Human Fertilisation and Embryology Bill [Lords]

Public Bill Committee, 3 June 2008.

(Except clauses 4, 11, 14 and 23, schedule 2, and any new clauses or new schedules relating to the termination of pregnancy by registered medical practitioners)

Roger Gale (Conservative, North Thanet)

I have a few announcements to make. Hon. Members may wish to remove their jackets. As long as I am in the Chair, that will be in order, but I cannot speak for my co-Chairman, who will be joining you next week. Will members of the Committee and others in the room please ensure that their mobile phones, pagers and other electronic devices are switched off during our proceedings—by “off”, I mean off? The Committee may wish to be reminded of the money resolution in connection with the Bill, copies of which are available in the room.

I remind members of the Committee that adequate notice must be given of amendments. As a general rule, Mr. Hood and I will not be calling starred amendments; neither do we intend to call amendments that are not signed by members of the Committee, because we would presume that they would not be moved. I mention that now because a number of amendments have already been tabled by hon. Members who are not members of the Committee. If members of the Committee wish to pick them up, they will need to add their names to them so that they can appear on the amendment paper for the next sitting.

I also remind hon. Members about the procedure at the start of today’s sitting. The Committee will first be asked to consider the programme motion, on which debate is limited to half an hour. We will then proceed to a motion to report written evidence before starting the clause-by-clause scrutiny of the Bill. I hope that everything is clear.

Dawn Primarolo (Labour, Bristol South)

I beg to move,

That—

(1) the Committee shall (in addition to its first meeting at 10.30 a.m. on Tuesday 3rd June) meet—

(a) at 4.00 p.m. on Tuesday 3rd June;

(b) at 9.00 a.m. and 1.00 p.m. on Thursday 5th June;

(c) at 10.30 a.m. and 4.00 p.m. on Tuesday 10th June;

(d) at 9.00 a.m. and 1.00 p.m. on Thursday 12th June;

(e) at 10.30 a.m. and 4.00 p.m. on Tuesday 17th June;

(2) the proceedings shall be taken in the following order: Clauses 1 to 3; Clause 5; Schedule 1; Clauses 6 to 10; Clauses 12 and 13; Schedules 3 and 4; Clauses 15 to 22; Clauses 24 to 28; Schedule 5; Clauses 29 to 56; Schedule 6; Clauses 57 to 65; Schedule 7; Clause 66; Schedule 8; Clauses 67 to 69; new Clauses (not relating to the termination of pregnancy by registered medical practitioners); new Schedules (not relating to the termination of pregnancy by registered medical practitioners); remaining proceedings on the Bill.

(3) the proceedings shall (so far as not previously concluded) be brought to a conclusion at 7.00 p.m. on Tuesday 17th June.

I welcome you to the Chair, Mr. Gale, as I will welcome Mr. Hood when he joins us for this important Committee. The Bill has received its Second Reading and certain clauses have been debated on the Floor of the House. It has been subjected to consultation and pre-legislative scrutiny, and it has attracted great attention from the Science and Technology Committee. We are fortunate that members of the Committee have extensive knowledge and expertise in respect of the Bill. I welcome, in particular, the presence of the hon. Members for Salisbury and for Oxford, West and Abingdon, and my hon. Friends the Members for Bolton, South-East, for Brighton, Kemptown and for Norwich, North, who served on the Science and Technology Committee. Indeed, the hon. Member for Salisbury and my hon. Friend the Member for Norwich, North also served on the pre-legislative scrutiny Committee. Their wisdom and expertise will benefit our consideration of the Bill.

I am also joined by my hon. Friends the Members for Warrington, North, for Calder Valley, for Crawley, for Cardiff, North and my right hon. Friend the Member for Coatbridge, Chryston and Bellshill. They are all experienced parliamentarians with a great interest in such matters and various views on the subjects that we shall be discussing. I welcome the hon. Member for Boston and Skegness, who has so far led his team in adopting a considered, thoughtful and diligent approach to this important Bill. I am grateful for the way in which he and his colleagues will bring great expertise to our proceedings and will continue to debate matters that we know are of importance.

I hope that the Lord Commissioner of Her Majesty’s Treasury, my hon. Friend the Member for Birmingham, Hall Green, and the hon. Member for Rugby and Kenilworth will not have much work to do and that we shall proceed in an orderly, timely fashion. I am sure that you intend to make sure that we do so, Mr. Gale.

When my hon. Friend the Member for Norwich, North was referring to his considerable knowledge of science during the debates on the Floor of the House, he said that he knew “science backwards”. That caused considerable discussion among journalists who asked whether there was any other way to consider science. The Bill regulates important areas of research science that are of crucial importance to our communities.

I assure the Committee that we do not intend to start at the back and work forward. We shall start at clause 1 and work logically through the Bill. Our proceedings will be challenging and I am confident that the excellent debates that took place on the Floor of House will continue in Committee and that, at the end of our deliberations, we will have a Bill that is worthy of the House. I commend the motion to the Committee.

Mark Simmonds (Conservative, Boston and Skegness)

I join the Minister in saying how pleased I am to see you in the Chair, Mr. Gale. I look forward to working under your guidance and that of Mr Hood during the passage of this Bill. You will be aware of the view of the Opposition that this Bill deserves completely free votes, and therefore there will be free votes for Conservative Members in all Divisions in Committee. It is a shame that the Government do not have the same policy.

I acknowledge the points that the Minister made about the very thorough and detailed pre-legislative scrutiny that took place prior to the introduction of this Bill. There was full debate and discussion, and many hon. Members who took part in that scrutiny are members of the Public Bill Committee, which is to be welcomed. We all look forward to benefiting from their expertise and experience in this area.

May I thank the Minister for her kind remarks? I have been impressed by her detailed knowledge and understanding of these very complex issues, both ethically and scientifically. I hope that we can continue the constructive dialogue that we have had so far to ensure that the Bill is as good as it can be. When it passes into law, I hope that it will have as good a reputation as the Human Fertilisation and Embryology Act 1990 and that it lasts as long as that Act, if not longer, despite many fast-moving scientific discoveries and advances.

I welcome to the Committee my hon. Friends the Members for Rugby and Kenilworth, for Hemel Hempstead, for Salisbury, and for South-West Devon, who will make their own points in their individual ways. Of course, we have a very wide range of opinions on this side of the Committee, which will become evident as the Bill progresses. I would finally like to say that there are a large number of issues in the Bill that were not debated on the Floor if the House and I hope we will discuss them in Committee. I have no problem with the programme motion.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I join those who have already spoken in welcoming you to the Chair, Mr. Gale. It has been about 18 months since I last served on a Public Bill Committee, but that was under your chairmanship and I, at least, had a good time, even if I cannot speak for you.

I echo the comments that have been made about the scrutiny that has been undertaken. The Government must be commended for issuing a consultation paper, a White Paper and a draft Bill. Throughout that process they made a number of changes, following the scrutiny by the Science and Technology Committee, which was initiated under the chairmanship of the hon. Member for Norwich, North, who chaired the big inquiry of 2005. I pay tribute to his work and that of the hon. Members for Bolton, South-East, for Salisbury and for Brighton, Kemptown, who are all veterans of that Committee and subsequent inquiries. While there was not always unanimity on that Committee, it is the case that in the first inquiry, all of us present who served on that Committee took a common view and we have lasted the course by seeing it through to this stage.

As the hon. Member for Boston and Skegness said, there will be free votes on this side of the Committee. Although the Liberal Democrats generally have policies in support of scientific progress in this area, there are different views from mine, as is exemplified by my hon. Friend the Member for Southport, who will seek to catch your eye, Mr. Gale, or kick me when he disagrees with anything.

Tom Clarke (Labour, Coatbridge, Chryston and Bellshill)

In view of what both Opposition spokesmen have said, I would like to make it clear that when I accepted the invitation of the Government Whips to serve on the Committee, they had the full knowledge that I did not support the Bill on Second Reading. They know that I intend to vote in accordance with the merits of the arguments as I see them.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I welcome that, and I think it is good that at least one person on the Government side of the Committee has different views from the Government line. I hope that we will not be dividing in Committee, but that we have the opportunity for Divisions on Report. Having Divisions in Committee, with just a few of us here, would not give scope for the free votes that we would want to have.

My hon. Friend the Member for Southport and the hon. Members for Boston and Skegness and for Hemel Hempstead made excellent speeches during earlier stages of the Bill’s passage. I pay tribute to them and hope that all members of the Committee, including those who do not speak from the Front Bench, will play as full a part as I expect that they will. I hope we will be able to make good progress, because it would be a tragedy if we had to rush any new clauses and amendments towards the end of our proceedings.

Roger Gale (Conservative, North Thanet)

Before we proceed, may I indicate that when the Programming Sub-Committee met last night, we discussed the possibility of needing more time. I think that hon. Members on both sides of the Committee have broadly agreed that that is unlikely to be necessary, but I have indicated that, as far as the Chair is concerned, I would be willing to sit on a Tuesday evening, in addition to Tuesday morning and afternoon, should that become necessary. If that were to happen, I would expect negotiation through the usual channels to ensure that both members of the Committee and, more significantly, the staff of the House, have adequate notice so that they can adjust their diaries.

Roger Gale (Conservative, North Thanet)

Copies of the memoranda that the Committee receives will be made available in the room. I know that one has been received already, and if we receive any more, they will be placed on the table.

Clause 1

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 16, in clause 1, page 1, line 10, after second ‘embryo’, insert ‘where fertilisation is complete’.

Roger Gale (Conservative, North Thanet)

With this it will be convenient to discuss the following amendments:

No. 17, in clause 1, page 1, line 14, at end insert—

‘(c) for this purpose fertilisation is not complete until the appearance of a two cell zygote.’.

No. 18, in clause 1, page 2, line 5, leave out from second ‘eggs’ to ‘but’ in line 6.

No. 19, in clause 1, page 2, line 10, leave out from second ‘sperm’ to ‘and’ in line 11.

No. 20, in clause 1, page 2, line 12, leave out ‘be read accordingly’ and insert ‘live human gametes’.

Mark Simmonds (Conservative, Boston and Skegness)

Clause 1 concerns the meaning of “embryo” and “gamete”. I have tabled the amendments—I acknowledge that they are probing amendments—as an attempt to extract from the Government the logic behind the changes to the 1990 Act and to determine whether this is merely to do with scientific advancement, or whether there is something more fundamental behind the changes proposed. The amendments would bring the wording of the provisions back in line with that in the 1990 Act, which essentially says that there is not a true embryo unless the embryo has been fertilised. The amendments would make the definition clearer than what is proposed in the Bill.

Before I run through the differences between the amendments, I would ask the Minister about the fact that changes due to scientific advancement—for example, clone embryos and licensed hybrids, which are based on the court judgement that was made—are allowed under the wording of the 1990 Act. If those have been allowed under the wording of the 1990 Act, why is there a necessity to change that Act in the way proposed in the Bill?

Amendment No. 17 addresses the fact that there is no definition of fertilisation anywhere else in the Bill. It would be helpful to understand why that is the case.

Ian Gibson (Labour, Norwich North)

I dread making this intervention, but whenever I see the word “zygote”, I always think that it is a single cell. I do not want to get into arguments meaning that a later process is rolled out of order because of some “Oxford English Dictionary” definition. Would the hon. Gentleman like to say where the two-cell zygote comes from? Two cells are never a zygote; one cell is a zygote. The hon. Gentleman was once a zygote; that was when he was a single cell with everything else to do in terms of multiplying and so on.

Mark Simmonds (Conservative, Boston and Skegness)

As indeed was the hon. Gentleman. That was why I said that these were probing amendments. I am attempting to draw from the Government exactly why these changes to the 1990 Act have been put in the Bill. I do not think that there is a definition of fertilisation elsewhere in the Bill, so it would be helpful if the Minister would establish why that was the case.

With amendment No. 18, we want to understand about the

“cells of the female germ lines at any stage of maturity”.

There is no definition of “eggs”, which include the cells of the female germ line. Amendment No. 19 relates to “sperm”, which includes

“cells of the male germ line at any stage of maturity”,

and, again, there is no definition of that in this part of the Bill.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I declare an interest as a member of the British Medical Association medical ethics committee, although I will not seek to speak about the Bill in Parliament on behalf of the BMA or the ethics committee, except where stated.

The group of probing amendments is useful because it gives the Government the opportunity to clarify why they have chosen such a formula for the definitions. I would note, however, that they are clearly probing amendments, because without the deletion of the proposed new subsection (1)(b) in subsection (2), one would still include an egg that was in the process of fertilisation in the definition of “embryo”.

My understanding is that there has always been some doubt about whether an egg in the process of fertilisation would be covered by the 1990 Act. The provisions would put it beyond doubt that it would. The alternative would be that an embryo was not created until the process of fertilisation was complete. I would be grateful if the Government could explain, for reasons of clarity, why they have gone for the suggestion that an egg

“in the process of fertilisation or...undergoing any other process capable of resulting in an embryo”

is the chosen option.

My concern with the Government’s formulation is that some work is being done on eggs. Eggs are extremely fascinating cells from a scientific point of view, and a lot of insights into fertility and basic biology are made by studying eggs. It is quite possible that, during the study of eggs, an egg might spontaneously divide through the process of parthenogenesis. Although the resulting entity does not develop much further, it is a dividing egg. For example, activating an egg either by the application of some compounds, or by providing an electric charge, can result in parthenogenesis. I would be grateful if the Minister could clarify whether such an egg undergoing parthenogenetic division—without the addition of sperm and in its haploid state—would still be an embryo for that purpose.

If that is the case, it means for researchers something that was raised in the House of Lords regarding a potential offence. Any researcher working on eggs without a licence from the Human Fertilisation and Embryology Authority, as they are permitted to do under regulations passed almost immediately after the 1990 Act, would run the risk of finding that they had created something defined under the Bill as an embryo if a parthenogenetically dividing egg—after just one division—was considered to be one. Without a licence, researchers would be committing an offence, albeit inadvertently and with no intention of creating an embryo, and although something had been created that clearly could not develop beyond its initial division, because it had only half the chromosomes. No one is suggesting that a parthenogenetically dividing egg in vitro could develop significantly far.

The worry is that if one creates an accidental “embryo”—under the definition proposed—one finds that one is liable to prosecution, or that one would need a licence for all work in case an embryo was created. That would defeat the purpose of much of the appropriate deregulation that was created after the 1990 Act to allow gametes to be studied in isolation without a process of fertilisation or cloning—clearly that would require a licence. I would be grateful if the Minister could offer any reassurance or provide her understanding about whether people currently working in egg research without a licence for embryos would have to go through the expensive and over-regulatory process of having to get a licence.

I am not sure whether the hon. Member for Norwich, North has a good point about amendment No. 17, but as I say, it is a probing amendment. My other point is about amendments Nos. 18 and 19. The question of whether the Government were being helpful or unhelpful by defining eggs as

“including cells of the female germ line at any stage of maturity”

was explored thoroughly in the Lords. I came to the view, which was shared by people from the science community, that the formulation given by the Government was helpful for a number of reasons, but mainly because if that was not in the definition of eggs, the permitted eggs and permitted sperm approach taken in clause 3 would not, without major amendment, allow in vitro maturation of gametes to be used in the creation of embryos. Sometimes, particularly with young children whose fertility is being preserved prior to chemotherapy, a biopsy would be taken of spermatogonal or ovarian tissue, and gametes would hopefully be derived from those gonadal stem cells in vitro. They would not be stem cell derived gametes; they would be gonadally derived. Without specifying that, it is extremely difficult to construct legislation that allows such a thing. I was reassured by debates in the Lords that the Government are doing the right thing with this definition, although there were a number of concerns. I hope that the Government will confirm that their approach is right.

Dawn Primarolo (Labour, Bristol South)

The drafting and the consultation about updating the legislation worked from the 1990 Act. During the passage through Parliament of the Bill that became that Act, the point at which the regulation of a human embryo should begin was discussed extensively. As a result, the Act provides that it should begin at the initiation of the process of fertilisation, rather than at the point at which the embryo reaches two cells.

To answer the point raised by the hon. Member for Boston and Skegness about the definition of fertilisation, the 1990 Act did not seek to define fertilisation. It was felt that that was a common term used in biology and that the HFEA should make a decision about the term and what it meant within legislation. As he pointed out in his opening remarks on the probing amendments, that Act has stood us in good stead and works. That is a specific answer. We sought to ensure that we were maintaining the position by keeping the wording that an embryo includes

“an egg that is in the process of fertilisation”.

The Science and Technology Committee stated in its 2005 report “Human Reproductive Technologies and the Law” that the definition of an embryo should be changed to begin only at the two-cell stage. That was based on concerns that research might be restricted into the treatment of mitochondrial diseases. Those concerns have been met in the Bill, first through the definition of “embryo”, as it now includes any human embryo created by any process, not just fertilisation, and, secondly, by removing the prohibition on the genetic modification of an embryo for research. Mitochondrial disease research has already been licensed by the HFEA and the changes in the Bill bring further clarification on that matter. That answers the point with regard to legal cases.

We seek to put the position beyond doubt by ensuring that it is reflected in legislation, rather than dealt with by reference to a court judgment. I appreciate that these are probing amendments, but they would reverse the position outlined in the 1990 Act, so that, for the purposes of the legislation, an embryo would not come into existence until the two-cell stage—the point at which the nucleus of an embryo fully forms for the first time. They would, in effect, remove single-cell embryos from regulation, meaning that the creation, keeping, storage and use of single-cell embryos would fall outside the law.

Research on single-cell embryos could then be undertaken without a licence, provided the cell did not divide, and it has clearly been the view of Parliament that we cannot allow the creation, keeping, storage and use of single-cell embryos to fall outside the law. These embryos should be regulated in the same way as embryos at the two-cell stage or later. The Government’s position is therefore that the existing principle, which remains unchanged since it was formed in 1990, should be upheld.

The definitions of “egg” and “sperm” in clause 1 are of equal importance to the Bill and to the HFEA, because terms such as “gamete”, “sperm” and “egg” are vital in setting out the authority’s regulatory remit. While we are often clear about what these terms mean from a biological point of view, definitions can be interpreted differently in the context of legislation. These definitions are designed to set out an effective remit for the authority, clearly indicating what biological material it regulates. How are we to make sure that biological definitions can be interpreted through a regulatory framework? That has always been the challenge. It was the challenge faced by the Committee that considered the 1990 Bill, and, as the hon. Gentleman rightly said, the resulting Act has stood us in good stead.

The definitions of the terms “gamete”, “sperm” and “egg” were drafted to include cells of the germ line at any stage of maturity, and it should be noted that the wording of this provision follows the precedent of section 3A of the 1990 Act, which was inserted by the Criminal Justice and Public Order Act 1994 and ensured that female germ line cells taken from an embryo or foetus could not be used in treatment.

