Sidley Austin
19 Experts
3 Contributions by Sidley Austin
![COVID-19 life sciences: UK and EU regulatory flexibilities on medicines, devices/PPE, clinical trials, inspections, supply, MDR delay, vaccines, R&D, funding and collaboration [Archived]](images/default-source/pa-pool/3.tmb-small.jpg)
PRACTICE NOTES
ARCHIVED : This Practice Note has been archived and is not maintained.
Coronavirus (COVID-19) poses an unparalleled test to the global life sciences sector. UK and EU regulators are issuing frequently updated guidance as the situation develops, and are supporting research and development aimed at limiting the spread’s impact.
This Practice Note outlines how UK and EU authorities are responding in relation to:
clinical trials and regulatory inspections
maintaining continuity of supply for medicinal products and medical devices
deferral of the application of Regulation (EU) 2017/745 (consolidated 24.04.2020), the Medical Devices Regulation (MDR)
It also highlights major R&D initiatives across the UK and EU, and summarises European Commission guidance on collecting and transfusing convalescent COVID-19 plasma. For sector-specific developments and updates on coronavirus, see the Practice Notes: Coronavirus (COVID-19)—EU life sciences tracker [Archived] and Coronavirus (COVID-19)—UK life sciences tracker
Life Sciences
PRACTICE NOTES
STOP PRESS :
In March 2025, the government set out its plans to fold the Payment Systems Regulator, and its functions primarily, into the Financial Conduct Authority. The intention is to simplify the regulatory landscape, cut duplication and reduce overlap, and enable firms to prioritise innovation and service delivery. When this change will take effect still remains uncertain; however, HM Treasury has stated in a letter that it intends to consult on the proposal’s details over the course of summer 2025 and to legislate as soon as it can. In the meantime, the PSR and the FCA expect to collaborate closely together.
General duties
The Payment Systems Regulator (PSR) holds a number of statutory duties and powers under the Financial Services (Banking Reform) Act 2013 (FS(BR)A 2013). In discharging its general functions in relation to payment systems, the PSR must, so far as is
Financial Services
PRACTICE NOTES
STOP PRESS :
In March 2025, the government signalled plans to fold the Payment Systems Regulator, and most of its functions, into the Financial Conduct Authority. The aim is to simplify the regulatory landscape, cut duplication, and let firms prioritise innovation and delivering services. While the implementation date is uncertain, HM Treasury stated in a letter that it intends to legislate at the earliest opportunity. Meanwhile, the PSR and FCA intend to work closely together. In September 2025, HM Treasury (HMT) launched a consultation on these consolidation proposals. It suggests moving the PSR’s responsibilities—including fostering competition and innovation in payment systems and advancing the interests of consumers and businesses—into the FCA’s framework under the Financial Services and Markets Act 2000 (FSMA 2000), or into a new FSMA 2000 part where required. The government plans to retain the current designation regime so
Financial Services
7 Contributions by Sidley Austin Experts
PRACTICE NOTES
Data—and by extension, adherence to data protection rules—sits at the heart of clinical research, whether for clinical trials, pharmacovigilance activities or wider scientific inquiry. This Practice Note examines the data protection ramifications of running clinical research. In particular, it addresses who is accountable for compliance, the lawful bases relied upon, and how transparency should be delivered in this context...
Allocation of responsibility for data protection compliance in clinical research
Appropriate legal grounds for processing personal data for research purposes
Transparency duties owed to participants and other data subjects
Collaborative research arrangements and data sharing practices
Derogations from data subject rights when processing for research
A practical checklist of data protection points to consider when planning research activities
The GDPR regimes
On 25 May 2018, the General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR) became directly
Life Sciences
PRACTICE NOTES
Scope of this Practice Note
This Practice Note explains the regulatory framework for consumer buy-to-let (CBTL) lending under the Mortgage Credit Directive Order 2015, SI 2015/910 (MCD Order 2015), which implemented the EU Mortgage Credit Directive (Directive 2014/17/EU) (the EU MCD) within the UK regime before the UK decided to leave the EU. The MCD Order 2015 was issued on 25 March 2015 and became fully operative on 21 March 2016, the deadline by which all Member States were required to implement the EU MCD. For a flowchart indicating whether CBTL registration obligations apply, see: Registration requirements for CBTL mortgages—flowchart. For an outline of the UK’s implementation of the EU MCD, see Practice Note: Mortgage Credit Directive—UK implementation and the post-Brexit regime. For an overview of the EU MCD framework, see Practice Note: EU Mortgage Credit
Financial Services
PRACTICE NOTES
ARCHIVED : This Practice Note has been archived and is not maintained.
