Unbeknownst to many, the drug safety bill recently passed by the senate - the Prescription Drug User Fee Act - contains language is critical of the compulsory licensing by other countries. This section of the bill was revealed during a briefing this morning by PhRMA’s Billy Tauzin and comes amid controversy over such moves by Thailand and Brazil.

The US Trade Rep recently placed Thailand on its priority watch list after Bangkok issued compulsory licenses for three meds, including two AIDS drugs, even though the office acknowledged Thailand didn’t violate world trade rules. That step came after several senators wrote a letter to the USTR worrying aloud about how the move would affect intellectual property rights and jobs. More recently, Brazil took the same step with one of Merck’s AIDS drugs.

In the same briefing, Thailand’s Public Health Minister, Mongkol N Songkhla said US trade officials didn’t relent on their opposition to his plan to copy drugs made by Abbott and Merck. He met with Commerce Secretary Carlos Gutierrez and Deputy U.S. Trade Representative John K. Veroneau yesterday in an effort to avoid retaliation. “They will be satisfied only when we cancel our compulsory licenses,” Mongkol said.

Here’s the language from section 516 of S.1082:

SEC. 516. SENSE OF THE SENATE REGARDING CERTAIN PATENT INFRINGEMENTS.

(a) Findings- The Senate makes the following findings:

(6) There are concerns that certain countries have engaged in unfair price manipulation and abuse of compulsory licensing. Americans bear the majority of research and development costs for the world, which could undermine the value of existing United States pharmaceutical patents and could impede access to important therapies.

b) Sense of the Senate- It is the sense of the Senate that:

(2) the United States Trade Representative should develop and submit to Congress a strategic plan to address the problem of countries that infringe upon American pharmaceutical intellectual
property rights and the problem of countries that engage in price manipulation.

Here’s the bill.
Further reading: Bloomberg News

Hat tip to Essential Action[tags]Compulsory Licensing, Patents, PDUFA[/tags]