PhRMA Comments on the 2010 Special 301 Report

PhRMA Comments on the 2010 Special 301 Report

Washington, D.C. (May 3, 2010) — Pharmaceutical Research and Manufacturers of America President, International, Christopher Singer issued the following statement today on the U.S. Trade Representative’s (USTR) "Special 301" annual report to Congress, outlining the Administration’s global intellectual property agenda:

“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 is the engine that will enable patients around the globe to receive the benefits of future discoveries of life-saving medicines. This is particularly important for patients around the world who are waiting for the more than 2,950 medicines currently in development by PhRMA member companies.

“Protecting American intellectual property is also important to the U.S. economy. Effective protection of IP is a critical element of meeting President Obama's objective of doubling US exports over the next five years. For these reasons 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 trading partners. PhRMA and our members appreciate the continuing efforts underway at all levels by USTR, the Departments of State and Commerce, and the effective advocacy of overseas missions to promote compliance with international obligations.

The value of IP protection should not be undermined by discriminatory market access barriers. 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.

“I applaud the report’s discussion on counterfeiting problems that present public health concerns in the United States and elsewhere in the world. Our member companies are actively engaged in seeking solutions to these problems with the U.S. Government, governments mentioned in this submission, allied industry associations, the World Health Organization and concerned health professionals and patient groups. PhRMA and its members are committed to being active participants in addressing the public health risks and other public interests that are compromised by those who traffic in counterfeit medicines.

“As outlined in PhRMA’s Special 301 submission, weak protection of intellectual property rights in Thailand is especially troubling. We therefore welcome the Administration in its announcement of an out-of-cycle review for Thailand.

“Out-of-Cycle Reviews offer a valuable opportunity for the U.S. government to work with trading partners to address IP concerns mentioned in the Special 301 report. I fully support this process and look forward to the active dialogue and cooperation it can foster. This is most effective when the OCR is completed as an interim review well before the issuance of the next year’s Special 301 Report thus giving the country under review the time and opportunity to receive the OCR analysis and work to improve their IP practices. To delay these reviews undermines their efficacy and the value of the 301 report itself.

“I am encouraged that the Administration has taken steps to highlight the deficiencies of China. China continues to circumvent its data protection obligations and permit widespread distribution of unregistered active pharmaceutical ingredients. Also, we believe a PWL designation is appropriate in the case of India, due to significant delays in the provision of data protection, as well as concerns about the scope of patents and coverage of incremental innovation, delays in provision of patents and recent actions in the courts to limit or undermine patentability.

“The Special 301 process continues to be effective in gaining high-level attention from our trading partners, attention that is needed to redress intellectual property violations and market access concerns. 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 pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008.

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