The European Generic Medicines Association (EGA) and Assogenerici, the Italian association for generic medicines, welcome the European Commission’s formal call on Italy to comply with European Union rules on the marketing authorization of generic medicines.

The European Commission (EC) infringement procedure started last year, following the EGA and Assogenerici’s official complaint to the EC against the delays in granting market authorization of generic medicines caused by incorrect linkage to intellectual property rights. Italy’s non-compliance with EU rules on marketing authorization and patent linkage provision in its Intellectual Property Code have led to lengthy delays for generic medicine manufacturers to access the market.

As stated by the EC in the pharmaceutical sector inquiry report, linking the marketing authorization process of generic medicines to intellectual property rights of the originator product (“patent linkage”) is a clear abuse of the EU regulatory system.

“We hope that this is the final step of the process and that very soon the patent linkage in the Italian Intellectual Property Code will be removed,” said Greg Perry, EGA director general.

Both associations also welcome the move from the Italian government headed by Mario Monti to tackle patent linkage in its Intellectual Property Code as the decision was made to delete article 68(1-bis).

“It is a substantial fact that, in laying down the foundations of the country's economic recovery, with the Liberalization Decree, Monti’s government has decided to include measures that expand the role of generic medicines, helping the Italian NHS to guarantee broader access to pharmaceutical care now and in the near future,” said Giorgio Foresti, president of Assogenerici. “By removing the obstacle represented by article 68 (1-bis) the government has not only responded to a specific request from the EC, but a new wave of competition is going to be injected into the market by getting rid of any patent linkage attempts.”

In addition, both associations call for the possible future insertion of a clear provision in the legislation stating that the Italian medicines agency (AIFA) should not take into account any patent issue in the marketing authorization process.

“In this time of severe economic difficulty faced by European citizens and public health authorities, it is of crucial importance that patients can access affordable treatment with no unnecessary delays. Delays in access to generic medicines were deemed unacceptable by the pharmaceutical sector inquiry and the economic crisis makes such blocks as patent linkage totally unjustifiable,” Perry concluded.