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Lords Chamber

Volume 669: debated on Tuesday 1 February 2005

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House Of Lords

Tuesday, 1 February 2005.

The House met at half-past two of the clock: The LORD CHANCELLOR on the Woolsack.

Prayers—Read by the Lord Bishop of Oxford.

The Lord Chancellor: Leave Of Absence

My Lords, before business begins, may I take the opportunity to inform the House that I will be undertaking a ministerial visit to Barnsley on Friday 4 February? Accordingly, I trust that the House will grant me leave of absence.

Sudan: Reconstruction And Humanitarian Aid

2.36 p.m.

My Lords, on behalf of the noble Earl, Lord Sandwich, and at his request, I beg leave to ask the Question standing in his name on the Order Paper.

The Question was as follows:

To ask Her Majesty's Government what they are doing to speed up reconstruction and humanitarian aid in southern Sudan during the interim period following the latest peace agreement.

My Lords, the signing of the Sudan comprehensive peace agreement opens new possibilities for humanitarian and reconstruction assistance. The Secretary of State for International Development has announced a £50 million UK contribution to the United Nations 2005 Workplan for Sudan and the Consolidated Appeal for Eastern Chad from a total allocation of £100 million for Sudan this year. We are encouraging other donors to make similarly early, up-front contributions.

My Lords, does the noble Baroness agree that the humanitarian aid programme in southern Sudan should be treated entirely separately from the ongoing negotiations in Darfur? Given the below average production of staple food crops in the south, and the probability of significant population returns to the area, the Security Council should take immediate steps to place on the ground the 11,000 peacekeepers that the Secretary-General demands. Is it possible for the humanitarian programme to be initiated before the peacekeepers are in situ?

My Lords, first, the money for southern Sudan and for Sudan as a whole is separate from the money that we are giving for humanitarian aid in Darfur. Secondly, with respect to the deployment of UN peacekeepers to monitor the comprehensive peace agreement, we are awaiting discussions to clarify the mandate for those peacekeepers, but once that is done they will be deployed. I was not entirely certain what the noble Lord was asking with respect to humanitarian aid and peacekeepers, but I will look at that in Hansard and I will write to him if I can add anything.

My Lords, what support are Her Majesty's Government providing to combat the outbreak of the rare W135 strain of meningitis in the refugee camps across the border from Darfur in Chad? What is the current known number infected? Are they taking steps to ensure that NGO workers in the area have adequate immunisation?

My Lords, I am afraid that I do not have any information about the numbers that might have been infected. The noble Baroness will know that we have been working with the World Health Organisation in looking at health issues in the refugee camps. I do not have the answer to her question on immunisation for NGO workers, but I will write to the noble Baroness.

My Lords, I welcome the peace agreement, but how will it affect events in Darfur?

My Lords, at the moment, the comprehensive peace agreement does not apply to Darfur, although there are institutional elements in the comprehensive peace agreement that will ultimately apply to Darfur once we have a peaceful settlement there. That depends on the outcomes of the Abuja negotiations under the auspices of President Obasanjo. I understand that those may restart later this month. We hope that they do, because the situation in Darfur remains critical.

My Lords, how do the Government intend to respond to the recommendation of the commission from the UN Secretary-General that Darfur, and the international human rights abuses in Darfur, should be referred to the International Criminal Court? Does the noble Baroness agree that if the Security Council does not support that proposal, one of the main planks in the high-level panel's report that more use should be made of such referrals would be made to look pretty weak?

My Lords, we will of course study carefully the recommendations coming out of that report. It was issued at about six o'clock last night in New York. With respect to the recommendation of a referral to the International Criminal Court. that is one way to deal with the situation, and that decision must be agreed by the Security Council. We will be talking to our partners in the Security Council about that as a matter of urgency.

My Lords, coming back to southern Sudan, which is the subject of the Question, how long will it take to establish what the mandate of the peacekeepers should be? How does the noble Baroness evaluate the risk of the present situation breaking down if there is any significant delay?

My Lords, I do not anticipate that it will take too long to agree the mandate for the peacekeepers—there is already discussion ongoing. If noble Lords recall, although the peace agreement was signed only in January, the agreement was reached at the end of last year, so we have already had some time to plan for this. In terms of a possible breakdown in the situation, there has, for example, been an outbreak of fighting in the eastern side of Sudan. That is a result of the fact that some rebel groups were not involved in the discussions around the comprehensive peace agreement. We have to ensure that they are brought into the process as well.

My Lords, on Darfur, has there been progress towards a complete ceasefire and the disarmament of all militias?

My Lords, I can only go back to what I said in response to an earlier question, which is that discussions are taking place in Abuja under the auspices of President Obasanjo. Those discussions are currently suspended, but we hope that they will restart towards the end of the month. Given the critical nature of the situation in Darfur, it is vital that both sides sign up to the protocols agreed in Abuja last year with respect, for example, to humanitarian access.

My Lords, further to the point made by the noble Lord, Lord Hoyle, does the noble Baroness agree that congratulations should be offered to our own people in the negotiations, and to all those from Kenya, the USA, Norway and Italy who took part in giving support to the Sudanese Government? Given that the new government will contain a large element of southern representatives, they must ensure that they are able to demonstrate a different political and economic attitude to the regions, in order to assure the rehabilitation of the south, the rescue of Darfur and the integrity of the whole country. Will Her Majesty's Government and other observers at Naivasha maintain the same active partnership to aid implementation of the peace agreement?

My Lords, the short answer is yes. The noble Duke will be aware that we, with the United States and Norway, were part of the Troika. We worked with members of the African Union and others to bring about the comprehensive peace settlement. The Government of Sudan were not the only key players involved; John Garang from the south was one of a number of others. Our continuing support will be absolutely critical.

Knowledge Transfer: Funding

2.45 p.m.

asked Her Majesty's Government:

What are their plans for funding knowledge transfer and links with industry and higher education.

My Lords, the Science & innovation investment framework 2004–2014, published in July 2004, sets out the Government's plans. Some £187 million is available through the Higher Education Innovation Fund for the academic years 2004–05 and 2005–06. The Government will further increase funding available for the HEIF. to £110 million a year by 2007–08. The Government will move towards a predictable funding allocation for knowledge transfer based essentially on metrics, starting from 2006–07.

My Lords, I thank my noble friend for that encouraging reply. Does he agree that UK universities have done very well in responding to government initiatives on knowledge and research transfer to industry on a commercial basis? If I declare an interest as chancellor, I can say that my own university—Bradford—has done well under the bidding system and lived up to its motto, "Making knowledge work". Nevertheless, if the science and innovation of our universities is to be a permanent part of our economic life and of the business of the community, does he also agree that universities will have to invest more in infrastructure and support staff to maintain such activity? In turn, does that not require a more permanent and consistent method of funding?

My Lords, huge progress has been made in the area by a number of universities, including that so ably represented by my noble friend. It is plain that, starting from a relatively low base, investment in the area to build capacity is one of the most important things that we can do. The Government have responded to the Lambert review, which deals with the long term. Our support for the Higher Education Innovation Fund has been described as a permanent third stream of funding for universities in England, to build capacity further in the university sector for knowledge transfer. That was the basis on which the increased investment that I mentioned was made. It will be a predictable funding stream and it will carry forward some excellent work into the future.

My Lords, how do the Government intend to resolve the tension between the concentration of research funding in top-rated departments and their aim to remove economic disparities between regions in the UK?

My Lords, that is a very important question. The Government's intention is to fund the best research wherever it is found. The aim is to ensure that the overall quality of the United Kingdom's research is competitive and comparable to the best in the world, wherever it is done. It is not the Government's policy to concentrate funding or research, and we are not convinced that there is any such concentration. The quality-related research funding is widely distributed. It is true that 75 per cent of the funding goes to 25 institutions, but at least one major institution is in receipt of major funding in every region of the country.

My Lords, does my noble friend accept that two of the best institutions that also provide links with industry are the Open University and Birkbeck, which provide part-time education for students? A commitment was given in the summer, when the Higher Education Bill was under consideration, that effectively offered money for those two institutions and I am delighted to hear my noble friend say that more money is being put into such areas. The buck was passed at that time to the Higher Education Funding Council. Does he accept that the Government must take responsibility? Can he assure us that the modest sum of money that would be needed for those two institutions would not cost too much out of the huge sums that he has already mentioned and that, whatever the HEFC's report says, that money will be provided?

My Lords, the basis of the discussion between the HEFC and those two institutions is to ensure that the manner in which part-time students are treated is not to their disadvantage. I believe that those discussions are at an advanced stage, but have not, as yet, culminated. I shall add only one observation, which is that links with business and industry, as my noble friend pointed out, are not just a question of funding; there is also the question of the sources of students and the links that they bring with them and take back after they have completed their courses. That is a very important factor regarding both Birkbeck and the Open University.

My Lords, given that the Minister said that in future the Higher Education Innovation Fund will be distributed by metrics and that it had nothing to do with rationalisation and concentration, what, precisely, will these metrics be?

My Lords, I have not come to the House today with the formula—much as I love formulae—and I apologise that I cannot answer that question as precisely as the noble Baroness would like. All that I can say is that the element of judgment between projects is giving way to a formula which the institutions generally feel will give rise to a very fair distribution.

My Lords, following the points made by the noble Baroness, Lady Morris, will the Minister say more about what is being done to encourage regional bodies, such as regional development boards and science and industry councils, to further knowledge transfer in the sub-regions and nations of this country?

My Lords, it is absolutely true that knowledge transfer applies equally to the economic well-being of regions as it does to the whole country and there have been a number of important developments. The Northern Way and other growth strategies are beginning to have a positive effect on the areas concerned and the department is working with partners, including the Higher Education Funding Council for England, the regional development agencies and government offices, to ensure that we reduce disparities within regions, while supporting excellence and competitiveness.

You can see in the consortia of universities across the north of England just how strongly they have taken up the challenge in front of them. Science and industry councils have now been established in a number of regions. Listing them now might be tedious for the House, so perhaps I may write to the noble Lord, Lord Dearing, with the complete list and the dates when they were started and place that in the Library, so that everyone can see the details.

China: Uk Arms Exports

2.53 p.m.

asked Her Majesty's Government:

Whether they intend to resume arms sales to China.

The Minister of State, Foreign and Commonwealth Office
(Baroness Symons of Vernham Dean)

My Lords, as our reports on strategic export controls make clear, there are currently exports of equipment on the military list from this country to China. The EU embargo does not prohibit such exports and United Kingdom policy on what may be exported to China was made explicit to Parliament in June 1998. Our exports are subject to the UK's consolidated criteria, which are among the strictest control measures anywhere in the world and, in our view, offer the best guarantee that military exports will not be used for internal repression or external aggression.

My Lords, I am grateful to the Minister for that reply. Has she discussed with our close allies, the United States of America, proposals, if they exist, to relax the EU embargo? What has been that country's reaction?

My Lords, perhaps I may be clear with the noble Lord, Lord Willoughby de Broke. We do not believe that this is a relaxation. I well understand the misapprehension, because the use of the word "embargo" might reasonably be interpreted by him, by me or by anyone else, as an absolute ban. It is not an absolute ban and the exports of our goods on the military list have been regulated under the code that I described-indeed, almost all refusals of exports to China are made under the code, not the embargo. Of course this issue has been discussed with the United States, most recently by my right honourable friend the Foreign Secretary.

My Lords, will my noble friend draw to the attention of the governments of France and Germany the last part of her Answer, relating to weapons used for internal repression or external aggression, since those governments seem to be the most keen to abandon the EU embargo? That would cause enormous dismay to Taiwan, which every day faces 600 missiles pointing its heart from the coast of China?

My Lords, I repeat that I understand the concerns about this matter, because the use of the word "embargo" implies that there is an absolute ban at the moment and that we would move from an absolute ban to a much freer market. The refusals for the export of items on the military list are, more often than not—not always—already made under the EU code. That code has also been adopted by our allies in France and Germany and, therefore, there is no need to draw their particular attention to that matter. However, under our forthcoming EU presidency, the UK Government would like to discuss strengthening in a number of key respects the code which regulates the export of items on the military list throughout the European Union.

My Lords, will the Minister confirm that a change in the formal status of EU policy towards arms sales to China is unlikely to produce any real change in what is sold? Will the British Government's plans for strengthening controls on EU arms sales give particular attention to enforcing those controls?

My Lords, when this matter was discussed recently at the EU meeting on 16 and 17 December, the extract from the presidency's conclusions underlined that,

"the result of any decision",
on whether or not lift the so-called embargo,
"should not be an increase of arms exports from EU member states to China, neither in quantitative or qualitative terms".
I hope that that is sufficiently explicit to the noble Lord. When I was studying in preparation to answer this Question, I, too, was surprised to learn that the word "embargo" did not mean an absolute ban. That was made explicit in 1998 by the then Minister of State in the Foreign Office, Derek Fatchett, and any of your Lordships who wish to see what was exported to China in 2003 can do so by reading pages 100 and 101 of the report published in June 2004.

My Lords, the trouble with the Minister's answers is that the Americans say that they understand very well indeed what the embargo implies and they do not like it at all. They have indicated that there will be further blocks on defence technology transfer to British firms. Furthermore, it has been indicated in Congress that the so-called ITAR waiver on the transfer of technology will be indefinitely blocked if the embargo is lifted. Why are we and the French pushing so hard for that? Are there huge, lucrative weapons contracts with China about which we have not been told?

My Lords, the fact is that the Minister's answer is a truthful description of the current position. It is possible that, understandably, those in the United States, like many others, have understood the word "embargo" to mean an absolute ban. I am sure that, as a result of my right honourable friend's discussions with his counterparts in the United States, that is now much clearer.

The question of the ITAR waiver must obviously be discussed. However, the noble Lord will know that that has been a matter of difficulty between the United Kingdom and the United States for a very long time. I think it is right that the United Kingdom pursues a foreign policy which it believes to be right, and the noble Lord would be the first to criticise the Government if he believed that we followed a policy only because we thought that that was what the United States wanted us to do.

Defence Projects: Funding

3.1 p.m.

asked Her Majesty's Government:

Whether they have delayed funding of the next stage in the projects to acquire Watchkeeper, new air-to-air refuelling capabilities, the carriers and the future rapid effects system; and if so, for what reasons.

My Lords, all these programmes are progressing well towards their respective main investment decision points, or main gates, as they are known. Under Smart acquisition, we are determined to spend the right amount of time and money ahead of main gate to gain a better understanding of the risks involved. As part of our normal annual planning process, we review all equipment projects. The current planning round is still under way. Final decisions on the 2005 equipment plan have not yet been taken.

My Lords, why has a major contract not been signed for any of these vital projects? Why has there been further delay? Has the MOD run out of money to pay for them, and when will a decision be made on the physical integrator for the carriers?

My Lords, I reassure the noble Lord that we have not run out of money. But we refuse to take decisions too early—something that has happened often in the past under governments of all parties. We rush to production for some of these major projects and find that we have not even begun to take out the risks. Then we meet them in the production phase, find that we are spending far too much money on them and the delays are intense. Therefore, in spite of the pressures to move to major investment decisions, we are determined to wait until we are ready.

My Lords, will the Minister consider delaying one aspect of funding associated with the carrier project? Do the Government have the ability to hold back some of the £2 billion promised towards the Joint Strike Fighter development until we receive assurances from the American Government over technology transfer, which we talked about in the previous Question?

My Lords, of course we are not spending all that money at this particular moment; we are spending it during the project phase of the Joint Strike Fighter. It is important to remind the noble Lord that, although there are great difficulties in getting technology transfer of any kind from the Americans—indeed, that was mentioned during the previous Question—the fact is that, so far, we have the technology transfer that we need for the Joint Strike Fighter. The real test will come in the next 18 months or so when we see whether we get the technology transfer that we need to support our own Joint Strike Fighter.

Before we are too critical about the Americans, I hope that the House noticed the outstanding contract that Augusta Westland won over the weekend to supply, along with American partners, the VXS—the presidential helicopter for the future. It was a great win for Britain.

My Lords, can the Minister tell the House whether major reports that British Aerospace may withdraw from the carrier programme should be taken seriously?

My Lords, there is always speculation on major projects of this kind, such as the CVF—the aircraft carrier—and I am not going to comment on speculation, whether it has appeared in the press or elsewhere. We are in discussions with BAe Systems, as we are with other companies involved in this major project.

My Lords, will my noble friend indicate whether the Ministry of Defence is spending more time and money on the assessment phase of procurement programmes, so attenuating the risk of project management?

My Lords, as I said to the noble Lord, Lord Astor, a minute ago, one of the justified criticisms in this whole field over many years is that we sign up to production too soon. I cannot repeat often enough that the result is that, at a later stage, problems arise. If those problems were dealt with earlier, we would not have the delay and cost increases to which defence procurement has been prey for 40 or 50 years. The principles of Smart acquisition call for spending more money and more time earlier, if necessary, to drive out risk before production begins. That is easier to say than to do because there are all kinds of pressures on us to get the contract signed, whether they be from industry, the media or others. We must resist those pressures.

My Lords, following the Minister's congratulations to Augusta Westland on its great achievement, does he recognise that it bears out that early authorisation must be given for projects of this kind? Perhaps I may say—not in false modesty, I hope—that I placed the order for the Merlin helicopter in 1991. It has now become the plane that has received the supreme accolade of being chosen as the executive aircraft for the President of the United States. But it warns of the tremendous time lag involved in the construction projects for these sophisticated weapons systems.

