The Chapter outlines the relevant provisions governing access to information concerning quality, safety and efficacy of medicinal products in the European Union. taking steps from the principle of transparency as enshrined in the treaty establishing the European Union and the Treaty on the Functioning of the European Union, the author flags the constantly increasing demand for transparency and how the European institutions and the European regulators, namely the European Medicines Agency, has progressively moved from a reactive (i.e. upon receiving request for access to documents and information) to proactive disclosure of relevant information concerning medicinal products which they consider of public interest. An additional part of the paper is devoted to the criteria to be applied in order to strike the right balance between the demand for transparency and the need to protect commercial confidential information in order to mitigate the risk that leakage of confidential information may seriously undermine the proprietary rights of pharmaceutical industry. The new transparency principles set by the EU Regulation 536/2014 on clinical trials and administrative and judicial remedies are also tackled
Access to Information
SALVATORE, VINCENZO
2015-01-01
Abstract
The Chapter outlines the relevant provisions governing access to information concerning quality, safety and efficacy of medicinal products in the European Union. taking steps from the principle of transparency as enshrined in the treaty establishing the European Union and the Treaty on the Functioning of the European Union, the author flags the constantly increasing demand for transparency and how the European institutions and the European regulators, namely the European Medicines Agency, has progressively moved from a reactive (i.e. upon receiving request for access to documents and information) to proactive disclosure of relevant information concerning medicinal products which they consider of public interest. An additional part of the paper is devoted to the criteria to be applied in order to strike the right balance between the demand for transparency and the need to protect commercial confidential information in order to mitigate the risk that leakage of confidential information may seriously undermine the proprietary rights of pharmaceutical industry. The new transparency principles set by the EU Regulation 536/2014 on clinical trials and administrative and judicial remedies are also tackled
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