CH(91)03
24 July 1991
Ref CH(91)3
To all Directors of Centres
Dear Director
DIRECTIONS ON INFORMATION REQUIREMENTS FROM 1 AUGUST 1991
From 1 August, the HFEA has to keep a register of information about donors, people for whom treatment is provided, treatment outcomes and the storage or use of gametes or embryos. A copy of each of the forms which centres are required to complete is contained in the enclosed directions (for insertion at section 4 of the Manual for Centres). The power to make these directions is given to the Authority under the Human Fertilisation and Embryology Act and centres must comply with them as a condition of their licence. The directions include an explanation of the purpose of each form. Guidance notes on how to complete the forms are also attached.
Other directions on consents to use and storage of gametes and embryos, information to be kept under a research licence and information to be provided when gametes and embryos are supplied are also attached. We are in the final stages of preparing the forms. We will be sending you supplies of those which your centre needs to complete once we receive your licence application.
I also enclose (for inclusion at section 6 of the Manual for Centres) copies of the following regulations which have been made under the Act, coming into force on 1 August:
a. The Human Fertilisation and Embryology (Special Exemptions) Regulations 1991 (SI 1991/1588). These regulations concern the exemption from licensing of gametes and embryos kept in connection with the investigation of crime (regulation 2) and of gametes stored for specified purposes not involving any treatment services (regulation 3).
b. The Human Fertilisation and Embryology (Statutory Storage Period) Regulations 1991 (SI 1991/1540). These regulations extend the maximum storage period for gametes (as set out in section 14 of the Act) in respect of people "whose fertility since providing them has or is likely to become, in the written opinion of a registered medical practitioner, significantly impaired".
Further explanations of these regulations are provided in page 3 of each document.
You will recall that my letter of 8 July gave details of the fee structure that will apply from 1 August. Some centres have asked for clarification about the basis on which the additional fee will be calculated.
Additional fees will be payable in respect of any treatments for which a centre has completed an IVF or DI treatment cycle form. Where IVF treatment is concerned, this will be for each monthly treatment cycle for each woman whether or not the cycle is abandoned before embryo transfer. Direction D1991/4 in the attached documents makes clear that a treatment cycle begins
" - if fresh embryos are to be used/ with the administration of drugs for the purpose of superovulation, or if no such drugs are used, with the collection of egg(s) or any attempt to collect them, or
- if stored embryos are to be used, when the stored embryos are taken out of storage in order to be transferred."
For treatment involving the use of donated gametes, the DI treatment cycle form should be completed when the donated gametes are used.
If any forms are returned in which there is in fact no relevant data to go on the register these will not be used in the assessment of additional fees. Centres should not therefore feel inhibited about sending us forms if in doubt.
If you have any queries about the register of information or the forms, please contact Carolyn Heaney on the number below. If you have any queries about the regulations or about the fees, please contact David Howell on the same number.
COLIN CAMPBELL
Page last updated: 15 August 2012