Congress Urged To Honor Trade Deals

by Ed Silverman
Published at pharmalot.com

More than 100 different organizations – representing consumers, labor, fair trade, health advocacy and religious groups – are banding together to urge Congress to support resolutions calling for the US to reaffirm its commitment to international treaties that promote access to medicines and innovations in new medical technologies in developing countries.

Specifically, the groups (you can see a list below) are referring to the Doha declaration of TRIPS, the trade-related aspects of intellectual property rights. (For a quick primer, look at this). A House resolution was introduced by Tom Allen, a Democrat from Maine, and Sherrod Brown, a Democrat from Ohio, introduced a resolution in the Senate.

“In developing countries, the price of medicines is often a life-and-death matter,” says the letter to Congress. “For example, generic competition for the older first-generation AIDS drugs has reduced their price in developing countries by more than 98 percent, which was critical to the massive scale-up in AIDS treatment seen over the past five years. However, most newer, second-generation treatments are under patent and current treatment levels…will not be sustainable unless much cheaper generic versions become available.”
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“The United States should support efforts to promote access to medicines in developing countries rather than extending Big Pharma’s monopoly protections,” says Rob Weissman, director of Essential Action. “Unfortunately, the US government has too frequently prioritized big pharma’s narrow commercial concerns over public health interests, most notably in the case of Thailand.” In the past year, Thailand has authorized the use of generic versions of three important AIDS med and heart disease, and plans to do the same with three cancer drugs, but has faced significant pressure from the US Trade Rep and the EU.

“Access to medicines and the innovation of new drugs should be complementary, not mutually exclusive, objectives. The United States should embrace efforts to move beyond the access-innovation trade-off by exploring new models of healthcare R&D that support innovation by means other than monopoly pricing of drugs,” says Weissman.

The resolutions call on the White House to honor commitments made in the 2001 World Trade Organization (WTO) Dohe Declaration on the TRIPS Agreement, and not pressure countries that exercise the flexibilities guaranteed in the Doha Declaration (including the right to issue compulsory licenses). The resolutions also urge the US to avoid seeking intellectual property provisions in bilateral and regional trade agreements that are more stringent than measures contained in the TRIPS agreement.

The resolutions also urge the US to support new global norms for promoting medical R&D that would address a needs-driven health agenda; the intent is to develop approaches to support R&D that don’t rely on charging sick people exorbitant prices for meds.

Here’s the list of organizations:

Action Aid International USA

ACT UP East Bay, Oakland, CA

ACT UP New York, New York, NY

ACT UP Philadelphia, Philadelphia, PA

Africa Action, Washington, DC

African Services Committee, New York, NY

AIDS Action Council, Washington, DC

AIDS Foundation of Chicago, Chicago, IL

AIDS Healthcare Foundation, Los Angeles, CA

AIDS Project Los Angeles, Los Angeles, CA

AIDS Vaccine Advocacy Coalition, New York, NY

AkPIRG (Alaska Public Interest Research Group)

Alliance for Democracy, Waltham, MA

Alliance for Responsible Trade, US

American Jewish World Service, USA

American Medical Student Association, Reston, VA

AREA (American Run to End AIDS), New York, NY

Association Mujer y Comunidad, San Francisco Libre, San Francisco, CA

CALPIRG (California Public Interest Research Group)

Campaign for Labor Rights, Washington, DC

Center for Policy Analysis on Trade and Health (CPATH), San Francisco, CA

Church World Service, USA

Citizens Trade Campaign (CTC), USA

Columban Missionaries Justice, Peace and Integrity of Creation Office, USA

Community Alliance for Global Justice – Washington State

Community HIV/AIDS Mobilization Project (CHAMP), New York, NY

Consumer Federation of America

Consumers Union, USA

CoPIRG (Colorado Public Interest Research Group)

Dominican Sisters of Hope, USA

End AIDS Now!, New York, NY

Essential Action, Washington, DC

Florida PIRG (Public Interest Research Group)

