Poland has failed to meet the deadline for implementing a number of European Union (EU) directives concerning its drug industry and is now facing the possibility of a serious reprimand from the European Commission.
The most important of the regulations was the adoption of the EU's uniform eight-year data exclusivity period. Under these guidelines, the research conducted on an original drug cannot be released to other companies by medical authorities. This acts as an addition to patent-protection law and delays approval of generics.
Also, Poland has not introduced EU legislation concerning methods for monitoring drug safety as well as surveillance of manufacturing. The country has also failed to bring in required changes to marketing and packaging. The outgoing Polish government attempted to ratify all of these amendments but were unsuccessful.
This leaves the current administration in a difficult position as it attempts to help the local drug industry. Accession to the EU has opened up lucrative markets to Polish exporters, but a failure to harmonise legislation could limit their room for maneuver in the short term.