What kind of regulator are we

Key facts

  • We are the UK's independent regulator overseeing the use of gametes and embryos in fertility treatment, storage and research 
  • We licence centres carrying out In Vitro Fertilisation (IVF), other assisted conception procedures and human embryo research, and provide a range of detailed information for patients, professionals, the public and Government
  • 1 in 7 people in the UK will have some problem conceiving (this equates to approximately 1.75 million couples of reproductive age - or 3.5 million people in total) 
  • About 80% of UK patients fund their own treatment.
  • There are 139 HFEA licensed treatment, storage and research establishments in the UK.

What is the role of the HFEA?

  • licence and monitor fertility clinics that carry out treatments 
  • licence and monitor centres undertaking human embryo research 
  • licence and monitor the storage of gametes and embryos 
  • produce a Code of Practice covering the proper conduct of HFEA licensed activities 
  • maintain a Register of information about donors, fertility treatments and their outcomes 
  • provide relevant advice and information to patients, donors and clinics 
  • review information about human embryos, the provision of treatment services and activities governed by the HFE Act (1990)

The HFEA is not:

  • a pressure group - our role is to implement the legislative framework decided by Parliament
  • responsible for regulating all infertility treatments  
  • responsible for regulating individual clinical practice - that is a matter for the professional bodies and, ultimately, the GMC or NMC 
  • an ombudsman  
  • involved in funding or financial regulation - NHS provision and treatment costs are not in our remit 
  • a research body

Why does regulation matter?

  • 71% of people believe that HFEA provides adequate ethical scrutiny of fertility treatment (Mori, 2005)
  • Public opinion is very finely balanced on human embryo research with firm and independent regulation a key driver of public confidence in this area
  • 56% of people believe that human embryo research should be allowed. 22% believe it should not (source - ICM, 2007) - However if a purpose is explicitly defined, support rises:
    - 79% support the use of human embryos in research to find out more about diseases such as Parkinson's or Motor Neurone Disease (MND)
    - 35% of people support the use of cytoplasmic hybrid embryos in research - rising to 61% if used for research into Parkinson´s or MND

What our treatment licensing responsibilities are

  • To issue treatment, storage and research licences to centres 
  • To help promote good clinical practice and ethical standards
  • To ensure clinics comply with the requirements of the 1990 HFE Act and the European Tissues and Cells Directive. 
  • To renew licences on an annual basis

What fertility treatments we licence

We currently licence 19 types of treatment - these include:

  • In Vitro Fertilisation  (IVF) (including using donor gametes)
  • Donor insemination (DI)
  • Intra Cytoplasmic Sperm Injection (ICSI) [including using donor sperm]
  • Preimplantation Genetic Diagnosis (PGD)
  • Preimplantation Genetic Screening (PGS)
  • Storage of gametes and Embryos 
  • Egg Sharing 
     

How we regulate embryo research

  • There are currently 31 HFEA research licensed projects
  • HFEA licence committees consider each application on a case-by-case basis
  • The criteria for licensing includes:
    - legality (is it within the scope of the HFE Act?)
    - necessity (is there an alternative method and is the use of embryos necessary?)
    - desirability (will it advance scientific knowledge?) 
  • Human embryos cannot be cultured beyond 14 days or implanted into a woman's uterus
  • If an application is approved we continue to scrutinise the research projects through regular monitoring and inspection of research progress and facilities
  • We invite public comments on every research application submitted before they are considered by a licence committee - applicants have to provide a lay-friendly explanation of their proposed research
  • When materially new research is proposed (e.g. using human eggs or hybrid embryos for research) we have conducted public consultations to establish an evidence base to support our policy-making

Further information

 

Last updated: 20 May 2008