The European Parliament has voted overwhelmingly to adopt legislation that is supposed to transform the way medicines are brought to market and accessed across much of Europe. But the effort — which must still be approved by the European Council — drew mixed reactions from the pharmaceutical industry and consumer groups.
A key sticking point concerns data protection. This refers to the period of time in which a generic company cannot use study data generated by brand-name manufacturers to win regulatory approval to sell a medicine. The issue is seen as crucial because drug companies want as much protection as possible to extend sales, while advocacy groups argue that added protection costs consumers more money.
The parliament voted in favor of dropping data protection slightly to seven-and-a-half years from the existing eight-year period. Drug companies would be eligible for 12 months of additional data protection if their medicine addresses an unmet medical need, six more months if comparative clinical trials are conducted, and yet another six months if a significant share of R&D work takes place in Europe.
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