THE LEGAL ASPECTS OF GENERIC DRUGS – EU AND POLAND
What are generic drugs?
Due to the registration qualifications, there are innovative and generic drugs as well as preparations with the so-called well established use. Companies producing innovative (original) drugs are of great importance in the development of new technologies. However, the pharmaceutical industry in Central and Eastern Europe is dominated by companies producing generic drugs (the so-called generics).
Generic drugs are equivalents of original products, the patent protection of which has already expired or has not been applied for. The original and generic medicine may differ in name, manufacturer and price. However, the active substance contained in them, which is responsible for the action of the drug, and its amount will always be the same.
Analysts say that the generic drugs market in 2008 was worth EUR 17.2 billion, and predict its further development. Also in Poland, generic companies have a large share in the pharmaceutical sector. Among many European countries, it is Poland that is the leader in terms of value and quantity of generic drugs sold. In terms of value, generic drugs constitute 88% of the drug market in our country, and in quantitative terms – approx. 66%, which is definitely more than in other countries.
