As a heavily regulated sector, healthcare products, services and professionals are all subject to extensive legislative requirements, which are monitored and enforced by various regulatory authorities. We set out below an overview of the main regulators and regulations in the life sciences sector.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) is the executive arm of the Department of Health and Social Care (DHSC) responsible for protecting and improving public health and supporting innovation through scientific research and development. The MHRA monitors and sets the applicable standards of safety, quality and efficacy of medicines, medical devices and blood components, as well as pursuing international harmonisation across the UK, EU and wider regulatory frameworks to ensure that these provide effective safeguards for public health whilst remaining risk proportionate. The MHRA also authorises and oversees the supply of these devices to the market, carries out post-market surveillance, and enforces sanctions on organisations responsible for supplying any non-compliant or unsafe medical devices.
The UK’s overarching framework regulating medicines and medical devices includes the amended Medical Devices Regulations 2002, the Medicines for Human Use (Clinical Trials) Regulations 2004, the Human Medicines Regulations 2012, the Veterinary Medicines Regulations 2013, and Medicines and Medical Devices Act 2021. The latter seeks to address the regulatory gap left by the repeal of the European Communities Act 1972 and provides the UK with the primary legislation it needs to be able to update its medicine and medical device laws.
The Care Quality Commission (CQC) is the independent regulator for the quality and safety of care in England (with Scotland and Wales regulating the same under their own independent Care Inspectorates), responsible for regulating providers of healthcare services, social care services and services for those whose rights are restricted under the Mental Health Act 1983. These powers extend to oversight of the NHS, local authorities, independent providers and certain voluntary organisations. The CQC registers and carries out inspections of care services and issues public information in relation to them. Under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 the CQC also holds a range of enforcement powers, including penalties and prosecution, where it finds that fundamental care standards have been breached.
Various authorities regulate UK health and care professionals, including:
- The General Medical Council (GMC), mandated under the Medical Act 1983 to oversee the medical education, registration and revalidation of doctors, provide them with guidance on professional conduct, performance and ethics issues, and protect patients across the UK.
- The General Pharmaceutical Council (GPhC), the independent regulatory authority for pharmacists, pharmacy technicians and pharmacy premises in the UK governed by the Medicines Act 1968, Poisons Act 1972, the Health and Social Care Acts, the Pharmacy Order 2010 and the Human Medicines Regulations 2012.
- The General Dental Council (GDC), mandated under the Dentists Act 1984 to regulate dental professionals in the UK, including clinical dental technicians and dental hygienists.
- The General Optical Council (GOC), mandated to regulate optometrists, dispensing opticians, student opticians and optical businesses in the UK under the Medicines Act 1968, Opticians Act 1989 as amended in 2005 and the Human Medicines Regulations 2012.
- The Nursing and Midwifery Council (NMC), which regulates nurses, midwives and nursing associates under the Health and Social Care Acts and the Nursing and Midwifery Order 2001.
- Councils are also in place for the independent regulation of chiropractors, osteopaths and a range of other health and care professionals including podiatrists, paramedics, speech and language therapists and social workers.
- The obligations of these regulatory authorities are in turn regulated by the Professional Standards Authority (PSA), established by the Health and Social Care Act 2012. The PSA seeks to protect the health and well-being of medical patients and the public by setting professional standards for the training and conduct of health and care professionals and monitoring the work of the independent regulatory bodies.
The regulators and regulations set out above are supplemented by the activities and standards of a variety of trade associations and voluntary codes. These are intended to provide guidance to and oversight of entities that are active in the life sciences sector. Self-regulatory regimes intend to maintain best practice without the need to resort to formal action by regulators under legislation. One important example is the Association of the British Pharmaceutical Industry (ABPI) which publishes the ABPI Code. This is enforced by the Prescription Medicines Code of Practice Authority (PMCPA).
Given the range of regulators, regulations and other bodies covering the life sciences sector, businesses need to tread carefully in relation to the products and services that they provide.
Gustaf Duhs