Welcome to the first issue of our EU Life Sciences Review . It is produced by our life sciences lawyers in London, Brussels, Frankfurt, Moscow, and Paris and covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month.

EU Court Declares EU/US Safe Harbor “Invalid” – What Now? -

U.S. companies with European business will most likely mark 6 October 2015 as a dark day on their calendars. The highest EU court, the European Court of Justice (ECJ) in Luxembourg, declared a fifteen-year-old longstanding EU decision authorising a EU/US Safe Harbor “invalid.” The judgment is not appealable. This is a serious issue for the entire industry. According to the European Commission, the United States is a country with “inadequate” data protection laws. The European Commission and the U.S. Department of Commerce, therefore, agreed in 2000 to a self-certification program for U.S. organisations that receive personal data from Europe operated by the U.S. Department of Commerce and enforced by the Federal Trade Commission. Thanks to the landmark ECJ decision, this Safe Harbor is now thrown into jeopardy.