[Ip-health] Pharmalot: A Whitewash? Trade Talks and Access to Meds

Peter Maybarduk pmaybarduk at citizen.org
Tue Sep 13 05:59:19 PDT 2011


A Whitewash? Trade Talks And Access To Meds 

By Ed Silverman // September 13th, 2011 // 7:43 am

Amid increasingly controversial trade talks, the Obama administration has released a white paper that emphasizes a commitment to providing access to needed medicines as part of its goals for the current TransPacific negotiations. But the five-page missive was met with derision by patient advocates who maintain the White House has become a stalking horse for the pharmaceutical industry.

At issue is an ongoing tension between fostering intellectual property protection and providing access to medicines that may be out of reach for many people in various nations. And the clash is playing out in various ways: a battle between India and the European Union over seizures of generic meds (see this); an effort in India by Novartis to win a patent for a new form of its Gleevec cancer drug (read here), and an increased willingness to issue compulsory licenses by some countries (look here). 

But behind-the-scenes trade negotiations remain a crucial front. Drugmakers say strong patent protections are needed to protect investments made to develop medicines. And the White House has made trade deals a key element of its plans to foster job growth. But patient advocates argue that ongoing trade talks threaten to rollback progress of the past few years and the new white paper from the US Trade Representative is merely a bid to paper over widening differences between countries.

"There's nothing here that is a new means for advancing access," Peter Maybarduk, who heads Public Citizen's access to medicines program, tells us. "They put this paper out because they're getting criticism and not having as much success as they'd like convincing everyone that their approach is the way to go...I think the talks are at an impasse. There's that much dissent."

In its white paper, the US Trade Representative issued a series of points, including expediting access to innovative and generic drugs through an "access window;" enhance legal certainty for generic drugmakers; reduce customs obstacles to medicines, and reaffirm a commitment to an an international trade known as TRIPS, among other things. The White House calls its effort a "TEAM" approach in talks with Australia, Brunei Darussalam, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam.

"These Trans-Pacific Partnership proposals will help to drive access to innovative and generic medicines, through tariff cuts, intellectual property provisions, and a host of other measures that will help to boost the availability of life-saving innovative and generic medicines to people throughout the Asia-Pacific region," US Trade Rep Ron Kirk says in a statement.

But his remarks evoked scorn from some critics. "Calling this an access to medicine policy is Orwellian," says Sean Flynn, associate director of the Program on Information Justice and Intellectual Property at the Washington College of Law. "Thanks to leaked proposals, we know what the administration's actual position is - this administration has endorsed a set of policy proposals in its trade negotiations with developing countries that is much worse for access to medicine concerns than those of any other past administration."

In his view, the USTR does not explain any positions it has taken in the leaked intellectual property proposal,data exclusivity, patent term extensions or patent-pharmaceutical linkage. There is also no reference, he continues, to concerns that the White House has abandoned an agreement between the Bush administration and Congress to safeguard elements of the TRIPS deal. And there is no evidence to support how policies will promote access to meds.

Meanwhile, Flynn writes that the White House is supposedly proposing to grant patent rights on substances that are already discovered; increase in-transit seizures on drugs; extend monopoly rights through data protection that operate independent of patent rights; eliminate the deal between the Bush Administration and Congress, and add a "first-ever restriction" on pharmaceutical reimbursement programs as a cost saving measure in developing countries.

Such concerns have been mounting since some details of the TransPacific talks emerged a few months ago when a leaked copy of USTR proposals emerged. At the time, Radio New Zealand reported that pressure was being placed on Pharmac, which manages the government prescription medicines program, to change its procedures for negotiations with drugmakers (back story). 

Since then, a group of 40 members of the House of Representatives wrote President Obama urging that the Trans Pacific Partnership talks currently under way should include a requirement that countries offer 12 years of data exclusivity for new biologics. The letter was the latest move by the pharmaceutical industry to create what it calls parity with US law (read here).

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