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 Regulation establishes that:
i. As of March 30, 2023, medicines included in ARCSA’s “List of OTC Medicines” will belong to the price-released regime.
ii. Until April 21, 2023, holders of valid sanitary registrations shall report to the Technical Secretariat of the Council (the “Secretariat”) the units sold and the retail price marked on the packaging to determine the medicines that will be under the constant criterion in paragraph b.
iii. Until June 30, 2023, the Secretariat must generate the methodology to determine the medicines to be covered by the criteria in paragraph b and send it to the Council for approval. After approval, the Secretariat will have one month to submit to the Council the technical reports for issuing the list of medicines that will meet the indicated criterion.
iv. Until June 30, 2023, the Secretariat must submit to the Council the technical reports for issuing the list of medicines that will be subject to the price-regulated regime based on this new definition.
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