CAFTA Allows Big Pharma To Block Generic Medicines

by Jim Lobe

(IPS) WASHINGTON -- With the U.S. House of Representatives due to vote this week on the fate of the Central American Free Trade Agreement (CAFTA), international health activists are warning that the intellectual property provisions included in the pact could spell serious health problems for hundreds of thousands of poor people.

They blame the lobbying clout of "Big Pharma," the brand-name pharmaceutical companies that have successfully inserted language in the accord, which covers the Dominican Republic as well as the nations of Central America, to prevent cheaper, generic drug manufacturers from selling their products, including life-preserving anti-retroviral treatments for AIDS victims, to needy patients in the region.

"With CAFTA, the Office of the U.S. Trade Representative, operating at the behest of BIG Pharma, has imposed on Central America and the Dominican Republic a trade deal that will deny millions access to life-saving and essential medicines," according to Robert Weissman, co-director of Essential Action, a public interest group here.

"The region's combined economy is about the size of Columbus, Ohio, and its poor populations mostly cannot afford high-priced brand-name pharmaceuticals. But what for Big Pharma is dollars and cents is life and death for the people of Central America," he said.

CAFTA, which was approved by the Senate last month by a 54-45 vote, could be sent to the House floor Wednesday or Thursday this week.

Most observers believe that its chances of approval -- despite near-unanimous Democratic opposition and serious reservations by Republicans from sugar- and textile-producing states -- are improving hour by hour as the White House peels away the dissidents by promising them unrelated benefits, such as big public-works and other pet projects, some of them worth billions of dollars.

In addition, the Republican leadership is arranging a vote on a harsh resolution aimed at curbing the flood of Chinese imports to the United States just before CAFTA reaches the floor, so that hesitant lawmakers can reassure their constituents that they are tough on trade and globalization issues and still vote for the regional accord.

The outcome is expected to be very close, in any event, although the Republican leadership is unlikely to send it to the floor until it is reasonably certain it has the votes in hand.

While most of the debate here over CAFTA has focused on fears that it will result in the export of more U.S. manufacturing jobs and a flood of cheaply produced sugar imports that could threaten domestic producers, health activists say it will also result in unprecedented gains by the major drug manufacturers at the expense of poor people who cannot afford brand-name prices.

Among those groups that have spoken out against CAFTA's intellectual-property provisions are the Global AIDS Alliance, Health GAP (Global Access Project), Oxfam International, and Doctors Without Borders (Medicins Sans Frontieres), as well as generic manufacturers and public interest groups in Central America itself.

"The text of CAFTA is a major score for Big Pharma," noted Roman Macaya, executive director of the National Chamber of Generic Products of Costa Rica. "In the name of 'free trade,' monopolies of medicines are being created or extended beyond what they would be under World Trade Organization (WTO) rules, which are already in place. CAFTA's new rules will cost human lives."

Indeed, brand-name drugs, including anti-retrovirals for treating HIV/AIDS victims, are currently far more expensive than generic versions of the same medications. Big Pharma has argued that, without the higher prices for their drugs, the industry could not afford to invest in the research and other resources that are required to develop new, life-saving medications.

To them, generic producers are essentially free-loading copycats who can charge lower prices because they do not bear the huge research and development costs.

Thus, the major brand-name manufacturers have sought to maintain their patent rights over new drugs in as many nations for as long a period of time as they possibly can, and, in that respect, CAFTA's intellectual-property provisions mark a major advance which they hope can be used as a precedent for similar free-trade accords with other countries.

As explained by the authoritative Congressional Quarterly, the treaty text provides that when a drug is approved in one of the pact countries, the data used to get approval for the drug will be protected in that country for at least five years, regardless of whether it had been approved in another country previously.

That provision means that Big Pharma companies may get twice as many years of protection as they do now under the North American Free Trade Agreement (NAFTA) under which companies get five years of exclusivity that starts when the drug is approved in any of the countries in the agreement.

In addition, CAFTA would allow for patent extensions for brand-name companies that go far beyond the protections in current U.S. law and also put in place new obstacles to governments that wish to license generic producers to manufacture specific medicines.

Because these provisions go beyond what both the WTO and even U.S. law have required, they have infuriated health advocates who see in them a betrayal of the Bush administration's previous rhetorical and other commitments to make anti-AIDS medications, in particular, affordable to all of those who need them.

Central America has the second-highest death rate from communicable diseases in the Latin American region, and more than 165,000 people there are living with HIV/AIDS, according to Oxfam America.

"Almost four years ago, the Bush administration signed a declaration at the WTO Ministerial meeting in Doha pledging that WTO members should prioritise public health and, in particular, access to medicines for all when adopting national rules governing protection of drug-company patent rights," noted Asia Russell, director of international policy at HealthGAP.

"The U.S. has broken that promise in CAFTA, and, in going back on its word, the White House has decided that being at Big Pharma's beck and call is more important than ensuring Central Americans have access to medicines that can lives," she said.

Indeed, a recent study by the Center for Public Integrity here found that the big pharmaceutical companies spent more than 800 million dollars over from 1998 through 2004 on "campaign contributions," most of which went to Republicans.

The pay-off resulted in, among other things, attaining a dominant presence on committees created by the U.S. Trade Representative to advise on U.S. trade policy. These committees, in turn, play a critical role in forging Washington's positions on particular trade issues, such as intellectual property rights.

Normally, health advocates could press Congress to oppose or amend specific provisions of legislation that comes before it. But trade agreements that come before Congress under so-called "fast-track" authority cannot be amended or altered on the floor in their entirety.