The Trouble with the TPP series continues with a surprising and troubling aspect of the intellectual property chapter: the criminalization of trade secret law (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, Day 8: Locking in Biologics Protection, Day 9: Limits on Medical Devices and Pharma Data Collection). The trade secret issue was flagged by Professor Dan Breznitz of the Munk School of Global Affairs in a column in the Globe and Mail late last year. While some have tried to downplay the issue, the reality is that the TPP represents a radical shift on trade secrets law for most participating countries, who can expect years of pressure to gradually expand the scope of criminal penalties for trade secret violations.
Post Tagged with: "tpp"
The Trouble with the TPP, Day 9: Limits on Medical Devices and Pharma Data Collection
The link between health care and the TPP’s intellectual property chapter is easy to spot, but there are other chapters with implications for the issue. The Trouble with the TPP series today considers Chapter 8, which covers Technical Barriers to Trade (TBT). The chapter contains some surprising restrictions on the ability for national regulators to require the disclosure of certain information as part of the regulatory review process for pharmaceutical products and medical devices (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, Day 8: Locking in Biologics Protection).
The Canadian government summary of the TBT chapter does not disclose that there are data collection restrictions. In fact, the only reference to the issue states that the chapter “improves regulatory transparency in the areas of cosmetics, medical devices, and pharmaceutical products.” Yet the chapter does far more than address regulatory transparency. For example, Annex 8-C 7bis requires each party to makes its determination on whether to grant marketing authorization for a specific pharmaceutical product on the basis on factors such as clinical data, manufacturing quality, and labelling information. However, it also states that:
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.
The Trouble with the TPP, Day 7: Patent Term Extensions
The Trouble with the TPP series now shifts to patent law reforms and the likely costs to the health care system (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). The TPP patent provision changes are very significant since they lock Canada into extending the term of patent protection, which will ultimately increase health care costs. Moreover, global organizations such Doctors Without Borders has warned that the agreement will raise the price of medicines for millions of people, particularly in the developing world.
The Conservative government tried to downplay the impact of patent law changes in the TPP, arguing that the agreement is consistent with current law or is “in line with outcomes secured in the Canada – EU Comprehensive Trade and Economic Agreement (CETA)”. The reference to CETA, which comes from the government’s TPP IP summary, represents a neat of sleight of hand.
The Trouble with the TPP, Day 6: The Price of Entry
An examination of the Trouble with the TPP copyright provisions would not be complete without discussing how Canada reformed its law before entering the negotiations as part of the price of admission to the TPP talks (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”). The pre-TPP reforms must surely be considered part of the cost of the agreement even if proponents now argue that the TPP is consistent with (the reformed) Canadian law.
Canada was not an initial participant in the TPP negotiations. The Harper government began working on entry into the TPP in 2009, leading to a formal request for participation in the negotiations in 2011. The U.S. held a consultation on Canada’s proposed entry into the TPP a year later, resulting in the IIPA, the lead lobby group for the movie, music, and software industry, urging the U.S. government to keep Canada out of the negotiations until a copyright bill was passed that satisfied U.S. expectations. The Canadian government responded by promising to pass the law and noting that it had also signed the Anti-Counterfeiting Trade Agreement (ACTA). The U.S. demands had an enormous impact on the contents of the Canadian copyright bill, particularly the retention of restrictive digital lock rules that were at the very top of the U.S. priority list.
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