Orders of the Day — Human Tissue Bill

House of Commons, 10 November 2004.

Clause 5 — Prohibition of activities without consent etc.

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

Alan Haselhurst (Deputy Speaker, Saffron Walden)

With this we may discuss Lords amendments Nos. 2, 10 to 17, 34, 35, 37 to 39, 50, 51 and 53.

Rosie Winterton (Labour, Doncaster Central)

These Government amendments were introduced to meet the concern expressed in the other place that giving magistrates the power to send researchers to prison conflicted with the Government's having stated that only the most serious offences would warrant a custodial sentence. The penalties available to magistrates relating to offences under the Bill were considered excessive, since the most serious cases would be referred to the Crown court anyway, so there was wide support for the view that fines should be a sufficient penalty for magistrates to impose in dealing with these offences.

The new offences created by the Bill are, in the jargon of the criminal justice system, triable either way; in other words, they can be dealt with by magistrates or by the Crown court. The amendments remove the scope that clauses 5 and 8 provide for magistrates to order a custodial sentence following summary conviction for offences relating to consent and to misuse of human tissue; the scope that clauses 25, 30 and 31 provide for such a sentence in respect of licensing offences; and the scope that clause 50 so provides in respect of the DNA offence.

We have not removed magistrates' power to order custodial sentences for all offences under the Bill because they can already order such sentences for most offences under the Human Organ Transplants Act 1989, which is concerned with trafficking in human organs and live transplants. They will continue to be able to do so for all offences transferred to the Bill from that Act.

The consequential amendments to clause 63 relate to the position pending the coming into force of the Criminal Justice Act 2003, and the consequential amendments to clauses 56 and 64 relate to the position in Scotland and Northern Ireland.

I have made it clear in this House, as did my noble Friend in the other place, that the penalties are there to act as a deterrent to future offences relating to consent and misuse of human tissue. We do not expect cases to come to court. The effect of the amendments will be, for example, that where a person stores or uses tissue taken from a deceased person for quality assurance without consent, if they are prosecuted and magistrates hear the case, the maximum penalty will be a fine. If the offence is so serious that the magistrates refer it to the Crown court, or if the defendant chooses to have a trial by jury, he or she can be sent to prison.

In introducing these amendments, we have responded to some of the concerns raised in the other place on behalf of researchers and pathologists. I therefore urge the House to accept the amendment.

Andrew Lansley (Conservative, South Cambridgeshire)

I am grateful to the Minister for explaining the purpose of the amendments tabled in the other place, though she will be aware that concerns were raised in Committee on 29 January. I made it clear then that we were surprised at the severity of the penalties and I argued that the provision for 12 months' imprisonment on summary conviction or three years on indictment seemed excessive. Happily, the Minister's colleague undertook to take the issue away for further consideration. It was not subsequently resolved in this House, but I am glad that it has been resolved in the other place.

Given our experience of the Human Organ Transplants Act 1989 and the availability of penalties to act as a deterrent there, the Lords amendment poses some questions. I was not aware of any concerns arising from consultation on the Bill about the lack of available penalties under earlier legislation or any abuse resulting from it. It seems that increasing the severity of penalties is not really needed in the Bill. None the less, I entirely take the point that the purpose of the penalties is to act as a deterrent. They will clearly do so because they are relatively severe.

My hon. Friend the Member for Westbury (Dr. Murrison) reminded me that, for those who are medically qualified, even the penalties relating to summary conviction and a fine before a magistrate are likely to have professional consequences, so it is important to recognise that the penalties will act as a deterrent to contravening the legislation. As the Minister argued in Committee, we all hope that it will never be necessary to bring any cases to trial.

My noble Friend Earl Howe raised some concerns and made it clear that we were unhappy about the prospect of prosecutions being brought before a magistrate and leading, on summary conviction, to imprisonment. Even though cases are triable either way and the defendant may elect for trial by jury, it seems inappropriate to implement such a procedure. I am happy that the Minister in the other place accepted that argument and that the Government tabled amendments to meet our concerns. We are content—indeed, pleased—that, in this respect at least, our concerns about penalties have been met.

Lords amendment agreed to.

Lords amendment No. 2 agreed to.

Clause 6 — Activities involving material from adults who lack capacity to consent

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

Alan Haselhurst (Deputy Speaker, Saffron Walden)

With this we may consider Lords amendment No. 44.

Rosie Winterton (Labour, Doncaster Central)

Lords Amendment No. 3 supplies a word in the Secretary of State's title in clause 6. I hesitate to say it, but it was spotted by eagle-eyed Opposition peers, though I am sure, of course, that it was also spotted by Opposition members of the Committee.

Lords amendment No. 44 corrects a drafting omission, which should have been included in the Bill when amendments were made by the House on Report, allowing the use of material or DNA analysis in certain circumstances in court orders. Clause 57 deals with the secondary legislation to be made under the Bill, including parliamentary procedure and consultation processes that apply to it. Subsections (1) and (2) refer to

"Any power to make orders . . . under this Act".

That is clearly intended to refer only to secondary legislation but, as drafted, it could also apply to the powers of the court to make orders under clause 7 and schedule 5. It would clearly be inappropriate for a clause dealing with secondary legislation to apply to court orders, so the amendment ensures that that would not be the case.

Lords amendment agreed to.

Clause 7 — Powers of court to dispense with need for consent

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

Alan Haselhurst (Deputy Speaker, Saffron Walden)

With this we may consider the following: Lords amendments Nos. 4 and 5, Lords amendment No. 6 and Government amendment (a) thereto, Lords amendments Nos. 7 to 9, 52, 54 and 62 to 69.

Rosie Winterton (Labour, Doncaster Central)

The Government introduced this group of amendments to clause 7 and schedule 5 in response to points raised in the other place about two issues. First, the amendments provide scope for orders to be granted to waive consent where people do not respond to requests for consent to use their tissue to inform the health care of someone else. Secondly, they take the power to make these types of order away from the High Court and give it to the Human Tissue Authority.

The amendments were made in response to debate on a related amendment in Grand Committee in the other place. The Opposition tabled an amendment to introduce a court order to allow a refusal of consent to use tissue for the benefit of a relative to be overridden in prescribed circumstances—for example, in DNA analysis. The Government did not and could not accept that, since overriding someone's refusal of consent would cut directly across the basic principle of the Bill, which is that people should be able to decide what happens to their bodily material.

The Government believe that overriding a refusal of consent in that way would be a step too far. We must establish systems, particularly in the sensitive area of genetics so that individuals are asked, when their tissue is taken, whether they are content for it to be used for purposes such as research or informing their families' care. We know that 99 per cent. of people will agree and we provided, when the Bill came to this House on Report, for a waiver of the need for consent in the case of "missing relatives", where the person whose tissue might be used simply cannot be found. However, the Government listened hard to the debate in the other place and discussed the matter further with key stakeholders in genetics, who are most interested in this issue. They suggested that, in reality, the need to override refusal was a very infrequent occurrence and, indeed, some agreed that such an order would not be justifiable.

Geneticists say, however, that sometimes individuals just do not respond to requests for consent, so that they neither give nor refuse consent to the use of their tissue for the benefit of a relative. This situation arises in connection with requests to test tissue for genetic markers for various forms of familial cancer, such as breast and bowel cancer. I shall give a practical illustration of that.

Let us say that a person's uncle has bowel cancer. If the nephew wishes to know whether he is at risk of getting the same disease, it may be possible to test an existing stored sample of the uncle's tissue to find out whether both people share a known specific genetic mutation. If the uncle agrees, then it is clear that tests can proceed. That will be what happens in almost all circumstances, as we know that people are generally happy to assist in that way, especially with diseases that may affect family members. However, the question arises about what we can or should do if such agreement is not given, either because the uncle cannot be traced—and we dealt with that on Report—or because he simply fails to respond to requests.

At present, the common law on these issues is unclear, but in practice there is no clear legal obstacle to using material in this way without the uncle's consent. Clinicians usually try to get consent from relatives but, where that is not successful, they may seek to obtain tissue samples through the medical network without consent. We do not believe that that is satisfactory from any point of view, and part of the purpose of this Bill is to give certainty to these situations. However, the Bill means that the use of tissue for the purpose that I have described will clearly require consent, Geneticists say that, if individuals do not respond to requests to use their tissue for genetic comparison, their relatives may be refused prospective tests for genetic diseases by the NHS. Obviously, that could well cause distress and get in the way of treatment or prevention measures in individual cases. Without the right information, patients may not know whether to embark on a regime of regular tests, some of which—colonoscopies, for example—may be invasive.

The Government decided to address this situation by extending the "missing relative" provision, in clause 7(1) and schedule 5(9), to these cases of "non-responding" relatives. These amendments therefore provide that, in such cases, as long as certain conditions set out in the amendments are met, the Human Tissue Authority can deem consent to be in place for the purpose of obtaining information to benefit a relative.

In the example that I gave, the amendments would be able to deal with the situation where the uncle failed to respond to requests to use his stored tissue. If the uncle said no, that would be the end of the matter, but if he simply did not respond, the nephew could make an application under clause 7.

The conditions for waiving the need for consent include the requirement that reasonable efforts are made to get the person to consent, and that the person involved is given notice of the application. The aim is to make it clear that the waivers will be exceptional, so that the power does not become a mechanism for avoiding the need to ask for consent.

The second effect of this group of amendments is to provide that, instead of orders to dispense with the need for consent in the case of "missing persons" and "non-responders" being made by the High Court, directions will be issued instead by the HTA. The intention is that, in due course, the functions of the HTA, including this one, will be taken over by the regulatory authority for fertility and tissue, which will be responsible for both fertility and tissue matters.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I want to ask the Minister about something in the first part of her remarks. Is she confident that Lords amendment No. 6 is narrow enough in scope to refer only to a person's specific treatment needs? Some people will argue that it is wide enough, especially given its reference to "scientific or medical information", to include purposes that might be considered research. Although that might benefit someone later, there does not have to be a specific individual whose needs must be considered immediately. Is the amendment narrow, or could it be applied more widely?

Rosie Winterton (Labour, Doncaster Central)

The aim of the amendments and the clauses that have been referred to is simple. We want to be able to determine whether something is likely to affect the person involved directly—whether, as I said, a person might be liable to contract a disease. The provision may therefore be called a mixture of research and treatment: research in the sense that it is about what might happen in the future, and treatment in the sense that it deals with what a person might receive in the meantime to prevent a possible illness in the future.

Asking whether the provision covers research or something that would lead to treatment is therefore rather like asking how many angels can dance on the head of a pin, but I shall be happy to help further if the hon. Gentleman wants to pursue the matter.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I will have another stab at this, and I may try and raise it later if I catch your eye, Mr. Deputy Speaker. Lords amendment No.6 talks about

"another person (including a future person)",

but says nothing about the need to identify that person at the time. As a result, some people may try to use the provision to get the HTA, as opposed to the High Court, to waive the requirement for consent in the case of a non-responder. I make no judgment about that one way or the other, but the requirement would not be waived when there was a person—or a future embryo, or a family— in a clinic who needed the treatment. The Government have rejected previous amendments that would have given the HTA power to use the information for research purposes.

Rosie Winterton (Labour, Doncaster Central)

That is dealt with separately. This amendment concerns a specific individual making an application because it would directly benefit him or her. If a person is worried that a particular condition may develop, that person must be able to get information about a relative. That is different from a researcher trying to do research, which is dealt with elsewhere.

The Government recognise that extending the "missing persons" order under clause 7(1) and schedule 5(9) to "non-responders" may result in an increase in the number of applications to waive consent to use tissue in these situations. It is clear, however, that the numbers will still be small. There are 18 genetics centres in England, for example, and we might anticipate that each might have a couple of cases a year. We consider that it should remain an exceptional circumstance, but to save any potential burden on, and cost to, the NHS and to make it easier for both professionals and patients, we consider it appropriate for such applications to be made to the Human Tissue Authority rather than to the High Court.

The Government consider that, taken together, this group of amendments provides a pragmatic solution to a situation that, while not common, could damage the interests of certain patients. We cannot countenance overriding a clear refusal of consent, but we have now provided for two sets of circumstances in which it may not be possible to get consent to use tissue to benefit another person. That will allow, in particular, genetic information from one person to be used to benefit the health care of a relative.

Andrew Murrison (Conservative, Westbury)

The amendments relate to clause 7, which was introduced late in our consideration of the Bill and in response to representations made by researchers, principally geneticists. The group is titled,

"Powers to dispense with the need for consent".

In a sense, that strikes at the heart of the Bill, because it is all about consent. Therefore, we need to tread a little warily. That said, the Opposition believe that the change is a pragmatic move that will strike the difficult balance between putting consent at the heart of everything we do medically and ensuring that researchers, especially in genetics, are not disadvantaged in the work that they do on behalf of us all.

I am sure that the Human Tissue Authority will be careful in drawing up codes of practice and guidance on the need to be assiduous in obtaining consent. We agree that the default position introduced by clause 7—that the authority may dispense with the need for consent if no response is received—implies that some effort has been made to ensure that the person concerned does not object to the use of their tissue. I suspect that some cases will emerge every year, given the sensitive nature of the issues surrounding genetics and DNA, in which people do object for a variety of reasons, some that we can imagine but others that we cannot. After all, genetics is a rapidly evolving science and will no doubt in future provide information about people that we are not presently aware of. For example, some religious groups may take exception to the use of tissue for this purpose and wish to object. In the case of objection, it would be inappropriate for the authority to have any powers to override. We must be sure that we give people every opportunity to object to the use of tissue and it is clear that we need, as a matter of some urgency, codes of practice from the authority that will clarify those points.

I have expressed the only concern that we have about the amendments. Broadly speaking, we welcome them, although it is a shame that they have been introduced at this late stage. We are concerned that some of the wording may be confusing, especially with regard to what is relevant directly to a person's condition and what might be relevant later. However, with that in mind, we will give the amendments a fair wind.

Richard Taylor (Independent, Wyre Forest)

I tabled amendment (a) as a probing amendment. Like the hon. Members for Westbury (Dr. Murrison) and for Oxford, West and Abingdon (Dr. Harris), I was concerned particularly about two phrases in Lords amendment No. 6. The first is

"obtaining scientific or medical information about the person".

That phrase exactly fits definition of research in the "Oxford English Dictionary" as well as the wider definition of research. The Minister has already clarified that, in this amendment, "research" is meant in the narrow sense of looking specifically at features of the donor that could affect people in the future.

My other query was about the definition of "another person". Could it mean other persons? Unless that is clarified, the wording could open the door to research on a wider circle of people. I would be grateful for absolute clarification of those two slight ambiguities.

While I have the chance, may I say how delighted I am that almost all the changes that we struggled to obtain in Committee have now reached the Bill at this stage?

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I wish to raise three points with the Minister on this group of amendments and, in particular, Lords amendment No. 6. I have already made the first point in an intervention on the Minister. I asked whether the amendment might be used to obtain permission for research without consent from the authority and not from the High Court, as provided for in clause 7(3). As the hon. Member for Wyre Forest (Dr. Taylor) said, it might be argued that to obtain scientific or medical information to help another person or future person is, by definition, a particular type of research project. The Minister kindly confirmed that we should be reassured—or, in the case of those who might have wished to use the provision to make such applications for permission, disappointed—because it is necessary for a person who would benefit from the information to make the application for permission to obtain it. Where in the amendments is the requirement for an application, or does some other provision in the Bill make it impossible for the application to be initiated unless by a person with specific diagnostic or treatment needs?

Will the authority have to decide applications for the purpose of research? Does the Minister think that it is appropriate that applications for research purposes should be decided by the High Court, as provided for in clause 7(3), rather than the authority? Will that make it difficult for any applications to be made, whatever their merits, because of the cost? If the Minister believes—as indicated by the amendments accepted in the other place—that the authority is expert enough to make decisions about dispensing with consent in some cases, why should it be the High Court that makes the decision about dispensing with explicit consent for other applications, such as those for research? I hope that I have made my concerns on that point clear. If not, I would be happy to accept an intervention to clarify them further.

Secondly, I would be grateful if the Minister would clarify the steps she expects will be taken to ensure that the donor from whom the authority is being asked to gain consent for the use of their tissue or genes has not died. The amendment refers to there being "no reason to believe" that the donor has died, which mirrors an amendment we discussed on Report—I think that that is worth returning to—but it talks elsewhere about "reasonable efforts" having been made to get the donor to decide whether to consent. If the donor had died, my understanding is that it would not be possible for that to be done, so one might argue that reasonable efforts ought to be made to establish whether a non-responding donor has died.

I presume that the clause is constructed around the knowledge that the person is not dead, but if it is the case that they are alive and not responding, it is curious that one would even need to mention the condition that there be no reason to believe that the donor had died. I am a little unsure of the circumstances in which that provision might apply and of the steps the Minister believes should be taken. Clearly, those who have died will not respond. I would be interested to know how she envisages certainty being obtained as to which applies.

The third issue relates to lack of capacity, and the Minister will be aware that I have raised that before. I understand that both Houses will debate the matter in the context of the Mental Capacity Bill. However, subsection (d) of amendment No. 6 states that

"there is no reason to believe. . .that the donor lacks capacity to consent to the use of material for that purpose".

It is thus clearly the Government's understanding that the Mental Capacity Bill will be used in that case to decide whether consent can be obtained. It is important that we debate that now, because this is the best place to get an idea from the Government now that Bill has been published—it was not when we previously debated this matter—on whether the best interests test is the best way forward.

It is hard to argue on an understanding of best interests that it is ever, narrowly, in someone's best interests to allow their material to be used for someone else's benefit. The Minister can say that best interests include what they would have wanted to do for a member of their family, but it seems to me that it would be better—I make this case again—to avoid the term "best interests" and use the expression "not against the best interests of the person concerned". That is a good example, and shows how using such terminology will not change the actual outcome, but it is a more honest way of saying how we are going to deal with issues of lack of capacity. Otherwise, people might feel that such cases are stretching the term "best interests" further than it need go.

I would be grateful if the Minister would comment on whether she envisages that it would almost always be the case—even though it is not always the case for a donor with capacity—that the advocate or their substituted decision maker would allow such a decision to be made. I hope that that is clear. Like the hon. Member for Westbury (Dr. Murrison), I welcome the fact that we are debating a series of amendments that have improved the Bill and I am pleased that the Government accepted—albeit in another place—some of the amendments that were pressed, which had their echo during debates that took place in this House.

Patsy Calton (Liberal Democrat, Cheadle)

I want to bring to the attention of the House a number of points that have surfaced recently from the cancer research world, on which I seek clarification from the Minister. The concerns relate to material that has been stored previously, such as material stored several years ago. As someone whose material was stored several years ago, I can speak with some authority on the matter. I understand that ethics committees are already refusing permission because of the lack of consent in cases such as that of my own stored material. A number of people in my position would be horrified to think that material that had been lying in a tissue bank for some years could not be used now because of misunderstandings about the intentions of the Bill.

I understand that Herceptin was discovered because of work that was done with material that had been stored—exactly like my own material—during the last few years. First, I would like the Minister to clarify whether material such as that stored six to eight years ago requires additional consent. Secondly, if consent is required, what form will it take? Will it require more than simply a letter to the last known address? Thirdly, are repeated consents necessary for new research as it arises? I apologise if that does not fit completely with Lords amendment No. 6, but like my hon. Friend the Member for Oxford, West and Abingdon (Dr. Harris), I was not clear whether "another person" referred to a specific person. I thought that the point was broader and would thus be acceptable.

I would be grateful if the Minister would clarify the three points I made about stored material from persons such as myself, who would be horrified to think that such material could not be used because ethics committees were erroneously of the opinion that fresh, modern, up-to-date consents of the type required by the Bill had to be obtained for every item stored in the past.

Rosie Winterton (Labour, Doncaster Central)

First, I shall deal with the amendment tabled by the hon. Member for Wyre Forest (Dr. Taylor). I hope that during the course of my opening remarks, I can clarify some points for him. I am sure that he is aware that the effect of his amendment would be to extend the waiving of consent applications for research purposes, which is why we could not accept it. We have said quite clearly that it is not about getting consent for research purposes, but about a link with an individual. To clarify his point, we have used the term "person" because it refers to an individual who wishes to find out information about the effect on themselves, or possibly their children. If someone was making a decision about whether to have a baby, for example, and felt that they might pass on a condition that a relative suffered from, it would be possible for consent to be waived in those circumstances. For those reasons, we cannot accept the amendment, but I hope that what I have said clarifies the points raised by his probing amendment.

I shall move on to points made by the hon. Members for Westbury (Dr. Murrison) and for Oxford, West and Abingdon (Dr. Harris). It is absolutely vital that proper efforts are made to locate a person and ensure that although they have received information, they have not in fact responded to it. The question of ascertaining whether someone had died would be covered by the attempt to find out whether they would respond to the information. The provision obviously concerns tissue from the living. If we were talking about someone who had died, the process would revert to getting consent from a relative.

Under the clause, the applicant should show that there is no reason to believe that the person has died. If it was necessary to prove that there was reason to believe that the person had died, those involved would have to revert to obtaining permission from a relative to use the stored material, so reasonable efforts would have to be made. The clause is nothing to do with trying to carry out research without gaining consent, as was suggested by the hon. Member for Oxford, West and Abingdon.

The reason why those issues can be dealt with by the Human Tissue Authority, rather than by the High Court, is that it will be possible to show that efforts have been made to contact the person or there will be clear evidence that the person is missing, so taking such cases to the High Court would be excessive.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

The Minister may have missed this, but my specific question was how she could be certain in her view, which she gave in answer to my earlier intervention, that an application under Lords amendment No. 6 must come from a person in a clinic who seeks a diagnostic or therapeutic intervention and could not be initiated by a clinician who seeks to use the tissue of someone who cannot be traced or who does not respond for the generic purpose of helping people in the future, even in circumstances that can be defined but are not specified. The Minister said that the application must originate from a person in the clinic. I should be grateful to her if she would say where that is made clear in the Bill.

Rosie Winterton (Labour, Doncaster Central)

Such things must relate to the interests of another person—an individual—and the application to the Human Tissue Authority must state that that person has asked that an attempt be made to obtain the material from their relative because they believe that they may have a certain condition. It must state that the proof that they have that condition is X and the reason why they want to find that out is Y, because the person may need treatment in between, perhaps to stop the condition developing.

The hon. Member for Cheadle (Mrs. Calton) asked about existing holdings. Existing holdings are exempt from consent provisions, but we will say in the code of practice—we expect research ethics committees to consider this at the moment, as we have said previously—that those involved should try to obtain consent from an individual if it is clear from using existing material that they were likely to identify, because they knew from whom the material had come, something that might affect the individual in the future or that might link to another condition.

If research ethics committees anonymise the material, it can be used anyway. Anonymising the material does not necessarily mean that they would not have access to a person's medical records, so they could look at the treatment that the person had received, but they would not know who the person was. However, it is for individual research ethics committees to consider the proposed research and decide whether it would be necessary, if at all possible, to get the person's consent because the research may have a direct effect on them. I hope that that answers the hon. Lady's questions.

Finally, the most appropriate method of getting permission from people who lack capacity is to obtain a relative's consent. The Mental Capacity Bill makes clear the steps that must be undertaken to obtain consent where, for example, research is to be carried out. However, if research is not involved, those involved must ensure that the necessary consultation takes place, while also considering the person's best interests. It could be in a person's best interest to have their tissue used to benefit a relative. As hon. Members may know, there have been some recent examples where a person who is looking after someone without mental capacity has wished to obtain treatment because they can then find out what is affecting them. So there may be a wider best interests test.

With those reassurances, I hope that the House will accept these Lords amendments.

Lords amendment agreed to.

Lords amendments Nos. 5 to 17 agreed to.

Clause 33 — Restriction on transplants involving a live donor

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

Alan Haselhurst (Deputy Speaker, Saffron Walden)

With this we may discuss Lords amendments Nos. 40, 43 and 47.

Rosie Winterton (Labour, Doncaster Central)

Lords amendments Nos. 18, 40, 43 and 47, which were moved by the Government, implement a recommendation made by the Delegated Powers and Regulatory Reform Committee in its 25th report, published on 16 July. The Government are grateful, as always, to the Committee for its detailed consideration of the Bill. These Lords amendments put right an anomaly in the Bill that was noted by the Committee.

Clause 33 deals with transplants from living patients. It is brought forward from, and updates, the Human Organ Transplants Act 1989. In effect, it states that live transplants carried out using transplantable material are unlawful unless carried out in circumstances, and in accordance with procedures, set out in regulations. Through that approach, we can specify the type of material to which the offence applies, as well as the circumstances in which live transplants may be allowed—for example, where no coercion or payment is involved—and specify how case-by-case approval must be sought from the Human Tissue Authority.

We use the term "transplantable material" because transplants no longer only involve organs—the term can relate to part-organs or different tissue samples—and because it can be updated by regulation, as new procedures are developed.

Under the Bill, the Human Tissue Authority must make the regulations that define the term "transplantable material", while the Secretary of State has the power to make regulations setting out how and when cases would be subject to an approval procedure. The Secretary of State's power is subject to affirmative resolution in both Houses and the HTA's power is subject to no parliamentary scrutiny at all. The Committee pointed out that inconsistency, and the Government have accepted its recommendation.

We accept that both regulation-making powers should be subject to the same level of scrutiny, and the amendments will thus make the definition of transplantable material a matter for regulations subject to the affirmative procedure made by the Secretary of State. As with the other affirmative powers in the Bill, the Secretary of State will have to consult the National Assembly for Wales and the relevant Northern Ireland Department before acting under the powers.

Andrew Murrison (Conservative, Westbury)

Although we can agree that the Lords amendments appear to increase the transparency of the way in which transplantable material will be defined, will the Minister confirm that that is the purpose of Lords amendment No. 18? Lords amendments Nos. 40, 43 and 47 appear to say that the Secretary of State may define transplantable material, but that that could not be annulled by a resolution of the House. I am somewhat confused about that, so I would be grateful for her clarification.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I welcome the amendments because it is always important to ensure that the House has the opportunity to comment on such regulations.

Does the Minister think that altruistic donation will fall within the procedures on which she expects the Secretary of State to make regulations? In Committee in the House of Lords, there was a debate on altruistic donation and on whether current arrangements allow for stranger donation or indeed domino donation. I have tabled parliamentary questions about the matter because it is unclear whether regulations that the Secretary of State has already promulgated under equivalent provisions in existing Acts allow such donations to take place. If the Minister does not think that that is the case, will she give me an undertaking that under the power that the amendments will rightly give the Secretary of State through clause 33(7), rapid progress will be made to provide a structure under which the relevant authority may determine whether such donations may go ahead? I have received many representations from people who believe that it should be possible to make such donations.

If the Secretary of State is to make regulations instead of the authority—it will have rather less on its plate than him, albeit still a lot—it would be helpful if the Minister could assure me that she and her colleagues are considering the issue urgently. People have been telling me for several years that the existing regulations do not allow the relevant authority to permit such donations. The Minister might think that this is a small point, but people's lives depend on ensuring that the pool of donors is as wide as possible, so I hope that she will be able to address my point.

Rosie Winterton (Labour, Doncaster Central)

The hon. Member for Westbury (Dr. Murrison) is right that the purpose of Lords amendment No. 18 is to give the power to the Secretary of State. The other amendments are consequential and relate to the procedure for making regulations.

To respond to the point made by the hon. Member for Oxford, West and Abingdon (Dr. Harris), altruistic donations are not prohibited at present, but the Unrelated Live Transplant Regulatory Authority does not currently allow them. The Human Tissue Authority will be in a position to consider altruistic donation further, and I know from our debates on Report and in Committee that the hon. Gentleman is concerned about the supply of transplantable material. However, although such donation is not prevented at the moment, ULTRA has the power to decide whether a procedure can go ahead. The matter is being considered, but as I am sure that he knows, many issues must be resolved before we can proceed. The HTA will be able to consider altruistic donation and will do so.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Is the Minister saying that if such donations are to be considered and carried out, new regulations under clause 33(7) need not be promulgated and the Secretary of State need not give approval?

Rosie Winterton (Labour, Doncaster Central)

Nothing prevents the donations at the moment except for the fact that ULTRA makes decisions about which donations can happen. If ULTRA said that altruistic donations could go ahead, I am not sure whether the Secretary of State would have to approve that. I suspect that ULTRA currently has the power to make the decision without referring back to the Secretary of State, but if that is not the case, I shall certainly write to the hon. Gentleman.

Lords amendment agreed to.

Clause 35 — Inspectorate of anatomy and pathology

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

Alan Haselhurst (Deputy Speaker, Saffron Walden)

With this is it will be convenient to consider Lords amendments Nos. 20 to 28, 31 to 33, 41, 42, 45, 46, 48, 58, 59, 70 and 71.

Rosie Winterton (Labour, Doncaster Central)

The structure of the Human Tissue Authority originally envisaged under the Bill was a single authority incorporating two inspectorates that would license and inspect regulated activities. The inspectorate for anatomy and pathology would have dealt principally with consent and ethical issues in relation to such matters as teaching anatomy and tissue banking for research. The inspectorate of organs and tissue for human use would have regulated banks holding tissue for transplantation and implemented the safety and quality protocols of the EU directive on tissues and cells.

As a result of the review of the arm's-length body, the Government announced in July that the Human Tissue Authority will merge its activities with those of the Human Fertilisation and Embryology Authority when the current review of the Human Fertilisation and Embryology Act 1990 is complete, which is likely to be in about 2008. At that time, both the HTA and the HFEA will be subsumed into a new organisation called the regulatory authority for fertility and tissue, or RAFT.

The Government listened to the debate on the structure of the inspectorates of the Human Tissue Authority in the other place and reconsidered their position. We believe that it will be helpful for the HTA to have maximum flexibility as it organises its activities alongside those of the HFEA and prepares for the eventual merger. We thus tabled the large group of amendments to remove the inspectorates of anatomy and pathology and of organs and tissue for human use from the structure of the HTA. The amendments will also allow the HTA to delegate its inspection and licensing functions to any members and staff of the HTA, or a committee composed of members and staff, or both.

The amendments will not in practice affect the way in which the authority will inspect and regulate licensed activities. It will still be able to call on the advice of experts in the various fields that it regulates, but it will operate in as streamlined a way as possible. It will still be possible for the HTA to hear appeals against decisions taken by those to whom it delegates certain functions, for example committees that deal with licensing decisions.

Opposition Members asked us in Committee to ensure that the system was not overly bureaucratic. I hope that the amendments address some of the points raised.

Andrew Lansley (Conservative, South Cambridgeshire)

Clauses come and clauses go, and quite a number are going in this respect.

The amendments address some of the questions raised about excessive bureaucracy, but we need further assurances. It was generally understood that one of the originating reasons for the design of the legislation, with the two parallel inspectorates under the authority, was not least because of the existing body of expertise and the confidence that was placed in the inspectorate of anatomy in particular. We were only too aware that the tragic events that gave rise to the mischief that the Bill is intended to remedy did not arise in respect of functions inspected by the inspectorate of anatomy. The measures partly originated to assure people that things done well, not least by the inspectorate of anatomy, would not be messed about. So the first assurance that we need is that the existing body of relevant expertise built up in the inspectorate of anatomy will be properly protected in the HTA.

That said, we are happy that what might have become a bureaucratic structure of parallel boards all within one authority is being dispensed with and that the HTA is being given the flexibility to structure its functions. Although the Minister did not refer to this, I am sure that she would recognise that clause 40 extends to the authority the ability to manage itself by giving agency functions to other public bodies and authorities. Given the intention to combine the HTA and HFEA into the regulatory authority for fertility and tissues from 2008, there are immediate questions for the HTA to consider about the extent to which it establishes parallel functions or agrees with the HFEA that they carry out functions on a jointly administered basis from the outset. I hope that the Minister can confirm that clause 40 does not bar any of that happening.

The amendments would probably have been desirable regardless of the arrangements proposed between the HFEA and HTA. They are not contingent on those two bodies being pushed together. However, the Minister has put them in that context, which raises one or two important issues.

The Minister will not be surprised if I remind her that on Third Reading on 28 June at column 118, I asked whether it was the intention of the Government, who had initiated the review of arm's-length bodies at that stage, to combine the work of the HFEA and HTA. Those of us who served on the Standing Committee were only too well aware that the two authorities were designed to function in a similar manner, and we raised that issue in February. Happily, our advice was that if that was the Government's intention, they should at least tell the other place before the Bill completed its passage. That was overtaken in September by further announcements on the review.

It does, however, mean that we are proposing to introduce the HTA for it to disappear at a future point into a new and different authority. That will only reinforce the public's occasional cynicism about the nature of the legislative process and how we conduct things. I say "we" advisedly. Governments of perhaps all descriptions tend to set things up with greater frequency than they get rid of them. At least on this occasion two turn into one rather than the other way around.

Many people who were surprised at the Retained Organs Commission disappearing before the HTA arrived will also be surprised to find that the HTA will be around for just three years. That raises a serious question, which the Minister should answer. The Government are looking for members of the HTA, comprising a chair and up to 14 members, with the understanding that they will be in office for three years. That is a normal term, but there is also the expectation that the authority will disappear after three years because it will be wrapped up in early 2008 and replaced by the new authority. There will be competing interests from members of the HFEA and HTA. Does that make sense? Is there a case for joint appointments to the two authorities and for anticipating some of the changes?

It is not for any of us to anticipate what Parliament may dispose of in relation to statutory bodies in future legislation, but we made it clear in Committee and on Third Reading that the two authorities could be run together and operate as one. There are compelling reasons to look critically at the range of inspectorates, going beyond the two authorities. I talked to hospitals about the number of inspectorates to which they were subjected in the course of their daily business. One drew up a list with 42 inspectorates.

I raised the problem at a meeting and discussed it with the chief executive of the Healthcare Commission. She did not think that 42 was correct. I thought that she would say that there are far fewer, but on the contrary I was astonished to find that she reckons there are 102 inspectorates. I have not seen that list, but these two inspectorates are part of the burgeoning inspection process overall.

It is essential to find ways to rationalise inspection. The Healthcare Commission wants to do that, and I hope that the Government support it to the utmost extent. Although authorities have responsibilities, which clearly have to be discharged, those institutions that are inspected find that if inspectors talk to one another, the duplication is removed and the processes of providing data and information are rationalised, including the processes of providing access and giving people the opportunity to visit premises and to put specific activities in context. The role of inspectors could be rationalised in a way that minimises the burden of inspection. Happily, clause 43, which requires the authority to

"carry out its functions effectively, efficiently and economically"

and to have regard to best regulatory practice, should help us to ensure that it has no choice but to participate. However, it depends on the Healthcare Commission exercising its function, and doing so aggressively.

My next point relates to the authority's membership. Before these clauses were removed, there were different mechanisms by which different areas of expertise would be included in the authority's decision-making processes, either through membership of the HTA itself or through the two boards or the two inspectorates. In the absence of those boards, it is even more important that the authority and its members can bring the relevant expertise and perspectives—I am distinguishing between the two—to their work.

The advertisement for the authority's chair and membership posts—which I note, for anybody listening to our debate, requires completed applications by tomorrow—gives examples of the areas of knowledge and experience from which people may be drawn, dividing them between lay and professional members. Examples of those who may want to apply to be professional members include pathologists, coroners, anatomists, surgeons, researchers and pharmacologists, which seems to imply that professional and academic expertise is being sought.

A range of examples are given for lay members, including the areas of media and finance, but no specific reference is made to industrial experience. I am thinking of the pharmaceutical industry, biotech industry or bio-industry experience. I do not understand how we are to try to ensure that some of the issues concerned, such as tissue banking and the conduct of research in a commercial context, which we have discussed in our proceedings on the Bill, will be covered by the relevant expertise.

Dividing the advertisement into lay and professional members and not including any reference to private sector and industrial expertise begs the question whether such expertise is likely to be included. It may depend on whether biochemists and pharmacologists who have worked in pharmaceutical or bio-industries are appointed. Let us face it: 13 categories of members are instanced in the advertisement, and only 12 appointments—up to 12—other than the chairman, will be made through the NHS Appointments Commission. It may therefore be difficult to ensure that members have the relevant expertise.

In Committee, my hon. Friend the Member for Westbury (Dr. Murrison) referred to the experience of pathologists. Although we know that there is no place for a representative, as it were, of the Royal College of Pathologists, it is difficult to see how the authority could conduct its business without being sure that it could draw on the expertise of a pathologist and, perhaps, an anatomist and someone with not only a pharmacological background but an understanding of the use of tissues in research. There are specific areas of expertise that clearly have to be represented.

I hope that we can have some assurance from the Minister that although the appointments are being conducted on Nolan principles, excluding conflicts of interest and ensuring that any appointment is entirely on merit, the NHS Appointments Commission will make it absolutely clear that specific areas of expertise and knowledge need to be represented on the authority if it is to be able to perform its functions effectively.

Subject to all those points, we, like the Government, are happy to remove the clauses from the Bill by way of these amendments.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I certainly agree with the hon. Member for South Cambridgeshire (Mr. Lansley) that neither the review of arm's-length bodies nor the particular conclusion of he review was required to argue that there should be flexibility for a new authority to maximise its efficiency by not simply seeking to transplant into it inspectorates from existing provision. That, arguably, seemed an easier thing to do at the outset than implementing what is now the very short provision in Lords amendment No. 58, which enables the authority to organise these matters as it wants.

I have a further point to make about the implications of the review of arm's-length bodies. To ensure that I remain in order, I do so only in the same terms as the debate in the Grand Committee in the House of Lords. These amendments presume that the merger of the HTA with the HFEA is sensible and rational. We have not had an opportunity for parliamentary debate on that, and that will not happen until Parliament, through primary legislation, approves that measure. That is not intended to happen for several years, and anything may happen in that time, including a general election.

Both bodies have inspectorates and an inspection function. Nevertheless, it has been argued, not least by Lord Jenkin of Roding, for whom I have a great deal of respect on these matters, that the merger is not rational policy making. I would argue that the HFEA and the Human Genetics Commission might have more in common. I hope that the Government still have an open mind on the matter and that it is still open for debate, particularly given the fact that the Science and Technology Committee is due to report on the HFEA and its future, which will hopefully inform the Department of Health's review. I understand the Government's wish to reduce the burden of regulation and the number of bodies, but that has to be done in a rational way. The fact that both the bodies that the Minister has indicated should be merged have inspectorates is not sufficient argument for the measure.

Further to the points that have just been made about the advertisement for jobs that has just gone out, I say to the House that part of the problem with the way in which policies and decisions are made is that the Government are advertising for people to apply for jobs in an organisation that will effectively be abolished, or at least merged, a few years down the line. The timing is unfortunate, to say the least; we are setting up new authorities only to have advertised in advance the fact that people will need to reapply for the jobs within a short time.

We accept the amendments on the understanding that while the Select Committee is looking at the issue and her Department is looking at the HFEA's future, the Minister realises that acceptance does not commit us to the view that the merger between the HTA and the HFEA is right. Although a merger may be a good thing in and of itself, we hope that there is room to explore whether the precise mergers proposed by the Minister are appropriate, given that there are issues other than inspection that various arm's-length bodies need to deal with.

Rosie Winterton (Labour, Doncaster Central)

I shall tackle one of the last points first. The people who apply for a job with the HTA will be aware of the position. It would have been more difficult for them if they had been appointed and then told, perhaps a year later, that the body was to be merged. When we talk about merging the two bodies to become the regulatory authority for fertility and tissue, it will be clear in which direction the body to which people are being appointed is going.

The hon. Member for Oxford, West and Abingdon asked whether the merger was appropriate. The HFEA currently licenses in vitro fertilisation, fertility clinics and the storage of sperm, eggs and embryos. We believe that its approach and structure and those of the HTA are similar and that merging will not significantly disrupt their activities.

I want to reassure the hon. Member for South Cambridgeshire (Mr. Lansley) that we do not want to lose any expertise that has been built up. Anatomy organisations will provide input through membership of the HTA. We will look to Her Majesty's inspector of anatomy for advice in drawing up codes. Various clauses set out the authority's remit and inspections will continue to be carried out. However, we have made it clear that we want the authority to have maximum flexibility in undertaking its duties.

Let us consider the current relationship between the HFEA and the HTA. Clause 40 assists by providing for a close working relationship between the two bodies. We are already considering ways in which the HFEA can work with us, for example, in providing back-office facilities and so on. That process can start almost immediately.

The hon. Member for South Cambridgeshire also mentioned the advert that has been distributed. It has been brought to the attention of the BioIndustry Association and the Association of the British Pharmaceutical Industry. We are open to applications from all sectors. Nothing is ruled out. The advert gave examples but others can apply. Furthermore, the HTA will regularly consult some of the experts that the hon. Gentleman mentioned. The NHS Appointments Commission must make decisions about the best candidates and consider, for example, his point about possible conflict of interest. It must take such matters into account.

We will ensure that we keep and build on the expertise that has accumulated over the years. We believe that our approach will ensure that no unnecessary duplication takes place and that we can move quickly to build in the sort of stability to which I referred so that people who come into post are well aware of the organisation's future direction and can participate in it.

Andrew Lansley (Conservative, South Cambridgeshire)

I assume that the Bill does not exclude the possibility of appointment to both the HFEA and the HTA.

Rosie Winterton (Labour, Doncaster Central)

That possibility is not excluded. Indeed, in some cases, it might be helpful in emphasising joint working. Again, it is for the NHS Appointments Commission to consider all the applications on their merits.

I hope that, with those assurances, hon. Members will accept the amendments.

Lords amendment agreed to.

Lords amendments Nos. 20 to 28 agreed to.

Lords amendment: No. 29

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

Sylvia Heal (Deputy Speaker, Halesowen and Rowley Regis)

With this we may discuss Lords amendment No. 30.

Rosie Winterton (Labour, Doncaster Central)

Clause 44 ensures that activities that are carried out for criminal justice purposes are excluded from regulation by the HTA. By criminal justice purposes, we mean the prevention, detection, investigation and prosecution of crimes, including appeals. However, the exclusion does not extend to coroners' post mortems.

One aspect deals with what happens when a body, or part of a body, is found at what is clearly a crime scene. We want to ensure that the police and investigating authorities are not hindered in carrying out their responsibilities. Although mortuaries that carry out post-mortems will have to have an HTA licence and be subject to periodic inspection, we would not require licensing of a crime scene, which might, for example, be in a forest, simply because a forensic pathologist needed to remove tissue samples at the scene.

Removing tissue from the deceased for a post-mortem examination is licensable, even when it is done for criminal justice purposes. Although in most cases the removal of samples could wait and be carried out in the licensed mortuary, there will be cases in which, as part of the criminal investigation, it is necessary to leave the body where it lies and take samples away for analysis.

Clause 44 therefore has two effects. Subsections (1) and (2) exclude from the regulatory regime of part 2 anything done for criminal justice purposes, other than the coroner's post-mortem examination. Subsection (3) excludes from the licensing requirement the removal of tissue for the purpose of investigating a suspicious death from a body at the scene where it is found. For example, when a person dies of a heart attack, the coroner might ask for a post mortem. That examination would be conducted in a place licensed and inspected by the HTA.

However, when a body has been found and it seems that a crime was involved, it might be important for the criminal investigation for samples, for example of blood, to be taken before the body is moved. As that would be part of the coroner's post-mortem, clause 44(2) provides that the location where the body was found must be licensed before the sample can be taken. That is clearly not sensible. We have, therefore, through clause 44(3), provided for the removal of tissue in those circumstances, once the police have attended, to be outside the regulatory scheme.

None of this has been contentious, but the difficulty that emerged during consideration in another place was the lack of clarity in the meaning of subsection (3), which is designed to ensure that coroners' post-mortem activities that take place "at the scene" do not require a licence from the HTA. The mention of the constable was possibly ambiguous as it could have referred to the police first removing tissue from the body, or to bodies being found only by the police, as opposed to passers-by. We recognised the possible ambiguity, so we tabled amendments Nos. 29 and 30 to clarify the purpose of subsection (3).

The usual expression "at the scene" was previously expressed as

"at the place where the body or part is first found by a constable."

