Public Health Organizations Urge Congress to Reject Trans-Pacific Partnership Agreement

McDonnell Boehnen Hulbert & Berghoff LLP

In a letter sent to members of Congress earlier this month, 58 public health organizations urged Congress to reject the Trans-Pacific Partnership (TPP) in its current form, stating that the coalition was "alarmed by the implications for access to medicines" of the TPP.  According to the signatories, the TPP, which was signed by the U.S. and eleven other countries in February, includes intellectual property, investment, and reimbursement listing provisions that "would do more to undermine access to affordable medicines than any previous U.S. trade agreement."

Arguing that "[g]eneric competition has consistently proven the most effective means of reducing prices and ensuring prices continue to fall over time," the group declares that:

By expanding the monopoly power of pharmaceutical companies, TPP provisions would restrict generic competition and thereby enable medicine prices to keep spiraling out of reach -- locking in a broken system here at home and exporting that system to the eleven other TPP countries and those that may join later, including lower-income developing countries where public resources are limited and most people pay for medicines out-of-pocket.

Among the TPP provisions causing the greatest concern for the coalition are the following patent-related provisions:

- Measures that enable patent "evergreening" by requiring countries to grant additional 20-year patents for new uses, new methods or new processes of using existing medicines.  These provisions facilitate abuse of the patent system and extend the monopoly protection that enables patent holders to keep prices high over many more years for products that are already on the market.

- Extension of patent terms beyond 20 years when the patent office review exceeds a certain period, and when patent holders allege delays in drug regulatory review of a medicine's safety and efficacy in order to grant marketing approval.  Patent term adjustments significantly delay market entry of generic medicines.

The signatories also found the following regulatory provisions to be of concern:

- Rules requiring data/marketing exclusivity of at least 5 years for small molecule medicines plus at least 3 years of additional exclusivity for modifications of existing medicines or 5 years for combinations.  These exclusivity periods create additional monopoly power separate from and independent of patents by blocking the registration and marketing approval of generic products.  This delays generic competition even if there is no patent on the medicine.

- For the first time in a U.S. trade agreement, there is a separate provision for monopoly protection for biologic medicines -- such as monoclonal anti[]bodies that are rapidly becoming the treatments of choice for many cancers and other illnesses.  Provisions include at least 8 years of exclusivity, or 5 years of exclusivity plus "other measures", either of which could undermine the Administration's budget proposals to provide no more than 7 years of exclusivity to allow less expensive follow-on biologics to come to the U.S. market sooner.  The Federal Trade Commission has concluded no exclusivity period for biologics is necessary for companies to recoup costs and incentivize innovation.  There is also concern that these provisions could keep prices higher for even longer if TPP parties enter into side agreements guaranteeing lengthier monopoly protection for these already high-cost medicines.

According to the coalition, "[i]ntellectual property protection is a public policy instrument intended to stimulate innovation in exchange for technological advancement that benefits the public," and governments are responsible for maintaining "an appropriate balance between promoting access to, and fostering innovation in, medicines."  The group of public health organizations argues that the TPP provisions described above "significantly skew that balance away from consumer access to medicines by unduly expanding pharmaceutical industry monopoly power."  In the U.S., the signatories contend that:

[T]he TPP is a danger to public health and fiscal responsibility because it would lock in policies that keep prices of too many medicines unaffordably high.  It would tie Congress's hands, potentially for decades to come, preventing policymakers from having flexibility as they formulate sensible policies to promote access and keep medicines affordable.

The following organizations signed the letter:

ACRIA Center on HIV & Aging
Act Up Boston
Adrian Dominican Sisters, Portfolio Advisory Board
African Services Committee
AIDS Alabama
AIDS Healthcare Foundation
Alliance for a Just Society
Alliance for Retired Americans
American Medical Student Association
Article 25
AVAC- Global Advocacy for HIV Prevention
Breast Cancer Action
Cancer Families for Affordable Medicine
Center for Policy Analysis on Trade and Health (CPATH)
Communications Workers of America (CWA)
Community Organizations in Action
Connecticut Citizen Action Group
CREDO Action
DC Fights Back
Dominican Sisters of Hope
Global Justice Institute of Metropolitan Community Churches
Health Alliance International
Health Global Access Project (GAP)
Hepatitis Education Project
Hesperian Health Guides
HIV Prevention Justice Alliance
Icahn School of Medicine at Mount Sinai
Indian People's Action
Initiative for Medicines, Access & Knowledge (I-MAK)
Interfaith Center on Corporate Responsibility, Domestic and Global Health Leadership Teams
Main Street Alliance
Maryknoll Office for Global Concerns
Médecins Sans Frontières/Doctors Without Borders USA
National Nurses United
National Physicians Alliance
NETWORK, A National Catholic Social Justice Lobby
Northwest Coalition for Responsible Investment
Oxfam America
People's Health Movement USA
Physicians for a National Health Program
Physicians for Social Responsibility
Project Inform
Public Citizen
Social Security Works
Student Global AIDS Campaign
Sum Of Us
Treatment Action Group
United Church of Christ, Justice and Witness Ministries
Universities Allied for Essential Medicines
Ursuline Sisters of Tildonk, U.S. Province
US Action
Virginia Organizing
Voices of Community Activists & Leaders (VOCAL-NY)
Washington Community Action Network
Yale Global Health Justice Partnership
Young Professionals Chronic Disease Network

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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