New Definition Of Strategic Medicines

• Law Firm: CorralRosales
• Subject Matter: Food, Drugs, Healthcare, Life Sciences
• Author: Mr Mario Fern'ndez
• Published date: 23 May 2023

The Regulation STFP-009-725-2023 of March 15, 2023 (the 'Regulation'), issued by the Board for Fixing and Reviewing the Prices of Medicines for Human Use and Consumption (the 'Board') approved the new definition of strategic medicines, effective as of March 30, 2023.

According to the Regulation, strategic medicines will be those subject to any of the following criteria:

a. Medicines included in the National List of Basic Medicines ('CNMB'), except those included in the 'List of OTC Medicines' published by the National Agency of Regulation, Control and Sanitary Surveillance ('ARCSA')
b. CNMB medicines, except those in which the number of competitors allows the release of its price.
c. Medicines that the Ministry of Public Health considers necessary for managing health strategies, programs, plans, and projects, including treating chronic, rare, catastrophic, and orphan diseases.
d. Medicines not appearing in the CNMB and whose acquisition has been authorized under Ministerial Agreement No. 18 published in the Official Gazette Supplement 573 of November 9, 2021 (or the norm that replaces it).
e. Medicines that the Superintendence of Control of Market Power qualifies as monopolistic or have relevant restrictions to competition.
f. Medicines containing active ingredients that have not been marketed in Ecuador.

Additionally, the...