Clearly, people other than the police will often find bodies, which may also be moved after having been found but before the police are involved. To avoid ambiguity, the amendments change the description of these "at the scene" post-mortem activities from

"at the place where the body or part is first found by a constable"

to

"at the first place, where the body or part is situated, to be attended by a constable."

I hope that that is clear. I recognise that these formulations are not elegant or easy, but I assure the House that the revised wording at least removes any possibility of ambiguity. Put simply, the exemption from licensing should apply only to the place where the police first arrive on the scene. I urge the House to accept the amendments.

Andrew Murrison (Conservative, Westbury)

I congratulate the Minister on dealing with an extremely clumsy amendment in her usual elegant fashion.

I shall describe to the hon. Lady one eventuality, which fortunately happens rarely—the situation that faces advanced trauma life support personnel. I should be grateful if she would say how the clause would classify and deal with the situation that I am about to describe. It concerns the scene of an accident or a crime at which, in order to get to a survivor to uncover them or to treat them, it is necessary to deal with someone who is deceased. That might mean moving the person or, in rare cases, removing parts of that person. How would such an eventuality be dealt with under the clause?

Rosie Winterton (Labour, Doncaster Central)

The clause deals with a coroner's post-mortem. What the hon. Gentleman described is the moving of a body from one place to another to try and reach another person to give them treatment. That is not necessarily relevant to the clause, which states that a coroner's post mortem must be licensed, but there will be circumstances where it may be necessary to take tissue from a body in order to assist the coroner's post mortem. That is where the clause applies. I hope I have correctly understood the situation that the hon. Gentleman describes.

Andrew Murrison (Conservative, Westbury)

Perhaps I can expand a little further. If a doctor was required, for example, to remove a part of a body—disarticulate a part of it—in order to get to or to treat someone who was living, how would he or she stand in relation to the clause?

Rosie Winterton (Labour, Doncaster Central)

The doctor would not be affected by the provision because, as I said, it applies to the situation where a coroner's post mortem was being carried out. One would look elsewhere for the actions that would be taken in respect of the situation that the hon. Gentleman describes. I do not know the relevant legislation that would cover it, but it sounds as though someone was taking action to help someone else. I do not believe the clause would apply.

Lords amendment agreed to.

Lords amendments Nos. 30 to 35 agreed to.

Lords amendment: No. 36

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

Clause 52 enables the de-accessioning—that is, moving out of their collection—of human remains by specified museums that are currently prevented from doing so by their governing statutes. The clause fulfils the terms of the July 2000 joint declaration between the UK and Australian Prime Ministers, in which the UK Government undertook to increase efforts to repatriate human remains to Australian indigenous communities.

Lords amendment No. 36 is a response to representations made to the Government on behalf of the museum sector, which, while recognising the need to provide for de-accessioning of the remains of indigenous peoples, was nevertheless concerned to ensure that the power did not make the collections held by the museums listed in clause 52 vulnerable to gratuitous or vexatious claims for de-accessioning. There was particular concern about the ancient collections of human remains in the British Museum, such as mummies. The amendment that we tabled responds to this concern by ensuring that the remains of people believed to have died more than 1,000 years before the clause comes into force are outside the scope of this power. The amendment was prepared following discussion between the Department for Culture, Media and Sport and the relevant museums, particularly the British Museum, the museum of London, and the natural history museum.

There are a number of reasons why the Government adopted the present formulation. First, specifying a cut-off point of 1,000 years will allow the museum of London to make use of this power in de-accessioning the substantial number of mediaeval remains in its collection, such as remains that originate from mediaeval burial grounds. The original proposal by peers on behalf of the museums had suggested a 500-year cut-off, but that would have prevented the use of the power for the de-accessioning of this category of material.

Secondly, I am told that dating such ancient remains can be rather difficult. There are a number of ways in which human remains can be dated. These include radiocarbon dating, and the examination of the circumstances in which the remains were found and of the artefacts with which they may have been buried. However, none of those methods will necessarily pinpoint the date of death to a precise year. We have therefore formulated this amendment so that it will be sufficient that the remains are "reasonably believed" to be those of people who died less than 1,000 years before the clause comes into force, in order for them to fall within the scope of the de-accessioning power. The Government's formulation therefore allows for professional judgment to be exercised on the part of museum curators, archaeologists and other experts regarding the dating of the human remains. I therefore hope that hon. Members will agree to accept the amendment.

Andrew Murrison (Conservative, Westbury)

I welcome the amendment. Like many others, my family and I enjoyed the mummy exhibition at the British Museum during the summer, and it would be a tragedy if those exhibits were to be dispersed. My understanding is that that would be prevented by the amendment and, to that extent, we welcome it. I am fascinated by the repatriation of indigenous remains, and the Minister clarified that that had taken place chiefly in response to requests by the Australian Government for the return of Aboriginal remains. I am not an expert in this field—the Minister is indicating that she is not an expert either, although I am sure that she is—but I suspect that there are other indigenous communities who would also be interested in this legislation, and I am concerned that there might be some remains that they would like to be repatriated.

As I understand it, this provision has to do with important artefacts. Clearly, mummies are important and the collection at the British Museum is of international importance. I suspect, however, that there are remains lurking in the depths of some museums that are of less significance historically and archaeologically, and it would be nice to think that, if they were significant to the communities from which they originally derived, they might be repatriated, even if they were more than 1,000 years old. I would be grateful to hear whether the Minister knows of any requests regarding such remains that might be made in the future and, if so, whether it might be appropriate to amend the proposal in some way so as to allow the professional judgment, as she put it, of the curators of the remains to prevail.

I am concerned about the term "reasonably believe", because the dating of these artefacts can, as the Minister hinted, be rather an inexact science. Carbon dating is probably the most exact, but other means, such as examining the artefacts buried with the person, might be slightly less specific. My concern is that curators could be tempted to cherry-pick the method by which they determine the age of an artefact if there were any doubt about whether the remains fell within the strictures of the Bill. What safeguards does the Minister envisage in that regard? Does she envisage any guidance being issued to museums on best practice in determining the age of artefacts?

Robert Key (Conservative, Salisbury)

Just as my predecessors at Old Sarum—all two of them—represented five electors, I have the privilege of representing no electors at Stonehenge. However, I do represent a large archaeological community in south Wiltshire, which contains many hundreds of scheduled ancient monuments. I am also a member of the all-party group on archaeology.

I warmly welcome the amendment. It was first proposed in the other place by Lord Redesdale and Baroness Kennedy that there should be an amendment to do what has now been achieved in finding the right balance between real and effective claims, particularly from first nation communities—all of which now fall within this time bracket—and the need properly to preserve archaeological collections for future research. There is, however, a little matter on which I would be very grateful to receive some advice.

The Trust for Wessex Archaeology, which is based in my constituency, is now the second biggest contract archaeologist. It moves in whenever excavations for road building, housing or industrial development have to be undertaken to satisfy the grant of planning permission for such developments, and it regularly comes across bodies. They might or might not be 1,000 years old. There is already, therefore, a Home Office licensing regime for excavating in certain circumstances, and there is no problem with that. However, I have been asked to seek clarification on one aspect of licensing.

I have read the Bill, obviously, and I have read clause 52. I have also read clause 16, in particular, which deals with licence requirements, but I cannot find anything to satisfy my query. An archaeologist excavating a site might comes across a body—probably only a skeleton—that will eventually end up in a museum somewhere. One hopes that it would be the Salisbury and South Wiltshire museum, which is by far the finest museum in the south of England. When the body is betwixt and between the original site from which it was excavated and its final resting place in a museum, is a licence required under the Bill? That is not quite clear. How would the interface work between the Home Office licensing regime and a licence required under the Bill? That is a practical consideration. I would frankly be amazed if even this excellent Minister could answer that question off the top of her head, or even with a little inspiration from on high. Therefore, if she cannot produce an answer this afternoon, I would be grateful if she could drop me a line on the matter, and put a copy in the Library of the House, so that we can clear up this practical point for the many hundreds of archaeologists who find bodies in these circumstances every day.

Rosie Winterton (Labour, Doncaster Central)

With regard to the issue raised by the hon. Member for Salisbury (Mr. Key), I hope that I will be able to give him some reassurance. If he is not fully reassured by my sudden attempt to become an expert in this area, I can assure him that, if he wished to write to Ministers at the Department for Culture, Media and Sport, they would be more than happy to go into detail on this matter. However, clause 16(4) provides that no licence is necessary in relation to the bodies of people who died more than 100 years before the Bill comes into force. Licences are necessary only in relation to certain activities, all of which are limited to scheduled purposes. Archaeologists may remove material from bodies for the purpose of determining the cause of death, in which case a licence would be required, but only if the body were less than 100 years old. Clause 16(4) was introduced precisely to meet the concerns of archaeologists in this regard. I hope that that is helpful, and I would like to thank the hon. Gentleman for giving my officials notice that he would raise this matter.

The hon. Member for Westbury (Dr. Murrison) sought clarification of whether we know of any further applications that have been made with regard to ancestral remains. The answer is no. I do not know of any other applications. I am sure that he will appreciate that the idea behind de-accessioning and the request for return of remains is that an ancestral link should be established, hence the Aboriginal connection and the attempt to meet the request from the Australian Government.