My Lords, I congratulate the noble Lord on the decision that he took. The helicopter that has arisen from that decision is a world-beater, as the recent result shows. However, I still maintain that, when looking at large procurements, it is important not to rush to production too soon.

My Lords, in view of the slightly unrevealing nature of his answers to my noble friends' questions, can the Minister give us an assurance that the in-service or commission date for the first of the two carriers is still 2012?

My Lords, the in-service date for any project is not decided upon until the main investment decision—main gate—is reached, for very good reason. It is then that you look at the whole project, see where you are with it and what the trade-offs have been and then decide on a date. The year 2012 is still the date that we have in mind for the first aircraft carrier.

Mental Capacity Bill 37 Pm

The Parliamentary Under-Secretary of State, Department for Constitutional Affairs
(Baroness Ashton of Upholland)

My Lords, I beg to move that the House do now again resolve itself into Committee on this Bill. Moved, That the House do now again resolve itself into Committee.—(Baroness Ashton of Upholland.)

On Question, Motion agreed to.

House in Committee accordingly.

[The CHAIRMAN OF COMMITTEES (Lord Brabazon of Tara) in the Chair.]

Clause 26 [Effect of advance decisions]:

moved Amendment No. 90:

Page 15, line 33, at end insert—
"( ) Where a person reasonably believes that an advance decision exists which is valid and applicable to the treatment, he does not incur liability for failing to implement the decision if and only if—
  • (a) to implement the decision would contravene a conscientious, ethical or religious belief which he holds, and
  • (b) he directs another person to take over responsibility for P's treatment."
  • The noble Earl said: We now come to an issue which has been mentioned to me by more than one member of the medical profession. This amendment, which is, I hope, very simple and self-explanatory, sets out that concern. I hope that the Minister will be sympathetic to it.

    Advance decisions will sometimes present doctors with a very difficult situation because implementing the decision would involve going completely against what they see as clinically necessary for the patient's welfare and best interests. Yet, if the decision is legally binding by being both valid and applicable in accordance with the Bill, there will be nothing that they can do about it.

    We need to give the medical profession the legal certainty in the Bill that, where a doctor in charge of a mentally incapacitated patient has a real ethical or conscientious objection to implementing that person's advance decision, he does not have to do so. A subsection of this kind would parallel other conscience clauses in legislation, such as the Abortion Act. However, of course, there has to be a proviso. A doctor cannot simply walk away from his patient. If he decides that he needs to trigger the conscience clause, he must ensure that he passes responsibility for the patient, in a formal way, to another suitable medical practitioner. I beg to move.

    I support the spirit which lies behind the amendment moved by the noble Earl. My only concern is the way in which it is phrased and whether it takes into account sufficiently the criticisms that have been made by the Joint Committee on Human Rights, which has looked at how conscience clauses work generally. It says in regard to this approach that it does not allow the doctor who does not want to be involved to walk away completely from the situation; he has to refer it on to someone who would be willing to do the things to which he takes ethical objection.

    We have to examine that question again in the context of the Abortion Act 1967, to which the noble Earl referred. The experience of that legislation is that it has placed an unhappy responsibility on practitioners who feel uneasy about what they are being asked to do and who do not therefore like to be asked to commission someone else to do what they would rather not do themselves. So I support the spirit of the amendment. I hope that we will incorporate a conscience clause into the Bill. It is an issue that I have raised with the Minister during our meetings; it is an issue that I raised at Second Reading. But we perhaps need to think a little further about the detail.

    I too support the spirit of the amendment. The rights to safeguard conscience are very much part of the culture of our country and are enshrined in law in a number of ways. Therefore, this provision would be nothing that is unusual or untoward. As has already been made clear, patients are not going to suffer as result of it because alternative provision has to be made. So it is eminently sensible and right to support at least the spirit of the amendment, even if the wording needs to be altered in some way.

    A small point. Members of the Committee have spoken largely about doctors, but the amendment does not mention them. The word "person" is so potentially broad that it needs to be adjusted to the kinds of things that I think were intended.

    3.15 p.m.

    I fully support the principle that I know lies behind the amendment. As I discussed with the noble Lord, Lord Alton, doctors are entitled to have their personal beliefs respected and should not be pressurised to act in a way that is contrary to those beliefs. We recognise that doctors and other health professionals may disagree in principle with a patient's right to refuse life-sustaining treatment or may have moral objections to withholding or withdrawing life-prolonging treatment in some circumstances.

    It is for that reason that the Bill does not change the current position on the issue of conscience. Doctors and other healthcare professionals can choose to relinquish the management of a patient's care if they have a conscientious objection to their refusal of consent to treatment. However, they have a duty—I make no apology for it—to ensure that arrangements are made for another doctor to take over their role, so that the care of the patient does not suffer. I refer noble Lords to the President of the Family Division in the case of Re B(Consent to Treatment: Capacity) [2002]. The case involved a patient with capacity who refused the continuation of artificial ventilation. The president said at paragraph 100:
    "If … the doctors are for any reason unable to carry out the wishes of the patient, their duty is to find other doctors who will do so".
    That is the position now, and it will remain the position under the Bill. Although the noble Lord, Lord Alton, may wish for something else, I am not sure that, if a patient has made a decision about himself—let us assume that he is with capacity—and a doctor feels unable for reasons of conscience or religious belief to participate, if I may put it like that, with the patient, it is for the doctor then to impose his view on the patient. The patient, after all, is an autonomous person.

    Although I understand the dilemmas in that situation, we have been very clear. Indeed, the British Medical Association and the General Medical Council have issued guidance to health professionals on the issue. Both bodies clearly state that if a doctor or health professional cannot, for reasons of conscience, accede to a clear, valid and applicable advance decision, he should make his views known to the patient at the outset, allowing him the opportunity of having his care and treatment transferred. If the person lacks capacity, the management of the case should be transferred to another suitably qualified health professional without delay, so that the patient's care does not suffer.

    We have reaffirmed the guidance of the BMA and the GMC in the draft code at paragraph 8.43. 1 say to the noble Lord, Lord Alton, that I understand the issues that lie at the heart of what the noble Earl seeks to achieve, but it is important to remember the raft of safeguards around advance decisions to make sure that a doctor is absolutely clear about when a decision is valid and applicable. Those now include the additional safeguards in the amendments tabled for Committee, so that an advance decision will have no application to any treatment which the doctor considers necessary to sustain life unless strict formalities have been complied with. I know that the noble Lord, Lord Alton, welcomes those safeguards. As I have said, there must in addition be an express statement that the decision stands, even if life is at risk.

    We have made sure also, in Clause 26, that, in any cases of doubt, the balance is tipped very firmly towards the preservation of life. That is one of many reasons why the Bill is so important. If a doctor or other healthcare professional is not satisfied that a valid and applicable advance decision exists—if he has any doubt at all—he can treat the patient without fear of liability.

    So the conscience clause already exists in what the BMA and GMC do. We have reaffirmed it in the code of practice. It has stood the test of time to enable doctors, understandably and rightly, to exercise their conscience and their religious beliefs appropriately while making sure that the patient is cared for. I am grateful to the noble Earl for raising the issue, but it is already covered in the existing rules. On that basis, I hope that the noble Earl will withdraw his amendment.

    The difficulty is that we need to be very clear. If a doctor, in conscience, feels that he cannot carry out a certain operation or technique on a patient, of course the patient must be allowed to get his treatment elsewhere. I think there would be no disagreement about that in the mind of any of us.

    The difficulty I had when I first read the amendment was that I thought that the doctor who had a conscience about carrying out that procedure was therefore duty bound to refer the patient to another doctor who, he knew, would carry out the procedure. My mind goes back to the examples that arose when we discussed the Abortion Bill. The conscience issue was huge there, and it has grown bigger, in a way, over the years, because so many doctors have been sacked and so many nurses have lost their job because they could not, according to their conscience, have a part in it. Everyone understands that, but for them then to be told that they must find a doctor or a nurse who would carry out that procedure is where the difficulty arises. If someone else is making that decision, fine: if the doctor is forced to make it, it puts him in a very difficult position.

    The noble Baroness would not expect me to comment on the assertion that people have been sacked. That is a matter that I will pass on to my noble friend Lord Warner. The noble Baroness makes an important point, which goes back to what the noble Lord, Lord Alton, also said.

    In reality, the position in the medical profession is that a doctor who has strong views and beliefs would make those known in any event to the management of the NHS trust, and procedures would follow that would enable somebody to be found for the patient without, as the noble Baroness, Lady Knight, said, the onus being on somebody to go against his conscience, which is, I think, the point that both noble Lords were making.

    I will talk to my officials and check how the GMC/ BMA guidance works. I do not think that either noble Lord is saying to me—I would not agree with them—that the patient has to accept what that particular doctor says, because he has made a decision none the less, rightly or wrongly in the view of doctors. Noble Lords are asking that we are clear that doctors who believe strongly should not be asked to seek out a colleague who would do something contrary, but rather that the process of management in the NHS trust should come into play. If that is what noble Lords are searching for, I am happy to make sure that it is the case.

    It seems to me that there is a great deal of point in this amendment, which places this proviso on the face of the Bill. Although I fully understand what the Minister said about the present situation, it is sometimes difficult to implement a change of care of the patient at the last minute unless it is absolutely clear to everybody, and is known to everybody, that this is what is required.

    I have had many letters about this. One of them told the story of a woman who had made a very specific advance directive, which was that if she should contract pneumonia she should not be given antibiotics. She went into a nursing home and became mentally incapable, but she had made the advance decision. The person who ran the nursing home rang her daughter to say that antibiotics were to be started that evening. The nurse in charge had no conscientious objection, although the doctor did. It was very difficult to persuade the nurse, who felt that she had to carry out her instructions. In the end, the woman was not given antibiotics but it was very difficult. Having this proviso on the face of the Bill would make the situation clearer. I therefore support the amendment, or something like it.

    I am grateful for the forbearance of the Committee and will be brief. The Minister has been extremely helpful in what she has said this afternoon. If we can find some way of putting that sentiment in words, as my noble friend suggested, it would go a long way to assist the patient and the doctor. Everyone would benefit.

    As the Minister deliberates further on the spirit of the noble Earl's amendment, I refer her to the decision of the Joint Committee on Human Rights on the conscience clause in the Assisted Dying for the Terminally Ill Bill promoted by the noble Lord, Lord Joffe. The Joint Committee found it to be contrary to the European Convention on Human Rights under Article 9(1). It said:
    "What must be avoided, in our view, is the imposition of any duty on an individual physician with a conscientious objection, requiring him or her to facilitate the actions contemplated by the Act to which they have such an objection".
    If that point could be incorporated with what the noble Earl is seeking, I think we could probably find consensus on this.

    I shall chip in briefly. Beauchamp and, more recently. Raanan Gillon—who I think published in the British Medical Journal in 1997—have written on the four principles of medical ethics. The first principle is respect for the autonomy of the patient. That is not the only issue here, by any means, but it seems to me that it is already covered in medical practice.

    While the autonomy of the patient in front of me as a doctor is crucial, there is also occasionally the question of my autonomy when there is an issue of conscience. For example, if a patient comes to me and requests a termination of pregnancy and I feel that, in conscience, I should not do it, I still have a duty of care to that patient. I already fulfil that duty by saying that there may be other medical practitioners who will he able to help her. My duty does not end with my refusal. That is already accepted in medical practice and I doubt whether an extra amendment is needed to enforce that principle.

    I am very grateful to all noble Lords who have contributed to this short debate and to the Minister for her reply. I found it encouraging as the inclusion of a suitable provision in the code of practice is a very important building block in the wall. I say to the noble Lord, Lord Christopher, that the word "person" appears in the amendment because I had in mind a case not unlike that mentioned by the noble Baroness, Lady Warnock, where it was a nurse who had a specific conscientious objection. It is not always a doctor in these situations.

    As I mentioned, I also had in mind the Abortion Act, which has a provision more or less along these lines within the statute. Therefore, I felt that it was not inappropriate to have a similar provision in this context. The Minister may be able to contradict me, but it seems to me that there is a difference between what we are looking at here and the Abortion Act.

    What we are looking at here is potentially a legally binding advance decision on the part of the patient. One might find that a doctor did not feel able to conform to that decision on conscience grounds. If he then elected to opt out using the conscience clause, he should have the certainty that he is not legally liable. That is a different situation from the Abortion Act where there is no question of a legally binding decision, merely a clinical decision that the doctor does not feel able to go along with. But there is a question of legal liability here. I would be very grateful if the Minister could look into that point.

    I shall reflect on all the points made, particularly the points made by the noble Lord, Lord Alton, and the noble Lord, Lord Winston, because I understand their concerns. No doubt this is a matter that we shall revisit at a later stage of the Bill.

    Before the noble Earl sits down, I shall ask a very simple question. I agree with him and I have listened to this debate and have had masses of correspondence. Although I agree that one must not confuse this situation with the abortion situation, does my noble friend agree that it is extremely difficult to draft an appropriate control of a conscience clause?

    I have no difficulty in agreeing with my noble friend. If he is saying to me that my amendment is far from perfect, I would be the first to agree with him. I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [Amendment No. 91 not moved.]

    Clause 26 agreed to.

    moved Amendment No. 92:

    After Clause 26, insert the following new clause—


    Notwithstanding sections 24 to 26, it is unlawful for a person responsible for the care or treatment of P at any time to withhold water or food or other sustenance, however administered, from P.
    The noble Baroness said: Those noble Lords who recall my attempts to bring in a Patients Protection Bill will not be surprised to see this amendment in the Marshalled List. The practice of failing to feed sick people in hospitals or deliberately placing food out of their reach has been well documented. There have been reports and articles in the press and there have been two television programmes showing it going on. Grieving relatives have very frequently spoken to me and to others about it. There is widespread condemnation of such acts and when I introduced my Bill I received support for it from every part of the House.

    At that time, the Government prevented my Bill becoming law, but they gave me assurances that the matter would be put right in the Bill that is now before us. I think that that was the firm intention of the noble Lord, Lord Filkin, when he spoke to me about it and I think it is the intention of the noble Baroness, Lady Ashton, whose kind and thoughtful words to me at the end of Thursday's debate I much appreciated.

    Indeed, the Government have stressed that the general purpose of the Bill is to give protection to sick and helpless people, not just to their carers. But having read the Bill over and over, I cannot rid myself of the unhappy conclusion that patients in hospital will still die from deliberate starvation and/or from lack of liquids. The amendments we have had do not forbid the withholding of food and fluids, only that when they are withheld doctors must not intend to kill the patient. But what else are they going to do? There is not a human being in all the world who can continue to live without food and fluid. It is a bit like saying that you can hold a pillow over someone's mouth and nose, or hold someone's head under water or push a person off a tall building, provided you do not mean to kill him or her. But what else are you going to do?

    In those three examples, I suppose you could say in the first that you merely meant to show him the difference between duck and goose feather filling; in the second that you were trying to disentangle his feet from the weeds and that is why you were holding his head under water; or, if you pushed a person off a building, you might say, "Well, they told me they could fly, so I was only trying to help". Surely, no one on the hospital staff would ever admit—would they?—that he or she was deliberately trying to kill somebody by withholding food and fluids? I do not understand how that could be.

    I would feel much happier if the provision was not just left to the words in the Bill, but that the amendment at least added something to the effect of, "if the alternative to withholding sustenance were also to he life-threatening and a choice had to be made between these two alternatives as to which would give the patient a better chance of life". Such words would certainly ease my mind; but they are not there.

    Anyone deprived of liquid will die within one to two weeks. There is no doubt about that and I do not think that there will be any argument from any side of the Committee. It is true that over-hydration would be dangerous to people with, say, lung congestion due to heart problems, and I know that there can be technical difficulties with an intravenous or a subcutaneous drip. But I have been told on very high authority indeed that hydration can always be supplied by one means or another, and that only in extremely rare cases is the placing of a peg not feasible.

    Surely the clinical and ethical rule must be to supply hydration to patients and surely patients should always be made as comfortable as possible. The Bill does not even say that, nor do the amendments enforce it. There have been cases of patients suffering agonies. One lady told me of her mother begging for some moistening of her mouth. When she saw her mother's mouth her teeth were stuck to the inside of the gum because her mouth was so dry. That poor woman had suffered grievously.

    In another case a man was denied liquid. After he died his tongue was found rolled right back down his throat through lack of simple moisturising. Things like that surely should never be allowed.

    Death by starvation, as distinct from death from lack of fluid, I understand takes weeks or months and involves acute discomfort. We all know that medical staff have, quite intentionally, caused that suffering to patients. They must answer why they have done so. My problem is that I cannot see that either the Bill or the amendments to it will end the practice.

    It is important to recall that the practice came into being through a relatively recent decision of the medical profession that giving the patient food and liquid should henceforward be classed as "medical treatment". Though no law has ever been passed permitting them to stop feeding patients, doctors are of course allowed to stop giving medical treatment.

    When Members of the Committee go out to dinner, do they class that as receiving medical attention? Does a mother give her baby medical attention when she feeds it? Does our excellent Refreshment Department in your Lordships' House dispense medical treatment at the Long Table, in the Barry Room or in the Bishops' Bar?

