• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » European Commission and Mario Monti seek to increase patient access to generic medicines

European Commission and Mario Monti seek to increase patient access to generic medicines

February 8, 2012
CenterWatch Staff

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.

    Upcoming Events

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 25Oct

      2023 WCG Patient Forum

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Donna Snyder

      New WCG Executive Physician Outlines Goals for Clinical Research

    • Hand Shake at Meeting

      Partnership to Bolster Trials in Low Resource Regions Kicks Off

    • Guidelines-360x240.png

      Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Monitoring

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing