CH(12)01

28 January 2012

Dear Colleague,

Implementation of the outcomes of the Donation Review

As Alan Doran recently outlined in his Chief Executive’s letter CE(11)02, the Authority has made a number of important changes to its policies on sperm and egg donation in the UK. This follows an extensive public consultation, ‘Donating sperm and eggs: have your say.’

I would like to take this opportunity to thank all clinic staff who participated in the review, either by responding to the consultation, attending meetings or informally, providing advice to our staff. Your views have been crucial in ensuring that the policy we develop works well in practice.

I am now pleased to notify you formally of the new donation policies and enclose details of changes to the Code of Practice. The changes, which are set out in detail at Annex A, will come into effect on 1 April 2012.

Compensation and reimbursement

When considering our new policy on donor compensation, we balanced the desire to treat donors fairly with the need to avoid a financial inducement to donate. We were also mindful of the retention of donors and to keep calls to keep paperwork to a minimum. We have therefore decided to move away from the current system of out-of-pocket expenses with a loss of earnings allowance capped at £250, instead allowing clinics to offer donors compensation which better reflects their expenses.

The new policies allow centres, from 1 April, to compensate egg donors £750 per cycle of donation and sperm donors £35 per clinic visit, with the provision to claim an excess to cover higher expenses. The Authority felt that this was a fair amount to compensate donors whilst not creating an inducement to donate. 

We have also decided that donors travelling from abroad will be compensated in the same way as UK donors, without additional travel expenses, and that the rules will not change on compensation permitted for imported gametes.

Benefits in kind

One key element of the consultation was the issue of benefits in kind (commonly known as egg sharing). We considered the potential implications of egg sharing for the donor and acknowledged the high value placed on those who entered into egg-sharing arrangements and the solidarity generated between egg-sharing donors and recipients.

The Authority decided that egg sharing should continue, but, given that our current guidance focuses almost exclusively on egg sharing, we have reviewed our guidance to make it clear what other benefits might be included (such as free or reduced storage and moving up the waiting list).

 

Family limit

We considered the family limit and agreed to maintain the current limit of 10. However, it became clear during the consultation that donor sperm is not always used to create the maximum number families to which the donor has consented. One of our responses to this has been to provide further guidance to clinics both in terms of optimising the use of donor sperm and ensuring that the 10 family limit is not breached.

 

Family donation

Following feedback from the consultation, the Authority decided to introduce guidance advising clinics not to undertake the mixing of gametes from close genetic relatives (eg, brother and sister). Although we know of no cases in the UK of close genetic relatives mixing their eggs and sperm, we were concerned that that there had not been an explicit ban on this kind of donation before now.

The Authority also considered family donation that involves relatives (eg, a women donating eggs to her sister) and saw that this type of family donation is often handled well by clinics. Therefore we agreed to share this good practice more widely by working with professional bodies to produce best practice guidelines in this area.

 

The wider landscape of donation

The Authority considered factors outside its regulatory remit which affect the availability of donor eggs and sperm, including donor recruitment and unlicensed treatment. We agreed to take a proactive approach to donor recruitment, retention and care by working with the IVF sector, professional bodies and voluntary organisations to raise awareness, improve the care of donors and ensure that donation continues to take place within a safe and ethical environment. This work will start over the next few months.

 

Transitional arrangements for new compensation policies

Donation is clearly a lengthy process and we understand that some donors will be in the middle of their course or cycle of donation on 1 April 2012.

Where this is the case, sperm donors may be compensated £35 for each clinic visit (as defined in Directions) on or after 1 April 2012. However, centres should not retrospectively compensate donors for clinic visits before this date.
Egg donors who have not yet completed their cycle of donation (as defined in Directions) on 1 April 2012 may be compensated £750 according to the new policy. However, any expenses and loss of earnings already paid to the donor in the same cycle should be deducted from this amount.

 

Sperm stored before 1991

Following legal advice received on the continued storage of sperm which was placed into storage before 1991 without written consent, we have made changes to the guidance we provide. The new guidance enclosed requires centres to treat sperm stored prior to 1991 without written consent in the same way as sperm (or eggs) stored under the written consent regime.

The revised Code of Practice and General Directions, hard copies of which are enclosed, will come into force on 1 April 2012. On that date, please replace the outdated guidance notes with the new ones, as instructed in the accompanying leaflet. We have provided copies of the complete guidance notes (rather than individual sheets with changes) to minimise the risk of errors when updating your paper copies.

If you have questions about the new Code of Practice or General Directions, please contact your Inspector.

 

Responding to requests for donor information

When responding to requests for information from donors, donor-conceived people and their parents, the HFEA has on occasion been made aware of differences between the data held on the HFEA Register and that held by a clinic. Reasons for these differences include incorrect donor centre/code submitted on treatments forms, cycles reported as donor cycles when they are not, frozen cycles not recorded as using donated gametes and duplicate counting of cycles.