The Bill is drafted to include germ line cells to ensure that the storage and use of ovarian tissue containing immature egg cells to create embryos is regulated by the HFEA and that, following maturation in the laboratory, any egg produced can be used in treatment. It also sets out a prohibition on placing anything other than a permitted egg, sperm or embryo into a woman, and so it is important that the definition of “gamete” includes immature cells of the female germ line. This ensures that the use of in vitro maturation within the context of assisted conception treatment is regulated and permitted. I am sure the hon. Gentleman understands that this is particularly important for women who are undergoing chemotherapy or radiotherapy and will lose their future fertility. Freezing mature eggs is difficult and often unsuccessful, whereas freezing ovarian tissue containing immature eggs is much more reliable.

The legislation that deals with these difficult and complex areas needs to be as clear as possible to ensure that the legality of complex reproductive medicine is equally clear. The clause as it stands ensures clarity around the regulation and use of single human embryos and immature eggs and sperm, making it clear that single-cell embryos fall within the authority’s remit and that immature gametes may be matured in the laboratory and used in treatment.

If the amendments were made, clarity would be lost and single-cell embryos would fall outside regulation. The law would, at best, become uncertain and, at worst, prohibit the use of immature eggs and sperm in reproductive therapies. In trying to address what were the difficult challenges in 1990, the Government have listened very closely to the evidence presented and to debates about the Bill in another place. We have proposed the wording as it stands. I assure the hon. Gentleman that the Government seek to continue to regulate and enforce according to the principles of the 1990 Act, which I know that he and many of his hon. Friends support. I hope that he accepts that his probing amendment has secured comments on the record for clarity and that he will withdraw it at as suitable time.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I would be grateful if the Minister would address herself to the point that I raised about her expectations of the impact of the new wording on people who are researching eggs, but not putting them through a process of cloning or fertilisation. In their research, an egg may start to divide as a consequence of manipulation that is done for perfectly legitimate scientific reasons—not as the deliberate end point of the research, but just as a happenstance. The 1990 Act stated:

“embryo means a live human embryo where fertilisation is complete, and...references to an embryo include an egg in the process of fertilisation”.

I understand that. It has been transferred to the Bill, but the new Bill also states that

“references to an embryo include an egg”

not just in the process of fertilisation, but

“undergoing any other process capable of resulting in an embryo.”

The Government had the option of stating that references to an embryo would include an egg that had undergone any other process capable of resulting in an embryo and, indeed, of considering a one-cell embryo to be an embryo, thus avoiding the worry about the distinction between one-cell and two-cell embryos. I accept the Minister’s view that one-cell embryos have to be included in regulation, but the wording “has undergone” would enable research that does not intend to produce an embryo to continue without a licence when it is looking at the properties of an egg. I wonder whether the Government considered using the wording, “has undergone any other process resulting in an embryo”, rather than

“is undergoing any other process capable of resulting in an embryo”.

The definition used is going to make things wider. At the moment, there is no defence for people researching eggs when there might be division. What is the Minister’s response to the point I raised originally? Secondly, did she consider the slightly narrower definition that, I think, would still tick all the boxes that she quite rightly feels ought to be ticked to ensure that regulation is accurate?

Dawn Primarolo (Labour, Bristol South)

The issue that the hon. Gentleman raises is not a new problem with regard to the interpretation of the regulations. Clearly, an embryo outside the body is subject to regulation. However, he touches on a practical issue for researchers and regulatory authorities regarding of the purpose of research. I said that when an egg is developing into an embryo, either a licence would be needed, or the egg would need to be destroyed. That is the position.

In answer to the hon. Gentleman’s second question, that matter was carefully considered. At every point, the struggle—if I may put it like that—in drafting legislation is to come up with definitions that clearly define regulation and therefore make the legality of the regulation work. The Government settled where they did on that basis. During the debates on the Floor of the House we found, as I am sure we will find time and time again as the Bill progresses, that there were very fine judgments and difficulties when going from biological definitions and trying to permit scientific development and then putting that into legislation so that it is capable of regulation.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am grateful to the Minister for addressing those points, and I beg the forgiveness of the hon. Member for Boston and Skegness for responding to the Minister’s comments before he finishes the debate. On the second point, the Minister is clearly saying that all options were considered and that this one was decided on for good reasons. One must accept that at this stage. I was interested to hear that the practical issue for researchers working on eggs could be dealt with in one of two ways. First, she said that that could be licensed. Obviously that would be possible, although it would be a burden if the intention of the research was not to produce an embryo or something capable of resulting in an embryo.

The Minister’s other option was that the egg would be destroyed. Perhaps she cannot give me more detail now, but if she could clarify what she means by that in a letter, I would be grateful. Is she saying that if this was unlicensed work, but the researcher noticed that an egg was dividing on its own, as long as that egg was destroyed, there would be no question of the researcher having to get a retrospective licence or being prosecuted? That would be a significant reassurance for researchers, some of whom have contacted me to raise their concerns. I ask her to confirm that now, or to offer useful clarification in a letter to me and other members of the Committee.

Mark Simmonds (Conservative, Boston and Skegness)

As I said at the beginning, these are probing amendments. I thank the Minister for her thorough and detailed response and her clear answers both to the amendments and to the comments made by the hon. Member for Oxford, West and Abingdon. It was never the intention of the amendment to remove research on single-cell embryos from the law. We were looking for greater clarity, not a loss of clarity. Of course, I accept the prohibitions that are set out and detailed in this part of the Bill. I also accept the challenges that the Minister highlighted of translating biological definitions into legislative drafting and structure. It is always a challenging journey to do that, and that will be a common theme as we go through the Committee stage. It is a challenging juxtaposition to get those two things right. With those comments, I beg to ask leave to withdraw the amendment.

Roger Gale (Conservative, North Thanet)

Those who have served on Committees under my chairmanship before know that I take a fairly relaxed view of stand part debates and breadth of discussion. It is often helpful for the Committee to have a broad-ranging debate on a first set of amendments as it tends to set the discussion in context. However, I am not prepared to permit two stand part debates, one at the beginning and one at the end. Inevitably, in this context, with a fairly narrowly drawn clause, we have already had a fairly broad debate so I suspect that I may be minded to consider that a stand-part debate is not necessary. It is only fair that I should tell the Committee that now.

Clause 2

Mark Simmonds (Conservative, Boston and Skegness)

I just have a brief question for the Minister about the definition of nuclear DNA. Why does the clause not include a definition of mitochondrial DNA, which is obviously different from nuclear DNA?

Dawn Primarolo (Labour, Bristol South)

The clause specifically deals only with nuclear DNA, and it was required only to ensure that the new definition in section 2 of the 1990 Act actually clarified the term “nuclear” to include the pronucleus of an embryo. That was specifically what we were trying to do here. We did not go on to define “mitochondrial” for the same reason that I gave the hon. Gentleman with regard to the definition of fertilisation in terms of where it was anchored in 1990. There is an accepted standard biological term in the case of “fertilisation”, as there also is in the case of “mitochondrial” and therefore it was considered not to be necessary.

Gary Streeter (Conservative, South West Devon)

The Minister says that the Bill deals only with nuclear DNA, but proposed new section 3ZA(2) and (3) refer to “nuclear or mitochondrial DNA.” Surely that would warrant a definition.

Dawn Primarolo (Labour, Bristol South)

The answer that I just gave to the hon. Member for Boston and Skegness was that we did not define “fertilisation” because it was not necessary to have a definition, since there was a clear biological meaning for HFEA to interpret. The same is true of “mitochondrial.” What was necessary was to clarify DNA to include the pronucleus, and that is why clause 2 is here. The biological definition of “mitochondrial” stands in the same way as that of “fertilisation”.

Mark Simmonds (Conservative, Boston and Skegness)

I am intrigued by this because later on in the Bill we are going to be discussing allowing mitochondrial DNA to be implanted to stop mitochondrial disease, but prohibiting nuclear DNA from being manipulated to stop nuclear DNA diseases being transferred. There is a distinct difference between the two kinds of DNA, depending on where they are located within the cell. That is why I am intrigued as to why there is no distinct definition between the two.

Dawn Primarolo (Labour, Bristol South)

And the answer I am giving is that, where a definition is contentious, where it is challenged, as it was between “nuclear” and “pronuclear”, it is necessary to define. Where it is not, as with “fertilisation” and “mitochondrial”, it is not necessary because the biological terms stand. It is not that the Bill is silent on this: it is anchored by the clear understanding.

Robert Key (Conservative, Salisbury)

What a pleasure it is to serve under your chairmanship, Mr. Gale. Clause 2 of the Bill refers at the end of the first line to

“the definition of ‘non-medical fertility services’”

in section 2(1) of the 1990 Act, but the 1990 Act does not mention “non-medical fertility services”. It is rather important, since we are dealing with definitions right at the start of the process, that we are absolutely sure what is meant by the term “non-medical fertility services”—the phrase is in quotes in the Bill. I am not at all sure at the moment.

Dawn Primarolo (Labour, Bristol South)

I shall make sure that the hon. Gentleman and the members of the Committee have a full definition of what that means, to ensure that they understand the position. I have a feeling that it will come up later, when we discuss the European Union tissue directive. I am trying not to jump ahead of myself in the Bill.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The Government, with the draft Bill, helpfully provided the 1990 Act as amended by the regulations—I think that they were the European tissue directive regulations. The regulations inserted the reference to “non-medical fertility services”. Those services would be

“any services that are provided, in the course of a business, for the purpose of assisting women to carry children, but are not medical, surgical or obstetric services.”

The European directive required us to widen the scope of some of our regulations to include that. I commend that document, because it gives the 1990 Act not only as amended by the draft Bill, but also as amended by the directive.

Robert Key (Conservative, Salisbury)

On a point of order, Mr. Gale. It seems appropriate for that document to be made available to the Committee, if the Bill as we have it does not take account of that.

Roger Gale (Conservative, North Thanet)

The hon. Gentleman pre-empts the announcement that I was about to make. That document will be made available. I apologise that it is not here. Why I apologise, I am not sure. I do not think that it is my responsibility, but we will make sure that it is made available.

Dawn Primarolo (Labour, Bristol South)

It is this document.

Mike Penning (Conservative, Hemel Hempstead)

Where is it?

Dawn Primarolo (Labour, Bristol South)

It was circulated with the Bill. If it is not in the room as well—

Roger Gale (Conservative, North Thanet)

Order. For clarification, we will ensure that that document, whether or not it has been circulated, is made available in the room in time for this afternoon’s sitting. Everyone happy?

Mark Simmonds (Conservative, Boston and Skegness)

May I say one final thing on clause 2? I am trying to draw information. Unusually, I am not particularly happy with the Minister’s response. I understand about the broader definition. As I said before, that will be one of the main challenges and themes running through the Bill. However, there are distinct differences between mitochondrial DNA, nuclear and pro-nuclear DNA. I think it would be sensible if the relevant individuals went back and gave some thought to whether that distinction needs to be made clear in the Bill.

Clause 3

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 1, in clause 3, page 3, line 7, at the end insert

‘except when the egg has in prescribed circumstances undergone a prescribed process designed to prevent the transmission of serious or life-threatening mitochondrial diseases.’.

Roger Gale (Conservative, North Thanet)

With this it will be convenient to discuss the following amendments: No. 2, in clause 3, page 3, leave out lines 19 to 24.

No. 33, in schedule 4, page 67, line 8, after ‘gametes’, insert ‘including the mitochondria,’.

Mark Simmonds (Conservative, Boston and Skegness)

Clause 3 deals with prohibitions in connection with embryos. Amendment No. 1 relates to the transfer of some serious and life-threatening diseases through the mitochondrial part of the cell—the outside part, surrounding the nucleus—which can be translated through generations. I am supportive of mitochondrial research, which could make a significant contribution to eradicating—certainly reducing the incidence of—some serious diseases that are passed on through the generations. The amendment would place a reference to mitochondrial transplant in the Bill, rather than in a regulation-making power. Such a serious area of medical research clearly throws up, as other parts of the Bill do, important moral and ethical issues, which Parliament needs to debate thoroughly.

You may or may not be aware, Mr. Gale, that there are no mitochondria in sperm. Scientists are working to remove the nucleus of a cell of a woman with a mitochondrial disease, place the cytoplasm of a healthy woman’s egg in there, and then fertilise it. Once normal mitochondria are established, future generations will also have normal mitochondria. The controversial part of this is that the resulting child will have 99.5 per cent. of the mother’s genetic material, 100 per cent. of the father’s genetic material and clearly 0.5 per cent. from a third party, although the DNA in the mitochondria—this is the part that I think is very significant—carries no information that defines any human attributes.

Indeed, Professor Turnbull at Newcastle university has carried out under licence a process whereby an ovum from a woman with a mitochondrial disease has been fertilised by her partner’s sperm. As soon as the first cell is formed, it contains two pronuclei, one from the woman and one from the partner, containing 100 per cent. of his DNA and 99.95 per cent. of hers. However, at the moment, the licence from the HFEA does not allow this embryo to be implanted in the woman. I think that this needs to be changed in the actual Bill rather than through regulation-making powers.

Amendment No. 2 removes the regulation-making power, which would be superfluous if the reference was included in the Bill.

Amendment No. 33 is a consequential amendment that, if mitochondria donation is permitted under amendment No. 1, ensures that consent is received from a person whose mitochondria are used in treatment. Mitochondria are tiny parts of the gamete, so it is important that the Bill refers not just to whole gametes but also to parts of gametes, and it is absolutely important that consent remains a fundamental cornerstone of the Bill and this particular part of the Bill.

Robert Key (Conservative, Salisbury)

I think I am right in saying that I am the only Back-Bench member of this Committee who is a veteran of the 1990 Standing Committee—although I am delighted to acknowledge the Minister as another veteran of that Bill. The amendment raises issues that are absolutely fundamental to this Bill. I entirely support what my hon. Friend has been saying about this specific issue. However, it raises the more fundamental issue of the purpose of the legislation and the process by which we need to consider it.

In the 1990 Act, we tried to set out the broad framework and established the HFEA as the body of specialists charged with carrying out the wishes of Parliament. That was one reason why the HFEA was never designed to be made up of people who were, on the one hand, very pro-science and pro the processes involved, and on the other hand, deeply philosophically and ethically opposed to it. That was not the function of the HFEA.

In terms of the legislation now before us, the pre-legislative scrutiny Committee of both Houses, on which I and others here sat, was equally clear that Parliament’s role was to establish the broad legislative framework, and the moral and ethical dimensions within which regulations should be made, by those who best knew what was happening. One of the problems from 1990 onwards—it was inevitable and it was forecast—was that science would always be ahead of Parliament. Parliament’s duty was to ensure that the Government of the day could take account of improvements in medical science and technology, of movements in public attitude and in the scientific approach to the moral and ethical issues. It was to ensure that the regulatory body made the final judgment on individual cases and applications for research projects and clinical trials. That is what we are up against here.

Since I, along with the pre-legislative joint Committee, recommended this procedure, I would prefer to see this particular clause stand as it is, and certainly not see it removed. That does not devalue what my hon. Friend the Member for Boston and Skegness has said. He is absolutely right. However, it does mean that we should not tinker with the fundamental principle that it is for Parliament to set the broad parameters and for the regulatory authority to decide the detail.

John Pugh (Liberal Democrat, Southport)

The business end of this group of amendments relates to subsection (5), which is related in turn to subsection (6), which repeals a section of the Human Reproductive Cloning Act 2001—which, I believe, is repealed in full elsewhere in this piece of legislation. There are some anxieties about doing that, but there is a desirable goal to be achieved, namely, preventing the transmission of serious mitochondrial disease. I support attempts to achieve that. The problem is that there are many ways to do it.

Pre-screening is one way with which we are familiar. However, if we look at nuclear transfer, which appears to be the object of the regulations mentioned in the Bill, there are different ways in which that may be done. There is the simple case of transferring one person’s egg into another person’s cytoplasm. There is also the transferring of a fertilised embryo into the cytoplasm of a third person. That creates some concerns. Lord Walton announced in the House of Lords that researchers at Newcastle university had found successful ways of doing that, and he pointed it out as something else that was new and which could be authorised by the legislation and subsequent regulations.

It is an inescapable fact that some mitochondrial diseases are not a product of diseased mitochondria per se, but have an origin in the nucleus of the cell itself. That is an indisputable scientific fact, and I do not think there is any argument about it. It would follow from that, necessarily, that regulations are therefore capable of prescribing in this particular case manipulation of the nucleus of human cells or some form of connected engineering. The Minister can contradict me on that, but it seems to me a fairly transparent reading of the legislation as it stands before us. It does not seem to be the case—particularly as we have not repealed the Human Reproductive Cloning Act 2001—that there is a loophole whereby cloning can also be authorised.

There are genuine ethical concerns here. I am concerned that this is, in a sense, carte blanche. It is an opportunity for a number of things to happen, some of which we will be comfortable with, and some of which we will not. Lord Walton, in the House of Lords, said that he thought this probably was encompassed by the legislation. However, in a less than complimentary article in Nature, Dr. Chinnery, who conducted the research to which Lord Walton referred, said:

“I wouldn't feel comfortable doing it [in patients] now for a number of reasons ... There are a number of scientific, legal and ethical issues—we've got to engage in a debate to ensure that society feels this is the right thing for us to do.”

Who is going to engage in the debate? It seems to me that if we leave the clause as it stands, the debate is only going to be had in the HFEA and nowhere else.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Does my hon. Friend accept that there has been some debate on this in recent years? There was debate both outside and inside Parliament, on the White Paper and on the draft Bill. Under the Bill as proposed, there would have to be further debate in Parliament and outside when regulations were brought allowing the manipulation of eggs or embryos to tackle the problem of mitochondrial disease. There has been a lot of debate, and there is plenty of scope for more.

John Pugh (Liberal Democrat, Southport)

I would be much relieved if I thought the fine detail of this were going to be examined by elected Members, but I do not think that that is the case. I think it is more likely to be the object of appreciable debate in the HFEA and nowhere else. It will simply happen. Even so, it is clear that we must know what we are doing and what the Bill encompasses. Matters are as simple as that.

The broad clause prescribes circumstances and processes for which regulations may provide. I am unhappy about such an approach. Had we moved amendment No. 21, I would have drawn attention to that. Elsewhere in the provisions that we have dealt with so far, clause 1(5) allows the Secretary of State to redefine key terms such as “gamete” and “embryo”. There are genuine anxieties about that. If fundamental concepts of legislation can be redefined on the hoof, concern will be expressed. We must be fairly clear about what is happening. It is not as though any of the learned papers that I have read so far about the provisions establishes a clear, moral consensus. That does not exist. We have blank cheque legislation. I used that expression on Second Reading, and do not repent doing so.

The more positive way in which to express matters is used by advocates of the Bill as it stands. They talk of future-proofing legislation. Future-proofing is a more positive way in which to describe what I referred to as blank cheque legislation. It is fine. I am all for future-proofing legislation. I do not have a fundamental difficulty with the concept per se, as long as we future-proof against a set of principles and moral ideas that we all clearly understand and we know where they are heading.

