House Democrats urge quick access to generic drugs in pending trade deal

The top House Democrats dealing with trade issues wrote to the government's lead trade negotiator on Wednesday urging him to embrace quick access to generic drugs for countries participating in the pending Asia-Pacific regional trade agreement.

The letter to United States Trade Representative Ron Kirk comes as the U.S. embarks on the ninth round of negotiations regarding the nine-nation Trans Pacific Partnership. It urges Kirk to adopt generic-friendly policies that would limit a brand-name manufacturer's exclusive marketing rights based on clinical trial data to five years, running concurrently with such protections in the U.S. 

"A core objective" of that policy, the letter says, is to ensure that free-trade agreements "do not put patients in poor countries in a position in which they could have to wait longer than patients in the United States to obtain affordable life saving generic medicines."

Brand-name drugmakers favor a different policy in the negotiations between the U.S and eight countries in Asia and Latin America: Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam. Pharmaceutical Research and Manufacturers of America, the drug lobby, wants the exclusivity period to begin in each country when approval for a drug is received in that country.

"You need to balance making sure countries get access and the need to ensure an adequate climate for innovation," argues the drug lobby Pharmaceutical Research and Manufacturers of America.

In their letter, House Democrats write that the brand-name drug industry's stance would be a move backward from a more generous Free Trade Agreement signed in 2006 with Peru. And they argue that such a policy would put U.S. taxpayers on the hook because the President's Emergency Plan for AIDS Relief pays the treatment costs for 31,000 people with HIV/AIDS in Vietnam.

"There would be significant concern if action through TPP could delay access to generic medicines which may result in higher costs to the U.S. government … or could result in removing patients from treatment," they write. PhRMA disputes that the regional trade agreement would have any impact on PEPFAR.

The letter is signed by ranking members Henry Waxman (D-Calif.), Energy and Commerce; Sander Levin (D-Mich.), Ways and Means; John Conyers (D-Mich), Judiciary; and Jim McDermott (D-Wash.).

This post was updated at 7:20 p.m. with comment from PhRMA

---