Gay Men’s Health Crisis, New York, NY

Georgia PIRG (Public Interest Research Group)

Global Aids Alliance, Washington, DC

Health GAP (Global Access Project), USA

HIVictorious, Inc., Madison, WI

Housing Works, Brooklyn, NY

Illinois PIRG (Public Interest Research Group)

INPIRG (Indiana Public Interest Research Group)

International Women’s Health Coalition, New York, NY

InterReligious Task Force on Central America, Cleveland, OH

Intersect Worldwide, New York, NY

Iowa PIRG (Public Interest Research Group)

Jubilee Northwest Coalition, Seattle, WA

Knowledge Ecology International, Washington, DC

Labor-Religion Coalition of New York State/ Economic Justice for All,
Latham, NY

Leadership Conference of Women Religious, Silver Spring, MD

Maryknoll Office for Global Concerns, Washington, DC

Maryland PIRG (Public Interest Research Group)

MASSPIRG (Massachusetts Public Interest Research Group)

Medical Mission Sisters (USA), Philadelphia, PA

Mennonite Central Committee U.S. Washington Office

Mennonite Mutual Aid, Goshen, IN

Mercy Investment Program, USA

Missionary Oblates of Mary Immaculate, Justice, Peace/Integrity of
Creation Office, USA

Mosaic Initiative, Chicago, IL

MoPIRG (Missouri Public Interest Research Group)

National Association of People with AIDS, Silver Spring, MD

National Physicians Alliance, Reston, VA

NCPIRG (North Carolina Public Interest Research Group)

NETWORK: A National Catholic Social Justice Lobby, USA

NHPIRG (New Hampshire Public Interest Research Group)

Nicaragua Network, Washington, DC

NJPIRG (New Jersey Public Interest Research Group)

NLARx Legislative Working Group on Trade and Prescription Drugs,
Hallowell, ME

NMPIRG (New Mexico Public Interest Research Group)

Nonviolence International, Washington, DC

Ohio PIRG (Public Interest Research Group)

OSPIRG (Oregon State Public Interest Research Group)

Oxfam America

Partners in Health, Boston, MA

Patients not Patents, Washington, DC

PennPIRG (Pennsylvania Public Interest Research Group)

Physicians for Human Rights, Cambridge, MA

PIRGIM (Public Interest Research Group in Michigan)

Program for Wellness Restoration, Houston, Texas

Project Inform, San Francisco, CA

Public Citizen’s Global Trade Watch, Washington, DC

Public Knowledge, Washington, DC

Quixote Center, Hyattsville, MD

RESULTS USA

RIPIRG (Rhode Island Public Interest Research Group)

Saint Michael’s College Student Global AIDS Campaign, Colchester, VT

Salud y Farmacos-USA, Austin, TX

Sisters of Charity of Saint Elizabeth, Convent Station, NJ

Sisters of Mercy Regional Community of Detroit, Detroit, MI

Sisters of the Holy Cross, Notre Dame, IN

Sisters of St. Francis of Assisi, Administrative Team, Milwaukee, WI

Sojourners/Call to Renewal, Washington, DC

Student Global AIDS Campaign, USA

Student Trade Justice Campaign, USA

TexPIRG (Texas Public Interest Research Group)

TransAfrica Forum, Washington, DC

Unitarian Universalist Association of Congregations, USA

Unitarian Universalist Global Aids Coalition, Portland, OR

United Church of Christ, Justice and Witness Ministries, USA

United Methodist Church, General Board of Church and Society, USA

United Steelworkers (USW), USA

Universities Allied for Essential Medicine, USA

Ursuline Sisters of Tildonk-U.S. Province, USA

U.S. PIRG (Public Interest Research Group)

Vermont Global Health Coalition

Washington Office on Africa (WOA), Washington, DC

WashPIRG (Washington State Public Interest Research Group)