If Lord Walton, who is from the university of Newcastle, sees no problem with something with which someone who undertakes research can see scientific and moral difficulties, then transparently, evidently and empirically that consensus does not exist. I know the Government’s intentions because they have outlined them on many occasions. They have said that they do not want to provide a loophole for reproductive cloning. That is entirely fine, and I dare say that they do not want genetic manipulation to take place either as a way to deal with mitochondrial diseases, but that is not what the Bill says. The Government’s intentions and their legislation are two different things. I am therefore genuinely concerned. In a sense, amendment No. 2 would strike out such matters, but it would also strike out laudable attempts to address mitochondrial disease where the cause is the mitochondria per se. People might be unhappy about that. I ask the hon. Member for Boston and Skegness to correct me if I have not understood the amendment properly. I do not think that the Committee would be comfortable with such a dramatic outcome.

Mark Simmonds (Conservative, Boston and Skegness)

I just wish to assist the hon. Gentleman and clarify the intentions of amendment No. 2. It would strike out the Secretary of State’s regulation-making power because the decision to allow the mitochondrial research would be inserted into the Bill. As a result, lines 19 to 24 of clause 3 on page 3 of the Bill would become superfluous.

John Pugh (Liberal Democrat, Southport)

I am comforted by that explanation and anything that would make the Government’s intentions more clear in the Bill and leaves discretion where it should be. A clear moral consensus about what may or may not be done would make me feel more comfortable about the Bill as a whole. However, if we look at it from the point of view of the parliamentary draftsman, we must say that it leaves the door wide open to all sorts of things that the Committee has not even envisaged.

Gary Streeter (Conservative, South West Devon)

I am delighted to serve in Committee under your chairmanship, Mr. Gale. I rise to support the last two speakers. Whereas the Bill takes great pains—to the credit of the draftsman—to prescribe and regulate tightly activities that may or may not take place, we find suddenly in subsection (5), the subject of amendment No. 2, which I support, that the Government may make regulations in the future to deal with something that is not permitted under the Bill at present. To correct the hon. Member for Southport, I must say that the regulations would be made not by the HFEA but by the Government.

Robert Key (Conservative, Salisbury)

By Parliament.

Gary Streeter (Conservative, South West Devon)

The regulations would be made by the Government tabling a statutory instrument before Parliament. We know the extent of scrutiny that that can involve—perhaps 90 minutes of debate which, first and foremost, would be within the Government themselves. There would then no doubt be a short debate in Parliament.

I want to ask the Minister whether the wording of subsection (5) is as tightly drawn as it might be. Reading with my legal eyes on, I agree that it could well become a loophole in the hands of future Governments—obviously not in those of this Government, who are sensible, moderate and regulatory and who we are thrilled are in place at the moment. We could even have a coalition Government; the hon. Member for Oxford, West and Abingdon could be the Secretary of State for Health. We do not know what might happen in future.

The clause is capable of a wide interpretation and I will explain why. If we read it as it might be drafted without its sub-definitions:

“Regulations may provide that—

(a) an egg can be a permitted egg, or

(b) an embryo can be a permitted embryo,

even though the egg or embryo has had applied to it—”

—in circumstances set out by regulation, a process also set out by regulation, which is—

“designed to prevent the transmission of serious mitochondrial disease.”

Control over the process and circumstances is entirely in the hands of the people who write the regulations. As I understand, that could be far wider than the issue that my hon. Friend the Member for Boston and Skegness referred to, which is at the back at the Government’s mind. That is the process by which we take a little bit from one egg, mainly the mother’s, and make an egg which is free from genetic diseases. Who could argue with the desire behind that? However, in my opinion the wording of the clause goes far beyond that. As technology develops, it could allow regulations to be made that take us well beyond that in terms of circumstances and processes that regulate what egg and what embryo.

I hope that the Government will look again at that point. Many people are concerned that new section 3ZA(5) is a loophole, probably unintended, but a loophole nonetheless. It could end in permitting the kind of reproductive cloning or genetic manipulation that the Government have rightly set their face against. I hope that when the Minister responds, she will not brush such concerns aside as they are held by a number of people. The point is more about drafting than ethics or science. The drafting of subsection (5) must be looked at again.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I rise to support the Bill as drafted and to follow up the point made by the hon. Member for Salisbury. I am delighted to see the amendments tabled by the hon. Member for Boston and Skegness. They press for a more permissive approach on the question of permitted embryos than the Government envisage. The idea behind them is that we should not need further regulations, and that there is enough information to show the likelihood that the technique will be both effective and safe enough to trial under informed consent. In addition, we have enough confidence in the regulator to ensure that those two provisions are policed with regard to effectiveness, safety and consent, so that we do not need Parliament to approve specific regulations. Those arrangements could be designed by the HFEA.

I have great sympathy with that approach. I have always pressed for a more permissive approach, given that we have an authority that everyone says is wonderful and adept at making the regulations. I know that the approach proposed by the hon. Member for Boston and Skegness was proposed in the House of Lords by Lord Walton, who has connections with Newcastle university where much of this work is being done by Doug Turnbull’s group. Although I have a huge amount of sympathy with the hon. Gentleman’s approach, one would have to have regulations to prescribe and circumscribe what we want. In the end, I can see no other way than to provide for the regulations, although I have sympathy with what he is doing. It is important that the House indicates very clearly that we want to be able to translate research—which is currently permitted in this area—into the clinic, and that we signal very strongly that we are minded not to oppose the concept of regulations, but to ensure that further scrutiny is of the regulations, not the principle. I am glad to see that there appears to be widespread support from all sides of the House for this sort of approach. I hope in the separate clause stand part debate to identify another area where we need to ensure that research that does not come under mitochondrial disease can be translated from the clinic to clinical therapies for patients.

My hon. Friend the Member for Southport was not really supporting the approach I just set out. He was arguing that we cannot simply leave it to regulations, because regulations would be a simple one and a half hour debate in both Houses under the affirmative procedure, as set out later on in the Bill. Clearly, whenever we agree to a regulation-making power, we limit the amount of amendments that can be made to the regulations. So I hope that the Government would agree, insofar as they can for this Government—because it may not be in the time scale of this current Government—that if they do propose to introduce these regulations, they will produce them in draft for consultation. After that, the regulations could be reconsidered and brought back again without having to be formally withdrawn. That would be considered quite a big step in this place: one rarely sees regulations that are laid in draft withdrawn, so I hope that the Government will take a consultative approach to the drafting of the regulations.

I would say again to my hon. Friend the Member for Southport that there was considerable debate about this during the consultation period, considerable debate around this in the White Paper, and considerable debate on the draft Bill. It was considered by a Joint Select Committee of both Houses and I think there has been plenty of public, as well as parliamentary, debate.

John Pugh (Liberal Democrat, Southport)

The point that I made that my hon. Friend has not addressed was in connection with the different ways in which one could tackle mitochondrial disease, either by doing something with the nucleus or by cell transfer. One represents a clear step in the direction of genetic engineering; the other, one could argue, does not to the same extent. My hon. Friend may not see that distinction, but other people do. If there is that kind of moral divide—it is a significant moral divide, though it may not be significant for everybody—would it not be more appropriate not to regulate but to tighten the legislation sufficiently to circumscribe what the legislation intends to facilitate?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I accept that point and I wanted to come on to it, along with the point made by the hon. Member for South-West Devon, because there is a small problem—which I admit I did not notice during the Bill’s passage through the Lords—with the phrasing of subsection (5). I just wanted to finish the point that I was making on the amendments more broadly.

Mitochondrial DNA, which causes some mitochondrial disease, represents about 0.5 per cent. of the genes that humans have. The DNA in the mitochondria do not code for any human attributes. These are genes that have been preserved through evolution from bacterial inclusions in cells, and therefore are common across many species, though they will differ between species.

On that basis, if one accepts that it is possible to change the DNA in mitochondria without its being considered germ-line gene therapy or germ-line gene engineering, because we restrict that to nuclear DNA, then I would argue that it is probably not appropriate to have the same consent arrangements for donors of mitochondria as for donors of nuclear DNA. So I question whether amendment No. 33, even within the construct that the hon. Member for Boston and Skegness has put, is appropriate, because it gives a status to the mitochondria in respect of consent that they do not deserve because they do not pass on recognisable human attributes, which is the basis for the very strong consenting arrangements that the Minister has proposed.

I would be grateful if the Minister could clarify that, as at the moment it is not clear whether there is, or needs to be, any difference in the consent arrangements for the donor of mitochondrial DNA. Clearly donors must consent to the donating of the tissue, but it is not clear whether that is done under the strong and strict consent arrangements that exist under the Human Tissue Act 2004, or whether the Government envisage going further and introducing regulations to raise the status of that donation. I am not convinced that we need to raise the status, as it is a tissue donation. I would not want it to be seen as a donation of a genetic attribute, as that would make it more difficult for us to defend what the Government are doing, with my support, in the Bill.

As this has been raised, it is appropriate to speak about subsection (6). However, we will come that in the next debate, so I will not mention it now. On the issue raised by my hon. Friend the Member for Southport and the hon. Member for South-West Devon, there may be a problem. I have seen a document from Human Genetics Alert—an organisation with which I generally disagree in principle and in practice—that points out this issue. Some mitochondrial diseases, including serious ones, are transmitted by nuclear DNA coding for some of the proteins in the mitochondria. The argument would be that the current wording of subsection (5) would permit in the regulations a process by which the egg or embryo could have nuclear transfer as the prescribed process, or at least gene transfer into the nucleus designed to prevent the transmission of serious mitochondrial disease. The Government have already said that that is not their intention and I do not believe that it is the intention of the researchers working on this in Newcastle university and elsewhere. They have made that absolutely clear. I do not believe that any Government would produce regulations permitting that, or that the HFEA, even if it could, would issue a licence for it. However, if that is the case, perhaps the Government would consider making that clear in subsection (5) of proposed new section 3ZA, which sets out what the regulations may provide. They might for example, at the end of the section

“even though the egg or embryo has had applied to it in prescribed circumstances a prescribed process designed to prevent the transmission of serious mitochondrial disease”

add “transmitted by DNA in the mitochondria”.

As I said, the two hon. Members who spoke before have raised a valid and fair point and I would be grateful if the Minister could address that in her response.

Dawn Primarolo (Labour, Bristol South)

This has been an interesting debate. There have been quite a few misunderstandings about the intention of the clause, which I hope that I can clarify.

Mitochondrial diseases are a collection of life-threatening conditions caused by mutations in the small amount of DNA found in the mitochondria. The mutations affect children and cause illnesses and other conditions such as fatal liver failure, stroke-like episodes, blindness, profound muscular weakness and diabetes. Research is currently being carried out under an HFEA licence to look at ways to avoid mitochondrial diseases.

In recognition of the severity of those conditions and the potential of this research to provide an effective treatment, the Bill provides, through a regulation-making power, for eggs or embryos that have had applied to them a specific process to avoid serious mitochondrial diseases to be considered as “permitted” and therefore used in treatment. The particular process and the particular circumstances in which it would be appropriate would be detailed in the regulations, and I want to come back specifically to how we would proceed with such regulations. First, I shall deal quickly with the amendments.

Amendment No. 1 adds the words “or life-threatening”, so that the technique could be used to treat serious or life-threatening conditions. I say very gently to the hon. Member for Boston and Skegness that, as I currently see it, that does not add anything to the Bill, which already allows for serious conditions, and clearly, life-threatening conditions are serious. The amendment seems unnecessary at that level, but it would also limit the way that the technique could be applied by restricting it to eggs only. That would mean that, if should it transpire, following research, that the best way to avoid serious mitochondrial disease would be through modifying recently fertilised eggs— which would therefore, according to the definition in the Bill, be embryos—it would not be possible.

If the regulating power were removed, there would be no flexibility to return to it in future. I want to be absolutely clear that the Bill provides limited powers for secondary legislation to ensure that the definitions of gamete and embryo are clear, and strictly limited powers to allow for the treatment of mitochondrial diseases at the embryonic stage. They are all affirmative resolutions by both Houses. There has clearly been some comment about what would precede the debates in both the Houses, and I shall come to that shortly.

Amendment No. 3 would amend new schedule 3ZA by including in the types of treatment for which counselling must be offered a specific reference to mitochondria. That would ensure that counselling was afforded if mitochondria of gametes were used in the treatment services rather than the gametes themselves. The amendment is not necessary because even if mitochondria were extracted from the egg, the egg would still have to be used for the purposes of these provisions, and the couple receiving the treatment would still be offered counselling. There is no need to add an additional provision.

On the relating power included in clause 3—

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Can the Minister clarify that there would not need to be counselling of the person providing the mitochondria in such a process, but just the couple having the child?

Dawn Primarolo (Labour, Bristol South)

At this stage I am referring just to the couple. I am coming on to the regulation-making power, what it can do, how we would proceed, the sort of questions that may be raised, and why it is not currently possible to put that into the Bill because of the process of the research.

The regulation-making power in the clause is to make secondary legislation, and it is about helping couples to conceive a child without a serious medical condition. It is not about reproductive cloning on which the Government are absolutely clear and committed to a ban. The Bill makes crystal clear the definitions of what is a permitted embryo and therefore what can be placed into a woman.

To date, research is looking at transferring genetic material from a recently fertilised egg from the couple seeking treatment into a donor egg with the genetic material removed. That does not involve somatic cell material. It is not anticipated that it would. The commitment to the ban on reproductive cloning and oversight of the technique as a whole would be ensured by setting out the specific process in regulations, and those regulations would be subject to the affirmative procedure.

John Pugh (Liberal Democrat, Southport)

Will the right hon. Lady give way?

Dawn Primarolo (Labour, Bristol South)

Will the hon. Gentleman be a little patient? He raised a lot of important issues in respect of how we will proceed with the regulations, and I intend to answer them.

It is not clear whether the research will demonstrate more success with eggs or embryos, hence the matter of whether it is specifically in the Bill. Although to date it focuses on very recently fertilised eggs, which under the Bill’s definition would be an embryo, we cannot rule out the possibility that eggs may offer the most successful treatment. It is therefore essential that the possibilities are not limited and that all treatment options are left open by ensuring that the prescribed process could be either for eggs or embryos.

In addition, details relating to the circumstances of mitochondrial donation can be provided for under the regulations as and when they are drafted and consulted on—both points made by the hon. Members for South-West Devon, for Southport and for Oxford, West and Abingdon. That would include consideration of whether all the donor information would apply to the mitochondrial donors. There is also scope to amend specifically the relevant consent provisions through the regulations. In addition, separately from the regulations, it would be standard practice in a clinic that any person donating eggs or material used to create an embryo, such as cells, would provide consent and be given the opportunity for counselling.

Returning to the point made by the hon. Member for Salisbury about the importance that Parliament sets on broad parameters and the way that we have proceeded in all the debates since 1990, the first step would be to prepare draft regulations for consultation. Because of the issues that will be raised, a full consultation would be undertaken in much the same way as we have done in respect of many aspects of the Bill.

The results of the consultation would be considered. Amended drafts would be made available, if necessary for further consultation before matters came to this House and the other place for debate and affirmative resolution. Because there are so many questions that we cannot yet answer, the Bill provides for the principle, but not the means—the regulations. They can be drafted only when the research is at a more advanced stage. That satisfies the dual principles that Parliament seeks to achieve. We want to approve—and rightly so—the specific details of the techniques prescribed in the regulations.

The regulating power would allow for consideration and consultation. It would be necessary to gather the views of the public, ethicists and relevant stakeholders on the appropriateness of using donor eggs for that specific process. That would need to be considered at that stage. The Bill provides the flexibility for further consideration by the public and Parliament, and for the specific details of the techniques to be specified in regulations. More importantly, the Bill allows that once the safety of the technique is established and not before. The provisions of the Bill will provide opportunities for couples to have a child safe in the knowledge that they will not suffer from serious mitochondrial conditions that may affect their families. That is precisely the intent. On that basis, I hope that the hon. Member for Boston and Skegness will reflect on the fact that his amendments would weaken the intent and curtail the debate so that it can be held at the appropriate time, when we have more accurate indications of the science and what we might be agreeing to.

John Pugh (Liberal Democrat, Southport)

The Minister used the phrase “crystal clear”. My point is that it is not crystal clear from the phrasing of the Bill that interference with somatic cells of the nucleus is prohibited. In fact, as the Bill is written, it is allowed. She has said that regulation will preclude that, but regulation is not legislation, and she might not be the regulator in the future. Would she confirm that? I know what the Government’s intentions are and I know what the regulations are likely to address if she is the Minister, but the Bill as it stands allows what I said, even though it does not want to do so.

The second point that I want to make, briefly, is about the scope of regulation, which the Minister has not really responded to. We are debating a Bill about human fertilisation and we are allowing “embryo”, “egg”, “sperm” and “gametes” to be redefined by regulation. If the hon. Member for Norwich, North were here and we had a terrorism Bill with a clause saying that “terrorism” could be redefined by regulation at a date subsequent to the passing of the Bill, he would be frankly appalled. There is an issue about the range of regulation, and also about what regulation can do and what it does.

Dawn Primarolo (Labour, Bristol South)

I said to the hon. Gentleman that I did not agree with his interpretation. More people take my view than take his. This is precisely the type of debate that has taken place since the 1980s about interpretations of what is possible and of the law. I believe that the fears that he holds will not come to pass, and I am convinced that the Bill protects that. I am grateful for what he says about what he believes will be done if I am the Minister—that would be the case—but I have absolute confidence that every parliamentarian in the House, whoever happened to be the Minister at the relevant time, would ensure that the scrutiny of the proposals was commensurate with the clear wishes of the House.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Will the Minister give way?

Dawn Primarolo (Labour, Bristol South)

Just a minute, please. The clear wish of the House—in the past, now and in the future—is for the issues to be scrutinised thoroughly. The reverse would be true if we tried to put an incomplete definition in the Bill that did not stand the test of time because it was drafted before the knowledge was available.

Dr. Harrisrose—

Dawn Primarolo (Labour, Bristol South)

I give way, once more, to the hon. Gentleman.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am grateful to the Minister for giving way to Opposition spokespeople who are probing her. I am grateful for her answer, which is clear as far as it goes. I raised a specific point that was made more generally by two other members of the Committee. Even if she proposes to do nothing about it, will she accept the principle of what regulations could provide, even if that is not her intention or, in her judgment, the intention of any future Minister? Is it her view that the provisions might permit a process designed to prevent the transmission of serious mitochondrial disease transmitted by nuclear DNA, not just by mitochondrial DNA? If she accepts that that is possible, and that people might therefore think that it is possible in the future by regulation, does she see any merit in having a look at that before Report to determine whether—very carefully and so as not to preclude any scientific advance—the provision could be narrowed sufficiently to make it absolutely clear to those who worry about a slippery slope and over-permissive legislation regarding genetic alteration that there may be scope to narrow things somewhat?

Dawn Primarolo (Labour, Bristol South)

To answer the point about redefining or adding, which was raised by the hon. Member for Southport: no. It is simply incorrect to assert that they can be redefined by secondary legislation.

The hon. Member for Oxford, West and Abingdon is theoretically correct, and if he can think of a better way of doing that, that is fine. However, nobody has so far managed to do so—including him, during pre-legislative scrutiny.

The Government have stated clearly that there should be a prohibition of genetic modification such as the Bill provides, so it is, frankly, dangerous for the hon. Gentleman to move into the sphere of what might theoretically be possible, even though it is prohibited, because he undermines the principles in the Bill to which he is committed.

