104. Spanish Agency for Medicines and Health Products (AEMPS). Adverse drug incidents
SUMMARY
A citizen submitted a request for access to information addressed to the Spanish Agency for Medicines and Health Products, of the Ministry of Health, Consumption and Social Welfare, to know the detail of each and every one of the adverse incidents reported by health professionals, since 2012, to the health product surveillance point of that Agency.
The administration denied the information because there was a limit to the confidentiality of the information, in application of article 14.1 of the LTAIBG and the specific legislation on medicines.
When the complaint was filed, the Council of Transparency and Good Government considered that the limit invoked was not applicable, with the right of access enshrined in the LTAIBG prevailing, since by making a joint interpretation of the health regulations, it turns out that adverse incidents reported by health professionals do not enjoy the duty of confidentiality.
