Clause 46 - Offences relating to non-consensual analysis of DNA

Human Tissue Bill – in a Public Bill Committee at 10:45 am on 5th February 2004.

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Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health 10:45 am, 5th February 2004

I beg to move amendment No. 184, in

clause 46, page 28, line 22, leave out paragraph (a) and insert—

'(a) he analyses or procures the analysis of any human DNA in any bodily material without qualifying consent intending—

(i) that the person from whose body the DNA has come be identified as such, and

(ii) that the results of the analysis be used otherwise than for the excepted purposes (see section 47),

unless he reasonably believes that he does the activity with qualifying consent or that what he does is not an activity to which this subsection applies,'.

Photo of Mr Alan Hurst Mr Alan Hurst Labour, Braintree

With this it will be convenient to discuss the following:

Amendment No. 179, in

clause 46, page 28, line 22, after 'material', insert

'not covered under section 7'.

Amendment No. 131, in

clause 46, page 28, line 23, after 'DNA', insert 'or RNA'.

Amendment No. 98, in

clause 46, page 28, line 23, after 'material', insert

'or derived from that material'.

Government amendments Nos. 157 and 158.

Amendment No. 187, in

clause 46, page 28, line 33, at end insert

', or

(c) it has been imported or come from a body which has been imported.'.

Government amendments Nos. 159 to 161.

Amendment No. 188, in

clause 46, page 29, line 5, at end add—

'(6) In this section, references to bodily material which has been imported do not include bodily material which has been imported after having been exported with a view to its subsequently being re-imported.'.

Clause stand part.

Amendment No. 186, in

schedule 5, page 54, line 8, at end insert—

'(1A) The analysis shall be regarded as being the subject of qualifying consent if the analysis of DNA for the listed purpose would be authorised under section 1(1) if the analysis were done in England, Wales or Northern Ireland.'.

Schedule 5 stand part.

Amendment No. 132, in

clause 47, page 29, line 10, at end insert 'and RNA'.

Amendment No. 185, in

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

'(g) in England, Wales and Northern Ireland, purposes specified in sections 1(1)(f) and 1(1)(g).'.

Amendment No. 133, in

clause 47, page 29, line 21, at end insert

'providing the material is anonymised'.

Amendment No. 134, in

clause 47, page 30, line 3, leave out subsection (7).

Amendment No. 135, in

clause 47, page 30, line 6, leave out from '(2)' to end of line 7.

Clause 47 stand part.

Government amendments Nos. 163 to 166, Nos. 180 and 181, and Nos. 167 to 175.

Government new schedule 2—Qualifying consent.

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

As amendment No. 184 leads the group, I shall speak to that before we hear the Minister explain how the Government intend to remove clause 47 and what was schedule 5, and insert instead new schedule 2. That will help us for a couple of reasons. I hope that she will not feel the need to talk to amendments Nos. 185 and 186 because amendment No. 185 is redundant, as is, I think, amendment No. 186 because it would ensure consistency between Scotland and other parts of the United Kingdom. That consistency has become clearer by virtue of the way in which new schedule 2 is expressed.

Most of our amendments, other than amendments Nos. 184 and 98, are affected by the way in which the Government have rejigged the structure, so they probably lose their immediate effectiveness. However, they were tabled in order to raise issues. Rather than refer at length to amendments and how they work, it is simpler to refer to the subjects they raise and how they arise.

My first question relates to the creation of an offence of intent. Amendment No. 184 is designed to question the nature of the offence that we are creating. When we considered retained organs and tissue generally, we discussed the offence of storing and using materials for which consent had not been received. At no point have we created an offence of an intention to do something. When considering DNA analysis, we should ask why the offence should be constructed around an intention.

Amendment No. 184 would change the clause's structure. The offence would be to undertake or procure the analysis unless it was, for example, consented, identifiable or for an excepted purpose. The idea of intention is questionable in principle and would be difficult to define in practice. The prospect is worrisome, particularly to those engaged in medical research who might feel that they are liable for an offence arising from an intention rather than from undertaking an activity.

My second question arises from amendment No. 98. Clause 46 refers to

''human DNA in the material'' and the question of its analysis. I hope that nobody—especially not the hon. Member for Norwich, North—will ask me how it works. Apparently, it is possible and indeed common to undertake DNA analysis not necessarily on material, but following a procedure known as PRC

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

Oh. PCR. Anyway, it is possible to derive a chemical sequence from the material and then not undertake DNA analysis on that material. I hope that I am correct and the hon. Member for Norwich, North will tell me if I not. From a legal perspective, however, the analysis does not occur on the material but on a sequence derived from the material. Is that issue properly covered?

