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Angie Drakulich was editorial director of Pharmaceutical Technology.
The European Commission adopted the final report on its anticompetitive inquiry into the pharmaceutical sector on July 8, 2009.
The European Commission adopted the
on its anticompetitive inquiry into the pharmaceutical sector on July 8, 2009. The inquiry began in January 2008 to investigate possible anticompetitive conditions in the pharmaceutical sector, specifically looking at why fewer new medicines were being brought to market in the European Union and why generic entry seemed to be delayed in some cases.
The EC received more than 70 comments on its preliminary report , which was issued in November 2008.
After reviewing a sampling of pharmaceutical drugs that faced exclusivity expiration between 2000 and 2007 in 17 EU countries, the inquiry team found that “citizens waited more than seven months after patent expiry for cheaper generic medicines, costing them 20% in extra spending.” Other major findings according to an EC press release included:
The European Commission intends to increase scrutiny under the EC Treaty antitrust law and bring specific cases where appropriate, according to the release. The inquiry panel also recommended the following:
"We must have more competition and less red tape in pharmaceuticals. The sector is too important to the health and finances of Europe's citizens and governments to accept anything less than the best,” said Neelie Kroes, European commissioner for competition, in a statement on the European Commission website.
“The inquiry has told us what is wrong with the sector, and now it is time to act. When it comes to generic entry, every week and month of delay costs money to patients and taxpayers. We will not hesitate to apply the antitrust rules where such delays result from anticompetitive practices. The first antitrust investigations are already under way, and regulatory adjustments are expected to follow dealing with a range of problems in the sector."
These changes, meant to provide EU citizens with quicker access to safe, innovative and affordable medicines, are expected to take effect immediately.
See this related PharmTech article:
European Commission Report: Originators Block Generic Competition (ePT newsletter)
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