CH(97)02

01 November 1997

Dear Colleague

This is the fifth in a series of letters that are intended to keep you and your colleagues informed of current HFEA policy and recent events. Following comments received from the RCOG and the BFS, this letter gives more background information on the policy decisions mentioned in this letter. I would value your comments on whether you find this change of approach helpful.

As you are aware, issues surrounding fertility treatments are increasingly in the public eye. The Department of Health has published two consultation documents recently, one on consent and the other on surrogacy arrangements. The HFEA will be producing a response to both these documents. If you would like to contribute to these reviews you should contact Mr. M Evans, Department of Health, Room 423 Wellington House, 133-155 Waterloo Road, London SE1 8UG.

There have been a number of internal changes within the HFEA. At the beginning of November Diana Brittan, Richard Holloway, Angela Mays and Rory Nicol left the Authority. Diana, Richard and Angela had been HFEA Members since 1991 and had given very generously of their time. Professor Andrew Grubb has joined the Authority from 6 November and Jane Denton has taken over as Deputy Chairman. Other appointments are expected to be announced by the Department of Health shortly.

In addition, there have been a number of staff moves within the Executive. The HFEA has a new Director of Communications, Barney Wyld; new Inspector Co-ordinators, Susan Duffin, Kim Hayes, Debbie Holland-Jaggers and Mary Wall; and a new Policy and Resources Manager, Derek Hodge. We have also recently lost two experienced Inspector Co-ordinators, Raquel Perry and Aaron Walker. Those of us working at the Authority will miss them and their departure will result in many clinics having a change in Inspector Co-ordinator. To help you keep up-to-date with who does what a list of the HFEA's staff and their extension numbers is attached.

I also enclose the latest version of the Authority's Code of Practice on Enforcement, Working with Centres, which has recently been updated.

The issues covered in the Annex to this letter are:

1. Payment for donors
2. New systems for return of forms to the Authority
3. Parental responsibility
4. Information requirements and the HFEA's audit programme
5. Licences for Pre-implantation Genetic Diagnosis
6. Mixing IVF and GIFT
7. Limit on the number of children born per donor
8. Welfare of the child - enquiries to be made of GPs
9. "Home made" consents

I hope that you find this information helpful. Please contact the inspector co-ordinator for your clinic, Carol Perkins or Bea Heales if you have any queries about this letter.

Yours faithfully

Ruth Deech
Chairman

1. Payment for donors

Following the HFEA's decision to withdraw payments to donors other than expenses a Working Group was set up to consider implementation of this policy. The Working Group reported to the HFEA in July and one of its main recommendations was that a consultation with clinics and other interested organisations should take place on how to implement the policy The consultation paper should be circulated within the next few months.

No decisions about implementation will be taken until responses to the consultation have been considered. Sufficient time will be given to clinics to prepare for any changes which may be introduced.

2. New systems for return of forms to the Authority

All clinics should have received the Chief Executive's letter of 22 August which outlines the problems with form submission and the introduction of new systems for the return of forms to the Authority. The new "batch" system will come into effect from 1 November 1997. All clinics will be issued with 6 tamper evident envelopes and 6 batch headers. Each month, in the week allocated to each clinic, one envelope should be returned to the Authority with a completed batch header and all the forms which are due for submission that month. If you have no forms to submit during any given month (because no treatments have taken place during the corresponding treatment period) you must still complete the batch header and return it to the Authority in the envelope provided. The requirement to fulfil this new procedure is outlined in the Direction ref. 1997/1 which is enclosed with this letter and should replace the Direction ref. 1996/2 in your Manual for Centres. Please note that the Direction also has increased the time period in which forms must be returned to the Authority from two to three months for IVF, DI and Outcome forms.

In addition to a new system for sending forms to the Authority there is also a new system for the data team to send forms back to your clinic for correction. From 1 November the data team will not return the actual copies of the forms to the clinic but will now send you a list of all the forms on which they have found an error. It will be necessary for those individuals who complete forms in your clinic to locate the original form, check and correct the mistake or omission which has been identified and also check that all the other fields on the forms listed have been completed correctly. When they are satisfied that the form is now complete and correct, a photocopy of the amended form should be sent to the Authority with the next month's batch, attached to a copy of the list received from the Authority, clearly indicating that it is an amended form.

All clinics should have already received a revised set of guidelines for completing forms correctly with a set of annotated forms for particular treatments scenarios which are known to be problematic. The regional workshops which have been held recently were also arranged to assist clinics with the completion of forms and to explain the new procedures for the "batch system" and returns systems in more detail. Please note that the data team will no longer tolerate any error or omission. If you wish to discuss any of these new procedures, please contact Joanna Thompson on extension 209.

3. Information requirements and the HFEA's audit programme

You will be aware that the HFEA's five year audit programme commenced in October 1996. Many issues have been raised as'a result of this programme and these have been helpful in suggesting areas where practice can be improved for both clinics and the HFEA.