My third question relates to amendments Nos. 187 and 188 and whether the provisions are consistent with earlier provisions on the importation of bodies or relevant material from bodies, which we have discussed. Amendment No. 132 explored whether RNA should be covered as well as DNA. Again, I would hate to explain it.

Taken together, amendments Nos. 96 and 133 are designed to determine whether it is possible to extend the list of excepted research purposes and ensure that the material is anonymised and cannot be used subsequently to identify anyone. That is important. If the material is anonymised and there are no consequences on the person concerned, considerable benefits for medical research would arise as specific consent would not be needed for every case.

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

The question of anonymisation is interesting, but we probably will not have enough time or energy to go into it. It is important to note that although something can be anonymised at the point of analysis, the question is whether that anonymisation is irreversible, so that it can never be tracked back to other aspects of the medical record—if not of the person. We need to consider, therefore, whether it would be better irreversibly anonymised and unlinked. That needs more clarification.

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

I think I understand the hon. Gentleman's point. Clearly, if there is scope for material on which DNA analysis is being undertaken subsequently to be identified, almost by definition the criterion of it being anonymous is not being met. He may well be right that practical and technological issues may be associated with whether something is anonymous but if, in practical and technological terms, it is irreversible, the legal point that the amendment tries to establish is that research ought to be able to be conducted in relation to that material.

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

I do not want to press the point, because it is not the key issue. I understand what the hon. Gentleman says. However, although the material may be anonymous for the purposes of research, that does not necessarily mean that it can never be tracked back. Indeed, research projects on anonymous samples sometimes allow the researchers to go back to the record, without knowing the name, to see what other factors were present and to see whether they can pick up a pattern. For example, they may find a genetic marker in a DNA analysis and want to look in the medical records, without knowing the person's name, to see whether he had a certain form of cancer. It is a complex area and, for the reasons that I have just given, more work needs to be done.

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

I am happy to accept the hon. Gentleman's point. It is an interesting one, but I cannot explore it further now. However, we may need to explore it once we have had the benefit of the Minister's response.

Those are the underlying purposes of the amendments. The only general point that I would make is that considerable concern has been expressed about the developing practice in medical genetics. When considering the process of DNA analysis, and the extent to which offences are created in relation to it, we want to know how it will relate to current practice. It seems to me that we have established elsewhere the principles of consent flow into DNA analysis, but it may cause problems for those engaged in medical genetics when linking consents to subsequent treatments for sets of related individuals, even those related on a rather tenuous basis.

Photo of Ian Gibson Ian Gibson Labour, Norwich North

The whole consent business has been handled through the biobank project, under which 500,000 people have consented to give DNA. It seems to be working well. It is controlled through GPs, ethical committees and so on. The procedures are in operation to give medical science the kind of information that it wants.

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

The hon. Gentleman makes a good point. It shows that we respect the principles of consent and are trying to find ways to work with them. Indeed, it is my intention not to forgo consent in relation to the undertaking of DNA analysis when a person can be identified. I recognise, however, that some of the relationships between people are indeed tenuous and that people are having to give consent for purposes that stretch a long way from their personal interests in order to assist others. That is fine. If he is right, and if we proceed down that path, we may be able to assist them. However, I hope that we do not make any changes that would make some of those processes more difficult to achieve.

I have raised a number of points and we need to understand how the Minister wants to structure this part of the Bill.

Photo of Evan Harris Evan Harris Liberal Democrat, Oxford West and Abingdon 11:00 am, 5th February 2004

I am also keen to hear from the Minister. Amendment No. 179 and others in the group are in my name. I realise that what I want to achieve on existing holdings will probably be better achieved by Government amendment No. 158. On that basis, I do not propose to press amendment No. 179 to a vote. If the Minister is generous with interventions and if I catch your eye, Mr Hurst, it may be possible to speak later.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

As hon. Gentlemen have said, the Government have tabled several linked amendments to clause 46 and introduced a new schedule to address some of the matters that have been brought to our attention by Committee members and other stakeholders. I have written to Committee members to explain our proposals and included a revised version of clause 46 showing how it will look if the amendments are accepted. I hope that the Government amendments will adequately address many of the Opposition amendments.

