US trade negotiators will be forced to limit the IP demands they make of their trading partners under a new policy announced by American politicians on May 10.
The shift in policy follows negotiations between the Democratic chairmen and the Republican ranking members of two key committees – the Ways and Means Committee and the Trade Subcommittee – and the Bush administration.
The Democrats captured the House of Representatives and the Senate in mid-term elections in November last year, giving them more control over trade deals. Now they say that the revised trade policy will "re-establish a fair balance between promoting access to medicine and protecting pharmaceutical innovation in developing countries".
The IP aspects of the new policy relate to data exclusivity, patent linkage and public health.
In particular, they say that although recently negotiated free trade agreements (FTAs) provide that a party "should" extend the term of a patent to compensate for any unreasonable delays in the patent or marketing approval process, provided the delay is not attributable to the applicant, "shall" would be changed to "may" with respect to patents on pharmaceutical products.
They also want FTAs to be amended so that there is no linkage requirement between any regulatory agencies and patent issues. In particular, there should be no requirement that the drug regulatory agency withhold approval of a generic until it can certify that no patent would be violated if the generic were marketed.
In addition, the Democrats say that the side letters dealing with public health issues that are now attached to FTAs should form part of the text of the trade deal itself. In it, the parties would affirm their commitment to the Doha Declaration and clarify that the deal should not prevent the parties from taking action to protect public health or from utilizing the public health provisions of the TRIPs Agreement.
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Congressman Charles Rangel |
Ellen 't Hoen, of Medécins Sans Frontières' Access to Essential Medicines campaign, described the new policy as "good news". In an emailed statement she said: "The USTR is being pushed back on its TRIPS-plus demands in some bilateral agreements. We hope this signals a more fundamental change in US trade policy. But it will mean little if the US continues to bully countries through the use of the 301 Watch List for policies that increase access to medicines."
The Democrats told US Trade Representative Susan Schwab on May 10 that the new terms must be included in free trade deals with Peru, Panama and Colombia. The Bush administration will need the support of the Democrats if it wants to get the deals approved.
"This is truly an historic breakthrough," said Charles Rangel, chairman of the Ways and Means Committee. "For decades now, trade has been a polarizing issue in Congress, but today's agreement signals a new direction and a renewed spirit of bipartisanship."