Some of these issues relate to the completion of treatment and outcome forms. It is essential to the data requirements of the HFEA that donors are registered and that their unique reference is used with consistency. It is the donor reference and the reference of the clinic at which the sample was obtained that must be entered onto HFEA forms and used in all correspondence. The HFEA has found that clinics that use blood groups at the end of a numerical reference to register a donor often do not supply this when transferring samples to a treatment centre even though this was included when the donor was first registered.

It would be helpful if donor references held by clinics were checked and amended where necessary to show both the donor and clinic references submitted at the time or donor registration.

4. Parental responsibility

Clinics should be aware that where an unmarried couple is being treated the male partner will not have "parental responsibility". Parental responsibility is defined by the Children Act 1989 as, "all the rights, duties, powers, responsibilities and authority which by law a parent of the child has in relation to the child and his property". Section 2 of that Act states:

"(1) Where a child's father and mother were married to each other at the time of his birth, they shall each have parental responsibility for the child.
(2) Where a child's father and mother were not married to each other at the time of his birth -
(a) the mother shall have parental responsibility for the child;
(b) the father shall not have parental responsibility for the child, unless he acquires it in accordance with the provisions of this Act."

Where clinics are treating unmarried couples they should recommend that they seek legal advice about the male partner's rights and responsibilities in relation to the potential child who may be born as a result of treatment.

5. Licences for Pre-implantation Genetic Diagnosis (PGD)

As you are aware, the HFEA has been considering the ethical issues surrounding the use of pre-implantation genetic diagnosis. The number of tests for inherited disorders is increasing and this proliferation naturally raises questions about which embryo screening tests are acceptable.

The HFEA has set up a joint Working Group with the Department of Health's Advisory Committee on Genetic Testing (ACGT). (The ACGT's remit is to provide advice to Ministers on the developments in testing for genetic disorders and their implications for the individuals being tested.) The joint working group is considering the preparation of a consultation document on PGD and a licensing strategy for the longer term.

The HFEA recently reviewed its approach to the licensing of centres carrying out PGD. As an interim measure, the Authority has decided to move to a system of licensing PGD which is based on the diagnostic tests in use at each clinic. In future, if a clinic licensed for PGD decides to introduce a new genetic test or to introduce a new disorder for which it wishes to offer the sexing of embryos, the clinic will be required to inform the Authority in advance. The Authority will be writing to clinics currently licensed for PGD to inform them of the details of the new licensing system once these have been finalised.

6. Mixing IVF and GIFT

The HFEA is aware that IVF and GIFT techniques are used in the same treatment cycle at one or two clinics. The HFEA intends reviewing the licensing of mixed IVF/GEFT treatments. In the meantime, clinics deciding to offer this form of treatment should be aware of the following:

? all IVF/GIFT mixed cycles must be carried out under a licence from the Authority and therefore the welfare of the child assessment must be carried out;

? the total number of eggs + embryos transferred must not exceed three, i.e. either two eggs and one embryo or one egg and two embryos may be transferred in an IVF/GIFT mixed cycle;

? IVF/GIFT mixed cycles will be excluded from a clinic's IVF data in the Patients1 Guide; and

? when completing the yellow HFEA(96)1 treatment form clinics should complete section 10a in the following way: tick the IVF box and write 'IVF and GIFT mixed cycle' next to other (please specify).

7. Limit on the number of children born per donor

The HFEA has set a limit often live children to be born from each donor. The HFEA receives many queries about exactly how-the limit is calculated and precisely when the limit may be exceeded. The HFEA thought clinics would find it helpful if the policy and the reasons for it were set out in this letter.

The HFEA adopted a limit on the number of live children born per donor to address public concern about genetic incest. The HFEA also took into account how the perception of donors might be harmed if the number of children born exceeded what could reasonably be called a "natural" family size and the risk of consanguinity.

The limit often is counted from the number of live children born rather than from the number of live birth events. For example, if one DI cycle results in twins, those twins would count as two children towards the limit often even though this is only one live birth event.

In exceptional circumstances the limit of ten may be exceeded. For example, the limit of ten may be exceeded where a recipient has had one child by the donor and wishes to use the same donor to have a subsequent child. This is different to the case where the recipient has received treatment using a donor's gametes which did not result in a live birth.

In some cases embryos created with a donor's gametes are in storage when that donor reaches the limit often. Provided these embryos were produced in good faith when the donor was not known to have produced 10 offspring, these embryos may be used in treatment or donated to others for treatment rather than be destroyed.

As stated at paragraph 7.18 of the Code of Practice, it is the responsibility of both the supplier and of the user to agree an appropriate procedure for ensuring that the limit is not exceeded except in the circumstances described above. The HFEA should always be notified whenever the limit often is exceeded.