WISPIRG (Wisconsin Public Interest Research Group)

Women’s Equity in Access to Care and Treatment WE-ACTx, Chicago, Il

Tags: Affordable Medicines, Compulsory Licensing, Doha, Patents, Thailand, TRIPS

Coalition Calls on Congress to Support Resolution for Access to Medicines in Developing Countries

September 25, 2007
For Immediate Release
For More Information, contact: Sarah Rimmington or Robert Weissman, Essential Action, 202-387-8030

Over 100 health, faith-based, consumer, development, labor and fair trade organizations have urged U.S. senators and representatives to co-sponsor S. Res 241 and H. Res 525. In a letter, the groups urged support for the resolutions, which call on the United States to re-affirm its commitment to the Doha Declaration on the TRIPS Agreement and Public Health to promote both access to medicines in developing countries, and the innovation of new medical technologies.

The resolutions were introduced by Senator Sherrod Brown of Ohio and Representative Tom Allen of Maine.

Organizations endorsing the letter include The American Medical Student Association, Consumer Federation of America, Consumers Union, Essential Action, Global AIDS Alliance, Health GAP, Knowledge Ecology International, Oxfam America, Public Citizen’s Global Trade Watch, Sojourners/Call to Renewal, The United Methodist Church, United Steelworkers, and U.S. PIRG.
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The letter emphasizes the importance of access to medicines issues for treating people with HIV/AIDS and maintaining the U.S. global AIDS program. “In developing countries, the price of medicines is often a life-and-death matter,” says the letter. “For example, generic competition for the older first-generation AIDS drugs has reduced their price in developing countries by more than 98 percent, which was critical to the massive scale-up in AIDS treatment seen over the past five years. However, most newer, second-generation treatments are under patent and current treatment levels (including people receiving treatment through PEPFAR funding) will not be sustainable unless much cheaper generic versions become available.”

“The United States should support efforts to promote access to medicines in developing countries rather than extending Big Pharma’s monopoly protections,” says Robert Weissman, director of Essential Action. “Unfortunately, the U.S. government has too frequently prioritized Big Pharma’s narrow commercial concerns over public health interests, most notably in the case of Thailand.” In the past year, Thailand has authorized the use of generic versions of three important medicines for HIV/AIDS and heart disease, but has faced significant pressure and the threat of trade sanctions from the United States and others.

“Access to medicines and the innovation of new drugs should be complementary, not mutually exclusive, objectives. The United States should embrace efforts to move beyond the access-innovation trade-off by exploring new models of healthcare R&D that support innovation by means other than monopoly pricing of drugs,” says Weissman.

S. Res 241 and H. Res 525 call on the administration to respect commitments made in the 2001 World Trade Organization (WTO) Doha Declaration on the TRIPS Agreement and Public Health, and not pressure countries that exercise the flexibilities guaranteed in the Doha Declaration (including the right to issue compulsory licenses —
authorizations of generic competition for products that remain on patent). The resolutions urge as well that the United States not seek intellectual property provisions in bilateral and regional trade agreements that are more stringent than measures contained in the WTO’s intellectual property agreement (TRIPS). The resolutions also urge that the United States support new global norms for promoting medical research and development that would address a needs-driven health agenda; the intent is to develop approaches to support R&D that do not rely on charging sick people exorbitant prices for medicines.

The letter is available below and with additional information on the resolution here.

September 25 2007

Dear Senator or Representative:

We are writing to urge you to co-sponsor Senate Resolution 241 or House Resolution 525, calling for a new direction in U.S. trade policy that encourages both access to essential medicines and the innovation of new medical technologies to promote public health in developing countries.

