FDAnews
www.fdanews.com/articles/70404-eu-accession-to-bring-mixed-fortunes-for-polish-pharma

EU Accession to Bring Mixed Fortunes for Polish Pharma

March 29, 2005

Although EU accession is expected to boost the fortunes of the pharmaceutical sector in Poland in the longer term, it is clear that the process is bringing severe cost challenges to local drugmakers. Poland has until 2008 to become fully compliant with EU norms, and the introduction of more rigorous data requirements is expected to cost the local industry some PLN1bn (US$280mn), equivalent to 7% of market value.

However, the obligation to expand data portfolios to include such information as bioequivalence studies, quality testing and adverse effects is only one likely challenge ahead of 2008. The distribution sector is also widely expected to consolidate, as there is currently a glut of warehousing facilities, and competition is expected to strengthen as Western European firms enter the market.

A major concession negotiated as part of the terms for Poland's EU accession was an extension to patent protection for innovative drugs, secured partly in exchange for a longer transition period. Given that the local industry is dominated by production of generics, this may imply a significant disadvantage in relation to regulatory conditions in rival generics-producing countries. While the multinational sector is expected to fill any gaps in supply as innovative drugs become more affordable, a round of privatisations and acquisitions is widely expected in the Polish drug sector.