    This cruel recategorisation came about when a majority decision of the Law Lords—it was only three out of five; not many Law Lords decided the matter—in the Bland case decided that this young man, who had been in a coma for four years and kept alive only because he was being fed artificially through a tube, should have his tube withdrawn. I am not in anyway speaking against that decision. I merely say to your Lordships that the situation we now have came about because of the decision in that case that it would be lawful to withdraw the tube. But it was made perfectly clear by one of those Law Lords that the judgment in that case should not be taken as a go ahead for all patients in a coma to have their feeding tubes turned off or pulled out. It was an individual decision for an individual case—nothing more.

    Those Law Lords never meant to hand down a judgment that henceforward sick people in hospital should be denied food and liquid; yet that is what has happened. Giving food and liquid is classed as "medical treatment", and—I repeat—it is quite legal for doctors to stop medical treatment. The government amendments do not alter that; my amendment does. If we want to stop what has been going on and to end one way in which patients have suffered grievously, we must surely accept this amendment.

    What if, as in the Bland case, sustenance can be given only through tube or peg—and one can certainly understand why that might be classed as a medical treatment—and the patient does not want that? He would of course have the right to say that he does not want it. Then the doctors could stop or, I hope, would have to explain to the patient what such a withdrawal would mean. If the patient could not speak but, with body language, flinching, crying or pulling out the tube or peg, indicated that he did not want that to go on, surely a decision would have to be made with staff, family, carers or others involved. But that is not what has been happening.

    I listed one case involving a Member of the other place. He found out what had been happening by accident. After visiting his wife for about three days he asked when she was being fed. They said: "Oh, we are not feeding her". He had no idea. He was not consulted at all. These are the things that led to my Bill and to my considerable concern about the matter.

    I agree completely with that rhyme about euthanasia:
    "Thou shalt not kill, but need'st not strive Officiously to keep alive".
    But nothing in my amendment would force a patient to undergo distressing or painful procedures against his will. 1 seek only to stop the present post-Bland situation where untold numbers have died in acute pain and discomfort because, quite wrongly, administering the essential for life has been classed as medical treatment instead of what it really is: the means for life itself.

    I must remind the Committee that the present situation is warmly supported by those who lobby for euthanasia to become legal. In 1984 a leader of that particular lobby said:
    "If we can get people to accept that the removal of food and fluid is a painful way to die, they will accept that it is in the patient's interest to allow lethal injection".

    What a cruel statement that is. There are thousands of people outside this House who pray for this new clause to become law. In seeking to insert it in the Bill, I seek to end this wicked and inhumane practice which has gone on for far too long.

    While I am on my feet, I should mention Amendment No. 198, which is also mine. I was concerned about that amendment, because it seems to provide exactly what I do not want and was the subject of considerable discussion between me and our helpful experts upstairs. I shall not move it, but it does flag up how the Bill has become extremely complicated and difficult to understand. In no way would I want a patient to be denied food and liquid just because it was coming to him through a tube or a peg. With those few words, I beg to move Amendment No. 92.

    When the noble Baroness, Lady Knight, introduced her Patients' Protection Bill to your Lordships' House, I strongly supported what she sought to do. She has rendered the Committee a service today by tabling Amendment No. 92 for our consideration. I certainly support the spirit of her remarks. My amendments, Amendments Nos. 98 and 199, are grouped. Although they do not depart from the spirit of what the noble Baroness said, they do depart from the detail, specifically on the issue of burdensome treatment. I was reassured, as I am sure the Committee was, to hear the noble Baroness state categorically at the end of her remarks that she does not believe that burdensome treatment should be a proper part of medical practice. I entirely agree.

    I draw the Committee's attention first, to Amendment No. 98, which is supported by my noble friends Lady Finlay of Llandaff, who sends her apologies to the Committee—I think that many Members know that she is overseas with the Select Committee considering the Patient (Assisted Dying) Bill in Switzerland at present, but she still wants to be associated with the spirit behind the amendment—and Lady Masham.

    Amendment No. 98 defines basic care as,
    "the relief of pain, suffering and discomfort … cleanliness".
    and, perhaps most importantly in paragraph (c),
    "the provision of nutrition and hydration, however, provided save where that provision would harm the person".
    Last week, we heard from Rob George when he came to give evidence to the pre-Committee hearing kindly organised by the noble Baroness, that there could be times when the artificial administration of food and fluid could hurt a patient—obviously, one would want to exclude that—or otherwise be unduly burdensome, the point made by the noble Baroness.

    In Amendment No. 199—which is in my name and those of the noble Lord, Lord Brennan, who, like my noble friend Lady Finlay, is overseas, but in his case on a humanitarian mission to Sri Lanka, and my noble friend Lady Masham—we have tried to exclude basic care,
    "which term shall include … the relief of pain, suffering and discomfort … cleanliness",
    "the provision of nutrition and hydration, however provided".
    as a medical treatment. In other words, we would revert to the standard practice that that is not medical treatment but basic care. It is an interesting question for those with a love of language to ask: since when was the giving of food and fluid regarded as a medical treatment rather than basic care? I do not know who changed the nomenclature, but it was obviously changed at some point along the line.

    My amendments would define basic care as delivering nutrition and hydration, however delivered, and remove from the Bill's definition of life-sustaining treatment the giving of food and fluid. The difference between my amendment and that of the noble Baroness is that it makes clear, although it was implicit in what she said, that delivering all food and fluid should not commence or be continued where it would harm the patient or become burdensome.

    As we have heard, widespread concern has been expressed that incapacitated individuals might inappropriately be denied basic care—in particular, nutrition and hydration—as a result of advance decisions or the decisions of attorneys. Amendment No. 98 addresses that concern. It would ensure that basic care, which includes pain relief and nutrition and hydration, however provided, is not withdrawn inappropriately. The provision of food and fluid by artificial means is not medical treatment; it is basic care. Many people with cystic fibrosis, for instance, are fed by gastric tube but live an otherwise normal life. Others with paralysis of the throat and swallowing mechanism feed via nasal tubes.

    3.45 p.m.

    My amendment would not make unlawful the withholding or withdrawal of food and fluids delivered by artificial means from a patient who is in the process of dying and where the placement of feeding tubes would be regarded as unduly intrusive and inappropriate, or where the risk of placement of feeding tubes would be excessive.

    In the Leslie Burke case, the High Court declared that it was hard to envisage any circumstances in which withdrawal of assisted nutrition and hydration (ANH) from a sentient patient, whether competent or incompetent, would be compatible with the European Convention on Human Rights. Richard Gordon QC has produced an opinion on the Bill. In paragraph 40 of his opinion, he refers to the Burke judgment and then argues in paragraph 41:
    "where it is proposed to withhold or withdraw life prolonging artificial nutrition and hydration prior judicial authorization must be obtained in most circumstances. The requirement that the Court be involved in such issues stems from the common law but it is enhanced by the Human Rights Act 1998 and the right to respect for private and family life under Article 8(1)".
    The judge in the Burke case also referred to the suffering of patients caused by dehydration and starvation. The Bill reflects current professional guidance on the withdrawal or withholding of treatment. As that has now been declared unlawful, the Bill clearly now requires amendment. This is what my amendments and those of the noble Baroness are intended to provide.

    In his evidence to the High Court in the Leslie Burke case, Dr David Westaby, consultant physician and gastroenterologist and head of gastroenterology at Chelsea and Westminster Hospital said:
    "ANH (artificial nutrition and hydration) should remain an area for active therapeutic decision making, based upon the best medical information available to the attending clinicians. I would emphasise that the instigation or maintenance of ANH is not a neutral decision but one that requires detailed assessment of the potential benefits and risks associated".
    Dr Westaby's cautious approach appears to conflict with that of the Bill. With ANH defined as 'treatment' for the purposes of the Bill, it can be withheld or withdrawn following an advance decision or a decision by an attorney. If doctors have a legal duty to comply with valid and applicable advance decisions and LPAs, what scope do they have to conduct,
    "a detailed assessment of the potential benefits and risks associated"—
    to use Dr Westaby's words—with ANH?

    The Bill does not provide for judicial scrutiny of decisions to withdraw ANH, and can therefore be said to be in breach of Article 8. In paragraph 21 of his opinion, Richard Gordon argues that the profound implications of Burke necessitate amendment of the Bill and cannot be left to the code of practice.

    The Joint Committee on Human Rights appears to be aware of the Bill's deficiency in relation to ANH. In its 23rd report of Session 2003–04, it stated at paragraph 2.51:
    "in relation to the withdrawal of ANH, the presumption in favour of life-sustaining treatment is not sufficiently strong in the Bill to satisfy the requirements of Articles 2, 3 and 8 as explained by the High Court in Burke".
    In its most recent report, the 4th report of Session 2004–05, the Joint Committee urged the Government to amend the Bill to make it clear that if ANH is to be withdrawn or withheld, the document making that refusal or conferring the authority to make that refusal, whether an advance decision or lasting power of attorney, must make it clear that it applies to the refusal of ANH. Otherwise, ANH should continue to be provided, the committee states. The Joint Committee considers that reference to "life-sustaining treatment" is too vague and that people may not appreciate that a decision to refuse life-sustaining treatment would mean that they would be deprived of nutrition and hydration.

    The denial of nutrition and hydration to non-dying patients gets to the nub of the argument about whether the Bill may become a vehicle for some form of euthanasia by omission. It is worth citing a letter that Keith Andrews, then director of medical services at the Royal Hospital for Neurodisability in London, wrote to the BMJ. He wrote:
    "It is ironic that the only reason that tube feeding 'gas been identified as 'treatment' has been so that it can he withdrawn. Much of the debate has concentrated on the argument that tube feeding is futile treatment. I would argue that tube feeding is extremely effective since it achieves all the things we intend it to do. What is really being argued is whether the patient's life is futile—hence the need to find some way of ending that life. Once this decision is made then whatever means we use to end that life must have the definite intention of doing so—that is, euthanasia".

    We do not seek in these amendments to overturn the Bland judgment, however concerned many of us were about that judgment and however many misgivings we have about it. I think that the Minister accepts and understands that. However, we say clearly in subsection (1) that it relates only to the working of this Act—in terms of the scope of this Act, it would be effective. It is a reasoned and reasonable attempt to address an issue that perturbs and frightens many people. I commend it to the Committee.

    When the noble Baroness, Lady Knight, brought her Patients' Protection Bill before the House, I took her concerns very seriously and wrote to a number of medical organisations to see whether they had any evidence to support the kind of examples that she put before us. I have to say that, so far, they have not come back to me with any real evidence that supports some of the horrific stories that the noble Baroness recounted at that time. I find it difficult, therefore, to support the amendments in the noble Baroness's name, particularly because of the phrase "however administered", which seems to cut out any medical procedure that would legitimately withdraw artificial nutrition and hydration.

    Of course there are degrees of discomfort or invasion in the way that water and other liquids are administered. Although I accept that not all administration of food and liquid artificially is invasive or burdensome, anybody who has read the Bland judgment and the description of the way in which Tony Bland received artificial hydration and nutrition cannot avoid the fact that it was a highly invasive, burdensome medical treatment.

    I am afraid that I cannot support the noble Baroness's amendments but I am very sympathetic to those in the name of the noble Lord, Lord Alton, and others. Amendment No. 98 includes the proper qualification:
    "however provided, save where that provision would harm the person or otherwise be unduly burdensome to him".
    I think that Members of the Committee are all agreed that that kind of phrase encapsulates the long tradition of both Catholic and Anglican moral theology on the subject and best medical treatment: there is no obligation to continue treatment if it is burdensome, invasive and futile. It is perfectly proper morally, medically and in every other way to withdraw nutrition and hydration if it falls into that category.

    I do not know whether that amendment is really necessary, because it seems that its contents are totally congruous with the whole spirit of the Bill. Nevertheless, I was very concerned by what the noble Lord, Lord Alton, said about the reaction of the Joint Committee on Human Rights to that. I am very grateful to him for bringing it before the House. I shall listen with great interest to the Minister's response to the Joint Committee's criticism.

    In Amendment No. 92 the noble Baroness, Lady Knight, expresses a not unreasonable anxiety that patients lacking capacity would be denied food and water regardless of whether they had made an advance directive and whether it would be of benefit to them. But the Bill seems riddled with safeguards to ensure that the idea of denial of sustenance to all and sundry could not be realised. The whole of Clause 4 describes best interests, and Clauses 5 and 6 set out how care should be provided.

    The provision is applicable only in the case of patients lacking capacity who have made an advance directive that can stand up to proper scrutiny, in which they have expressly indicated that they do not want to have fluid and nutrients forced upon them through a gastric tube through their nose, a gastrostomy tube through their abdominal wall or even an intravenous fluid, none of which is absolutely free of complications. Even here the medical attendant who feels that some benefit could be derived from providing fluid and nutrients, can give it. But if patients gain no benefit, putting tubes into them against their express wishes could well be regarded as common assault in a person who had capacity, and we should not deny that right to people who lack capacity.

    There is one area in which I agree wholeheartedly with the noble Baroness: relief of suffering is the absolute bedrock of good medical care. The denial of fluid and nutrients by mouth in the horrific stories that she described is bad practice; indeed, the Bill goes some way to trying to prevent some of that bad practice.

    The other amendment in this group suggests that food and water should be given unless it is harmful or unduly burdensome to the patient. That goes some way to meeting my concerns, but I am not entirely convinced that it is necessary to state it in the Bill. There are two or three situations in which that consideration might be relevant. For patients for whom food and water are beneficial—the vast majority of patients—it is clearly wrong, and likely to be a criminal offence, not to give it. Then there are patients for whom, perhaps because of nausea, vomiting or difficulty in swallowing, giving nutrients by mouth could cause harm and be unduly burdensome. It is important to be able to give those patients nutrition by other routes such as a gastrostomy tube. Indeed, it may well be essential to do that, even though there are complications in some patients.

    On the other hand, there are patients who have given a firm, advance directive that they do not want artificial nutrition should they be in a particular state and lack capacity to refuse it at the time. Why should we deny patients who lack capacity the facility to refuse artificial nutrition in an advance directive, when we cannot refuse a person who has capacity? For that reason, I do not find this particular amendment entirely attractive; it is covered elsewhere in the Bill.

    My name is attached to all the amendments because the noble Baroness, Lady Knight of Collingtree, has her heart and spirit in the right place, as does my noble friend Lord Alton. The point of Committee stage is to tease out what is right. Some provision is needed in the Bill because there is much concern on the part of vulnerable people throughout the country that they may be starved when they go into hospital. Even though there may be safeguards in the Bill, they are not firm enough for those people, who are very fearful.

    My husband, when he had a serious operation, was fed by a tube through the vein in his neck for three weeks in intensive care; it saved his life. So tube-feeding is very important but it should not be done against anyone's wishes. However, we live in a very complex time: hospital food no longer comes under the domain of a nurse but under that of a housekeeping department. Those giving out food may be trained as housekeepers but are not nurses. Due care must be taken because food and fluid save lives.

    It is very important to give good basic care, including mouth care, to people who have a problem eating and swallowing, as their mouths get gooed up and need to be cleaned three or four times a day. Nurses need that basic training. Sometimes their training is all academic and not about the actual basic care. We need to get back to TLC. I am sure that most Members of the Committee know that the phrase TLC refers to tender loving care.

    4 p.m.

    There are many people looking to the House of Lords for safeguards, particularly as regards patients and the provision of food and fluid. Not to have fluid or food if you want it can result in a horrible death. I hope that the Minister, who is very helpful and caring, will do something to help everyone in this matter.

    Because food is given out by the housekeeping department, that does not in any way absolve the nursing on the ward from responsibility for the care of the patient. In speaking to the four amendments, as a central moral principle, I have—just like the people who have tabled the amendments—the notion of the fundamental sanctity of human life, which is the central pillar of all our morality.

    I am also aware of the British Geriatrics Society and its 1,400 members who very largely oppose euthanasia and totally oppose the notion of assisted dying, as I do. But I do not believe that these amendments are helpful. The truth is that illness at this stage is too diverse and too complex to be decided in this way: it has to be left to the individual circumstance.

    I do not want to dwell personally too much, but four weeks ago my mother, aged 92, was admitted to hospital with severe diabetes and cellulitis of the leg, which can easily kill a diabetic. That needed massive antibiotic therapy; namely, four grams of flucloxacillin and four grams of ampicillyn every six hours. When that was not tolerated by mouth, the question was whether it could be given by intramuscular injection. Clearly, that would be totally unacceptable and an extremely torturous thing to do.

    When my mother was conscious and able to refuse, she refused to have an intravenous line put up. Sometimes, of course, she was just unconscious and not able to refuse. But putting a line up was excessively difficult. I watched her nursing with great concern. Throughout the two weeks that my mother was in hospital, a close member of my family sat with her throughout the day until 11 p.m. So I saw exactly the nursing in that ward, not only with my mother but also with other people who were often in extremis.

    On one occasion, I was so distressed by the attempts of the quite senior registrar to put up an intravenous line that I said, "Hold on a bit. I am surgically qualified. Would you like me to have a go?". It is not easy to put up an intravenous line on one's mother. I got it into the vein, but it immediately clogged up. At that point, one has to make an individual decision. Basically, one asks oneself, "Do I go on accepting that my mother will be tortured by repeated attempts at veinipuncture or do I accept that her autonomy in this situation is really rather important?".

