European Parliament Passes Pharmaceutical Regulatory Reform

Law360, New York (December 17, 2003, 12:00 AM EST) -- The European Parliament adopted sweeping new legislation Wednesday aimed at standardizing regulatory data protection for drugs across the European Union.

Under intense pressure from lobbyists for research-based and generic drug makers, the European Parliament reached a compromise for regulatory data protection known as “8+2+1,” under which new drugs will receive 10 years of protection from generic competition, including eight years of data protection, plus an additional year for new uses.

A final approval of the new regulatory environment by European Union ministers is expected in the...
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