Developments in UK Life Sciences – Spring Update 2022 - McDermott Will & Emery

Developments in UK Life Sciences – Spring Update 2022

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MHRA Launches UK Clinical Trial Regulation Consultation

Sharon Lamb | David Gibson

The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial regulations.

Following the United Kingdom’s departure from the European Union, the UK Government is seeking to create an attractive regulatory environment for clinical trials alongside a programme that is intended to enhance the United Kingdom’s status as a go-to destination for the development of new healthcare products and innovation. The Government set out its wider life sciences ambitions in July 2021 in its Life Sciences Vision.

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ICO Draft Guidance and Consultation – Health Data

Sharon Lamb | Michaela Novakova

What Health and Life Sciences Companies Should Know about ICO Draft Guidance on the UK Data Protection Legislation Research Provisions

The Information Commissioner’s Office (ICO) published new draft guidance on the provisions in the UK General Data Protection Regulation and Data Protection Act 2018 (collectively, the UK GDPR) relating to processing personal data for research purposes.

The guidance provides clarity to health and life sciences companies and will be broadly welcomed in an area that is often difficult to navigate, not least because the law is contained in various provisions and there has been varying guidance on how to interpret the provisions. The ICO consultation on the guidance closed on 22 April 2022.

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Bring Me Sunshine?

David Gibson

The Health and Care Bill — now in the final Parliamentary stage before receiving Royal Assent and becoming legislation — gives the UK’s Secretary of State for Health and Social Care power for the first time to introduce regulations that would require manufacturers and commercial suppliers of healthcare products to report payments or benefits that they provide to healthcare providers and others that provide healthcare or activities connected with the provision of healthcare. This power would allow the Secretary of State to introduce new laws to the United Kingdom that reflect the approach used in the US Physician Payments Sunshine Act that compels pharmaceutical and medical device manufacturers to declare transfers of value (including expenses) to physicians or teaching hospitals. The draft legislation reflects concerns that there is insufficient transparency about payments to healthcare professionals and institutions.

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New UK International Data Transfer Provisions

Ludovica Rabitti

The UK international data transfer agreement (IDTA) and the UK addendum to the new EU standard contractual clauses (SCCs) (the UK Addendum) came into force on 21 March 2022 following Parliamentary approval.

Both the IDTA and the UK Addendum fully reflect the requirements of the UK General Data Protection Regulation (GDPR) as well as the European Court of Justice judgement in Schrems II and represent a significant improvement from the old EU SCCs (originally drafted under the Data Protection Directive) which were still being relied upon for international transfers from the United Kingdom following Brexit.

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What Standard of Care in CRO Agreements?

Michael Darowski | Derek Safadi

The recent High Court case of Cardiorentis AG v IQVIA Limited and another (EWHC 250 (Comm) (10 February 2022) (Butcher J)) demonstrates the ever-present risks to contract-research organisations (CROs) and their clients.

The long and highly technical judgment in Cardiorentis, in particular, highlights the necessity for clear, well-drafted and bespoke legal documentation for all parties when outsourcing research to CROs.

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“Spring Statement” 2022

Gary Howes

At the end of March 2022, UK Chancellor Rishi Sunak set out in his Spring Statement the current state of the economy, the outlook for the future and his planned changes to UK tax policy.

His statement contained several pointers regarding the provision and funding of healthcare generally, and possible enhanced incentives for the life sciences industry.

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