All Insights https://www.osborneclarke.com/ en Mon, 24 Jun 2024 10:02:07 +0100 Wed, 19 Jun 2024 11:01:24 +0100 EU AI Act's 'deployers' definition has wide-ranging significance for life sciences https://www.osborneclarke.com/insights/eu-ai-acts-deployers-definition-has-wide-ranging-significance-life-sciences-2 <p><strong>Identifying businesses as deployers of high-risk AI systems is crucial for understanding new regulatory responsibilities</strong></p> Wed, 19 Jun 2024 11:01:24 +0100 All Insights Government updates guidance on the UK National Security and Investment Act https://www.osborneclarke.com/insights/government-updates-guidance-uk-national-security-and-investment-act &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_010.jpg?VersionId=X6cyEJ1XgnOPivlTQEB4JYyRFzSCaGaU' /><br /><p><strong>Changes cover call-in powers, universities and research bodies, outward direct investment and notification forms</strong></p>]]&gt; Wed, 05 Jun 2024 10:48:31 +0100 All Insights Low-risk AI bears high stakes for digital health in new EU regulation https://www.osborneclarke.com/insights/low-risk-ai-bears-high-stakes-digital-health-new-eu-regulation &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/01/04/OC_KI_02_014.jpg?VersionId=AEBQYDxL7rVMAUNNBw1dcm_ButwBOcBO' /><br /><p><strong>Life sciences providers of low- or medium-risk AI will also be subject to the EU AI Act</strong></p>]]&gt; Wed, 15 May 2024 09:10:14 +0100 All Insights UK Medicines and Healthcare products Regulatory Agency outlines AI strategy https://www.osborneclarke.com/insights/uk-medicines-and-healthcare-products-regulatory-agency-outlines-ai-strategy &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_015.jpg?VersionId=iC3nv_Tqxn2J.lILXsbwqvgjqdgByp3I' /><br /><p><strong>The MHRA has published its response on how it is aligning with the principles of the AI regulation white paper</strong></p>]]&gt; Fri, 10 May 2024 15:38:52 +0100 All Insights A new CE marking for European healthcare: when and why? https://www.osborneclarke.com/insights/new-ce-marking-european-healthcare-when-and-why &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/01/04/OC_KI_097.jpg?VersionId=7QRJRvWETIJ2yCPfCEBhy3dvQALV.EdV' /><br /><p><strong>The EU AI Act's new CE-marking regime for high-risk systems has implications for life sciences and healthcare businesses</strong></p>]]&gt; Wed, 08 May 2024 08:17:34 +0100 All Insights Future Foods Update | May 2024 https://www.osborneclarke.com/insights/future-foods-update-may-2024 &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_014.jpg?VersionId=1Tib4fKv.Nqk2w1K5VvdlIwCYl9oKOlf' /><br /><p><strong>This edition includes new UK guidance on plant-based dairy products, an Austrian case on naming plant-based products, and EU developments on lab-grown meat.</strong></p>]]&gt; Fri, 03 May 2024 14:42:06 +0100 All Insights High-risk AI systems in life sciences face strict regulatory scrutiny from new EU rules https://www.osborneclarke.com/insights/high-risk-ai-systems-life-sciences-face-strict-regulatory-scrutiny-new-eu-rules-0 <p><strong>Businesses should consider if and how AI is used internally or externally and get ready for the risk-based approach</strong></p> Thu, 02 May 2024 08:24:21 +0100 All Insights New AI legislation's reach extends into European healthcare https://www.osborneclarke.com/insights/new-ai-legislations-reach-extends-european-healthcare &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_016.jpg?VersionId=yH.Fj5yw3zblBLbP.zyG.6mWS_UJup2e' /><br /><p><strong>What impact could the sector-neutral EU AI Act have on public health and patient care across Europe?</strong></p>]]&gt; Wed, 24 Apr 2024 08:33:58 +0100 All Insights The UK is developing its approach to deregulating gene editing in plants https://www.osborneclarke.com/insights/uk-developing-its-approach-deregulating-gene-editing-plants &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_001.jpg?VersionId=DcHvflLJQ7EFMmbxqof2Zpxmp34kT003' /><br /><p><strong>The UK has pursued a post-Brexit deregulatory agenda via new legislation but has it failed to capitalise on the changes?