Tune into the second episode of Covington’s Life Sciences Audiocast, where Sarah Cowlishaw, Ellie Handy, and Léna Beley discuss key developments in the medical device sector in the EU and the UK. Our speakers review the major legal developments for medical devices in the last few years, including the issues surrounding the
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UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize. Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals, plus changes to the regulation and support
CJEU Provides Further Clarifications on Food for Special Medical Purposes
On 2 March 2023, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling clarifying various aspects around the classification of products as foods for special medical purposes (“FSMPs”). The CJEU reinforced and supplemented its prior ruling in Case C-418/21 Orthomol (see our blog here for further details).
This case touches on
German Government presents new law to incentivize paediatric medicines and antibiotics and to combat generics shortages
On 14 February 2023, the German Federal Ministry of Health (BMG) has presented the new draft “Act to Combat Supply Shortages of Off-Patent Medicines and to Improve the Supply of Paediatric Medicines” (Arzneimittel-Lieferengpassbekämpfungs- und Versorgungsverbesserungsgesetz or “ALBVVG”). Some commentators also refer to the new law as the “Generics Act” but this term appears
EU Talking Life Sciences Audiocast: Episode 1 – Key Developments in the Pharma Sector: A Review of 2022 and Insights for 2023
Tune into the first episode of Covington’s Talking Life Sciences Audiocast, where Grant Castle, Peter Bogaert and Marie Doyle-Rossi discuss key developments and trends in the pharma sector. Our speakers review the major issues of 2022, including the Clinical Trials Regulation, the Health Technology Assessment Regulation, European Health Data Space proposal and Brexit.
Submit your views! Consultation on the New Global Biodiversity Fund Paid For by Life Sciences Companies that “Use Digital Sequence Information on Genetic Resources”
On 19 December 2022, the parties to the Convention on Biological Diversity (CBD) decided to create a new global mechanism requiring the private sector to pay into a new Global Biodiversity Trust Fund.
The new fund is expected to generate up to 15 billion USD per year, based on contributions from companies that “use
UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media
On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).
The Guidance is the first of its kind in the UK and is long-awaited.
The PMCPA is the self-regulatory body that administers and enforces the ABPI Code (the voluntary advertising code that
CJEU Rules on the Advertising of “Unspecified Medicinal Products” in the EU
On 22 December 2022, the Court of Justice of the European Union (CJEU) — sitting in Grand Chamber — published its judgement in case C-530, Euroaptieka. The judgement adds further commentary to the meaning of “advertising medicinal products” in the EU and the competencies of EU Member States to restrict drug advertising activities. The
European Commission proposes significant changes to transition timelines of the Medical Device Regulation and IVD Regulation
Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet
Outcome from COP 15: a New Global Biodiversity Fund Paid For by Life Sciences Companies that “Use Digital Sequence Information on Genetic Resources”
A snapshot by yours truly while following the debate on synthetic biology. As you can see, business gets a seat in a place far, far away – in the back of the room.
After two weeks of intense negotiations in Montreal, on 19 December 2022, the Conference of the Parties (COP) to the Convention on