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The other area is work for the benefit of the relatives. That is best illustrated by sudden cardiac death in young adults, which is usually caused by a variety of cardiomyopathies, some of which are inherited. To sample the heart requires appropriate consent. Qualified consent, as in the Human Tissue Act, would cover only the DNA analysis, so to take a piece of tissue requires appropriate consent. The trouble is that if one person refuses consent, and they may well do in the trauma and turmoil of being immediately bereaved, all other relatives are denied the benefit as the heart cannot be examined further. When another family member dies suddenly, the tragedy is more than doubled. It is important to remember that some of these conditions are inherited as autosomal dominants, not autosomal recessives.

I am sure that the Government will say that consent is at the heart of the Human Tissue Act, and I am completely in agreement with the principle of consent, but it must be truly informed consent so relatives who have done no wrong are better served and miscarriages of justice can be more easily detected in future. Consent and well-being are at the heart of these amendments. I beg to move.

9 pm

Lord Alderdice:My Lords, I rise to support the two amendments tabled by the noble Baroness, Lady Finlay of Llandaff, and to speak to Amendment 34, which is tabled in my name and that of my noble friend Lord Thomas of Gresford. The noble Baroness, Lady Finlay, has with great elegance and eloquence, as usual, conveyed some of the problems that have arisen out of legislation and regulations that came into being after a considerable emotional response by the community to certain events with which we are familiar. The difficulty is that sometimes when one reacts to things in legislation of a relatively straightforward nature, only later do the complexities become apparent. In order to address the needs of families who are emotionally concerned, particularly at times of death, regulations were put into place, and it has become apparent that they go against those families' best interests and what they want.

In the past, a pathologist, as part of his professional understanding and commitment to the work, the patient and his relatives, would normally have gone a little further in completing the post-mortem and finding out what happened and its implications. Now, that is forbidden; it is not possible to go ahead. Knowledge is set back, and it is knowledge that is of great interest for the families, particularly when it comes to genetic disorders. The case put forward by the noble Baroness merits a strong, positive response from the Government. I have no doubt that the Minister appreciates some of these subtleties and that it is not easy to put them in place. However, we do not visit the Coroners Act on a regular basis. It is done once in a lifetime. The problem is that during those 25 or 30 years, many other things change.

That takes me to my Amendment 34. It is clear that not only for the convenience and satisfaction of the family, but also, I suspect, for economic reasons in order to make sure that post-mortem examinations

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can be done quickly and relatively cheaply, it is being suggested that rather than full post-mortems, partial post-mortems or particular kinds of examinations might be undertaken. They would be briefer and less expensive. Of course, with new technology, they may be extremely helpful, and the technology will continue to develop over the next 20 years or so. The problem is that if a partial post- mortem is requested, it will be conducted by a medical practitioner-in many, if not all, cases a forensic pathologist-who will understand that each finding must be related to the findings in the body as a whole.

However, the Bill implies-indeed, it rather clearly states-that a particular kind of examination that is not a partial or full post-mortem but perhaps a radiological or other less intrusive examination can be ordered by someone who may not be medically qualified. Indeed, a lot of these specialist examinations are increasingly being undertaken by people who are not medical practitioners, whether those examinations are haematological, biochemical, neurophysiological or histopathological.

The problem is that that person, with their expertise, can come up with a perfectly accurate answer for the particular thing that they are asked to look at, but a coroner is not medically qualified and does not have the training, background or understanding of the body as a whole. Moreover, he requests a test to be conducted by someone who does not have that understanding, which is why this amendment asks that the coroner should consult a medical examiner. Perhaps other medically qualified people could be consulted-I do not have my mind closed to that-but the idea that it should not be someone with a medical understanding is a serious error and is likely to lead to misjudgments and serious mistakes in the conduct of these examinations and therefore to the wrong result from the inquest.

I was not clear from the Minister's last response why there will be such a problem of delay. The main force of that response was that to insist that the coroner consults the medical examiner would occasion such delay as to be of great disadvantage to the family. It is unlikely that a medical examiner would be so unavailable that he could not be consulted. However, if there are other ways in which this problem can be satisfied, I look forward to what the Minister has to say in response.

