CE(11)02 - Donation Review: Preparing for implementation

22 December 2011

I wrote to you in November telling you about the timetable for implementing our new policies on donation, developed as a result of the Donation Review. Since then, our Compliance Committee has agreed the changes to the Code of Practice and General Directions 0001 to implement the policies.

Our next step is to prepare the new sections of the Code of Practice for print, the final versions of which will be sent to you in the New Year. I am writing to you now to give you details of the forthcoming changes to the Code of Practice to help prepare you for implementation on 1 April 2012. I also enclose the revised General Directions 0001, which come into force on the same date.

This will cover the changes on:

Donor compensation
Benefits in kind
Donor family limit
Upper age limit for sperm donation
Family donation
Conditional donation

Donor compensation

Fixed sum compensation
On compensation for donors, from 1 April 2012 centres will be permitted to compensate donors a fixed amount to cover all financial losses incurred in connection with the donation.

Centres will be able to 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 will be able to 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 will be able to compensate the donor for subsequent visits on a ‘per clinic visit’ basis.

Compensating donors excess expenses
Centres will be permitted to 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 will only be able to 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
Centres will be permitted to compensate donors who are not permanent residents of the UK in the same way as UK donors, with the exception of the excess expenses allowance for the overseas part of the travel. Centres will not be permitted to directly or indirectly pay the overseas travel of a non-UK donor.

Compensation for imported gametes
On compensation for imported gametes, the policy will remain as it currently is. So, the centre will be required 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, the centre will be required 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.

The above changes on donor compensation will be implemented through:

General Directions 0001: Gamete and Embryo donation; and
Guidance note 13: Payment to donors

Benefits in kind

Centres will continue to be able to offer benefits in kind to donors in return for supplying gametes for donation. The definition of benefits in kind will be expanded to include licensed treatment, storage and access to licensed services, in return for supplying gametes for donation.

The above changes will be implemented through:

General Direction 0001: Gamete and Embryo donation; and
Guidance note12: Egg sharing arrangements.

Further minor changes will be made to Guidance note 11: Donor recruitment, assessment and screening and Guidance note 5: Consent to treatment, storage, donation, and disclosure of information.

Family limit

Monitoring donor usage
No changes have been made to the donor family limit. Centres will continue to be able use donor sperm to create up to ten families. Centres will be reminded that they must 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.

The Code of Practice will therefore explicitly state that:

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

Following implementation of the new donation polices the HFEA will monitor the usage of donor sperm by running a report at three-monthly intervals to get an overview of whether donors appear to be donating at different centres and on the frequency of donation, eg, a sperm donor donating twice weekly at two different clinics.

Centres should contact the Register Information Team at the HFEA to check if a potential donor has registered recently at another clinic.

The above changes on monitoring donor usage will be implemented through:

Guidance note 5: Consent to treatment, storage, donation, and disclosure of information; and
Guidance note 11: Donor recruitment, assessment and screening.

Upper age limit for sperm donation

On the upper age limit for sperm donation, changes to Code of Practice guidance aims to bring our guidance closer in line with professional guidelines. The Code will:

give centres the flexibility to assess the possible impact of donor age on a case by case basis, referring to the professional body guidance and relevant literature;
require clinics 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; and
refer to the Royal College of Obstetricians and Gynaecologists (RCOG) recommendations on reproductive ageing.

The above changes on the upper age limit for sperm donors will be implemented through:

Guidance note 11: Donor recruitment, assessment and screening; and
Guidance note 20: Donor-assisted conception.

Family donation

Changes to Code of Practice guidance will state that centres should not perform treatment which involves mixing gametes (eg, insemination, IVF or ICSI) of close relatives who are genetically related. This will include 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 restrictions will not include treatment which involves replacing the gametes of close relatives who are genetically related (eg, sister to sister egg donation).

On family donation, the HFEA will work in collaboration with the professions, in consultation with relevant stakeholder groups, to support the production of joint professional guidance on family donation. This guidance will be produced later in 2012.

The above changes on family donation will be implemented through:

Guidance note 11: Donor recruitment, assessment and screening.

Conditional donation

Code of Practice guidance will advise centres to inform anyone providing gametes that they can, if they wish, specify extra conditions for using their gametes (or embryos created using them).

Guidance will advise 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 will need to 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).
The above changes on conditional donation will be implemented through:

Guidance note 11: Donor recruitment, assessment and screening.

Steps for implementation

For implementation on 1 April 2012, centres will need to take the necessary steps to revise their systems, processes and protocols to reflect the above changes, specified in General Directions 0001 and revised guidance.

Centres are reminded that these changes will come into force until 1 April 2012. Early in the New Year centres will receive a formal notification on the above policy changes, including a Chair’s letter with copies of the updated guidance notes and General Direction 0001 for implementation.

If you have any questions about the above changes please do not hesitate to contact your inspector.

Yours sincerely,

Alan Doran CB
Chief Executive