Accession Treaty approved, pharmaceutical firms relieved

Brussels yesterday approved the final version of the EU accession treaty. Pharmaceutical companies breathed a sigh of relief, as they were battling over regulations for medicines almost to the very end as those proposed by the Union did not reflect the settlements negotiated in Copenhagen. The concerns surrounded SPC, a drug safety certificate. In member states the SPC is valid from the initial registration date of a pharmaceutical within EU territory. This effectively blocked the sale of drugs from candidate countries being sold in the EU during the transition period. Under agreements reached in Copenhagen, such products could be made available throughout the Union, but in the treaty's previous draft the restriction still applied to Polish pharmaceuticals. "The treaty restricted this requirement to Poland only. It is a minor detail that could have had very serious consequences," explained Cezary Sledziewski of Pilvy Krakow. (Puls Biznesu, p. 8) A.C.