Lord Hunt of Wirral: My Lords, we are indebted to the noble Baroness, Lady Finlay of Llandaff, for introducing a very important subject. As I understand it, both she and the noble Lord, Lord Alderdice, understand and support the central importance of consent in the removal, storage and use of post-mortem tissue samples. They highlight the fact that, since the Human Tissue Act 2004, a number of situations have developed that are probably beyond the circumstances that this House and the other place had in mind when we debated that legislation and it was taken through Parliament.

We are indebted to the noble Baroness for giving examples of those situations, which were not envisaged. I was particularly struck by the circumstances she outlined in which pathologists are prevented from

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undertaking potentially life-saving research for the benefit of relatives of the deceased; in which vital forensic research is possible only with the consent of the accused; in which evidence that may become crucial to a successful criminal investigation cannot lawfully be retained; and in which public health research, such as the example given of the project into the epidemiology of variant Creutzfeldt-Jakob disease, has proved to be logistically impossible.

I am greatly benefited by a letter, which the noble Baroness shared with me, from Professor Peter Furness, President of the Royal College of Pathologists. We must now look to the Minister to outline how the Government intend to respond to these situations, and how we can create the necessary flexibility to solve the most important of these problems while maintaining an appropriate level of scrutiny that would satisfy this House-and of course the public-that the underlying intent of the Human Tissue Act 2004 is not being undermined or eroded. We therefore await the Minister's response with great interest.

Lord Tunnicliffe: My Lords, I, too, thank the noble Baroness, Lady Finlay of Llandaff, for again raising this area of concern. The noble Lords, Lord Hunt and Lord Alderdice, have said that this is a difficult, complex and subtle area. Because the level of subtlety is such that we need to write in response to this debate, I will end by inviting the noble Baroness to withdraw her amendment and inviting noble Lords not to press their amendments. In those circumstances, I understand that it would be appropriate for amendments to be brought back at Third Reading if we were unable to satisfy the general direction that we have talked about. I will, of course, add that caveat about the spirit.

We have once again returned to the emotive issue of post-mortems and tissue retention and, as in Committee, we have heard a number of highly informed opinions. I am confident that most if not all of the issues raised in Amendment 32 can be more than adequately dealt with in other ways. These include guidance issued by the Chief Coroner, the provisions of the Charter for Bereaved Families and provision in regulations to be made under Clause 38(3)(g) governing the preservation, retention, release or disposal of bodies, including body parts.

I would wholeheartedly agree that, as a matter of best practice, it may well be appropriate for the coroner to attempt to explain and discuss the extent and purpose of any post-mortem examination before the examination is commissioned and carried out. Among other things the coroner would explain what would happen to any tissues taken as samples after the coroner's jurisdiction over them has finished. However, such prior contact with the next of kin may not always be appropriate or practical, particularly in situations where the next of kin cannot be immediately contacted, where the death is especially complicated or distressing, or in situations where the next of kin may be implicated in the death. It may also be the case that the coroner is not best placed to ascertain the wishes of the family. It is often the case that either a medical professional or a police officer is liaising with the family in the immediate aftermath of a death and they would be best placed to raise this issue.



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The draft Charter for Bereaved Families, published alongside the Bill, already contains relevant passages at paragraphs 15 to 20, 36 and 37, and we will consult further on this as part of the implementation process. In addition, I should say that the concept of "appropriate consent" is predicated on who gives the consent rather than on to whom the consent is given, so any such consent given to a coroner or to a coroner's officer, police officer or medical practitioner is already regarded as appropriate consent under the Human Tissue Act 2004.

The 1984 coroners' rules, which were updated in 2005 following the passage of the Human Tissue Act, contain provisions on material retained after a post-mortem examination. The coroner is required to inform the deceased's relatives of the period that material will be retained and the options regarding the material at the end of that period. One of those options is that the relatives may consent to the material being retained and used for medical research. Similar provisions could be made in regulations under Clause 38(3)(g) and we consider that this would be preferable to ascertaining wishes before the post-mortem when the family may be distressed and treating those wishes as consent.

As regards Amendment 33, I must reiterate the Government's position that the regime set up by the Human Tissue Act 2004 is a consent-based regime and that the consent of the next of kin should be obtained in all circumstances before human tissue samples are kept for the purpose of scientific research, including those samples taken during a coroner's post-mortem. The Government cannot give their backing to any proposal that seeks to undermine the fundamental principle of next of kin consent established by Parliament in passing the Human Tissue Act. Therefore, once the coroner has finished his or her investigation and their jurisdiction is at an end, and if there is no requirement for tissue to be kept for evidential purposes, the state has no right to retain tissue without appropriate consent from the next of kin.

