The Pharmaceutical Market: Poland

The Polish pharmaceutical industry has experienced many structural changes in recent years. Most of the state-owned companies have been privatised and the remainder are expected to be sold to private investors by the end of 2009. Many firms have benefited from the high level of foreign direct investment, with the modernisation of facilities leading to the issuing of GMP certificates. However, the regulatory environment still lacks transparency and Poland has not yet managed to fully amend its pharmaceutical legislation with the latest EU regulations. The drug reimbursement process is in need of attention, as applications are not dealt with in a timely manner and the system favours domestic producers.

Intellectual property rights remain a contentious issue, with the Polish authorities continuing to receive criticism from the international pharmaceutical community. IT has been reported that local generic pharmaceuticals are registered before the patents of original drugs expire; communication needs to be strengthened between the Polish Patent Office and the Office for Registration of Medicinal Products, Medical Devices and Biocides, in order to prevent patent infringements taking place.

around 66% of the pharmaceutical market is supplied by imports. Germany and France were the leading suppliers in 2006, accounting for over 30% of imports. Domestic production tends to concentrate on the generics market.