PhRMA Statement on 2013 Special 301 Report

PhRMA Statement on 2013 Special 301 Report

WASHINGTON, D.C. (May 1, 2013) – Pharmaceutical Research and Manufacturers of America (PhRMA) International Vice President Jay Taylor issued the following statement today:

Maintaining global incentives for research and development into new medicines is essential for continued innovation of treatments for improving the health and lives of patients. Worldwide respect for intellectual property helps to ensure that patients around the globe receive the benefits of future discoveries of life-saving medicines, including the more than 5,000 medicines currently in development by the pharmaceutical industry.

The Special 301 process garners high-level attention from our trading partners -- attention that is needed to redress intellectual property violations and market access concerns within individual markets and to send signals to other U.S. trading partners that protecting American intellectual property is important to the U.S. economy.

PhRMA and our members place a high priority on addressing the harm caused by inadequate IP protection and by the market access barriers put in place by some U.S. trading partners. We appreciate the continuing efforts underway at all levels by USTR, the Departments of State and Commerce, and the effective advocacy of U.S. overseas missions to promote compliance with international obligations.

However, we are dismayed that USTR did not grant an out-of-cycle review for India. The deteriorating protections for patented medicines in India have become increasingly concerning. Over the past year, the Government of India has issued several intellectual property decisions that have disproportionately impacted U.S. biopharmaceutical companies and a number of other innovative sectors. The IP regime in India has been structured and applied in ways that prop up local industries to the detriment of U.S. jobs and the worlds patients.

While PhRMA appreciates the fact that USTR raises serious concerns regarding numerous Canadian pharmaceutical IP measures, we are nonetheless disappointed that USTR has changed Canada’s designation despite the fact that no progress has been made on this front. Canadian policies and judicial opinions continue to harm international innovators to the benefit of domestic industries. Canadian regulators have, for example, created a discriminatory right of appeal regime under which Canadian medicine manufacturers challenging the validity of a medicine patent may appeal an adverse decision through an administrative proceeding while innovative international biopharmaceutical companies cannot. We also are concerned that the heightened standard for patentable utility for pharmaceutical patents is inconsistent with Canada’s trade treaty obligations. USTR and the Interagency process should push Canada to provide more adequate IP protections.

The value of IP protection should not be undermined by discriminatory market access barriers, including discriminatory government pricing and reimbursement policies. We welcome USTR’s recognition of market access barriers faced by U.S. pharmaceutical companies and their efforts to eliminate them in many countries in order to provide for affordable health care today and support the innovation that assures improved health care tomorrow.

PhRMA members look forward to working with the staff of the USTR as they continue to represent the interests of U.S. consumers, patients, workers and industry by addressing unfair trade practices in key countries around the world.


The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone.

Find PhRMA Online:

For information on how innovative medicines save lives, visit: http://www.innovation.org

For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org

For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org

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