In order to ensure that reliable, accurate personal data is supplied in every instance, we will need to cross check our data with clinic data, as part of the checking process for handling request of this kind. This means that our Register Information Team will contact an identified member of your staff who can confirm the recorded outcomes for each donor, on a case by case basis. We would be most grateful if your staff could respond to these requests in a timely manner.

Yours sincerely,

 Professor Lisa Jardine CBE
Chair, Human Fertilisation and Embryology Authority

Annex A: Changes to General Directions and guidance

The following guidance notes in the Code of Practice contain revised guidance:

  • General Directions 0001: Gamete and embryo donation
  • Guidance Note 5: Consent to treatment, storage, donation and disclosure of information
  • Guidance Note 11: Donor recruitment, assessment and screening
  • Guidance Note 12: Egg sharing arrangements
  • Guidance Note 13: Payment for donors
  • Guidance Note 17: Storage of gametes and embryos
  • Guidance Note 20: Donor assisted conception

General Directions 0001: Gamete and embryo donation

Paragraphs 3 through to 16 have been updated to reflect our new policy on donor compensation and benefits in kind.

Fixed sum compensation

On fixed sum compensation, paragraphs 5 to 7 have been amended to reflect that:

  • Centres may compensate donors a fixed amount to cover all financial losses incurred in connection with the donation. 
  • Centres may compensate sperm donors a fixed sum of up to £35 per clinic visit; and egg donors a fixed sum of up to £750 per cycle of donation. 
  • In cases where a prospective egg donor does not complete the cycle, centres may compensate the egg donor on a ‘per clinic visit’ basis. Also, where a person has stored gametes or embryos for use in their own treatment but then consents to donate them, centres may compensate  the donor for subsequent visits on a ‘per clinic visit’ basis.

Compensating donors excess expenses

Paragraphs 8 and 10 reflect that:

  • Centres may compensate donors for additional expenses where their expenses (not including loss of earnings) exceed the amounts specified in HFEA Directions (ie, where they exceed £35 per clinic visit for sperm donors or £750 per cycle of donation for egg donors) 
  • Centres may only provide excess expenses (such as for travel, accommodation or childcare) which are reasonable; do not include loss of earnings; have been incurred by the donor in connection with the donation of gametes provided to that centre; and have been incurred by the donor solely within the United Kingdom. Centres will be required to keep:
    •  a record of the actual excess expenses incurred by the donor; 
    • a record of the amount reimbursed to the donor; and 
    • the receipts produced by the donor, and/or the steps taken by the person responsible to satisfy themselves that the excess expenses claimed by the donor have in fact been incurred.

Compensation for overseas donors

Paragraph 9 has been amended to reflect that donors who are not permanent residents of the UK may be compensated in the same way as UK donors, with the exception of the excess expenses allowance for the overseas part of the travel. Centres are not permitted directly or indirectly to pay the overseas travel of a non-UK donor.

Compensation for imported gametes

On compensation for imported gametes, the policy is remaining as it currently is. So, paragraph 12 has been amended to require centres to ensure that the donor has not received compensation which exceeds: 

  • reasonable expenses incurred by the donor in connection with the donation of gametes provided to that centre, and
  • loss of earnings (but not for other costs or inconveniences) incurred by the donor up to a daily maximum of £61.28 but with an overall limit of £250 for each course or cycle of donation (local currency equivalent).

When receiving donated gametes from overseas, paragraph 13 requires the centre to keep a record (provided by the overseas centre) of the actual expenses incurred by the donor; the amount reimbursed to the donor; and the receipts produced by the donor, and/or the steps taken by the person responsible to satisfy themselves that the excess expenses claimed by the donor have in fact been incurred.

Benefits in kind

Paragraph 15 has been amended to include the revised definition of benefits in kind, which has been expanded to include licensed treatment, storage and access to licensed services, in return for supplying gametes for donation. Therefore centres may offer patients free or reduced fertility treatment, storage or quicker access to licensed services.

 

Guidance Note 5: Consent to treatment, storage, donation and disclosure of information

Donor family limit

The ‘Interpretation of mandatory requirements’ box (5A) has been amended to clarify that the use of gametes or embryos to create more families than a donor has consented to is a breach of Schedule 3 of the HFEA Act 1990 (as amended).

Benefits in kind

Section 5.21-5.22 on egg sharing has been expanded to include other forms of benefits in kind.

Sperm stored before 1991

Separate from donation, the ‘Interpretation of mandatory requirements’ box (5D) has been revised following legal advice received on sperm stored before 1991.

The Human Fertilisation and Embryology Act 1990 requires consent to be written, it allows for sperm samples which were already in storage when the Act came into force (1 August 1991) to have remained in storage without obtaining written consent from the gamete provider. We currently have a paragraph in the Code of Practice which summarises this.

Part of the summary suggests that, whilst continued storage is permissible, centres are not legally obliged to keep the samples in storage. However, our lawyers advise that this is not the correct position. Instead, gametes placed in storage before 1991 may remain in storage without written consent, provided that the storage has been correctly extended under the relevant Regulations. As such, they should be handled in the same way as sperm (or eggs) stored under the written consent regime.

