Public Health, Consumer Groups Respond to 2009 USTR Special 301 Report

Essential Action, Knowledge Ecology International (KEI), Oxfam America,
AU Program on Information Justice and Intellectual Property (PIJIP),
Forum on Democracy and Trade, Health GAP (Global Access Project)

FOR IMMEDIATE RELEASE | April 30, 2009
Contact Information for each organization accompanies quotations below

Today, the US Trade Representative (USTR) released its annual “Special 301 Report,” identifying countries it views as denying “adequate and effective protection of intellectual property rights.” Despite committing to the World Trade Organization’s TRIPS flexibilities meant to encourage access to low-cost generic medicines, the United States regularly singles out countries for pro-health policies that are TRIPS compliant in the Special 301 Report. The report is based on comments submitted to USTR, most of which come from businesses holding copyrights and patents. The pharmaceutical industry’s trade association submits detailed comments each year, which USTR draws on extensively. (To view all the comments received by USTR for the 2009 report, see www.regulations.gov).

Public health and consumer groups had hoped the Obama administration would turn a new page and recognize the right of countries to take TRIPS-compliant measures that increase access to medicines, and thus are disappointed that this year’s report mirrors not only Big Pharma’s demands, but the policies previously pursued by the Bush administration.
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Following are comments from several representatives of U.S. civil society groups to the 2009 Special 301 Report:

We can only hope that today’s report is a product of a USTR-on-autopilot. There’s nothing to distinguish this report from the familiar anti-health reports of the Bush administration. That USTR continues to harp on Thailand’s TRIPS-compliant issuance of compulsory licenses – an effort which has lowered price in the public sector and expanded access to lifesaving medicines – is a deeply embarrassing action by an administration that says it aims to repair America’s reputation in the world.
– Robert Weissman, Director, Essential Action
202-387-8030 | [email protected]

This is really George Bush’s last 301 report. It lacks every element of the kind of transparent and fair government process that the Obama administration promotes. The findings in the report are based on submissions of data by industries that no serious academic would believe to be true. There is no opportunity for countries or civil society to respond to industry accusations, challenge methodologies, appeal determinations or have an open hearing before the report is issued. This is not a process that is designed to promote truth seeking. Its main effect is to antagonize our trading partners.

The Special 301 program unilaterally threatens and sanctions countries for policies that do not violate international trade rules. The program is widely thought by international trade experts as directly contrary to the norms of the World Trade Organization requiring multilateral dispute resolution. If a country challenged its listing in the WTO, I believe the program would likely be struck down, opening the U.S. for retaliation by trading partners. Governments and civil society organizations should pressing the Obama Administration and Congress to do away with this program.”
– Sean Flynn, Professor of Law, Program on Information Justice and Intellectual Property American University, Washington College of Law, 202-274-4157 |
[email protected]

The report shows key trade officials are still led by corporate lobbies. There is scant evidence of new or independent analysis on innovation or consumer protection issues.”
– James Love, Director, Knowledge Ecology International.
202.361.3040 | [email protected]

The 2009 Special 301 Report that USTR released today is a deceptive unilateral trade tool that largely serves the interests U.S. corporations that have the resources to lobby Washington. It is shameful and disappointing that the first report of the new Obama administration cites developing countries for amending or using their laws in ways that are legal under the WTO rules. Ironically, the USA would do quite poorly if subjected to the same standards applied to others. The US has broader national exceptions, and issue more compulsory licenses than any developing country.
– Judit Rius Sanjuan, Attorney, Knowledge Ecology International
202-332-2670 | [email protected]

This year’s Special 301 Report also persists in scolding countries for alleged barriers to innovation, such as the use of reference pricing, that have nothing to do with intellectual property. Good thing that the Special 301 report doesn’t target U.S. jurisdictions, since the vast majority of states also use reference pricing as part of their efforts to manage spiraling drug costs.
– Peter Riggs, Director, Forum on Democracy & Trade
360-789-2520 | [email protected]

The strong arm of U.S. corporate power, especially its pharmaceutical industry, still holds sway over U.S. trade policy. The Annual Special 301 Report is a cut and paste job from industry’s submissions and is virtually indistinguishable from those issued for eight years by the Bush Administration. Poor people in developing countries desperately need access to life-saving and life-enhancing medicines and countries need intellectual property rules that prioritize public health not just obscene corporate profits. The new Obama administration is not yet showing to new IP/trade face to our global neighbors.
– Professor Brook Baker, Northeastern University School of Law & Health GAP
617-259-0760 | [email protected]

The US Trade Representative’s office has issued a Special 301 report that still champions the narrow commercial interests of the multinational pharmaceutical industry while punishing developing countries seeking to protect public health. Although the US Trade Representative claims in the report to support developing countries that wish to take measures to ensure access to affordable medicines, it clearly fails to follow its own advice by singling out countries for taking actions that are succeeding in improving the health and well-being of poor people. Developing countries face daunting public health challenges, and the current flu outbreak is yet another reminder why governments must have the right to make public health concerns a top priority. It’s time the US fully lives up to its commitments assumed eight years ago through the Doha Declaration on TRIPS and Public Health and support, not hinder, the right of developing countries to use public health safeguards and flexibilities to ensure access to affordable medicines.
– Rohit Malpani, Senior Policy Advisor, Oxfam America
For Press inquiries, please contact Laura Rusu
202 496 1169 | [email protected]

