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A summary of the one hundred and thirteenth meeting of the
Human Fertilisation and Embryology Authority on 29th November 2001

Members were informed that this was the last Authority meeting for both Hugh Whittall and James Yeandel. The Chairman thanked both members of staff for their valuable contribution to the work of the Authority and wished them well in their future positions.

Matters arising from the minutes of the October Authority meeting

Members were informed that the Human Genetics Commission/Human Fertilisation and Embryology Authority Pre-implantation Genetic Diagnosis report had been disseminated.

Chairman's Business

The Chairman reported on several international meetings that she had attended on behalf of the Authority.

Chief Executive's Business

The Chief Executive reported to Members on issues relating to billing, changes in staffing of the Executive, a review by the external consultants Health Quality Systems and the provision of some quality assurance and risk management training for the Executive. Members were informed that the composition of the Hampshire licence committee had changed and it would be meeting again shortly. In addition, a separate independent panel was about to start investigating lessons the HFEA could learn from the incident and would report their findings to the Authority in due course.

Risk management would be further developed once the reports from HQS and the Hampshire investigation had been received.

Members noted that the emergency cloning bill was being debated in the House of Commons and that it had already passed through the House of Lords earlier in the week. It was anticipated that the new bill to outlaw reproductive cloning would become law at the beginning of December.

Members were informed that the Executive had represented the Authority at a European meeting in Brussels and the Chief Executive had given evidence to the Canadian High Commission.

Licensing of Pre-Implantation Genetic Screening for Aneuploidy

Members were asked whether the proposed standard licence conditions, list for data collection and the suggested guidance contained in the paper would be appropriate as an interim regulatory measure.

It was agreed that the proposed standard licence conditions should be changed to read 'Women with a history of recurrent miscarriage' and the list for data collection needed polar body testing adding to it.

It was agreed that the Authority should collect the data from the centres to monitor the use of the new procedure and this information could be added to the Register in the future as appropriate.

It was agreed that the amended versions would be approved by a subset of Members before being finalised.

Strengthening Statutory Functions

Discussions were held about strengthening the Authority's statutory functions. A case was put for strengthening data management and licensing to take on board quinquennial review (QQR) recommendations. There was agreement that the HFEA should have a strategic approach and implementation plan.

As these were issues that came out of the QQR, there was agreement that these projects should have a high priority and there should be discussion as to how best to secure additional funding.

ICSI - Risks, Surveillance and Action

The current understanding of the risks associated with the use of ICSI in treatment services was explained. It also set out a number of options for short and long-term action to be taken by the HFEA to address those risks that had been identified.

Members were reminded that the evidence relating to the safety of ICSI had in the past been considered on a regular basis by the Working Group on New Developments in Reproductive Technology. More recently additional evidence had been presented at the American Society of Genetics and this had suggested that ICSI might increase the incidence of imprinting disorders, such as Angelman and Beckwith-Weidemann Syndromes.

Following this report the Chief Medical Officer expressed concerns about the safety of ICSI and the need for proper surveillance. To address these concerns the Authority hosted a meeting involving interested parties and experts. A brief report of this meeting was sent to the Chief Medical Officer and the Chief Executive of the Medical Research Council.

Members were informed that the Authority was having meetings with the Medical Research Council regarding follow-up of children conceived following ICSI and possibly those conceived through other assisted reproductive technologies.

Members welcomed the proposals put forward in the paper and agreed that the Executive should take them forward. The importance of providing patients with accurate information about the possible risks was emphasised and it was agreed that the HFEA's ICSI leaflet should be reviewed.

Ethical Issues in the Creation and Selection of Preimplantation Embryos to Produce Tissue Donors

This information paper was introduced setting out the discussions and conclusions that had been reached by the Ethics Committee during their deliberations on this topic.

Members noted the contents of this paper.

Application for PGD with Tissue Typing

Members considered the issues put forward in the paper alongside the opinion of the Ethics Committee that had been presented in the previous paper.

Members noted that the initial application for tissue typing using PGD was for a cord blood donation from one sibling to another. Several Members had concerns that related to the possibility of bone marrow transplant in the future from the tissue matched child if the cord blood transplant was unsuccessful. The donation of cord blood caused no suffering or pain to the child and simply made use of cells that would normally have been destroyed. Harvesting of bone marrow, on the other hand, was a very invasive technique that would require a general anaesthetic. Members accepted that the HFEA could not place conditions on a treatment licence that would allow them to stop any future bone marrow transplant taking place. However, there were procedures designed to protect child bone marrow donors in place already and such a child would enjoy the same protection as any other child against medical interventions that are not in their best interests.

Concerns were expressed about the psychological burden that may be placed on a child who was an 'engineered' match as oppose to a 'natural' match. In addition, there were concerns expressed about the psychological welfare of the child donor if the sibling recipient stills dies. It was noted that this would be the same whether the tissue typing match was achieved through PGD or naturally.

Members then discussed whether tissue typing through PGD could be allowed where PGD was not required to avoid a serious genetic disorder. Members felt that to allow PGD for tissue typing alone would run contrary to the requirements of the welfare of the child assessment. Therefore, it was agreed that tissue typing using PGD should only be offered where PGD was already necessary to avoid the passing on of a serious genetic disorder.

In addition, it was agreed that each individual proposal for the application of PGD for tissue typing should be considered by a licence committee in contrast to normal PGD applications where a centre has to obtain approval for the initial case only.

Reports from Committees and Working Groups

Reports were presented from the Licensing and Fees Committee and the Working Group on New Developments in Reproductive Technology. The LFC reported their discussions on a report on licensing and licensing operational issues. The OFC reported on their discussions on strengthening statutory functions and the development of the strategic plan.

Any Other Business

Members approved the changes in cheque signatories and budget holders as proposed by the Finance Team.

Date of Next Meeting

The next meeting of the Authority is on Thursday 24th January 2002 at 2pm.

Page last updated: 24 October 2011

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