U.S TRADE POLICY AND HIV/AIDS MEDICINES — DETAILS AND RECOMMENDATIONS
For millions of people living with HIV/AIDS in developing countries, the price of medicines is still too high for most people to afford. This is especially true for newer, more effective AIDS medicines that are still protected by patent monopolies.
For people in poor countries who need these medications, the impact of patent barriers created by World Trade Organization (WTO) rules are life-threatening.
Background
Patents monopolies prohibit competition from generic drug manufacturers. This is of particular concern in developing countries, where millions of people with AIDS live on less than a dollar a day.
The price difference between patented and generic medicines can be dramatic. When a drug patent expires in the U.S. and multiple generic producers enter the market, the price can drop by as much as 80%.
Even though WTO rules allow countries to break patent monopolies, wealthy nations like the United States (working with pharmaceutical companies) historically have bullied countries that tried to use that leeway in order to drive the cost of medicine down.
The WTO requires all member countries to follow the rules set out in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The agreement requires countries to protect intellectual property rights (IPRs), including granting at least 20-year patents on essential goods like medicines.
But after strong push-back from poor countries at the third WTO Ministerial meeting in Doha, Qatar in 2001, WTO members promised to allow countries to prioritize the health needs of their citizens when implementing IPRs.
WTO rules allow countries to "break" patents and produce life-saving medication generically — if it is in the interest of the health of its citizens. In recent years, Brazil and Thailand have taken advantage of this flexibility to lower the cost of medicine in their country.
The Doha Declaration
At the WTO Doha Ministerial Meeting in November 2001, AIDS activists, developing country governments, and other allies forced the WTO to begin to correct the imbalance between the rights of poor people to access lifesaving drugs, and the commercial interests of pharmaceutical companies.
The Doha Declaration on the TRIPS Agreement and Public Health (the "Doha Declaration"), signed on November 14, 2001, states that TRIPS can and should support "WTO members' right to protect public health and, in particular, to promote access to medicines for all." The Doha Declaration also reaffirmed WTO members' right "to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility" for the purposes of promoting public health and access to medicines for all.
Thailand and Brazil's decision to issue licenses for generic production of important patented AIDS drugs like efavirenz and lopinavir/ritonavir are examples of how nations can use the flexibility that was reaffirmed by the Doha Declaration to save thousands of lives while remaining completely lawful under the TRIPS Agreement.
The Bush administration breaks its promise and moves to protect big pharma
In response to the WTO's affirmation of the right of countries to prioritize access to medicines ahead of the profits of pharmaceutical companies, the Bush Administration has accelerated trade negotiations with individual countries and groups of countries, signing trade agreements that impose new requirements on countries to protect drug company patents.
These new trade agreements disregard the Doha Declaration and exceed the standards for protection of intellectual property rights in the TRIPS Agreement. A recent study of the impact of the U.S./Jordan Free Trade Agreement shows that the "TRIPS-plus" provisions of that agreement have increased the cost of medicines, with none of the benefits promised.
Putting the breaks on "fast track"
The Bush Administration has been able to sign and implement trade agreements that require countries to trade away their right to health because the current Congress has no ability to amend trade agreements. Congress is only permitted a yes-or-no vote.
Trade Promotion Authority (TPA, also called "Fast Track") is the law that cedes Congressional power over trade to the President—Fast Track expired July 1, 2007, and is not expected to be renewed during the rest of President Bush's term.
The issue of public health and access to medicines is at the center of current Congressional debates on U.S. trade policy. For example, negotiations between Democratic Congressional leaders and the United States Trade Representative (USTR) over trade agreements with Peru and Panama have resulted in limited changes that have mitigated a small amount of the harm of the intellectual property provisions in those two agreements.
These changes are very small, initial steps toward a U.S. trade policy that allows countries to prioritize public health and access to medicines. But more substantive changes that will actually result in increased access to medicines in developing countries will only come if lawmakers are pressured to support and fight for those changes.
For example, the current agreement between Democrats and the USTR still requires countries to grant a period of exclusive rights to pharmaceutical companies over data generated by studies they perform on the medication—this is a huge gift to pharmaceutical companies, it is not required by TRIPS, and it delays the market entry of cost-cutting generics.
Our next President must put people before profits
The next president of the United States must support a positive trade agenda which that allows countries to use the flexibility allowed by the WTO to break patents and produce low-cost generic drugs. Our new trade policy must promote access to medicine by actually providing appropriate incentives for countries to break patents.
US policy must not effectively extend monopolies beyond the original 20 years by allowing for data exclusivity (DE). Data exclusivity prohibits the data from the clinical trial that showed a medicine is effective from being used to prove that a generic version of the same medicine is also effective. (Generic companies are normally not required to repeat clinical trials).
Clinical trial data is essential for generic manufacturers to get approval to sell their drug, and protections of the data can result in extensions of monopolies beyond patent terms, because generic manufacturers can't get approval for their drugs without clinical trials data to prove the drug is effective.
Data exclusivity has been standard in trade agreements negotiated by President Bush under Fast Track, but newer agreements negotiated with input from House Democratic Leadership have reduced the harm of these provisions in developing countries by limiting the term of DE to the five years that drug companies are granted exclusivity in the US.
Take action to save lives!
By pressuring lawmakers, presidential candidates, and other influential decision makers to support alternatives to the current U.S. trade policy, we can win major changes that ensure countries can use public health flexibilities to increase generic competition, drive down medicine costs, and increase access to medicine in developing countries.
LINKS TO MORE INFORMATION
WTO Declaration on the TRIPS agreement and public health:
http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
Food and Drug Administration, Center for Drug Evaluation and Research (CDER). "Generic Competition and Drug Prices." April 4, 2006. http://www.fda.gov/CDER/ogd/generic_competition.htm Accessed May 3 2007.
Available at: http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_trips_e.htm
"All costs, no benefits: how TRIPS-plus intellectual property rules in the US-Jordan FTA affect access to medicines." 21 March 2007. http://www.oxfam.org.uk/what_we_do/issues/health/bp102_trips.htm Access March 24 2007.
