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PhRMA press release on the Special 301 Report

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Source: PhRMA

May 1,2013

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.



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