The Generative Brain

HFEA, Human Fertilisation and Embryology Authority (UK fertility regulator), PGT-M condition approvals

The HFEA is the UK's independent statutory regulator of fertility treatment and research using human embryos, an arm's length body of the Department of Health that licenses, inspects and can sanction clinics. It was created by the Human Fertilisation and Embryology Act 1990 and came into effect on 1 August 1991. Under the Act, as amended in 2008, embryos may be tested for a genetic abnormality only where the HFEA is satisfied there is a significant risk of a serious disability, illness or medical condition. In practice it keeps a list of conditions approved for PGT-M, decided by its Statutory Approvals Committee, and treatment must be at a clinic it has licensed for embryo testing. Search excerpts of that list show Creutzfeldt-Jakob disease (OMIM 123400), Gerstmann-Straussler disease (OMIM 137440) and fatal familial insomnia (OMIM 600072) as approved, but the rows could not be confirmed from a full read. Information only, not medical, reproductive or legal advice.

Key facts

  • The HFEA describes itself as the UK's independent regulator of fertility treatment and research using human embryos and the first statutory body of its type in the world; it licenses, monitors and inspects clinics and can amend, suspend or revoke a licence.
  • It was created by the Human Fertilisation and Embryology Act 1990, which came into effect on 1 August 1991, and is an executive non-departmental public body of the Department of Health and Social Care.
  • Paragraph 1ZA of Schedule 2 to the 1990 Act limits licensed embryo testing to listed purposes; testing for a genetic abnormality is allowed only if the HFEA is satisfied there is a significant risk of a serious physical or mental disability, serious illness or other serious medical condition. This paragraph was inserted by the 2008 Act and took effect on 1 October 2009.
  • The Statutory Approvals Committee decides which conditions may be tested for with PGT-M, and also handles mitochondrial donation and HLA tissue typing applications, using published decision trees.
  • PGT-M, formerly PGD, is done within IVF and must be carried out at a clinic licensed by the HFEA for embryo testing; over 2,000 conditions have been approved, and NHS funding may be available depending on situation and location.
  • A condition not on the list can be added only by a licensed clinic applying on a patient's behalf; decisions usually take two to three months, and a missing condition may simply never have been applied for.
  • The list follows OMIM naming where possible and the HFEA advises searching by OMIM number; the current downloadable full list is dated 17 September 2026.
  • Search excerpts of the list show Creutzfeldt-Jakob Disease (CJD) approved under OMIM 123400, Gerstmann-Straussler Disease (GSD) approved under 137440 and Fatal Familial Insomnia (FFI) approved under 600072; these were not confirmed from a full read and no approval dates were found.
  • OMIM 123400 corresponds in NCBI MedGen to inherited Creutzfeldt-Jakob disease, grouped under genetic prion disease with gCJD, FFI and GSS phenotypes.
  • According to a search excerpt of its Q&A page, the National Prion Clinic tells families that IVF-based techniques may allow a baby known not to carry the faulty gene and that this can be discussed with its doctors.

Timeline

  1. 1990Human Fertilisation and Embryology Act 1990 passed, creating the HFEA.
  2. 1991The 1990 Act comes into effect and the HFEA begins work.
  3. 2008Human Fertilisation and Embryology Act 2008 receives Royal Assent.
  4. 2009Schedule 2 paragraph 1ZA, setting the serious condition test for embryo testing, comes into force.
  5. 2016HFEA PGT-M and PGT-SR information page published.
  6. 2016HFEA approved PGT-M and PTT conditions page published.
  7. 2026PGT-M pages last reviewed.
  8. 2026Date of the current downloadable full approved PGT-M condition list.
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