Spain Adopts Decree For Introduction Of Generics

After much debate, Spain has finally approved the additional law on the1997 budgets, which introduces amendments in favor of the introduction of generics in the country (Marketletter January 6).

The Spanish pharmaceutical industry association, Farmaindustria, has been successful in its lobbying to ensure that a generic product should be bioequivalent to the original product. Furthermore, a spokesperson for Farmaindustria told the Marketletter that the decree also says that a generic can only enter the market 10 years after continued clinical use of the original product, a condition for which the association had argued.

This could mean that certain products may, in effect, have protection longer than originally granted through their patents.