SUMMARY

A citizen submitted a request for access to information addressed to the Spanish Agency for Medicines and Health Products (AEMPS), of the Ministry of Health, Social Services and Equality, to know the number of cases notified and in investigation of the incidents associated with the product Ala Octa: toxicological analysis, chemical tests, name of experts and reports of results,...

The Administration denied the information on the grounds that it is being prepared and that there is a specific access regulation (Royal Decree 1591/2009, which regulates medical devices) applicable in preference to the transparency law.

When a complaint was filed, the Council for Transparency and Good Governance considered it in part, given that this regulation contains a specific provision, not of access to information, but of confidentiality that translates into a limit to the right of access in relation to the methodology used in the tests of the manufacturing laboratory that may contain commercial secrets, as well as to the progress in the current investigation. The Transparency Council understands that the fact of identifying the participating experts does not affect the protection of personal data, since a social alarm situation has been created that substantially affects public health, which presupposes the existence of a higher public interest to be taken into account.