Regulation of the health, care and life sciences sectors

Our health lawyers have successfully represented trusts, related institutions and key individuals

Health, care and life sciences regulatory legal advice. Sensitively handled, strategically planned, and robustly managed.

As some of the most regulated sectors in the UK and internationally, all organisations operating within health, care and life sciences need a strategic approach to achieving and demonstrating regulatory compliance. These organisations also need to be able to respond swiftly and decisively to incidents, investigations and enforcement action or prosecution when things go wrong.

Fundamental to this is having the support of a specialist legal team with a comprehensive understanding of the legal and regulatory requirements in the sector; mature relationships with providers, commissioners and regulators alike; and a deep understanding of the unique issues and motivators they face.

Our team of expert regulatory lawyers regularly advise all types of organisations on the legal and regulatory requirements in the health, care and life sciences sectors, from routine regulatory advice, developing compliance solutions for innovative services, through to providing sensitive and pragmatic support throughout regulatory investigation or enforcement action.

We regularly advise on corporate transactions in the health, care and life sciences sectors, identifying regulatory risk and providing pragmatic advice on how this can be managed.

How we can advise you

We can advise you on all legal and regulatory requirements in the health, care and life sciences sectors, including the regulation of:

1. Delivery of health and care services

Health and care services by the Care Quality Commission (CQC), including fundamental standards of care, fit and proper requirements and the duty of candour, in all settings including hospitals, clinics, mental health providers, community providers, GP practices, dental practices, care homes and domiciliary service providers
By the Human Fertilisation and Embryology Authority (HFEA) of assisted conception services
Health and care professionals such as doctors, nurses, dentists and pharmacists by the General Medical Council (GMC), Nursing and Midwifery Council (NMC), General Dental Council (GDC), General Pharmaceutical Council (GPhC), Health and Care Professions Council (HCPC), Professional Standards Authority (PSA) and others.

For the providers of NHS services, we advise on regulation by NHS England and Integrated Care Boards (ICBs), including the NHS provider licence, NHS regulation and oversight, NHS mergers and acquisitions, patient choice, primary care practitioners (performers lists), and primary care providers and services (primary care contracts and pharmaceutical lists)

For providers of private health, care and fertility services, we advise on regulation by the Competition and Markets Authority (CMA), Advertising Standards Authority (ASA) Information Commissioner’s Office and trading standards of compliance with competition, advertising, marketing and consumer law.

2. Medicines, medical devices, tissue samples and patient data – including use for research and product development

Medicines by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Home Office, including regulation and licensing of controlled drugs, specials and other medicines; prescribing and pharmaceutical requirements; and pharmacovigilance and quality agreements
Pharmacies by the GPhC
Clinical trials and research by the Health Research Authority (HRA),including advising on clinical trial agreements
Medical devices by the MHRA, including regulation of software as a medical device
Human tissue and organs by the Human Tissue Authority (HTA)
Personal data by the Information Commissioner’s Office (ICO). View our information governance expertise
AI and cyber risk, as regulators globally move towards greater regulation of these areas

3. Health and safety

Health and safety by local authorities and the Health and Safety Executive (HSE), including application of the Health and Safety at Work Act 1974 and related regulations
Environmental protection by local authorities and the Environment Agency, including the regulation of hazardous substances, waste and radiation

How our team will work with you
We provide fully comprehensive support to our clients on regulatory issues wherever and whenever they arise. Whatever the scenario, our support is sensitive, pragmatic and timely. The services we provide include:
Ad hoc advice on specific regulatory queries, including distilling complex and technical regulatory issues into clear, pragmatic and applied advice
Developing regulatory compliance strategies, solutions and action plans
Implementing effective corporate and clinical governance systems to anticipate, identify, investigate and learn from claims, complaints and incidents of all types
Supporting serious incident responses including investigations, patient recalls, duty of candour notifications and regulatory notifications
Acting in all types and at every stage of regulatory investigations, enforcement action, and prosecution, including regulatory, disciplinary, civil and criminal proceedings, including representation in interviews/investigations and at courts and in tribunals
Undertaking specialist due diligence in corporate transactions, for investors, buyers and sellers
Providing training and sharing knowledge
Secondments
Our clients
Our clients include:
NHS commissioners, providers and national bodies
Private health and care providers and other businesses
Local authorities
Insurers
Investors
Regulators
Individuals
Our experience
Advising a private hospital chain on a major project involving communications with and the recall of a significant number of patients as a result of adverse clinical incidents, involving advice on the duty of candour and the drafting of various policies and procedures touching on the regulation of healthcare professionals and the sharing of information with professional regulatory bodies
Advising on and successfully defending an NHS Foundation Trust in respect of proposed criminal enforcement action by the CQC
Advising the CQC and NHS England on the interpretation and application of legislation and guidance in relation to care standards and performers lists and representing those bodies in appeals before the First-tier Tribunal, providing case preparation services and advocacy at any hearings
Acting for the PSA in its referral of fitness to practise cases to the High Court
Advising NHS commissioners on the regulatory framework for the commissioning of primary medical, dental, ophthalmic and pharmaceutical services, including advising NHS commissioners on the regulation and expansion of digital-first primary care models and representing NHS commissioners in appeals before the Primary Care Appeals service, civil litigation and judicial reviews regarding primary care services
Advising an NHS Foundation Trust on the regulatory requirements and licences necessary to establish a Nightingale hospital during the COVID-19 pandemic
Advising a leading international digital healthcare provider on compliance with regulatory requirements in relation to cross-border telemedicine, digital identification and verification, and prescribing
Advising and representing private clinics in relation to enquiries and potential enforcement action by the CMA
Advising assisted fertility clinics and clinic groups on compliance with regulatory requirements, also having acted previously as legal assessor to a range of the HFEA’s statutory committees
Advising a medical device company on compliance with MHRA rules on software as a medical device (SaMD) in relation to an innovative medical chatbot platform
Advising an NHS Trust on issues relating to supply of controlled drugs to care homes and advising NHS provider organisations on medicines regulation and processes under the Medicines Act 1968 and the Human Medicines Regulations 2012
Advising a private healthcare clinic on potential breaches of Home Office licence conditions
Advising businesses at all stages of the supply chain on Home Office and MHRA licensing requirements
Undertaking specialist due diligence in corporate transactions, including for the acquisition/investment in large private hospital chains and online pharmacies
Advising a national NHS body on the respective obligations of the NHS and local authorities for the collection of clinical waste from domestic properties
Advising an NHS Foundation Trust on legal and regulatory issues associated with clinical trials and the use of data for research, including cross-border programmes
Advising health technology companies on regulatory compliance solutions for their digital imaging and AI-driven services and technologies
Advising and representing healthcare professionals in respect of allegations regarding clinical and professional conduct