Access to Drugs in Developing Countries
Edited by Kenneth C. Shadlen, Samira Guennif, Alenka Guzmán and N. Lalitha
Chapter 4: The Invisible Threat: Trade, Intellectual Property, and Pharmaceutical Regulations in Colombia
Tatiana Andia As is the case in many other developing countries, since the mid-1990s Colombia has actively pursued an ongoing transformation of intellectual property rights (IPRs) and pharmaceutical legislation. Along with these legislative developments, other aspects of the IPRs and pharmaceutical sector have changed, including governmental agencies’ functions and stakeholders’– NGOs and the local pharmaceutical industry – political strategies. There are two trends that loom large as key elements of the new pharmaceutical regulatory era in Colombia: on the one hand, the proliferation of international free trade agreement (FTA) negotiations, which include pharmaceutical intellectual property (IP) provisions, and, on the other hand, the recent rise of local non-IP and non-trade regulatory reforms regarding the marketing approval of drugs and price controls, which are meant to complement pharmaceutical IPR enforcement. The first of these trends – the multiplication of FTAs negotiation – has been characterized by the increased public attention accorded to health issues and by the incessant lobbying exercised by the coalition of health NGOs and the local pharmaceutical industry against stronger IPR protection. In turn, these two factors helped prevent the country from granting higher IPR protection standards. In contrast, the second trend – the introduction of another type of pharmaceutical legislation, not trade or IP-related1 – was confronted less effectively by the health NGOs and 1 Some of these measures may respond to indirect trade-related pressures, such as those exercised in the context of temporary trade preferences acts such as the Andean Trade Preference Act–ATPA, but are not strictly trade related because...
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