It was brought to our attention that, as drafted, the Bill would not allow appropriate DNA analysis of existing holdings of human material without falling foul of the offence in clause 46. The use of existing holdings of relevant material for scheduled purposes in England, Wales and Northern Ireland was exempted from the DNA offence. However, the clause currently does not deal adequately with existing holdings of other types of material such as hair, which is covered by the DNA offence. We heard about an example of research carried out by the Natural History museum on hair samples taken over the past 100 years from now extinct tribes. That would not fall within the description of research in schedule 1, and the material used would not be ''relevant material''. We have no desire to prevent such research. The clause also does not apply to existing holdings in Scotland.

To cater for such situations, we have attempted to simplify the DNA provisions. As amended, clause 46 will make it an offence for any bodily material to be held with the intention to analyse the DNA in it unless there is qualifying consent, as defined in part 1 of new schedule 2. There will be no offence if the results of the

analysis were to be used for an excepted purpose, if the material itself is excepted or if the person reasonably believes that to be the case.

The hon. Member for South Cambridgeshire asked about the nature of the offence, and I can reassure him that we have deliberately framed the offence so that it is limited to bodily material held with the intention to carry out unlawful analysis of the DNA in it. We have not planned to make it an offence to carry out the analysis, as the offence is aimed at those who obtain human material with unlawful intentions rather than those who carry out the analysis further down the line. To put it in a real context, we are talking about the newspaper, not the technician. As a result, the whole of clause 47 should be omitted and its provisions transferred to the new schedule. For the purposes of the DNA offence, part 1 of the new schedule sets out what constitutes qualifying consent.

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

I am afraid that the Minister has confused me. The changes seem to open up the possibility that if someone obtained material that was subsequently used unlawfully, the person who engaged in the second activity would not be committing an offence. To have it that way round seems odd.

Photo of Rosie Winterton Rosie Winterton The Minister of State, Department of Health

If the hon. Gentleman lets me work through more of the issues surrounding the offence, I may be able to give him further reassurance.

As I said, such consent can be given by the person from whose body the material came, or by their parents if the person is a child. Once the person has died, consent may be given by anyone who stood in a qualifying relationship with the deceased immediately before they died. Those rules apply to the whole UK, and specific provisions relating to Scotland are set out in paragraph 3 of the new schedule.

The list of excepted purposes in clause 47 will be in part 2 of the new schedule. The purposes listed in paragraph 5 are the same as those that were in the Bill when it was introduced, but they also include criminal justice purposes, national security and so on.

Paragraph 6 provides for an excepted purpose to apply where existing holdings are used for scheduled purposes other than anatomical examination and public display, which are not relevant. That will allow existing holdings of any material, wherever it is held in the UK, and regardless of whether it is relevant material, to be used for such purposes, without an offence being committed under clause 46.

Paragraph 7 reflects the Bill as drafted and provides that it will not be an offence under clause 46 to use any material that has come from the body of a living person, whether that material was held before or after the Bill came into force, for the purposes listed in part 2 of schedule 1.

Paragraph 8 reflects part 1 of the Bill. If there is authority under part 1 to use relevant material in England, Wales or Northern Ireland, the use of that material for DNA analysis will not be an offence under clause 46. That will include cases where appropriate consent is given under part 1, or where there is an

exemption from the requirement for consent to be given because the relevant material has, for example, been imported.

The hon. Member for South Cambridgeshire mentioned importation. We cannot accept automatic authorisation for use of imported bodily material that is not relevant material, such as hair, nails and gametes, or for any material imported into Scotland. That would create a loophole and enable non-consensual DNA testing to be conducted in the UK simply by importing bodily material, or perhaps even by exporting and quickly re-importing it.

The hon. Gentleman also raised the issue of person A who innocently holds material that is then passed to person B, who carries out DNA analysis without consent. In those circumstances, person A, who held the material innocently, would not be subject to the offence, because they had no intention of carrying out an illegal activity. Person B would be liable because they would have held the material before proceeding with the DNA analysis. Therefore, the offence lies with person B, who intends to carry out the unlawful activity.

Paragraph 9 is a new measure, which provides that if there is authority under section 51 of the Adults with Incapacity (Scotland) Act 2000 to use material from incapacitated adults for research, the use of that material for DNA analysis will not be an offence under clause 46.

