How the United States is undermining the commitments made to public health in developing countries in the Doha Declaration on the TRIPS Agreement and Public Health

In 2001, all 150 members of the World Trade Organization (WTO) - including the United States - signed the Doha Declaration on the TRIPS Agreement and Public Health. The Declaration emphasizes the importance of public health considerations in implementing the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS). It "affirm[s] that the [TRIPS] agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all."

Despite signing the Doha Declaration, the U.S. government has sought to undermine public health safeguards included in the TRIPS Agreement, and to pressure and sanction countries that have used these safeguards.

What is the Doha Declaration?

Following the adoption of TRIPS in 1995, the novelty of the agreement and its hard-to-understand text left developing countries uncertain of their right to promote access to essential medicines. It was clear that there were conflicting understandings as to how developing countries could implement the sections relating to pharmaceutical patents.

The Doha Declaration clarified that developing countries maintain substantial flexibilities under TRIPS, and that TRIPS should be interpreted in a fashion that supports the obligation to protect public health and promote access to medicines.

One key section of the Declaration indicates that developing country members have the right to grant compulsory licenses on patented medicines and the freedom to determine the grounds upon which such licenses are granted. Compulsory licenses authorize price-lowering generic competition for products that remain on patent. Generic competition for AIDS drugs has reduced their price in developing countries by more than 98 percent.

The United States joined the consensus of WTO member countries adopting the Doha Declaration in 2001. Unfortunately, the administration has not respected the letter or spirit of the Declaration in several ways, including by negotiating provisions in bilateral trade agreements that restrict the use of TRIPS flexibilities, and by threatening countries using the flexibilities.

Bilateral Trade Agreements

The common TRIPS-plus features in bilateral and regional trade deals that the United States has entered with developing countries include:

• Provisions establishing special 5-10 year monopoly protections for pharmaceutical test data required to demonstrate drug safety and efficacy and to authorize a drug for use ("data exclusivity"). Data exclusivity may effectively bar compulsory licensing or generic competition for drugs that are not patent protected.

• Measures prohibiting drug regulatory agencies from granting marketing approval to a generic version of a medicine if the product is covered by a patent ("linkage"). As even the Bush administration has acknowledged, such requirements have been subject to repeated abuse in the United States, unjustifiably delaying the introduction of generic competition.

• Patent extensions beyond the 20 years of monopoly protection mandated by the WTO.

• Restrictions on the ability of countries to undertake re-importation (also known as parallel importation).

• Obligations to extend patent protection to minor improvements in, or new uses of, older products.

"I strongly support the position of the governments of Thailand and Brazil and their decision after futile negotiations to break these patents… No company will live or die because of high price premiums for AIDS drugs in middle-income countries, but patients may."

President Bill Clinton

May 8, 2007

The Special 301 Report

Under Special 301, the Office of the U.S. Trade Representative (USTR) conducts an annual review of trading partners' intellectual property rules, and highlights those countries deemed to deny adequate protection for patents, copyright, trademarks, and other forms of intellectual property. Countries are placed on the "watch list" or "priority watch list," or designated a "priority foreign country," based on the seriousness of allegations against them.

USTR has placed countries on these various Special 301 lists for pharmaceutical-related practices that are TRIPS compliant. Twenty-one developing countries are cited in the 2007 Special 301 Report for not providing monopoly protections on pharmaceutical test data (data exclusivity).

In a very notable case in the 2007 report, USTR elevated Thailand to the priority watch list from the watch list, citing Thailand’s issuance of three lawful compulsory licenses on two HIV/AIDS medicines and one heart disease medicine to be provided to the poor through the public health system.

In another troubling case, the 2007 report criticized Brazil simply for considering a lawful compulsory license on medicines to help stem the HIV/AIDS pandemic. Brazil subsequently issued a compulsory license on an important AIDS medicine.

For more information contact: Sarah Rimmington at srimmington@essentialinformation.org or (202) 387-8030.