Consumer, Public Health and Labor Groups plus State Legislators Support Bi-Partisan U.S. Biogeneric Bills

On April 22, 2009, Essential Action, along with the American Medical Student Association (AMSA) , Breast Cancer Action, Consumers Union, the Department for Professional Employees of the AFL-CIO, Knowledge Ecology International (KEI), National Legislative Association on Prescription Drug Prices (NLARx), National Women’s Health Network, Public Citizen, Universities Allied for Essential Medicines (UAEM) and U.S. PIRG (Public Interest Research Group) sent a letter to U.S. House and Senate members endorsing the bipartisan Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427/ S.726), which introduces a much-needed pathway for Food and Drug Administration (FDA) approval of safe, effective and affordable generic biotech drugs.

“Biologic drugs — including key treatments for cancer, diabetes, heart disease, MS and autoimmune disorders like arthritis — are the fastest growing part of the nation’s prescription drug bill,” says the letter. “By 2010 it is estimated that 50% of all new drug approvals will be biologics. At the same time, brand-name biologic drugs are priced significantly higher on average than brand-name conventional pharmaceuticals, heightening the need for generics. In some cases, prices approach or exceed $100,000 per patient, per year.”

The letter lauds the bills –whose lead co-sponsors are Democrat Henry Waxman and Republican Nathan Deal in the House and Democrat Charles Schumer and Republican Susan Collins in the Senate, — because they “will result billions of dollars of cost savings for individual patients, insurers, and national and state government programs.”

The groups are endorsing these identical bills even though they offer brand-name pharmaceutical and biotech companies marketing monopolies of at least five years because this proposal is much better than alternatives such as that spearheaded by Representatives Anna Eshoo and Joe Barton (H.R. 1548).

The original version of both the senate and house letters (where are identical except for the addressees) can be downloaded here:
SchS726supportletter2009.pdf
WaxHR1427supportletter2009.pdf

You can also read the text of the complete house letter in the continuation of this post.
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April 22, 2009

The Honorable Henry A. Waxman
Chairman, Committee on Energy and
Commerce
United States House of Representatives
Washington, D.C. 20515

The Honorable Frank Pallone, Jr.
Chairman, Subcommittee on Health
Committee on Energy and Commerce
United States House of Representatives
Washington, D.C. 20515

The Honorable Nathan Deal
Ranking Member, Subcommittee on Health
Committee on Energy and Commerce
United States House of Representatives
Washington, D.C. 20515

The Honorable Jo Ann Emerson
Ranking Member, Subcommittee on
Financial Services and Government
Committee on Appropriations
United States House of Representatives
Washington, D.C. 20515

Dear Chairman Waxman and Representatives Deal, Pallone and Emerson,

We, the undersigned consumer, patient and public health groups and unions, are pleased to endorse the bipartisan Promoting Innovation and Access to Life-Saving Medicine Act (H.R. 1427). This important bill will create a much-needed pathway for Food and Drug Administration (FDA) approval of safe, effective and affordable biogenerics. Your proposal will result billions of dollars of cost savings for individual patients, insurers, and national and state government programs. At a time when health care costs are spiraling out of control and health care reform is an urgent priority, the time is ripe for action.

There is a lot at stake in crafting biogenerics legislation. Biologic drugs — including key treatments for cancer, diabetes, heart disease, MS and autoimmune disorders like arthritis — are the fastest growing part of the nation’s prescription drug bill. By 2010 it is estimated that 50% of all new drug approvals will be biologics. At the same time, brand-name biologic drugs are priced significantly higher on average than brand-name conventional pharmaceuticals, heightening the need for generics. In some cases, prices approach or exceed $100,000 per patient, per year. Biologics priced at tens of thousands of dollars per patient per year are commonplace. In 2006, the five top-selling biologic drugs alone constituted 30 percent of Medicare Part B spending. These prices make it very difficult and sometimes impossible for large numbers of Americans to gain access to the most cutting edge life-saving treatments.

Of course, how much consumers will save — and when — depends crucially on the details of the new FDA regulatory approval process. Your bill would establish a rational and streamlined pathway for the timely introduction of generic price competition for biologics.

We thank-you for your leadership and look forward to working with you to build support for this essential element of health care reform.

Sincerely,

American Medical Student Association (AMSA)

Breast Cancer Action

Consumers Union

Department for Professional Employees, AFL-CIO

Essential Action

Knowledge Ecology International (KEI)

National Legislative Association on Prescription Drug Prices (NLARx)

National Women’s Health Network

Public Citizen

Universities Allied for Essential Medicines (UAEM)

U.S. PIRG (Public Interest Research Group)

Contact person:
Sarah Rimmington
Attorney
Essential Action
Access to Medicines Project
Tel: (202) 387-8030
Mobile: (202) 422-2687
Email: [email protected]