Global health. The current scenario and future perspectives

268 Patents and health registrations in Chile Chile, as part of the WTO and in compliance with TRIPS, through the National Institute of Industrial Property (INAPI), grants patents for medicines; that is, exclusive marketing rights for a product or procedure for a period of 20 years from the date the patent is applied for. In terms of pharmaceutical products, a patent can be granted for a molecule or an active ingredient, for a process of preparing a pharmaceutical formulation or for a second use or new therapeutic indication of a compound, while meeting the requirements of inventive level, industrial application and novelty (Gobierno de Chile, 2006). Companies holding a pharmaceutical patent can only exercise exclusive marketing rights over the pharmaceutical product once they have obtained health registration to allow distribution in the country. This registration is granted by the Public Health Institute in Chile (ISP) after thorough evaluation and compliance with safety, efficacy and quality parameters (Gobierno de Chile, 2011). Pharmaceutical products can be categorized as new or similar. New ones are those that may contain, among other novelties, a new molecule which is either a new active ingredient or chemical entity. Similar products are those that do not differ from an already registered on e 30 . Preclinical and clinical studies must accompany health registration applications for new products. For similar product registrations, presentation of such studies cannot be required since their safety and efficacy have been proven and it would not be ethical to experiment on people again without any benefit to humanity. This principle is stipulated in the Declaration of Helsinki (World Medical Association, 1964) because of atrocities committed against people during World War II. From this we can conclude that a pharmaceutical product distributed in Chile with a new active ingredient must have health registration; however, it may or may not have patent protection. To access certain medications that are not registered in Chile yet but authorized by the ISP, provisionally sold or used without prior registration due to urgent medicinal use, scientific research, clinical trials and when unavailable in the country (Gobierno de Chile, 2011). This authorization is granted after evaluation and through a resolution that serves as a registration resolution. This situation may arise for example when private entities decide not to register a medication in the country, such as the controversial case of the morning-after pill (emergency contraceptive). The pharmaceutical industry 30 A similar medication has the same pharmaceutical form, concentration, active ingredient, route of administration, and therapeutic indication as one already registered (Editor’s Note).