Executive Branch opens public consultation on the withdrawal of drugs from circulation and suggests to file initiative to regulate such market
21 enero 2022


On January 21, the Ministry of Health launched a public consultation on the Regulation for the Withdrawal from Trade or Circulation of Products of Health Interest, through which it seeks to establish general guidelines for the withdrawal from trade or circulation of products such as drugs, including oncological drugs, when they present problems of safety, quality, efficacy, safety, or non-compliance with sanitary regulations. According to the notice, interested parties may send their observations and comments with the respective technical, scientific or legal regulation until Thursday, February 3, 2022 to [email protected]. Likewise, the Commission to Promote Competition (COPROCOM in Spanish) requested to file the bill that seeks to regulate the drug market.

As proposed by the Regulation, the Ministry of Health is empowered to order the withdrawal from the market of products of sanitary interest, including drugs, after verifying that they do not meet the requirements to circulate in the country as their consumption or exposure is considered to represent a risk to public health. In case of voluntary withdrawal, the Ministry will analyze the notification sent by the person responsible for the product with the data included in Annex I of the regulation. According to the text, voluntary recalls or recalls ordered by the Ministry must be executed within 30 working days.

On the other hand, COPROCOM, a body with technical independence from the Ministry of Economy, Industry and Commerce (MEIC), proposes that the bill that seeks to promote competition in the drug market be shelved since it could generate distortions in this area, according to an analysis made by the entity. According to the entity’s arguments, the initiative seeks to prohibit practices that are not necessarily anti-competitive; it does not establish the criteria that would determine the appropriateness of price regulation, leaving these to the MEIC’s current head; and it also eliminates the power of COPROCOM to issue criteria in relation to the appropriateness of price regulation. It is worth mentioning that currently the initiative does not have a committee assigned to its study.