Global health. The current scenario and future perspectives
271 the impact of the TPP and also requested Chile’s withdrawal from this treaty 36 . One red line is linkage , which would administratively link the ISP and the INAPI, forcing the ISP not to grant health registrations in case of conflicts between companies over pharmaceutical patents. In Chile, health registrations are granted by the ISP and patents are granted by the INAPI; both institutions act independently from each other and are governed by different laws. The industry must resort to courts in case of conflicts arising from these matters. Another red line under the TPP is second-use patents with lax criteria. This means granting a patent for a new indication of an already known product, which does not meet the novelty requirement since such indication was always an action of an already patented product described in its monograph. Red lines related to a health agency include extending health protection granted by the ISP from 5 to 8 years for new biologic pharmaceutical products. This was one of the most discussed topics during negotiation rounds. The TPP also establishes the creation of 3-year health protection for new therapeutic indications – a quite complex situation as it would prevent using or prescribing a product for second indication – a restriction difficult to control in practice. Lastly, reference registration was established as a red line to grant health registration solely based on registration with another health agency to a product without it undergoing an evaluation process but receiving all health protection benefits possessed by that agency, which turns us into a mailbox country. It is worth noting that changes in health regulations have already incorporated this mechanism. Another topic discussed under the TPP but not commented here is the potential patenting of plant species, issues related to internet service providers and the existence of special tribunals that would hinder the implementation of regulatory improvements or public policies which could be subject to demands from international companies. After years of intense negotiations, the TPP was closed in October 2015 in Atlanta, USA. In 2017, the Trump administration announced the withdrawal of the US from the treaty and the remaining eleven countries 36 “The Fourth Attachment is an instance that the Subrei has established to inform, either the start of a trade negotiation or to communicate its progress during the process, in order to generate a dialogue with interested parties.” Subrei (2021) “What is the Fourth Attachment?”. Available at: https://www.subrei.gob.cl/participacion-ciudadana/cuarto-adjunto.
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