8. Welfare of the child - enquiries to be made of GPs

The HFEA has been approached by a number of clinics about the nature of the enquiries that need to be made of GPs. This has sometimes been prompted by a lack of success in obtaining responses or because some GPs have asked for more information about what they are required to provide. Clinics should remember that there is no standard letter for use with GPs and that different approaches may be adopted. It is not necessary for the patient's GP to complete a detailed questionnaire, but your clinic may find this a more effective mechanism for obtaining information. If you would like to consider letters which other clinics have used, please contact David Thome who will be able to provide some sample letters.

9. "Home made" consents

Recently the HFEA was asked whether sperm could be extracted and stored from a patient who had been declared brain dead and was on a life support machine. In existence was a "home made" written consent dated and signed by the patient confirming that in the circumstances of his death sperm could be "saved" for his wife in order that she could use it to create their children after his death.

For a consent for storage or use of gametes to be acceptable it must satisfy Schedule 3 of the Human Fertilisation and Embryology Act 1990. This is necessary regardless of whether the gametes are solely to be stored or are contained in testicular tissue. HFEA forms have been designed to meet those requirements. However, consent can still be valid even if the appropriate HFEA form has not been used if the consent complies with Schedule 3. To do that the following must be present:

  • the consent must be in writing;
  • the consent must not have been withdrawn;
  • the consent must specify if the gametes are to be used for one or more of the following purposes:
    • use in that person's treatment or for treatment together of that person and another specified person;
    • use in the treatment of other persons;
    • use for a research project
  • specify the conditions subject to which the embryo may remain in store or be used, for example, that the embryo may only be used in the treatment of their partner;
  • if the gametes are to be stored then the maximum period of storage must be given if this is to be less than the statutory storage period; and
  • state what is to be done with the gametes if the person who gave the consent dies or is unable because of incapacity to vary the terms of the consent or to revoke it.

It is a statutory prerequisite that, before a person can give effective consent in accordance with the provisions of the 1990 Act, he or she must be given a suitable opportunity to receive "proper" counselling about the implications of their proposed action and be given "proper" relevant information. The person must understand that he or she can vary or withdraw their consent at any time up until an embryo made with their gametes has been used. It is up to the Person Responsible to satisfy themselves that the person concerned could have received counselling if he or she had asked for it and had received the "proper" information.

Each situation will need to be judged on its own merits.

 

The Authority's Executive Staff

Senior Managers     Job Title     Telephone Extension
Suzanne McCarthy     Chief Executive     202 (Julie Jones)
Mark Salmon                Policy & Finance     Manager     208
Dr David Thorne     Licensing Manager     215

Administration
Derek Hodge     Personnel & Facilities Manager     229
Melle Stripp     Office Manager     201
Tony Burkett Administration Officer     218
Julie Jones Administration Officer/
PA to Suzanne McCarthy     202
Dilpha Patel Administration Assistant

Audit
Katy Lloyd     Head of Internal Audit     222
Jane Davis     Systems & Data Auditor     212

Communications
Barney Wyld Director of Communications 205
pager 0941 113146

Data
Richard Baranowski Deputy Information Manager 218
Joanna Thompson Deputy Information Manager 209
Rob Aitchison Data Officer 210
Maureen Goodman Data Officer 231
Patricia Honor Data Officer 220
Gaby Jeremiah Data Officer 220
Sandy Lathlieff Data Officer 220
Doug Pearce Data Officer 220

Finance
David Axworthy Finance Manager 204
Tony Smith Accounts Manager 200

Licensing
Susan Duffin Inspector Co-ordinator 223
Kim Hayes Inspector Co-ordinator 211
Debbie Holland-Jaggers Inspector Co-ordinator
(from 1/12/97) N/A
Nan Hume Inspector Co-ordinator 222
Mary Wall Inspector Co-ordinator 214
Kerri Treston Licence Administrator 216

Policy
Bea Heales Policy Manager 207
Derek Hodge Policy Manager 229
Carol Perkins Policy Manager 219

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WORKING WITH CENTRES
THE HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY'S CODE OF PRACTICE ON ENFORCEMENT

A Code of Practice confirming the level or service that licensed centres and the public can expect from the HFEA

Published 1997

HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY (HFEA)
CODE OF PRACTICE ON ENFORCEMENT
INTRODUCTION

1. This document contains the Human Fertilisation and Embryology Authority's standards for dealing with the centres it licenses. The HFEA already publishes a code of practice for its centres which offers guidance on the proper conduct of licensed activities. However, this document is different. This code of practice on enforcement confirms the level of service that licensed centres and members of the public can expect from the
HFEA.

