Access to information of regulatory approval of medicines within the framework of the right to health protection

Abstract

Introduction: the right of access to administrative information is a fundamental right enshrined in the Political Constitution of Costa Rica. The information that companies present regarding safety, quality, and efficacy for the State to grant approval to market a drug in the country is necessary for a rational use of drugs. Objective: To determine if the Costa Rican population has access to the public information of the sanitary registry of a medicine. Methods: a detailed review of the national regulations related to access to public information was made and its application to the records of health records in the country. Results: According to national legislation, this information is publicly accessible, except for data on new substances. However, the Costa Rican Ministry of Health does not allow citizens to know this information, as it does not have a public database, accessible in real time, from a digital platform. Conclusion: there is a violation of the fundamental right to access administrative information by the Ministry of Health of Costa Rica.