Sustaining Generic Medicines Markets in Europe

Sustaining generic medicines markets 305.2 Generic medicines policy5.2.1 Intellectual property rightsAs in many Central and Eastern European countries, prescription of generic medicines iscommon practice due to the limited availability of originator medicines in ambulatory care prior tothe end of communism in 1989 and due to the absence of product patents until the early 1990s.The Polish generic medicines market benefited from regulation imposing a three-year dataexclusivity period until EU accession of Poland. During the data exclusivity period, the applicationfor marketing authorisation for a generic medicine cannot refer to the pre-clinical and clinicaldocumentation of the originator medicine. As the Polish data exclusivity period was shorter thanthe 6-10 years of data exclusivity granted in the EU at that time, this served to speed up entry ofgeneric medicines into the Polish market.In recent years, there has been a significant increase in the market share of imported originatormedicines (Krumschmidt, 2006). Furthermore, the introduction of Supplementary ProtectionCertificates for all patented medicines registered in Poland since 2000 can be expected to reducegeneric medicines market shares in future years.5.2.2 PricingPolish medicine prices tend to be lower than those in other EU countries (Pharmacos, 2005).Poland operates a price-regulated system for medicines that wish to be entered on thereimbursement list.5.2.3 Reference pricingPoland runs two RPS in parallel, one by active substance and the other by pharmacologicalclass. The RP is set below or equal to the price of the cheapest generic medicine.5.2.4 Incentives for physiciansPrescribing of branded and unbranded generic medicines is common because physicians havelong-term, positive experience with generic medicines and because they are conscious of thelimited ability of patients to meet co-payments. Physicians are not encouraged to prescribe byINN and they are not assisted in generic prescribing.