I think we have had a very interesting debate. This is a very difficult area—there are not many simple areas in the Bill—but I hope that the thoroughness of the consultation and the extensive contributions that have been made to the process satisfy members of the Committee that the Bill is as accurate and as well crafted as possible, and that there is therefore no reason not to proceed with the arrangements in the clause. When the hon. Member for Boston and Skegness replies, I sincerely hope that he will consider withdrawing his amendment, at least to allow further reflection, rather than pressing it to a Division.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I thank the Minister for responding to my point. I appreciate it when she addresses a point that I raise. I accept that there is a risk of being over-prescriptive for fear of something that is theoretically possible. She knows that I want to see something that allows Parliament to have confidence in regulation, but that is not over-regulatory as far as scientists, researchers and clinicians are concerned. I want something that allows this country to be seen as a properly regulated, ethical place in which to do research, but a place that allows research to go on.

I confess that I did not spot this issue in the pre-legislative scrutiny period. I do not find it easy to acknowledge that it was pointed out to me by Human Genetics Alert, an organisation that, I think, gets it wrong a lot of the time and interprets incorrectly some of the proposals that we are addressing. The Minister has accepted that there is a point here. I have not thought about what the drafting would be, but I think that she has given an invitation to others to look at whether there can be drafting that makes it very clear that we are not envisaging the alteration of nuclear DNA. She mentioned that the Bill provides for a ban on the alteration of nuclear DNA, which is found in proposed new section 3ZA(4), which states:

“An embryo is a permitted embryo if...no nuclear or mitochondrial DNA of any cell of the embryo has been altered”.

That situation is altered, as far as mitochondrial DNA is concerned, under subsection (5), or at least that is the intention. In other words, the ban that rightly exists on nuclear DNA alteration is in the same terms as the ban on mitochondrial DNA alteration, which subsection (5) overturns subject to regulations.

Although I am reassured—the Minister knows I am reassured—of the Government’s intention on the existing ban, other people may consider that this provision does allow regulations to make provision on that. While I accept the Minister’s sincerity, and indeed her judgment, if it is possible for this to be dealt with at a later stage, I think that we should.

Dawn Primarolo (Labour, Bristol South)

Does the hon. Gentleman accept that it is absolutely the Government’s intention to ban this? I understand the point that he is making. Although I am utterly convinced that this work has been done, I will do all I can in this process as the Minister—including reflecting on the point he has made—to ensure that what I am saying is absolutely correct and there are no lacunae or any way that the situation could be undermined.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I absolutely accept the Minister’s position and that she does not envisage any alteration to nuclear DNA being permitted under regulations. I also said that I agreed with her judgment that no other Government would permit this. Such interventions show her to be the thoughtful and helpful Minister who she is. It is extremely valuable that she has given us the opportunity to think further about whether action might be necessary—I accept that she does not say that it is necessary to do something—and, if it is judged necessary, whether it can be done without being over-restrictive.

Mark Simmonds (Conservative, Boston and Skegness)

I thank the Minister for her helpful responses to a debate that was stimulated by a series of amendments that I tabled. I would just like to pick up one or two of the points that have been made by hon. Members.

My hon. Friend the Member for Salisbury was absolutely right to set out that Parliament must decide the principles, but the HFEA must be allowed to regulate. I think that the job for us in Parliament, as members of this Committee, is to establish where the balance between those two particular principles lies. The Minister certainly put my mind at rest with regard to the regulatory powers and the fact that they will be published in draft for consultation, although I share the concern of the hon. Member for Oxford, West and Abingdon, in that I cannot think of any draft regulations that have been altered as a consequence of such consultation during my time in Parliament. If the Minister and her officials could give an example of when that has happened, I would be grateful.

Dawn Primarolo (Labour, Bristol South)

As a former Treasury Minister, I can assure the hon. Gentleman that that was the case for Finance Bills. We got to the point where something like more than half of a Finance Bill had been consulted on by being published in draft, amended, brought back and consulted on. The House does that, and there has been very full consultation in this area.

Mark Simmonds (Conservative, Boston and Skegness)

I am sure that the Minister will be aware that that is not the same as altering regulatory powers and draft regulations. Indeed, the Government have problems with the current Finance Bill. I think the concern that I share with the hon. Member for Oxford, West and Abingdon is that there needs to be a genuine consultation, not just—I do not want to go down this road too far—a sham consultation, as we have in some circumstances. The consultation needs to be genuine because this is a very significant and important area.

I thought that it was clear from the Bill that nuclear DNA would be prohibited. Following the exchange that hon. Members have had with the Minister, I am now not so sure, so I am pleased that she is going to reflect on that because I would otherwise be uncomfortable with the situation. There is a big distinction between nuclear DNA and mitochondrial DNA. As I have said, I am comfortable with mitochondrial DNA, and we need to send a message to encourage that particular research.

My hon. Friend the Member for South-West Devon was absolutely right to talk about the possibility of loose language in the clause, so I hope that the Minister said will reflect on that. Concern about reproductive cloning was also highlighted, and if I have time, I would like to discuss that when we consider the next amendment. However, I think the Minister has put on the record some extremely helpful foundations as to why this clause is phrased as it is and why there needs to be a regulatory power.

One of the reasons why the 1990 Act has lasted for so long is because intermittent regulations have been put down to update it to catch up with scientific advancements. If we all want the Bill to have longevity after it comes out of Parliament, we will have to allow regulatory powers in certain areas. However, it needs to be clear what Parliament will and will not allow. I certainly have concerns, which were highlighted by the hon. Member for Southport, about the possible change to the definition of gametes and embryos. However, on the basis of the Minister’s helpful reply and the fact that she is prepared to reflect on hon. Members’ comments, I beg to ask leave to withdraw the amendment.

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 3, in clause 3, page 3, line 29, leave out subsection (6) and insert—

‘(6) (a) A person who places in a woman a human embryo which has been created otherwise than by fertilisation is guilty of an offence.

(b) A person who is guilty of the offence specified in paragraph (a) is liable on conviction on indictment to imprisonment for a term not exceeding 10 years or a fine or both.’.

This is a probing amendment to try to elicit a response from the Minister as to why the exact wording that was set out in the Human Reproductive Cloning Act 2001 is not in the Bill. I do not necessarily subscribe to this view, but there is genuine concern that the Bill might leave a door open to enable cloning to take place. Ministers have said in Committee and elsewhere that the Bill completely supersedes the 2001 Act. Why are the Act’s exact provisions not in the Bill? My amendment would put the wording of the Act into the Bill. It is absolutely essential that Parliament sends a message that we do not approve of reproductive cloning and that it needs to be outlawed and prohibited completely.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am grateful to the hon. Member for Boston and Skegness for tabling the amendment because it gives us an opportunity to discuss this issue. The repeal of the Human Reproductive Cloning Act 2001 has been raised by several members of the public, mainly—perhaps exclusively—by those who are opposed to many measures that the Human Fertilisation and Embryology Act 1990 permitted and that this Bill will continue to permit. It is important that they are reassured that the repeal of the 2001 Act in no way permits reproductive cloning.

My understanding—the Minister will obviously go into this in detail—is that there is a new helpful structure in clause 3. That is a clever way of dealing with things because it specifies that the only thing that can be implanted is a permitted embryo, and that a permitted embryo can be created only from a permitted sperm and a permitted egg, and defines that in the Bill. Therefore, nothing else, clearly including a cloned embryo—that is not a permitted embryo because it has not been created by the fertilisation of a permitted egg by a permitted sperm—is going to be implanted. It is incredibly important for that provision to be set out clearly, which the Bill does. It is a red herring for people to suggest that a repeal of the Human Reproductive Cloning Act 2001 somehow allows reproductive cloning.

It is also unfair to argue that treating mitochondrial disease by cytoplasmic or mitochondrial transplant is in any way cloning. It is not: cloning involves the nuclear transfer of a nucleus, not cytoplasm. It is thus a complete misreading and an incorrect interpretation of this Bill to suggest that treatment of mitochondrial disease is somehow reproductive cloning. Certainly, the 2001 Act would not need to be repealed to allow what we discussed earlier. It is being repealed because it is inconsistent with the regime that the Government have set up.

There is duplication in the penalties applied, because there are penalties that exist around this area anyway, without needing the Human Reproductive Cloning Act 2001 to lock people up and throw away the key. The important point must be made that the HFEA would not license anything like this, even if there were not a ban in primary legislation. I did not think the 2001 Act was necessary in practice, even it was felt necessary politically, and I do not think that there are any scientists or researchers in this country who would dream of implanting a cloned embryo. Anyone around the world who says they are seeking to do it—whether they are maverick scientists seeking publicity for other purposes or fantasist cults in Canada—should not be taken seriously because the technology is nowhere near there, and they would not be able to succeed even if they were serious. We should not be panicked by the prospect of reproductive cloning.

Ian Gibson (Labour, Norwich North)

The hon. Gentleman says that the technology is not yet there. Is he insinuating that if it were there, we would need to have a rethink? Is his annoyance and repugnance of the technology based on something else—morality, ethics, or whatever?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The hon. Gentleman raises a good question that was covered in the report by the Committee that he chaired. I do not have the report to hand but, if I remember correctly, there were several grounds for arguing for a ban. One reason was ethical, another was that the practice was not possible, and another that even if it were possible, it would not be safe and could never be done ethically. Informed consent would not be given for something that was not required or necessary and did not have sufficient justification. His report laid down a challenge to politicians to come up with strong, ethical arguments against the practice—now is not the time to do that but there are many—in case there came a point where, under another jurisdiction, it was shown to be safe and effective. I do not think that we will ever get to that stage and there are good ethical arguments against it, but I will not hold up the Committee by going into them. However, the hon. Gentleman raises the good point that when we talk about a ban on reproductive cloning, we must consider all the reasons why that is not a good idea.

Dawn Primarolo (Labour, Bristol South)

The 1990 Act set out to regulate the creation, keeping and use of embryos outside of the human body, both for treatment purposes and for research. The Act referred only to the creation of human embryos by fertilisation—embryos created using an egg and a sperm. We have already touched on that debate this morning. Since then, technology advanced to the point at which it could be possible to create embryos by other means, namely cloning. That led the Government to introduce the Human Reproductive Cloning Act 2001, which made it an offence to place in a woman an embryo created by a process other than fertilisation. This takes us back to the key debate about fertilisation in clause 1.

In reviewing the 1990 Act, the Government had to take account of emerging technologies that could be used to create embryos and that could go further than just reproductive cloning. Modern science can be used to create gametes using adult or embryonic stem cells—so-called artificial gametes—and the technology exists to genetically modify those gametes, which, when used, would create an embryo containing germ line genetic modifications.

The Bill will permit the creation, keeping and use of genetically modified embryos for research purposes only under licence, and it will enable research on artificial gametes, subject to regulation. However, the Government do not intend that such embryos and gametes should be used in treatment. For that reason, as the hon. Member for Oxford, West and Abingdon pointed out, the Bill introduces the concept of permitted sperm, permitted eggs and permitted embryos. Permitted sperm and eggs are the only gametes that may be used in reproductive treatments such as artificial insemination or in vitro fertilisation.

To be permitted, a sperm must have come from the testes of a man, and an egg from the ovaries of a woman. Additionally, the gametes must not have been genetically modified in any way. It follows that a permitted embryo is an embryo that may be created only by the fertilisation of a permitted egg with a permitted sperm. In essence, that means that no embryo may be used in treatment unless it is created using natural unmodified gametes and by fertilisation. As the hon. Gentleman says, it is quite clear how we have approached this subject. I hesitate to say this but I will: I cannot see how that can be interpreted in any other way.

I understand why hon. Members and people outside the House would be wedded to the wording of the Human Reproductive Cloning Act 2001, as it has served us well. I also understand their concerns that the Bill will repeal that legislation. However, it does not just repeal it; it replaces it with much fuller protection. The Bill prohibits not only the use of cloned human embryos in treatment, but the use of genetically modified embryos and genetically modified gametes. It will prevent the use of artificial gametes and, until regulations permit, it will prohibit the use of embryos altered to prevent the transmission of serious mitochondrial disease.

The amendment would, by reinstating the wording of the Human Reproductive Cloning Act 2001, make no difference to the Bill. As drafted, the Bill clearly bans reproductive cloning. To put it in simple and direct terms, the amendment would add nothing to the purpose of the prohibition, nor would it add to the fact that cloning is an offence and not allowed.

Mark Simmonds (Conservative, Boston and Skegness)

I understand what the Minister says. She was right to highlight the permitted sperm, the permitted eggs and the permitted embryo, and the prohibition of cloning because of those categories. However, what was in the 2001 Act but is not in the Bill is the offence. I do not know whether the hon. Member for Oxford, West and Abingdon was correct when he said that the offence is covered by other legislation. Will the right hon. Lady explain where the offence is covered, because is not covered by the Bill? It is the main difference between the 2001 Act and clause 3(6).

Dawn Primarolo (Labour, Bristol South)

The offence is covered elsewhere and I referred to it earlier this morning. Forgive me, I cannot find the reference now, although, as if by magic, I have now found it. It is section 41 of the 1990 Act, as amended. The offence is the same, and the penalty is 10 years in prison. If that is the problem that the hon. Gentleman seeks clarification on, I shall be happy to give him and all members of the Committee a fuller explanation in a letter to make it absolutely clear that the offence is the same and the penalty is 10 years in prison.

Mark Simmonds (Conservative, Boston and Skegness)

I understand that section 41 appears in the 1990 Act. If that is the case, why did the provision need to be replicated in the Human Reproductive Cloning Act 2001? Why is it therefore not set out in the 2008 Bill when the 2001 Act was preceded by the 1990 Act?

Dawn Primarolo (Labour, Bristol South)

We are becoming a bit techie about how x become a Bill and how the Bill that we are discussing is an amendment to an existing Act. I am happy to provide the hon. Gentleman with such information. The Bill is an amendment to the 1990 Act, which is from where the references, as amended, come. I fear that I am not helping him by giving a particularly clear explanation of the interaction between the 1990 Act and the Bill, so I am happy to write to him. If he is still troubled, he will have an opportunity to refer to that. I assure him that the provision is in place.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful to the Minister for her response. I look forward to receiving her correspondence as soon as possible to clarify the matter. It is essential that Parliament sends out a clear message that reproductive cloning should be prohibited in totality. On that basis, I beg to ask leave to withdraw the amendment.

Roger Gale (Conservative, North Thanet)

The hon. Member for Oxford, West and Abingdon said earlier that he wished to raise other matters. I hope that he will make sure that they are other matters as the clause has been discussed fairly fully already.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

It is not my intention to cover the issues we have just debated. I want to raise the issue of the use of stem cell-derived gametes or in vitro-derived gametes, also called—I think misleadingly—artificial gametes in treatment.

Let us be clear that the clause as drafted precludes, by primary legislation, the use of in vitro-derived or stem-cell derived gametes in treatment. That has serious implications which this House needs to debate, and I ask the Government—and, indeed, the Conservative Front Bench spokesman—to consider whether there is a good enough reason for not allowing some form of regulation-making power to deal with the concerns and enable this research to proceed without the prospect of being banned in primary legislation and never put into the clinic. Such a power would improve the potential treatment prospects of thousands of patients who suffer from infertility.

When talking about the prospects of stem cell therapies I am always very careful not to claim that this will inevitably lead to treatments or, indeed, that we can expect cures. What I say is that the hope is that the research will deliver insights into causes, new ways of testing and new treatments, and might provide for cures. In this case, however, I think that one can be confident that if the research works, there is very little left to do other than run a clinical trial.

There are thousands of patients who suffer from the inability of their gonads to make gametes, whether sperm or eggs, and new technology offers the promise that such infertility can be treated by the generation of new gametes from stem cells—I am talking about adult stem cell technology. It could be done in other ways, but the leading technology in animal models is adult stem cell technology, so it is not as controversial as other measures such as the embryonic stem cell technologies envisaged elsewhere in the Bill. Nor does it involve the creation of embryos other than those created for the purpose of producing children, which is what the 1990 Act was all about. I would argue that this is less contentious even than the regulation-making power that we have just discussed, which allows for cytoplasmic transfer, genetic contributions from three parents and other such issues which, as the Committee knows, I support, but which, I accept can be considered controversial.

Ian Gibson (Labour, Norwich North)

Just to show that this is not science fiction, will the hon. Gentleman cite the people doing this kind of work, where it has got to, and how long it has been going on?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am happy to do so, and will come to that in a moment. This stem cell technology has made progress in animal models, and in laboratory studies of human cells, in generating gamete precursor cells from bone marrow cells. Bone marrow cells are taken, and gamete precursor cells have been shown to be derived both in animal models and in humans. I am somewhat restricted from going into further detail because I have not seen a recent publication on the human work, and I am reluctant to quote only from New Scientist, unpublished work and the work of researchers.

We do know that there are several leading groups working in this area. In the UK we have Professor Karim Nyernya, who may be known to members of the Committee. He has come to this country because of the legislative support that exists for this sort of research. He has derived sperm from mouse stem cells and has used it to fertilise mouse eggs, and has previously derived early-stage sperm cells, I am told, from human bone marrow. Research in this field is progressing rapidly, and the intention of his research is to look at the possibility of attempting to restore fertility in young men who have undergone chemotherapy. The Bill as drafted effectively places a ban—it would require a whole new Bill to overturn it—on ever using the product of such research to actually treat patients, despite it permitting explicitly the use of gametes that have been grown and matured from gamete stem cells derived from the testes and ovaries, and despite it containing a regulation-making power to allow the use of embryos created from eggs which have been manipulated by cytoplasmic transfer to treat mitochondrial disease.

Mark Simmonds (Conservative, Boston and Skegness)

First, will the hon. Gentleman tell the Committee how many scientists in this country are currently involved in such research? Secondly—I suspect that he plans to address this point—it is theoretically possible to turn an adult skin stem cell into a gamete: one could turn a male adult skin cell into an egg or a female adult skin cell into a sperm. It is theoretically possible, therefore, to produce from stem cells a genetic offspring of one person. I would feel extremely uncomfortably about going down that route.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I understand the hon. Gentleman’s point, and shall talk in a moment about how that can be precluded using primary legislation and the provision of regulation-making powers. If he is satisfied that it can be so dealt with, I hope that he will accept that we are in exactly the same position—arguably it is a better position—as with the mitochondrial disease regulation-making powers, which might not be as tight as we would want.

I tabled a starred amendment that was not selected, but which was debated in the other place. It can be seen unselected on the amendment paper today, on the Order Paper in the Lords and in the House of Lords Hansard. The amendment would have provided

“that—

(a) an egg can be a permitted egg, or

(b) a sperm can be a permitted sperm, even though the egg or sperm has been developed from one or more human cells in a prescribed process designed to treat infertility.”

