APPENDIX 75
Supplementary memorandum from the Human
Fertilisation and Embryology Authority
Further questions
1. Has the HFEA ever been advised by
its legal adviser that it has acted ultra vires?
We have not been advised by our legal advisers
that we have acted outside our remit. But we are in regular discussions
now with our in-house legal adviser and previously with external
solicitors about planned work and the limits of the 1990 Act (for
example regarding internet sperm providers, treatment of patients
with certain drugs or clinical practices abroad).
2. Authority quorum and attendance over
the last two years
The Authority quorum is specified in the Standing
Orders as one third of the total number of members (18 including
chair). The majority of the people present have to be lay members.
Members attending authority meetings for
the past two years
|
| 2004 | Members attending
|
|
| July | 16 |
| June | 15 |
| May | 17 |
| March | 16
|
| February | 13
|
| January | 12
|
| 2003 | |
| November | 13
|
| October | 15
|
| September | 15
|
| July | 12 |
| June | 16 |
| 1 May | 10
|
| 15 May | 10
|
| March | 17
|
| February | 13
|
| January | 12
|
| 2002 | |
| November | 10
|
| October | 16
|
| September | 18
|
| July | 19 |
|
3. Consultations and responses
Since 2002, five major consultations:
— Modernisation of the HFEA and fees strategy: 56
responses, mostly professional, including membership organisations.
— Sex selection: 640 responses, mostly "general
public", plus qualitative research through focus groups and
MORI poll of more than 200 people.
— Code of Practice: 61 responses, mostly professional
— Five-year Corporate Plan: two major consultation
meetings, one for patient groups etc, one for professionals.
— Regulation of research (including research fees):
11 responses, mostly professional, including membership organisations.
We also regularly consult with the sector over changes in
regulation (for example regarding the safety of dewars) and with
patient organisations (for example about information needs).
4. Number of research licences that have been refused
or not extended
Out of 152 research licence applications received, 22 were
not granted from the outset and seven were not renewed.
5. Treatment of single women or lesbians
In a survey of all treatment centres we did in 2003, we asked
clinics whether they had special eligibility criteria for different
groups of patients.
With regard to single women:
— 17 clinics stated they had specific eligibility
criteria for single women;
— six clinics stated they would not treat single
women;
— four clinics stated that they would consider each
case individually; and
— two clinics stated that they could not treat single
women on the NHS, but privately, due to funding arrangements with
NHS trusts.
With regard to lesbian couples:
— 19 clinics stated that they had specific eligibility
criteria for lesbian couples;
— eight stated that they would not treat lesbians;
— four stated that they would consider each case
individually; and
— two stated that they could not treat lesbian women
on the NHS, but privately, due to funding arrangements with NHS
trusts.
6. Toft report media briefing and email to witnesses?
Everyone who had been interviewed during the Toft inquiry
was given the opportunity to look at the relevant parts of an
early draft of the report purely for factual accuracy. Professor
Toft/the Department of Health had specific requirements regarding
the confidentiality of this draft (no photocopying, no note taking,
the report had to stay in one room), which we followed.
Prior to the expected publication of the report, HFEA staff
had some informal conversations with a number of key stakeholders
about the possible impact the publication of the report might
have and how to maintain confidence in the sector. No formal media
briefings were given to anyone outside of the organisation. We
only issued formal and detailed statements once the report was
actually published.
7. Number of previous incidents similar to Leeds and
reports on these incidents
Professor Toft asked us to identify how many other incidents
similar to the Leeds incident the HFEA was aware of. These incidents
would have happened before the introduction of our incident reporting
and alert system, but we managed to retrieve the data for the
preceding 10 years and found that there were nine incidents involving
identification errors. In no cases were there pregnancies/children
resulting. There were no external inquiries into any of these,
but obviously the HFEA followed up incidents with the clinics
that reported them through regulation staff and licensing committees.
8. Nucleus/pro-nucleus research
We have received a research application regarding the transfer
of the two pro-nuclei from a one cell zygote to another zygote
from which the pro-nuclei have been removed. We have asked for
legal advice on whether a pro-nucleus is the same as a nucleus
and whether this research would be breeching the 1990 Act, as
the replacing of a nucleus of a cell of the embryo with the nucleus
of another cell is prohibited under Section 3 (3d) of the HF&E
Act 1990. We are awaiting the answer from our legal adviser—and
will then follow this interpretation of the Act. If it turns out
that a careful interpretation of the Act does not allow such research,
Parliament would have to decide whether it wishes such research
to be allowed and, if so, to agree to change the 1990 Act.
9. Teaching licences
Currently the HFE Act does not allow the issuing of licences
for teaching or training purposes. We have suggested to the Department
of Health that this is unsatisfactory and might need to be addressed
during the Review of the Act.
10. Summary of evidence on PGD/HLA
Will be on the HFEA website from the end of August.
September 2004
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