The resolutions, introduced by Senator Sherrod Brown and Representative Tom Allen, call on the United States to:

• Honor the commitments it made in the 2001 World Trade Organization (WTO) Doha Declaration on the TRIPS Agreement and Public Health. The Doha Declaration affirms that WTO Members may use “to the full” the flexibilities in the Agreement on Trade-Related Aspect of Intellectual Property Rights (TRIPS) “to protect public health and, in particular, to promote access to medicines for all,” including the issuance of compulsory licenses on grounds determined by member states. Compulsory licenses permit countries to import or produce lower-priced generic versions of on-patent medicines to promote and protect public health.

• Refrain from punishing or threatening trade partners for using TRIPS flexibilities to advance public health objectives. Earlier this year, the U.S. Trade Representative (USTR) cited Thailand’s lawful issuance of compulsory licenses for three important, high-priced drugs as a reason to place the country on the Special 301 Priority Watch list. USTR also
complained in Brazil’s Special 301 listing that the country was considering a lawful compulsory license (which it has since issued). USTR has also cited numerous countries for not providing monopolies (“data exclusivity”) for use of clinical test data generated by brand-name pharmaceutical companies, a rule which exceeds obligations under the TRIPS Agreement and causes serious harm to public health in developing countries.

• Refrain from seeking intellectual property measures more stringent than those provided for in TRIPS. Bilateral and regional trade agreements negotiated by the United States over the last decade contain a wide range of “TRIPS-plus” measures, such as data exclusivity, that slow the introduction of generic competition.

• Support new global norms for promoting medical research and development that provide a sustainable basis for a needs-driven essential health agenda. Much of the opposition to the use of compulsory licensing and other public health safeguards is based upon concerns that such measures will undermine research and development (R&D) for new medicines. The resolution addresses this concern in a new and positive way. Several health groups and experts are calling for a new global framework that focuses on measures to support priority medical R&D, as an alternative to the current global framework which focuses on tough intellectual property rules and other measures to promote high drug prices. The World Health Organization has created an Intergovernmental Working Group (IGWG) to discuss the feasibility and benefits of a new global framework that would reconcile the needs for both innovation and access to medicines, investigate new sustainable mechanisms for funding R&D for diseases and conditions that have disproportionate impact on poor people living in developing countries, and to consider new incentive systems, such as prizes, that de-link R&D rewards from the prices of products. The resolution supports these efforts.

Both access to medicines and the innovation of new treatments are crucial public health goals. In developing countries, the price of medicines is often a life-and-death matter. For example, generic competition for the older first-generation AIDS drugs has reduced their price in developing countries by more than 98 percent, which was critical to the massive scale-up in AIDS treatment seen over the past five years. However, most newer, second-generation treatments are under patent and current treatment levels (including people receiving treatment through PEPFAR funding) will not be sustainable unless much cheaper generic versions become available. At the same time, new approaches to medical R&D are needed in order to spur innovation to meet priority health needs ignored within the existing global system to
support medical research and development.

We need your leadership and engagement to ensure the public health needs of those in developing countries are protected and promoted. We urge you to co-sponsor S. Res 241 or H. Res 525 to help make the public health
principles of innovation and access the governing feature of U.S. trade policy with respect to intellectual property rules.

Yours truly,

Action Aid International USA

ACT UP East Bay, Oakland, CA

ACT UP New York, New York, NY

ACT UP Philadelphia, Philadelphia, PA

Africa Action, Washington, DC

African Services Committee, New York, NY

AIDS Action Council, Washington, DC

AIDS Foundation of Chicago, Chicago, IL

AIDS Healthcare Foundation, Los Angeles, CA

AIDS Project Los Angeles, Los Angeles, CA

AIDS Vaccine Advocacy Coalition, New York, NY

AkPIRG (Alaska Public Interest Research Group)

Alliance for Democracy, Waltham, MA

Alliance for Responsible Trade, US

American Jewish World Service, USA

American Medical Student Association, Reston, VA

AREA (American Run to End AIDS), New York, NY

Association Mujer y Comunidad, San Francisco Libre, San Francisco, CA

CALPIRG (California Public Interest Research Group)

