Clause 29 - Prohibition of commercial dealings in human material

Human Tissue Bill – in a Public Bill Committee at 4:30 pm on 3rd February 2004.

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Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon 4:30 pm, 3rd February 2004

I beg to move amendment No. 116, in

clause 29, page 18, line 39, after 'if', insert

'in England, Wales or Northern Ireland'.

Photo of Joe Benton Joe Benton Labour, Bootle

With this it will be convenient to discuss the following:

Amendment No. 117, in

clause 29, page 18, line 41, at end insert

'whether in England, Wales or Northern Ireland or elsewhere'.

Amendment No. 118, in

clause 29, page 18, line 43, at end insert

'whether in England, Wales or Northern Ireland or elsewhere'.

Amendment No. 119, in

clause 29, page 19, line 2, at end insert

'whether in England, Wales or Northern Ireland or elsewhere'.

Amendment No. 120, in

clause 29, page 19, line 5, at end insert

'whether in England, Wales or Northern Ireland or elsewhere'.

Amendment No. 121, in

clause 29, page 19, line 8, at end insert

'whether in England, Wales or Northern Ireland or elsewhere'.

Amendment No. 122, in

clause 29, page 19, line 10, at end insert

'in England, Wales or Northern Ireland'.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

The purpose of this group of amendments is to probe the extent to which the offences in the clause would be offences geographically that existed in the Human Organ Transplants Act 1989. I accept that that may not be right, but it is what I understand to be the case. Without the amendments, the prohibition would seem to be restricted to the area of the United Kingdom to which the clause applies—England, Wales and Northern Ireland.

Amendment No. 116 makes it clear that the person commits the offence in England, Wales or Northern Ireland, but amendments Nos. 117 to 122 add to various parts of the clause the words

''whether in England, Wales or Northern Ireland or elsewhere''.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

The hon. Gentleman raises an interesting point, which I confess I had not noticed. The 1989 Act said at that point, ''in Great Britain''. Clearly, the amendments would have an extra-territorial application to England, Wales, Northern Ireland or elsewhere, elsewhere being anywhere. Did he consider using the words ''in Great Britain''? Is that the point that he is trying to make?

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

No, the point that I am trying to make is that the Human Organ Transplants Act 1989 made it an offence for someone in Great Britain at that time—I believe that there is now separate provision for Scotland, but I am happy to be corrected as to extent of the Bill—to do some of those things anywhere in the world. Therefore, a person committed an offence if, as in subsection (1)(a), he

''gives or receives a reward for the supply of, or for an offer to supply, the body of a deceased person or any relevant bodily material'' anywhere in the world, even though he is committing the offence in this country. The provision may not be required any more, but it was suggested to me that the geographical area where the transactions that were being prohibited could take place was being restricted, by default, to England, Wales and Northern Ireland.

I shall not go through all the areas where my amendments make it clear that the provision applies elsewhere, but they can be seen at the end of lines 41 and 43 on page 18, and lines 2, 5, 8 and 10 on page 19. Therefore, I am probing whether there has been a specific change and, if there has, what the motivation and justification are for apparently restricting the provision. As I said, the clause may apply to offences committed anywhere in the world. In that case, it is not clear that the committing of the offence is restricted either. I should be grateful for clarification.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

I thought that it was clear and I am now extremely confused. Perhaps the Under-Secretary will be able to shed light where suddenly there is darkness.

I do not understand the purpose of the hon. Gentleman's amendment. I thought that he was going to talk about materials, such as blood, that can be

traded internationally, and the fact that the Bill might make that more difficult. I, too, seek clarification, but for slightly different reasons from the hon. Gentleman.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

Like the hon. Member for Westbury, darkness often falls over me when I listen to the hon. Member for Oxford, West and Abingdon. I think that I can give the hon. Member for Oxford, West and Abingdon the assurance that he needs, but let me say first that his amendments would leave the Bill as it is.