</strong></p>]]&gt; Mon, 22 Apr 2024 10:05:00 +0100 All Insights New EU AI Act is poised to shape the future for life sciences in Europe https://www.osborneclarke.com/insights/new-eu-ai-act-poised-shape-future-life-sciences-europe &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_015.jpg?VersionId=iC3nv_Tqxn2J.lILXsbwqvgjqdgByp3I' /><br /><p><strong>What is the extent of the sector's application of AI and the regulatory outlook following European Parliament approval?</strong></p>]]&gt; Tue, 16 Apr 2024 12:33:59 +0100 All Insights European Parliament formally adopts Product Liability Directive https://www.osborneclarke.com/insights/european-parliament-formally-adopts-product-liability-directive <p><strong>What changes and practical actions should businesses be considering?</strong></p> Fri, 12 Apr 2024 14:21:12 +0100 All Insights Setting sail globally: launching internationally in an interconnected world https://www.osborneclarke.com/insights/setting-sail-globally-launching-internationally-interconnected-world &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/24/04/10/3d-view-planet-earth.jpg?VersionId=cM23G49hBcASfJteDbyvmY40GxOQKXsv' /><br /><p><strong>Launching a business internationally can be a game-changer but comes with its own set of challenges and considerations</strong></p>]]&gt; Wed, 10 Apr 2024 15:42:37 +0100 All Insights UK government unveils draft procurement regulations for public sector bids https://www.osborneclarke.com/insights/uk-government-unveils-draft-procurement-regulations-public-sector-bids &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_014.jpg?VersionId=1Tib4fKv.Nqk2w1K5VvdlIwCYl9oKOlf' /><br /><p><strong>Authorities and suppliers will need to keep an eye on information published about procurements and resulting contracts</strong></p>]]&gt; Thu, 04 Apr 2024 11:17:51 +0100 All Insights Decision time for UK medical device regulation: diverge or converge with the EU? https://www.osborneclarke.com/insights/decision-time-uk-medical-device-regulation-diverge-or-converge-eu-0 &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/21/12/30/LSH_person_research_laboratory.jpg?VersionId=d041eFKatl96uuEchm8S9eVeBbUtgrEq' /><br /><p><strong>The MHRA appears to be considering an approach for UK regulations that would broadly mirror the EU model</strong></p>]]&gt; Thu, 28 Mar 2024 17:16:10 +0000 All Insights Medication advertising in the digital age https://www.osborneclarke.com/insights/medication-advertising-digital-age &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/21/12/30/LSH_pills_medical.jpg?VersionId=cvEep6dWRixrjr0gUwBpWVi.n_lLSX8S' /><br /><p><strong>The Generalitat of Catalonia has updated its guide to advertising medicines for human use with a focus on digital advertising</strong></p>]]&gt; Mon, 25 Mar 2024 15:55:41 +0000 All Insights What qualifies as a legitimate reason to object to parallel trade of medicines in Europe? https://www.osborneclarke.com/insights/what-qualifies-legitimate-reason-object-parallel-trade-medicines-europe &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/21/12/30/LSH_pills_medical.jpg?VersionId=cvEep6dWRixrjr0gUwBpWVi.n_lLSX8S' /><br /><p><strong>Trade mark owners are able to object to the parallel trade of medicines provided that there are legitimate reasons</strong></p>]]&gt; Wed, 20 Mar 2024 16:35:13 +0000 All Insights What are the patentability implications of deregulating gene editing in plants in the EU? https://www.osborneclarke.com/insights/what-are-patentability-implications-deregulating-gene-editing-plants-eu &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_012.jpg?VersionId=DOPO7JT0G9CbAApZAM_JwAFZt.YjKolj' /><br /><p><strong>The European Parliament has