    I came to the conclusion that if my mother was to die in that situation, her dignity should be respected. To continue to offer her that treatment, which probably would not help anyway, was unacceptable. It was an individual decision made by me as a relative, as geriatricians frequently have to do in consultation with relatives.

    I do not understand this, but, remarkably, someone intervened. In spite of my mother not having that massive antibiotic therapy, after 48 hours the cellulitis resolved. She had no treatment, nor was she properly drinking or properly hydrated most of the time. She could not tolerate fluids because she was vomiting everything. But her leg started to get better and two weeks after her admission she was discharged from hospital. She has been at home for the past four weeks.

    There comes a point when we should accept amendments to a Bill, which already covers those issues. This Bill strengthens practice; it does not diminish it. I doubt whether these amendments would allow for the individual circumstances of patients under proper medical care where there is not a dereliction of duty of medical practice, as my noble friend Lord Turnberg has mentioned.

    I have to apologise to Members of the Committee. I would like to hear the response to the amendment from my noble friend the Minister. But, during Question Time, I heard that, four weeks after my mother's discharge, she has been admitted to hospital in coma again. I intend to leave Westminster as soon as I can. I shall sit for another half an hour, because I think that she is still being triaged in casualty. But I doubt whether I shall be able to stay until the end of these amendments.

    Before the noble Lord sits down, the whole Chamber will have been very moved by what the noble Lord has just said. I think that he will understand and agree that no Members of the Committee have been arguing for any kind of burdensome treatment. Indeed, I think that we all would have acted in the humane way in which the noble Lord has acted.

    Has the noble Lord, Lord Winston, had a chance to reflect on what the Joint Committee on Human Rights has said about the inadequacy of the Bill, post-Burke, and whether we should therefore be incorporating something along the lines of these amendments in the Bill to do precisely what he has just been arguing?

    I am sure that the Minister will take a look at the human rights legislation, if she has not already done that. I have no doubt that she will draw attention to that issue in her summing up.

    This group of amendments covers a very sensitive area. One might say that Amendment No. 92, tabled by the noble Baroness, Lady Knight of Collingtree, represents the "absolutist" position. It contains the phrase,

    "at any time … however administered".
    But there are other amendments that indicate that ANH could be withdrawn if the treatment was unduly burdensome. It may help Members of the Committee if I remind them of the conclusions of the Joint Select Committee, on which, of course, the noble Baroness was a member. We considered this point extremely carefully. Our recommendations were that,
    "the Bill should seek to draw a distinction between basic care (which would include the giving of nutrition and hydration by normal means as well as actions to assist the general hygiene and comfort), and the use of artificial means of nutrition and hydration, such as drips or naso-gastric tubes. We support the view that the former"—
    the basic care—
    "falls outside what is normally considered to be treatment and should always be available to people whereas the latter should be regarded as treatment in that the decision to use such artificial means is a clinical one to be made in accordance with best professional practice, and in the best interests of the patient concerned, and having consulted those specified"—
    in what was then a clause of the draft Bill and what is now a different clause in this Bill. The recommendations continue:
    "We further recommend that the use of such artificial means should be determined by the doctors concerned in consultation where possible with the patient's family, friends or recognised representatives, on the basis of that patient's best interests and having due regard to previously expressed wishes given in any advance decision. If a valid and a clearly expressed wish not to have artificial means of nutrition and hydration is expressed, and the advance decision is otherwise valid, then that wish should be respected".
    That was the recommendation of the Joint Select Committee.

    We have heard a lot about the Bland judgment. Incidentally, I think that, unintentionally, the noble Baroness was wrong and that the five Law Lords were unanimous in their decision. I have looked through the Bland judgment and the noble and learned Lords, Lord Goff of Chieveley, Lord Browne-Wilkinson and Lord Mustill, and Lord Keith of Kinkel and Lord Lowry, were unanimous in their decision.

    I have the Bland judgment here: I have just checked that. I can assure the noble Baroness that they were unanimous that the appeal should be dismissed, which is how they put it.

    There is an important point in the Bland judgement. The noble Lord, Lord Alton, and other Members of the Committee have their names attached to amendments concerning "harm to the person" and "unduly burdensome". This is the problem that I have with it. At the end of the first page of his judgment, Lord Keith of Kinkel states:
    "The undisputed consensus of eminent medical opinion is that there is no prospect whatever that Anthony Bland will ever make any recovery from his present condition, but that there is every likelihood that he will maintain his present state of existence for many years to come, provided that the medical care which he is now receiving is continued".
    Obviously that form of treatment does not cause harm and is clearly not unduly burdensome if it will keep someone alive for years to come. Under that reading, the wish of the noble Lord not to overturn the Bland judgment is not met by the amendments, if one accepts what the Law Lords had to say.

    I am grateful to the noble Lord for raising that point. We have been advised that it does not disturb the Bland judgment. I have also discussed that assurance with the Minister, as I think the noble Lord is aware.

    Perhaps I may briefly reflect on an incident in Liverpool, where I was serving as a Member of Parliament at the time, resulting from the Hillsborough tragedy. On the same day that Tony Bland fell into his coma at the football game, although several of my constituents died, one went into exactly the same kind of coma. Several years later the Guardian printed a story on its front page about my constituent, Andrew Devine, who by then had regained a great deal of his own personal capacity and is still alive to this day.

    That proves the point that this must be dealt with on a case-by-case basis. However, I return to the argument that if Tony Bland could have remained alive for many years in his condition because his treatment was neither harming him nor was it unduly burdensome, I am not sure how that would be dealt with by the amendments before us.

    I have made clear the conclusions of the Joint Select Committee, and I stress again that these are intensely personal decisions. My noble friend Lord Winston has related his experience. Over the past few months I have had a similar one. A close member of my family who received artificial nutrition and hydration for 24 days unfortunately did not live. However, one had to take decisions because she was unconscious. We were in North America and Canada. There fresh forms have to be signed continuously. One had to take decisions on the provision of ANH as well as on other treatments such as dialysis. Such decisions are very difficult and are best dealt with on a case-by-case basis. For that reason I seek a reassurance from my noble friend on the Front Bench that she is quite satisfied that the safeguards in the Bill meet the concerns that have been expressed in this debate.

    I rise to contribute briefly to the debate. I want to return to what was said by my noble friend Lady Masham, for which I have immense sympathy. She is always on the side of the sick patient and the needs of the frail person. Unfortunately, we know that quite a number of elderly people in our hospitals suffer from malnutrition because they are not adequately fed or provided with sufficient hydration. That is bad practice, some of which comes about because such people need a lot of care and attention, which takes up a tremendous amount of time. Professor Ian Philp, who is the leader of the national service framework, is doing a great deal to try to change the position so that good practice becomes the norm. That is an excellent initiative and I wish that it were given the legal force that I think it needs. Best practice must be observed everywhere in this country and it should not be diminished, as is often the case at the moment.

    However, we must recognise that nothing in the Bill would diminish good practice because it is at the forefront of what is being talked about. The "basic care" of a patient includes keeping that patient comfortable with sufficient hydration and nutrition where they can take food. Here we are considering intrusive treatments as opposed to "basic care"—which comprises keeping someone's mouth moist and ensuring that they remain comfortable and reasonably happy.

    I sympathise deeply with what has been said by both the noble Baroness, Lady Knight, and my noble friend Lady Masham. Whenever a patient receives bad treatment we must fight that, but in my view that should not be done through this Bill, which has at its heart the best interests of the patient. This issue is covered by the principles of best practice and would not be addressed by seeking to change the Bill.

    At the risk of making it appear that doctors speak with one voice, which in itself would he an unusual event, I agree with what was said by the noble Lord, Lord Turnberg. The Bill already ensures all that is sought by the amendment. While the Minister needs to clarify that in her response, 1 believe that that is the case.

    I want to make a point about what the Minister noted in the GMC guidance. Doctors recognise that nutrition and hydration are as much a part of treatment as any other medical procedure. That guidance makes doctors take an interest in the importance of adequate nutrition and hydration in the care of patients. It was not, as has been suggested, produced to enable ANH to be withdrawn by defining it as a treatment; that is to misinterpret it.

    4.15 p.m.

    I rise briefly to add one point. I am sorry that the noble Lord, Lord Winston, has had to leave the Chamber. I wish for him the same as I wish for all those who are in his situation: that they may do what is right and causes the least pain to the person they love. As the noble Lord, Lord Carter, has explained most eloquently, I remain convinced that the Bill will enable clinicians, alongside families, to reach decisions. Those will be taken at different points and under different circumstances for every individual patient.

    I want to make one comment about the amendments. As I was throughout our deliberations in the Joint Committee, I am deeply sympathetic to the argument put forward by the noble Baroness, Lady Knight of Collingtree. She put her case to the committee with great conviction, which I salute. However, I acknowledge the point made to me by the noble Baroness, Lady Finlay of Llandaff. These amendments may have an unintended consequence. If someone is at an advanced stage of their disease and is dying at home, the provisions of these amendments would raise a question of whether a clinician would have to remove that person from their home to a place where they could receive the sorts of procedures we have been talking about. However, the person concerned would not wish for that; they would want to die at home, peacefully, with dignity and surrounded by the people they love.

    We may be trying to use legislation, which is a fearfully blunt instrument, to make decisions about situations that can change very fast. Those of us who served on the Joint Committee considered these matters at great length. We sought to construct a legal framework that would include as many safeguards as possible while still allowing room to make what are ultimately clinical decisions.

    Does the noble Baroness want to clarify her remark about the noble Baroness, Lady Finlay? She is actually a signatory to my Amendment No. 98 and is a strong supporter of it. She believes that there is a need to strengthen these provisions, if not in precisely the way sought by some of the other amendments. However, the amendments were all grouped together.

    We have had one of the most important debates on this Bill and I am extremely grateful to all those who have contributed to it. Many noble Lords have testified to the importance of the legislation in its aim to ensure that it protects and empowers individuals who lack capacity, thus enabling the right decisions to be made on their behalf. I shall begin by agreeing with the noble Lord, Lord Alton. in expressing on behalf of the whole House our concern for my noble friend Lord Winston's mum. Under the circumstances, it was amazing that my noble friend remained in his place to raise these issues. It is important for us to hear from him both as an individual and in his professional capacity.

    I also want to make a point which may have already arisen. I am very conscious that we have referred repeatedly to the Bland judgment. It is time to send our wishes to the family of Tony Bland. They have seen his name used as a judgment over the years, but I am sure that no Member of the Committee needs to be reminded of the essential person that was Tony Bland. We should send our good wishes to his family. In no way should we suggest that we have forgotten that Tony Bland was a young man with his whole life ahead of him.

    I want to clarify the context of that judgment. There was a difference of view among the judges. Although nine judges were unanimous on the outcome of Mr Tony Bland's position, they disagreed on the legal analysis. Some Law Lords said that the definition of ANH as medical treatment did not matter. So neither the noble Baroness, Lady Knight of Collingtree, nor my noble friend Lord Carter were wrong in what they said; they merely referred to slightly different elements of the Bland judgment. I shall go through the amendments and endeavour to address some of the concerns raised. I shall do so with a complete recognition that there is much on which we agree; the question is how we get there. The points of disagreement—some of which have already been raised—will become very clear. In essence, noble Lords have raised a clear underlying issue, either from their personal experience or from the experiences of those they know and love, about the quality of care that is offered to people.

    There is absolutely no doubt in my mind that we need to make sure that the care offered to patients is of the highest possible quality. I have felt very strongly about that during the course of listening to your Lordships in this debate, from reading the debates in another place and from discussing the issue with many organisations and individuals. We need to think further about ensuring that high quality care is always provided.

    Let us be absolutely clear that where it is in the best interests of a patient, food and water—however delivered—should never be withheld. I have made it very clear that the best interests test at the core of the Bill is critical. As has already been said, in the vast majority of cases of course it is in the interests of patients to provide them with food and water. We must accept, too, in the analysis of the care that is given and the ways in which we provide succour, that patients who may not be able to eat and drink, but who should have their mouths moistened, should not suffer deprivation of the kind to which the noble Baroness, Lady Knight of Collingtree, referred. We are in absolute agreement: it is absolutely essential that such care is provided. I think that all noble Lords who have spoken in their professional capacities as doctors or experts in other fields would agree with that.

    As with any other medical intervention, if artificial nutrition and hydration is withheld when it is clearly in the best interests of the patient, the clinician could be prosecuted for gross negligence, manslaughter or even murder. The Bill does not change that basic position. Where it is right and proper and in the best interests of the patient that it should be provided, it must be provided.

    The Bill requires all decisions to be made in the best interests of the patient. This means that the Bill will help to ensure that people are given food, water and pain relief according to their best interests. For the first time—and this struck me when my noble friend Lord Winston was speaking—it gives a statutory right for families, carers and friends to be consulted. I do not know about other noble Lords, but I thought that that provision was there anyway. It is not—but it will be. Such people will be consulted.

    As noble Lords have indicated—particularly in the examples given by the noble Baroness, Lady Knight of Collingtree—it has often been the patient's spouse, friends or loved ones who have said "Hang on a minute, what is happening here?". Now they will have to be consulted. We need to be clear about that important point.

    I know that noble Lords feel passionately about the question of whether or not artificial nutrition and hydration is a treatment. I was grateful for the opportunity—the noble Lord, Lord Alton, referred to this point—to invite the chair of the BMA Medical Ethics Committee and Mr Rob George from the Centre of Bioethics and Philosophy of Medicine, an expert in palliative care, to talk to noble Lords who were available to attend. I have sent out copies of the presentation to some noble Lords. If any noble Lords have not received copies, I shall be happy to send them and, indeed, to set up another conversation. I found it extremely helpful and useful.

    What came out of that for me is that ANH is a treatment because of what goes alongside it. I am putting this in laywoman's terms and I hope that those who are expert in this field will forgive me for doing so. I say that is what I took away from it because ANH runs the risk of high infection, you have to monitor for fluid balance, you have to take blood to monitor the kidneys and you have to look at concerns such as diarrhoea, regurgitation, nausea and vomiting. In other words, without being too specific, there are real issues concerning the provision of artificial nutrition and hydration which make it a treatment in the eyes of the medical profession. It is what goes with it that creates that opinion.

    So that, in a sense, is why we have to consider ANH and why we are concerned to ensure that people are very clear about the treatments and circumstances they are discussing when making advance decisions. We have already said that people need to be clear and specific when they are considering making an advance decision on a treatment that could be life-sustaining.

    I say that because I have also learnt on the way to the Bill something that I probably should have known: that is, that many treatments can be life-sustaining depending on the circumstances. We have mentioned antibiotics but there are many other treatments. Even artificial nutrition and hydration can he used in hospital care but not necessarily in life-threatening situations. For example, it could be used where someone needs to be sedated for a period of time in intensive care. It need not be in a life-threatening situation—if the patient did not have it he would not die—but perhaps it is beneficial and helps the patient to recover more quickly and so on. So ANH by itself is not always a life-sustaining treatment.

    We have sought in the Bill to be very clear that if a person is going to make an advance decision about a treatment that could be life-sustaining he has to be prepared to say "I do not want that treatment even if my life is at risk". So the person not only has to name the treatment and the circumstances but he also has to indicate that it applies even if his life is at risk. That is a very important safeguard. As my noble friend Lord Carter said, we need to be clear that that has been dealt with.

    I turn now to the amendments of the noble Lord, Lord Alton, and the noble Baroness, Lady Finlay, who I know is not in her place. We would have welcomed her interventions but I am sure that we shall hear further from her as the Bill continues its progress. I know from what the noble Baroness, Lady Masham, said that noble Lords are concerned about trying to define, in a sense, this basic care and the issue about what is available to people. Amendment No. 98 seeks to define that.

    Noble Lords who have known me from the other parts I have played in the life of your Lordships' House will know that I have a real aversion to lists. That is because, without exception, there is always the difficulty that you leave something off a list. Basic care is a classic case because it will differ from one individual to another. So I shall resist lists because it is not in my nature to accept them, particularly on the face of the Bill.

    That does not mean that I do not accept what Members of the Committee seek—that is, to be as clear as we possibly can that we should not deny proper care and treatment to some of the most vulnerable people in our society. I share that aim. It is why I am a strong and passionate supporter of the Bill. For a number of the reasons that I have already given about involving families, about being clear about a doctor being able to treat and about being clear about what an advance decision is, I resist the amendments. I do not want to narrow the definition of care. l know the Committee will recognise that it is in that spirit that I resist the amendments.

    4.30 p.m.

    What we are seeking to do is not very different from what noble Lords are seeking to do. I accept that the noble Baroness, Lady Knight of Collingtree, does not agree with the verdict in the case of Mr Bland, and that is an acceptable position to hold. But it is not the position of the Government; we believe that the process involved in those very difficult individual cases is right. Some noble Lords may not agree with the outcome but accept that the process is right, and that is important too. That is probably the biggest area of difference between us.

    We are at one in wanting to ensure that people receive basic high-quality care and that treatment is not denied unless it is absolutely clear that it is not in the best interests of a person to receive it, such as the kind of circumstances about which my noble friend Lord Winston talked. Most importantly, within this, there is something about each individual case. Doctors involved in the care of people at the end of their life say that a day-by-day, hour-by-hour, sometimes minuteby-minute, series of decisions is made, working with the patient and the family to give the best high-quality care.