The first reassurance, therefore, is that it would be designed to treat infertility, and I do not think that the use of one person to provide both egg and sperm could be described as treating infertility. Even if the regulation-making power only went that far, it could not permit—

Roger Gale (Conservative, North Thanet)

Order. I am sorry to interrupt the hon. Gentleman, but I cannot have private conversations taking place in the Committee Room. Benches are provided outside for that purpose.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Even if the provision only went that far, I do not see how any Government could make regulations allowing the sort of thing to which the hon. Gentleman drew attention. Neither do I see how the HFEA could license such a thing. It licenses the treatment of infertility and only allows the use of embryos in such treatment when that is the best way of doing it. The way to treat male infertility is not through the creation of eggs, but through the creation or donation of sperm. I do not think that clinicians would want to go through such a process when the easiest way to treat a man who has his own sperm is not to give him an egg but to provide an egg donor. Similarly, the easiest way to treat a woman who has eggs is not to provide sperm, but to provide a sperm donor.

Nevertheless, after the concerns just raised by the hon. Member for Boston and Skegness were raised in the other place by the noble Earl Howe and others, an amendment was considered there, which specified that the regulations envisaged “must”—not “may”—

“provide that any sperm be developed from one or more cells of a genetic male and any egg be derived from one or more cells of a genetic female”.

That deals with the problem. In Committee in the other place, the Minister and the noble Earl Howe specified that in theory it might be possible to create both an egg and sperm from a male adult stem cell. It is much harder to see how a sperm could be derived from a female cell, because those do not have the essential Y chromosome. As I say, the regulation-making power that I envisage would clearly specify that regulations would proscribe that.

Safety is clearly a concern, as has been mentioned by others, and is catered for in the proposal that I would like the Committee or the Government to consider. If the technology works and has matured, it should be up to Parliament to decide whether it is safe enough for the HFEA to consider licensing it. If Parliament decides that it is not safe enough to allow the HFEA to consider licensing something, Parliament would not draft, confirm or pass the regulations.

Any application would have to be licensed by the HFEA, which Parliament has set up to judge the safety of individual applications of reproductive technology that fall within the law, so there is a second lock.

The HFEA is particularly focused on safety, as is the individual clinician, given the need to take account of the welfare of any child that may result from fertility treatment—we have had extensive debates on that and know how important Parliament considers it to be.

If we do not allow even a regulation-making power, UK researchers such as the one I mentioned—members of the Committee have received letters and a briefing from the head of the research department, Professor Michael Whitaker, the dean of development of the faculty of medical sciences at Newcastle university expressing his concern about the failure of the Bill to consider that—will pursue research projects to develop treatments for fertility that are illegal under primary legislation, and that would require another Bill in 10 or, judging by precedent, 20 years. That has consequences for future patients, but how would it be possible to obtain funding for research and to safeguard the careers of researchers if research funders know that that research is directed toward a treatment that is banned by primary legislation? It does not make sense, given what we said about mitochondrial disease. Can we claim to be an attractive country to researchers on adult as well as embryonic stem cells when we close down the possibilities of such therapies?

We heard earlier this year of the difficulty that many cancer patients have in getting fertility treatment, whether that is safeguarding their fertility through the freezing of sperm, eggs and embryos, which is not necessarily known to work long term, and accessing such treatment on the NHS. The technology provides the only chance for patients who have not had sperm or eggs frozen before their treatment—there are tens of thousands of such patients—to have their own children, even before we consider the problem of the shortage of donor gametes. In response to the failure of the NHS to preserve the fertility of cancer patients, the Department of Health spokesman said in December:

“We recognise how important it is for cancer patients to be assured that all possible steps will be taken to preserve their ability to have children”.

I am suggesting that there is a solution for those for whom preservation by gamete storage simply comes too late.

My proposal has the support of a number of organisations that represent patients—they want the clause to be amended. Infertility Network UK supports the proposal, recognising that the HFEA must ensure safety, effectiveness and ethical approval, as does Progress Educational Trust.

Patient organisations are not the only ones to urge a change to the measure. When the Government issued their consultation—it is important to recognise that they did so—they asked whether there should a regulation-making power. In response, the BMA said:

“The BMA agrees that the use of artificial gametes in treatment should be prohibited for the time being. Aside from safety issues, the ethical implications of the use in treatment of artificial gametes have yet to be fully explored. The inclusion of a regulation-making power, however, would be an appropriate way of ‘future proofing’ the legislation. In view of the likely sensitivities around this issue...we hope that these regulations will be required to go through the affirmative procedure so that there is proper scrutiny by Parliament.”

The British Fertility Society, which represents fertility clinicians, would go further than my proposal. It said:

“It is the majority view of the BFS that primary legislation is not necessary to ensure good clinical practice. The BFS expects that existing clinical governance regulations and the regulations under the EU Tissues and Cells directive will mean that there is no requirement”

even

“for additional regulation on this issue”,

and that the Bill should provide for that. I would not go as far as that—I think that the Bill should provide for regulation-making powers.

When asked, scientific organisations have expressed support, which is not surprising because they are all charged with ensuring that it is possible to translate research into the clinic. In response to the consultation, the MRC said:

“We agree that there should be inbuilt flexibility to allow the use of artificial gametes if and when research findings demonstrate that this would be beneficial.”

In response to the Government’s proposition

“that the use of artificial gametes in assisted reproduction treatment should not be permitted but that the HFE Act should contain a regulation-making power giving Parliament more flexibility to allow the use of artificial gametes in future should it wish to do so”,

the Academy of Medical Sciences said:

“Agreed, but it is important that research on artificial gametes is permitted”.

As the hon. Member for Norwich, North, will remember, the Royal Society expressed a view in its evidence to the Science and Technology Committee inquiry into human reproductive technologies in 2004—nearly four years ago. It said:

“At present, it is too early to say whether so-called ‘synthetic’ eggs and sperm obtained by the in vitro differentiation of embryonic stem cells”—

or adult stem cells—

“will provide an alternative source of functionally normal gametes. Clearly, further developments in this area need to be followed closely. However, we do not feel at this time that these recent developments raise any additional ethical or scientific issues that are not adequately addressed in the existing legislation”.

We have a situation in which patients want a regulation-making power and scientists back it, and because the procedure is possible as a result of adult stem cell research, it is less ethically difficult than many of the issues that we have debated in the Bill, so on what basis do the Government want to oppose this proposal? They have said that they are concerned about the possible eventual derivation of an egg from a man’s stem cell, and I accept that the concern has been raised elsewhere, but it can be addressed by specifying that regulations can prevent such a procedure.

The last part of the jigsaw is whether a regulation-making power that prevents the derivation of sperm from anything other than male genetic cells and the derivation of eggs from anything other than female genetic cells raises issues of discrimination.

John Pugh (Liberal Democrat, Southport)

My hon. Friend read a quote that mentioned gametes developed from embryonic stem cells. Clearly, there is a difference between ensuring fertility by making up for what the gonads do not produce. In the case of gametes from embryonic stem cells, the paternity or maternity of the child produced would go back to somebody who was unborn. Does my hon. Friend see a moral difference there? Would he wish that to be embodied in regulations?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Clearly, there is a difference. That is why regulations can make it clear, and the House would have the opportunity to say, that only adult stem cell technologies would be allowed, or that induced pluripotent stem cell technologies would be allowed if they come to fruition. One could argue that one could clone an embryo, derive stem cells from it and then derive gametes from them, and they would be genetically identical because one was using a cloned embryo of the person whose somatic cell was used—from the patient who is infertile. However, if that could be done through adult stem cell technology, the structure of the Human Fertilisation and Embryology Act 1990 would require it to be done without the derivation of embryos and it would require the HFEA to ask questions about that. Scientists and clinicians will take the path of least regulatory and scientific resistance because they want to bring their research to fruition.

Ian Gibson (Labour, Norwich North)

Is not the real difficulty in such research—the hon. Gentleman will know that I am in favour of research if it will lead to something—that we start with a diploid cell and end up with a haploid cell? How do we get rid of the extra chromosomes? How are they selected? What kind of gamete would it be? It would have only half the chromosomes that are present in the adult cell, so there will be a big difference in the genetic material.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Given the time, I do not want to go into the science of this—

Gary Streeter (Conservative, South West Devon)

Please.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

All right. I have in my hand a scientific background briefing paper from the University of Newcastle that explains exactly how the process would work. The point is that one derives a gamete precursor, which goes through the usual process of myosis to produce the immature gamete that would be used. I have to tell the hon. Member for Norwich, North that the same issue exists to a certain extent in relation to the clause’s reference to a permitted egg. As we know from our earlier discussion, a permitted egg is cells of the female germ line at any stage of maturity. At what point eggs go through myosis to halve the number of chromosomes is a contentious issue because they are frozen mid-myosis throughout most of a woman’s life until ovulation of that particular egg. I do not really want to go into the matter—I have been drawn into it.

Ian Gibson (Labour, Norwich North)

The point is that there are difficulties. It is not just around the corner.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The hon. Gentleman says from a sedentary position that there are difficulties and it is not just around the corner. Those difficulties are what the research is dealing with. He says the process is not just around the corner and I accept that, but the Government have not made the argument—I do not believe that the Conservative party have made the argument either—that it is not necessary because it is 10 or 20 years off.

The judgment of scientists, including the Hinxton group, which was a set of scientists brought together to analyse the state of the research through peer review—a process that I know the hon. Gentleman respects and acknowledges—is that they think the process would be ready for the clinic in five to 10 years. I do not think that we will have another Bill; I suspect that many of us hope that there will not be another Bill in that time frame and I do not think that we can expect a future Government to bring back a Bill.

To respond to the hon. Gentleman’s intervention, I hope he accepts that it would be better to have a regulation-making power that provides for the process if it is needed. If it is not needed, because the research does not work, we are in exactly the same position as with mitochondrial donation, where regulations were not brought forward. It is important to show researchers and funders that we do not have a ban in primary legislation, especially an irrational one, that is not based on legitimate concerns because they are dealt with in the regulations.

I just want to explain where we are with the issue of discrimination. When it was raised by Lord Patel in the House of Lords on Report on 15 January 2008, with the provision that regulations must provide, for example, that sperm are developed from genetic male cells, this was welcomed by Baroness Jay and also welcomed by Earl Howe, who said

“The noble Lord, Lord Patel, has made a powerful case and I support him.”

That was because the concern he had raised in Committee had been addressed. Baroness Royall, the Minister, said in response to the specific amendment:

“I realise that the scope of this amendment is not as wide as the one moved in Committee”—

including the provision that sperm is only from male cells and eggs from female cells—

“and that many concerns have been removed.”—[Official Report, House of Lords, 15 January 2008; Vol. 697, c. 1200-01.]

However, she raised an important point about whether there is a problem with discrimination law, which is what I want the Government to address in their reply, because her concern was that it would be discriminatory not to allow same-sex couples to use the technology to create children using their combined genetic material, and whether it would be proportionate to prevent them from benefiting from the treatment in the future.

I would like the Minister to set out whether that is her view—that is, the legal advice she has had. I think it is highly arguable that there would not be a legitimate purpose in that indirect discrimination, but it would be entirely proportionate to insist that infertile or same-sex couples treat their infertility through gamete donation—that is the option available to them; it is not closed down. It is thus entirely proportionate to say that the process should be providing for specific male germ cells from male cells and that it is not, in fact, discriminatory. I question whether that is the case and I have seen no information about the matter from the Government.

The Government’s position has evolved and I would like them in their response to explain the basis for their evolving position. I have already set out the question raised in the 2005 consultation, that

“the Government proposes that the use of artificial gametes in assisted reproduction treatment should not be permitted but that the HFE Act should contain a regulation making power giving Parliament more flexibility to allow the use of artificial gametes in future should it wish to do so.”.

John Pugh (Liberal Democrat, Southport)

Is my hon. Friend arguing that legislation or regulations should allow for us to address cases where there is infertility or does he think that they should be allowed in cases where people are not biologically infertile but may not wish to go through the normal processes that human beings go through for reproduction?

Roger Gale (Conservative, North Thanet)

Order. I have been listening carefully to the argument of the hon. Member for Oxford, West and Abingdon and it seems to me that 98 per cent. of what he has said so far is covered by clause 3(2). He is now beginning to move into entirely different areas.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I shall just clarify matters, for the assistance of the Committee. The proposal is that there could be a regulation-making power to allow the definition of the term “permitted eggs” to be wider than is provided for in subsections (2) and (5). The latter defines permitted sperm as only those that

“have been produced by or extracted from the testes of a man”.

I want to argue in this stand part debate that that is not a wide enough definition to look after the interests of scientists working in the field of stem cell-derived gametes, or of patients who could benefit from a wider definition.

In the last part of my speech I am trying to deal with the point that was raised in another place—this has been the only opportunity to do so: that is the argument of my hon. Friend the Member for Southport about whether the provision would allow same-sex couples to reproduce using their own gametes. I say no, because the amendment proposed on Report and Third Reading in the House of Lords clearly said that regulations must provide that sperm could come only from male cells, and eggs could come only from female cells. Something else that was discussed in the House of Lords, which I urge the Committee to consider, is the fact that the intention is to treat infertility, and the HFEA would regulate that.

Will the Government explain the basis on which, in the White Paper, they changed their view on the provision? The White Paper stated:

“The Government has considered whether such a ban on the use of artificial gametes should be capable of being removed through secondary legislation ...This would provide a ready mechanism to alter the law if safety concerns were allayed in future. The Government has decided, on balance, not to recommend such a power, proposing instead that this would be a matter requiring primary legislation.”

I think that the Government did that on the basis of a response to the consultation from people who opposed all the other things, such as hybrid embryos, that the Government have decided to stick with, and mitochondrial transplantation. I urge the Minister, even if her reply is not a positive one, to set out her advice on whether a regulation-making power such as I have described would be discriminatory against same-sex couples.

I am president of the Liberal Democrat campaign for lesbian and gay equality and I serve on the Joint Committee on Human Rights and have discussed the issue with several human rights specialists. They cannot see how a regulation-making power to prohibit the derivation of an egg from a male cell or a sperm from a female cell could possibly be discriminatory under the Human Rights Act 1989. I urge the Minister to consider that carefully, and I also urge the hon. Member for Boston and Skegness to consider it, because I know that he wants to support researchers such as those at Newcastle, and does not want unreasonably to close down the potential for therapies for infertile people.

Dawn Primarolo (Labour, Bristol South)

The Bill introduces the concept of permitted gametes and embryos. That is to distinguish between those that are created and used in the course of research and those that are created and used in the course of someone’s treatment. Although it is possible to create embryos and gametes in several ways, some of which are necessary and desirable for research purposes, only those embryos that are created by fertilisation and those gametes that are produced by and extracted from testes and ovaries are allowed to be used in treatment. The Bill defines those as “permitted”. That is crucial, both in the 1990 Act and in the amendments to it in the Bill. It raises enough issues in itself.

One of the major challenges that we as parliamentarians encounter in Committee and that we encountered in all the pre-scrutiny consideration of the Bill and on the Floor of the House is to study the scientific evidence and try to work our way through the possibilities—where the scientific development will take us and thus how we should legislate. Sometimes it is not possible for us to answer all the questions, and in those circumstances and at that point in time we back away.

There is currently research into in vitro maturation and in vitro growth of gametes. That involves taking immature eggs or sperm and maturing them in vitro. That would allow eggs to be matured from ovarian tissue.

Roger Gale (Conservative, North Thanet)

Order. The Committee will sit again at 4 pm and the room will be locked until then. Hon. Members may leave their papers in the room if they wish. In the meantime we shall try to do something about the air quality in the room.

(Except clauses 4, 11, 14 and 23, schedule 2, and any new clauses or new schedules relating to the termination of pregnancy by registered medical practitioners) - Written evidence to be reported to the House

Clause 3

Dawn Primarolo (Labour, Bristol South)

Before we broke for lunch, I was responding to the hon. Member for Oxford, West and Abingdon on the subject of artificial gametes. I was explaining to the Committee that there is currently research into in vitro maturation and in vitro growth of gametes, and this involves taking immature eggs or sperm and maturing them in vitro. This could allow eggs to be matured from ovarian tissue and sperm from testicular tissue without the need for the tissue to be transplanted back into someone. It could also be used to treat certain types of infertility where there the development of the eggs or sperm is blocked.

The current definitions do allow gametes matured in vitro to be considered permitted. The Bill also allows research into the development of artificial gametes, including the ultimate test as to whether an artificial gamete is considered functional fertilisation. If an artificially derived sperm can fertilise an egg, or an artificially derived egg can be fertilised, the sperm or the egg could be described as functional. However, the hon. Gentleman, in quoting various references, including quite a lot of the debate in another place, did not do justice to the challenge that researchers face. A lot more research and reassurance would be required on the functionality of such gametes before it would be appropriate to use them in treatment.

The Government’s position is that, if research into artificial gametes demonstrates that they might effectively be used in treatment, this should of course be considered. However, our current view is that there is too little research into how these cells might be derived, and into the safety of such techniques, to be able to make an informed judgment about their use. The application of this technology would be highly significant. It would mean a baby being born having been created from cells other than eggs and sperm, and it is my view that it would not be appropriate to allow such a significant development without proper consultation and parliamentary scrutiny.

The hon. Gentleman touched on that himself when he quoted the British Medical Association. I disagree with the view of the BMA in that I think we need more than regulations—even affirmative ones—in order to discuss the matter. It is something that will significantly change the way people have children, and it is entirely appropriate that proper consideration is given to any decision about allowing it. The hon. Gentleman also touched on who, under the regulations, would be allowed such treatment, and whether the regulations could prescribe those who would be allowed access to this treatment if it turned out, in x years’ time, to be successful. Given all the complexities with regard to DNA and its development, and this particular route of research, could any regulations restrict those who would be entitled to apply for it?

First, any regulating power would need to be considered in the light of the need for the Government’s action to be compatible with the European convention on human rights. If the technology could be made available to same-sex couples and heterosexual couples—and there is a continual series of “if”s in these sentences—there would need to be a strong, objective justification for treating same-sex couples differently. I have to say to the hon. Gentleman, regardless of whom he has spoken to in his extensive discussions on this matter, that I am not aware of any such strong justification for the writing of a power to prevent access by some.

Of course, the point about discrimination is crucial. The use of this technology for heterosexual couples only would be difficult to justify objectively, but there are wider questions. This is fundamentally different. It raises different ethical issues to those raised on mitochondrial donation. The Government are not saying “no” to this ever happening in the future. We are saying that, at the point at which this research is, further work needs to be done, further consideration of the ethical and scientific reasons for pursuing it—

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Will the right hon. Lady give way?

Dawn Primarolo (Labour, Bristol South)

The hon. Gentleman spoke for half an hour. If he will allow me to conclude my points, I will be happy for him to come back in.

It also seems to me that when this House considers the science, particularly in this area, we need to be able to satisfy ourselves where that science may take us, what issues will be raised and whether or not we feel able to come to decisions on this subject. His hon. Friend the Member for Southport talked about a blank cheque. I entirely reject that notion. Research is at an early stage, and we are not clear where it is taking us. We have not had a full debate about what is possible or discussion of the ethical issues involved. The Government are not saying no to the idea, but we are saying that further consideration needs to be given and proper consultation carried out. Now is not the time, and a regulating power is not the way forward.

