During the end stages of the TPP negotiations, no issue was more controversial than that of access to affordable medicines. U.S. negotiators, pushed by big Pharmaceutical lobby blocks such as PHrMA, proposed new measures that would transform countries’ laws on patents and medical test data, including attacks on government medicine formularies. Because of push-back from Mexico and Australia, these provisions were weakened slightly, but would still mean a strengthening, lengthening, and broadening of pharmeceutical monopolies and would mean a step backwards from Bush-era trade agreements on ensuring access to affordable medicines, threatening the financial stability of U.S. programs like Medicare and abandoning 10 million people worldwide who depend on affordable access to these medicines.
How would TPP threaten access to affordable medicines?
Expand the scope of pharmaceutical patents and creates new drug monopolies by lowering patentability standards and requiring patents be available for surgical and treatment methods as well as minor variations on old medicines — even if they do not enhance efficacy.
Lengthen drug monopolies by requiring countries extend patent terms if review at the patent office or regulatory authority exceeds a prescribed period.
Eliminate safeguards against patent abuse, including, among others, the right of third parties to challenge patent applications (pre-grant opposition)
Risk facilitating patent abuse by requiring countries to condition marketing approval on patent status (patent linkage). Under patent linage, even spurious patents may function as barriers to generic drug registration.
Extend commercial control over regulatory information (expand “data exclusivity”) by providing at least five years exclusivity for information related to new products and three more in cases of new uses for old medicines — even when that information is in the public domain.
Resources for Retirees and Seniors on access to medicines: https://www.citizen.org/documents/TPP-threats-to-US-healthcare.pdf
Resources on access to medicines in low income countries: http://www.msfaccess.org/spotlight-on/trans-pacific-partnership-agreement
Washington advocates spoke out long before negotiations had concluded but were ignored (see letter, below). Now, it is up to us to make sure these harmful rules never come into force by making sure Congress votes down the TPP.
Public Health Organizations in WA state
join national letter to USTR Ron Kirk
Calling for continued Access to Generic Medicines
The Honorable Ron Kirk
United States Trade Representative
600 17th Street NW
Washington, DC 20508
Dear Ambassador Kirk:
Leaked texts in the Trans-Pacific Partnership Free Trade Agreement negotiations suggest that your office has made proposals that would decrease countries’ ability to obtain affordable, generic medications for sick people. We find this deeply troubling.
Access to generic medications is critical to saving lives and preventing the spread of communicable and non-communicable diseases. American taxpayer-supported programs like the President’s Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria, as well as UNITAID, UNICEF and others, all rely heavily on the use of generics. For millions of people throughout the globe with life-threatening diseases, delaying access to quality generic medications means delaying access to treatment.
If implemented as presented in the leaked texts, the U.S. intellectual property proposals for the Trans-Pacific Partnership would grant both new and extended monopoly patent rights to pharmaceutical companies, rolling back access to generic medications for people in developing and developed countries alike. As such, these proposals pose a very real threat to public health.
Specifically, we disagree with U.S. proposals for the Trans-Pacific Partnership that would: broaden the scope of patentability by making it easier for pharmaceutical companies to patent new uses and minor variations of old medicines; slow the production of new generics by expanding “data exclusivity” over clinical trials, even for biologics products; constrict safeguards against patent abuse by making it harder for public health advocates to challenge the granting of unjustified new patents; extend drug patent lengths in order to “compensate” companies for time spent meeting regulatory approval requirements; or mandate that countries allow patents on surgical methods. We do not believe a proposed “access window” will do anything to promote access to generic medicines. On the contrary, these measures will only hurt access to affordable medicines.
We also disagree with using the auspices of a trade agreement to in any way restrict government health programs’ ability to utilize drug formularies as a tool for keeping drug prices in check. Such restrictions, while of obvious benefit to patent-holders, are likely to result in higher health care costs for people throughout the world, including here in the United States.
The Trans-Pacific Partnership must not become a tool for putting drug company profits ahead of public health. We demand the public release of the negotiating texts, which is a prerequisite for evidence-based and better-informed negotiations.
In WA State
International Community Health Services
Physicians for a National Health Program Western Washington
People of Color Against AIDS Network (POCAAN)
Puget Sound Alliance for Retired Americans
Washington Community Action Network
WA Physicians for Social Responsibility
California Nurses Association
Minnesota Nurses Association
Texas Nurses United
Unitarian Universalist Global AIDS Coalition
National Legislative Association on Prescription Drug Prices
American Medical Student Association (AMSA)
American Public Health Association Trade and Health Forum
Universities Allied for Essential Medicines
Health Alliance International
Maine Labor Group on Health
California Nurses Association
Maine Equal Justice Partners
Consumers for Affordable Health Care
Advocacy Initiative Network of Maine