    Inevitably, the unintended consequence of the amendments would be that people would have to have treatment when it was inappropriate and would not be able to make the kind of clear decisions—whether noble Lords like them or not—that we can all make now, as autonomous people. They would define basic care in a way that would not help us. However, I accept that we need to do more within the code of practice and with what comes out of the Bill, because I do not think that every clinician or every nurse in every facility will read these provisions to make sure that they get it right.

    I do not want to detain the Committee unduly, but the Minister has just said that if your Lordships agree to the amendments people would have treatments inflicted upon them that they did not want. Yet Amendment No. 98 categorically says,

    "save where that provision would harm the person or otherwise be unduly burdensome to him".

    I was trying to be very clear that I understand the intention behind the amendments. However, as I have indicated, it is quite difficult when it comes to interpretation. I accept that the anxiety behind the amendments is to make things safer and better for vulnerable people, and I share that desire. My argument is very straightforward: we should not do this on the face of the Bill. Just as importantly, we have to be clear that artificial nutrition and hydration, while an emotive issue for very good reasons, is a treatment, for the reasons I have given. As such, it needs to come under the safeguards provided for treatments and we have sought to provide clarity in the Bill to ensure that when people decide not to accept a treatment, they are absolutely certain about what they are doing.

    My final point is about the Joint Committee on Human Rights. As regards the Burke judgment, which the right reverend Prelate raised, there are issues to be considered. As noble Lords will know from what I said earlier, the Burke judgment is currently under appeal. The Department of Health has joined in the appeal to obtain clarity about the potential universality of what might be covered, but not on the basis of trying to move away from the provision of ANH when it is clearly in someone's interests to receive it.

    We are looking carefully at what the committee has said. We have had the report for only a few days. As noble Lords would expect, 1 will consider very carefully what the committee has said and will perhaps have the opportunity to pick up some of these issues later.

    On that basis, I hope that noble Lords will be reassured that I completely understand these important issues. We believe that either they should be pursued in a different way or that we do not necessarily achieve what the noble Baroness and the noble Lord seek on the face of the Bill.

    Before the noble Baroness sits down, I am very grateful for what she said about her willingness to reflect further on what the Joint Committee said about the inadequacies in the Bill. Will she consider a mechanism, before we reach Report stage, for discussing with opposition spokesmen and other Members of your Lordships' House the possibility of taking those concerns into account?

    I am not sure that the committee said that the Bill was particularly inadequate. In fact, it has been largely very supportive of the Bill. Jean Corston raised specific points with me, some of which we have taken on board. I know there is concern that when people appoint a power of attorney or make an advance decision they know that ANH is part of treatment. There is an issue about whether people include that. I will look at the committee's findings and write to noble Lords who were involved in it to let them know what my deliberations suggest, so that there are no surprises on Report.

    It is always a great pleasure to listen to the noble Baroness, Lady Ashton. The more carefully one listens to her, the more information one obtains. After making one or two brief remarks, I shall return to what she has said. Reports of debates such as these are extremely important—Hansard goes far wider than we may realise.

    I have said, time and again, that I am not trying, through my amendment, to force painful procedures on patients. Certainly no one here is trying to overturn the Bland decision. In fact, I should like to reassure the noble Baroness: I think that the Bland decision was perfectly understandable. I said that I was against keeping people alive in certain circumstances, and I explained why.

    However, I was amazed and really rather shocked that the right reverend Prelate the Bishop of Oxford made it quite plain that he did not believe one word I was saying. I am puzzled about why he should feel—

    That is a little unfair. I took what the noble Baroness said very seriously. In fact, I took it so seriously that I wrote to all the reputable medical organisations to share with them her concerns and to ask whether they had any supporting evidence.

    I think that if one wished to be balanced in the matter, one might seek other information, not just from the people most closely concerned. What the right reverend Prelate said was most hurtful, because I assure the Committee that I did not introduce the Patients' Protection Bill because of a flight of imagination. If he would like to meet the people who talk to me about their concerns, including the Member of Parliament whose wife was affected, I would be more than happy to arrange it. I will, if he wishes, also arrange to let him see the newspaper reports and details of the television programmes. The facts were such that they worried me. I talked to people and heard what they had to say; I introduced the Bill, and later this amendment, because of what they said.

    I do not doubt for a moment that the best interests of the patients are intended to be at the heart of the Bill. I do not dissent from that, quarrel with it or fail to notice it. All we were trying to say was that the protection for patients against what had been happening could be more clearly written in the Bill. We were certainly not saying that the Bill did not have the very best of good intentions.

    I was particularly pleased to hear what the noble Baroness said about consultation being imperative. The Member of Parliament I mentioned was not consulted, yet his wife was being systematically starved. We could use the Bill to ensure that patients receive better protection.

    I am so impressed with what the noble Baroness has said that I should like to consider carefully every point she has made and talk with my noble friend Lady Masham and others on this matter. If we may also talk with the Minister and there are still concerns, we can return to them at a later stage. I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [ Amendment No. 93 not moved.]

    Clause 27 [ Family relationships etc.]:

    [ Amendment No. 94 not moved.]

    Clause 27 agreed to.

    [ Amendment No. 95 not moved.]

    Clause 28 agreed to. [ Amendment No. 96 not moved.]

    Clause 29 agreed to.

    [ Amendments Nos. 97 to 98 not moved.]

    [ Amendment No. 99 had been withdrawn from the Marshalled List.]

    Clause 30 [ Research]:

    moved Amendment No. 100:

    Page 17, line 3, after "Intrusive.' insert ". physical or social"

    The noble Baroness said: We now move on to another extremely important subject and extremely important part of the Bill—the question of research and participation in research by people who lack capacity. Members of the Committee have tabled many amendments to this part of the Bill. They all seek reassurance on a fundamental issue; that is. the extent to which it is possible for people with mental incapacity to take part in research where sufficient safeguards exist to ensure that they are not exploited.

    Other Members of the Committee will talk in more detail about particular aspects of that matter, but as a member of the Joint Committee I take this opportunity to say that members of the Joint Committee considering the draft Bill paid considerable attention to this matter and examined it in great detail. It was a subject upon which we received a great deal of evidence from a wide range of organisations reflecting diverse opinions.

    The members of the Joint Committee ultimately recommended to the Government that the Bill should contain provisions that would enable people with mental incapacity to take part in research for two key reasons. First, a number of conditions have the effect of reducing the capacity of an individual—the patient interest groups made this clear to us—and it is important to conduct further research to find out more about those conditions. We felt that that research should be supported, albeit it within the right context. Secondly, the Joint Committee believed that a strong system of medical ethics and medical ethics committees already exists in this country. However, we considered that it would be helpful to address an existing anomaly; namely, so far as we know, there is no statutory provision governing such research and the ethics behind it. We considered that it would be helpful to address that anomaly and thereby to create a safeguard for people who lack capacity.

    Amendment No. 100 deals with a slightly broader subject but none the less an important one. Obviously, for understandable reasons, most of the debates that we entered into covered physical medical research into particular conditions. However, as we have said many times, this Bill is about the lives of people who lack capacity in all its forms. It is important for us to tease out the Government's view on the ethics governing social research, including on people with mental incapacity.

    Many forms of research can be intrusive but not physically intrusive; for example, research involving the observation of people's behavioural activities. Those of us who have had the pleasure of sitting through debates on DWP matters will know that intrusive questions—which it is legitimate to ask—may be asked about people's finances. People with capacity sometimes find those questions objectionable. Nevertheless, poverty among carers and people with disabilities is an important matter that we need to examine.

    The purpose of Amendment No. 100, which may seem rather odd—I hope that it does not convey misunderstanding of the broad sweep of this part of the Bill—is to ask the Government what are the ethical standards that would protect people who lack capacity as regards forms of research other than those which are strictly medical. I beg to move.

    4.45 p.m.

    I wish to speak to Amendments Nos. 101 and 116, which are grouped with Amendment No. 100. Amendment No. 101 seeks to substitute the words,

    "lawful if and only if,
    for "unlawful unless" in Clause 30(1). This may seem rather odd, as it might be thought that the phrases are identical in meaning and effect. However, perhaps I may briefly explain the thinking behind it.

    There is a concern in the scientific community that the use of the words "lawful unless" implies that Clauses 30 to 33 are not enabling provisions in the fullest sense; that is to say, it cannot be said that it is lawful to include incapacitated adults in intrusive research if all of the requirements of those clauses are met. The interpretation that might be put on the current wording is that Clauses 30 to 33 are not exhaustive but instead impose requirements additional to any that may already exist at law, either under the Bill itself or under the existing common law of necessity.

    The current law is in fact unclear and difficult to apply in a research context. The law of necessity requires that the research is in the best interests of the patient, which as we know is one of the overarching themes of this Bill. But research is rather different from other sorts of activity done for or on behalf of a patient. The nature of research is such that it is very difficult to say at the outset that its outcomes will benefit those patients participating in it, or, indeed, anyone else. In fact it is that very uncertainty that tends to make the research necessary. Research is really about exploring potential opportunities to benefit patients, present and future. So it is sometimes quite difficult to argue that this kind of activity is in an individual patient's best interests, unless one extends best interests to include the opportunity to fulfil the patient's belief in being altruistic.

    I therefore share the misgivings of the scientific community about the appropriateness of the best interests test in a research context. If we insisted upon it, it could jeopardise much valuable research work that could be of great value to those suffering from mental illness or impairment, or at risk of suffering from them. If Clauses 30 to 33 are not enabling provisions and the best interests test under common law will continue to apply in addition to them, very considerable problems will persist as researchers attempt to apply the law. We want the law to be clear, but many fear that these provisions are not as clear as they might be.

    I turn briefly to Amendment No. 116, which is in this group. There is a concern that the requirements in Clause 31 have been drawn up on the basis of our current understanding of how medical research works and how it benefits individuals. I am not a great one for giving Ministers more order-making powers, and perhaps the terms of the amendment are rather broader than on reflection I would wish, but this may be one case where a power of some kind is desirable to ensure that if there are scientific developments in the future that we cannot anticipate at present, the law can adapt to those without the need for passing primary legislation.

    In passing, and in her absence, perhaps I may refer to Amendment No. 102, standing in the name of the noble Baroness, Lady Finlay. I think that it is appropriate for me to speak briefly to this amendment as it chimes in with an amendment that the noble Lord, Lord Turnberg, moved, I think, on the first day of our Committee proceedings. I believe that we have covered the material point in question that the noble Baroness raises in Amendment No. 102, but perhaps the Minister when replying could respond so that there is a reply on the record.

    I should like to support the noble Earl's Amendment No. 101, to which my name is attached. I support it for all the reasons that he has so eloquently set out. The question here is whether the words "unlawful unless" in relation to research are paramount and conflict with the later Clauses 31 and 32, which outline the formal steps researchers have to go through before doing a study. As the noble Earl has suggested, might it not be simpler if the words "lawful if such and such were in place" were substituted? I hope that my noble friend the Minister will take that on board.

    The principle behind Amendment No. 100 has my full sympathy. I support the amendment, though I am not absolutely convinced about the need for it. If we inserted the words "physical" and "social", I would wonder why we have not included the word "psychological", because psychological research also can be intrusive. It may indeed be the case that we need to introduce too many qualifying terms. Might it not be better to think of intrusive research as meaning any type of research? That might be enough. I just wonder about that.

    I should also like to comment on Amendment No. 102, tabled by noble the Baroness, Lady Finlay, in her absence. I think that this is an important amendment and would allow certain types of research not to be lost. If the Committee will forgive me, I can use here the example which I gave in an earlier amendment of the human biobank study in which half a million people are being asked whether they will volunteer to take part in a long-term research project over 10 to 30 years, in which time they will be followed very closely. If, as seems inevitable, some of the 500,000 people become incapacitated at some time, it would be a problem if the data collected on them—the accumulated data available—could not continue to be used in the research. This amendment seeks simply to ensure that the data for which consent had been obtained can continue to be used as the patient loses capacity. I support this amendment.

    When the Minister replies to this group of amendments, perhaps he could say a word about the place of local medical research ethics committees in this whole scene. For several years I was the chairman of one of these local committees in Scotland, and we had in our area a hospital where there were a number of people with insufficient capacity to make up their minds for themselves. A great many research projects were put before us, a number of which applied to that hospital.

    When these research projects were suggested, I was astonished at the care that the committee which I chaired applied to discussing them. The defence of the patients and the thought about how they might be affected were enormously careful. We were all aware that the best defence of all would be given by the nurses in that hospital, who would not dream of allowing the patient to be exploited. When we are thinking about the Bill's provisions and the process applied to proposed research projects, we must realise that the local ethics committee will take much detailed care over the proposals.

    The noble Baroness, Lady Barker, tabled Amendment No. 100 to express her anxiety about the possible intrusiveness of physical or social research. I thought that she made an extremely good point. However, it caused me to remember that when such research was suggested to our committee, it was one of the things about which we were most careful. What the noble Baroness says is absolutely right. At the same time, as the noble Lord, Lord Turnberg, pointed out, it is not just social and physical research that might be applied: there are other sorts of research that are not drug trials or strictly medical trials.

    I think that the word "intrusive" would have been enough for our committee to go into great detail about exactly what the form of intrusiveness would be. We turned down quite a few trials. I should like to know from the Minister whether a local committee's rejection of a proposal will put a stop to it or whether the Bill will override that. These committees have a very important place. They are not amateur committees at all. They include some nonprofessionals, and there is usually a philosopher or theologian of some sort to stand back and look at the issues, but they also include professionals from a variety of professions. The committees usually contain bright people who not only know a great deal about the subject but are there specifically to think of individual cases in an individual place. So I would like to know exactly the place of those committees, if the Minister would be willing to give it.

    I would not want the silence at this stage of the debate on research to be misunderstood as agreement with carrying out research in these circumstances unless other safeguards are put in place. Without pre-empting my own Amendment No. 127 and amendments in the name of the noble Baroness, Lady Knight, and others, we will be having that debate a little later. This is almost a back-to-front debate. I think it would have been better in some respects if we had decided whether and in what circumstances there should be research before getting these kinds of detail.

    Notwithstanding that, the amendment in the name of my noble friend Lady Finlay of Llandaff clearly relates to someone who has capacity deciding in advance, while they have capacity, that if they lose capacity later, they would wish the research to continue. That seems a perfectly proper approach and is one with which I have no problem. If the other safeguards which we will discuss later are put in place, I do not really have any difficulty with the points that other Members of the Committee have already advanced.

    I should like to ask the Minister a question about the use of the word "intrusive", a point touched on by the noble Lord, Lord Turnberg, and the noble Baroness, Lady Carnegy. I wonder whether the word "invasive", which is often used in these circumstances, was considered and why we have chosen "intrusive" rather than "invasive" in these circumstances.

    5 p.m.

    I thank noble Lords for raising a number of important points about the inclusion of provisions on research in the Bill and about the purpose of Clause 30 in particular. As this is the first group of amendments on research, it might be helpful for me to give a full response to the amendments and say a bit about the thinking behind our approach to this section of the Bill.

    Clauses 30 to 33 make provision for research to be conducted involving people who lack capacity, but only where it complies with the relevant conditions and safeguards, about which I will say more later. The Government can be said to have taken careful note of the view of the Joint Committee that if the Bill did not address research it would leave considerable uncertainty about what research would be lawful. The provisions are based on international consensus set out by groups such as the World Medical Association, as recommended by the Joint Committee.

    The research provisions in Clauses 30 to 33 established a requirement to put the interests and wishes of P at the forefront of considerations. All intrusive research, that is research that would require consent if an adult had capacity, is covered except for clinical trials of medicines, which are subject to separate and equivalent regulation in accordance with a European directive. Under this Bill, research would only be lawful if it is approved by an appropriate body as set out in regulations. Such a body would normally be an independent research ethics committee such as those set up by the NHS. We have left provision for specifying this by means of regulations, because a number of noble Lords may remember that during the course of the Human Tissue Bill I announced that we were reviewing the functioning of NHS research ethics committees and changes to the structures that appoint and provide operational support to research ethics committees. There had been some concern to see whether we could improve some of those procedures and processes. That is what we are doing as part of this review. On the assumption that spring is a little late, I hope that we may be able to make a further announcement around that time.

    My department is also developing a research governance framework for social care research to complement that for NHS healthcare research. I say to the noble Baroness, Lady Carnegy, that under the terms of this Bill the research ethics committees, which I agree take a great deal of trouble over the applications in front of them, will have to approve proposals before they can proceed.

    The noble Baroness, Lady Barker, has proposed inserting "physical or social" after "intrusive" in the opening reference to the general provisions in Clause 30. I understand her purposes, but her wording narrows the terms of the Bill. We must not forget that the safeguards in Clause 31 make it clear that the research is to be connected in some manner with the thing that leads to the impairment or results from it, and to improve treatment, care or advance scientific understanding. This all means that it is clear that the provisions relate to scientific, health or social care research in the full sense of those terms, not to other types of research, such as market surveys.

