Introduction
You've invited me to talk to you today about effective ways of getting your voices heard in the forthcoming consultation on the shape and content of the Regulations to govern the operation of the HFE Register of Information after it opens in 2008. As many of you will be aware, the Register was set up under Section 31(4) of the HFE Act 1990 and includes details about every birth that has resulted from donor assisted conception, including information about the donor.

You've also asked about how to make sure that all of you who may be affected can have a say:

• people conceived using donated gamete/s (including children and adults);
• their mothers and fathers;
• donors;
• offspring of donors other than those conceived through assisted conception;
• other family members (brothers and sisters, grandparents, aunts, uncles etc

In doing so, you've acknowledged and respected that we each view the world through a slightly different lens and that we keep re-focusing it throughout our lives as a new bit of the picture comes into view. And of course while one of us is busy looking at one part of the picture and may even sneakily believe that we've really got the whole picture (or at least got the best view!), lo and behold, one of the others is zooming in on something different!!

So, of course there will be differences as well as similarities in the responses that each of you may have to the consultation, reflecting the complexity of this whole area. There may be differences between family members (sometimes painful differences), including between couples and there may be differences between families. Today is not intended to find ways of diluting those differences but it may suggest ways of representing them to the outside world of government. For some of you, it may also lead you to a bit of re-focusing and you may find yourself thinking and talking with others or on your own about the ever unfolding business of being directly involved in the outcome of donor assisted treatments.

Outline of the talk
In order to participate in a government consultation, it can be helpful to know what the process of that consultation is - how does it come about; what happens and when; who decides what to ask and how to ask, and whose views to listen to; what happens after the consultation is over.

Next, I thought it might be useful to say a little about the wider context in which this consultation will take place - the Labour Government's approach to consultation, changes in the health service and in wider society; changing approaches to assisted conception and genetics.

Finally, I will talk about how you might go about submitting your responses to the consultation - what works.

Process
Public consultation especially on matters that are deemed to be of social or moral significance, can take place on:

1. matters that might result in new laws being made or
2. regulations to put flesh on existing laws

(Of course, legislation can also be brought in without consultation - for example legislation to bring about the Government's policies (the Queen's Speech), and private member's legislation - and consultations can also offer an opportunity to express views which go a little wider that the actual questions being asked).

Thus, the forthcoming consultation will be specifically about the operation of the Register of Information. The HFE Act 1990 (what is called primary legislation) set up the Register but only made minimum conditions about its operation in the Act itself (Section 31). This gives us the skeleton.

However, Parliament also recognised that fuller use of it might be desirable so it allowed for the possibility of drawing up what are called Regulations about its fuller use - or what we might see as the flesh for the skeleton. However, this is by no means compulsory and it remains possible, though very unlikely, that there will not be any Regulations in place for the opening of the Register and the minimum rules of access only will apply.

If we do get Regulations (and I believe we will) then they will operate in a similar way to the HFEA Code of Practice (take a copy) which offers detailed guidance to licensed clinics about what they can and cannot do and which is used by HFEA Inspectors in their work. The proposed Regulations about the use of the Register will perform a similar function for those in charge of the Register. Both documents are open to public scrutiny and subject to Parliamentary scrutiny.

The consultation will allow people to express views about what the Regulations should say - i.e. what information should be made available to donor offspring post 2008; what information should be collected in the future.

It could also allow for identifiable information about donors to be made available in the future (prospective).

The consultation could also theoretically influence the debate about whether new legislation is needed to make retrospective disclosure of identifiable information about donors compulsory. And it could also add pressure to the campaign to allow people conceived prior to August 1991 the right of access to their records.

So, what sort of consultations have there been already in this field?

There have been many consultations since the Human Fertilisation & Embryology Act of 1990 was brought in on the 1st August 1991, including:

• Parental orders for gamete donors regulations 1993 (governing surrogacy) Dept of Health
• Donated ovarian tissue in embryo research and assisted conception, 1994 - HFEA
• Publication of centres' success rates for IVF and DI, 1995 - HFEA
• Consent and the law (following the Diane Blood case), 1997 - Dept of Health
• Withdrawal of payments to donors, 1998 - HFEA
• Safe cryopreservation of gametes and embryos, 1998 - HFEA · Cloning issues in reproduction, science and medicine, 1998 - Human Genetics Advisory Commission and HFEA
• Surrogacy: Review of the Current Arrangements for Payment and Regulations, 1998 - Dept of Health
• Preimplantation Genetic Diagnosis, November 1999 - HFEA and Advisory Committee on Genetic Testing

The Dept of Health always takes the lead in consultations where legislation is involved.