Paragraph 10 provides a power to amend the references in the new schedule to excepted purposes. In that way, we will be able to reflect any changes that may be made to the purposes listed in schedule 1.

We propose some changes to the categories of excepted material, which are outside the scope of the offence altogether. That includes material from a person who died more than 100 years ago, which is consistent with our approach elsewhere in the Bill, and also includes embryos outside the body, which are covered by the Human Fertilisation and Embryology Act 1990.

An additional type of excepted material proposed by the amendments is that of existing holdings of material for which the identity of the person from whom it came is not known and is not likely to become known. That would mean that DNA analysis of existing anonymised holdings of material would not be an offence, whatever it was used for. That would allow, for example, the Natural History museum research project that I described to continue.

The other amendments are consequential on the changes that I have described, particularly the removal of clause 47, and the fact that the schedule now applies to all of the UK. Hon. Members raised the issue of use of DNA analysis and PCR on sequencing derived from the material. Under part 1 of the Bill, consent would be required to obtain the material to carry out PCR. We are aware that experts have argued that it is illogical to limit the offence to DNA because there are numerous other methods for the analysis of genetic information. We have deliberately chosen not to extend the definition beyond the general concept of analysis of human DNA because there are many

potential ways to infer the make-up of a person's DNA. The Bill is not the correct place to list complex and technical terminology, which constantly changes.

I hope that the Committee will welcome the amendments, which are intended to address the many helpful comments and amendments suggested by Opposition Members and stakeholders outside the House. I commend the Government amendments to the Committee.

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

I am not sure how we are to structure this debate, given that the Minister has finished her remarks. Perhaps you will give us guidance on that, Mr. Hurst. I imagine that I am to speak and—

Photo of Mr Alan Hurst Mr Alan Hurst Labour, Braintree

Order. Not for the encouragement of the Committee, it is open for Members to speak more than once in each debate.

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

That is helpful, Mr. Hurst.

A number of points that the Minister raised require further scrutiny. I hope that I will not pre-empt any points that the hon. Member for South Cambridgeshire intends to make. My first question is about DNA and RNA. The Minister said that the offence has deliberately been left general. I would have thought that specifying human DNA rather than genetic or sequenceable material would compound the problem that the she is attempting to solve by keeping the offence general. That needs further exploration and clarification—today, rather than later. Incidentally, I suppose that one could back-sequence from protein as well these days.

Dr. Gibson indicated assent.

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

The hon. Gentleman is nodding. No doubt he is already thinking about a grant application.

My second point concerns correspondence that I have had on the issue of intention. Will the Minister expand on intentional offences? I am sure that there are intentional offences, but we must be careful before legislating in that area because of the difficulty of proof. I do not suggest that she seeks to create a thought crime that might be too wide, but we know the sort of thing that she is considering. Is there any evidence that the sorts of offences that we are talking about will be caught by the measure? In the scenario that she painted, in which person A has the material innocently and person B carries out the DNA analysis, it is possible that, although the analysis is carried out without consent, no one would be found guilty because the person who committed the offence reasonably believed that the material was accepted and that consent had been given.

We must stress that there is a duty to be careful when carrying out DNA analyses because of the other purposes to which they may be put. The exemption for reasonable belief might—I surprise myself by saying this—allow cases to slip through, and people carrying out DNA analysis might not be required to be careful about ensuring that they have consent. There must be

a requirement that people are not reckless about consent. The default situation should be that gaining consent is carefully done.

The ethics and law surrounding the analysis of a person's DNA for the clinical benefit of someone else have not been raised. Someone might require information about someone else's genetics to find out whether they have a condition and, if so, what is the right treatment available. That might be the case particularly for the advice needed for genetic counselling. I regret that I cannot illustrate a scenario now, but that is why schedule 1 provides for research to be done for the benefit of another individual. If it emerges that information from a dead person might be useful but that he gave no recent consent for DNA analysis, would the person whom it might help have recourse to using it? Schedule 1 refers to:

''Obtaining scientific or medical information about a living or deceased person which may be relevant to any other person''.

Clearly, that normally requires consent. However, in the case of DNA analysis, what are the Government's intentions if the interests of two people sharing genetic information must be considered? That case may not arise, but it is a concern.