Amendment No. 116 would limit the activities prohibited by clause 29 to those done in England, Wales or Northern Ireland. However, that is the effect of the clause in any event and is the extent of the Bill. Amendments Nos. 117 to 122 would provide that the supply of the human material to which the unlawful activity relates could take place anywhere in the world, which is also the effect of the clause. The offences that a person would commit are described in clause 29. If people advertise for material in England, they are committing an offence even though it may ultimately be supplied somewhere else in the world. Equally, a person might seek someone in England who was willing to supply material, but that offence would take place here, because it would be a prohibited activity. I hope that that provides the reassurance that the hon. Gentleman seeks.

I should like to bring to hon. Members' attention clause 4 of the Asylum and Immigration (Treatment of Claimants, etc.) Bill, which is currently before Parliament. That is also relevant because it introduces a new criminal offence of trafficking people into or out of the UK for the purpose of exploitation. A person commits the offence if he arranges for a person to enter or leave the UK to exploit them. The offence is also committed if a person has arranged travel to the UK knowing that the passenger has been brought into the UK to be exploited. Exploitation, in that case, would include organ removal. I hope that that provides sufficient reassurance for the hon. Gentleman.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

I understand the point that the Under-Secretary is making on geographical differentiation—I understood that that was so—but there is a consequent difference in terms of the penalties associated with the offence. Clause 29(4)(a) says that there would be

''on summary conviction . . . imprisonment for a term not exceeding 12 months'', which would presumably apply in England and Wales. However, clause 53 substitutes the words ''6 months'' for Northern Ireland and presumably, by extension, under the Human Organ Transplants Act that becomes three months in Scotland, because its regime continues to apply there. I wonder why the Under-Secretary thinks that it is reasonable for there to be three different penalties in different parts of the United Kingdom for what is effectively the same offence.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

The hon. Gentleman is probably probing the effects of devolution. These are the narrow lanes down which we have to travel in a devolved constitution. I undertake to review the matter to ensure that everything is as consistent as it can be.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

As far as I can see, these are not devolved matters. I am probing not the effects of devolution, but the way we behave here in what he might regard as the devolved context.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

I accept the hon. Gentleman's assurance that he is now a committed devolutionist and hope that the hon. Member for Oxford, West and Abingdon will withdraw his amendment.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

I am rather wounded by the Under-Secretary's response—he was uncharacteristically churlish in responding to a briefly put probing amendment. If he wants non-probing amendments to be taken to a Division and proposed at length, I am sure that many of us on the Opposition Benches could meet that requirement. He should not allow the lateness of the day to make him so grumpy. Clearly, he is satisfied that he understands his Bill and I am delighted that he does. That is the minimum that we expect from a Under-Secretary who is paid to do such a job. However, people are asking whether the extent of the measure in respect of from where the trafficking is being done is different because of the way in which the provision is worded, so it is legitimate for us to probe such matters. I am grateful that, in an indirect way, the Under-Secretary has said that we need not worry. We have heard him say that before, but we can be reassured in this case. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

I beg to move amendment No. 152, in

clause 29, page 19, line 21, at end insert—

'(c) he pays an intermediary to locate and obtain relevant bodily material for purposes under paragraphs 3 and 7 of Schedule 1, providing that this shall not apply in relation to offering or giving of any reward that relates specifically to relevant bodily material or to the body of a deceased person.'.

Photo of Joe Benton Joe Benton Labour, Bootle

With this it will be convenient to discuss the following:

Amendment No. 8, in

clause 29, page 19, line 47, at end insert—

'(c) any expenses incurred in adding value to, or increasing the utility of, relevant material.'.

Amendment No. 153, in

clause 29, page 20, line 16, at end add—

'that relates specifically to relevant bodily material or to the body of a deceased person'.

