Colombia and Chile advance with regulation of biotech and biogeneric drugs
13 marzo 2019

In several Latin American countries, issues related to biogeneric and biotechnological medicines are increasingly weighing on the national political agenda. In particular, the Colombian and Chilean congresses are currently debating bills that will limit the commercialization of biotech drugs and regulate bioequivalent drugs, respectively. In each country and indeed generally at the regional level, the availability and accessibility of these types of drug are matters of growing importance.

In the case of Colombia, the director of the Drug Observatory of the Colombian Medical Federation, Oscar Andia, publicly denounced the draft National Development Plan 2018-2022 (PND), which is currently being discussed in Congress. According to Andia, this bill seeks to avoid competition in the commercialization of biotechnology drugs, which in turn would undermine the Statutory Health Law which establishes that doctors must provide their patients with the best possible care. Andia argues that the PND, if passed, would end up favoring companies already selling these types of drug in the country, barring the entry of cheaper alternatives. The House of Representatives and Senate Third Committees will discuss the PND this week, with a view to approving it in the coming weeks.

As for Chile, the Chamber of Deputies Health Committee passed the Drug II Bill (Exp. No. 9914-11). The bill modifies the Health Code to regulate generic bioequivalent drugs, with the goal of increasing the availability and incorporation of these drugs in the national market. The bill was sent to the Finance Committee to consider its financial aspects. After this happens the bill will be sent to the Deputies floor for its debate. This could happen in the first weeks of April.