1 / 62

Authority Meeting

Authority Meeting. Wednesday 11 May 2011 The Hatton, 51-53 Hatton Garden. Please turn off all mobile phones and internet dongles to prevent interference with the audio recording. Welcome, Apologies and Declarations of Interest. Item 1. Minutes of 23 March 2011. Item 2. Chair’s Report.

bazyli
Download Presentation

Authority Meeting

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Authority Meeting Wednesday 11 May 2011 The Hatton, 51-53 Hatton Garden Please turn off all mobile phones and internet dongles to prevent interference with the audio recording

  2. Welcome, Apologies andDeclarations of Interest Item 1

  3. Minutes of 23 March 2011 Item 2

  4. Chair’s Report Item 3

  5. Chief Executive’s Report Item 4

  6. Business Plan 2011/12 • Draft budget for 2011/12: • GIA £1.85m out of total £7.3m • Planning to reduce costs by £0.7m • Cash balance increasing • DH support to address cash balance by: • (a) reducing fees, and • (b) move to zero-rate fee for eSET (using GIA) • Further detailed work to follow

  7. Directors’ Reports Item 5

  8. Donation Consultation Update Item 6 Hannah Darby and Danielle Hamm

  9. Hannah Darby and Danielle Hamm

  10. Review and consultation process Agreed policy on age limit & donor codes, policy options intra family Discussed outcome of evaluation & agreed review Evidence gathering phase Agreed plan for the review SEED evaluation Aug – Dec 2009 Mar – Sep 2010 Dec 2009 Mar 2010 July 2010 Agreed: - structure of consultation document - name of the review - consultation strategy Agreed policy options for compensation & family limit Authority sign off consultation text and questions. Discussed engagement plan. Consultation period Sep 2010 Oct 2010 Dec 2010 17 Jan – 8 Apr 2011

  11. Best practice in consultations In line with BERR ‘Code of Practice on Consultation’. Consultation process: • Consultation launched after evaluation of current policies, allowing identification of policies for public consultation • Evidence gathering phase – informed development of policy options • Policy options consulted on for 12 weeks • Outcome of consultation will aid the Authority when making decisions about the policy options • Details of process, options and expected costs & benefits outlined in publicly available Authority papers

  12. Best practice in consultations contd. Burden of consultation kept to a minimum: • Consultation based online: website format & PDF • Website format accessible & easy to use, with lay language • Separate questionnaires for each topic • Responders didn’t need to register for a username & password

  13. Best practice in consultations contd. Methods of gathering opinions and evidence: • Text written in meaningful and accessible way to encourage lay respondents • Variety of engagement methods used to suit specific groups • Raised awareness: speaking at conferences, leaflets, stakeholder newsletters, press, use of dedicated inbox etc.

  14. Best practice in consultations contd. Regulatory impact assessment: • In the process of carrying out a regulatory impact assessment Learning lessons: • System in place for learning lessons from the consultation; this is integral to the project management system at the HFEA.

  15. Online questionnaire Clinic meetings: Four meetings to discuss operational issues: London, Glasgow, Bath and Birmingham Opinions and evidence gathered • Stakeholder engagement: • - Policy seminar - SAP/AHRC • Stakeholder meetings - SING, BICA, DCN, PROGAR • Discussions at Fertility 2011 & RCN conferences Qualitative work: Discussion groups, online forums and interviews with donors, donor conceived and general public

  16. Online questionnaires: breakdown & analysis 890 respondents (individuals and organisations) NB. 157 respondents selected more than 1 respondent type

  17. Online questionnaires: breakdown & analysis 2459 questionnaires completed NB. These figures may vary slightly following full analysis

  18. Proposed timetable • 17 May Advisory group meeting – discussion of evidence • 20 June Members’ workshop – discussion of evidence • 13 July Authority to consider evidence & policy recommendations on: • - family donation • - family limit • - changing landscape • 19 October Authority to consider evidence & policy recommendations on compensation, reimbursement & benefits in kind

  19. Considerations • How would Members like us to handle submissions not made through the online questionnaire? • Is the Authority satisfied that the types of information gathered will allow Members to make well-founded policy decisions?

  20. Licences and Enforcement: A Guide to Compliance Item 7 Dr Chris O’Toole Head of Research Regulation & Clinical Governance

  21. Regulation For inspectors Authorisation of processes

  22. Licensed Activities Creation of embryos in vitro Procuring embryos Keeping embryos Testing embryos Processing embryos Distribution of embryos • Procuring gametes • Keeping gametes • Testing gametes • Processing gametes • Distribution of gametes • Use of gametes • Using embryos for the purpose of training persons in embryo biopsy, embryo storage or other embryological techniques • Storage of sperm • Storage of eggs • Storage of embryos • Placing any permitted embryo in a woman

  23. Licence Conditions All licences issued by the Authority are subject to standard licence conditions. These conditions may be either: • statutory (prescribed in legislation) or • discretionary (applied by the HFEA pursuant to powers conferred on it by legislation) In addition conditions may also be applied to individual licences under powers contained in the legislation.