Campaign for Labor Rights, Washington, DC

Center for Policy Analysis on Trade and Health (CPATH), San Francisco, CA

Church World Service, USA

Citizens Trade Campaign (CTC), USA

Columban Missionaries Justice, Peace and Integrity of Creation Office, USA

Community Alliance for Global Justice – Washington State

Community HIV/AIDS Mobilization Project (CHAMP), New York, NY

Consumer Federation of America

Consumers Union, USA

CoPIRG (Colorado Public Interest Research Group)

Dominican Sisters of Hope, USA

End AIDS Now!, New York, NY

Essential Action, Washington, DC

Florida PIRG (Public Interest Research Group)

Gay Men’s Health Crisis, New York, NY

Georgia PIRG (Public Interest Research Group)

Global Aids Alliance, Washington, DC

Health GAP (Global Access Project), USA

HIVictorious, Inc., Madison, WI

Housing Works, Brooklyn, NY

Illinois PIRG (Public Interest Research Group)

INPIRG (Indiana Public Interest Research Group)

International Women’s Health Coalition, New York, NY

InterReligious Task Force on Central America, Cleveland, OH

Intersect Worldwide, New York, NY

Iowa PIRG (Public Interest Research Group)

Jubilee Northwest Coalition, Seattle, WA

Knowledge Ecology International, Washington, DC

Labor-Religion Coalition of New York State/ Economic Justice for All,
Latham, NY

Leadership Conference of Women Religious, Silver Spring, MD

Maryknoll Office for Global Concerns, Washington, DC

Maryland PIRG (Public Interest Research Group)

MASSPIRG (Massachusetts Public Interest Research Group)

Medical Mission Sisters (USA), Philadelphia, PA

Mennonite Central Committee U.S. Washington Office

Mennonite Mutual Aid, Goshen, IN

Mercy Investment Program, USA

Missionary Oblates of Mary Immaculate, Justice, Peace/Integrity of
Creation Office, USA

Mosaic Initiative, Chicago, IL

MoPIRG (Missouri Public Interest Research Group)

National Association of People with AIDS, Silver Spring, MD

National Physicians Alliance, Reston, VA

National Women’s Health Network, Washington, DC

NCPIRG (North Carolina Public Interest Research Group)

NETWORK: A National Catholic Social Justice Lobby, USA

NHPIRG (New Hampshire Public Interest Research Group)

Nicaragua Network, Washington, DC

NJPIRG (New Jersey Public Interest Research Group)

NLARx Legislative Working Group on Trade and Prescription Drugs,
Hallowell, ME

NMPIRG (New Mexico Public Interest Research Group)

Nonviolence International, Washington, DC

Ohio PIRG (Public Interest Research Group)

OSPIRG (Oregon State Public Interest Research Group)

Oxfam America

Partners in Health, Boston, MA

Patients not Patents, Washington, DC

PennPIRG (Pennsylvania Public Interest Research Group)

Physicians for Human Rights, Cambridge, MA

PIRGIM (Public Interest Research Group in Michigan)

Program for Wellness Restoration, Houston, Texas

Project Inform, San Francisco, CA

Public Citizen’s Global Trade Watch, Washington, DC

Public Knowledge, Washington, DC

Quixote Center, Hyattsville, MD

RESULTS USA

RIPIRG (Rhode Island Public Interest Research Group)

Saint Michael’s College Student Global AIDS Campaign, Colchester, VT

Salud y Farmacos-USA, Austin, TX

Sisters of Charity of Saint Elizabeth, Convent Station, NJ

Sisters of Mercy Regional Community of Detroit, Detroit, MI

Sisters of the Holy Cross, Notre Dame, IN

Sisters of St. Francis of Assisi, Administrative Team, Milwaukee, WI

Sojourners/Call to Renewal, Washington, DC

Student Global AIDS Campaign, USA

Student Trade Justice Campaign, USA

TexPIRG (Texas Public Interest Research Group)

