It is important to note that, in accordance with paragraph 6 of the Doha Declaration, the system will operate in a scenario where there is only one global supplier of patented medicines and therefore there will be no source available for generic drugs. The application of such a system is necessary when the patent holder refuses to supply a patented drug in a country (whose drug manufacturing capacity is insufficient or non-existent) at a price acceptable to the country concerned or under other conditions acceptable to the country concerned. The basic assumption for the application of the system is therefore a situation in which a) a drug is available and could be sold by the patent holder to the country in need, and b) the patent holder opposes it. Office of the U.S. Trade Representative. Agreement between the United States of America, the United States of Mexico and Canada. ustr.gov/trade-agreements/free-trade-agreements/united-states-mexico-canada-agreement/agreement-between. Access 14 Dec 2018. 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.
Next, we conducted a systematic comparative analysis of the legal texts of four recently concluded trade and investment agreements to define a comprehensive set of drug rules. The agreements chosen were as follows: the North American Free Trade Agreement (NAFTA) between Canada, Mexico and the United States, which came into force on January 1, 1994, also contributed to the establishment of a new global standard for intellectual protection procedures and became the model for subsequent U.S. trade agreements. This was the case especially for drugs. Patents allow pharmaceutical manufacturers to collect prices above marginal costs, recover research and development expenses and generate profits. The AIDS crisis in Africa and mounting evidence of the negative impact of patents on poor people`s access to medicines have focused on the relationship between TRIPS and health. With more than 30 million people infected with HIV, most of them in the world`s poorest regions, the need to address the problem of access to patented medicines has become a global priority. While it is true, as the pharmaceutical industry asserts, that other factors, such as infrastructure and professional assistance, play an important role in determining access to drug games3, it is true that patent prices ultimately determine the number of deaths from AIDS and other diseases in the years to come. The final step was to continue the potential impact of the provisions on the main core policy objectives mentioned in the agreements (as noted above) by analyzing possible avenues, on the disciplinary expertise and research experience of authors in the field of trade agreements and pharmaceutical policy, as well as on published research results (available and relevant). The aim was to identify possible pathways and possible effects that should be at the heart of health and human rights assessment and scientific research.