Access to adverse drug reaction reports

Pieejamās valodas  :  bg.es.cs.da.de.et.el.en.fr.ga.it.lv.lt.hu.mt.nl.pl.pt.ro.sk.sl.fi.sv
  • Lieta :  3106/2007/(TS)FOR
    Uzsākta {0} 2008.21.4 - Atzinuma projekts par {0} 2011.8.2, 2011.8.2 - Lēmums par {0} 2011.14.12
  • Saistītā(-s) iestāde(-s) :  Eiropas Zāļu aģentūra
  • Tiesību joma(-s) :  Tautu Eiropa
  • Iespējamo kļūdu pārvaldē veidi – i) pārkāpumi vai ii) pārkāpumi saistībā ar pienākumiem attiecībā uz :  Lūgumi publiski piekļūt dokumentiem [ELAPK 23. pants]
  • Jautājums(-i) :  Prasības attiecībā uz lūgumiem iesniegt informāciju un nodrošināt piekļuvi dokumentiem (pārskatāmība)
Medication
Autors:
Autortiesības: Stocklib © Anna Khomulo

Summary of decision on complaint 3106/2007/(TS)FOR against the European Medicines Agency

The complainant, who works for a Greek law firm, requested that the European Medicines Agency give him public access to certain documents, namely, suspected serious adverse reaction reports relating to Septrin, a pharmaceutical product. The Agency refused his request for access. It based its decision on the need to protect commercial interests.

After examining the arguments put forward by the complainant and the Agency, the Ombudsman made a draft recommendation to the Agency. He considered that the EU rules on public access to documents do apply to documents held by the Agency. He found that it was not evident that the requested reports contain commercially confidential information or other information which would damage any legitimate business interests of a third party. He noted, however, that the Agency added a new argument to the effect that personal data (such as the personal data of patients and reporting doctors) contained in the requested documents would need to be redacted.

In its response to the draft recommendation, the Agency acknowledged the fundamental principles of openness and transparency, and agreed to provide the complainant with access to the requested data, after removing personal data.

The complainant thanked the Ombudsman for his efforts to help him.

In closing the case, the Ombudsman recognised the important progress that the Agency has made in rendering its work more transparent. He went on to point out that such significant improvements serve to ensure that citizens will have greater trust in the Agency, thus increasing both its legitimacy and its effectiveness in carrying out its important tasks.