Licence

Human fertilisation and embryology licence

You need a licence to undertake the procurement, testing, processing, preservation, storage and distribution of gametes, embryos and/or provide in-vitro fertilisation, or artificial insemination treatments

England, Wales, Scotland and Northern Ireland Issued by Department of Health and Social Care

What this covers

Biomedical scienceHealthcare

Why you need it

Parliament created it. The power to require it comes from Human Fertilisation and Embryology Act 1990.

What the Act carries

What our graph holds for Human Fertilisation and Embryology Act 1990 as a whole — the Act behind this licence, not the licence conditions themselves.

Duties on businesses
14
Penalties
1
Exemptions
5

Duties on businesses under the Act

  • Do not store gametes after the donor's death Schedule 3 para.11
  • Get written consent before using an embryo taken from a woman Schedule 3 para.7
  • Get written consent before using anyone's eggs, sperm or cells for IVF or research Schedule 3 para.6
  • Obtain effective consent before storing a human admixed embryo Schedule 3 para.13
  • Obtain effective consent before storing gametes or embryos Schedule 3 para.8
  • Obtain effective consent before using gametes or human cells to create research embryos Schedule 3 para.12

… and 8 more business duties in the same Act.

What happens if you get it wrong

  • Fail to comply with HFEA inspection or access requirements Unlimited fine

Exemptions that may take you outside it

  • Consent not required for pre-stored research cells used to create embryos — Cells lawfully stored for research before the commencement date, with a licence authorising this paragraph
  • Exemption from annual consent renewal for gamete storage when donor lacks capacity — The gamete donor has been certified (in writing provided to the storage facility) as lacking capacity to renew consent to …
  • Exemption from consent rules when person withdraws permission for cell use — P has capacity to consent and gives written notice to the person keeping the human cells that P does not …
  • Exemption from duty to request consent renewal when patient dies, withdraws, or lacks capacity — P has died, or P has withdrawn consent to storage, or P has been certified as lacking capacity to renew …
  • Using own gametes for own treatment exempt from paragraph 5 consent — Use of a person's gametes is for that person (or that person and another together) receiving treatment services

Read our full dossier on Human Fertilisation and Embryology Act 1990

Who issues it

This one does not go to your council. It is issued by Department of Health and Social Care.

Where to apply

Duty, penalty and exemption labels are Guvnor’s analysis of the enabling instrument, not the instrument itself. Fees, forms and conditions are set by the issuing authority — always check the linked source.