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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The Trouble with the TPP series concludes the first week with a look at how the TPP treats the interests of rights holders and users completely differently (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). I noted in the discussion on Internet providers that the most telling provision comes at the very end, where the parties recognize the importance of taking into account the impacts on rights holders and Internet providers. Internet users and the general public do not merit a mention as their interests do not seem to count for the purposes of a notice-and-takedown system for copyright works on the Internet.
The absence of users in the Internet provider section is not an anomaly. Throughout the TPP IP chapter, there are two distinct approaches. Where rights holders interests are concerned, the requirements are typically mandatory (ie. “shall”). Where the issue involves user rights or access, the requirements are not requirements, but rather non-mandated provisions (ie. “may”). For example, consider the international IP treaty obligations in the TPP. Article 18.7 identifies nine international IP treaties and protocols that are all requirements for TPP members (Patent Cooperation Treaty, Paris Convention, Berne Convention, Madrid Protocol, Budapest Treaty, Singapore Treaty, UPOV 1991, WCT, and WPPT). What about the Marrakesh Treaty to facilitate access to published works for the blind and visually impaired? It is relegated to a footnote with no obligation to implement:
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The Trouble with the TPP series continues with one of the most high profile copyright concerns associated with the TPP: mandatory copyright term extension (prior posts include Day 1: US Blocks Balancing Provisions, Day 2: Locking in Digital Locks). The term of copyright in Canada is presently life of the author plus an additional 50 years, a term consistent with the international standard set by the Berne Convention. This is also the standard in half of the TPP countries with Japan, Malaysia, New Zealand, Brunei, and Vietnam also providing protection for life plus 50 years.
From a Canadian perspective, the issue of extending the term of copyright was raised on several prior occasions and consistently rejected by governments and trade negotiators. For example, term extension was discussed during the 2009 national copyright consultation, but the Canadian government wisely decided against it. Further, the European Union initially demanded that Canada extend the term of copyright in the Canada-EU Trade Agreement, but that too was effectively rebuffed with the issue of term removed from the final text.
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The Trouble with the TPP series (Day 1: US Blocks Balancing Provisions) spends the next few days examining the TPP’s copyright provisions. One of the most controversial aspects of the 2012 Canadian copyright reform process involved the anti-circumvention provisions, often referred to as the digital lock rules. The U.S. pressured Canada to include anti-circumvention rules, which were required for ratification of the WIPO Internet Treaties, within the copyright reform package. They feature legal protections for technological protection measures (TPMs, a broader umbrella that captures digital rights management or DRM) and rights management information (RMI).
There was an enormous amount of scholarly analysis on these issues throughout the reform process. For example, I wrote about the flexibility in implementing the WIPO Internet Treaties, Carys Craig wrote about the negative implications for fair dealing, Ian Kerr wrote about the broader implications of digital locks, Jeremy deBeer focused on the constitutional concerns, and Mark Perry wrote about rights management information. Moreover, David Lametti, now a Liberal MP and the Parliamentary Secretary for International Trade, wrote about the incoherence of the digital lock rules. The academic analysis was decidedly negative about the legal reforms as was the broader public, which made the issue a top priority as part of the 2009 copyright consultation.
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The debate over the merits of the Trans Pacific Partnership is likely to play out in Canada and other TPP countries throughout 2016. While it seems likely that the treaty will be signed in early February (February 4th is the earliest possible date for the U.S. to sign), decisions on whether to ratify the agreement will extend into 2017 and beyond. I’ve already posted some thoughts on the TPP’s digital policy implications (and spoken about the issue in this speech and on this panel) but wanted to expand on the trouble with the TPP in more detail. With that goal in mind, I plan to post each weekday until February 4th on problems associated with the TPP. The series will include posts on copyright, privacy, Internet governance, and many other issues.
The Trouble with the TPP series starts with the slimmed down objectives of the intellectual property chapter. Leaked versions of earlier drafts shows that most TPP countries (including Canada) were supportive of expanded objectives that emphasized balance, the public domain, and timely access to affordable medicines. The full objectives provision, supported in full or in principle by New Zealand, Chile, Peru, Vietnam, Brunei, Malaysia, Singapore, Canada, and Mexico stated:
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