October 2002
A summary of the one hundred and twenty first meeting of the
Human Fertilisation & Embryology Authority on 24th October 2002
Matters arising from the September meeting
The minutes of the September meeting were approved subject to minor amendments.
The Authority was advised that an audit of embryos stored by licensed centres had started.
It was agreed that the Chair and Chief Executive would seek a meeting with the Chief Medical Officer to discuss concerns about multiple births resulting from multiple embryo transfers.
Members were informed that the Report of the Independent Steering Group Improving the Performance of the HFEA was currently being produced for circulation to stakeholders with a response from the Chair. These documents and a summary of responses to the fees consultation would be posted on the website.
The Chair expressed her thanks on behalf of the Authority to Professor Tom Baldwin and staff within the Policy and the Communications Directorates for their work on the consultation document Sex Selection: choice and responsibility in human reproduction. The document was launched on 23rd October 2002.
Various improvements in inspection and licensing were discussed, including a target of having inspection reports available for approval by the inspection chair within seven days.
The Chair also requested that a review of the Members Committee Structure be commenced by 15th November.
It was noted that the Department of Health was drafting a response to the House of Commons Science & Technology Select Committee report on human genetics and embryology.
Chairman's Report
The Chair thanked Sue Avery, Christine Gosden, Stuart Lewis, Jean Smith, Lis Woods and Francoise Shenfield, whose appointment terms had come to an end, for their contributions. She noted that they had all been extremely helpful and supportive to HFEA.
The Chair reported on her recent visit to Washington with Peter Mills, where she made a presentation to The Presidents Council on Bioethics, for which the HFEA had been highly praised on its regulation of IVF and research.
Conflict of Interest
Further to discussion of the existing HFEA policy and practice regarding conflict of interest, it was agreed that the HFEA Executive would prepare a framework, which is in line with Cabinet Office guidelines, for approval at a future meeting.
Whilst Authority Members agreed it was relatively easy to define pecuniary interest, strongly held points of view were more complex to define.
It was agreed that an individual's level of involvement in an organisation should be recorded e.g. whether she/he subscribed to an organisation, was one of its representatives or simply held views sympathetic to that organisation.
Director or indirect pecuniary interest should also be declared. For example, if a member of a Licence Committee was involved in reviewing a rival clinic this could be considered as an indirect interest. For this reason it was noted that future Licence Committees may have heightened level of disqualification as the HFEA became more likely to be subject to challenge. A possible approach would be to always announce any potential conflict of interest and, where this was considered appropriate, the individual would take no further part in the discussion or take no part in the decision-making process.
It was agreed that in reviewing the HFEA Code regarding Conflict of Interest it would be necessary to go beyond pecuniary interests. A paper would be presented to Members at the January 2003 meeting.
Chief Executive's Report
The Chief Executive presented her report, indicating that the audit process had commenced by reviewing records, and that three formal training events had taken place over the past four weeks. These included training for new auditors, new Regulatory staff and inspectors. A second meeting with inspectors was scheduled for November. A key message is the importance of continuing education and training both for staff and others working with the HFEA.
Plans to separate inspection and licensing were discussed and would be considered by the Licensing And Fees Committee. A review of all documentation was under way, which would require a continuous protocol, compliance and manual update to take place alongside the review and revision of the HFEA's Code of Practice.
The Chief Executive reported the intention to move to a full day inspection from half days. Where there is a need to look in detail at the records the Regulatory Officer would go to the centre the day before to do this.
It was agreed that in order to allow patients and potential patients to make evidence based decisions Patient Information Literature must be kept up to date. Concern was expressed about whether there were mechanisms in place to ensure that centres were made aware of changes to our information leaflets and that all our literature was consistent in its advice. The Director of Communications acknowledged that more attention to this was needed and indicated that if funding for this post becomes available a publications officer would be appointed, who would undertake this role.
Regulatory Activity Report
The acting Director of Regulation reported that there had been difficulties in arranging full inspection teams, due to the lack of inspectors available at short notice. He stressed that the Regulation team were working hard to meet the timetable of planned inspections.
The Chief Executive confirmed that the incident management process was being assessed.
The Chair confirmed that there had been very positive feedback from recent inspections and expressed her thanks to the team.
Annual Report
The meeting approved the Eleventh Annual Report and Accounts 2002, subject to certain minor alterations. Subject to approval by the Minister, the report would be laid before Parliament at the end of November.
Preimplantation Genetic Diagnosis
New guidance to be incorporated into the Code of Practice was presented.
Discussion centred on the importance of whether each PGD licensed clinic should be licensed separately for each different probe a clinic wished to undertake.
The definition of serious abnormality was discussed and it was noted that the HFEA's PGD guidance is in line with Royal College of Obstetricians & Gynaecologists guidance on termination of pregnancy on grounds of fetal abnormality.
The Ethics Committee was asked to consider and advise the Authority as to the appropriateness of licensing PGD in respect of late onset and mental health disorders.
Bulk Import of Sperm
A suggestion was made that the HFEA should consider factors which constrain supply and whether there is anything that can be done to ameliorate that situation. As an Interim Policy it was agreed that all requests for bulk import sperm licences will be considered on a case by case basis
Committee Reports
Members noted the minutes of the Audit Committee and a note of a meeting of the Ethics Committee.
Date of Next Meeting
The date of the next Authority meeting is 28 November 2002.
Page last updated: 24 October 2011