SPC meaning

In this issue: Medical devices Intellectual property Data protection and life sciences Pharmaceuticals—regulatory framework Research and development Competition in life sciences Daily and weekly news alerts New and updated content Trackers Useful information Medical devices Government supports new UK medical device rules following consultation The Medicines and Healthcare products Regulatory Agency (MHRA) has issued the government’s concluding response to its consultation on planned updates to medical device legislation, setting out future pathways to market for medical devices. The government will advance three principal changes: adopting an international reliance framework, removing the UKCA marking requirement once devices carry unique device identification (UDI), and revising the classification of in vitro diagnostic (IVD) devices. Collectively, these measures are intended to modernise oversight while promoting innovation and protecting patient safety. See: LNB News 23/07/2025 14. AI developers, users see EU’s guidelines on general-purpose AI models MLex: On 18 July 2025, the European Commission released guidance...

In this issue: Research and development Pharmaceuticals—regulatory framework Advanced therapeutics Commercialisation Medical devices Advertising of medicines Intellectual property Daily and weekly news alerts New and updated content Trackers Useful information There will be no Weekly Highlights on 24 April 2025 Research and development Commission updates guidelines on responsible use of generative AI in research On 10 April 2025, the European Commission’s Directorate‑General for Research and Innovation released the second edition of its guidance on the responsible use of generative artificial intelligence (AI) in research. Targeted at researchers, research organisations and funders, the update complements the EU Artificial Intelligence Act (EU AI act). It details core principles—reliability, truthfulness, respect and accountability—for AI use. The guidance also calls for transparency about the AI tools employed, safeguards for sensitive data and intellectual property rights, and bans heavy reliance on AI in peer review. See: LNB News 10/04/2025 30...

In this issue: Intellectual property Medicines advertising Medical devices Data protection in life sciences Pharmaceuticals—regulatory framework Research and development Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Intellectual property Ian Jones, partner at Gill Jennings & Every LLP, reviews upcoming changes to UK marketing authorisations (MAs) and supplementary protection certificates (SPCs) following the UK Intellectual Property Office’s statutory guidance on SPCs for medicines, set to apply from 1 January 2025. On 31 October 2024, the UK IPO issued guidance detailing significant updates to MAs for medicines in the UK, grounded in the Windsor Framework, which will come into force on 1 January 2025. These reforms will influence existing and prospective SPCs, as well as the types of authorisation used to support SPC applications. See News Analysis: Changes to marketing authorisations and SPCs in the UK. The Patents Court has revoked two mRNA patents related...

Types of special purpose vehicle and orphan trust The deployment of special purpose vehicle structures is widespread in aviation finance. They offer lenders several advantages, including tax benefits and a bankruptcy-remote platform for the financing. A special purpose vehicle (SPV), also known as a single purpose company (SPC), is a legal entity established for a limited aim; in aviation finance this is commonly to own an aircraft for a particular transaction. There are numerous forms of SPV used in aviation finance, with the principal categories being: subsidiary companies orphan trusts limited partnerships Each of these is considered below. The type of SPV selected will vary on a transaction-by-transaction basis. Subsidiary companies Subsidiary companies are typically limited liability companies incorporated in a tax-friendly jurisdiction...

Service provision changes (SPCs) This Practice Note explores service provision changes (SPCs) under the Transfer of Undertakings (Protection of Employment) Regulations 2006 (TUPE 2006), SI 2006/246, reg 3(1)(b), arising when activities are outsourced, brought back in-house, or a contractor or service provider is replaced. It explains the approach for cases where the relevant transfer under TUPE 2006 occurs on or after 31 January 2014, and addresses scenarios typically encountered in outsourcing, insourcing, or a change of provider. The Note also clarifies how SPCs operate in those contexts. For the pre-31 January 2014 position, refer to the government’s TUPE 2006 guidance (June 2009)—applicable only to transfers on or before 30 January 2014 and not updated in light of more recent case law—and to Practice Note: TUPE—the pre-January 2014 position [Archived]—Service provision changes. A switch in service provider can constitute a ‘service provision change’ within TUPE 2006, irrespective of whether it is also a ‘business transfer’. For further detail on business transfers, see Practice Note: TUPE—business transfers. Distinct from...

Brief history Before it went into liquidation, Primeo Fund (Primeo) operated as an open‑ended mutual investment vehicle. It was sponsored by Bank Austria and domiciled in the Cayman Islands. As is typical, it collected capital from investors and deployed those monies. A significant proportion of investors were Austrian private individuals, subscribing for shares in Primeo. At the outset, between 1993 and 1996, Primeo allocated its portfolio to several external managers, including Bernard L. Madoff Investment Securities LLC (BLMIS). The directors’ first allocation mandated that 7.5% of Primeo’s assets be placed with BLMIS. In 1996, reflecting BLMIS’s seemingly strong performance, Primeo bifurcated into two sub‑funds: the existing fund became Primeo Global, while a new vehicle, Primeo Select, was formed to invest solely with BLMIS. By February 2001, a decision was taken to wind down Primeo Global, which had underperformed markedly compared with Primeo Select. Primeo Select maintained a direct relationship with BLMIS until May 2007, when it was reorganised to gain exposure indirectly via Herald Fund SPC (Herald). Under that...

For general guidance on demergers, see: Demergers—overview. You might wish to assess: whether the intended demerger constitutes (a) a business transfer or (b) a service provision change (SPC) under the Transfer of Undertakings (Protection of Employment Regulations) 2006 (TUPE 2006), SI 2006/246 if so, the consequences of a relevant transfer under TUPE 2006, SI 2006/246 for employees of Company A (ie would the transfer result in those employees moving to Company B, which will depend on the nature of the transfer) if the employee cannot establish the sought-after right under TUPE 2006, SI 2006/246, whether they can contend that they are in fact (and were pre-transfer) employed by Company B, despite, for example, holding a contract of employment with Company A Is there a business transfer under TUPE 2006?...