This change has also been reflected in Guidance note 17 ‘Interpretation of mandatory requirements’ box (17B).

In order to help centres understand what is a complicated area of the law, we have added an additional explanation of the relevant storage Regulations in the ‘Interpretation of mandatory requirements’ box (5D). A more extensive guide will be sent to clinics in the next issue of Clinic Focus.

Guidance Note 11: Donor recruitment, assessment and screening

Age of prospective donors

Revised guidance at section 11.2-11.5 advises centres to refer to the relevant professional guidelines on age limits before accepting gametes for the treatment of others.

Current professional guidelines state that eggs should not be taken from donors aged 36 or over, and sperm should not be taken from donors aged 41 or over.

For donated eggs, centres should observe the relevant age limit unless there are exceptional reasons not to do so. The centre should record any such reasons in the patient’s medical records.

For donated sperm, centres should normally observe the relevant age limit. However, due to less substantial evidence on age limits for sperm donors, centres should assess the possible effect of the donor’s age on a case-by-case basis. The centre should record in the patient’s medical records the reasons for using a donor above the recommended age limit.

Family donation

Guidance has been added at section 11.15-11.16 to advise that centres should not perform treatment that involves mixing gametes (eg, through insemination, IVF or ICSI) of close relatives who are genetically related, including between:

  • grandfather and granddaughter 
  • grandmother and grandson 
  • father and daughter 
  • mother and son 
  • brother and sister
  • half-brother and half-sister
  • uncle and niece 
  • aunt and nephew 
  • uncle and half-niece 
  • aunt and half-nephew.

The restriction described above does not include treatment that involves replacing the gametes of close relatives who are genetically related (eg, sister-to-sister egg donation).

Conditional donation

Guidance has been added at section 11.18 which advises centres to inform anyone providing gametes that they can, if they wish, specify extra conditions for storing or using their gametes (or embryos created using them).

Section 11.19-11.20 advises centres to be aware that some conditions imposed by donors may be incompatible with the Equality Act 2010. The Act prohibits service providers (such as clinics) from discriminating by treating people less favourably because of various protected characteristics.

Therefore, when deciding whether or not to recruit donors who place conditions on the use of their gametes or embryos, centres should judge whether this will result in less favourable treatment because of a protected characteristic (eg, if it will reduce the choice of donors for a particular person by virtue of a protected characteristic).

Monitoring donor usage

Centres are reminded that it is the responsibility of the centre to monitor the usage of donor sperm, both in terms of optimising the use of donor sperm and ensuring that the 10 family limit is not breached.

To reflect this, new guidance has been added to explicitly state that:

  • the use of gametes or embryos to create more families than a donor has consented to is a breach of Schedule 3 of the HFEA Act 1990 (as amended) (Interpretation of mandatory requirements, box 11D). 
  • centres should aim to make best use of donated sperm within the number of families the donor has consented to (up to the 10-family limit) (11.40).
  • if the donor has consented to using the sperm for more than one family, the recruiting centre should not allow patients to reserve more sperm than is reasonable for one family allocation (11.41).
  • where the centre uses sperm from donors who have been recruited at another centre, the centre should take reasonable steps to assure itself that patients have not reserved more sperm than is reasonable for one family allocation (11.42).
  • primary centres should notify secondary centres, and vice versa, when embryos created using a donor’s gametes are removed from storage and allowed to perish, donated to research or used for training (11.50).

Following implementation of the new donation polices, centres should contact the Register Information Team at the HFEA to check if a potential donor has registered recently at another clinic. (NB The donor is only registered with the HFEA once the gametes have been made available for use).

Benefits in kind

Section 11.51–11.52 has been amended to include the revised definition of benefits in kind.

 

Guidance Note 12: Egg sharing arrangements

The mandatory requirements box has been amended to reflect the revised definition of benefits in kind as outlined in General Directions 0001.

Guidance note 12 has been revised to take into account other forms of benefits in kind beyond egg sharing, such as storage and quicker access to licensed services, in return for supplying gametes for donation.

 

Guidance Note 13: Payments for donors

Guidance note 13 has been amended to reflect the revisions made to Directions on compensation for donors (see General Directions 0001: Gamete and embryo donation).

 

Guidance Note 17: Storage of gametes and embryos

‘Interpretation of mandatory requirements’ box (17B) has been amended to reflect revised guidance on sperm stored before 1991.

 

Guidance Note 20: Donor assisted conception

Following revisions made to guidance on the upper age limit of sperm donors, section 20.1 has been amended to include a requirement to tell people seeking treatment with donate gametes and embryos about the age of the donor and the associated risk of miscarriage and chromosomal abnormalities.

Under ‘Other legislation, professional guidelines and information’ a link to the Royal College of Obstetricians and Gynaecologists (RCOG) recommendations on reproductive ageing has been provided.

Page last updated: 17 August 2012