With regard to the issue of reasonably believing, and how that would be interpreted, the Department for Culture, Media and Sport will issue guidance following its current consultation on human remains in museums. With those clarifications, I hope that the House will accept the amendments.

Lords amendment agreed to.

Lords amendments Nos. 37 to 48 agreed to.

Clause 57 — Orders and regulations

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

This one should be easy—[Laughter.] The amendment requires that the Secretary of State should exercise his powers to make orders and regulations on a number of issues under the Bill only after having consulted

"such other persons as he considers appropriate".

That is in addition to the existing requirement to consult the devolved bodies, where appropriate. The amendment responds to requests made by various people wanting to be reassured that consultation with relevant stakeholders would take place. While we had indicated that such consultation would invariably take place in any event, but we nevertheless agreed to set that down in the Bill.

The provision applies to the more important secondary powers in the Bill—the orders and regulations listed at clause 57(4), which will be subject to the affirmative resolution procedure. The amendment makes it a statutory requirement that, in each of those cases, the Secretary of State should consult. I urge the House to agree to the amendment.

Andrew Murrison (Conservative, Westbury)

The—[Interruption.] The Minister invites me to say yes. She suggested that the amendment might be straightforward, but nothing is ever straightforward.

Of course, we welcome the amendment. It was a long time coming, however, because one thing that has not characterised the Bill, and its passage through both Houses, is consultation. We might have to return to the subject of pre-legislative scrutiny, but I thought that I would take this opportunity to moan about the lack of it and the fact that the Bill might have been improved earlier had we consulted more widely.

Clearly, the amendment, as far as it goes, is welcome. My noble Friend Earl Howe was instrumental in including this measure in the Bill, and he is to be congratulated on that, as on much of the Bill to which he has contributed. The amendment, however, is a little thin, as all it does is put a duty on the Secretary of State to consult those whom he feels it appropriate to consult. It would be helpful if the Minister, without committing herself too much, could give us an indication of who those consultees might be.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I had not realised that this amendment would be an issue, and perhaps I have overlooked something, but I would be grateful if the Minister would provide clarification.

Although the Minister's briefing refers to a list of provisions under clause 57(7)—to which we added section 33(7) in an earlier group of amendments—that list does not correspond entirely with the list given in the amendment, even though her briefing note implies that it should. Obviously, some clauses have been removed, so I do not expect her to defend consulting on clauses that do not exist. For example, section 4(10)(b), section 8(4)(d), section 16(3) and a couple of others are listed as provisions under which the Secretary of State

"shall consult the National Assembly for Wales and the relevant Northern Ireland department"

before acting, but some in that list are not included in the list in Lords amendment No. 49. If that is the case, can she clarify the reason why?

Rosie Winterton (Labour, Doncaster Central)

Those who would be consulted would include professional bodies, family-patient organisations, religious groups and individuals who had been involved in our consultation on the Bill, and in the earlier review and consultation exercises. Anyone else who expressed a view or an interest in issues covered by the consultation could also be included. I do not want to prescribe an exclusive list, and I assure the hon. Member for Westbury (Dr. Murrison) that we want consultation to be as open as possible.

The hon. Member for Oxford, West and Abingdon (Dr. Harris) said that the list did not correspond with that in clause 57(7). The orders or regulations to which we refer are subject to affirmative resolution under clause 57(4).

Lords amendment agreed to.

Lords amendments Nos. 50 to 54 agreed to.

Clause 65 — Commencement

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

The amendment would allow a three-month gap between publication of the codes of practice relating to consent and implementation of the penalties relating to consent in clauses 5 and 8. That would enable practitioners to prepare to meet the necessary standards in order to eliminate any risk—which would in any event be very small in the case of anyone already working to proper standards—that they might inadvertently commit offences during the transition period.

An amendment of this sort was proposed in the other place, reflecting a certain anxiety about the possibility that some practitioners might need to adapt to some aspects of the new legislative framework, especially as they will look to guidance to help them to understand their specific responsibilities. Having agreed to examine the issue further, my noble Friend Lord Warner returned with this amendment.

We recognise the importance of allowing people an opportunity to become familiar with the implications of the legislation, including the codes of practice that will help to support the required standards. That is particularly so when criminal sanctions may be at issue.

Consultation during the drafting of codes of practice will keep stakeholders in the picture, and it seems most unlikely that the codes will diverge significantly from what is currently considered to be good practice. For example, the taking and recording of consent for use in research of tissue following a post-mortem examination is already the norm, and health professionals have no reason to be nervous of a legislative framework that will support that approach.

Nevertheless, we recognise that there are anxieties. The three-month delay introduced by the amendment will allow everyone to be confident that they are complying with any new standards before the penalties take effect.

Andrew Murrison (Conservative, Westbury)

We heard on Second Reading and in Committee of the anxieties of many who work in the research community about their liabilities and potential penalties under the Bill. In particular, I recall corresponding with Cancer Research UK, which was of the opinion that such measures might put off people who wanted to enter research. I hope that they will not be put off—I am sure that they will not be, particularly as the Bill has been revised as it has passed through both Houses and now appears to be sensible. However, we must be mindful of the fact that many of those who have been observing what has been going on have been filled with a certain amount of trepidation, are a little uncertain and are concerned about how they stand personally in terms of their legal liabilities.

I welcome the measure, which will mean that people will be able to get to grips with the codes of practice well in advance of them beginning to bite, which is right and proper. However, the measure should not be used to delay the rolling-out of the codes of practice. It is important that we crack on with that.

Lords amendment agreed to.

Schedule 1 — Scheduled purposes

Rosie Winterton (Labour, Doncaster Central)

I beg to move, That this House agrees with the Lords in the said amendment.

Sylvia Heal (Deputy Speaker, Halesowen and Rowley Regis)

With this we may discuss Lords amendments Nos. 57, 60 and 61.

Rosie Winterton (Labour, Doncaster Central)

On several occasions, arguments have been advanced to the Government, from both within and outside the House, suggesting that the Bill as drafted would have an adverse impact on the training of doctors and researchers. The difficulty related to the question of whether consent should be needed for the storage and use in training related to research of residual tissue samples following diagnostic or clinical procedures. We have listened long and hard to all the points that were made and recognised that there is some force behind the arguments.

Following debate in the other place, several Opposition amendments were passed to clause 1, schedule 1 and schedule 5. Those all had the intention of allowing use of residual tissue for research education and training without any consent, or with certain safeguards. Taken together, however, those amendments would have been unworkable. Therefore, we tabled Lords amendments Nos. 57, 60 and 61, which, when taken with Lords amendment No. 56, achieve a similar but more consistent and clear effect.

The amendments remove education and training in research techniques from part 1 of schedule 1, allowing that purpose to be subsumed within education and training in human health, so that it will be lawful to store and to use tissue from the living for both those purposes without consent under part 2 of schedule 1. Amendments to schedule 5 will similarly allow DNA analysis for education and training in research techniques without consent.

We chose that route to allow education and training in research techniques without consent, rather than the alternative option proposed in Opposition amendments of tissue anonymisation, for reasons of simplicity and clarity. We initially took the view that the use of residual samples for that purpose was too far removed from the original reason for taking the sample—for diagnosis or treatment—for the material to be used without consent. Unlike training in clinical and diagnostic procedures, training in research techniques is not part of what patients would ordinarily regard as part of the package of receiving treatment. That is why we felt that consent would be needed or, as a minimum, some other protection, such as anonymisation.

We heard many arguments relating to the potential difficulty of distinguishing between education and training in research and that required for clinical practice, because the processes themselves are often the same. Moreover, we recognise that the training of doctors must include research training, and training activities will often include both clinical and research trainees. We therefore considered it best to save further confusion by aligning the two—clinical and research training—under the general heading of "Education or training relating to human health" in paragraph 9 of schedule 1.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

Can the Minister confirm that even though the Bill no longer specifies that education or training relating to research should be considered as education or training relating to human health, rather than research, it is her expectation that it should be understood to be so considered by those operating within the Act, and indeed by the courts in the event of any challenge?

Rosie Winterton (Labour, Doncaster Central)

Yes, I can certainly confirm that.

I must emphasise one point: this will not provide a back door to the use in research of tissue without consent. For example, this will not permit people to undertake such research without consent simply by involving a research trainee. That is not the idea at all.

Training and education in research techniques are clearly distinct from carrying out research. Research is concerned with creating new knowledge by addressing clearly defined questions with systematic and rigorous methods. Training, on the other hand, is more about showing medical students or technical trainees how to use equipment or about showing them research methods. So research, and training and education in relation to research, are distinct activities.

Andrew Murrison (Conservative, Westbury)

Can the Minister confirm that a research ethics committee would clearly be bound by the Act, so no confusion is possible between research and treatment activities?

Rosie Winterton (Labour, Doncaster Central)

Yes, I can certainly confirm that.