Coronavirus (COVID-19) poses an unparalleled test to the global life sciences sector. UK and EU regulators are issuing frequently updated guidance as the situation develops, and are supporting research and development aimed at limiting the spread’s impact.
This Practice Note outlines how UK and EU authorities are responding in relation to:
clinical trials and regulatory inspections
maintaining continuity of supply for medicinal products and medical devices
deferral of the application of Regulation (EU) 2017/745 (consolidated 24.04.2020), the Medical Devices Regulation (MDR)
It also highlights major R&D initiatives across the UK and EU, and summarises European Commission guidance on collecting and transfusing convalescent COVID-19 plasma. For sector-specific developments and updates on coronavirus, see the Practice Notes: Coronavirus (COVID-19)—EU life sciences tracker [Archived] and Coronavirus (COVID-19)—UK life sciences tracker
Life Sciences
PRACTICE NOTES
This Practice Note outlines passporting entitlements and related notification obligations for credit intermediaries under the Mortgage Credit Directive (Directive 2014/17/EU) (MCD) in the setting of cross-border activity across the EU/EEA. It explains the MCD framework governing the freedom to provide services and the freedom of establishment, alongside the connected notification, supervisory and enforcement arrangements. References to ‘Member State’ are to EU Member States and, where appropriate, EEA States that have implemented the MCD.
Key points are as follows:
The MCD (Directive 2014/17/EU) creates an EU/EEA regime for regulating and supervising creditors and credit intermediaries in respect of certain consumer mortgage credit agreements, covering authorisation, conduct of business and consumer information duties.
Subject to exceptions, the MCD applies to credit agreements (i) secured by a mortgage (or equivalent security) on residential immovable property (or a related right) and (ii) concluded for the purpose of
EU Law
PRACTICE NOTES
On 11 June 2021, ISDA issued the 2021 ISDA Interest Rate Derivatives Definitions (the 2021 Definitions), intended to supersede the 2006 ISDA Definitions as the standard ISDA definitional text for cleared and non‑cleared interest rate derivatives. ISDA no longer maintains the 2006 ISDA Definitions. The 2021 Definitions were the first of what is expected to be many publications on ISDA’s new digital ‘online library’. Historically, ISDA’s definitional booklets were printed as hard‑copy booklets, with each change requiring a separate supplement (in the case of the 2006 ISDA Definitions, there were almost 100 by December 2022). Working through the booklets together with numerous standalone supplements was often a demanding exercise. With the new digital online library, ISDA will implement updates to the 2021 Definitions by releasing refreshed electronic versions, each bearing a publication date, which can be easily compared with any earlier
Banking & Finance
PRACTICE NOTES
Developers, manufacturers and distributors in digital health—spanning mHealth apps and any associated Software as Medical Device (SaMD), artificial intelligence (AI) system or Artificial intelligence as a Medical Device (AIaMD)—must meet stringent data protection regulations in tandem with regulatory compliance across the entire lifecycle, from development through to commercialisation
This Practice Note concentrates on data protection and privacy issues for mHealth (mobile health) and also considers the tighter safeguards governing the collection of an individual user’s health data. It does not cover broader life sciences regulatory matters, such as those relating to medical devices
What is mHealth?
For related guidance, see:
Practice Note: Digital health—regulation of mHealth apps and medical software.
Practice Note: Mobile app development and data protection.
Practice Note: Digital health—data protection and privacy case studies, including wearables and AI diagnostic tools...
Life Sciences
FLOWCHARTS
Purpose of the CBTL flowchart
The aim of this flowchart is to support firms in deciding whether they are required to register to carry on regulated activities in connection with consumer buy-to-let (CBTL) mortgages under the Mortgage Credit Directive Order 2015, SI 2015/910 (MCD Order 2015). That Order transposed the EU Mortgage Credit Directive (Directive 2014/17/EU) (the EU MCD) into the UK regulatory framework ahead of the UK’s decision to leave the EU. It should also be read alongside Practice Note: Regulation of consumer buy-to-let lending in the UK. The CBTL flowchart...
Financial Services
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