EGA Press Release

Rome-Brussels - Friday, 27 January 2012

EUROPEAN COMMISSION AND MARIO MONTI’S GOVERNMENT SEEK
TO INCREASE PATIENT ACCESS TO GENERIC MEDICINES

 

The European Generic medicines Association (EGA) together with the Italian association for generic medicines (ASSOGENERICI) welcome the European Commission’s formal call yesterday on Italy to comply with EU rules on the marketing authorisation of generic medicines.

The European Commission infringement procedure started last year, following the EGA and ASSOGENERICI’s official complaint to the European Commission against the delays in granting market authorisation of generic medicines caused by incorrect linkage to intellectual property rights. Italy’s non-compliance with EU rules on marketing authorisation 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 European Commission in the pharmaceutical sector inquiry report, linking the marketing authorisation process of generic medicines to intellectual property rights of the originator product (so called: “patent linkage”) is a clear abuse of the EU regulatory system*.

Greg Perry, EGA Director General, declared: “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”.

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 Liberalisation 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. By removing the obstacle represented by art. 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” ASSOGENERICI President Giorgio Foresti commented.

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 authorisation 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” Greg Perry concluded.

*http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/communication_en.pdf

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For further information contact Beata Stepniewska
E-mail: or ASSOGENERICI Ufficio Stampa Assogenerici Massimo Cherubin mobile +39/335.82.31.700 tel. +39/02.20.24.13.57 m.cherubini@vrelations.it