I appreciate that it is a long-standing contention of bodies such as the Royal College of Pathologists that it is desirable that tissue be retained when it is for the good of the family; for example, when there is a genetic element to a cause of death. But the Government take the view that it is ultimately for the family to decide what is in their interests, and not for the state to dictate that their relative's tissue should be retained "for their own good". The current legislation allows such tissue to be retained for these purposes with appropriate consent, and we wish that to retain that position. I can offer the noble Baroness some comfort with regard to paragraph (b) of Amendment 33 in that, under PACE, powers already exist for tissue to be seized as evidence and retained for criminal justice purposes.

The provision at paragraph (c) regarding,

would provide the Secretary of State with wide-ranging powers to take away decisions about the retention of tissue from families, without even the safeguard of the requirement for parliamentary approval for such a change in the law. This would again contravene the spirit of the Human Tissue Act which has at its heart the concept that it is for individuals and their families

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to have the right to decide what happens to their bodies after they are dead. I am sure that organisations such as those representing the families affected by Alder Hey, Bristol and other organ retention scandals in the past would be very concerned at any attempt to weaken this principle. Also deeply concerned would be those who belong to many faith groups, who believe strongly that a funeral should take place with the body of the deceased person untampered with as far as possible.

I hope that I have been able at least to satisfy the noble Baroness that her first amendment is unnecessary. I know that she will not be satisfied with my response to her second amendment, but I hope that she will agree that it raises an important point of principle which goes to the heart of the Human Tissue Act and, as such, this is not the occasion to take the matter further. I repeat that we will look at her speech with great care, consider its general thrust and write to her as soon as is reasonably practical. We will copy that letter to other noble Lords who have taken part in the debate.

Finally, on Amendment 34, I reiterate that we anticipate that guidance about post-mortems issued by the Chief Coroner, in conjunction with and on the advice of the medical adviser to the Chief Coroner, would address the circumstances in which a non-invasive post-mortem might be appropriate and those cases which might warrant a kind of post-mortem plus. This might be, for example, when family members have concerns about a possible congenital defect, which a routine post-mortem may not reveal, if one or more family members die at an unexpectedly young age. Provided that the family consent, there is no reason why such a post-mortem cannot be held-they could even be contacted by phone while the post-mortem is taking place.

It is expected that the new medical examiners, whose primary responsibility is to confirm the cause of death entered by doctors on medical certificates, will indeed make important contributions to that decision-making process in the following situations. The first is where a coroner may be unsure as to whether a post-mortem, or related scientific examination, is required in a particular case. In that circumstance, the coroner will be able to consult the local medical examiner for advice, in the same way that he or she may consult the medical examiner about other issues which relate to the deceased person's medical cause of death. Alternatively, a medical examiner may refer one of their own cases to a coroner because, after consulting the treating doctor, he or she is unable to confirm the cause of death given on the death certificate.

In making the referral, the medical examiner may make a suggestion about a particular kind of scientific examination which may assist, or may be consulted by the coroner about the sort of examination that the medical examiner would recommend. On the coroner's involvement in research projects, to which the noble Baroness referred, this is a matter that will be dealt with by the Chief Coroner in the future. We envisage that his approach will be more constructive than some individual coroners in the current system. I agree with the noble Lord, Lord Alderdice, that there needs to be

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a close working partnership between coroners and medical examiners. The difficulty I have with his amendment is that it would place in primary legislation a statutory requirement for the coroner to consult a medical examiner in all situations where a partial post-mortem examination or a particular kind of examination was being requested. I believe that such an approach would be unnecessarily rigid and could lead to delays in arranging post-mortem examinations, which could in turn lead to delays for families in making funeral arrangements. I hope we can agree that such delays would be undesirable and that, accordingly, it would be better to leave such matters to the discretion of the coroner.

I thank the noble Baroness, Lady Finlay, for the time that she has spent with us both today and beforehand. We shall of course be available for further consultation after we have written to her. On that basis, I invite her to withdraw the amendment.

Baroness Finlay of Llandaff: I am most grateful to the Minister for his extensive reply and for those extensive discussions before we came on to the Floor of the House, which have been most helpful. I am also reassured that he will write to me. I shall not respond to the individual points that he made; he has given me a lot of important reassurances today which are on the record.