Amendment No. 154, in

clause 29, page 20, line 16, at end add—

'(11) References in subsections (1) and (2) to reward, in relation to the supply of the body of a deceased person or the supply of relevant bodily material, do not include payment in money or money's worth for services provided in relation to—

(a) preserving the body of a deceased person supplied or the relevant bodily material supplied for use in a purpose specified in Schedule 1;

(b) preparing the body of a deceased person supplied or the relevant bodily material supplied for use in a purpose specified in Schedule 1; or

(c) generating data relating to the body of a deceased person supplied or to the relevant bodily material supplied in carrying out a purpose specified in Schedule 1.'.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

The amendments are not all designed for the same purpose, but they are all derived from the same worry. Members of the Committee will have observed that, under clause 29, we are transferring what has hitherto been a regime designed to stop commercial dealing in organs for transplant into an appropriate regime for the prohibition of commercial dealing in human material. To do that, we are having to consider a range of currently legitimate purposes along with the risks associated with rendering them illegal. The range of activities associated with all the scheduled purposes and the kinds of tissues that are used go much wider and are much more difficult to constrain than the matter of organs for transplantation.

Although there are differences between the Human Organ Transplants Act regime and clause 29, the new regime will be based on that. The purpose of the amendments is to examine to what extent the current structure of clause 29, in practice, will avoid criminalising current legitimate and ethical activity. I shall start with amendment No. 152 because, on the face of it, there is a problem associated with what is currently common practice, which is that of organisations providing some form of seek-and-supply or brokerage service to make difficult to obtain or rare specimens accessible for research. That can be based on a prospective collection basis or presumably from pre-existing tissue banks. The services are provided for commercial gain and are currently regarded as ethically acceptable. It seems that they would be prohibited under clause 29.

I raise the matter partly because of representations from the biotechnology industry, but last night I discussed the issue with scientists who work for Breakthrough Breast Cancer next to Royal Marsden hospital in Chelsea. They said that one of the things they do to obtain the necessary tissues is to procure them from commercial sources. Obviously, they would like to do so at as least a cost as possible. If they do not have to pay anything other than the costs associated with preparing, preserving, storing, transporting and adding utility to the tissue samples, and are not paying for the material per se, that is how they wish the position to be and that is the position as we wish it to be. It also seems to be the position that the biotechnology industry wishes it to be.

The question is whether we have covered accurately the definitions of what is accepted under subsection (3), which deals with particular activities or categories that are not to be regarded as committing an offence if they are undertaken. Amendment No. 152 is about intermediaries who locate and obtain relevant bodily material. Those activities are currently legitimate, but should they be included in subsection (3), so as not to create a criminal offence out of them? Brokering is clearly not an expense incurred in transporting, removing, preparing, preserving or storing.

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We are dealing with the application of criminal sanctions to intermediaries. They provide a vital service and gain access to sufficient numbers of specimens for meaningful studies, including those of scientists engaged in important research.

Amendment No. 8 deals with expenses. Subsection (7) excludes expenses but it does not exclude the ''expenses incurred'' when adding value. Preparing, preserving and storing may be how value is added. We must be clear that it would in practice include freezing tissue for transportation, preparing histological sections, undertaking pathological review, embedding tissue in paraffin blocks, generating data from tissue and obtaining and providing that data, which adds utility for those people who might wish to obtain it for research purposes.

Some of those activities may be covered by the definitions is subsection (7). Others may not. The amendment seeks to make it clear whether expenses incurred in adding value or increasing the utility of relevant material would not be regarded as trafficking in human material.

Amendment No. 153 reinforces the previous point by defining reward as the description of financial or other material advantage

''that relates specifically to relevant bodily material or the body of a deceased person.''

It focuses the criminal offence upon the question of whether reward is being sought or given in relation to the human material or the body, as distinct from the processes or the added value that may result from any activity associated with it.

Amendment No. 154 tries to clarify the position on payment of services. I hope that preserving and preparing the body—proposed paragraphs (a) and (b)—are covered by subsection (7), but generating data relating to the body of a deceased person may not be. The amendment sought further clarification about the activities, currently legal and ethically acceptable, that will be criminalised or are at risk of being criminalised by clause 29.

I hope that the Under-Secretary understands the direction from which we are approaching the matter. We are trying to arrive at what I hope are shared purposes, although from the first time I read the clause, I was worried that a measure that had first been drafted for a narrower purpose was being extended to a much wider range of activities.

