On 18 November 2016, the European Commission published a notice on the application of certain key provisions within Regulation (EC) No. 141/2000 on orphan medicinal products (the “Orphan Regulation”). Orphan medicinal products are medicinal products that are used for the diagnosis, prevention or treatment of rare diseases. An orphan designation allows a pharmaceutical company to benefit from EU incentives to develop a medicinal product, such as fee waivers for the regulatory procedures or a ten year market exclusivity. Continue Reading European Commission Publishes Revised Guidelines on Criteria for Orphan Designations of Medicinal Products

On 15 December 2015, the European Council and representatives of the European Parliament reached a consensus on the European Commission’s proposed Directive on “the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure.” The Commission’s original proposal  Continue Reading The New European Directive on the Protection of Trade Secrets

On 9 December 2015, the European Commission has proposed new rules concerning content portability across the so-called Digital Single Market. Under the first set of proposals, which will need to be discussed with and endorsed by the European Parliament and the Council of the European Union, Europeans will be able to access online services they Continue Reading The Digital Single Market – Commission Announces Plans to Ensure Wider Access to Online Content Across Europe

In its judgment of 6 October 2015 (C-362/14), the Court of Justice of the European Union (“CJEU”) held that transfers of personal data of European citizens to the United States made under the so-called Safe Harbor scheme are subject to significant risks, and declared the corresponding decision of the European Commission to be invalid. As a consequence, EU entities of U.S. companies so far relying on Safe Harbor will need to revise their practice of submitting personal data to the U.S. to comply with EU data protection law. Continue Reading Redefining Data Protection? Court of Justice of the European Union Strikes Down the Commissions “Safe Harbor” Decision

On 26 March 2015, the EU Commissioner in charge of competition policy, Margrethe Vestager, announced plans to inquiry into the e-commerce sector. The possibility of conducting sector inquiries is provided for in Art. 12 of Council Regulation 17/62 which allows the commission to conduct a general investigation into an economic sector “[i]f  in any sector of the economy the trend of trade between Member States, price movements, inflexibility of prices or other circumstances suggest that in the economic sector concerned competition is being restricted or distorted within the common market”. Continue Reading Commission Announces E-Commerce Sector Inquiry