“The Regulatory Framework for Assisted Reproductive Technologies” – Sylvia Rumball

Sylvia Rumball: Thank you, Linda. Good evening everybody, kia ora, and thank you for coming out to hear what I hope is good information about this topic.

My role is just a 10-minute role, which indicates that the sort of subject area I am covering, is to briefly describe the regulatory landscape and the role that the Advisory Committee on Assisted Reproductive Technology will play in setting future policy. As Linda said, that is the committee I chair.

In 2004 a new piece of legislation was enacted in New Zealand, and that is the Human Assisted Reproductive Technology Act – the so-called HART Act. That got passed at the end of 2004. You need to know that that is the first piece of legislation New Zealand has had that would regulate both the treatment and research aspects of assisted reproductive technology, and it was many, many years in its gestation. Nevertheless that Act was passed at the end of 2004, and, although there are a number of purposes set out in the Act, the one I think is the most relevant is that its intent is to provide a robust and flexible framework for regulating and guiding the performance of assisted reproductive procedures – and we use the word “procedure” when we are thinking about treatment aspects – and the conducting of human reproductive research – and that is more the focus of this evening because this is a research-focused evening.

The Act has been set up to ensure that in these areas they work for the benefit of New Zealanders but that there is a robust regulatory framework attached to them.

The Act is a very interesting one in that right at its outset it said that certain procedures in New Zealand are prohibited. So there is a list of prohibitions. At the other end of the spectrum it says that there are other procedures – IVF in the treatment area – that have been around for a sufficient length of time that we are comfortable with them, and those are allowed and they are under the control of the providers of fertility services in New Zealand. Those are referred to as “established procedures”. So there is a list of prohibited actions and a list of established procedures that can proceed without any regulatory oversight.

In between there is another area of procedures or research that can take place only under guidelines, and those ones go to a committee that was set up under the Act called the Ethics Committee on Assisted Reproductive Technology. That committee has to assess those applications to work in those areas on a case-by-case basis. So that is our third category – allowed with guidelines.

There is another category where the Act – and I think at the stage the Act was passed maybe our select committee was finding it a bit hard and getting tired – says in two sections, “We are not going to make any decision”. There is one section of the Act that gives a list of areas concerning research where it says, “There is not going to be any decision as to whether they are prohibited or whether they are allowed, and, if so, under what circumstances. We are just leaving those and we are going to have a committee called the Advisory Committee on Assisted Reproductive Technology. That committee is charged with giving advice to the Minister.” So, Linda, it is not quite the situation that ACART will actually give out recommendations. That is not true. What ACART has to do in terms of the Act is give advice to the Minister on some very specific areas.

With respect to research, it says “The Advisory Committee must provide the Minister with information, advice, and, if it thinks fit, recommendations on the following matters in relation to the use of gametes and embryos in human reproductive research. The areas they list – and this is all with respect to research – are: cloned embryos, donation of human embryos, genetic modification of human gametes and human embryos, human gametes derived from foetuses or deceased persons, hybrid embryos, import into or export from New Zealand of in vitro human gametes or in vitro human embryos. Intertwined in all these we are to pay particular attention to requirements for informed consent. So our brief is to provide advice to the Minister on those areas. There is another section that says that we must also give advice with respect to some treatment areas, but I won’t go into that tonight because we are focused on research tonight.

So that is the shape of the Act. It is interesting if you look at the Acts in other countries there is a contrast in that I don’t know that there is any other Act that is set up so that we have this range of prohibited and allowed and a section on which you must give advice and therefore the Minister will make some decisions based on that advice. But that is the way we have chosen to do it in New Zealand.

Under the Act two committees have been set up. The Advisory Committee on Assisted Reproductive Technology has 12 members, and the Act says what expertise different members must have: it must have members with a community viewpoint, members with a particular Maori viewpoint, members with different particular expertise, and it must be chaired by a lay person, which is myself.

