Colombia’s Ministry of Health (Minsal, for its acronym in Spanish) has launched a new legislative approach to medicines enshrined in the terms endorsed by the WHO. A resolution was published defining the guidelines for evaluating how biological medicines compare with reference medicines. The regulation will enter into force in May 2020.

The Guide on Evaluation of the Comparability of Biological Medicines, drawn up by the Colombian National Food and Drug Surveillance Institute (INVIMA, for its acronym in Spanish), includes procedures whose purpose is to demonstrate that the drug to be registered for distribution in the country is similar to the reference drug. The Guide was drafted on the basis of the recommendations included in the Guidelines on Similar Biotherapeutic Products (SBPs) devised by the WHO Expert Committee on Biological Standardization (ECBS). If laboratories fail to comply with the resolution, they will be sanctioned according to the provisions foreseen in Decree 677 on the Health Surveillance of Medicines.

Colombian Minister of Health Juan Pablo Uribe has expressed his intention of modifying current regulations requiring laboratories to set the price of a drug they want to register in Colombia up-front as a prerequisite for INVIMA issuing the corresponding health register. Iván Darío González, Vice Minister of Public Health, said: “We are preparing a new draft as a change directed by the president’s office through a decree with legal force.

The original mechanism establishing the entry of medicines into Colombia set the price of products in this category on the basis of their innovative value, meaning their therapeutic contribution differential compared with products already present on the market. Thus, if a new product contributed something new compared to drugs already in circulation, this would justify paying a higher price. Otherwise, the price of the product would be adjusted to a value similar to that of similar drugs available on the market. There will also be a technical modification to the current regulations, as they will no longer require the laboratory to inform the price in order for INVIMA to grant the health registration, as is currently done. However, the way in which the health entity fixes the prices of medicines will not be limited.