That is why, when the hon. Member for Oxford, West and Abingdon and others raised it before, the Government declined to take the route that they suggested. It is not the right way to proceed with legislation to say afterwards that we will answer all the questions once we have given a regulating power that we may or may not switch on. In the previous discussions, we clearly flagged up what the regulations would need to address—for instance, for mitochondrial donation, and those debates are already going on. It is on that basis that I would decline such an amendment to the Bill if it were before us—it is not. I hope that the clause will stand part of the Bill.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

It is not clear to me whether the Minister is giving way. If she does not give way, her remarks become just an exposition. The whole point of a ministerial response to a debate is to allow interventions if the Minister is sure of her ground, as I am sure the right hon. Lady is. I do not know why she would not wish to take interventions. If she does not, it gives her the right to stay seated and not respond to specific questions after she has set out her position. So I am asking whether she is willing to respond again—

Dawn Primaroloindicated dissent.

Roger Gale (Conservative, North Thanet)

Order. The right hon. Lady has made her position plain. She has stated her case and she has sat down. It is entirely open to the hon. Gentleman to come back, as the right hon. Lady indicated.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am coming back, but I was wondering whether I would be wasting my breath in a sense in asking her to respond to particular points, as is usual in a Committee stage debate, or whether she is just intending to stay seated. I would like to know that so that I can bear it in mind when I choose what points to make. Either I am making concluding points, or I am asking further questions.

Roger Gale (Conservative, North Thanet)

Order. I suggest, respectfully, that the hon. Gentleman puts it to the test.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I think that is wise advice. Let us see if the Minister is prepared to answer a couple of questions. I am grateful to her for setting out what she did, and I would like to deal with two key points that she raised. First, on discrimination. she argued that strong, objective justification would be needed to treat same-sex couples differently from heterosexual couples. This is an interesting question, because we are talking about whether an individual will be able to access specific treatment. An infertile male who is being treated with a woman may currently receive treatment from an in vitro fertilisation clinic in the form, for example, of donor sperm—they do not receive donor eggs. Where a woman is infertile, the problem is dealt with by means of donor eggs, not donor sperm. That could be an individual woman seeking treatment on her own, where no couple is involved.

One could therefore argue that the test is whether the person is being treated in a reasonable way and whether they are receiving treatment. My understanding of the Human Rights Act 1998 is that it does not give people the right to receive a specific treatment, as long as they are not unreasonably, disproportionately discriminated against in accessing treatment or services. My first question, therefore, is whether the Government have legal advice stating that there is an issue of discrimination against same-sex couples. Secondly, can they see no objective justification for legitimising the distinction that I have described by setting it out in regulations that a man must be treated with sperm from stem cells and that a woman must be treated with eggs from stem cells? I have taken informal advice from human rights lawyers, and they believe that there is an objective justification for such a provision, even if it involves different treatment that might be considered indirectly discriminatory. Same-sex couples can be treated with donor sperm and eggs. We are talking about treating infertile individuals to give them their only chance to have children with the same genetic relationship that one would expect with a father.

On my second question, the Minister said that the proposals would raise different ethical issues, and I listened carefully to what she said in identifying them. She said that the proposals would significantly change the way in which people have children and that we would be creating children through cells other than eggs or sperm. However, I do not think that we would be doing that, because we would still have to create an embryo “by...fertilisation”, to use the words in the clause. The fertilisation would have to be done by a germ cell, even if it had been derived from a somatic cell. The words in the clause—I am keen to stick to them—specify that very clearly. It cannot be said that the regulations would allow anything other than an embryo to be created by fertilisation. The Minister herself referred to the fact that gametes are widely defined for these purposes as germline cells at any stage of maturation. They are not necessarily sperm or eggs—they are certainly not necessarily sperm. Immature spermatagonal cells count as gametes in this respect. If they are grown or matured in vitro, they would not necessarily be sperm. The Bill therefore already provides for embryos to be created by fertilisation using cells that are not sperm—we should be clear about that. Given that necessary protection in the Bill, it is not right to say that embryos will be created by cells other than eggs or sperm, except to the extent that is already permitted for immature gametes for the purposes that the Minister has set out.

The proposals would not significantly change the way in which people have children. If the Government thought that the issue was ripe for consultation in 2005—indeed, it was put out for consultation—it should be ripe for discussion in the House now. It cannot be considered premature, a priori, to debate the issue in the House of Lords and the House of Commons. In 2005, the Government were of the view that a regulation-making power was legitimate; that is the position that they started from in their consultation paper. I am concerned that they have decided against allowing a regulation-making power without having very good reasons, albeit that they have pragmatic concerns. Their position is not clear to me. It does not look as though the Minister is responding to the two points that I am making.

In a consensus statement dated 11 April 2008, the Hinxton group set out how close it thought this science was to reaching the clinic. My understanding is that this peer review group thought that it was five to 10 years away. That is before the time scale within which another Bill is likely to be introduced. They recommended that the Government look kindly on permissive legislation which would allow that to happen, and made it clear that they thought there was a great deal of hope, with this technology, for clinical treatment of individuals. It is unfortunate that the Government seem to be opposed to allowing a regulation-making power now without setting out clearly why they think it would be discriminatory to restrict it and, separately, what the key ethical issues are and why they are new compared to other issues.

I conclude my remarks by regretting that the Government have not been willing to set out clearly their grounds for believing that the amendment tabled in the Lords would be too discriminatory, not setting out why they think there are fresh and significant ethical concerns here, and not appearing to be willing to have a debate in a Committee of Parliament about those issues.

Dawn Primarolo (Labour, Bristol South)

The hon. Gentleman creates a case, advances it, and then, when he does not get the answer he wants, says that a justification has not been given. He asked me a question about discrimination, and I gave him the answer with regard to advice. The hon. Gentleman knows that it is not normal for Governments to publish legal advice, and we are not about to start now. I went on to say that, notwithstanding the advice, there are ethical issues, beyond what is in the Bill, that need further consideration, and there is a difference between what we are currently providing for and what would be provided for in these circumstances. What we have is a stand-off. The hon. Gentleman simply does not agree with me. It seems to me that there is a difference between a power dealing with mitochondrial donation to avoid the transmission of serious diseases and with the repairing of existing embryos—which is where the regulation-making power is—and a different power dealing with artificial gametes and the creation of gametes and new life. There is a fine distinction.

On behalf of the Government, I am saying not that we have set our face against this, but that further discussion and further consideration of the issues is needed. I hear what the hon. Gentleman says, but not everybody agrees about how far away the science is from possible use. The appropriate way forward would be proper consultation on these issues and, if necessary, amendments to primary legislation. That is a far more significant and important place to have these sorts of discussions. I hear what the hon. Gentleman is saying and I understand that he disagrees with me, but no matter how many times he puts this proposition to me, that will be my reply on behalf of the Government.

There is a question of understanding the very fine differences between what science might be able to do in the future and how we seek to regulate it, and that goes to the very heart of what we are trying to deal with in discussing this Bill and its predecessor. Discrimination is a subset of that, but the ethical issues must come first. I am sorry if the hon. Gentleman does not agree because there is a lot about which we have agreed. However, in response to his raising such important issues in a clause stand part debate, I have laid out the reasons for the Government’s view and if the House takes a different view, that is a matter for the House. We remain wedded to our view.

Schedule 1

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 22, in schedule 1, page 54, line 4, at end insert—

‘(za) at end of sub-paragraph (2) insert—

“and no person may be appointed for more than six years in total”.’.

May I take amendment No. 23 with amendment No. 22?

Roger Gale (Conservative, North Thanet)

Order. I have no strong aversion to that, but we separated the amendments deliberately because they do not cover the same issues. The hon. Gentleman will have the opportunity to debate both amendments, but preferably one at a time.

Mark Simmonds (Conservative, Boston and Skegness)

Thank you for your guidance, Mr. Gale. The purpose of amendment No. 22 is to get across to both the Government and the Human Fertilisation and Embryology Authority that, while the HFEA is held in very high regard and is perceived globally as the lead regulator in such issues, there is concern that it has in the past and perhaps will in the future be a closed shop. The amendment would ensure that amenable clinicians who wished to serve on the HFEA and others who wanted to be reappointed could not be reappointed again and again, as can happen at the moment. The effect of that practice is keeping others out as the ratio of expert members is limited.

The majority of clinics have a good relationship with the HFEA, but that is not universal, as I have found out in my meetings with those who have had dealings with the HFEA. Some clinics have had difficulties and they put that down primarily—not solely—to the static membership of the authority. There have also been issues of competitive conflict, and it is important that clinicians do not sit on licensing committees when determining policy that might have a beneficial impact on their own clinics. I shall not give specific examples of that, but I am sure that officials are aware that that has happened.

Under the amendment, members of the HFEA could not stand for more than two consecutive terms.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Does the hon. Gentleman have similar concerns about clinicians who are rivals to other clinicians being involved in inspections, and delivering a report that might impact on the business of those other people? I do not know whether it is possible to avoid that situation, but perhaps it also needs to be considered.

Mark Simmonds (Conservative, Boston and Skegness)

The hon. Gentleman is absolutely right. The purpose of a future amendment is not only to ensure that such a situation does not arise, but to prevent clinicians without specialist and expert knowledge in certain subjects producing reports that often have to be corrected or reworked later. I shall deal with that when we come to the subsequent amendment.

It would also be helpful if the HFEA made public the dates of appointments so that people could see how long someone had been a member of the authority. The public should also be given assurances about the HFEA’s fresh expertise and vigour. It is clear from my discussions that if the Bill passes—as most of us on this Committee hope it will, as a result of the substantial discussions in pre-legislative scrutiny and both Houses of Parliament—the HFEA will have an even busier time, as we gradually extend the type of activities that it can license. It is therefore important that it does not atrophy—although I am not suggesting that it has—but continues to move forward with vigour, bringing in new blood as often as possible. That is the purpose of amendment No. 22.

Dawn Primarolo (Labour, Bristol South)

Members of the HFEA are appointed by the Appointments Commission on behalf of the Secretary of State for Health following advertisements in the national press. Anyone is free to apply and can be considered for membership. The Human Fertilisation and Embryology Act 1990 provides that:

“A person shall not be appointed as a member of the Authority for more than three years at a time”.

However, that can be extended for another three years with the agreement of the Appointments Commission. After six years, if members wish to continue to sit on the authority, it is not prohibited, but they must reapply through an open competition. They may be reappointed, but only if they are the best candidate for the job.

The hon. Gentleman’s amendment would set a six-year limit on the full period that any member can serve. Although it does not necessarily sound unreasonable, it would mean a lack of flexibility to reappoint people with valuable expertise and experience in their field. It is essential that the HFEA comprises the best calibre of candidates available. The amendment could restrict that.

While the hon. Gentleman was speaking, I was looking at some of my notes in relation to his point about the dates when people were appointed and how long their term ran for. I do not have that information. I think that some members of the HFEA have served for more than six years, but they started before the process was run by the Appointments Commission. I understand that three members have served for six years. They would have to apply for reappointment under the current recruitment exercise.

Mike Penning (Conservative, Hemel Hempstead)

Will the Minister clarify whether that is retrospective? If they have already served six years when the legislation comes into force, will they then have another three plus three before they have to apply, or will the previous years be taken into account, meaning that they will have to apply straight away?

Dawn Primarolo (Labour, Bristol South)

I think that I am correct in saying that, once the Appointments Commission became responsible, the period considered included whatever period they might already have served. If the hon. Gentleman will forgive me, I will need to double-check that, but the point is that it is common on many public bodies to have a period in which people can be reappointed before going through a complete re-application. As I said to the hon. Member for Boston and Skegness, an open competition is advertised and run by the Appointments Commission, which is specifically charged with ensuring that the public body—in this case HFEA—is staffed by people with appropriate skills. It will also look to ensure that anybody who applies meets the specification. Although this is published nationally, that would still happen. I am not aware whether appointment periods are in the public domain or whether they were on the HFEA website. I do not have that information to hand, but I am happy to check.

What the hon. Gentleman is trying to achieve in terms of the make up of the HFEA is already in place with respect to the break at six years and the need to reapply. I am sure that he would agree that the converse is true, and that even if someone has served six years, if they clearly have the expertise and are the best person despite advertising, national recruitment and consideration, we would not want to refuse them access to being appointed by the Appointments Commission. I hope that he is reassured that he can track how long members have served—I will check that that is the case—and that there is, in effect, a six-year break, with the caveat that people can reapply. I am sure that he would agree with that, and I hope that he is satisfied.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful to the Minister for that response. Of course, I understand and agree with the flexibility argument that she put forward. Obviously, we must have people of the best calibre on the authority. However, she will also be aware that there are a limited number of clinician places on the authority. I am not going to press the amendment to a Division, but I wanted to ensure that the Minister, the Committee and those responsible for the HFEA understood the concern that a position on the authority should not be a permanent fixture that is renewable every three years. Certainly, publicly detailing appointment dates and the length of time that those on the authority have served would go some way towards satisfying people, and it would show that there was change and turnover. I beg to ask leave to withdraw the amendment.

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 23, in schedule 1, page 54, line 17, at end add—

‘4 In sub-paragraph 8(2), after “experience”, insert “in at least one of the activities that may be licensed under this Act”.

The amendment would add a provision to schedule 1, which amends the 1990 Act. To return to the point made by the hon. Member for Oxford, West and Abingdon, it would ensure that HFEA inspectors were doctors, embryologists or researchers who were qualified to conduct inspection at IVF research units. That is not necessarily what happens at the moment, and there have been conflicts between clinics and the HFEA, some of which have been successfully challenged through negotiations and, ultimately, the threat of legal action.

The inspection reports take place during the licensed period—either three or five years—or at the end of those licensed periods for renewal for IVF clinics. They are undertaken to inform the authority about whether a licence should be renewed or whether there are issues as the licensed period progresses. Those are, of course, made public and are accessible to those who use the clinics. There have been some issues when the interim report that the inspectors put together has been completely disagreed with by the clinic. There is a great nervousness among those who run some—although not all—of the clinics that part of the reason for that is that those doing the inspections do not necessarily have the expertise that they require and there is a lack of understanding. There are numerous examples of having to rework the reports.

I understand the positive move that clinics now have the ability to make official responses to those inspectorate reports, which are also made public. However, the starting point must be that those doing the inspections in the first place have a detailed understanding and knowledge of what they are inspecting. Picking up the point made by the hon. Member for Oxford, West and Abingdon, we must also ensure that we do not get into a situation in which someone who is doing an inspection has a conflict of interest, or an interest in producing a relatively negative report on a particular clinic that might may have an advantageous effect on the clinic that they work for.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I am grateful to the hon. Member for Boston and Skegness for raising this matter. Although I encouraged him to make his point, there is a difficulty for the HFEA in finding someone with clinical expertise who is not in competition with someone else, unless it has a cadre of professional inspectors, which might be possible, or one has a way of identifying people who clearly are not in competition. For example, we would have to consider the situation for people working in London.

Mark Simmonds (Conservative, Boston and Skegness)

The hon. Gentleman is absolutely right to make that point. I am not going to raise specific examples, but I am sure that he will be aware of one particular example in the HFEA when this very situation arose because of the very close proximity in geographical terms of the two clinics. That is the sort of issue that needs to be avoided.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Absolutely. The hon. Gentleman’s analysis is spot on. I would say that more creative thinking needs to be done by the HFEA to ensure not only that conflicts of interest do not arise, but that suspicions of conflicts of interest do not arise. This is unfortunately—or, some would say, fortunately—a very competitive field in which large amounts of income are at stake. I know that the HFEA and indeed the Government are aware of the situation, which is why they strive to ensure that there are basic standards so that people are not misinformed about what success rates are, for example.

Dawn Primarolo (Labour, Bristol South)

The hon. Members for Boston and Skegness and for Oxford, West and Abingdon have raised an important point, and the hon. Member for Oxford, West and Abingdon went on to elaborate why the balance is difficult to strike. Perhaps it would be helpful if I gave the hon. Gentlemen some indication of how the HFEA is proceeding.

At present, the HFEA has nine inspectors. Three are embryologists, three are nurses, one is a doctor, one is a scientist and one is a generalist with an audit background. The HFEA has in-house inspectors and no longer uses inspectors from outside the HFEA.

The amendment would require inspectors to have experience in at least one of the activities that may be licensed under the Act. That would mean that the HFEA would be able to recruit only people who were, for example, doctors or nurses with experience in infertility, embryologists, scientists with experience of using human embryos in research, and people who perhaps run internet sperm delivery services—I think that the hon. Member for Oxford, West and Abingdon was touching on that point.

The qualities that make a good inspector are not necessarily limited to experience in licensable activities, although that may be helpful. The ability to gather evidence to ensure that centres are conducting licensable activities in adherence with the Act, the licence conditions, and the code of practice are vital. Therefore, people with experience of auditing or investigating, or scientists, nurses, and doctors with other specialist knowledge, could make equally good inspectors as those who work in the field.

I do recognise, and of course it is obvious, that an understanding of the licensable activities is essential for an HFEA inspector. The authority has thus introduced a competency-based training programme for all new inspectors to achieve that. Part of the programme includes spending time in a licensed centre to observe practice and to gain an understanding of how a centre works from day to day. The HFEA also has a number of external advisors who have experience in activities that may be licensed under the Act, such as nurses, doctors and embryologists who act as inspectors on a number of inspections every year.

I think that the concerns of the hon. Member for Boston and Skegness are being addressed by ensuring that the inspectors are suitably qualified and able to report with regard to the codeand the licence conditions. He and the hon. Member for Oxford, West and Abingdon flag up a live issue to the HFEA concerning a reasonably small community of practitioners, the importance of having such expertise, and the need not to undermine the commercial or business concerns that often underpin these clinics.

I hope that the hon. Member for Boston and Skegness will accept that the amendment is not necessary, that it would be over-restrictive, and that there might be problems with recruiting the qualified people he feels might be necessary. Nonetheless, the HFEA is addressing this matter, and what is important is that the inspectors can consider the issues before them. I hope, on that basis, that he will be prepared to withdraw his amendment.

I am not sure how this might be achieved, but if the hon. Gentleman is particularly interested in the specific work that the HFEA is doing with regard to its in-house inspectors and their qualifications and how to avoid any of the problems that he feels might exist, I am sure that we could find a way of ensuring that he is kept in touch with developments so that he can satisfy himself and his colleagues on those issues.

Mark Simmonds (Conservative, Boston and Skegness)

I thank the Minister for that answer and for the offer to keep me in touch as the HFEA develops its thinking and makes progress in that area. I would certainly like to take her up on that offer. I am pleased that the HFEA recognises that there is an issue that needs to be addressed, and I was comforted by the fact that the Minister felt progress was being made.

Of course, I understand that the community is small and that no particular clinic likes to be criticised, whether that criticism is justified or not. There are clearly sensitivities. Certainly, one of the things I felt when meeting people involved in the clinics was that they tended to divide into two camps: those who were satisfied with the reports and inspections they were getting from the HFEA, and those who definitely were not. This is not the only reason why they were not satisfied, but clearly progress needs to be made. I also understand that we cannot possibly have a situation where we are over-restrictive on the recruiting pool. We need to have appropriate number of inspectors to make inspections, and particularly to produce the interim reports at the end of a licence. On that basis, I beg to ask leave to withdraw the amendment.

