A new trade agreement between Congress and the White House contains provisions that open the door to more sales of generic drugs in developing countries. The plan, reversing earlier gains for US drugmakers backed by President Bush, marks the first big setback for big pharma since Democrats claimed Capitol Hill, notes The Wall Street Journal.

For now, the provisions likely only affect pending trade deals with Peru, Panama and Colombia. But the plan also signals a broader shift as congressional leaders give greater weight in trade talks to providing cheaper medicines for the poor, even if it means denying the Republican-friendly drug industry some of the protection it says it needs.

The administration “has permitted the weakening of intellectual-property protections in these agreements,” PhRMA’s Billy Tauzin tells the Journal. “They were desperate to get continuing trade authority” from Democrats in Congress. “The fact is, their leverage changed since November.”

The main focus of the bipartisan trade deal, announced last week, involves requiring US trade partners to meet new standards for giving their workers labor rights and ensuring environmental protections. But the deal also allows developing countries more flexibility in dealing with US drugmakers than they would have had under earlier versions.

Specifically, the policy would ease requirements on developing-country regulators to prevent the sale of patent-infringing products, the Journal reports. It also releases trading partners from a requirement to extend the time for patent protections as a form of compensation for delays in drug approvals.

Public-health advocacy groups have argued for years that US trade policy under Mr. Bush often protected big pharma at the expense of poor countries in need of more affordable treatments. Many of those groups said they weren’t satisfied with last week’s deal. Even with the changes, they say, the Peru and Panama deals advance many of the protections drugmakers want - just fewer than would have existed if the Bush administration had stuck with its earlier trade stance.

“Compared to the many steps backward that have been taken since 2003, this is a bit of relief for people who want access to affordable medicines,” Ellen Shaffer, co-director of the Center for Policy Analysis on Trade and Health in San Francisco, tells the Journal. “Compared to an actual policy that would provide affordable medicines for people and fairly balance that with innovation, it is a small step forward.”

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[tags]Generics, Patents, Pricing[/tags]