We have to prepare that advice. The Act also says that in preparing that advice we must take into account the public opinion on those areas that I have read out. So ACART is charged with gathering in public opinion on all those areas. What ACART has been doing is to prepare a discussion document that will encompass all those areas, and we hope it will be out in front of the public in about 6 weeks to 2 months. We will then be going through a procedure of asking for both formal submissions, holding public meetings if there is interest in that, gathering oral submissions if that is what people wish to do, holding hui, and taking in that stream of advice, analysing all those submissions, and, on that basis, preparing some advice to the Minister. It is going to be quite a comprehensive document that is placed before you. The document has been prepared, and it is getting close to being completed. It presents perspectives on all those aspects of gamete and embryo research – from a scientific perspective, an ethical perspective, a legal perspective, and a policy perspective. We have to look at all those different perspectives when we are trying to make up our minds about how we might feel about those things. We will be putting some questions at the end of the document, having tried to lay out an information background, and also a chapter that looks at what other countries have done. There will be one chapter that lays out the countries that we think are similar to New Zealand, looking at what other jurisdictions we think we can usefully benchmark: UK, Australia, Canada, one or two European countries, Singapore, because it is a close neighbour – bringing to your attention what those countries have done. This is part of the background information we are trying to give you.

Then we will be asking you questions. The most important question we would be asking at the outset is do you think that there are circumstances under which you believe that research involving gametes and embryos should be permitted. Then we go on to say, “If you think there may be situations in which you think that is the case, we want to ask you what your opinion is on different sources of embryos for research” because there is a range of embryonic sources ranging from embryos that we call “surplus embryos” – ones that have been created in the course of IVF treatment but where the parents, if we give them this option, may say, “We don’t need them ourselves. We don’t wish to donate them to someone else for reproductive purposes, but, rather than just have them destroyed, we would like to give them for research.” So that is one source of embryos and one that many countries use.

There are embryos that you can use IVF to create purposefully for research – and the UK allows that. Then there are new techniques for creating embryos called nuclear transfer. That is something that some countries allow but we will be asking the New Zealand public what it believes should happen in New Zealand.

Many of you might say, “I will be quite happy to have embryos used for research for ‘this purpose’ but perhaps not for ‘this purpose’”, so we will be giving you examples or ranges of different areas of research where research on embryos is commonly used and we will be asking for your opinion on those different areas. The main area where embryos are used in research is a contribution to a basic, fundamental understanding about growth and development. Another area is a contribution to our understanding of the reasons for infertility. Another area is a contribution to the prevention of hereditary diseases, because much research involving embryos – and I think Richard will be speaking about that – does contribute to our understanding of what causes hereditary diseases and how we might approach the treatment of them. A fourth area is a contribution to curing of human diseases in general.

So we know from experiences in other countries that people vary quite a lot as to whether some areas of research sit well with them but maybe others do not. So we will be asking you about that.

Because the HART Act asks us to also explore with you, we have been asked specifically to gather opinion so we can advise the Minister on whether you believe in the course of research, that genetic modification of human gametes and human embryos should be allowed, and whether you believe that hybrid embryos – this is quite a complex area but it will all be explained in our document – should be allowed to be used for that research.

These are the sorts of questions we will be asking. We will not, in that discussion document, be coming out with proposed guidelines. We have thought long and hard about it, but have decided that this is such an important area that the most important thing that we can do is to lay this information in front of everybody and then to ask for your opinion on those key areas. We will take that back in and it will be analysed, which will help us to frame what might be some draft advice. That will be the first stage where we want your opinion on those areas, so we do hope that you will all accept the invitation to take part in that consultation. I do welcome the role that the Bioethics Council has played in this. We discussed it with the Bioethics Council and said that, given the resources ACART has, we did not think we could do justice to the kind of extensive dialogue and interchange with people on these areas that it deserved. So we were delighted when the Bioethics Council said that they would undertake this preliminary dialogue, which will assist them to frame a response to our submission. But this is an opportunity for information-giving and for people to develop their thinking, so ACART is very grateful to the Bioethics Council that it has agreed to work in partnership with us and to undertake this exercise, which will then feed into what I know will be a more formal ACART consultation.

That’s it from ACART, so thank you for listening.

Linda Clark: Thank you Sylvia. Our next speaker is Dr Ruth Fitzgerald.

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