Anvisa’s Board of Directors approved, at a meeting held on March 11, 2021, the proposal for a Resolution of the Board of Directors (RDC) that provides for the economic monitoring to which medical devices are subject, since the Agency is responsible for monitoring the evolution of prices of medical devices. medicines, equipment, components, supplies and health services.
In this sense, aiming to regulate the excerpt of the Law for the creation of the Agency (Law No. 9782, of January 26, 1999) that confers such competence, Anvisa approved Resolution RDC No. 478, of March 12, 2021, being certain that economic monitoring will be carried out initially for the medical devices selected by it and already disclosed through Normative Instruction No. 84, of March 12, 2021.
Through economic monitoring, it is estimated to reduce the asymmetry that exists in the market today, through the adoption of strategic measures, such as: disclosure of statistics on the price history of monitored medical devices, definition and disclosure of technical attributes and disclosure of other information that the Agency deems relevant, safeguarding information protected by fiscal secrecy.
Anvisa selected the medical devices object of initial monitoring, and should collect historical prices practiced in the market, remembering that only medical devices with valid registration with the Agency were considered.
The collection of information will be done in accordance with the provisions of art. 18 of the present RDC, namely: I – through an active search of the available databases; II – through the sharing of information by other public agencies; III – technical-scientific publications; or IV – a request to holders of medical device registrations or other economic agents operating in this market.
The agency’s goal is to ensure that monitoring is implemented for the largest number of medical devices of interest in the shortest possible time.
The results of economic monitoring may even be used to assist in setting the price benchmark for public or private acquisitions of medical devices.
The selection of devices for monitoring should be carried out taking into account the following: – the financial impact for the Unified Health System (SUS) and for the supplementary health system and the relevance for public health.
Holders of medical device registration will be responsible for sending, through specific requests, information regarding the technical attributes of each model of the medical device subject to economic monitoring.
Anvisa will make available, on its website, a tool that will allow the consultation of historical price statistics practiced by grouping of medical devices with similar technical characteristics, according to the technical attributes reported for each model.
Failure to respect the established obligations of the DRC highlighted, or the provision of false information constitutes a health infraction and will be sanctioned in accordance with applicable law.
The present RDC will be revised after three years, counted from its entry into force, which will take place on April 1, 2021, and Collegiate Board Resolution No. 185, of October 13, 2006, and Resolution-RE No. 3,385, are hereby revoked. , of October 13, 2006.
Co-authors: Sueli de Freitas Veríssimo Vieira and Marcos Silva Santiago
