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NGOs cry foul at drug patent rules in TPP

NGOs say draft US-Pacific Rim trade deal threatens access to life-saving drugs

Peter O’Donnell and Ellis Kim
Aug. 6, 2015, 8:11 p.m.

The international pharmaceutical industry is under renewed attack for squeezing trading partners into tight intellectual property rights requirements.

In a re-run of many health campaigners’ arguments against the plans for the transatlantic free-trade area TTIP, NGOs say that the latest draft of the Trans-Pacific Partnership (TPP) — now nearing finalization between the U.S. and 11 Pacific Rim countries — is “strengthening regulatory monopolies and patents for industry giants while reducing the availability of cheaper, generic alternatives.”

Health campaigners blame drug firms for pressuring the U.S. administration into forcing the hand of weaker partners — mirroring the frequent attacks on undue branded-drug industry influence on the TTIP negotiations.

According to U.S. NGO Knowledge Ecology International, the latest TPP draft — a supposedly secret document — is aiming to impose 12 years’ monopoly on data used to register biologic drugs and vaccines.

A leaked text also indicates U.S. pressure for wider patent protection for pharmaceuticals, vaccines and medical devices, and patent terms exceeding the customary term of 20 years. And this latest draft would, says Knowledge Ecology International, boost the chances for successful “ever-greening” of patents — keeping patents valid by repeatedly registering minor variations.

It would require drug regulatory agencies to evaluate and enforce patent holders’ assertions that their continuing rights were being infringed.

Responding on Wednesday to the leaked text, Médecins Sans Frontières described the draft agreement as threatening access to life-saving medicines for millions. Judit Rius Sanjuan, U.S. manager and legal policy adviser for MSF’s Access Campaign, highlighted the provisions on data exclusivity for biologic products. This “will have a devastating impact on global health,” she said.

Médecins Sans Frontières says the measure would prevent national regulatory authorities from making use of clinical trial data needed to approve cheaper copies of biologic products, even after the patents have expired.

The medical NGO is urging negotiators in the Pacific Rim countries to reject these provisions. It warns that securing carve-out exemptions for selected countries — one of the concessions being offered in the negotiations — won’t suffice.

“What we really need is these provisions removed completely from the TPP, not special deals that exempt only specific countries from these rules,” said Rius Sanjuan.


Source: Politico