    The code of practice sets out a definition based on widely accepted principles of research governance, which I will not read out in full, but as the noble Baroness will see, paragraph 12.5 of the draft code already says:
    "Research has been defined as an activity that attempts to derive new knowledge by addressing clearly defined questions (hypotheses) using systematic and rigorous methods. The knowledge gained may provide information that can be generalised to the particular illness, disorder, or circumstances under investigation".
    That is the scope of research, and it has to be intrusive. I infer from the question asked by the noble Lord, Lord Alton, that there is doubt about the meaning of "intrusive". It is emphatically not synonymous with "invasive". "Intrusive" means doing research activities that would ordinarily, if the person had capacity, require their consent. It could be analysing a questionnaire or their medical notes; it could be doing research on some tissue removed from them during surgery. It is not the same as "invasive", which applies to research acts that require putting something into a person's body, perhaps to remove a sample, to provide some therapeutic substance, or to measure some characteristic of their body. It is wider than "invasive".

    With that in mind, while I welcome any additional elements which reinforce this intention, I am reluctant to consider changes that have the effect of narrowing too far the scope of research clauses in the Bill. We feel that these already provide an appropriate balance between enabling research and protecting vulnerable individuals. We would not wish to see their scope drawn too narrowly.

    Also, and with great respect, I fear that the amendment does not achieve the desired effect of improving clarity. For example, it would unfortunately give an impression that the scope of the clauses is limited to research that involves physical contact with the person who lacks capacity. Some may feel that this is all that the Bill should cover, but we have sought to ensure that it covers the whole range of research activities that would require a person's consent if that person had capacity, which includes research involving them, their tissue or their data. As I understood from the noble Baroness, Lady Barker, it was these wider issues that she was most concerned about. For example, some researchers may want to film the person without capacity through a two-way mirror to study something related to the working of their mind. Some researchers may want to use their personal and medical data, but these might not be said to be "physical" research activities. Are they "social" research activities? It is unclear. Therefore, we used a broader term and related it to capacity.

    We want an independent research ethics committee to have the power to refuse approval to a project that made unjustified invasions of privacy, every bit as much as controlling direct, hands-on clinical research. In the light of those comments, I encourage the noble Baroness to withdraw her amendment.

    I understand why Amendment No. 101 has been proposed. We have carefully considered the concerns expressed at Second Reading. Several important and respected organisations engaged in research have provided comments on this point, and they were alluded to by the noble Earl, Lord Howe. The Academy of Medical Sciences, the Medical Research Council, the Wellcome Trust and the Royal College of Physicians have raised the question of whether the provisions in Clauses 30 to 33 on research are enabling provisions, or whether they simply impose additional requirements beyond the common law and the other provisions of the Bill. Let me be clear. As regards treatment, the common law doctrine of necessity is replaced by the statutory provisions in the Mental Capacity Bill. Clause 5 codifies elements of the doctrine of necessity in relation to the provision of care and treatment according to a person's best interests. Clauses 30 to 33 deal with research. The Bill's provisions about the assessment of capacity apply across the whole Bill.

    The purpose of Clauses 30 to 33 is to make provision for acts in connection with research that cannot necessarily be shown precisely to coincide with the person's best interests. It may be that the research procedure involves different or additional approaches to a person's care, which might not meet a narrow assessment of best interest. It is also clear that properly conducted research can, overall, lead to improvements in the lives and the health of individuals and of others with the same condition. Morally, the case can be made to permit carefully controlled research involving those without capacity.

    The provisions regarding research are framed as they are because of the need to allow for situations where research is but one aspect of the clinical or professional care of the person who lacks capacity. Any research has to be against a background of the other needs that the person has, and those must in turn comply with the provisions of the Bill, particularly in relation to the determination of best interests. But that does not mean that a research procedure which is part of an approved research project in which the person who lacks capacity has been properly enrolled has to be, in addition, judged against the best interests test. In that respect, the research procedures provide an alternative to a best interests determination.

    Clause 30 makes it clear that research that would normally require consent if the person had capacity will be unlawful unless it is done as part of a project approved by an appropriate body—usually a research ethics committee—and in accordance with the requirements for consultation with a carer or other nominated person. It must also respect any prior statement made by the person and any indication that he or she wants to be withdrawn from the study.

    Although the amendment is well intentioned, it is not acceptable, unfortunately. It is legally not possible to make such a change to satisfy researchers that those research provisions are an exhaustive list of the legal duties that apply to research involving adults who lack capacity. Alongside the Bill, researchers must also consider their wider legal duties, such as requirements of confidentiality, data protection, health and safety at work or their employer's liability insurance. We cannot accept an amendment along those lines, because it would involve giving researchers some false notion of indemnity against their wider legal obligations. In practice, we want to continue to promote proper research governance arrangements, of the sort required for NHS research. Those can help to ensure that researchers consider all their legal and professional duties, including those set out in the Bill.

    A number of Members of the Committee spoke to Amendment No. 102 in the absence of the noble Baroness, Lady Finlay. It raises some important issues, and I recall that she made similar points during the passage of the then Human Tissue Bill. I will repeat the assurances made previously by my noble friend Lady Andrews. Researchers need to understand clearly whether consent given in advance to an ongoing or long-term research project continues to be valid when the person concerned loses capacity. We need, of course, to make sure that adequate safeguards are in place to protect the individuals who may lose capacity during a research project. We need to ensure that we put proper arrangements in place so that existing research projects are not adversely affected by the Bill where that would be inappropriate.

    I can go further today in addressing the specific points raised in the amendment. If we consider Clause 30, the definition of what is intrusive research hinges on whether a person with capacity would have to consent to it for it to be lawful. If a researcher has the consent of a person to carry out research involving them, that consent endures beyond loss of capacity, but only up to a point. That point is when the researcher wants to do some act to which a person who had capacity could refuse consent, such as a request to take a further blood sample, perform a physiological measurement or answer some personal or health question.

    If the participant lacks capacity to consent to that additional matter, or to withhold or refuse consent to it, the safeguards in the Bill should apply so that the person has equivalent protections that a person with capacity would have. In particular, the researcher needs to approach the person's carers for advice and to respect the views of the person without capacity and any objections that they may make.

    I can give one or two simple examples to illustrate how we believe that the provisions around intrusive research apply. In a simple case, I may be about to have routine surgery. My surgeon seeks my consent to do some research involving a new medical device while I am under the anaesthetic. At that stage, I have temporarily lost capacity, but it does not follow that the surgeon has to undertake the additional procedures called for in Clauses 32 or 33. I had given my consent to the research while I had capacity, so what is being done to me in the name of research is not intrusive research under Clause 32(2). Therefore, my consent survives the onset of the temporary incapacity.

    That is a simple example. Others may be more complex. I shall take a different case to illustrate the matter. I may consent to join a long-term research study to follow my general health over the course of several decades. That is not fanciful; there are many such research studies. I have appointments with the research team each year and they take my blood, my blood pressure and so on and ask me some health questions. I initially consented to them doing so, and to them studying my blood samples in the laboratory and analysing my health data in their computers. But between research appointments, I unexpectedly lose capacity due to some injury or illness. The researchers are not to know that, and it would therefore follow that my consent to their laboratory researches should endure.

    5.15 p.m.

    However, when the time comes for my next appointment, it will become clear that I have lost capacity. At that point, the researchers' actions will depend to some extent on what was decided in their research protocol or their original consent. The research design may mean that they do not want me in the research any longer. They may not want any new samples or information from me, but may wish to keep the previously collected data. Alternately, they may have anticipated that some people in such a long study would lose capacity and made arrangements.

    If the latter is the case, the Bill requires that the researchers comply with Clauses 30 to 33. In particular, they would need to identify my carer, next of kin or other person interested in my welfare, tell them about the research and ask what, in their opinion, my wishes and feelings would have been. They would also, under Clause 32, ask whether my carer or next of kin thought that I still wanted to he part of the study. They would also, so far as possible, try to find out what 1 wanted. If my next of kin or I indicated that I did not want to be sampled or studied any longer, that would be that. No further samples could be taken from me. But that is not to say that the earlier samples would automatically need to be destroyed or removed from the analysis. That would depend to an extent on what I had consented to in advance.

    I set that out at some length so that people can read it afterwards, because the area is complex. I hope that I have explained that we need to cover a range of circumstances. As my noble friend Lady Andrews said, we will want to look carefully at what should happen to research that started before the Bill came into force. I therefore repeat her assurances that we will look carefully at the suggestion and consult on it. I do not want to make any promises, but we will see whether an amendment can be brought forward to tackle some of the issues.

    I am grateful to the noble Earl for tabling Amendment No. 116; as he said, it reflects concerns in the medical research community. Clause 31 contains some of the core safeguards that affect research. Every research project involving those who lack capacity must be approved by the appropriate body, the research ethics committee. It is required to be satisfied that the research is connected to a condition that affects P and is linked to the impairment of mind or brain. Crucially, it must be satisfied that the research could not be done as effectively with those who could consent.

    Then there is the question of whether the benefit to P of the research is not disproportionate to the burden—the inconvenience, discomfort or bother of the study. If the research is not likely directly to benefit P, there have to be assurances that the risk to them is negligible, that it will not interfere with their privacy in a significant way, and that it is not unduly invasive or restrictive. We must not forget that there is a need for each individual to be properly enrolled in a study, in consultation with their carers or other nominees, and also respect P's previous and ongoing wishes and views. Those are all already extremely important safeguards, and it is true that they are based on our current understanding of—and, to a large extent, the international consensus on—research involving those without capacity.

    I set out this matter at length, because it crossed my mind that there may be some disquiet in some quarters that Ministers, other than the present benign lot, could omit or vary some of those safeguards by means of an order. I detected that the noble Earl, Lord Howe, might have a twitch of doubt about that as he spoke to this amendment. I sympathise with the research community's desire to lay down flexible rules governing research that can adapt to advances in scientific knowledge, but we must bear in mind the strong safeguards in the Bill.

    The Bill requires an independent research ethics committee to exercise judgment in the light of the facts of the research. That is why we tend to resist attempts to alter those safeguards. Another important way of enabling a flexible, yet strict, approach to research is the code of practice. I hope that the research community will work with us to ensure that the code is sufficiently detailed in that regard.

    However, as someone who has done his best to co-operate with the research community, I recognise some of the issues with which they are concerned and we wish to ensure that there is sufficient flexibility in the Bill and to provide for that to be adapted in the light of experience, if that is necessary. Without giving any commitments at this stage, we would be glad to consider this issue further and return to it on Report, to see whether there can be any movement in this area.

    I thank the Minister for that detailed and considered answer, which contained some very helpful information. However, there was much in his comments that left me with more doubts about the extent to which different types of research will fall within the provisions of the clause. I appreciate the point made by the noble Lord, Lord Turnberg, about the imperfections of the amendment—it was tabled solely as a means of having this debate. In my defence, I should say that all the amendments relate to medical research. Indeed, the only bodies mentioned in all these clauses are medical, so it is not surprising that those who have considered this Bill have focused on medical research. That is right, because medical research is the most contentious issue. I was grateful to the noble Baroness, Lady Carnegie of Lour, for talking so knowledgeably about the work of her committee, and how, even for medical ethics committees, questions of social research are those that cause the greatest difficulty. I am sorry that the noble Lord, Lord Alton, did not receive the reply he had hoped for, because his point about "invasive" versus "intrusive" went to the heart of the matter. But the Minister then continued to use the word "invasive" throughout his response. So I am somewhat concerned about that.

    The Minister mentioned that the Department of Health was setting up a research governance framework for social research, and that is most welcome. Could he, for my benefit, at some point explain the nature of the mechanism that will implement that governance framework? Will it run parallel to the local ethics committees? That would be extremely useful. Perhaps we will have to leave it to the noble Baroness, Lady Finlay of Llandaff, to respond to the Minister's reply to her amendment. From the two examples that he gave, I picked up conflicting messages about the extent to which consent can endure when it is given by someone with capacity; although I was interested in the detailed example given by the Minister about how someone taking part in a longitudinal research programme could continue to be a participant, despite lacking capacity. I suspect that what he says is what happens—that researchers in those circumstances do consult families about whether or not research would be appropriate.

    I accept the mild criticism given by the noble Lord, Lord Alton, that we were jumping into a far wider debate, but this has been a useful place from which to start. I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [Amendments Nos. 101 and 102 not moved.]

    On Question, Whether Clause 30 shall stand part of the Bill?

    Before we bid farewell to Clause 30 there is one issue on which I hope that the Minister can be of assistance. The noble Lord was kind enough to write to me and others last month, setting out some of the Government's thinking on this part of the Bill and relating these provisions to the corresponding provisions in the Human Tissue Act and the clinical trials regulations. I thank him for doing that, as I found his letter most helpful.

    He said in his letter, rightly, that it was essential for the various elements of the legislative framework for research on mentally incapacitated people to be mutually consistent and to march together in harmony. I have compared the three sets of provisions and they seem, to me at least, to sit comfortably with each other. However, can the Minister say whether he and his department are entirely satisfied on that question? He mentioned that Ministers were looking at the possibility of amending the clinical trials regulations to enable research in emergencies to proceed. That is a provision that we shall shortly debate in the Bill. It would be useful to hear whether that is the only adjustment that the Government are contemplating and when those regulations are likely to come forward. Can the Minister say when the Government expect to bring forward regulations under the relevant provisions of the Human Tissue Act in relation to storage and use of tissue from mentally-incapacitated patients?

    Apart from the emergency research areas, which the noble Earl mentioned, I am unaware of any other areas where we have concerns. I hope that the letter and the chart were helpful. I cannot provide a precise timetable regarding the amendments arising out of emergency research. We are undergoing a consultation process on that. I shall need advice on where we stand on the Human Tissue Act. I shall write to the noble Lord on both issues.

    Clause 30 agreed to.

    Clause 31 [Research]:

    moved Amendment No. 103:

    Page 17, line 33, leave out "or brain" and insert ", brain or disorders in other bodily systems associated with or attributable to the incapacity"

    The noble Lord said: My reason for moving the amendment is that there are several complications which occur in patients who lack capacity, which are associated with, or attributable to, their lack of capacity, but which do not directly affect the mind or the brain. It is equally as important to research those areas as it is to research the conditions that only affect the mind or the brain.

    I shall give some examples. First, a patient brought into hospital after a head injury sustained in, say, a motor car accident, may have multiple injuries which require research. Secondly, patients in coma after a stroke may be particularly susceptible to infection and their immune systems may be awry. The reasons for that need to be examined, while a search is made for a treatment which may combat or prevent the complications.

    Patients who go into hospital after a heart attack may lose consciousness, but the research that is needed will be on the heart, the circulation, the lungs and the kidneys—all of which may be affected. There are many other examples of disorders which affect only incapacitated patients, but do not involve the mind or the brain in any direct manner.

    I hope that I have said enough to convince my noble friend of this matter. I should say that it is possible that the same end may be achieved by Amendment No. 104, tabled by the noble Earl, Lord Howe, so I am not wedded to my own amendment, as one can achieve the same ends in different ways. I beg to move.

    5.30 p.m.

    I am not sure that I totally subscribe to the wording of the amendment in the name of the noble Lord, Lord Turnberg. I think that he may have sacrificed explicitness for neatness and therefore the amendment may not achieve all that it should. But that is not to say that I claim anything like perfection in relation to my own amendment—Amendment No. 104—even though its aim, as the noble Lord rightly said, is broadly the same.

    I share the noble Lord's welcome for this clause. Indeed, perhaps I may say that the changes made in another place to this part of the Bill were extremely helpful. But I am worried that the wording remains ambiguous. As we debated earlier, research is all about exploration. When you start it, you do not know whether, at the end, your initial hypothesis will be borne out in full, partly or not at all. It seems to me that the wording in Clause 31(2)(b) is too categoric. While you can posit beforehand that a particular condition is,
    "attributable to, or causes or contributes to",
    an impairment of the mind or brain, you cannot be sure that your eventual conclusions will bear that out. Nor can a researcher necessarily read into the words "connected with" that it would be legal for him to investigate the side effects of a drug which is used to treat a particular condition. So, like the noble Lord, Lord Turnberg, I think that the wording of this part of the clause needs to be reconsidered.

    I am very sorry that my noble friend and the noble Earl cannot agree about their amendments. I hope that I can bring comfort to both of them in what I say.

    Perhaps I may start by addressing Amendment No. 104. We are grateful to the noble Earl for proposing the amendment and we certainly understand his reason for tabling it. We are also aware that it reflects concerns put forward by some of the leading medical bodies.

    As the noble Earl said, in another place we have already moved to clarify the original policy intention—and very necessary that was too. We accepted that the original drafting of Clause 31(2)(b) unintentionally prevented research into a condition or illness that causes incapacity. For example, it would have prevented research into the prion proteins that are believed to cause variant CJD or, indeed, into the genetic causes of early-onset Alzheimer's disease, even where that might have been of benefit to the person involved.

    So the amendment ensures that research connected to a condition affecting the person without capacity and which causes or contributes to, as well as being attributable to, the person's condition would be covered. It is also consistent with the spirit of, and the policy intention in, the Bill. Therefore, as the noble Earl said, the amendments which are usefully before us are another attempt to reduce ambiguity.

