Global health. The current scenario and future perspectives

270 Later, the US joined this bloc during the Bush administration and transformed it into the Trans-Pacific Partnership Agreement and was also joined by Australia, Canada, Japan, Malaysia, Mexico, Peru and Vietnam. As a result of TRIPS and FTA with the USA, our Industrial Property Law from 1991 was modified in 2005 and 2007 to increase the patent protection term from 15 to 20 years. Furthermore, an additional period for supplementary protection was added once the patent is granted by the INAPI or health registration by the ISP, due to unjustified administrative delays in granting patents or health registrations. This extra period can be requested at the Industrial Property Court (TDPI ) 34 . In case of patents, this benefit could be justified. However, delay in granting a health registration for a new active ingredient is justified if its safety and efficacy have not been demonstrated yet. Under no circumstances should the registration be granted until the health authority has all the necessary information to ensure it is safe for the population. Another addition from the FTA with the US is the definition in the industrial property law of a new chemical entity which corresponds to a new active ingredient, including health protection measures for studies accompanying the health registration of pharmaceutical products with a new active ingredient, which grants exclusive marketing rights for 5 years once registered. This measure could favor those products containing new active ingredients that do not qualify for obtaining a patent due to the lack of an inventive step, e.g., the invention of Omeprazole could obtain a patent but its derivatives like Esomeprazole and Lansoprazole could not, as they correspond to minor modifications. Since it is a new product in the health field it can choose to obtain data exclusivity known as undisclosed information or data protection, a benefit granted by the ISP during which similar products cannot be registered even when the health authority has already formed the conviction that such active ingredient is effective and safe (WHO, 1997). When there is a registered medicine with health protection, for 5 years the ISP cannot use the information it has to grant registration for similar products. If a company wanted to register a similar product within this period, it would have to present its own studies, thus forcing the repetition of human trials. This goes against what is stated in the Helsinki Declaration of the World Medical Association, as it forces experimentation on humans without any benefit to humanity, but only economic benefit for a private company. These forms of protection incorporated in the FTA with the US are included in the TPP and have been called red lines in terms of health due to their negative impact on access 35 . The Ministry of Health issued a report on 34 Institution website: www.tdpi.cl. 35 Undersecretariat of International Economic Relations. Institution website: www.subrei.gob.cl .