| Author (Corporate) | European Ombudsman |
|---|---|
| Series Title | Press Release |
| Series Details | EO/14/13 (16.05.14) |
| Publication Date | 16/05/2014 |
| Content Type | News |
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The European Ombudsman, Emily O'Reilly, wrote to the European Medicines Agency (EMA) in May 2014, expressing concern about a significant change of clinical trial data transparency policy. In June 2014 the Ombudsman issued the following statement (not formally published): 'The European Ombudsman is not satisfied with EMA's reply to her letter. It does not give an answer to the key question of why EMA has changed its policy in a way that does not give effect to the fundamental citizens' right of public access to documents. Most importantly, EMA has still not answered the Ombudsman's direct question of how EMA will deal with individual requests for public access (under the EU's access to documents rules, Reg 1049/2001), to clinical-trial data in the future, only saying it will discuss the matter with the European Commission. The Ombudsman remains disappointed that EMA has clearly stepped back from enabling independent review of the evidence used by them 'in an analysable format'. The restrictive 'look-but-don’t-touch' approach to allow researchers to view the data on-screen only does not meet the standards of transparency expected in today's world. Independent researchers need to be able to download, save, print and be able to re-use the data. Furthermore, the restrictions and legal warnings placed around the usage of the new approach places hurdles so high, as to make it near meaningless. Next steps: The Ombudsman will ask the European Commission to publish its opinion as regards transparency in this area as EMA needs the Commission's agreement for the adoption of its pro-active policy. She will consult with concerned Members of the European Parliament as well. Furthermore, the Ombudsman opened an investigation into how EMA handles an access to document request for clinical studies reports relating to the approval of the drug Humira.' EMA's management board will meet on 12 June 2014 to discuss EMA's new transparency policy. |
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| Source Link | http://europa.eu/rapid/press-release_EO-14-13_en.htm |
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| Subject Categories | Business and Industry, Health, Politics and International Relations |
| Countries / Regions | Europe |
