Medical Devices, Trade Talks, Medicine Manufacturing: EU Public Policy March 13 Update
Council adopts EU rules on Medical Devices
On March 7 2017, the Council of the EU adopted rules which would be contributing to the safety of medical devices in the EU. These rules comprise of two proposals, a Regulation on Medical Devices and a Regulation on Vitro Diagnostic Medical Devices. The adopted rules will give manufacturers the opportunity to improve any devices on a continuous basis, as well as to implement fast and effective measures when faced with safety problems.
The European Parliament is expected to adopt these rules in April 2017, after which the rules will be submitted for publication at the Official Journal of the EU.
EU-US agreement on Mutual Recognition of Inspections of Medicine Manufacturers
The European Commission and the United States Food and Drugs Administration adopted on March 2 2017 an agreement to mutually recognize inspections of premises where medicines are produced. The agreement will not affect the procedure of approving medicines but will allow the EU to identify problems at medicine factories faster and will reduce the administrative burdens and costs for pharmaceutical manufacturers.
EU Trade Talks
On March 10 2017, the EU and the Association of Southeast Asian Nations (ASEAN) agreed in a joint statement to take new steps to continue their trade talks for a region-to-region agreement.
Similarly, on March 7 2017, the EU Commissioner for Trade Cecilia Malmström and New Zealand’s Trade Minister Todd McClay met in Brussels to agree on the last elements of the preparatory talks over a Free Trade Agreement. The European Commission will now be seeking a negotiating mandate by the EU28 Member States to begin the trade negotiations with New Zealand.
White Paper about the Future of Europe
The European Commission published on March 1 2017 a White Paper outlining 5 scenarios about the Future of Europe. The White Papers provides reflections and scenarios for EU27 Member States by 2025, during which time the Brexit process is estimated to be completed.