Authority MeetingWednesday 11 May 2011The Hatton, 51-53 Hatton Garden

Please turn off all mobile phones and internet dongles to prevent interference with the audio recording

Welcome, Apologies andDeclarations of Interest

Item 1

Minutes of 23 March 2011

Item 2

Chair’s Report

Item 3

Chief Executive’s Report

Item 4

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

Directors’ Reports

Item 5

Donation Consultation Update

Hannah Darby and Danielle Hamm

Item 6

Hannah Darby and Danielle Hamm

Review and consultation process

Mar 2010Dec 2009

Discussed outcome of evaluation & agreed review

Agreed plan for the reviewSEED

evaluation

Aug – Dec 2009

Evidence gathering

phase

Mar – Sep 2010

Agreed policy options for

compensation & family limit

Sep 2010

Agreed: - structure of consultation document - name of the review - consultation strategy

Oct 2010

Authority sign off consultation text and questions. Discussed

engagement plan.

Agreed policy on age limit & donor codes, policy options intra

family

July 2010

17 Jan – 8 Apr 2011Dec 2010

Consultation period

Best practice in consultationsIn 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

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

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.

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.

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

Clinic meetings:Four meetings to discuss operational issues:London, Glasgow, Bath and Birmingham

Online questionnaire

Opinions and evidence gathered

Online questionnaires: breakdown & analysis

890 respondents (individuals and organisations)

NB. 157 respondents selected more than 1 respondent type

Online questionnaires: breakdown & analysis

2459 questionnaires completed

NB. These figures may vary slightly following full analysis

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

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?

Licences and Enforcement: A Guide to Compliance

Dr Chris O’Toole

Head of Research Regulation & Clinical Governance

Item 7

Regulation

Authorisation of processes

Authorisation of processes

For inspectors

Licensed Activities• Procuring gametes

• Keeping gametes

• Testing gametes

• Processing gametes

• Distribution of gametes

• Use of gametes

• Creation of embryos in vitro

• Procuring embryos

• Keeping embryos

• Testing embryos

• Processing embryos

• Distribution of embryos

• Storage of sperm

• Storage of eggs

• Storage of embryos

• Placing any permitted embryo in a woman

• Using embryos for the purpose of training persons in embryo biopsy, embryo storage or other embryological techniques

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.

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.

Summary of proposed changes

• 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

• 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

Proposal – delete from T&S Licences

Proposal – move from T&S licences to guidance

Proposal – revise wording of T&S conditions

Proposal – delete from research licences

Proposal – move from research licences to guidance

Proposal – revise wording of research conditions

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

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.

Examples from the Assessment Framework

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

Regulating new processes

Jessica Watkin, Policy Manager

Item 8

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

Options for regulating processes

1. ‘Prohibited processes’ list: Centres can proceed with any process unless Authority has evidence of harm and prohibits it

2. ‘Permitted processes’ list: centres can only proceed if Authority has considered and approved the process

3. ‘Permitted processes’ list + centre by centre approval: as option 2 with each centre needing advance permission from HFEA to carry out new process

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’

Recommendation

Option 1Risk to patient safety/special status of the embryo; may not be compatible with EUTDOption 3Heavy administrative consequences

Option 2High level, proportionate approach (protects patient safety/special status of embryo with clinical/scientific judgement and keeps administration to a minimum)

Fertility: Have your say survey results

Sharon Neaves

Communications Manager

Item 9

Background

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

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

Knowledge of HFEA

3%

17%

34%

24%21%

K nowledge of HFEA at beginning of treatment

A great deal

When you started treatment, how much would you say you knew about the HFEA?

Base: All who have received treatment (128), fieldwork dates: 1st March – 31st March 2011

Afair

amount

Justa

little

Heard of but

know nothing about

NeverHeard

of

• Relatively high awareness of HFEA• Lack of awareness of what HFEA does

Sources of information• More likely to ask their GP for information• GPs unable to provide sufficient information

47%

11%

9%

4%

3%

1%

21%

1%

2%

30%

68%

1%

Sources of information used

Yes

Q And did you receive any information from your GP on fertility treatment?