I simply repeat that consent must be at the heart of processes, but I should like to go one stage further and say that we must make sure that it is truly informed consent for it to be valid. That means recognising that, in acute bereavement, people are sometimes in such a state of shock that they really cannot give true, informed consent. CRY, an organisation that deals with sudden death, knows of families where consent forms have been sitting on the kitchen table for up to two years before they could even face tackling them. That is the extent to which people are traumatised. I am most grateful for the Minister's response. I beg leave to withdraw the amendment at this stage, but may return to it.

Amendment 32 withdrawn.

Amendments 33 and 34 not moved.

Amendment 35

Moved by Lord Bach

35: After Clause 18, insert the following new Clause-

"National Medical Examiner

(1) The Secretary of State may appoint a person as National Medical Examiner.

(2) The National Medical Examiner is to have-

(a) the function of issuing guidance to medical examiners with a view to securing that they carry out their functions in an effective and proportionate manner;

(b) any further functions conferred by regulations made by the Secretary of State.

(3) Before appointing a person as National Medical Examiner or making regulations under subsection (2)(b), the Secretary of State must consult the Welsh Ministers.

(4) A person may be appointed as the National Medical Examiner only if, at the time of the appointment, he or she-

(a) is a registered medical practitioner and has been throughout the previous 5 years, and



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(b) practises as such or has done within the previous 5 years.

(5) The appointment of a person as National Medical Examiner is to be on whatever terms and conditions the Secretary of State thinks appropriate.

(6) The Secretary of State may pay to the National Medical Examiner-

(a) amounts determined by the Secretary of State by way of remuneration or allowances;

(b) amounts determined by the Secretary of State towards expenses incurred in performing functions as such.

(7) The National Medical Examiner may amend or revoke any guidance issued under subsection (2)(a).

(8) The National Medical Examiner must consult the Welsh Ministers before issuing, amending or revoking any such guidance.

(9) Medical examiners must have regard to any such guidance in carrying out their functions."

Lord Bach: This group of government amendments places on a statutory footing the separate posts of the national medical examiner and the medical adviser to the Chief Coroner. The Government have tabled the amendments after careful consideration of the views expressed in Committee by the noble Baroness, Lady Finlay, and the noble Lords, Lord Thomas of Gresford, Lord Alderdice and Lord Alton.

Amendments 35 and 143 allow for the appointment of a national medical examiner, who will provide professional leadership to medical examiners and, in particular, issue guidance with a view to securing that they carry out their functions effectively and proportionately. It will be for the Secretary of State for Health to agree the detailed job description of the national medical examiner. However, it is envisaged that the national medical examiner will also act as the main point of liaison with the medical adviser to the Chief Coroner to ensure that close working relationships between coroners and medical examiners at local level are also mirrored at national level.

In terms of qualifications for the appointment, the national medical examiner will have been a registered medical practitioner for at least five years and have practised within the previous five years. The Secretary of State will determine the terms and conditions of the national medical examiner and their remuneration or allowances.

Amendments 49 and 51 provide for the Lord Chancellor to appoint a medical adviser to the Chief Coroner and as many deputy medical advisers to the Chief Coroner as the Lord Chancellor thinks appropriate. As the title suggests, the medical adviser will advise and assist the Chief Coroner in relation to medical matters which are relevant to the coronial system.

It will be for the Lord Chancellor, in consultation with the Chief Coroner, to agree the precise job description. It may be helpful if I confirm what we envisage to be the key elements of the post. First, it is likely to be a strategic role, involving liaison with organisations such as the British Medical Association, the General Medical Council, the Royal College of Pathologists, the Human Tissue Authority and the Commissioner for Mental Health, as well as specialists in particular medical fields. More particularly, he or she will establish a strong working relationship with the new national medical examiner. The second main tranche of work is likely to see the medical adviser

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being responsible for formulating, promulgating and monitoring the use of best practice for medical aspects of the coroner system, including post-mortem examinations, the release of bodies and organ and tissue retention.

The amendment keeps open the option of appointing more than one in terms of deputy medical advisers. We anticipate that there will be one deputy, but the amendment keeps open the option of appointing more than one in case the need arises at some point in future. This is important, given that the medical adviser is a new role, and one which may evolve in future. As for qualifications, the medical adviser and deputy will have been registered medical practitioners for at least five years, and have practised within the past five years. The Lord Chancellor will decide the roles' terms and conditions and remuneration or allowances.


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