Trips Agreement And Pharmaceuticals

More than 20 years ago, the 1995 World Trade Organization agreement on trade-related aspects of intellectual property rights (the TRIPS) established global minimum standards for intellectual property rights, including the requirement for members to provide patent conditions of at least 20 years for medicines (initiated from the date of notification) [1, 2]. Footnote 1 Since that time, subsequent bilateral and regional trade agreements, including those negotiated by the United States and the EU (home to the headquarters of the research-based global pharmaceutical industry), have gradually expanded ip (IP) protection and extended it beyond TRIPS requirements through a number of additional provisions: TRIPS Plus guarantees [1,2,3]. ISDS has become highly controversial due to the increasing number of cases, including several high-level cases in environmental and public health policy,33 Such a case was a claim by tobacco giant Philip Morris against the Australian government because of its tobacco packaging legislation [34]. Footnote 9 Following this controversy, recently negotiated investment chapters (for example. (B) Chapter 9 of the TPP) contain clauses to reduce the likelihood that investors will win lawsuits against legitimate and non-discriminatory health measures. Many of these clauses have not yet been tested and some legal experts have expressed doubts about the extent to which such so-called safeguards would help countries defend rights against health and environmental laws and laws [35]. On the other hand, some recently concluded bilateral trade agreements have explicitly excluded any measures in the area of public health and/or specific public health programmes (see z.B the Peru-Australia Free Trade Agreement, Chapter 8, Footnote 17) [36]. In paragraph 6, the Doha Declaration ordered the Council to address this sensitive issue: how can members who do not have or lack sufficient production capacity effectively use compulsory licences6.6 The fundamental problem underlying paragraph 6 is that many developing countries do not have or do not have sufficient capacity to manufacture medicines themselves. Drug production capacity is very unevenly distributed around the world. Few countries are capable of producing both active substances and formulations, and very few countries have significant research and development capabilities. Both agreements contain articles aimed at harmonizing marketing authorisation procedures and aligning them with international and regional standards.