Trips Agreement Pharmaceutical Industry

On the other hand, Chapter 28 of the USMCA contains a much more prescriptive and detailed set of requirements, most of the provisions being contained in binding legal language (each party “must”) and are also enforceable by the USMCA dispute resolution procedure, at least for “persistent or recurrent practice or inaction incompatible with a provision of this chapter” (Article 28.20). The main concern of pharmaceutical policy is that detailed requirements for the development of national industry regulatory measures can lead to complaints (for example. B that the search for viable alternatives, information used in decision-making and/or information on proposed regulatory measures was insufficient). In addition, each contracting party to the USMCA: when specialized advisory groups are set up to advise regulators, “encourage their regulators to ensure that membership in an expert group or body includes a number of views and interests, depending on the context” (Article 28.10.3), and strives to “provide interested individuals with the means to provide contributions to expert groups or bodies” (art. 28.10.5). This can be used to justify industry membership in expert groups and bodies or to help thwart efforts to avoid conflicts of interest in the development of pharmaceutical policy. CETA takes a somewhat different approach, including a protocol on mutual recognition of the compliance and implementation of good drug manufacturing practices program, which aims to “strengthen cooperation between the parties` authorities to ensure that drugs and drugs meet the mutual recognition of certificates of compliance with the requirements of good manufacturing practices of GMP” (Article 2). Depending on how this happens, mutual recognition and cooperation between inspection regulators can improve consumer safety. The most important example of ISDS with respect to drugs is an action brought by the American pharmaceutical company Eli Lilly against the Canadian government after Canadian courts invalidated patents relating to the use of two drugs that do not offer the promised benefits [41]. Eli Lilly challenged not only the concrete decisions regarding these drugs, but also the manner in which Canadian courts relied on the claims made in the patent application to judge the usefulness of a patent (the so-called promise/benefits doctrine) [42]. Eli Lilly failed in his isIS challenge, but the Supreme Court of Canada subsequently weakened supply requirements and reduced the amount of evidence needed to successfully defend patents – a move that some commentators have put to account for continued pressure from the United States and the pharmaceutical industry . .

. Each of the four agreements (TPP, CPTPP, CETA, USMCA) contains IP chapters containing on IP TRIPS Plus provisions that, depending on a country`s existing IP legislation and pharmaceutical policy, could delay general competition and have potentially negative effects on access to medicines. Footnote 7 For example, each of these agreements includes patent adaptations and data protection for new pharmaceuticals. Table 2 below summarizes the types of TRIPS plus rules and how they are used to extend exclusivity and delay competition between generic drugs.

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