A series of issues have emerged as a result of the inclusion of criminal justice purposes that do not require consent. There is a civil liberties issue concerning the circumstances under which DNA analysis of such material should be permitted. Would it be permitted if people were charged or detained, or would it be permitted in all cases? How will the provisions relate to criminal justice measures that have either been proposed or enacted? Many people are concerned that their DNA might be used for criminal justice purposes without their knowledge even if they are not in the frame or have not been charged. We must be clear about the circumstances under which DNA analysis is permitted.

There are other significant issues to which we may need to return, but I am conscious of the time so I will leave my remarks at that.

Photo of Andrew Lansley Andrew Lansley Shadow Secretary of State for Health 11:15 am, 5th February 2004

We may indeed need to return to those other significant issues. I do not begrudge the hon. Member for Oxford, West and Abingdon the opportunity to make his points, and he did so perfectly fairly.

I am not entirely persuaded why it is desirable that the structure of creating an offence around the idea of ''intention'' in relation to the analysis of DNA material should be completely different to the structure of an offence in relation to the retention of organs and tissues. Why is the offence not one of having relevant material with the intention of undertaking activities without appropriate consent, as in the earlier part of the Bill? We have a choice about how to proceed, but the provisions raise all the questions that the hon. Gentleman mentioned about establishing burdens of proof. We may have to return to that.

We will need to work through the issue of medical genetics. Balances are currently struck, in the absence of legislation, in cases in which substantial benefits can flow to given individuals from the analysis of DNA material when consent has not been given. We need to

be sure that there are no circumstances in which it might be more ethical for the analysis of DNA to go ahead because of the overwhelming benefits that would accrue. Obviously, that should not be to the detriment of the individual whose material was being used, even if their consent had not been obtained. We are talking about life-saving or life-changing procedures, for which consent may not have been obtained, and we need to work through that.

I will stop at that point, not least because I want to consider some of those issues and the Minister's response in detail, although I may reserve the option to return to them on Report. On that basis, 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

On a point of order, Mr. Hurst. I am not sure whether it is feasible for us to finish in the remaining three minutes, so we seem to be in the worst of all worlds. We have put questions to the Minister on this important subject, but she has not had an opportunity to respond to some of them, although she did, in effect, read out what was, I accept, a very helpful letter. What recourse do we have? Perhaps it is too late to ensure that we have a full debate on some of the issues that the hon. Member for South Cambridgeshire and I raised.

Photo of Mr Alan Hurst Mr Alan Hurst Labour, Braintree

The position is as the hon. Gentleman describes it. Hon. Members have lost the opportunity to discuss those matters because we have just concluded the debate on the group that included

clause stand part. Hon. Members will have to take another opportunity to raise their concerns as the Bill proceeds through its different stages.

Amendments made: No. 157, in

clause 46, page 28, line 25, leave out

'excepted purposes (see section 47)'

and insert 'an excepted purpose'.

No. 158, in

clause 46, page 28, line 32, after 'death,' insert—

'( ) it is an existing holding and the person who has it is not in possession, and not likely to come into possession, of information from which the individual from whose body the material has come can be identified,'.

No. 159, in

clause 46, page 29, line 1, leave out from 'Schedule' to 'has' in line 2 and insert

'(Section 46: Supplementary) (which makes provision for the interpretation of ''qualifying consent'' and ''use for an excepted purpose'' in subsection (1)(a))'.

No. 160, in

clause 46, page 29, line 3, after 'section', insert

'(and Schedule (Section 46: Supplementary))'.

No. 161, in

clause 46, page 29, line 5, at end add—

'''existing holding'' means bodily material held immediately before the day on which this section comes into force.'.—[Ms Winterton.]

Clause 46, as amended, ordered to stand part of the Bill.

Schedule 5 disagreed to.

Clause 47 disagreed to.

It being twenty-five minutes past Eleven o'clock, The Chairman adjourned the Committee without Question put, pursuant to the Standing Order.

Adjourned till this day at half-past Two o'clock.

Hurst, Mr. Alan ( Chairman)

Cohen, Harry

Davey, Valerie

Ellman, Mrs.

Francois, Mr.

Gibson, Dr.

Harris, Dr. Evan

Ladyman, Dr.

Lansley, Mr.

Lucas, Ian

Murrison, Dr.

Naysmith, Dr.

Ryan, Joan

Taylor, Dr. Richard

Watson, Mr.

Winterton, Ms Rosie