Hoping to improve Europe’s clinical trial environment, EU officials launched an initiative Jan. 13 to transform how clinical trials are designed and conducted.
The EU is on its way to becoming one of the first to implement a historic global tax reform agreement, setting a minimum effective tax rate of 15% for large multinational groups, including biopharma and med-tech companies.
The effect of the COVID-19 pandemic on the roll-out of European Union’s new med-tech regulations has sparked concerns about in vitro diagnostic availability, but relief from compliance deadlines has now been achieved. The European Parliament and the European Council have agreed to ease the compliance dates of the In Vitro Diagnostic Regulation (IVDR).
Following extensive discussions with their British counterparts, the European Commission (EC) advanced proposals to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland and to address supply concerns in Cyprus, Ireland and Malta, which historically have been dependent on drugs from the U.K.
The European Council reached an agreement Dec. 20 that will allow the European Health Emergency Preparedness and Response Authority to respond much more quickly to public health emergencies such as the COVID-19 pandemic by activating urgent and targeted medical countermeasures (MCMs) across the EU.
PERTH, Australia – Australia attracted international attention in July when a Federal Court ruled that artificial intelligence can be named as the inventor of a patent. In Thaler v. Commissioner of Patents, Federal Court Justice Jonathan Beach ruled that under Australian patent law, inventors don’t necessarily have to be human. The decision challenges the assumption that only human beings can be inventors. Beach did rule, however, that an AI system cannot apply for a patent or receive a patent.
The EMA and the EU Heads of Medicines Agencies are launching a pilot project to support not-for-profit organizations and academia in the repurposing of an authorized drug for a new indication in an area of public health interest.
Regulatory agencies are starting to catch up on their guidance agendas, including the European Union’s Medical Device Coordination Group (MDCG), which has posted a guidance for risk classification. Rather than provide a list of risk classes for specific device types, the guidance provides a framework by which the manufacturer does its own evaluation of the inherent risk of the device, opening the door to disagreements between the manufacturer and its notified body.
LONDON – Industry groups, patients’ representatives and clinicians have launched the European Alliance for Cardiovascular Health (EACH) to lobby for a comprehensive EU policy to address the increasing burden of cardiovascular disease.
The European Commission and Astrazeneca plc have ended their legal row over COVID-19 vaccines, while also reaching an agreement over supplies of remaining shots to Europe. The settlement brings to an end an unseemly row over vaccine supply, which further soured relations between the EU and U.K. following Brexit.
