Possible Strategies of Protection of Biopharmaceutical Products in Columbia

Abstract

Biopharmaceutical products are nowadays a substantial part of one of the most important economic sectors in the world. Companies producing biopharmaceuticals seek to ensure a long period of exclusivity in the market in order to recoup the high investment involved in the development of this kind of product. However, this exclusivity is usually linked with high prices that are detrimental to the coverage of the health systems.

Colombia is one of the most important markets for pharmaceuticals in Latin America, having a local industry based principally on generic-producing companies. Taking into account this situation, this Thesis explores to what extent the commonly used strategies of protection of biopharmaceutical products are applicable within the Colombian context.

After the analysis of both the legislation and common practice in the country, this Thesis concludes that strategies used in jurisdictions such as the United States and Europe cannot be directly applied in Colombia, as, in principle, local policies try to balance both the interests of originator companies and the necessity for wide availability and affordable medicines for the whole population.

Keywords: MIPLC, biopharmaceutical products, biotechnological patents, Biosimilars, Follow-on Biologics, Colombian legislation