UK Act of Parliament 1990 United Kingdom

Human Fertilisation and Embryology Act 1990

Read the Act on legislation.gov.uk (opens in a new tab)
Enforced by
HFEA
Status
Amended (in force with amendments)
Penalty ceiling
Prosecution 1 of 21 obligations carry an unlimited fine. 20 have no criminal penalty — flagged in the list below.

Does it bind you?

Business-side roles with duties under this instrument.

Any Person10 Licence Holder4

Plus 7 duties on the regulator, Crown ministers and public bodies — folded into the section list below.

Other Acts binding the same actors

If a role above is yours, these are the other instruments that most often bind it.

Any Person — also bound by 2340 other Acts
Licence Holder — also bound by 225 other Acts

What it requires

Sections creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.

91 other provisions — procedural and definitional
s.001 Meaning of “embryo”, “gamete” and associated expressions. (opens in a new tab)
s.001 Reference to Directives
s.002 Other terms. (opens in a new tab)
s.002 Third party agreements
s.002 Meaning of “importing licensee”, “third country premises” etc
s.003 Prohibitions in connection with embryos. (opens in a new tab)
s.003 Prohibition in connection with germ cells.
s.003 Permitted eggs, permitted sperm and permitted embryos
s.004 Prohibitions in connection with gametes. (opens in a new tab)
s.004 Prohibitions in connection with genetic material not of human origin
s.005 The Human Fertilisation and Embryology Authority. (opens in a new tab)
s.006 Accounts and audit. (opens in a new tab)
s.007 Reports to Secretary of State. (opens in a new tab)
s.008 General functions of the Authority. (opens in a new tab)
s.008 Duty of Authority to communicate with competent authorities of EEA states: Northern Ireland
s.008 Agency arrangements and provision of services
s.008 Contracting out functions of Authority
s.008 Disclosure of information where functions of Authority exercised by others
s.008 Power to assist other public authorities
s.008 Duties in relation to carrying out its functions
s.008 Duties of the Authority in relation to the Single European Code: Northern Ireland
s.009 Power to delegate and establish committees
s.010 Licensing procedure. (opens in a new tab)
s.011 Licences for treatment, storage and research. (opens in a new tab)
s.012 General conditions. (opens in a new tab)
s.013 Conditions of licences for treatment. (opens in a new tab)
s.013 Conditions of licences for non-medical fertility services
s.014 Conditions of storage licences. (opens in a new tab)
s.014 Conditions of licences: human application
s.015 Conditions of research licences. (opens in a new tab)
s.015 Duties of the Authority in relation to serious adverse events and serious adverse reactions
s.015 Inspection of third country premises etc.: Northern Ireland
s.015 Third country premises and third country suppliers: report of inspections etc: Northern Ireland
s.016 Grant of licence. (opens in a new tab)
s.017 The person responsible. (opens in a new tab)
s.018 Revocation of licence (opens in a new tab)
s.018 Variation of licence
s.019 Procedure in relation to licensing decisions (opens in a new tab)
s.019 Notification of licensing decisions
s.019 Applications under this Act
s.019 Power to suspend licence
s.020 Right to reconsideration of licensing decisions (opens in a new tab)
s.020 Appeals committee
s.020 Procedure on reconsideration
s.021 Appeal on a point of law (opens in a new tab)
s.022 Temporary suspension of licence. (opens in a new tab)
s.023 Directions: general. (opens in a new tab)
s.024 Directions as to particular matters. (opens in a new tab)
s.025 Code of practice. (opens in a new tab)
s.026 Procedure for approval of code. (opens in a new tab)
s.027 Meaning of “mother”. (opens in a new tab)
s.028 Meaning of “father”. (opens in a new tab)
s.029 Effect of sections 27 and 28. (opens in a new tab)
s.030 Parental orders in favour of gamete donors. (opens in a new tab)
s.031 Register of information (opens in a new tab)
s.031 The Authority's register of licences
s.031 The Authority's register of serious adverse events and serious adverse reactions
s.031 Request for information as to genetic parentage
s.031 Request for information as to intended spouse etc.
s.031 Power of Authority to inform donor of request for information
s.031 Provision to donor of information about resulting children
s.031 Provision of information about donor-conceived genetic siblings
s.031 Power of Authority to keep voluntary contact register
s.031 Financial assistance for person setting up or keeping voluntary contact register
s.032 Information to be provided to Registrar General. (opens in a new tab)
s.033 Disclosure of information
s.033 Consent required to authorise certain disclosures
s.033 Power to provide for additional exceptions from section 33A(1)
s.033 Disclosure for the purposes of medical or other research
s.034 Disclosure in interests of justice. (opens in a new tab)
s.035 Disclosure in interests of justice: congenital disabilities, etc. (opens in a new tab)
s.035 Mitochondrial donation
s.035 Fees
s.036 Amendment of Surrogacy Arrangements Act 1985. (opens in a new tab)
s.037 Amendment of law relating to termination of pregnancy. (opens in a new tab)
s.038 Conscientious objection. (opens in a new tab)
s.038 Inspection, entry, search and seizure
s.039 Powers of members and employees of Authority. (opens in a new tab)
s.040 Power to enter premises. (opens in a new tab)
s.041 Offences. (opens in a new tab)
s.042 Consent to prosecution. (opens in a new tab)
s.042 Powers to make regulations in relation to standards of quality and safety
s.043 Keeping and examining gametes and embryos in connection with crime, etc. (opens in a new tab)
s.044 Civil liability to child with disability. (opens in a new tab)
s.045 Regulations. (opens in a new tab)
s.045 Power to make consequential provision
s.045 Orders
s.046 Notices. (opens in a new tab)
s.047 Index. (opens in a new tab)
s.048 Northern Ireland. (opens in a new tab)
s.049 Short title, commencement, etc. (opens in a new tab)
Schedules

