Latest news about the TPP

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.

Back to Trans-Pacific FTA Page



Copyright © 2016 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.

Public Citizen, Inc. and Public Citizen Foundation


Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.


To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.