The risk we run of criminalising existing legal activities depends entirely on whether the exceptions and definitions included are able to clarify what is acceptable. Focusing on the question of not obtaining reward for the human material or the body seems to be at the heart of the matter. I hope that the Under-Secretary will be able to assist us.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

There is agreement across the board about what the clause should achieve: there should be no financial gain from trafficking in human body parts. By transposing clause 29 from the Human Organ Transplants Act 1989, we thought that we were achieving those objectives and allowing for

recompense for expenses incurred in such dealings. Having said that, we recognise that the representatives of the biotechnology industry have serious reservations about whether what we have attempted to do has been achieved in these provisions. The hon. Gentleman has restated those reservations. If he is prepared to withdraw his amendment, I am prepared to ensure that we review the clause thoroughly, and if necessary bring back some clarifying amendments on Report.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

The hour makes us even more grateful to the Under-Secretary for his willingness to do that. I am grateful to the Committee for bearing with me while I set out the concerns. I think that I have covered them. I hope that we will have a productive discussion when it comes to ensuring that our purposes are met but legitimate activity is not criminalised. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

I beg to move amendment No. 107, in

clause 29, page 20, line 8, after 'hair', insert ', teeth'.

This is very simple. The materials excepted from the clause are listed on page 20. There has been some debate about the nature of the tissues listed in various forms in the Bill. The purpose of my amendment is to add the word ''teeth'' to subsection (9)(c). The debate so far seems to have centred on cells. We had an interesting discussion at an earlier stage of the Committee about how that extended to hair, which does contain cellular material, in part, even though most of us think of it as a dead material that is acellular. We are in an area that is fraught with definitional difficulties and it strikes me that there is no particularly good reason for excluding teeth from subsection (9)(c). I would be grateful if the Under-Secretary considered that matter.

While my hon. Friend the Member for South Cambridgeshire was on his feet, it occurred to me that a number of materials can be, and probably still are, used commercially that could be excepted in some way. I was thinking in particular of placentas, which used to be traded commercially. I suspect that they still are traded in one way or another for the beneficial uses to which they can be put in research and for the materials and chemicals that can be extracted from them. One might include placentas in the list of exceptions, but I will leave that aside and focus on my amendment, which would include teeth with hair and nail.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

This is commonly known as the tooth fairy amendment. Teeth have value in research and education, so it is appropriate that they are covered in the Bill. However, I can give the hon. Gentleman, and any other Committee members with children, confidence that we do not intend to use the Bill to prosecute the tooth fairy. Members of the Government will not be hiding outside bedrooms to ensure that no inappropriate activities with teeth take place. The only thing I would encourage the Human Tissue Authority to consider is including teeth in good practice guidance, so that my daughter will not be able

to insist on getting enough money from the tooth fairy to buy an S Club 7 CD every time she loses one of her milk teeth.

It is right that teeth are included in the Bill. I ask the hon. Gentleman to withdraw his amendment.

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

After such an eloquent description of the activities of the tooth fairy, and knowing full well what the Under-Secretary means, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

I beg to move amendment No. 123, in

clause 29, page 20, line 9, leave out paragraph (d).

The purpose of the amendment is to get the Government to put on the record what they understand by the exception provided for in subsection (9)(d), and to specify what sort of things it covers. In much of the Bill, that is not clear and darkness descends on many of those seeking to read and understand it. It is not always clear, and perhaps the Under-Secretary will take this to explain what is meant by the words

''material which is the subject of property because of an application of human skill.''

Will the Under-Secretary give the examples of that, which I know he has?

Photo of Andrew Murrison Andrew Murrison Shadow Minister (Health)

I join the hon. Member for Oxford, West and Abingdon in being slightly bewildered by what is meant by ''human skill''. It seems to me that that term is quantitative as well as qualitative. We can all think of things that require an enormous amount of human skill. I suppose that mummies are the quintessential example of that, although they are excluded from the Bill. There are other examples, such as simple embalming, which involve a certain amount of skill but I do not suppose that they are on the Under-Secretary's mind. Like the hon. Member for Oxford, West and Abingdon, I seek clarification of the matter.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

The proposals for new legislation on human organs and tissue that were issued in September 2003 by the chief medical officers for England and Wales said that the new legislation should incorporate the principle that the human body and its parts should not give rise to financial gain. The clause gives effect to that underlying principle subject to certain exceptions, and one such exception is material that is the subject of property because of the application of human skill.