TransAfrica Forum, Washington, DC

Unitarian Universalist Association of Congregations, USA

Unitarian Universalist Global Aids Coalition, Portland, OR

United Church of Christ, Justice and Witness Ministries, USA

United Methodist Church, General Board of Church and Society, USA

United Steelworkers (USW), USA

Universities Allied for Essential Medicine, USA

Ursuline Sisters of Tildonk-U.S. Province, USA

U.S. PIRG (Public Interest Research Group)

Vermont Global Health Coalition

Washington Office on Africa (WOA), Washington, DC

WashPIRG (Washington State Public Interest Research Group)

WISPIRG (Wisconsin Public Interest Research Group)

Women’s Equity in Access to Care and Treatment WE-ACTx, Chicago, IL

Access to Medicines in Thailand: Interference by the United States

Click here to download a fact sheet on Access to Medicines in Thailand: Interference by the United States.

Click here for the html version of the fact sheet on Access to Medicines in Thailand: Interference by the United States.

Click here for a January 2007 letter from 22 Members of the U.S. Congress to USTR, asking for an end to pressure on Thailand for its compulsory license.

Click here for USTR’s response to the January 2007 letter from 22 Members of the U.S. Congress.

Click here for a June 2007 letter from 35 Members of the U.S. Congress to USTR, criticizing the placement of Thailand on the “priority watch” list of countries allegedly undermining U.S. intellectual property claims.

Pharma Responses to Call for Disclosure of Charitable and Educational Contributions

In July, a coalition of public health and consumer groups called on the largest pharmaceutical companies and the leading industry trade associations to adopt a policy of disclosing all of their charitable and educational contributions, on a global basis. To view this letter, click here.

Most of the companies responded to this request, or to a follow-up note. The responses were not uniform, and several companies indicated that they are or will expand their disclosures, or examine the issue.

Pfizer

Phrma

Eli Lilly

IFPMA

Schering

PhRMA Won’t Disclose Charitable Donations

by Ed Silverman
Published at pharmalot.com

The position by the trade group is revealed in a letter written by Billy Tauzin, PhRMA’s ceo, to Essential Action, one of several advocacy groups that are pushing drugmakers to disclose their global contributions. The reason? Concern that charitable and educational donations result in off-label marketing by groups receiving funds; mask the agendas of public policy groups that debate policy issues, and allow researchers to circumvent normal disclosure requirements.

Two months ago, the groups wrote the ceo of each drugmaker and large trade group asking them to commit to full disclosure on a worldwide basis. Since then, Lilly agreed, expanding an earlier promise to reveal all US donations. But the International Federation of Pharmaceutical Manufacturers Associations declined, saying disclosure should be made on a national level.

Tauzin used similar reasoning. “Member companies should make individual decisions regarding how they work together and communicate about their work to others,” he wrote. Meanwhile, Pfizer’s Richard Bagger, senior vp of ww public policy, wrote that the drugmaker is taking disclosure steps in the US and the UK, but stopped short of commiting to a global effort. And Schering-Plough ceo Fred Hassan wrote back that he’s instructed his team to undertake a “thorough review” of the suggestion.
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In response, Essential Action’s Rob Weissman says that Pfizer will be urged to follow through and to disclose other kinds of charitable donations, especially support to policy advocacy organizations and think tanks. “The announcement by the world’s largest drug maker that it is prepared to disclose its funding of patient groups and medical education further undermines the never-credible claims that such disclosures are infeasible.”

But he had harsh words for Tauzin, and noted that PhRMA maintains various codes, covering continuing medical education, among other things. “Billy Tauzin’s position is that PhRMA as a trade association has no role in setting a standard for industry disclosure practice. It is hard to take this seriously as anything other than a brush off,” says Weissman. “The cascading series of scandals and outrages involving industry misuse of charitable and educational contributions demands, at the very least, an industry policy of disclosure.”