Clause 6

Mark Simmonds (Conservative, Boston and Skegness)

I beg to move amendment No. 4, in clause 6, page 5, line 35, leave out subsection (3).

The amendment relates particularly to the charging of fees specifically to give advice. There is no question that there is a necessity for the HFEA to be allowed to charge for licensing, even though some of the licensing fees, based on the number of people benefiting from and using the clinic, are very substantial indeed, in some cases running into the hundreds of thousands of pounds.

The amendment would remove the right of the authority to charge a fee for advice. Will the Minister explain what that advice might be? What, in fact, might the HFEA want to charge for? Surely advice should be freely available to allow those who are considering applying for a licence to have the best opportunity to submit all the relevant documents in the first place. That should be part of a consultation process free at the point of access with the HFEA.

From my reading of the clause, it would also enable the authority to charge a person considering treatment for providing gametes or embryos. In my view, this should be free, as the current process is costly, traumatic and time-consuming enough. There has to be an assumption that the HFEA will give free advice to clinics to enable them to meet the criteria, to get the licence and to ensure that they are safe. There is concern from within the clinic community that HFEA charges could amount to not insubstantial sums for carrying out roles that the authority should be fulfilling in the first place. I am referring to the additional information that is required for obtaining a licence, for renewing a licence, or for future discussions and advice on interim inspection reports.

Will the Minister clarify what sort of categories of advice the HFEA will be able to charge for? Is it advice about confidentiality, consent or licensing? Might it also be advice to those donating embryos and gametes, because the last thing that we want to do is to deter people from wanting to be donors?

Robert Key (Conservative, Salisbury)

I support the amendment very strongly because it addresses the fundamental issue of whether it is right for some of the services in the national health service to be paid for by the patient. Any licence charge is inevitably passed on to patients—and in different ways. Quite a lot of it comes down in the end to postcoding. I object very strongly to the discrimination against fertility centres in the national health service. They find themselves faced with very high charges, as my hon. Friend the Member for Boston and Skegness said. As far as I can see, this measure is an extension of that, although perhaps the Minister will convince me that it is nothing to do with that, that patients will not suffer or lose a penny, and that the primary care trust will not be able to pass on any of the charges to patients.

My basic point is that there should be no discrimination against fertility treatment. Fertility treatment is not a luxury; it relates to a medical condition. The rich will continue to look after themselves. If we are not careful, we will see the national health service clobbering the poor—it is as stark as that. This is an issue of principle. My hon. Friend is seeking, in a far kinder way than me, to press the Minister to explain the measure, and I support him. I shall take some convincing that the amendment should be withdrawn, and I hope that it is not.

Dawn Primarolo (Labour, Bristol South)

The intention behind the provision is not to implement the charging to which the hon. Members for Salisbury and for Boston and Skegness have referred. The clause provides for a discretion, not a duty. It is discretionary to charge a fee for advice provided under the clause when the advice requested from people to whom licences apply is greater—let me explain.

The provision is intended to allow the HFEA to recover costs that it has incurred in providing specialist advice. It was considered appropriate to make the power discretionary, which enables the HFEA to consider whether a charge is necessary. It is not about income generation. It is a discretionary levy that will be used only when appropriate, such as if a clinic wants to consider what systems it needs to put in place to comply with a European directive. It will be provided for within the national health service if we are required to move the entire service to comply with a particular European directive, or if a restructuring of the service is necessary. The amount of work generated for the HFEA by such a request could go way beyond the usual requests suggested by the hon. Members for Boston and Skegness and for Salisbury.

If the information provided by the HFEA goes beyond that by helping the structure of the business, it has the option to charge a fee. That power will be used sparingly because such a thing will occur only in rare circumstances, but none the less it will happen. The public purse would otherwise be under pressure and strain because of having to provide advice to private organisations on how to comply with requirements. That does not seem to be the correct way to proceed.

I absolutely understand the point made by the hon. Member for Salisbury. I imagine that he was thinking of clinics asking for information. We are talking specifically about them going beyond that and asking for much more detailed advice about compliance or structure.

Jeremy Wright (Conservative, Rugby and Kenilworth)

Of course we accept the Minister’s reassurances once again, albeit with the caveat that she will not always be the Minister. Will she answer this specific question? If I understand her correctly, she seems to be arguing that in the majority of cases in which information or advice is sought by organisations or individuals, the HFEA would not contemplate charging a fee, but that in exceptional cases, it might. Why does the clause not say that a fee is not to be charged save in exceptional circumstances?

Dawn Primarolo (Labour, Bristol South)

The power would be a duty if it was required in all circumstances. It is a discretionary power regarding not information, but specific advice. If we intended the HFEA to charge for everything—information and advice—we would put a duty on it to do so. We are requiring it to charge, with discretion, if the demand goes beyond information. The authority will have to decide whether to make a charge.

Robert Key (Conservative, Salisbury)

The Minister has the enormous advantage of having been a Treasury Minister for many successful years. She will know that in the arguments that we had with the HFEA over the charging of primary care trusts or, more usually and more directly, fertility clinics, the authority said that it was bound by the instructions of the Treasury. That is about as discretionary as a local council charging council tax to its residents.

I am totally unconvinced by the Minister’s argument. She has been unable to give a guarantee that the charges will be discretionary. We all know of discretionary charges in almost every area of life, and I am not convinced that the charges will not be passed straight on to primary care trusts and fertility clinics—and ultimately to those seeking help.

Dawn Primarolo (Labour, Bristol South)

I want to resolve this. I understand the hon. Gentleman’s fears, but this is discretion under specific circumstances. If he has a way forward, I would be happy to take a further intervention. When there is a request for substantial advice from the HFEA that would cause substantial cost and go beyond the information that it normally gives or the work that it would normally do, it has the discretion to decide whether or not it charges a fee. It need not definitely charge a fee, but it may do so, to ensure that the public purse is not unduly called upon. Has the hon. Gentleman a way of having that caveat but not removing the provision completely, which is what the amendment would do? The amendment would completely remove the HFEA’s ability to have the discretion to decide whether it wants to recoup its costs in exceptional circumstances when the cost is great.

Robert Key (Conservative, Salisbury)

Of course, the answer is to include the phrase “exceptional circumstances” somewhere and then to define them. Will the Minister also point to anywhere in the Bill that describes what the normal function of the regulatory authority is?

Dawn Primarolo (Labour, Bristol South)

Given the advice and the information collected, the work that the HFEA has done predicated on the 1990 Act, and the hon. Gentleman’s expertise in this area, he knows full well that the HFEA will be regularly asked for information. The caveat that I am drawing here is about advice. I am loth to leave the HFEA exposed when there might be substantial claims on its resources through providing advice, but I absolutely agree with the hon. Gentleman that we are not sending a signal in the Bill or from the Committee that we would expect everything to be charged. This is a caveat that is additional to the provisions in place. Given that the Bill amends the 1990 Act, when it is silent, it means that the measure is in the 1990 Act.

I want to be open with the Committee, but I do not want to accept a complete removal of the proposition. I would ask the hon. Member for Boston and Skegness to reconsider his amendment and give us time to think about it. Regrettably, if he feels that he must press the amendment to a Division, I fear that I must ask my colleagues to resist it. It would be better to try and sort this out properly.

Mark Simmonds (Conservative, Boston and Skegness)

I listened with great interest to the Minister’s response. She initiated her comments by using the word “discretion”. My hon. Friend the Member for Salisbury ably made the point that Governments have the discretion to raise taxes all the time. I am not suggesting that fees for advice from the HFEA are the equivalent of tax, but they could definitely have an impact on costs for someone wishing to receive treatment from one of the clinics, if an element of those fees was passed on.

If all this is about implementing EU directives, my hon. Friend the Member for Rugby and Kenilworth came up with exactly the right wording: “exceptional circumstances”. I would argue that implementing EU directives is probably an appropriate call on the taxpayer, rather than the individuals using clinics. The HFEA, since its inception, has survived perfectly adequately without having to charge for advice under existing structures. Also, there could be a major deterrent for those who are using the clinics in what is already sometimes an extremely costly exercise.

I am sorry to disappoint the Minister. I am grateful for her offer of looking at the point again, but I am not prepared to withdraw the amendment and I shall press it to a Division.

Clause 7

Mark Simmonds (Conservative, Boston and Skegness)

Clause 7 strikes me as a curious measure. It states that the authority, meaning the HFEA, should carry out its duties

“effectively, efficiently and economically”,

but one would have thought that that is implicit for any Government authority. Does it mean that the HFEA has so far been ineffective, inefficient and uneconomic? What would be the impact on the HFEA if the clause was not included? The HFEA’s behaviour and performance should not be altered because it should operate that way whether or not the clause is included.

John Pugh (Liberal Democrat, Southport)

My question is on proposed new section 8ZA(2), which states:

“In carrying out its functions, the Authority must, so far as is relevant”—

I am not clear when it would not be relevant—

“have regard to the principles of best regulatory practice...including the principles under which regulatory activities should be transparent, accountable”

and so on. It is accepted that the HFEA and its delegated committees will make some big decisions, but it is not guaranteed to be without conflicts of interest, whether financial, as have been mentioned, or based on research—people may wish to encourage research in which they are involved or actively discourage research in which they are involved. In fact, such conflicts of interest, far from being hypothetical, are regarded as extremely likely by most members of the Committee who have spoken. There are also public funding issues.

I recognise that the HFEA has a strong lay element, but in any environment in which there are lay and professional people, the latter have a big impact on what the former decide and think. The HFEA has a strong ethics committee, but that is largely concerned with the treatment of its clients.

It is perfectly likely—I am assured that this happens—that when making decisions that have financial or research implications, members declare and state their interests. However, I pondered some time ago whether there was a standing register of interests. My hon. Friend the Member for Oxford, West and Abingdon declared an interest at the beginning of the previous sitting, but I assume that if we check carefully, we will find a further declaration in the Register of Members’ Interests—[Interruption.] One would indeed hope so. I have scoured HFEA’s website to find out what are people’s relevant standing interests, whether financial or research. I could not find that information, so I contacted the HFEA and asked whether it had a standing register of interests. I thought that that was a good idea if only because there will be huge sums of money riding on some of its decisions—one has only to see the investment by the Wellcome Trust and others to realise how big those sums might be. Does the Minister know whether there is a standing register of interests for HFEA members? If not, suggesting that it produce one might be a laudable way of future-proofing legislation.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I point out to my hon. Friend that there is a difference between declarable interests that one might want to make Parliament aware of and registerable interests. The registrar is quite fussy about what he or she thinks it is necessary to register.

My point concerns the issue of HFEA mission creep. If the Minister will permit me, I think that it is appropriate to raise it here, because it is relevant to proposed new section 8ZA(2), which says:

“In carrying out its functions, the Authority must, so far as relevant, have regard to the principles of best regulatory practice (including the principles under which regulatory activities should be transparent, accountable, proportionate, consistent and targeted only at cases in which action is needed).”

It is a minor concern, but I hope that the Minister can set my mind at rest. A couple of years ago, the HFEA sent out a mission statement to Members of Parliament. The mission statement did not stick to what Parliament had intended the HFEA to do. The HFEA decided that part of its job was to maintain public confidence in the law. If Parliament makes the law, it is Parliament’s job to maintain confidence in the law. Otherwise, acceptable activity that Parliament has said should be licensed and considered appropriately should not be subject to extra regulation because of a perceived need to keep public opinion on board.

Otherwise, newspapers could raise scare stories and, if the HFEA’s mission has crept to include a general issue of public confidence rather than what is set out in proposed new section 8ZA(2), it might say, “Well, we might have licensed this and permitted it, but it might kick up a fuss. There’s an institutional risk.” That is the other thing. The HFEA’s policy documents include a little section saying what the risk is to itself of bad headlines, rating them low, medium, high or whatever. It is inappropriate for the HFEA, which was set up by Parliament to do a job—a job that, generally speaking, it does well—to start having regard to interests such as what the Daily Mail might say about its decisions.

The HFEA rowed back from that position when I raised the matter, asking where it came from, as I could not find it in the HFEA’s own terms of reference or the statute. It would be helpful if the Minister confirmed that the excellent paragraph that she proposes to insert in the Bill makes it clear that

“activities should be...targeted only at cases in which action is needed”,

and that nothing in the statute requires the HFEA to distort what it is doing in order to please what it perceives as public or media opinion. Unfortunately, it is in the firing line. I respect the HFEA for what it does, because it gets a lot of hassle from some in the media, and indeed some politicians, when it takes a decision that they do not like. However, it would be open to greater criticism if it bent towards that or away from implied criticism. I hope that she will make it clear, albeit only briefly, that the HFEA’s job is to implement the law as Parliament has laid it down and develop policy where appropriate. Perceptions of public opinion, short of formal consultations where the HFEA feels them to be relevant, are not part of its remit.

Dawn Primarolo (Labour, Bristol South)

It is always surprising what things catch a Minister in Committee. I thought that clause 7 was very straightforward. Perhaps I can explain why the Government did it and then answer the points.

Of course the Government expect all public authorities to operate effectively, efficiently and economically. That is not a reflection on the HFEA’s past practice or performance. It is simply that the principles of better regulation were implemented following the Hampton report, which was quite a long way after the 1990 Act. They require regulation to be transparent. Regulators should be open and keep regulations simple and user-friendly. Regulation must be accountable. Regulators must be able to justify decisions and be subject to public scrutiny. It must be proportionate. Regulators should intervene only when necessary. Remedies should be appropriate to the risk posed and costs must be identified and minimised. The principles also require regulation to be consistent whereby rules and standards must be joined up and implemented fairly. They require regulation to be targeted so that it is focused on the problem and minimise the side effects.

The Government took the opportunity provided by the fact that we were updating the 1990 Act and included the principles in the Bill. They have been widely accepted by the House. It was no more, no less than that. Such action was not a reflection on the performance of the HFEA. We just took the opportunity offered by the Bill to put on the record something that we already expected. We did so for clarity. We did not mean to cause difficulties in Committee. In answer to the points that have been made, I must say that it is nothing to do with whether I continue to be the Minister; it is simply a tidying-up exercise.

The hon. Member for Southport raised a different issue—a register of what is declared. I am not exactly sure about what detail is provided publicly at the moment, but I agree with him. I shall put to the HFEA the point that such a register should exist and be accessible. It would be good practice and I thank the hon. Gentleman for raising it with me.

The hon. Member for Oxford, West and Abingdon asked me to confirm that the measure is about complying with the Bill, not with the views of the media. I am happy to confirm that. I think that he wanted to make sure that that was on the record, and I am pleased to assist him. I hope that members of the Committee will accept that there was no other motive behind the provision, expect that it is a good principle. I hope that I have put their concerns to rest, and that they agree that what must be the most modest clause in the entire Bill should now stand part.

Clause 8

Mark Simmonds (Conservative, Boston and Skegness)

I have one or two queries about the clause. It gives the HFEA the power to contract out particular functions to other Departments or public offices. How would the contracted-out bodies be accountable? It would be helpful if the Minister could give us an idea of which bodies might be involved? Will it be the Human Tissue Authority, the Department of Health or the Medicines and Healthcare products Regulatory Agency? In what circumstances does the Minister think that the powers would be necessary?

To make sure that my understanding of the Bill is correct, I must know whether contracting out will exclude licensing and the guidance of the HFEA, and that there will be no opportunities for licensing, for example. What about inspections? We discussed that earlier. They are not specific to the granting of a licence, but are relevant to it. Such matters go to the authority for discussion and consideration. Will issues be confined to a public authority or will the HFEA contract out to the independent sector, including the private sector? What criteria will be put in place by the Department of Health or will it be left to the HFEA to make sure that the contractee will have the relevant level of appropriate skills and expertise, experience and qualifications to do the particular job?

My third and final specific question about clause 8 concerns proposed new section 8C(2)(c) that states:

“it is a function of making subordinate legislation (within the meaning of the Interpretation Act 1978).”

Perhaps the Minister could clarify what is meant by subordinate legislation, and whether it is the same, or different, from regulation.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I thought that the hon. Member for Boston and Skegness asked interesting questions. I am particularly interested in the answer to the last one, as I, too, had that written down. Inspections would not be excluded from being contracted out under proposed new section 8C(2), and that leads to the question about whether it is necessary to identify other people who can provide inspections, albeit apparently public bodies.

My purpose in supporting clause 8 is to recognise that in this increasingly complex area of regulation, particularly with the advent of potential stem cell therapies, it is important that the HFEA is able to hand over this aspect of its work and contract it out, under negotiation and with consultation, to the HTA or the MHRA, so that there is a smooth working arrangement. The MHRA, for example, could take the lead and would obviously have to refer back on occasion to the HFEA. From the reading that I have done of some of the complexities around the European directive on cells and tissues for human application, it seems that that sort of thing will be necessary. I hope that the Minister will confirm that.

I understand and hope—again I might be wrong—that one of the other points of this is to ensure that the authority can delegate certain powers to a sub-committee, which might speed up processes. There is concern in the clinical world that it can take a very long time for the authority to make a decision. I think that without that provision, the authority has to meet as a full authority to sign off a number of things, and that potentially refers to the creation of sub-committees or committees of the authority. Again, I would be grateful if the Minister could clarify that.

Mark Simmonds (Conservative, Boston and Skegness)

The hon. Gentleman is absolutely right. Perhaps I may refer him to clause 10, which relates to the power to delegate and establish committees. The purpose of that clause is to speed up the licence process. He is right to highlight the concern of many clinics about the time it takes for the HFEA to make its decisions.

Roger Gale (Conservative, North Thanet)

Order. The hon. Gentleman is right—we shall come on to clause 10 in due course.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I agree with you, Mr. Gale. The hon. Member for Boston and Skegness is right, and perhaps that answers the point. Clause 10 deals with that concern, not clause 8.

Dawn Primarolo (Labour, Bristol South)

At present, the 1990 Act does not allow the HFEA to enter into an arrangement with either a public or private body to undertake any of its functions. That means that there is limited flexibility when carrying out some of its functions, which could lead to the duplication of inspections or other aspects of its regulatory work. The new provision in clause 8 introduces more flexibility to the way in which the authority operates. The provisions work together with those in clause 9—we are coming on to that—that enable the HFEA to assist other public bodies. It will help the authority to carry out its functions more effectively and avoid duplication, thus reducing the burden on clinics and others subject to licensing. The provision was thought to be sensible to modernise the regulation and keep certain issues within the Bill, following the removal of proposals to establish the regulatory authority for tissue and embryos.

Proposed new section 8B gives the authority power to make agency arrangements with Government bodies, other public authorities or holders of public office, and provides for that body to exercise the authority’s functions, or for it to provide services to the authority. Such arrangements may include, for example, those with the Human Tissue Authority or the Healthcare Commission to carry out inspections on its behalf. Both those authorities are regulated, transparent and responsible. However, the responsibility for the functions themselves would remain with the HFEA, so that body would still be accountable.

Proposed new section 8C gives the power to make a contract with any person to carry out functions of the authority. However, under the provision, the authority cannot contract out functions related to licensing decisions, the right to enter, the search or seizure of property, or other functions prescribed in an order made by the Secretary of State.

