28 Feb, 2021 Back to the future: the European Commission is consulting on the upcoming revision of the blood, tissues and cells Directives By Mariana Ricardo Significant technological and scientific development over the last few years has shown that the EU’s framework on blood, tissues and...
28 Feb, 2021 UK investment in life sciences By Victoria Rhodes At a time when the importance of the life sciences industry to our daily lives has never been clearer, the UK Government has been...
25 Feb, 2021 Interim EDPB guidance on the application of GDPR to health research By James Clark In response to a set of questions from the European Commission, the European Data Protection Board (“EDPB”) has published some high level...
22 Feb, 2021 Portuguese VAT exemption to transfers of medical devices for in-vitro diagnosis of COVID-19, its vaccines and related provision of services By Inês Santana Metello Portugal published Law no. 4-C/2021, which transposes the Directive (EU) 2020/2020 from the 7th of December 2020, as regards temporary...
22 Feb, 2021 Proposed Reform to the UK's NHS Procurement Regime By Hannah Gardiner On 11 February 2021, the Department of Health and Social Care published a white paper - Integration and innovation: working together to...
22 Feb, 2021 EUDAMED: streamlining the registration process between Legacy and Regulation Devices By Kate Black The European Commission has published a guidance document aiming to further assist manufacturers with understanding how Legacy Devices...
22 Feb, 2021 The Australian PBAC reforms its review process of unimplemented positive recommendations By Nicholas Tyacke Sarah Parkin Joanne Lim The Australian Pharmaceutical Benefits Advisory Committee (PBAC) has amended its process for reviewing positive PBAC recommendations that...
22 Feb, 2021 The importance of an SESG strategy for life sciences companies By Moritz von Hesberg In the recent past, sustainability, environmental, social and governance (SESG) issues took center stage in global business. In distinct...
17 Feb, 2021 TGA Consultation on the Repurposing of Prescription Medicines By Joanne Lim The Australian Therapeutic Goods Administration (TGA) is currently conducting a public consultation into the “repurposing” of...
16 Feb, 2021 An ever-changing landscape - European regulator looks to speed up authorisation process for modified vaccines addressing COVID-19 variants By Kate Black At a time where drug makers are taking action to develop modified versions of their vaccines in order to address the evolving variants of...
15 Feb, 2021 Ireland: Cannabis Medical Access Programme By Caoimhe Clarkin Louise McErlean Cannabis remains a controlled substance in most jurisdictions, but demand for medicinal and wellbeing cannabis products and their...
15 Feb, 2021 The European Commission accepts commitments by Aspen to reduce prices for six off-patent cancer medicines By Vadim Barbu The European Commission has accepted commitments by Aspen to reduce the price of six critical, off-patent, cancer medicines by 73% on...
12 Feb, 2021 Telehealth update in Romania – February 2021 By Vadim Barbu Romania is one step closer to regulating telemedicine, as the draft general legal framework is now open to public debate ahead of its...
10 Feb, 2021 The emergence of strategic assets in the health sector: Portugal takes the final step to create a National Medicines Laboratory By Mariana Ricardo Inês Santana Metello When the Covid-19 pandemic hit Europe in 2020, the Portuguese Government took the opportunity to establish the health sector as a...
09 Feb, 2021 Prohibition Partners: Interview for the the North American Cannabis Report By Robert Fonn This week I was kindly asked by Prohibition Partners - a leading consultancy focused on the global cannabis industry, to be interviewed...
05 Feb, 2021 Russia Pharmaceuticals Sector Update - February 2021 By Hannah Gardiner In this month's 'Russia Pharmaceuticals Sector Update', Julien Hansen, Elena Mikhailovskaia and Pavel Arievich of DLA Piper's Moscow...