    Before I say how we are going to proceed, I shall briefly address what the clause aims to do. It specifies that the research must be relevant to the patient's (P's) condition—that is, the condition affecting the patient—or in some way be linked to the impairment or disturbance in the functioning of P's mind. As noble Lords will know, that is directly related to the principle in Clause 2, which sets out when people are considered to lack capacity. We have set out elsewhere what we consider to be the diagnostic test and have said that impairment or disturbance could be due to a range of conditions, including psychiatric illness, a learning disability, dementia, a head injury and so on. It may also be permanent or temporary.

    Why is the link with impairment or disturbance such an important and explicit safeguard? It is because the notion that we are discussing is a widely accepted principle in the governance of research—one to which we shall return in later amendments. The research involving those who lack capacity must be related to the condition that causes the incapacity. That is an important but elusive concept. For example, the Helsinki Declaration requires that,
    "the physical or mental condition that prevents obtaining informed consent must be a necessary characteristic of the research population".
    The Law Commission put it more clearly by recommending that research should be lawful if,
    "the research is into an incapacitating condition with which the person concerned is or may be affected".
    So in these amendments we are discussing how to define and be absolutely clear about that link and, of course, the research ethics committee must also be clear about it.

    We have spelt that out in a way which, in our view, allows a wide range of research into conditions which result from the incapacitating condition, subject to the other safeguards. For example, it can include clinical research into the effects on bodily systems following severe head injuries, and research into gene mutations or infectious disease agents and so on. But, as was pointed out by the noble Baroness, Lady Barker, who is not in her place, it also covers direct health and social care problems.

    The amendments invite us to extend the scope of the definition to include conditions which "commonly accompany" a mentally incapacitating condition or research into the side effects of the management of the condition. I know that the noble Earl has been referred by researchers to instances which appear to be ambiguous and where there is a question over whether they are covered. One example was whether the drafting permits research into sexual dysfunction (the condition) that commonly accompanies schizophrenia (the impairment). In short, we believe that if all the other conditions were satisfied, that piece of research would indeed be covered by the drafting, hut the research ethics committee would have to be satisfied that that was the case. It was very useful to hear the tribute paid by the noble Baroness, Lady Carnegy, to the expertise and good common sense of the research ethics committee.

    The second part of the amendment is about side effects. Again, we believe that such research may be approved by an REC if it is satisfied that the side effect is attributable, albeit perhaps indirectly. The second example, which I think the noble Earl will have seen, is research into obesity associated with certain drugs used to treat schizophrenia. Again, we believe that that would be regulated under the clinical trials regulations because those regulations, and not the Bill, deal with the safety or efficacy of medicinal products. I have gone into detail in my reply because, although we believe that the type of example and the concerns raised could be covered by the Bill, we understand that it is very important to be as clear as possible on this matter, with all the attendant safeguards. So we shall now consider whether there needs to be further amendment to the clause, with a possible view to returning to the issue on Report.

    I am also aware that there is a need for clear advice on how the Bill relates to recent legislation, such as the Human Tissue Act, the clinical trials regulations and so on, and the noble Earl has referred to the useful analysis that we set out. We are now looking at how to achieve that by means of the code of practice and other guidance. We obviously want to consult the medical bodies fully and, as my noble friend said, we are looking forward to considering with them what we might do.

    I turn to Amendment No. 103. Again, I understand my noble friend's concerns. As he said, at times researchers may wish to examine other aspects of a person's condition which do not have a direct causal relationship with the disturbance of the mind. He gave an example that I can endorse. It related to research into how to prevent heart failure during a coma induced by an infection or organ failure following a major trauma. Such research might well be of good therapeutic benefit.

    The aim of the clause is to specify that the research must be relevant to P's condition or be linked to the illness, impairment or trauma that causes P to lack capacity in relation to consent to research. Again, I can sympathise with concerns about the current drafting. It may not be drawn widely enough to allow potentially beneficial research into something that may not be linked causally. But there may also be a danger of circularity: incapacity is not defined and that would lead back directly to the terminology in Clause 2. As I said earlier, we have used the same form of words—"impairment or', and so on—that appear in Clause 2. That lays down the general interpretation of the Act, and we would not want to tinker with Clause 2 because it is of such fundamental importance. We do not want to weaken it.

    However, as I said, we are sympathetic to the issues raised by the probing amendments concerning the vocabulary and the implications. We shall reconsider the issue to see whether there needs to be a further amendment to the clause—again, with a view to coming back on Report. I hope that noble Lords will be pleased with our openness in this matter and that my noble friend Lord Turnberg will be able to withdraw his amendment.

    I am grateful to my noble friend for that thorough and full explanation of the reasons why my amendment is not acceptable. However, it is important to clarify the issue, if only for the research ethics committees, which are placed in a difficult position and have to make difficult decisions. The more guidance and help that they are given one way or another, the better. Having said that, I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [ Amendment No. 104 not moved.]

    moved Amendment No. 105:

    Page 17, line 38, leave out "have the potential to" and insert "directly"

    The noble Baroness said: Clauses 30 to 33 worry me very much. I would never have believed that we in Britain would pass a law to permit experimentation and research—intrusive research, at that—on mentally handicapped people without their consent, but however one reads the Bill, that is what it does. It is claimed that the safeguards will protect mentally handicapped people, but I cannot see that the Bill's safeguards alter what is proposed. I simply cannot think it right to make use of living, breathing human beings unless they knowingly give their agreement.

    Let us look at the alleged safeguards. Clause 30(1) states that the research must be carried out,
    "as part of a research project".
    So what? That certainly does not protect the patient necessarily. The Bill states also that the research must be subject to regulations, if it is a clinical trial. I accept that the regulations—we have heard a little about them—are in place and effective, but they still do not alter what the Bill permits; namely, the use of mentally handicapped people without their permission. The regulations do not change in any way the fact that that is what the Bill does.

    The wording of subsection (2) is rather odd, because it tries to define "intrusive". We heard quite a bit about that earlier. I would not have thought that it was necessary to invent a new meaning for "intrusive". We can reach up for a dictionary or get one from the Library. I looked in my dictionary to see what "intrusive" meant there. The word was simply defined as,
    "to push or force something upon one; being forced on a person without leave".
    If we are going to make a new definition all together in this Bill, we should at least understand what we are doing.

    The Bill states that research would be "intrusive"—we have heard a little mention of this—if it would be unlawful to carry it out on someone who had capacity to consent but without his consent. I puzzled over that a great deal; would it not be illegal anyway? Is it not surely illegal to carry out research on people who have already said they do not want it? I wonder whether that happens very much. I would think that if it does, we should have seen some lawsuits about that little matter. Nobody is nervous about going to law these days. We are becoming increasingly litigious. I would have thought that to find that you have had a piece of research carried out on you when you specifically said that you did not want it would be grounds for a court case. The definition of "intrusive" proposed by the Bill is a very strange yardstick, and it certainly does not give protection to our mentally handicapped patients.

    Clause 31(2) states:
    "The research must be connected with a condition which affects P".
    "Connected with"? It is not necessary that he definitely has that condition. The research must be "connected" with him. The clause does not state how. It is not something that the patient suffers from. We can all be affected by something that we do not suffer from; for example, if one has a deaf partner. You should try living with someone who wants the television turned up so loud that it nearly blasts the windows out. That is "connected with", but it is not your condition. There is no protection in that, and it is protection for these people that I am seeking.

    What about all the people who will be consulted about all this, or "consultees", if I may call them that? Will they be family? The Bill does not state that. Perhaps it does not state it because many mentally handicapped people have no one who really cares much. We all know that women and married couples who are older are more likely to have handicapped children. That has often happened, and I have seen it happen. Those parents have died by the time the mentally handicapped person grows up a little. In my old constituency, I have seen many of these people looked after by some wonderful nuns, but they could not be consultees because they do that job "in a professional capacity", as the Bill states, so that is not where the consultees are coming from.

    The Bill goes on to state that the researcher must provide someone to consult. Researcher? That is rather like a gamekeeper asking another gamekeeper to be the researcher, or the poacher doing the same thing. If the researcher is the one who has to provide the person to consult, is not he at least likely to appoint somebody who will be on his side? The Bill then states that the researcher must nominate a consultee who,
    "has no connection with the project".
    But he can easily nominate someone who is connected with the researcher. The Bill does not state that he should not do that. That is the kind of thing that worries me. Nothing in the Bill, as far as I can see, would stop a researcher nominating a consultee who is his cousin or wife or perhaps somebody whom he has known for years and is a very good friend.

    Clause 33(2) states that nothing may be done to the patient to which he shows signs of objecting. Who is going to blow the whistle on that? Who else is present, when the research is being carried out, except those who are actually carrying it out? Who is going to say, "Oh, yes, I was watching that bit of research, and I saw him clearly object"? People like that will not be there. Who is to ensure that the patient has not been given drugs that render protest impossible? That certainly is not illegal in any way under the Bill.

    One correspondent of mine who is a researcher wrote to me after he read my speech on the matter on another occasion. He told me how much researchers want to have warm, live human beings to work on. He said that the pharmaceutical industry stands to gain immense profits when full research on people is able to go on. He said that bribery could certainly be involved if the possibility of such research came about. and he urged me to continue to express concern and continue to fight for mentally handicapped people. All of the things which I describe could happen under the Bill. I am not saying that they will; I am saying that I do not see any surety in the Bill that they will not.

    We are told that the only way in which knowledge about conditions that cause mental illness can be obtained is by use of these poor people, but that is not true. Doctors at the Brain Research Institute of the University of California have been researching Alzheimer's disease for some time. Last year, they announced that they had made what they called a "significant breakthrough" in their knowledge of what causes Alzheimer's disease and how to treat it and so on. They did it without using any human guinea pigs. Why not at least look at that research? Why not ask them what they did and how it has come about and see whether it is possible to advance in that way?

    It worries me that, if one checks the wording in Clauses 30 to 33, the mentally handicapped patient will be sacrificed without any certainty that he will benefit. The Bill does not say that there must be no risk to the patient, merely that the risk must be negligible. The Minister said that it would be negligible but the wording in Clause 31(5)(a) is "likely to be negligible". not "negligible". Even if the wording was "negligible". it would worry me, but "likely to be negligible" is a matter of extreme concern. It would be bad enough if the Bill just said that the risk must be negligible, but "likely to be negligible" worries me.

    Where there is any risk at all, I do not think that anyone should be experimented upon, or be the subject of research, without his agreement. To give tacit agreement to inflicting risk that is only "likely to be negligible" cannot be right. One person's interpretation of negligible may be quite different from another person's. A brave man might call having his leg off a "negligible" operation. His mother or his wife might take a very different view.

    That brings me to another of my concerns about the Bill. Many years ago, I was warned by a very experienced parliamentary draftsman never to use the word "reasonable". He said that it is impossible to define. What is reasonable to one person will be extremely unreasonable to other people. "Reasonable" is woolly and vague and its meaning is never clear. Yet the Bill is deluged with the word "reasonable". It is peppered with it more thickly than Gordon Ramsay peppers his steak au poivre. The word is used 22 times up to Clause 30. It is used three times in Clause 31 alone. After that, I gave up counting. The word is so vague that it should be used rarely, if at all. To have it appear so copiously in a Bill of such importance to life, death and ethics is highly alarming. I think it was the Queen in Alice's Adventures in Wonderland, or maybe it was somebody else in Through the Looking-Glass, who said, "It means whatever I want it to mean". That is what "reasonably" means. A person may not find something reasonable at all. I would have much preferred to see these clauses removed from the Bill and "hoovered" so that they would not have the word "reasonably" in them at all. I would like to have inserted more thought and care for the people who we are talking about. I believe with all my heart that we should extend more, not less, care to the mentally handicapped and we should certainly not do to them what we would never do to those who are fortunate enough to have all their capabilities.

    A doctor wrote to me:
    "In the work of research, ethics must sometimes prevail, in spite of the importance of research to medical progress. The Government is trying to rush this too far in favour of researchers and to the detriment of 'subjects'".
    I agree with that. It is a matter that we should consider because it is of great concern outside this House.

    Supporters of the Bill claim that research under it can be done only if it benefits the patient. But the Bill negates that in Clause 31(4)(d) where we see that research must:
    "be intended to provide knowledge of the causes or treatment of, or of the care of persons affected by, the same or a similar condition".
    It does not even require it to relate to the same condition. That is another instance where the words used do not give the protection for which I beg.

    As one stumbles through the maze of undergrowth in the Bill, it becomes plain that the research and experimentation legalised by the Bill need not benefit the subject at all. This was acknowledged during the debates of the Select Committee set up to study the Bill. One answer to my objection to using mentally handicapped people in this way was that I wanted to prevent such people benefiting society. I want to save them from being used when they have not agreed to be used. If they cannot agree, they should not be used. I think mentally handicapped people are like children. They are not on this earth for our convenience. We should give them far more care and consideration than we give the rest of us. I beg to move.

    As I put my name to these amendments, I support what the noble Baroness, Lady Knight, has just said. At a recent meeting here in your Lordships' House, several people with learning difficulties said that they were concerned that other people would be taking decisions on their behalf and that they did not like that. We should recommend that people who have full capacity and agree to research should be the ones who take part in research, not those who have said that they do not want even their relatives to take decisions on their behalf. The noble Baroness, Lady Knight, was at the meeting when they said that quite clearly. We have to think very carefully. It is a different matter when people agree to something. That is all I have to say, as it has been well said by the noble Baroness.

    I appreciate the reason behind the amendment of the noble Baroness, Lady Knight. She wishes to make the reason for doing research to be of direct benefit to the patient. Unfortunately, that conflicts with the purpose for which research is done. Please resist the idea that I am trying to support unethical research. I am not. I only support research that is done ethically.

    Research should be done only where the answer is not known before the research is done. It is because there is doubt that research is done. If one knows that doing something to a patient will benefit him, instead of that it has the potential to benefit him, then it is no longer research. Indeed, it would be unethical to perform research when the answer is already clear. It would be unethical to deny the patient the benefit of the treatment on which the research is supposed to be being done. It is only if it is not known whether drug A is better than drug B that research needs to be done.

    The logic of this amendment would prevent even placebo-controlled trials, since half the patients would be given a placebo and would not be expected to benefit. The noble Baroness gave an example of research in the USA into Alzheimer's disease that did not involve patients. Much basic research is done in that way but, at some time, that research has to be applied to patients. One will not know that something will work until it has been tried on patients, so they may, or may not, benefit. It was only when we suspected, but did not know, that early anticoagulation was valuable in patients with cerebral thrombosis that the research was necessary. Once we knew, research on that specific issue became redundant.

    6 p.m.

    So, one cannot know whether research is beneficial until it has been completed. If it turns out not to be beneficial, we will at least know that that line of management is not worth taking in future patients. For that sort of reason I do not think that this amendment is workable in practice.

    Another point arose on research in general on which I should comment. Every one of us relies heavily on research carried out on others who may not have benefited themselves. All those who lack capacity for one reason or another today rely absolutely for their care on research conducted previously on similar patients. There is of course, as the noble Baroness said, a difference between patients who lack capacity and those who do not give consent. But I believe that the robust safeguards which these clauses provide for such patients are clear and unambiguous and should give some reassurance on the reasonableness of this approach.

    If the amendments are agreed, we will be denying patients lacking in capacity the opportunity that the rest of us have of gaining the benefits that research can bring.

    As the noble Baroness, Lady Knight, was moving Amendment No. 105, I was thinking of a piece of fiction written just after the Second World War by C S Lewis called That Hideous Strength. One of its central characters is Lord Feverston, a fictitious Member of your Lordships' House, who sets up an organisation called NICE. The acronym stands for the National Institution of Coordinated Experiments. He attracts a young academic, Mark Studdock, into the work on which he is engaged. It takes on a real momentum because there is a desire to make the kind of progress often advanced by those in favour of experiments and research. Those on one side of the argument who are opposed to the development are called the Diehards and those on the other side are called the Progressive Element.

    The debate taking place in the Committee today in a way reflects the division recorded in that piece of fiction. Of course the progressive element will argue that good can come from research. The noble Lord, Lord Turnberg, advanced the kind of instances where we with capacity give consent for our organs and bodies to be used for research if we become seriously ill and believe that such research will bring advances for other patients and the wider community. That can be a deeply altruistic and generous thing for someone to do. I certainly have no problem with it and know that the noble Baroness does not either.

    However, the noble Baroness has very carefully in her amendment and in the argument drawn the distinction between that situation and the situation for people lacking in capacity where we are deciding on their behalf that it will be for the greater good to allow and permit these experiments. In those circumstances, we must at least address some of the central points that the noble Baroness made in what I thought was a very persuasive speech to the Committee today.

    I should like to take the Committee back to the use of the word "reasonahle"—a point raised by the noble Baroness—and directly ask the noble Baroness, Lady Andrews, why that very casual test and very soft word has been used so repetitively throughout this section. There is also the other issue of direct interest. We all know that if we have a hobby-horse, an issue that we care passionately about, sometimes we are tempted to drive that on at the expense of all other considerations. Therefore, ethical issues and concerns could be—not always will be—set aside, sometimes out of nothing more malicious than enthusiasm. However, I think that if the researcher has a direct interest with the person without capacity, and that researcher is the person who gives permission for the research to be carried out, a cordon sanitaire needs to be erected between the person lacking capacity and the person performing the research; some other person should be involved in validating such a decision.