That exception reflects the current legal position as determined by case law, that there is no property in the human body or its parts, so they cannot be bought or sold, except where human skill has been applied. The Bill recognises, but does not change, that legal position; the Bill leaves the position as it is now. I would rather, at this time of the evening, avoid citing some of the cases to which the hon. Member for Oxford, West and Abingdon refers, so I encourage him to read about them for himself.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

The Under-Secretary's comments are understandable. I know that there has been a long-standing provision in case law that there is no property in human bodies, with the given exception. The problem is that it is not entirely clear what sort of things the exception covers. I suppose that the answer to those who wondered whether they might fall foul of the law in that respect is to go and read the case law or get a lawyer. I seek the Under-Secretary's help.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

It would be appropriate, given the best practice guidelines, to give people that help, which will explain the issue. There are examples in case law, such as the 1998 case where the value of certain body parts was increased extensively by a dissection process that took many hours. The courts found that human skill had been applied and that the value of those parts had increased as a result of that human skill. Simply dipping the parts in formaldehyde would not, in my view, constitute the application of human skill, which is what the Bill provides for.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

The Bill therefore leaves unclear the qualitative and quantitative—in the Under-Secretary's example—extent to which the exemption applies. Peril is created for those in the business, and it seems a conscious decision of Government not to use statute law to define the issue any further, and to continue with the status quo.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

If it helps us make progress, I am happy to consider the clause again.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon

I am grateful, and I am keen to make progress as well, given the time. In light of that—as I was about to say in any event—I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health 5:00 pm, 3rd February 2004

I beg to move amendment No. 155, in

clause 29, page 20, line 10, at end insert—

'(e) material necessary for the conduct of clinical trials of pharmaceutical preparations or products (including diagnostics and medical devices).'.

The amendment relates to another part of the clause on which we seek the Under-Secretary's help, either in explaining or considering it. The point has to do with the conduct of clinical trials. If one were simply consenting patients for the trial itself, the immediate response of the patient to treatment would not really be affected. If we are talking about the sort of clinical trial that involves the collection of tissue samples and subsequent examination, that might involve the tissues being transferred from a number of centres to some kind of co-ordinating centre that provides a service in relation to the clinical trial, perhaps on a commercial basis. It might involve research companies, charities and the NHS itself. The Under-Secretary is only too familiar with how that works.

The question is how that is to be dealt with. Does it follow that that will be illegal, because the taking of the tissue samples must be covered by the consents making it lawful under the legislation, and therefore must be regulated by the authority and licensed? Do we need to

be concerned that clinical trials of that kind will not necessarily fall within such definitions, and therefore need to be excepted from the Bill? I suppose there are one or two aspects of clinical trials themselves, such as advertising for people to participate in them or the process of payment for the transfer of tissues between those in them, that raise exactly the kind of issues that we have debated under amendment No. 152. They are not within the regulatory structure of the authority for giving licensing premises, licensing individuals and regulating consent for the activities themselves, but go beyond that into commercial dealing. As I understand it, the authority cannot make commercial dealing legal; it has to regulate what it regulates, and commercial dealing, outwith what it regulates, is illegal. There may be a risk, particularly where advertising is concerned, of it being rendered illegal but perhaps the Under-Secretary will help us on that matter, too.

Photo of Stephen Ladyman Stephen Ladyman Parliamentary Under-Secretary, Department of Health

We believe that the Bill is appropriate as it stands, but having said that, the hon. Gentleman is right to say that these are complex and important matters. We certainly would not want any wording to interfere in the conduct of clinical trials. If the hon. Gentleman is prepared to withdraw his amendment, I am prepared to ensure that we review both the wording of the clause in its entirety, and the impact of the hon. Gentleman's point, before Report.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health

I am grateful to the Under-Secretary, and I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 29 ordered to stand part of the Bill.

Further consideration adjourned.—[Joan Ryan.]

Adjourned accordingly at three minutes past Five o'clock till Thursday 5 February at ten minutes past Nine o'clock.