SUMMARY

A citizen submitted a request for access to information addressed to the Community of Madrid to access the detail of the adverse incidents reported by health professionals, since 2012, to the point of surveillance of health products.

The administration referred the claimant to the State General Administration and the State General Administration denied the information, citing the limitation on confidentiality and the application of Additional Provision 1º.2 of the LTAIBG: existence of a specific access procedure contained in the regulations governing medical devices.

When the complaint was filed, the Transparency and Good Government Council considered that the limit invoked was not applicable, since the information is partially public and since, according to this regulation, the information intended for users sent by the manufacturer or health professionals is not confidential, provided that they may end up in serious illness or death of patients or users.

It also analyzes the regulations governing medical devices, concluding that there is no procedure for access to public information and that there is, instead, an obvious public interest in the dissemination of such information.