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Public Citizen Applauds EU Commission Call for Removal of Linkage Between Patents and Generic Medicines Authorization

Today, the European Commission issued a formal request to Italy to remove linkage between patents and generic medicines authorization which it says is causing delays in generics reaching the market. The Commission highlighted that patent linkage procedures place generic drugs at a disadvantage on the market.

The European Commission’s announcement can be found here: and the details of the news can be reached from here:

Sharing these concerns, the Director General of the European Generics Medicines Association (EGA) stated, “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.” See the EGA press release here:

The TPPA IP chapter contains provisions on linking marketing approval to patent status (see Article 9.5 of the U.S. proposal). Under patent linkage, even spurious patents may function as barriers to generic drug registration. Patent linkage can facilitate abuse, since the financial benefits to patent holders of deterring generic market entry may outweigh risks of penalties. The effect of linking the drug regulatory process to patents has a deleterious effect on access to affordable medicines which is recognized by many authorities, including the European Commission. The U.S. is one of the only countries in the world which advocates for patent linkage provisions in order to protect its domestic pharmaceutical industry (aka Big Pharma), and we encourage negotiating countries to take a closer look at how their proposal would affect access to affordable medicines in their countries.

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