COL. The Colombian National Food and Drug Surveillance Institute will introduce a fast track for drug registrations
4 enero 2018

The Colombian National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Alimentos y Medicamentos or Invima) announced the creation of a fast track to register competing medications. The measure reduces the processing time for competing medications of chemical or biological origin to enter the marketplace in order to eliminate monopoly or duopoly conditions (when there are only one or two holders of a drug registration).

In this manner, the authorities hope to reduce prices and generate savings for the health care system in the amount of US$ 4.488 billion over the next two years. Invima has indicated that 467 medications that are under monopoly conditions represented an outlay of US$ 46 billion in 2016. Currently, 40 of these products already have competing medications with pending registrations.

According to the Minister of Health, Alejandro Gaviria, “technological pressure has been one of the leading causes of the system’s financial crisis. This pressure is demonstrated when breakthrough medications maintain their monopoly conditions for longer than necessary. For this reason, we are sure that Invima’s measure will have a positive impact on the wallets of Colombian citizens and on the health care system’s finances.” Conversely, Invima’s director, Javier Guzmán, affirms that intellectual property rights will not be affected by the implementation of the fast track.


Nonetheless, the decision generated a strong reaction from the pharmaceutical industry, represented by the Association of Pharmaceutical Laboratories for Research and Development (Asociación de Laboratorios Farmacéuticos de Investigación y Desarrollo or Afidro). In a releaseGustavo Morales, the executive chair of Afidro, assures that Invima’s measure is “discriminatory and arbitrary,” in the sense that it applies only to competing medications. “Under the principle of equality, this alternative should include all the medications that request verification of their safety and efficacy.”

“The so-called ‘first come, first served” principle should always be applied in agencies requiring a process to operate in the marketplace: the oldest applications should be reviewed before the most recent ones. There are petitions that are more than a year behind that comply with all the requirements for obtaining a registration, so why not fast track them is the question raised by the trade association. Likewise, Afidro questions the fact that an agency of a scientific nature such as Invima makes decisions favoring the competition and places itself “at the service of just one subsector of the medication industry.”

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