Post Tagged with: "biologics"

Foreign Minister Freeland, U.S. Trade Representative Lighthizer and Mexican Ministry of Economy Guajardo Participate in the Fourth Round of NAFTA Negotiations by US Department of State, US government work, https://flic.kr/p/Zyj1pK

Crunch Time in the NAFTA Negotiations: What’s at Play for Canada on Digital Policy

As the NAFTA negotiations hit a possible home stretch this week, the focal point has been primarily on issues such as dispute resolution, the dairy sector, and the auto industry. However, the digital policy issues will have huge implications for Canada and the outline of the agreement between the U.S. and Mexico suggests that Canada is facing considerable pressure to agree to changes to our copyright, patent, IP enforcement, and digital policy rules, contrary to our preferred negotiation approach.

The U.S. appears to be pushing for a TPP+ approach – the TPP provisions plus some additional changes it did not get as part of those negotiations. This is notable since Canadian authorities admitted that the TPP went far beyond any previous Canadian free trade agreement. The Canadian starting point is presumably the CPTPP,  the revised TPP where Canada successfully argued for the suspension of some of the U.S.-backed provisions. This post outlines five of the biggest issues that are likely at play, though many others such as de minimis rules for shipments that affect online commerce will be closely watched and could ultimately require future reforms.

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August 30, 2018 12 comments News
Enbrel by Nicole Mays (CC BY-NC 2.0) https://flic.kr/p/FDzpx

The Trouble with the TPP, Day 8: Locking In Biologics Protection

As the TPP negotiations reached their conclusion in Atlanta last October, one outstanding issue stood above all others: protection for biologics. While not well understood by the public, at issue was billions of dollars and access to cutting edge medicines. The Trouble with the TPP series examines the outcome of the biologics issue and argues that even with less protection than the U.S. advocated, the TPP’s requirements still represent a significant problem for global health (prior posts include Day 1: US Blocks Balancing Provisions, Day 2: Locking in Digital Locks, Day 3: Copyright Term Extension, Day 4: Copyright Notice and Takedown Rules, Day 5: Rights Holders “Shall” vs. Users “May”, Day 6: Price of Entry, Day 7: Patent Term Extensions).

Biological drugs are pharmaceuticals involving complex molecules or mixtures of molecules that are made of biological sources manufactured within a living system. They differ from conventional drugs that are manufactured by combining chemical ingredients. Building on greater knowledge of genetics and cell processes, the area represents a major growth area for the pharmaceutical industry. With the complexity comes cost, however, with biological drugs far more expensive than conventional ones. Much like the generic pharmaceutical industry creates cheaper, generic versions of chemical drugs, companies have begun to create “biosimilars” as cheaper versions of biological drugs, relying on data from clinical trials to formulate the alternative. Pharmaceutical companies have therefore sought protection for the clinical data.

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January 13, 2016 3 comments News