No

Don’t know/can’t remember

Q Which one of the following sources, if any, did you use when you were first looking for information about fertility treatment?

Base: All respondents (137), fieldwork dates: 1st

March – 31st March 2011

Your GP

Base: All who did not use their GP as their initial source of info (73)*, fieldwork dates: 1st March – 31st March 2011

* Small base size means findings indicative only

None of these

Don’t know

HFEA websiteIndividual fertility clinic

websitesFertility support groups

HFEA ‘Getting Started’ guideNHS Choices

Other

47%

91%

• 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

Information on the HFEA website

Patient experience• Overall positive about treatment received – 81%

44%

38%

7%

8%4%

Overall views on fertility service received

Very good

Base: All who have received treatment (128), fieldwork dates: 1st March – 31st March 2011

Overall, how would you rate the fertility service you have received at your clinic?

Fairly good

Neither/nor

Fairly poorVery poor

81%

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

68%

47%

19%

18%

15%

8%

6%

3%

2%

6%

Important factors when choosing c linic

Location

Which one or two would you say were/would be the most important when making your choice of clinic?

Base: All respondents (137), fieldwork dates: 1st March – 31st March 2011

Physical environment

Staff

Success rates (live birth rates)

Cost

Services/treatments available

NHS referral

Personal recommendation

GP recommended

Other

Factors considered when thinking about success rates

74%

64%

55%

48%

35%

31%

9%

3%

3%

Factors considered when thinking about c linics’ success rate

The type of patients that a clinic treats (eg age or diagnosis)

Which of the following factors, if any, have you considered when thinking about clinics’ success rates?

Base: All respondents (137), fieldwork dates: 1st March – 31st March 2011

The number of embryos the clinic routinely transfers in treatment cycles

The number of treatment cycles the clinic’s success rate is based on

How the clinic compares to the national average

That success rates cannot give a personal prediction of your chance to having a baby

How recent the published success rates are

Other

I didn’t consider any of these factors when thinking about clinics’ success rates

I have never thought about clinics’ success rates

• Positive to see that people are considering the type of patient a clinic treats

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

Cost of treatment

• 45% did not receive a costed treatment plan

• More than a quarter who did receive a plan say that their treatment was more expensive

Consent

• 76% felt the staff explained what they were consenting to

• 23% said it was not explained very well

• 6% said it was not explained at all

Counselling• 83% were offered counselling

• 16% weren’t offered counselling

Patient feedback questionnaires• 57% did not complete it, as they were

not aware of the questionnaire

Improvements to treatment• Better attitude of clinic staff

• More empathy

• More counselling & follow-up care

?

Confidence in fertility treatment

• Inspecting clinics to ensure that they follow proper conduct (47%)

• Ensuring the safety of medical treatments and scientific developments (47%)

Protecting the interests of patients

• Majority agree – 66%

• 12% say HFEA is not protecting their interests well

• 22% say they don’t know

Issues to address

Provide better information to GPs

More information to patients at the start of treatment

Education on success rates, up to date statistics & HFEA’s role

Investigation into improved patient feedback mechanisms

Other areas such as counselling, consent & cost require more focus on inspection

Consent to Disclosure for Research:

Identifying donor information

Charlotte Augst,

Head of Business Intelligence

Item 10

Two separate disclosure regimes

Legal complexity

• Complicated interface of primary legislation (consents) and Research Regulations

• Initially modelled our handling of disclosure based on consent on disclosure based on the Regulations

• Legal Advice now clarifies that we can disclose information about donors, recipients and the donor conceived to researchers on the basis of consent

Unless the information links donors and donor conceived people (because then it is deemed ‘identifying donor information’)

Update from Committee Chairs

Item 12

Any Other Business

Item 13

Date of next meeting

Wednesday 13 July 2011

London