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 healthcare 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 and care sectors, including the regulation of:
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
- Human Fertilisation and Embryology Authority (HFEA) of assisted conception services
- Health and care professionals such as doctors, nurses, dentists and pharmacistsby 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.
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
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