Schedules

21 of 108 shown
s.sch003 A person's gametes must not be kept in storage by... Regulated
  • Do not store gametes after the donor's deathAny Person
s.sch003 (1) A person's gametes or human cells must not be... Regulated
  • Obtain effective consent before using gametes or human cells to create research embryosAny Person
s.sch003 (1) A human admixed embryo the creation of which was... Regulated
  • Obtain effective consent before storing a human admixed embryoAny Person
s.sch003 (1) This paragraph applies in relation to a person who... Regulated
Other duties (1) — Crown / regulator
  • Consult a carer or nominated person before using incapacitated adult's cells for researchStatutory regulator
s.sch003 (1) A person’s gametes or human cells must not be... Regulated
  • Get written consent before using anyone's eggs, sperm or cells for IVF or researchAny Person
s.sch003 (1) An embryo taken from a woman must not be... Regulated
  • Get written consent before using an embryo taken from a womanAny Person
s.sch003 (1) A person’s gametes must not be kept in storage... Regulated
  • Obtain effective consent before storing gametes or embryosAny Person
s.sch003a Licence conditions shall require that all persons to whom a... Regulated
  • Adopt HFEA-approved traceability systemsAny Person
s.sch003a Licence conditions shall require compliance with the requirements laid down... Regulated
Other duties (1) — Crown / regulator
  • HFEA must embed EU Directive standards in clinic licence conditionsStatutory regulator
s.sch003a In respect of gametes and embryos preparation processes, licence conditions... Regulated
  • Meet EU processing standards for licensed gametes and embryosLicence Holder
s.sch003a In relation to Great Britain, licence conditions shall require such—... Regulated
  • Set up systems to report and recall serious adverse events and reactionsLicence Holder
s.sch003a In relation to Northern Ireland, licence conditions shall require such—... Regulated
  • Maintain adverse event reporting and product recall systemsLicence Holder
s.sch003a For the purpose of securing compliance with the requirements of... Regulated
Other duties (1) — Crown / regulator
  • HFEA must specify storage termination and third-party rules in licencesStatutory regulator
s.sch003a Licence conditions shall require all persons to whom a licence... Regulated
  • Meet Article 2 procurement requirements for gametes and embryosAny Person
s.sch003a In relation to partner-donated sperm which is not , or... Regulated
Other duties (1) — Crown / regulator
  • HFEA must require donor screening and lab tests for processed partner gametesStatutory regulator
s.sch003a Subject to paragraph 7A, in relation to donations of gametes... Regulated
Other duties (1) — Crown / regulator
  • Licence conditions must require donor selection and lab testing complianceStatutory regulator
s.sch003a (1) In relation to a donation within paragraph 7 which... Regulated
Other duties (1) — Crown / regulator
  • HFEA must not require HIV-negative test for certain donationsStatutory regulator
s.sch003a Licence conditions shall require that the laboratory tests required by... Regulated
Other duties (1) — Crown / regulator
  • HFEA must require licensed labs to meet biological marker test standardsStatutory regulator
s.sch003a In relation to— (a) donation and procurement procedures, and Regulated
  • Comply with EU procurement and tissue reception standards under your licenceLicence Holder
s.sch003aa The following requirements must be specified in directions under section... Regulated
  • Notify HFEA of changes, adverse events, and ceasing importsAny Person
s.sch003b A person who— (a) fails without reasonable excuse to comply... Prosecution
  • Fail to comply with HFEA inspection or access requirementsAny Person

