The European Commission has formally asked Italy to apply EU legislation on the marketing authorization procedures for generic medicines.
According to Directive 2001/83/EC [Editor's note: in Italy implemented with Legislative Decree 219/06], the implementation can take place without affecting the protection of interests in terms of industrial and commercial property. On the other hand, the holder of the authorization of a generic medicine cannot place a product on the market before the patent of the reference product has expired.
Brussels believes that Italy has not met the deadline for the adoption of EU amendments into national law and therefore continues to fail in its obligation to adequately protect manufacturers. In particular, in Italy a law prohibits manufacturers of generic products from submitting the application for marketing authorization before the penultimate year of validity of the patent of a reference product.
For this reason, the Commission urges Italy to ensure full compliance with the directive within two months. Today's request takes the form of a "reasoned opinion", on the basis of EU infringement proceedings.
If Italy fails to comply within the set deadline, the executive could decide to refer the case to the European Court of Justice.
January 27, 2012 – PharmaKronos
Generics: market almost doubled between 2010 and 2017
