Poland. Pharmaceutical Market Access in the Country

Intellectual property rights. As in many Central and Eastern European countries, prescription of generic medicines is common practice in Poland due to the limited availability of originator medicines in ambulatory care prior to the end of communism in 1989 and due to the absence of product patents until the early 1990s. The introduction of patents gave a 20-year protection to originator medicines. Furthermore, Supplementary Protection Certificates can extend this period for a maximum of 5 additional years for products that have a valid patent and that first gained market authorization after January 1, 2000. These Certificates can be expected to restrain the development of the Polish generic medicines market in future years.

In the 1990s and early 2000s, the Polish generic medicines market benefited from regulation imposing a three-year data exclusivity period until accession of Poland to the European Union (EU) in May 2004. During the data exclusivity period, the application for marketing authorization for a generic medicine cannot refer to the pre-clinical and clinical documentation of the originator medicine. As the Polish data exclusivity period was shorter than the 6-10 years of data exclusivity granted in the EU at that time, this served to speed up entry of generic medicines into the Polish market.

Data exclusivity provisions have changed over time. During negotiations for EU accession, Poland agreed to implement a six-year data exclusivity period and ten years for high-technology products authorized by the European Medicines Agency. Current European legislation has created a harmonized EU data exclusivity period of 8 years plus 2 years of market exclusivity plus 1 additional year if the product obtains a new therapeutic indication (the so called 8 + 2 + 1 rule). Poland has asked for a 15-year transitional period to implement this legislation.

Registration.Conforming to European legislation, Poland has in place a simplified registration procedure that facilitates market entry for generic medicines. If the application relates to an active principle that has been registered for at least 8 years in one of the EU countries and if the generic medicine is essentially similar to the reference medicine, the generic medicines company does not need to provide pre-clinical and clinical documentation, but can refer to the documentation of the reference medicine. This implies that pharmaceutical companies can submit an abridged application for a generic medicine after the first 10 years of the patent on the original medicine have passed.

Pricing and reimbursement approval. Generic medicines enter the market after the determination of pricing and reimbursement status by Polish authorities. The Transparency Directive 89/105/EEC specifies a 90-day limit for adopting a pricing decision and a 90-day limit for reimbursement for all EU Member States (11). However, a market review undertaken by the European Generic Medicines Association in 2006 found that it takes an average of 180 days for a generic medicine in Poland to obtain pricing and reimbursement approval following marketing authorization.