voted to embrace more flexibility in the regulation of gene-edited plants but has proposed a ban on patents</strong></p>]]&gt; Fri, 15 Mar 2024 13:26:38 +0000 All Insights Navigating Belgium's life sciences terrain: a strategic overview https://www.osborneclarke.com/insights/navigating-belgiums-life-sciences-terrain-strategic-overview-1 <p>Insights into regulations, trends, and strategic pathways for the pharmaceutical, medical device and food (supplement) industries</p> Wed, 13 Mar 2024 10:36:07 +0000 All Insights EU assesses competition picture of the pharma sector https://www.osborneclarke.com/insights/eu-assesses-competition-picture-pharma-sector &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_019.jpg?VersionId=SOEK1hpiphKyJIF5JdYDps3xlufrcuUt' /><br /><p><strong>Commission reports to the Council on how EU antitrust and merger rules in the pharmaceutical sector have been enforced in the period 2018-2022</strong></p>]]&gt; Thu, 07 Mar 2024 08:39:55 +0000 All Insights The UK Procurement Act 2023 brings new rules for frameworks and dynamic markets https://www.osborneclarke.com/insights/uk-procurement-act-2023-brings-new-rules-frameworks-and-dynamic-markets &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_022.jpg?VersionId=txqsSQcC_sRPe3rt52na9FkaLtw2_mvy' /><br /><p><strong>The changes that are set to be introduced later this year could prove useful for both suppliers and authorities</strong></p>]]&gt; Mon, 04 Mar 2024 11:37:41 +0000 All Insights Updated EPO examination guidelines address AI, accelerated oppositions and antibody claims https://www.osborneclarke.com/insights/updated-epo-examination-guidelines-address-ai-accelerated-oppositions-and-antibody-claims &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/21/12/23/DT-gamer-controller.jpg?VersionId=aOWhoXvz9V8ZY5BWYGCrPdhqgW42oN4Y' /><br /><p><strong>The European Patent Office's new guidelines entered into force on 1 March&nbsp;</strong></p>]]&gt; Fri, 01 Mar 2024 16:32:48 +0000 All Insights English High Court considers limitation of liability for dishonest breach https://www.osborneclarke.com/insights/english-high-court-considers-limitation-liability-dishonest-breach &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/wp/18/07/03/LSH_pills_medical.jpg?VersionId=VT43iz7CCe7eGmeWe2a6zERd6GXS5y93' /><br /><p><strong>The case reinforces the importance of clear drafting and the courts' literal approach to interpreting clauses</strong></p>]]&gt; Wed, 28 Feb 2024 10:51:29 +0000 All Insights Will cannabis now be legal in Germany? German parliament passes new Cannabis Act https://www.osborneclarke.com/insights/will-cannabis-now-be-legal-germany-german-parliament-passes-new-cannabis-act &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/23/04/19/MicrosoftTeams-image.png?VersionId=sFSPsSjqNOjnJqn.aQCHwWVvw8c2.h5C' /><br /><p><strong>Cannabis legalisation for recreational use in Germany is coming – however only as a limited partial decriminalisation for now.</strong></p>]]&gt; Fri, 23 Feb 2024 17:02:07 +0000 All Insights Technology, Media, and Communications Annual Review 2024: key themes https://www.osborneclarke.com/insights/technology-media-and-communications-annual-review-2024-key-themes <p><strong>AI, digital regulation, M&amp;A and emerging 'inclusive' policies are among the areas of focus for this year's review</strong></p> Tue, 20 Feb 2024 14:16:00 +0000 All Insights Reform of the Veterinary Medicines Regulations 2013 takes shape for GB https://www.osborneclarke.com/insights/reform-veterinary-medicines-regulations-2013-takes-shape-gb &lt;[CDATA[<img src='https://oc-static.poweredbyproctors.co.uk/public/images/22/03/16/OC-IS_001.jpg?VersionId=DcHvflLJQ7EFMmbxqof2Zpxmp34kT003' /><br /><p><strong>Modernisation of the regulatory framework aims to reduce the administrative burden for businesses in Great Britain</strong></p>]]&gt; Fri, 16 Feb 2024 10:22:07 +0000 All Insights