While storing and using tissue for training purposes will now fall under part 2 of schedule 1, and may be done without consent, storing and using tissue for research itself will remain under part 1 of the schedule, requiring consent or, alternatively, anonymisation and, as the hon. Gentleman said, ethical approval for the project concerned, whether or not a research trainee is taking part. Of course, a trainee will often observe properly approved research, but that does not make it a training activity.

We can imagine a situation in which a research project is being carried out and a research trainee is also being taught. The researcher is examining tissue for the project and then demonstrating the technique to the trainee. Clearly, both activities—each for a different purpose—are taking place: one is research, the other is training. The training purpose does not require consent, but the research purpose still requires consent or REC approval with anonymisation. Satisfying the requirements for one activity does not obviate the need to satisfy the requirements for the other.

We have listened very carefully to the debate on this issue and I believe that we have come up with a solution that is pragmatic, in that it enables appropriate training to take place without undue restrictions, while ensuring that the door is not opened to research being conducted without proper approval. I hope that Members will welcome these amendments, which fully meet the concerns expressed in previous debates in this House and in the other place. I urge Members to accept them.

Andrew Murrison (Conservative, Westbury)

Along with the amendments relating to clause 7, Lords amendment No. 56 is probably the most crucial that we have considered today. It is fairly straightforward, in that it removes from schedule 1 the reference to

"education or training relating to . . . research".

In so doing, it addresses many of the concerns expressed to us by the research community. I know that it must have been very difficult for the Minister to allow this amendment. The Bill is about consent, and the amendment rows back slightly from that; however, in our view it is a pragmatic solution that should allow the research community to proceed relatively unhindered with the important work that it does on our behalf, while retaining the Bill's original purpose. So to that extent, we of course welcome the amendment.

Residual tissue was a hotly contested issue in Committee and the general public have a clear view on the difference between the handling of organs from a corpse for such purposes and residual tissue taken from operations—in other words, tissue taken from somebody who is alive. Emotionally, the two are profoundly different, and we have finally managed to get a Bill that adequately reflects that difference. Of course, several months ago that was not the case. The two were closely allied, even though the popular perception and feeling was that they were quite different. The original Bill was out of line with popular sentiment in that regard, and given that it stemmed from the Kennedy, Redfern and Isaacs inquiry, I found that rather surprising. But we got there eventually, although it has been a hard slog. Given that the Bill is not partisan but very technical, it is a great pity that it was not subjected to pre-legislative scrutiny. The issues that this amendment and others have dealt with could have been sorted out by discussing them with the relevant expert organisations, but we will simply have to live with that in the months and years ahead.

We can all think of problematic situations—they have been described to us at great length—in which this amendment will help. We can perhaps envisage the law being broken every day in every medical school throughout the country, with one side of a lecture theatre learning how to treat patients and the other learning about research techniques, fundamentally the same instruction being given and the poor lecturer in the middle, trying to wade his way through the legislation to make sure that he is steering a proper course and not transgressing the law in any way. This problem is particularly relevant to cytology. Noble Lords discussed cytology in another place in defence of their amendments, the substance of which was eventually accepted by Ministers. We clearly need to train people in histopathology and cytology, which involve staining. Many stains are used in the course of therapeutics, but many others are research tools. Both can now be dealt with at the same time during the instruction of those who are learning how to treat patients and those who are learning research techniques.

It would make no sense at all to retain the Bill as originally drafted, as it would cause major disruption to medical schools. I believe that the amendments help to get around most of the problems. To that extent, they are extremely welcome and I am very pleased to see them. I am just sorry that we could not have reached this point sooner.

The downside, of course, has been an element of confusion in the minds of many who work in this field—pathologists, researchers, people in the NHS and in research generally—and they may be left wondering what is going on. I very much hope that any such confusion will be short-lived and that they will be able to get on with their work in the certain knowledge that they will not be transgressing when they carry out activities that most of us would regard, in a common sense way, as perfectly reasonable.

I share the Minister's hope that the amendment will not prove to be a back door to research without consent. I come back to the original tenet of the Bill, stemming from the tragedies at Alder Hey and the Bristol royal infirmary, that consent must be at the heart of everything that we do. I hope that neither this amendment nor any others will degrade or detract from that original intention. Indeed, I am sure that they will not.

Evan Harris (Liberal Democrat, Oxford West and Abingdon)

I shall comment on the specific amendment and then associate myself with some of the more general remarks made by the hon. Member for Westbury (Dr. Murrison). We are now at the last group of amendments, so it will be our last debate on the Bill.

The amendment deals with an important issue. Previously, the Government were in a bizarre position, as I pointed out on Report on 28 June this year when I said:

"If the education and training in research techniques were done on anonymised tissue, subject to the approval of a research ethics committee,"

it would not

"be exempt from the requirement for consent, as the research is"

because the Government had specified that such education and training in research techniques required explicit consent. A weird situation would have arisen, whereby parts of the research materials would have required explicit consent while other parts were anonymised. The Minister said:

"Yes, that is the case."—[Official Report, 28 June 2004; Vol. 423, c. 98.]

The Minister understood the problem that there were at least three categories of consent in that regard. There was education and training, which did not need consent; research that did not need consent as long as the samples were anonymised and gained research ethics approval; and training in research techniques that would always require explicit consent.

It would have been good if the Government had reflected further on the problem and tabled their own amendments, such as we now have, earlier in the other place. That would have shown their recognition, after consultation, of the problem. However, I understand that on Report in the other place, the Government resisted the proposals and pressed for a Division. Only following the Government's defeat at that stage did they table the necessary correcting amendments to ensure consistency. As the hon. Member for Westbury said, those amendments were important and the Minister has accepted that. We have to say that, on this occasion, unlike the others where the Government clearly listened and volunteered the amendments themselves, we had to wait for the Government to fail to secure a majority in the House of Lords. Thank goodness for the fact that it is a more proportional Chamber, if I may put it that way—[Interruption.] I will put it that way, at least once on every Bill.

Having said that, I wholly concur with what the Minister said about it being necessary to ensure that this is not seen as providing a back-door way to avoid the need for consent in research. The temptations may well be there, because much of the actual stuff of research is done by people who are being trained in some way or another. Indeed, researchers are always in training, up to the highest level. The Minister was right to put the point on the record and I am delighted that the hon. Member for Westbury agreed. We need to be clear and the research community needs to be very clear.

It will reassure the research community and health professionals working in this field that a sensible option has prevailed in the final stages of the Bill's consideration. I shall not repeat the general points made by the hon. Member for Westbury, although I associate myself with them. With amendments such as this and the others in the group, we can ensure that the Bill is satisfactory for patients and the public, but we must also make sure that people still want to practise pathology and pursue clinical research in this country. They should not have to fight against the interests of the public, as their work is valuable and benefits the public.

It is true that we need regulation, but we must ensure that we do not have too much bureaucracy. We need a climate that welcomes people into this area of research. We must make sure that they do not feel that they have to disguise the fact of what they do. There is a crisis in recruitment in some of these disciplines and I hope that the Bill will go some way towards dealing with that problem rather than making it worse.

Richard Taylor (Independent, Wyre Forest)

I also welcome the amendment and I associate myself with the remarks made by other hon. Members. In its final form, the Bill will be acceptable to the professions, but I have one final question for the Minister. Will she repeat what I think she said earlier about the anonymisation of material collected for research without consent but with the agreement of the ethical committee? Will she confirm that the linkage of material to a patient's disease and the treatment that has been received will remain, despite that anonymisation, as it will be essential?

Rosie Winterton (Labour, Doncaster Central)

I can certainly give the hon. Gentleman that assurance.

As the hon. Member for Westbury (Dr. Murrison) said, this amendment is very important. I am pleased that it enjoys his support and that of the hon. Member for Oxford, West and Abingdon (Dr. Harris). It epitomises the principles on which the Bill is based.

We wanted the Bill to be based on consent, not least because of the very tragic events at the Alder Hey and Bristol hospitals. At the same time, we wanted to ensure that the regulation that all society wanted us to introduce was accompanied by reassurance that the Bill would be based on the principles of consent. We also wanted to convince the research and medical community that we were not trying to stifle some of the excellent work being done.

I believe that the Bill achieves all that now, and that, as a result, people will be very willing to give tissue or organs for research and other purposes. At the same time, it will give the medical and research community confidence that it is operating in an environment that they understand, and one that they know that others understand as well.

Our task has been to get the balance right between those two very important principles. I think that the Bill achieves that and I want to take this opportunity to thank everyone who has made possible amendments such as the one that we are discussing. In that respect, I want to make particular mention of my officials, but hon. Members of all parties in this House, and in the other place, have all contributed to making this a very good Bill. I am sure that it will satisfy some deeply held principles and the requirement that we provide the right atmosphere for the medical and research community to carry out its work. At the same time, it will provide some important safeguards for families, as desired by those who suffered from earlier events. The Bill will also encourage people to engage in the sort of activities that we have talked about. I am grateful to all involved and I urge the House to agree to the remaining amendments.

Lords amendment agreed to.

Lords amendments Nos. 57 to 71 agreed to.