July 21, 2005

Dear Colleague:

As the House prepares to consider CAFTA, I want to alert you to a recent report prepared by the Government Reform Committee Minority Staff, which finds that CAFTA would impede access to safe and affordable prescription drugs for patients throughout the Central American region. The report, "Trade Agreements and Access to Medications Under the Bush Administration," is available at http://www.democrats.reform.house.gov.

Specifically, as the report explains, CAFTA would block governments from approving the sale of generic drugs for at least five years after a new drug is introduced in each market, even if the drug's patent has already expired. The agreement would also make unlimited patent extensions available if there are delays in the drug approval process, and would block the approval of generics unless drug regulators can prove that the drug's patent has expired. These obligations will inhibit generic competition and create significant burdens on developing countries that need to focus the limited resources of their regulatory agencies on monitoring the safety and efficacy of products. As a result, patients in poor countries will often have to wait longer than those in the United States to gain access to generic drugs.

USTR claims that these provisions are merely an extension of a U.S. law known as Hatch-Waxman. As an author of that legislation, I strongly disagree. Hatch-Waxman was a carefully crafted measure that reflected both the need to promote innovation and the need to facilitate access for generic competition. In contrast, CAFTA does not establish a proper balance between the interests of brand name drug companies and consumers, between intellectual property rights and the human rights of patients.

It is reckless and dangerous to force our partners in the developing world to trade away their timely access to inexpensive, lifesaving medications. It is wrong for CAFTA to advance the financial interests of large multinational drug companies at the expense of the developing world's ability to address public health problems.

If you have any questions about this issue or the report, please contact Zahava Goldman at x5-3976.

Sincerely,

HENRY A. WAXMAN
Member of Congress