2. The Human Fertilisation and Embryology Authority was set up in 1990 by the Human Fertilisation and Embryology Act and took up its full powers in August 1991. Its remit is to regulate the field of reproductive technology, particularly In Vitro Fertilisation (IVF), Donor Insemination (DI), the storage of gametes (embryos and sperm), and any research on human embryos. The HFEA maintains a national system of regulation, aiming
to ensure that the highest possible standards in the provision of fertility treatment are achieved. Many of the HFEA's procedures are laid down in the 1990 Act.

WORKING WITH BUSINESS

3. The Human Fertilisation and Embryology Authority has always striven to balance the requirements of regulation with the need to minimise the burdens of administration and the cost imposed on the centres it licenses. The HFEA attempts to accomplish these goals in a number of ways.

3i. Publication of Standards

Available to licensed centres and others is a comprehensive manual for centres which explains inspection, licensing, and appeals procedures. It also contains a Code of Practice for centres which distinguishes between obligatory requirements and those guidelines which, though not mandatory, are desirable, and it explains the requirements of the Authority for record keeping. The manual for centres is available form the HFEA.

Applicants for new treatment licenses are told that the Authority expects to deal with applications, including inspection of the proposed premises, within three months from receipt of appropriate papers. Applicants for a renewal licence can expect to have their applications dealt with within four months. The timescale for issuing research licenses cannot be so closely defined since the Authority depends on the co-operation of scientists to subject research projects to peer review.

3ii. Information and Openness

The accounts of the Authority are a matter of public record, and the annual statement of accounts must comply with any direction given by the Secretary of State for Health with the approval of the Treasury, the Authority endeavours to meet any demands that centres or the public have for information. Centres have been supplied with copies of leaflets for patients explaining the role of the HFEA. The Authority also publishes an Annual Report which reviews activity for the past year and sets out the Authority's plans for the coming year and since 1995, a Patients'Guide to DI and IVF clinics giving information on the outcomes of such treatments. On average the HFEA receives approximately 12,000 requests each year from clinics and the general public for its published information. The Manual for Centres and the Code of Practice are periodically reviewed ensuring that they reflect the needs of licensed centres as well as those of the Authority and of the wider public. The Chairman also writes twice yearly to clinics advising them of recent HFEA policy decisions.

3iii. Consultation and Communication

Identified inspector co-ordinators are responsible for organising inspection and licensing for particular centres, and that ensures that there is close liaison between centres and the Authority. The HFEA also holds an annual conference where staff of licensed centres, inspectors, Authority Members and other interested persons have the chance to discuss the area of fertility treatment and the HFEA's potential for improvement. In terms of its policy decisions, the Authority will continue to consult a wide range of groups, organisations and individuals on various ethical issues through the publication of public consultation documents in order to receive a cross-section of views. The Authority welcomes suggestions for improving its channels of communication with centres and with the public.

3iv. Courtesy and Helpfulness

Centres have their own appointed inspector co-ordinator who is willing to answer any questions or help in any way with advice, guidance or information. Each member of the HFEA's Executive can answer or refer to the appropriate person questions and enquires from centres and from the public. This is done promptly and efficiently, and with the staff member giving their name.

3v. Complaints

All letters to the Authority can be addressed to the Chief Executive of the HFEA at Paxton House, 30 Artillery Lane, London, El 7LS. Centres and individuals should not feel inhibited from complaining about the HFEA. All written complaints will be followed up promptly and will normally receive a full written reply within three weeks of receipt. The Authority periodically reviews its effectiveness in handling complaints and undertake to make any changes that are necessary. There is also a statutory procedure for appealing against a licensing committees's decision. Everyday queries and/or complaints from the public will be dealt with individually, as promptly as possible.

If centres and the public feel that their needs are not being met by the Authority, complaints can be referred for independent review to the Head of Health Promotion, Branch 3, Department of Health, Wellington House, 133-155 Waterloo Road, London, SE1 8UG. If individuals wish to the matter further, they can contact the Secretary of State or the ombudsman through their MP.

3vi. Value for Money

The Authority has always tried to balance the requirements of regulation with the need to minimise the cost imposed on the centres the Authority licenses. The Members and staff of the Authority are constantly aware of the costs of offering and receiving treatment and have therefore made every effort to minimise its administrative costs so that fees are kept to the minimum. All expenditure is carefully checked to ensure that it is justified, necessary and provides good value for money. The Authority will continue to endeavour to meet this goal and to account for all costs, spending money wisely and within budget. Any questions about the Authority's fees' structure should be addressed to our finance department and will be dealt with accordingly.

CONTACT

4. All staff at centres and members of the public can contact the Authority at the following address and phone/fax numbers:

Human Fertilisation and Embryology Authority
Paxton House
30 Artillery Lane
London
E17LS

(Tel) 0171 377 5077
(Fax) 0171 377 1871

The Authority's Chairman is Mrs Ruth Deech and its Chief Executive is Mrs Suzanne McCarthy.

Page last updated: 03 April 2009