The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021. The consultation sets out proposed changes
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Inside EU Life Sciences
Updates on Legal Developments in the EU Life Sciences Industry
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Growing calls for separate Nutraceutical regulation in the UK
Following the UK’s departure from the EU, the UK Government has been exploring ways to leverage its new regulatory freedoms. In particular, the life sciences sector has been a key Government priority. As early as January 2021, for example, the…
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EU Plans Ban on Titanium Dioxide in Food
On 6 May 2021, the European Food Safety Authority (“EFSA”) published its updated safety assessment on titanium dioxide as a food additive (E171). EFSA examined new evidence on nanoparticles and found that there was uncertainty about E171’s ability to accumulate…
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New Early Access and Off-Label Use Rules in France
On 1 July 2021, the new French rules on early access to unauthorized medicinal products and off-label use of authorized medicinal products entered into force. The rules were introduced by the Social Security Financing Law for 2021 (LOI n° 2020-1576…
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WHO Launches Global BioHub for Pathogen Sharing
On May 24, 2021, the World Health Organization (WHO) announced it singed an MoU with Switzerland to host the WHO’s first BioHub Facility, which is part of the new BioHub System first announced at the World Health Assembly in November 2020.…
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Major Cyber-Attack on Irish Health System Causes Commercial Concern
By Marie Daly
On May 20, 2021 there was a major ransomware attack on the Irish health system. The centralized HSE (Health Service Executive) which provides and manages healthcare for the Irish population was targeted on May 14, and has seen significant disruption…
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European Commission outlines Strategy on COVID-19 Therapeutics
On 6 May 2021, the European Commission published its “EU Strategy on COVID-19 Therapeutics” (the “Strategy”). With the vaccination programme now under way, the EU is shifting focus towards the development, approval and procurement of COVID-19 therapeutic products. The Commission…
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Brazil Ratifies the Nagoya Protocol
On March 4, 2021, Brazil deposited with the United Nations its ratification of the Nagoya Protocol (“Protocol”) (see here the announcement of Brazil’s Ministry of Foreign Affairs). This represents Brazil’s formal commitment to be bound by the Protocol.
On August…
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German Patent Law Reform Would Introduce “Disproportionality” Defence
On 27 January 2021, the German Parliament discussed a draft law that would limit a patent owner’s ability to stop the production and distribution of an infringing product. The new law would enable the infringer to rely on a defence…
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EU Adopts Export Authorization Scheme for COVID-19 Vaccines and their Active Substances
By Bart Van Vooren & Loïc Waty
On January 30, 2021, the European Commission published the Regulation establishing an export authorization and notification scheme relating to COVID-19 vaccines and their active substances. It applies “for a limited duration” to COVID-19 vaccines covered by Advanced Purchased Agreements (“APAs”)…
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