Congressional Democrats, the branded drug industry, and public health groups have commented on USTR’s new approach to intellectual property described in its recently published white paper on trade and access to medicines. Speaking to Inside US Trade, Rep. McDermott said that USTR’s “intention is clearly to erode the May 10 agreement,” referring to a 2007 policy agreement to place limits on TRIPS-Plus intellectual property provisions that affect the availability of generics.  Rep. Levin was also critical of USTR’s new policy.

Meanwhile, the drug industry sources said that they are unsure how the proposal to link TRIPS-Plus intellectual property protection to product registration would work in practice.  An unnamed source from the industry told Inside US Trade that “drug companies would prefer to receive stronger patent protections in all TPP countries after quickly applying for approval in just one of the TPP countries.”

Public health groups were immediately critical of the white paper, noting that it did not adequately describe the actual text proposed by the U.S.  They point out that provisions proposed by the U.S. in an earlier draft leaked in February – such as lower standards for patentability and rules enabling the seizures of goods in transit – would block access to generic medicines.  Additional text tabled in September by the U.S. is rumored to include other measures that would limit access to generics, such as data exclusivity and linkage requirements.

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USTR White Paper on Access to Medicines