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