And how are consultations carried out?

Whether to consult
The first step is for the political decision to be made about whether or not to consult. In this case, this decision will be made by the Minister with responsibility for public health at the Dept of Health, Yvette Cooper (or Lord Hunt assuming that she is still on maternity leave at the time). There are often some prior non-public soundings taken and perhaps the compilation of a draft confidential consultation paper as part of this decision making. This has been true in this case and both Progar and DC Network have been involved in this.

How to consult
Once the decision is made, plans are finalised for:

	What form it should take - final wording, publicity process, distribution
	How long it should be
	When it should start
	How the responses will be dealt with

A document is then published setting out the different issues to be considered and posing a set number of questions that it asks for comments on.

How long to consult for
Some have a very short time scale but that is NOT likely for this consultation - it will almost certainly be a six months time scale:

To allow relevant individuals and bodies to get together with each other if required, draft something, consult with each, produce a final document and submit

Governments have been known to go for shorter time-scales when they are wanting to implement something quickly and want to be seen to have consulted (or, less cynically, to test the water); equally they may use consultation to slow a process down! Similarly public bodies may have vested interests in speeding up or slowing down their lobbying.

What format for the responses
Responses can be made in different formats - letter is the usual format but there is nothing to stop you submitting an audio-cassette, a video, a poem etc.. What is most important is that:

Who can respond
Individuals can write; whole families can make a response; professional bodies; political organisations; pressure groups etc.. You can be involved in making more than one response - theoretically you could make 5 or 6 inputs:

1. As an individual
2. As a family
3. As a member of a group such as DC Network
4. As a member of a professional organisation if you are in one
5. As a member of a political group, e.g. Progress

Whose responses you can try to influence
You can also use this time and that following the consultation to influence public and political opinion through lobbying - targetting key people is especially important:

• Your own MP - especially useful if they have an interest - Yvette Cooper; Alan Milburn; their PPS's; David Hinchliffe
• Members of the Lords - Mary Warnock
• Members of the Health Select Committee
• Hold a Westminster tea party
• Lawyers
• Medics
• The media

Confidentiality - it is usually made clear whether or not your response will ever be made public. You have a right as an individual to it remaining confidential if you wish, hence you can mark your response accordingly - i.e. private and confidential. Individual replies are not usually made public.

And how are the responses collated?
Following the deadline, the relevant civil servants have the task of sifting the responses and preparing a report for the Minister. Everything is read and filed; similarities in views are noted as are differences. Weighting systems are used to guide the Minister about the relative importance of the different view points. The views of those who are directly affected by the matter in hand are given particular attention, as are the views of professional bodies who are directly affected - so one immediate crucial part of your response is to make it clear right at the beginning that you are directly affected.

And what happens next?
The Dept of Health consultations usually result in a Ministerial statement about what action will be taken (or not) following the consultation.

There is no statutory time-scale for action following a consultation. This applies to both the time that the civil servants take to prepare the report for the Minister and the time that the Minister takes to make a decision.

Once the Ministerial decision is made, assuming that it is in favour of drawing up Regulations, the civil servants have to draft the Regulations, often with seconded expert help. Parliamentary time then has to be negotiated for, if it hasn't been already, and the draft Regulations are put before Parliament and debated. Once the final version is approved, there is then a time-scale agreed for their implementation.

So what do we know about this already for
this particular consultation?

• likely to be before Christmas
• been told it will be fairly short - earlier drafts ran to 30-40 pages in two sections and this is likely to significantly reduce

Possible wording of consultation document:
One of the dangers in any consultation is that you will find your reply restricted by the framework and wording within which the consultation is set out. Even if it asks the sort of questions that you consider need to be asked, it may use a form of words which may influence your replies or which may lead you to miss out certain comments that you might otherwise make. There is no such thing as a value free document - and there is also no such thing as a totally unambiguous text. It:

• may refer to children conceived (rather than people) which will take you away from thinking about the life long implications and needs arising from the experience in the same way as it would if it talked about people
• may refer primarily to couples, by which it will mean heterosexual couples…….. § very likely to put an emphasis on the supply of sperm and eggs and embryos and the impact of either lifting anonymity or requiring fuller information to be collected - danger of getting drawn into the supply and demand arguments
• is likely to include a list of outcomes for the areas that you are asked to comment on (if anonymity is lifted, this might result in….). It is important to scrutinise any wording carefully to see if it is misleading or unbalanced (and point this out in any lobbying that you do). For example, if the list of outcomes primarily deals with negative effects such as a potential drop off in donor numbers and the list of positive effects, such as the potential value for parents needing to answer their growing child's questions is much smaller and more ambiguously worded, then you need to be aware of this and its effect on you and others - and point it out in both your reply and any lobbying that you do.
• Finally, the document may refer to the need for an evidence base and talk about the need for numbers in support of change to be available to justify any change: The examples used and the arguments which are set out for comment may imply or even argue that there needs to be a clear evidence base and 'adequate' numbers to justify any change in practice or in the law. If so, it is less likely to point out that there is no evidence base to support the continuation of existing practice. For example, anonymity and the limited collection of biographical information about donors is current practice - there is no evidence base to support this practice because we don't have a comprehensive research base about its outcome. And yet the practice continues and Parliament decided that it should be legalised in this format. Similarly with the new egg sharing arrangements, the HFEA recently issued guidance to licensed clinics to tell them NOT to tell either egg donors or egg recipients about the outcome of treatment because it might prove distressing to the egg donor if she were unsuccessful and the recipient were successful although there is no evidence base to support this policy. So don't be sidetracked - but use the framework that feels right for you - this is not about one version of evidence only or about 'proving' that there are 'enough' donor offspring wanting to search (after all, how many is enough)……

What might the questions cover?

• may ask something as basic as whether or not donor offspring should be able to obtain any information at all about their donor/s? (without regulations, they couldn't) - and, if so, whether that should be only at age 18 or earlier
• if yes, may ask what sort of information should they be able to receive - personal/medical/information about other children born to the donor/other § very likely to ask about identifying information - and why
• may ask about what sort of information should be collected from current donors § may ask about a dual system - one for donors who are willing to be identified and one for those who are not
• may ask what sort of services will be needed for those making enquiries of the Register
• may ask about systems for ensuring that people conceived through d.a.c. find out about their conception without that being dependent on someone telling them - e.g. on the birth certificate
• may ask whether there should be any differences in systems or services according to whether it is sperm, eggs or embryo that has been donated

So that's the process - what is the context within which this is happening which might favour us?

Context

So what runs in our favour; what can we make the most of?

1. Labour is committed to public consultation and open government

Historical development from the Tories onwards:

Corporate planning in the 1970s - customer services in the 1980's - citizenship in the 1990s - accountability and participative democracy in the late 20C and 21C including things like Best Value; Citizen's Juries; Patient's Panels etc.

Human Rights Act

2. The NHS Modernisation agenda includes a clear policy imperative to open up the health service and the medical profession to greater public scrutiny. Although many of the assisted conception services are in the private health sector, this is not being left out - the new Care Standards Act will apply to private health as will clinical governance.

Bristol (heart ops)
Alder Hey (body parts after post mortem)
Harold Shipman (GP who murdered)

3. Matters specific to assisted conception

	Political preoccupation with the family may work against us. The family will be seen (rightly) as the current family. Politicians and others will need to believe that it is to the benefit of current families to promote openness (especially given that arguments will be put forward about supply of donors and many professional voices will advocate secrecy as I outline below).
	Public and political unease with reproductive science - the 'yuk' factor
	The international scene - relatively little being done elsewhere; this could of course work in our favour if we are seen as 'leading the world'.

What works in effective consultation?

You will not all agree in the detail of your responses but it will be important to make sure that certain key messages are given.

You are members of the DC Network because you are committed to being open with your child or children about the nature of their conception and that is a key message. Beyond that there will no doubt be a range of views in the Network - and indeed within families, some of which may feel dangerous to explore. Some of you may be choosing to remain very private about your involvement in donor assisted conception and the numbers of people who know about it may remain very small indeed - your child/ren may not yet know (privacy and secrecy are not the same). Others will have told the world and their mother. It's a broad spectrum and in the words of the song:

'You say tomato; I say tomato
You say potato; I say potato
Tomato, tomato, potato, potato……..'

Let's look at some of the main areas where there may be differences (all quotes are from Australia):

So how can you go about collecting and expressing your thoughts?

So let's start with where you're at (or at least with my particular way of attempting to help you get at that by using the handout that you found on your chairs:

Refer to handout and prompts

AT THE END OF THE DAY REMEMBER THAT IN THIS CONSULTATION MANY OF THOSE WHO REPLY WILL BE DOING SO AS GUESTS WITHIN YOUR WORLD OF EXPERIENCE - IT'S YOUR LIVES SO FLEX YOUR MUSCLES!