Refused access to internal audit reports of the Agency

Tillgängliga språk :  bg.es.cs.da.de.et.el.en.fr.ga.it.lv.lt.hu.mt.nl.pl.pt.ro.sk.sl.fi.sv
  • Ärende :  2914/2009/DK
    Undersökning inledd den 2009-dec-18 - Beslut den 2012-mar-14, 2012-mar-14
  • Berörd(a) institution(er) :  Europeiska läkemedelsmyndigheten
  • Juridiskt/juridiska område(n) :  Miljö, konsument- och hälsoskydd
  • Typ av påstått administrativt missförhållande – (i) brott mot, eller (ii) brott mot skyldighet avseende :  Allmänhetens tillgång till handlingar [Artikel 23 EKGF)
  • Ämne(n) :  Hantering av förfrågningar om information och tillgången till handlingar (öppenhet)
Research
Författare:
Upphovsrätt: Stocklib © darren baker

Summary of the decision on complaint 2914/2009/DK against the European Medicines Agency

In July 2009, the complainant, a French citizen, requested that the European Medicines Agency give him public access to two internal audit reports, one on access to information and another on selected administrative procedures relating to scientific evaluation of medicines. When the Agency refused access to the reports, the complainant turned to the European Ombudsman.

The Ombudsman found that the Agency wrongly refused public access to the reports when it argued that public access would undermine the protection of the purpose of inspections, investigations, and audits. Moreover, the Ombudsman found that the audit exercises in question had already been concluded and that there was thus no risk that the auditing exercise would be undermined by the public disclosure of the reports. The Ombudsman therefore made a proposal for a friendly solution in which he asked the Agency to reconsider its refusal to grant access to the two audit reports.

In its reply to the Ombudsman's friendly solution proposal, the Agency agreed to reconsider its refusal to make the reports public. In December 2011, the Agency provided the complainant with the two audit reports, as well as with an accompanying note on the implementation of the recommendations made in the reports.

When closing his inquiry with a finding that a friendly solution had been achieved, the Ombudsman underlined the notable progress that the Agency has recently made in rendering its work more transparent. He added that such significant improvements serve to ensure that citizens will have greater trust in the Agency, thus increasing its legitimacy and effectiveness in carrying out its important public health tasks.