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Orders of the Day

Human Tissue Bill

Lords amendments considered.

Clause 5

Prohibition of activities without consent etc.

Lords amendment: No. 1

1.37 pm

The Minister of State, Department of Health (Ms Rosie Winterton): I beg to move, That this House agrees with the Lords in the said amendment.

Mr. Deputy Speaker (Sir Alan Haselhurst): With this we may discuss Lords amendments Nos. 2, 10 to 17, 34, 35, 37 to 39, 50, 51 and 53.

Ms Winterton: 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.
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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.

Mr. Andrew Lansley (South Cambridgeshire) (Con): 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.

1.45 pm

Clause 6

Activities involving material from adults who lack capacity to consent

Lords amendment: No. 3

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

Mr. Deputy Speaker: With this we may consider Lords amendment No. 44.

Ms Winterton: Lords Amendment No. 3 supplies a word in the Secretary of State's title in clause 6. I hesitate
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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

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

Lords amendment: No. 4

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

Mr. Deputy Speaker: 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.

Ms Winterton: 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
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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
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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.

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