Ministry of Health of Argentina – Resolution No. 1380/2020: National Program for the Monitoring of Protected Sanitary Technologies.
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Healthcare & Life Sciences Department Report | Ministry of Health of Argentina – Resolution No. 1380/2020: National Program for the Monitoring of Protected Sanitary Technologies
Dear Sir or Madam,
On August 19, 2020, the Ministry of Health of Argentina (Ministerio de Salud de la Nación) issued Resolution No. 1380/2020 (the “Resolution”), published in the Official Gazette on August 20, 2020, creating the National Program for the Monitoring of Protected Sanitary Technologies (the “Program”), according to instructions of Resolution No. 1114/2020 of the Ministry of Health. By means of said resolution, the Ministry ended the agreement that had been signed last year between the former Secretariat of Health with Biogen, in relation to Spinraza product.
The Program’s goal is to ensure the adequate and correct use of sanitary technologies in medicines and medical practices, as well as to establish the scope of its coverage. This, in order to avoid the inappropriate use of these practices based on pharmaco-economic principles, impact on health, degree of security, efficacy, effectiveness, and clinical efficiency.
The Resolution, within the framework of the Program, creates the Unique Registry of Protected Technologies (Registro Único de Tecnologías Tuteladas − R.U.T.T.), by means of which the protected technologies or pathologies that are incorporated into the Program will be registered, in order to provide timely, and efficiently follow-up.
It establishes what should be considered Protected Sanitary Technology, indicating that they will be those that meet at least one of the following criteria:
• It is intended for the treatment of low prevalence pathologies.
• It generates a high impact on the public budget due to its high price.
• It causes uncertainty regarding its efficacy and safety.
• Its cost-effectiveness has not been determined at the local level.
• It enters the country under the Exception Access to Medicines Regime for not having registration in the Registry of Pharmaceutical Products or having obtained a Registry under Special Conditions.
This Program shall, among others, evaluate the incorporation into the Program of prioritized sanitary technologies or pathologies, develop a strategic plan for inclusion, needs and priorities criteria in the incorporation of new technologies or pathologies, evaluate the impact on health and therapeutic response of the protected technology or pathology and propose the exclusion of technology or pathology from the Program through a well-founded report.
Should you require any further information on this matter, please do not hesitate to contact us.
Sincerely,
Ana Andrés