My Lords, stem cell research is a matter of profound medical, legal and social significance. I must, therefore, begin with two very important cautions. First, the topic deserves to be debated with intellectual discipline and reliable reasoning; therefore, the message should not go out from this House today that stem cell research will produce cures for serious disease. It might. It is a speculative aspiration. It is unproven whether it will cure and, if it does cure, it is unknown when.
The second caution is that we must not proceed in the expectation that the legislative framework embodied in the regulations of 2001 represents valid law. Next February, the Judicial Committee of this House will hear the final appeal on the question of whether the regulations are valid. Its decision will involve a major question of constitutional importance: whether the courts of our country have any role in plugging legislative gaps created by the legislature or whether those matters should be remedied by the organ of democracy that created them.
Central to the report is the assumption that the regulatory framework of the Human Fertilisation and Embryology Authority—I shall hereafter refer to it as "the authority"—works effectively in the public interest and can be seen to do so. Secondly, it assumes that there is a reliable legislative framework overall. Thirdly, the committee readily accepted the limited nature of its inquiry into the field. It did not, and could not, come to any conclusions about the degree of control society should exercise over the use of the products of stem cell research for the benefit of the community. I will deal with each point in turn.
First, does the authority have an adequate system of regulatory control in practice? Let us test the proposition. One, licence applications are never published before they are considered by the authority. It is, therefore, impossible for the public to know to what the licence application is directed. As a result, it is impossible for them to know whether the Government's undertakings and the authority's declared policy are being met, namely that stem cell research will be permitted only where it is necessary, desirable and there is no alternative. How are the public to know?
Secondly, after licensing decisions are made they are not referred to in public for up to two years after they have been made. The report of the authority for the year November 1999 to November 2000 was only published in the late summer of the year 2002. When I say "published" as regards what happens with these licences, I am being generous. By way of example, in the 1997 report there is one page that embraces 19 licence decisions, the longest of which stretches to just over 40 words in its description. That cannot plausibly be said to represent informing the public about a licensing decision. In any event, it is too late for anyone to do anything about it because the licence has been given and acted on.
Finally, the right reverend Prelate quite rightly emphasised that at the heart of this question is the integrity and value of the research that is accomplished. Outside the world of this authority, science seeks to achieve those standards by peer review. I shall test with noble Lords the proposition of whether the peer review system under the authority is established as being reliable to our satisfaction: we do not know the system of selection; we never know the expertise of the peer reviewer; and we do not know whether there is any conflict of interest. If your Lordships think that I am being overly strict, I have with me a real-life example from a licensed applicant. In evidence given to the Science and Technology Select Committee of the other place, Dr Austin Smith—who is a holder of a licence and a declared peer reviewer—said:
"Unfortunately the [Authority's] . . . committees seem insufficiently familiar with the science also. In responding to my queries it seems that the [Authority] . . . looks to the Medical Research Council for specialist input, who in turn ask my view, with the result that I am asked my view of a ruling which I am seeking. Research regulation seems to be at the margin of their activities".
He measured his words carefully, but it is almost risible to suggest that that is a proper system of peer review. It may not be representative; indeed, he may be wrong. However, we do not know.
From all of those propositions I invite noble Lords to consider with me the following suggestion. In scientific issues of this importance, should we not endorse the views of the Science and Technology Select Committee of the other place, which observed in 1999 that there was a crisis of confidence by the public in the regulation of science and technology and called for greater openness and dialogue. Do any of us disagree? If that is a proper objective, I invite my Government to consider the following proposals with the authority. First, adequate details of licence applications should be published. This should not be brushed aside with reference to the nonsense of commercial confidentiality. We are talking about the investigation of humankind for the benefit of humankind.
Secondly, adequate details of decisions should be published. Thirdly, the people who are peer reviewing should be identified, as should their expertise and terms of reference, and a declaration should be required of no conflict of interest. Fourthly, let the authority explain why this research was the only alternative. And, fifthly, let the licence holder who sought leave to investigate report its conclusions, successful or otherwise, back to the authority so that it can summarise the conclusions in its annual report.
None of that presently happens. Therefore I question the conclusions in paragraphs 8.1 and 8.2 that the public can be satisfied that the authority works in a way that we know and can understand.
The second question is whether there is an adequate legislative framework. The authority is reported as declaring in the report at paragraph 8.22 that it does not have regulatory control over stem cells once extracted from the embryo. I understand that it repeated the same declaration in a court case about tissue typing the other day: embryo control, yes; extracted material, no control by us.
Unless I have misunderstood the science, it is the extracted material that founds much of the research intended to be carried out. If the authority declares that it has no regulatory control over it and no competence in that regard, how can it be said that the present legislative framework is there?
I give two illustrative examples. Extracted material can be used for either research or treatment, but in both instances without regulatory control. It can be so used without any criterion applied as to whether it is necessary and desirable and whether there is an alternative. What we legally require in respect of embryos, we do not legislatively require in respect of material extracted from them.
I turn to the question of commercial control. I do not want to give my own views, to which I spoke in January 2001, about where all this was going and who was going to own these wonderful benefits to society: the Geron corporation which has just bought up the Dolly company in the North of England and now has most of the patents in the world in this field; or should it be us, the people who want the benefit from it?
In the evidence to the committee at page 448, Professor Wyatt, a sceptic on stem cell research, concluded:
"The extent of funding of all research involving embryos should be transparent and open to public scrutiny . . . The commercial ownership of cell-lines and research data needs careful regulatory and public scrutiny. There should be legal protection of 'whistle-blowing' by scientists in commercial organisations if ethical concerns are raised".
Who is to disagree? I turn to a stem-cell research enthusiast, the noble Lord, Lord Walton of Detchant, at page 156, who put the matter crisply in a way that cannot be improved on:
"My own personal belief is that the results of such research should be universally available without significant commercial considerations".
Who would disagree?
Whichever line one takes, there is no government policy of which I am aware, nor any external policy of NGOs in the medical world, as to how society will obtain the benefits of this research, if they ever occur, in a way that serves the community and not the profit-maker. I recall for your Lordships the phrase "intellectual discipline and reliable reasoning". Where are we going?
My conclusion is short and, I hope, simple. The authority should grant no licences until steps regarding the system I have recommended are, at the very least, considered; until the legislative framework covers the concerns I have expressed; and until society can be satisfied that what is sought to be done will serve society. This debate is not the end; it is merely an episode in a long-running debate on a legal and social concern for us all. The need for legislative oversight cannot be deferred until the end of the decade; it is a constant requirement. I for one intend to pursue that oversight.
I have not troubled your Lordships with my disagreement with the committee's conclusion. I adopt the reasoned arguments of the noble Lords, Lord Alton and Lord Tombs. I thank noble Lords for their patience.