EMEA and EU Commission – Topical News
Draft of EMEA Transparency Policy published for Public Consultation
Dr. Brigitte Friese
Rechtsanwältin, Wyk-Wrixum auf Föhr, Germany
On June 19, 2009, the EMEA published the draft of the EMEA transparency policy for public consultation until 25 September 2009 (Document EMEA/232037/2009). This draft shall represent a step forward to the establishment of a single EMEA Transparency Policy which shall be harmonised with transparency principles of national competent authorities. In this draft the EMEA defines rationale and scope of the transparency policy, describes its objectives and the measures and activities it intends to perform to achieve these objectives. One important aspect of these activities is the intention of applying a more active approach towards transparency in proactively (without consumers' or patients' prior request) providing information on product-related issues. In this respect the principles of transparency and protection of confidential information have to be balanced correctly. To this end the EMEA intends to redefine the notion of commercially confidential information, a process, which should closely be attended by pharmaceutical industry.
pharmind 2009, Nr. 7, Seite 1148