The government has just created the Commission for Intellectual Property in Health (COMPIS) and the Articulation Group for Intellectual Property and Health (GAPIS), according to Ordinance 2466/2020 of the Ministry of Health this Thursday, 15.
The same ordinance also alters a 2017 consolidation that addresses the requirements for a drug to be considered of interest for drug assistance policies and requires prior consent from the National Health Surveillance Agency (Anvisa) in the patent application process.
According to the publication, they come to be understood as of public interest and mandatory consent by Anvisa:
- object of request for priority examination by the Ministry of Health to the National Institute of Industrial Property (INPI);
- technology related to the patent application that is the subject of a lawsuit to obtain access to the drug, upon request from the Ministry of Health to ANVISA.
- To be related, based on technological prospecting, to a topic of relevance to the actions of the Ministry of Health; and
- be selected by ANVISA, according to the therapeutic purposes specified in this Chapter, from the following groups:
- infectious and parasitic diseases;
- Respiratory System diseases;
- diseases of the Nervous System;
- diseases characterized as rare;
- digestive system diseases;
- blood diseases or blood-forming organs;
- immune system diseases;
- diseases of the Circulatory System;
- neoplasms; and
- vaccines and serums.
The objective of GAPIS is to prospect and identify patent applications for pharmaceutical products and processes, including those considered strategic for public health policies, subsidizing decision-making by the Ministry of Health and the work of COMPIS, a group also created by the same act. This group will be composed of representatives from the Department of Science, Technology, Innovation and Strategic Health Supplies of the Ministry of Health and the Intellectual Property Coordination of the National Health Surveillance Agency. Representatives and specialists from other bodies and entities, public or private, may also participate in the meetings.
COMPIS will be responsible for preparing, monitoring and monitoring the implementation of a policy in the area of intellectual property in health within the scope of the Ministry of Health; propose priority areas for diagnoses, evaluations and management actions in the area of intellectual property in health and technically support activities aimed at offering subsidies to intellectual property in health.
The Commission should also subsidize the participation of the Ministry of Health in interministerial collegiate bodies related to the theme, in particular the Interministerial Group on Intellectual Property (GIPI); propose studies, debates, events and public consultations on the topic of intellectual property in health; subsidize the participation of the Ministry of Health in the activities of national and international forums related to intellectual property in health and subsidize the Ministry of Health in decision-making regarding requests for priority exams with the National Institute of Industrial Property (INPI).
The commission will be composed of representatives from the Health Surveillance Secretariat; Specialized Health Care; Primary Health Care; that of the Special Secretariat for Indigenous Health and the International Health Affairs Advisory. In addition, the following will participate in the collegiate: representative of the Oswaldo Cruz Foundation (FIOCRUZ); the National Cancer Institute (INCA); the National Institute of Cardiology (INC); representative of the National Institute of Traumatology and Orthopedics (INTO); the National Health Surveillance Agency (ANVISA); and the National Research Ethics Commission (CONEP). People of notorious knowledge in matters related to intellectual property in the field of health may also participate in the meetings, without the right to vote.
-Portaria 1466/2020 – Ministério da Saúde