In Latvia decision on inclusion of medicinal products in the list of compensated medicinal products is made by the National Health Service. Changes in the list of compensated medicinal products (inclusion and exclusion of medicinal products from the list, change of base or reference price) are made by the National Health Service twice a year on 1 July and 1 January.