  24. Review of Licence Conditions Proposed review of discretionary licence conditions with the aim: • that the conditions are clear and easy to understand; • that the conditions reflect current policy; and • that requirements contained in licence conditions are not duplicated.

  25. Summary of proposed changes • Research licences • Delete 2 discretionary conditions plus one statutory condition • Move 2 discretionary conditions to Code of Practice or website • Revise the wording of 1 discretionary condition & 2 statutory conditions • Leave 15 discretionary conditions as already worded • T & S licences • Add 1 new discretionary licence condition – multiple births • Delete 5 discretionary conditions • Move 4 discretionary conditions to Code of Practice or website • Revise the wording of 10 discretionary conditions plus 6 statutory conditions • Leave 10 discretionary conditions as already worded

  26. Proposal – delete from T&S Licences

  27. Proposal – move from T&S licences to guidance

  28. Proposal – revise wording of T&S conditions

  29. Proposal – delete from research licences

  30. Proposal – move from research licences to guidance

  31. Proposal – revise wording of research conditions

  32. HFEA Enforcement Policy This policy sets out the Authority’s approach for promoting and maintaining compliance with: • the HF&E Act • licence conditions • directions • the Code of Practice

  33. Assessment framework This framework will aid: • inspectors in making consistent assessments • Inspectors determine whether non compliance with the HF&E Act 1990 (as amended), directions, licence conditions or the Code of Practice should be categorised as critical, major or other.

  34. Examples from the Assessment Framework

  35. Recommendations The Authority is asked to agree: • the proposed changes to the discretionary licence conditions contained in Annex B to this paper; • the enforcement policy contained in Annex D to this paper; • that the use of the assessment framework will be tested between now and September; and • to delegate the adoption of the assessment framework to the Authority’s Compliance Committee

  36. Regulating new processes Item 8 Jessica Watkin, Policy Manager

  37. Why review this? • Legal requirement: introduced by EUTD • Current procedure: inconsistent, unclear • Principles governing new procedure: • Patient safety • Special status of the embryo • Legal and regulatory responsibilities • Respect clinical/ scientific judgment • Minimise administrative consequences

  38. Options for regulating processes • ‘Prohibited processes’ list: Centres can proceed with any process unless Authority has evidence of harm and prohibits it • ‘Permitted processes’ list: centres can only proceed if Authority has considered and approved the process • ‘Permitted processes’ list + centre by centre approval: as option 2 with each centre needing advance permission from HFEA to carry out new process

  39. Consultation • Targeted consultation with members of LCP, Compliance Committee, SCAAC, BFS, ACE • Discussion at Compliance Committee in April • Option 1: support from LCP members • Option 2: Compliance Committee (with extra safeguards), ACE, BFS, SCAAC‘mitigates against risk’‘proportionate and transparent’

  40. Recommendation • Option 1 • Risk to patient safety/special status of the embryo; may not be compatible with EUTD • Option 3 • Heavy administrative consequences • Option 2 • High level, proportionate approach (protects patient safety/special status of embryo with clinical/scientific judgement and keeps administration to a minimum)

  41. Fertility: Have your say survey results Item 9 Sharon Neaves Communications Manager

  42. Background • Relaunch of patients’ panel • 171 members joined • March 2011 – Ipsos MORI • Online survey • 137 responses – response rate of 80%

  43. Treatment stage • 42% had received treatment and it was successful • 34% had received treatment and it was unsuccessful • 18% were currently receiving treatment • 4% were currently considering treatment • 2% had considered treatment but didn’t have it

  44. Relatively high awareness of HFEA • Lack of awareness of what HFEA does Knowledge of HFEA

  45. Sources of information • More likely to ask their GP for information • GPs unable to provide sufficient information 47%

  46. Information on the HFEA website • 91% of members have used the HFEA website • 92% found the information useful • Most say they found some of the information • Only a minority used it as their initial source of information 91%

  47. Patient experience 81% • Overall positive about treatment received – 81%

  48. Choosing a clinic • A clinic’s success rate – 68% • Location of the clinic – 47%

  49. Factors considered when thinking about success rates • Positive to see that people are considering the type of patient a clinic treats

  50. Risks of treatment • 68% were told about risks • 45% felt they were told a fair amount • Just under 23% were told a great deal • 5% weren’t told about the risks Greatest risks • OHSS & multiple births • Less than half say they know what the multiple birth rate is at their clinic

More Related