Unlimited fine

87 other schedules
s.sch001 The Authority shall not be regarded as the servant or...
s.sch001 (1) A member of the Authority who is in any...
s.sch001 The validity of any proceedings of the Authority, or of...
s.sch001 The fixing of the seal of the Authority shall be...
s.sch001 A document purporting to be duly executed under the seal...
s.sch001 The Authority shall be subject to investigation by the Parliamentary...
s.sch001 The Statutory Instruments Act 1946 applies to any power to...
s.sch001 The Authority shall have power to do anything which is...
s.sch001 The Secretary of State may, with the consent of the...
s.sch001 (1) All the members of the Authority (including the chairman...
s.sch001 (1) A person (“P”) is disqualified for being appointed as...
s.sch001 (1) Subject to the following provisions of this paragraph and...
s.sch001 The Secretary of State may suspend a member from office...
s.sch001 (1) This paragraph applies where the Secretary of State decides...
s.sch001 In Part II of Schedule 1 to the House of...
s.sch001 (1) The Authority may— (a) pay to the chairman such...
s.sch001 (1) The Authority may appoint such employees as it thinks...
s.sch001 (1) Subject to any provision of this Act, the Authority...
s.sch002 (1) A licence under this paragraph may authorise any of...
s.sch002 (1) A licence under this paragraph may authorise any of...
s.sch002 (1) A licence under paragraph 1 cannot authorise the testing...
s.sch002 (1) A licence under paragraph 1 cannot authorise any practice...
s.sch002 (1) Regulations may make any amendment of paragraph 1ZA (embryo...
s.sch002 (1) A licence under this paragraph or paragraph 1 or...
s.sch002 (1) A licence under this paragraph may authorise any of...
s.sch002 (1) A licence under paragraph 3 cannot authorise any activity...
s.sch002 (1) A licence under this Schedule can only authorise activities...
s.sch003 (1) A consent under this Schedule, any renewal of consent,...
s.sch003 (1) The gametes of a person (“P”) may be kept...
s.sch003 (1) This paragraph applies where— (a) the gametes of a...
s.sch003 (1) For the purposes of paragraph 11A, each of the...
s.sch003 (1) This paragraph applies where— (a) an embryo, the creation...
s.sch003 (1) For the purposes of paragraph 11C , each of...
s.sch003 For the purposes of paragraphs 12 and 13, each of...
s.sch003 (1) In relation to a person who has not attained...
s.sch003 (1) If, in relation to the proposed use under a...
s.sch003 (1) The conditions referred to in paragraph 16(1)(a) are as...
s.sch003 (1) Paragraph 16 does not apply to the use of...
s.sch003 (1) A consent to the use of any embryo must...
s.sch003 (1) Where a licence authorises the application of this paragraph...
s.sch003 (1) A licence may not authorise the application of paragraph...
s.sch003 (1) In this Schedule references to human cells are to...
s.sch003 (1) Before a person gives or renews consent under this...
s.sch003 (1) The terms of any consent under this Schedule may...
s.sch003 (1) This paragraph applies where— (a) a permitted embryo, the...
s.sch003 (1) A person’s gametes must not be used for the...
s.sch003 (1) The gametes of a person (“C”) may be kept...
s.sch003a (1) The modifications to the first Directive are as follows....
s.sch003a (1) The modifications to the second Directive are as follows....
s.sch003a (1) The modifications to the third Directive are as follows....
s.sch003a In this Schedule— “ HIV ” means human immunodeficiency virus,...
s.sch003a Licence conditions imposed in accordance with paragraph 1 may specify...
s.sch003a For the purposes of this Act, as it applies in...
s.sch003a For the purpose of this Schedule, Article 1 of the...
s.sch003aa A direction given under section 24(4AA) must require the person...
s.sch003aa A direction given under section 24(4AB) must require the person...
s.sch003aa (1) The modifications to the fourth Directive are as follows....
s.sch003aa In this Schedule— “changes of circumstances” means any changes in...
s.sch003aa For the purposes of this Act, as it applies in...
s.sch003b (1) A duly authorised person may require a person to...
s.sch003b In this Schedule— (a) “duly authorised person”, in the context...
s.sch003b (1) This paragraph applies in relation to Northern Ireland where—...
s.sch003b (1) Where a person— (a) makes an enquiry to the...
s.sch003b (1) A duly authorised person may at any reasonable time...
s.sch003b (1) Subject to sub-paragraph (2), the Authority shall arrange for...
s.sch003b (1) This paragraph applies in relation to Northern Ireland where—...
s.sch003b (1) If a justice of the peace is satisfied on...
s.sch003b (1) Entry and search under a warrant under paragraph 5...
s.sch003b (1) A duly authorised person entering and inspecting premises under...
s.sch003b (1) Power under this Schedule to enter and inspect or...
s.sch003b (1) A person's right to exercise a power under this...
s.sch003za The treatment services involve the use of the gametes of...
s.sch003za The treatment services involve the use of any embryo the...
s.sch003za The treatment services involve the use of an embryo taken...
s.sch003za A man gives the person responsible a notice under paragraph...
s.sch003za The woman for whom the treatment services are provided gives...
s.sch003za A woman gives the person responsible notice under paragraph (a)...
s.sch003za The woman for whom the treatment services are provided gives...
s.sch004 In section 25 of the Family Law Reform Act 1969...
s.sch004 Minor and Consequential Amendments
s.sch004 Minor and Consequential Amendments
s.sch004 Minor and Consequential Amendments
s.sch004 In Article 13 of the Family Law Reform (Northern Ireland)...
s.sch004 . . . . . . . . . ....
s.sch004 In Article 15 of the Adoption (Northern Ireland) Order 1987...
s.sch004 Minor and Consequential Amendments
s.sch004 Minor and Consequential Amendments

Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.