Summary of clinical trial transparency in the EU / EU Ombudsman rules clinical trials not trade secrets


Clinical trial data is often argued by industry (although not all companies!) to be a ‘commercially sensitive’ ‘trade secret’. For this reason, intellectual property chapters in trade agreements are relevant to clinical trial transparency.

Summary from HAI policy paper:
The European Ombudsman: disclosure of CSRs and trial protocols does not undermine commercial interests During the Ombudsman’s examination of the Nordic Cochrane Centre vs EMA case, the Ombudsman concluded that the requested clinical trial data:

– Did not contain information that could be classified as a trade secret (i.e. formulae, manufacturing or control processes)
-Did not fall into the definition of commercial confidences i.e. “every piece of information which does not have a commercial value as such, but its disclosure might provoke damage to the party (e.g. the structures and development plans of a company, marketing strategies, etc.),
– Did not contain information on the composition of the medicinal products subject to the clinical studies, or other related key information. The Ombudsman noted that the two concerned medicines had been patented before an application for marketing authorisation was made to the EMA (which indicates that IP-related information was already publicly available and could not be commercially confidential).

European Ombudsman. Decision of the European Ombudsman closing his inquiry into complaint 2560/2007/BEH against the European Medicines Agency (November 24,
2010).

http://haieurope.org/wp-content/uploads/2013/10/HAI_Protecting-citizenshealth-transparency-of-clinical-trial-data-on-medicines-in-the-EU.pdf

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