Generic medicines

Equivalents of Original Medicinal Products
Generic medicinal products are equivalents of original products, which can enter market upon the end of patent life for original pharmaceuticals (usually patent is issued for 20 years). 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.

In order to prove that generic medicinal products have equal therapeutic effect as the original product manufacturers have to carry out the so-called bioequivalence study. Only after scientific argumentation of bioequivalence of the original medicinal products the respective generic medicinal products are registered and can enter the market.

Market of generic medicinal products is regulated by the international patent law. Name of such medicinal products is its generic scientific name or general name or name given by a manufacturer.

Qualitative Medicinal Products for Reasonable Price
Generic medicinal products meet the same quality, safety and efficiency requirements as the original medicinal products and those are manufactured in line with strict pharmaceutical standards and requirements of good manufacturing practice. And usually the price of generic medicinal products is 20–90% less compared to the original medicinal products. The reason for that may be that during the patent protection period original medicinal products have been used for treatment for several years and initial clinical study has been carried out proving safety and efficiency of such products, and therefore manufacturers are not required to carry out clinical study in order to prove safety and efficiency of medicinal products with the same active substance. In the case of generic medicinal products clinical studies are replaced by bioequivalence studies proving identity with the respective original medicinal products.

Generic medicinal products are widely used in the European Union allowing saving costs for patients, governments and insurance companies at the same time providing patient as effective and qualitative treatment as the costly original medicinal products. According to IMS Institute for Healthcare report in 2014 the presence of generic medicines in market contributed to savings of 100 BN euros in the healthcare budgets of the European Union member states and the private budgets of the patients, thus making medicinal products more affordable for patients and allowing using the saved funds for other healthcare purposes.

Public Benefit
Accessibility is one of the major benefits of generic medicinal products providing every citizen access to qualitative medicinal products and treatment. Therefore the role of generic medicinal products in the healthcare system is substantial.

European Union is growing old and every year due to increase in costs for medicinal products and treatment the burden to national healthcare budget of all Member States increases. Generic medicinal products constitute a considerable solution for this situation providing treatment of much cheaper, though as qualitative treatment.

The huge economy (100 BN euros in 2014) in the national healthcare budgets of the EU member states thanks to generic medicines not only provides patients better access to medicinal products, but also allows to use the saved funds for other, including more costly, healthcare needs.

Economically Reasonable Pharmaceutical Care
Currently generic medicinal products constitute a great share of the total provision of medicinal products in Central- and Eastern Europe with up to 70% of the total supply of medicinal products, though only 30% of the costs. Wherewith the role of generic medicinal products in the pharmaceutical industry is significant and keeps increasing challenging original medicinal products as regards the price and quality, thus promoting cost-efficient and cheaper medicinal products in the market. Due to the competition patients and national healthcare systems depend less on multinational pharmaceutical companies.

Development and Jobs
Contribution of generic medicinal products in the national economy can be proved by the fact that up to 30% of the income from sales of generic medicinal products comes back to national economy in the form of investment in research and development of new products. Research laboratories and production units of pharmaceuticals provide jobs for a great number of professionals in the industry. Currently there are more than 350 manufacturing sites if generic medicinal products employing 160 thousand European citizens.

Benefits from the Use of Generic Medicinal Products in the Healthcare Industry:

  • reduced prices
  • stimulation of competition
  • expansion of scope and increase of funds for development of new innovative products
  • base for new enterprises producing goods of high added value