Regulation

Human Fertilisation & Embryology Authority (HFEA)

The Human Fertilisation & Embryology Authority is the UK’s regulator of fertility treatment and research using human embryos and was the first statutory body of its type in the world. HFEA is responsible for licensing, monitoring and inspecting fertility clinics to make sure that clinics and research centres comply with the law.  HFEA collects data about fertility treatments for many reasons, e.g., so people conceived with a donor can learn of their genetic origins.

Medicines & Healthcare Products Regulatory Agency (MHRA)

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care. MHRA is responsible for ensuring that medicines and medical devices work and are acceptably safe, thus fulfilling a similar role to the FDA in the US.  Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific R&D.  It has three centres: 

  • The Clinical Practice Research Datalink (CPRD) is a real-world research service supporting retrospective and prospective public health and clinical studies using anonymized NHS clinical data
  • The National Institute for Biological Standards and Control (NIBSC) is a global leader in the characterization, standardization and control of biological medicines. NIBSC plays a major role in assuring the quality of biological medicines worldwide through the provision of biological reference materials, by testing products and carrying out research
  • The MHRA regulates medicines, medical devices and blood components for transfusion, and is responsible for ensuring their safety, quality and effectiveness

The MHRA employs some 1200 people with facilities in London, York and Hertfordshire.  Among its key priorities is making its regulation more supportive of safe innovation.  The MHRA Innovation Office is open to ideas for innovative medicines, medical devices and manufacturing processes.  It provides free and confidential expert regulatory information, advice and guidance to organisations of all backgrounds and sizes.  This can include a Scientific Advice Service for which there is a charge.

National Institute for Health & Care Excellence (NICE)

The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care.  It was created back in 1999 and its first published piece of guidance was a rapid assessment of flu product zanamivir, while its first technology appraisal in 2000 was a guidance on the extraction of wisdom teeth!  NICE carries out its role by: producing evidence-based guidance and advice for health, public health and social care practioners; developing quality standards and performance metrics for those providing and commissioning health, public health and social care services; providing a range of information services for commissioners, practitioners and managers across health and social care.  Its programmes include guidance, financial planning tools, advice, standards and indicators, NICE pathways, and topic selection.  NICE International is an advisory service for international organisations, ministries and government organisations for consultancy services, speaking engagements, seminars and using NICE content outside the UK.  Industry can engage with NICE during health technology development to achieve better outcomes.  Here services include HealthTech Connect, UK Pharma Scan, the Office for Market Access, and scientific advice.  In developing a market access strategy, it makes sense to engage with the Office for Market Access to help you understand the changing healthcare landscape, identify the most appropriate route to NHS access, and to explore your value proposition with system stakeholders.  Engagement meetings are conducted in a safe harbour environment to ensure a confidential, free-flowing discussion with relevant stakeholders from the healthcare system.  These meetings carry a fee-for-service, not for profit charge and are provided outside of the guidance providing services of NICE to ensure there are no conflicts of interest.