For example, the provision allows a private company to undertake inspections of laboratories on behalf of the authority, and the clause provides that the authority remains in control of its functions and responsible for all acts or omissions under such arrangements. We are seeking to remove duplication with other public authorities when that is sensible, thus reducing the number of inspections and the regulatory burden. Any powers in the area would have to be subordinate to the legislation, and that includes the regulating-making powers. It could also include powers such as making orders. The approach is quite straightforward, and because of the exclusions on specific issues, I hope that hon. Members will accept that this is about using similar inspections and expertise in the public sector and reducing duplication, not the HFEA losing control of its responsibilities or transparency. I hope they will also accept my points about what cannot be contracted out and what will remain absolutely central to the work of the HFEA.

Mark Simmonds (Conservative, Boston and Skegness)

I might have misunderstood what the Minister said. Did she clarify the point about this relating only to other public sector bodies so that no independent or private sector charitable or voluntary organisations will get involved, particularly with regard to inspections? Inspections are not specifically excluded as are, quite rightly, licensing and the other issue with regard to the code of practice. What about the specific point regarding the interim inspections?

Dawn Primarolo (Labour, Bristol South)

May I help the hon. Gentleman by making an intervention? Proposed new section 8C gives authority to contract with another person to carry out functions and sets out exclusions. In the example I gave, such a function might be undertaking an inspection of a laboratory on its appropriateness, but would not include the other functions: licensing, right of entry, and search or seizure. That would occur in limited circumstances, and that possibly could go beyond a public authority. However, others provisions relate to public authorities.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful for that clarification, as I understood what the Minister just confirmed: the HFEA is going to be allowed to contract out not just to the public sector, but, in very specifically defined circumstances, to the independent sector, as the Minister explained.

None

Mike Penning (Conservative, Hemel Hempstead)

I will not detain the Committee for long. I find the clause quite interesting because of the ambiguous language in the Bill. It allows the authority to assist other public authorities and then, quite naturally, to charge them should it do so. I am conscious that those bodies could be some of the ones that the authority has already contracted out to that could be charged for the work that the authority does for them. I am particularly concerned about proposed new section 8E(2), which states:

“Assistance provided by the Authority under this section may be provided on such terms, including terms as to payment, as it thinks fit.”

Could we be in a situation in which one department—the authority—is charging another part of Government, but they do not agree and therefore the work cannot be done? The measure is very ambiguous. This is the second time this afternoon that we have seen such terminology—“as it thinks fit”—in the Bill, so will the Minister clarify it?

Dawn Primarolo (Labour, Bristol South)

The provision is a reciprocal arrangement with proposed new section 8B. New section 8E will permit the HFEA to provide services to other public bodies, such as the Human Tissue Authority or the Healthcare Commission, undertaking inspections in the same premises as the HFEA. They might arrange for the HFEA to cover their inspection in the course of the authority’s inspection regime. The HFEA, not the Healthcare Commission or the Human Tissue Authority, would then carry the cost of undertaking the inspection. The provision gives a mechanism for sharing the benefits of reducing the burden to those who are inspected and the cost to the public authorities performing the inspections.

Mike Penning (Conservative, Hemel Hempstead)

I thank the Minister for being so clear. I only wish that this part of the Bill, which is quite long and detailed, had given us a couple more sentences, as the Minister has done. The provision is very simply put: “as it thinks fit”. I do not wish the Minister to disappear soon, but other Ministers will be around to take her place. They will see the provision in the Bill, and the situation is not as clear in the Bill as the Minister has described.

Dawn Primarolo (Labour, Bristol South)

But the clauses interact together, so if we rewind to the debate on better regulation and the obligations of the HFEA in discharging its duties as a public authority, the same duties apply to the Healthcare Commission or the Human Tissue Authority. Those public bodies would act responsibly and accountably. I think that the hon. Gentleman is concerned that the HFEA would act in a predatory fashion by charging another public authority for the purposes of income generation, following which there would be a dispute.

I do not know why parliamentary draftsmen settle for these phrases, although they are excellent people who do fantastic things and get our legislation into understandable forms, whatever the hue of the Government. I assure the hon. Gentleman that the measure does not provide for some sort of turf war or disagreement on charging, and I hope that he accepts that. It is reasonable to reduce regulation, and when there is a gain to one authority because another authority has undertaken work, there will be a sharing of benefits between the authorities, as well as a clear benefit to the establishment that was inspected, because it will end up with only one inspection, rather than two.

Clause 10

Mark Simmonds (Conservative, Boston and Skegness)

Again, I just have a few questions for the Minister. Will she clarify the exact possible workings of clause 10, which deals with contracting out to, and the setting up of, committees? The clause gives the authority the power to delegate and establish committees, and there is concern over the accountability and transparency of the process. Will the Minister tell us her thoughts on which committees the HFEA thinks it might be appropriate to set up? To whom would it delegate and on what terms, and what would be the relationship between the committees and the HFEA?

I also understand that the committees can include people who are not members of the HFEA, thereby potentially linking back to some of our discussions on earlier clauses about the appropriateness, the qualifications and the relevance of some of the people who may serve on the committees. Will the Minister explain exactly why it is necessary for the authority to be able to set up the committees? What has not worked well in the HFEA to date that makes it necessary? Why is it necessary to be able to bring in outside people who are not members of the authority?

I would also like to make sure that clause 10 will not allow the authority to move away from decisions licensed by the senior level in the authority and from responsibility for the code of practice. I understand that the purpose—again, it would be helpful if the Minister confirmed this—is to speed up the decision-making process. There is clearly concern about the time that some licensing decisions take, but it is important to maintain transparency and accountability. Some clinics have serious concerns about licensing being renewed at a purely executive level, not an authority level. A confirmation is needed that the appeal process will remain in place, despite the powers to delegate down, and that it will remain the same structure and fall to the people on the appeal panel, not the people who made the original decisions.

The Minister will also be aware of the context. There has been judicial criticism of the former chief executive. I do not want to go into detail, but it may in part drive some of the concerns. Of course I understand that a process is needed for speeding up decision-making for granting licences, but it would be helpful if she would confirm whether delegation applies to all categories set out in the Bill for which the HFEA has responsibility, which include licensing, variation, suspension and revocation.

Robert Key (Conservative, Salisbury)

The explanatory notes to clause 10 have, I regret to say, managed to confuse me. I should be grateful for clarification on two simple points. If the Minister can convince me, my mind will be at rest. I am not clear whether it is meant that staff will be able to take licensing decisions and develop the code of practice. That is what it seems to say. Can she also point us to the measure in the Bill—if she cannot, could she tell us—what functions will still be able to be exercised only by members of the HFEA?

Dawn Primarolo (Labour, Bristol South)

At present, the 1990 Act requires HFEA members to be involved in all licensing decisions. As hon. Members have said, there has been comment about whether that is overly restrictive on the speed with which decisions are taken, particularly with regard to what might be considered routine licence applications. Clause 10 provides that the authority can set up committees to which it can delegate any of its functions. It will give the HFEA the flexibility to determine how best to manage its licensing process. That may involve divisions between more routine decisions and decisions that are slightly more challenging or contentious.

The new provisions mean that there will no longer be a specific requirement for a licence committee to be set up, nor will any such committee be required to comprise only HFEA members. Under the new provisions, for instance, the delegation to any committee could include members as well as a member of staff.

Under the 1990 Act, the authority could not delegate any function relating to licensing in that way. The Bill ensures that the HFEA can delegate licensing decisions to staff, ensuring that such decisions can be made quickly and within a framework set by the authority. There will need to be an escalation procedure to ensure that difficult or more contentious decisions are taken with the appropriate authority under these delegated powers. Therefore, we are asking the HFEA to consider how to deal speedily with licence applications.

The provisions are sensible and provide flexibility so that the authority can speed up its decision making and meet requirements of better regulatory practice. That will help the authority respond proportionately to its functions, delegating when appropriate, which should speed up decision making and cut costs. We thought that this provision was sensible to modernise regulation and would be in keeping with the Bill. It was particularly necessary following the removal of the proposal to establish the regulatory authority for tissue and embryos. As we took that part of the regulation out, we needed to have something in this clause instead. The provision should help to speed up the matter, but it does not remove the responsibility of the entire authority for the decisions that are taken. It is a question whether—I am struggling for the words to describe this—there are less complicated decisions that could then be endorsed by the full Committee, but that could be considered more quickly. The question of the appeal process and everything that needs to be in place is there. That is the main requirement. Arrangements are continuing to be reviewed and put in place to ensure that the provision is robust.

I hope that members of the Committee will be reassured that this is a proportionate response to criticism of lack of speed in agreeing licences, particularly when they are straightforward. The provision recognises the full range of expertise in the authority, but none the less makes it clear that decision making has to be speeded up.

Robert Key (Conservative, Salisbury)

I should be grateful if the Minister would be so kind as to write to me in response to one of my points and share the letter with members of the Committee. I asked her what functions could be exercised only by the members and could not be delegated.

Dawn Primarolo (Labour, Bristol South)

I am happy to do that. The members will still be responsible for all decisions, because there will need to be an endorsement. In that sense, there is no removal of power from the members of the board. As regards providing flexibility to the HFEA, I will be happy to write to all members of the Committee, through you, Mr. Gale, to explain the sort of things that we would want to interact to ensure that there is no loss of accountability, expertise and scrutiny in this area by the regulatory authority that we have put in place.

Mark Simmonds (Conservative, Boston and Skegness)

My hon. Friend the Member for Salisbury has, as always, hit the nail on the head. I am very grateful to the Minister for consenting to his request to circulate a clarification letter to the Committee. I think that there would be concerns if the HFEA was allowed to delegate the totality of functions, including licence suspension or revocation, without retaining control over the key ones. I am grateful to the Minister for giving way and also for agreeing to send us a letter, which we will look at closely.

Dawn Primarolo (Labour, Bristol South)

I am more than happy to do that. This was a matter that the pre-legislative scrutiny Committee looked at when considering flexibility for the HFEA, although not necessarily in this area. I assure the hon. Members for Boston and Skegness and for Salisbury that the points that they have raised were precisely those that I and my officials, who will remain nameless, focused on. We wanted to ensure that the regulatory authority continued to discharge its statutory duties correctly. I happily undertake to get those details to members of the Committee as quickly as I can.

Roger Gale (Conservative, North Thanet)

For clarification, and in case anyone thinks I have had a brain storm, clause 11 was taken on the Floor of the House.

Clause 12

Dawn Primarolo (Labour, Bristol South)

I beg to move amendment No. 39, in clause 12, page 8, leave out line 31 and insert—

‘(1) Section 12 of the 1990 Act (general conditions of licences under that Act) is amended as follows.

(2) In’.

Roger Gale (Conservative, North Thanet)

With this it will be convenient to discuss Government amendments Nos. 40 to 43, 106, 108 and 115 to 117.

Dawn Primarolo (Labour, Bristol South)

I was looking for clause 11, Mr. Gale—it has been rather a long afternoon already.

During the passage of the Bill through another place, a debate took place on the use of embryonic stem cells derived under research licences in therapeutic applications. The Government subsequently wrote to all peers involved in that debate setting out how, in the Government’s view, embryonic stem cells derived under an HFEA research licence could be used in therapeutic applications. The amendments are consequential to the Government’s taking that view in another place. They will ensure that research centres deriving embryonic stem cells that are intended for therapeutic use are required to abide by the quality and safety standards set out in the European tissues and cells directive, in relation to stem cells and the embryos from which they are derived.

The directive lays down standards of quality and safety for human tissues and cells intended for human application, including gametes and embryos. The relevant requirements already apply to embryos used in reproductive treatment under the Human Fertilisation and Embryology (Quality and Safety) Regulations 2007. Stem cells derived from embryos are also regulated under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. It is important that those standards are applied also to the embryos used to derive stem cells in human applications in order to ensure the necessary levels of quality and safety of tissues to be used in treatment.

I commend the amendments to the Committee.

Mark Simmonds (Conservative, Boston and Skegness)

I am grateful to the Minister for introducing this batch of amendments. I have one or two queries. I understand the logic of what she said, but there is no mention anywhere else in the Bill of therapeutic applications for humans. Indeed, on the Floor of the House I and the hon. Member for Oxford, West and Abingdon tabled separate amendments and new clauses to allow licence for therapies to take place, but they were rejected by the Minister.

It would be helpful if the Minister were to explain the wording used in the letter that she kindly sent Committee members. How does the phrase

“intended for non-reproductive therapeutic application for humans”

fit in with her view that she will not allow licences for therapies in the Bill? That letter then refers to

“Directives on safety and quality of cells and tissues for human applications”

and “the relevant requirements”. What are the relevant requirements to which the Minister refers? The letter refers euphemistically to “these safeguards”. Will the Minister explain what they are?

After the debates in the other place, I initially thought that the application of the EU directive did not apply to non-medical fertility services. However, the Minister has confirmed today that it does apply to them. Will she clarify that matter? Does it also cover the provision of gametes for such purposes for both non-medical fertility services and non-reproductive therapeutic applications?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I seek your advice, Mr. Gale. I think that the last two important questions raised by the hon. Member for Boston and Skegness, were clause stand part-type questions, because the deletion of the exception for non-medical fertility services is already in clause 12. We are debating, initially, additional amendments to that. Will you let me know shortly whether you wish me to deal with my questions around non-medical fertility services?

The hon. Member for Boston and Skegness has raised an important issue. I am aware that we cannot really reopen the question of licences for therapy at this stage, but, as he said, the issue involves stem cells intended for non-reproductive therapeutic applications to humans. My question for the Minister is simple. Would that cover non-research applications to humans, or would that always cover research applications for the lifetime of the Bill? If it includes non-research applications, then further questions are raised about whether the Government are right to be confident that any applications of stem cells derived from embryos created under a licence could be created under a licence for research, because there will always be research involved in the process? We cannot reopen that discussion here, and I am not proposing to, but it would be helpful for the Minister to clarify her view. Would those non-reproductive therapeutic applications to humans apply to non-research applications? Does her definition of research apply to clinical trials? That is one understanding—research carried out under a research ethics committee approval, with a clear protocol. Or is research to be read more widely—some would say much more widely?

I will make two more points. It is important, looking at the 1990 Act as amended, that the safeguards apply here. The safeguards referred to include the transfer of money and information and maintaining proper records. The clause is important, therefore, because those are the general conditions of licences.

My second question I cannot remember. I might seek to intervene on the Minister, if it occurs to me.

Roger Gale (Conservative, North Thanet)

Order. I indicated earlier that, in principle, I was perfectly happy to have a stand part debate at the start rather than at the end. For that reason, given that it is often easier to take matters in context, I am perfectly happy to allow the debate now. If the hon. Gentleman wishes to add to his remarks, please feel free to do so.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

On the issue of non-medical fertility services, I think that what the Government are doing in the clause is removing the exception for such services from the provisions. The tissue directive and indeed the European Communities Act 1972 section 2 process did not permit the Government to apply the licence conditions that we see in the clause to non-medical fertility services.

What are non-medical fertility services? They are defined in section 2 of the Act as

“any services that are provided in the course of a business, for the purpose of assisting women to carry children, but are not medical, surgical or obstetric services.”

It would be useful for the Committee to know what are not the “medical”, which I guess is using drugs, “surgical or obstetric”, which speak for themselves, “services” that will be covered by the general licence conditions, which are extensive. How have we survived for so long under the 1990 Act with non-medical fertility services—my reading of the measure might not be correct—apparently not subject to the licence conditions? To put it another way, will the Minister assure us that this is not a discretionary regulation and, even if it is, that it is not over-regulation of services that would not necessarily require regulation by the HFEA? There is a general trend that as soon as an authority is regulating things, it wants to continue regulating them and identify new things to regulate. It is sometimes the job of Parliament to retreat from that trend. [Interruption.] The ironic laughter of the hon. Member for Norwich, North reminds me that a number of Select Committee reports, particularly the report that came out under his chairmanship in 2005, argued that it was time that the HFEA did not regulate basic fertility treatment because it is now pretty standard. It is useful to collect information, but is it right that licensable matters are subject to all such regulations, while, for example, surgery to remove the blocking of fallopian tubes to treat infertility continue to be completely unregulated by the HFEA? Such treatment is currently subject to all the other regulation that currently binds doctors. That is a wider issue, but I have been provoked by the inclusion of non-medical fertility services in the scope of the licence conditions in the clause.

Dawn Primarolo (Labour, Bristol South)

Can I reassure the hon. Member for Oxford, West and Abingdon that he should not be provoked by the use of the term

“non-medical fertility services”?

He asked me what they might be: essentially, the measure is about internet sperm delivery services—he may have mentioned those. They have to be described as “non-medical” in case any attempt is made to deliver services other than via the internet, which currently happens, apparently.—[Interruption.] Perhaps I should have used a different phrase.

Moving on, I should explain why the amendments are necessary, which will answer the point made by the hon. Member for Boston and Skegness. The quality and safety standards that are set out in the EU directive are aimed at preventing the transmission of disease from donor to recipient of tissues or cells. Two separate points were made and I do not want to lose the distinction. The EU directive requires that provision is based on the safety and quality of services, and that consent is obtained. That is the set of issues to which the amendments relate.

The second set of issues relate to therapeutic services. The Government believe that the measure applies to research only. Our view is that, under a research licence, an embryo can be used to derive stem cells for human application as long as it can be shown to be part of a project of research. The amendments would introduce a requirement to comply with the directive that is aimed specifically at the limited area of quality and safety, as I described. Two separate issues were conflated by my use of the word “therapeutic” in my earlier remarks. However, the issues are not connected. The amendments relate specifically to the directive arrangements.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I know what the Minister says, but it shows that the provision of stem cells for therapeutic application cannot be said to be irrelevant to the HFEA or to the Bill. It could be argued that it is a matter for the Human Tissue Act 2004 or the Medicines and Healthcare products Regulatory Agency; that once the cells are used, the embryo is long gone, so it is not a matter for the Bill or HFEA licences. I am keen not to provoke the Minister because we are nearing the end of the sitting, but does she recognise that, even as far as this relatively minor provision goes, when stem cells derived from embryos—not embryos—are put into humans, the licence conditions for the storage, use and creation of the embryo are relevant to the end use, at least in principle? That goes to the question, to which we might return, whether there needs to be greater specificity in other aspects of the licence arrangements for such end uses.

Dawn Primarolo (Labour, Bristol South)

Was that an intervention, Mr. Gale?

Roger Gale (Conservative, North Thanet)

Yes, but it was a very long intervention.

Dawn Primarolo (Labour, Bristol South)

Yes, and I listened very carefully to it. The Government have not said that the provision of stem cells for therapeutic application is irrelevant to the HFEA. The issue, which we discussed on the Floor of the House, is whether therapy licences are necessary. It is a separate issue. I can see the tenuous link that the hon. Gentleman is trying to make, which is why I was careful to anchor my comments by saying that we are talking about research for therapeutic services, not the therapies themselves. We had a debate on that on the Floor of the House, as I said. I have concluded my remarks on that and I hope that they were helpful to the Committee.