    A sterner test is required, as is suggested in the amendment. Clause 31(4)(a) states,
    "have the potential to".
    The noble Baroness, quite rightly, directed us towards her preferred choice of words,
    "directly benefit P".
    That is a better test in these circumstances where we will be acting on behalf of someone lacking capacity. Any research that is carried out should be of direct benefit to that person. I think we would be well advised further to consider the issue.

    I well understand the issues raised by the noble Baroness and the noble Lord, Lord Alton. Clearly, there must he sufficient safeguards in the circumstances described to ensure that research is properly carried out. I look forward to my noble friend's response.

    My problem is with the wording of the noble Baroness's amendment. I should have thought that replacing the word "potential" benefit by "directly" benefit would have precluded all research. I do not see how one can start with a thought that there will be an absolute guarantee that a person affected in this way will directly benefit. Surely, research is a voyage of discovery. We do not know the outcome of that research. We can presume and hope that there will he benefits. But I do not see how one could absolutely guarantee in advance that there would be a direct benefit. I should be grateful for some clarification on that point.

    The noble Lord brings great experience to this debate from his previous ministerial responsibilities. Does he accept that a linkage should be made between the specific condition of the patient and the research being carried out, so that there is a possibility that it might help or remedy the condition that the patient experiences, rather than just a wider and much vaguer idea of the general good?

    Once one starts to define matters in the way the noble Lord does, I suspect that it becomes much more difficult to undertake research. I must confess that I am attracted to the concept of the greater good. Whatever our circumstances I think that there is justification for that, provided there are sufficient safeguards. Certainly, the amendment proposed by the noble Baroness is far too draconian. I do not think any researcher could set out under those circumstances.

    Will the noble Lord, Lord Turnberg, give the Committee a few examples of the sort of research that would be conducted on people with learning difficulties that could not be carried out on other people? I know that a lot of research is performed on the brains of dead people. I have seen an Alzheimer's brain, which is quite different from a normal brain. But research on dead people is quite different from research on the living.

    I am not sure that I can dream up a research project on the spot. I imagine that patients with learning disability have specific defects in their learning. One would want to conduct the research on that particular element. One would want to know how and why the learning difficulty affected them and perhaps try to improve on their management. The aim would be directly to benefit those with learning difficulty, but one could never be sure of improving directly the care and attention of that specific patient on whom the research was conducted.

    In general terms, quite a lot of research demonstrates that people who engage in research projects—that is, the subjects—receive better care and attention and fare better than those who are not involved in research projects. That is an indirect effect, which is due to the fact that greater attention is paid to their care.

    In Amendment No. 106, I take a slightly different tack from that adopted by my noble friend. As I said earlier, I think that the words "have the potential to" are the only appropriate words in the context of research, which is, by definition, exploratory. I agree fully with what the noble Lords, Lord Hunt and Lord Turnberg, said in that connection.

    Having said that, I am sympathetic to my noble friend's wish to insert the word "directly" here. Surely, we are talking about two distinct types of research in paragraphs (a) and (b). Paragraph (a) is research where there is a possible benefit to P; and paragraph (b) is research where there will be no benefit to P, but potential benefits to other people.

    That is a perfectly valid distinction; it is undesirable to blur the line between the two. I am not happy that, as the clause is now worded, the first category could include research where the potential benefits to P are not direct therapeutic benefits at all, but benefits that are, at best, indirect and certainly nothing to do with the patient's actual condition. For example, the patient may be suffering from an irreversible genetic condition. The research conducted on him may be designed primarily to benefit a family member with the same genetic profile. In the loosest sense, the research could be taken as benefiting P, but it would not be of direct benefit to P. That sort of research should rightly fall under paragraph (b), but it would get in under the wire of paragraph (a).

    What is the merit in not being absolutely clear cut about the distinction? It is a distinction that matters because the wording of Article 17 of the European convention makes a particular point of distinguishing research that has,
    "the potential to produce real and direct benefit to [the person's] health",
    and research that,
    "has not the potential to produce results of direct benefit to the health of the person".
    The second sort of research may be authorised only under exceptional circumstances. I have resisted the idea of introducing the word "real" here—as I said, the convention talks about "real and direct benefit"—because I am not at all sure what the word "real" means or what force it carries. But the word "direct" has a very clear meaning and reduces the potential for lines to be blurred. If the European convention contains it, why have the Government not included it?

    This has been an absolutely fascinating debate. I shall try my best to answer the questions raised. I want do so carefully and to be careful not to use emotive language. I will not use the word "experimentation", although I understand the noble Baroness's reasons for using it. The debate has enabled us to explore the safeguards that must be met before people who lack capacity can be involved in research. I respect the intention behind both amendments.

    I shall begin by talking about consent. The noble Baroness based a large part of her argument on the assumption that people who do not have capacity do not have to give consent to be involved in research. That is not true. In Clause 30(2)(2), we make it absolutely clear that those who lack capacity can be involved in research only if they have given consent. As the noble Baroness went on to say, in other cases carers and families are most closely and carefully involved. So just as none of us can be involved in a research project without giving our consent—the noble Baroness was quite right about that—neither can anyone who lacks capacity. They must give consent or, if there are difficulties with interpreting consent, their carers and families must give consent on their behalf.

    I am most grateful to the noble Baroness for giving way. She referred to Clause 32(2). Was that what she meant? I am finding a little difficulty in following that, but I shall think very carefully about the rest of what she said.

    I meant Clause 30(2)(b). If there is any further ambiguity, we can discuss that later.

    I appreciate that the noble Baroness and other noble Lords do not want people without capacity swept up into research on a casual, frivolous basis, or being exploited in any way because researchers are too lazy to search for a control group of people with capacity or are simply not scrupulous enough to follow up their best interests. Absolutely not; I could not agree more. None of us wants that. That is precisely why we have drawn the Bill so carefully; why its language is careful; and why the safeguards are strong. I shall come to the safeguards in a moment.

    6.15 p.m.

    I shall try to reassure the Committee about the purpose of research. That has been very well addressed by my noble friends Lord Turnberg and Lord Hunt. I remind the Committee what we said. My noble friend Lord Warner cited the code of practice, which states:
    "Research has been defined as an activity that attempts to derive new knowledge by investigating clearly defined questions (hypotheses) using systematic and rigorous methods".
    Research is about finding out things that we do not know. Research involves intellectual risks. It involves elusive uncertainties. Important discoveries are made by accident, so to say that research should not explore potential to benefit is exactly like saying that research should explore only what is known. That is a contradiction in terms.

    When we took the advice of the Joint Committee about including research, we took its point that the Bill would be incomplete without reference to such a critical activity that promises so much benefit to our understanding and treatment of distressing conditions. The committee said that it was right that people who lack capacity should not be denied the benefit of research. On Second Reading, I was struck by what the noble Baroness, Lady Barker, told us: that a person who is disabled or lacks capacity may still have the capacity to want to give, to want to contribute. It is part of the civil rights of those who lack capacity to be involved, where they want to and are able to. That has been echoed by the Making Decisions Alliance. I am sure that we all agree with that.

    I turn to the amendment. Let me explain what we want to achieve for people with mental incapacity and those who may develop conditions in future. As I said, research is a complex term. It is challenging. It is based on the collection, testing and validation of evidence. When I address issues such as what is reasonableness, I shall talk about the nature of evidence and what we mean by it. It must be constantly reviewed and refined.

    We do not want potentially to condemn people with incapacitative conditions to medical treatments that are based on extrapolation from studies involving only people who consent. Some research can, to be effective, be done only with consent from people who have the condition. Otherwise, if we are extrapolating from people without the condition, we may end up with incorrect solutions, or we may err unnecessarily on the side of caution. In any case, that conflicts with the principle of evidence-based medicine.

    The desire that we all share is for well regulated, properly conducted research with maximum safeguards that will lead to new and effective treatments and improvement in services for people who lack capacity and to ensure stringent safeguards for the people who take part in research. Very often, we know only with the benefit of hindsight which treatment produces more benefits for the participants.

    I shall give the Committee one example. Research proceeds on the basis of testing and discarding hypotheses. There was a recent trial, called the CRASH trial, of the therapeutic value of steroids for head injuries. It was supposed to prove the effectiveness of a standard treatment of steroids to prevent brain damage in those with serious head injuries. That was the aim. Instead, research showed that steroids reduced survival and that it was wrong to assume that what was effective for other trauma was equally effective for head injuries.

    We need to perform such research to test some assumptions that have been the basis of medical practice for many years. We now have the knowledge and, often, the technology, to revisit some of our medical assumptions. That is extremely important, because it is the only way that people will benefit in future. We perform research not only for those who are suffering today but those who can be prevented from suffering tomorrow.

    Our key consideration in the ethical governance of research, and in the Bill, is how to balance the need for the ability to benefit from the full range and the full methodologies of research—from its purest form, looking for a cure, to its most applied form, looking at how we manage and improve the situation of people in, say, care homes. We want to enable and support all forms of research to get the maximum benefit.

    The noble Baroness was concerned about our safeguards. They are very strict, indeed uncompromising, and there are four of them in Clauses 30 to 33. In determining approval for research at the first stage, research will be carried out on people lacking capacity only if a research ethics committee agrees that the project is necessary, based on its collective wisdom and experience. Again, I refer to what the noble Baroness, Lady Carnegy, said about the scrupulous way in which the experience of the research ethics committee is brought to bear on those people. She said that more time and care is taken with people who have problems with capacity and other more vulnerable people. That is what we would expect to happen. As she said, these are not amateur bodies. Research will be carried out only if it is safe in relation to the likely benefit to that person or to others.

    I shall talk about what we mean by "disproportionate burden" because that involves what we mean by "safe". The research will include participants with mental incapacity only if it cannot be done effectively using people who have mental capacity. The researcher must make the strongest possible case to the research ethics committee that there is not another group of people with capacity who can equally produce the valid research that will make the difference. Those are not simple tests. Noble Lords who have been involved in research know that they are stringent tests, where the evidence is challenged by experts. Most importantly, as I said, the research will be carried out only if the person is content to participate and his or her family or carer agrees that the individual can be part of the research.

    There are three other conditions. The research must be into the condition that the person has or is in; it must not be possible to carry out research involving those with capacity. The research must have the potential to benefit and must not be disproportionate to the risk or burden. What do we mean by the notion of safety? By "burden" we mean the risk or inconvenience of a trial. For example, researchers might submit a proposal to use an MRI scanner to understand the brain structures of people with dementia or schizophrenia. It might be of potential benefit to their treatment. But if the use of an MR1 scanner required long confinement—we know that people with mental capacity or those suffering from cancer or claustrophobia can be very vulnerable to extreme worry in these situations—or perhaps regular or frequent scans, an ethics committee might decide that the research would simply not bring enough benefit to justify the extra scans or trauma that might be involved. So the request to carry out research could be rejected.

    It is for the experienced research ethics committee to make those decisions. We must also bear in mind that, to be valid, research must achieve what we call equipoise: the aim and design of the research must produce the valid result and not something that is skewed accidentally. We must not overlook the provisions about safeguards on research once consent for the individual's participation has been obtained—the noble Baroness paid a lot of attention to that.

    Every person who lacks capacity will have to be properly enrolled in the study and the views of his or her carers sought. The noble Baroness asked who would speak up for the participant. Anyone who is involved can object, not only to the person's participation in the research but to their response to being in the project. Under Clause 33(3), anyone who comes into contact with the person and who has an interest can say that the person is not responding well to the research and that they would like him to be withdrawn or not to take part in the first place. The person's current or previous views must be respected. Researchers must respect any request or indication from a carer.

    It is wrong to assume that researchers will be more cavalier about the safety and comfort of research participants who do not have capacity. The amendment would remove the requirement that the research "have the potential to" benefit the person. My noble friend Lord Hunt spoke powerfully about what that means. What would we lose if we were only to research problems that could guarantee a direct benefit? What about accidental discoveries?

    An example is that research using MRI scanners has shown that the brains of people previously thought to have learning disabilities resembled those of people with schizophrenia. That has indicated that the primary problem is schizophrenia and there are therefore huge differences in diagnosis and treatment. Until the research was carried out, we would not have known that. Obviously, if the researcher had not been able to satisfy the research ethics committee, it would never have agreed to the research.

    The amendment is well intentioned, but there is serious danger that much of the vital research that we count on to make the difference with people with mental incapacity could be imperilled. We must be very careful.

    What can we do to strengthen the safeguards? What assurances can I give the noble Baroness? We have a code of practice to accompany the Bill. We are looking very closely at the issue, and this debate is important in the process. We will consult widely and look hard at how else we can assist and guide ethics committees and researchers in the appropriate interpretation of the provisions. There will be very full consultation.

    The noble Earl's amendment would insert the word "directly". We dealt with the problem in principle, but I must tell him that, contrary to his assertion that the amendment would clarify the provision, it could seriously complicate what we are trying to do. How would one define "direct"? As an immediate, specific change affecting the person, in a day, a week or a month? How would you measure it? If defined as a marked change of condition, who would determine that? Would it be a new therapy or a new treatment, for example? Our conclusion is that to make the test any stricter would mean that ultimately only the courts could decide what was or was not a direct benefit.

    In response to the noble Baroness, the noble Earl and the noble Lord, Lord Alton, who is concerned that we have not lowered the threshold for acceptability, the point about "direct" is covered in a way that is not dealt with in the international conventions, which is why we are confident about our approach. We must not make the mistake of looking only at Clause 31(4) and overlooking the importance of Clause 31(2). The clause ties the research to a condition that the person is in and to the cause of their incapacity. There is interlinking between subsections (2), (3) and (4). It will be bound to follow that the end benefit that accrues from the research, and the way that it is packaged, will be of direct and real relevance to the committee.

    The joint scrutiny committee wrestled with the notion of "direct". It drew attention to the difficulty of applying the equivalent Scottish Act's test of "real and direct". It heard from a Scottish clinician that one of the provisions was that research must be likely to be of real and direct benefit to the adults. But the judgment was that there was real difficulty in doing that. The doctor in question said that, if they were going to do what would be of real and direct benefit, they would be doing it; they would not be researching it. That is a fairly substantial answer.

    To prove reasonableness, there must be a test of evidence. "Reasonable grounds" is not a casual or low threshold. The research councils must satisfy themselves that the conditions have been met and there must be reasonable grounds. To establish reasonable grounds, they must show that they have knowledge of relevant facts or have taken into account relevant information, which includes matters of which they ought to have knowledge, and that they have not taken account of irrelevant information in reaching their determination. For example, under Clause 31(5) they should be able to show what evidence they used to assess the degree of risk to P from taking part in the project.

    The noble Lord has referred to the international conventions. The Bill is consistent with, but not identical to, the Council of Europe biomedicine convention. We are aware that that is now eight years old. It has already spawned an additional protocol. The Council of Europe will seek the views of member states on aspects of the convention; so the convention is not immovable. It is only one of a number of important sources that we are drawing on.

    6.30 p.m.

    I hope that I have addressed most of the issues that were raised. I have not addressed the distinction between Clause 31(4)(a) and (b), to which the noble Lord was right to draw attention. We will come to that in the next group of amendments, in, I hope, a little less detail. It looks as if I have not addressed most of the points raised by Members of the Committee, but I have done my best. Perhaps the noble Baroness will feel able to withdraw her amendment at this stage.

    Before the noble Baroness withdraws her amendment, I should like the Minister to return to a point that was raised earlier as regards the direct interest that a researcher might have with the person on whom research was taking place. Should a suitable barrier be in place so that no researcher should ever be able to give the authority for research to proceed?

    I cannot give the noble Lord a swift answer on that. It may be that there are protocols in the governance of research which prevent that from happening. I shall have to seek advice from my noble friend, but I shall be happy to look into it and to answer the question.

    Before my noble friend sits down, perhaps I may suggest that Amendment No. 120, standing in my name, might help the noble Lord, Lord Alton.

    I am grateful to the noble Baroness for much of what she said. I confess that I do not think that all of my concerns have been met, but I have no doubt that she has done her very best.

    Either I misunderstood the noble Baroness or one of us is wrong. I understood her to say at the beginning of her remarks that Clause 30(2) indicated that a mentally handicapped person could not be used without his consent. But I do not think that Clause 30(2) means that. It states: "Research is intrusive"—but what is "intrusive"?—
    "if it is of a kind that would be unlawful if it was carried out—
  • (a) on or in relation to a person who had capacity to consent to it, but
  • (b) without his consent".
  • From that, I do not understand that the clause states that a mentally handicapped person will not be used.

    The noble Baroness and I will have to disagree. My interpretation and best advice is that no research will be carried out that would be unlawful on a person with capacity. Consent must be obtained from the person without capacity. I will write to the noble Baroness to give her more supporting and contextual evidence.

    Before the noble Baroness sits down, perhaps I may say that all people with a learning disability—referred to just now as mental handicap—do not necessarily lack capacity.

    I am most grateful for that point. In my experience, during discussions outside this Chamber but within this House with people who are in some way impaired, I was very pleased to find that quite a number of them do not lack capacity.

    I am not in any way against research. I am trying to say that one must never make use of a person who cannot give consent. In connection with that, European legislation makes it clear that the interests of the patient always—I repeat, always—prevail over those of science and society. It is that that I am so anxious to preserve. I wish we could—perhaps we may—look at the numbers of people who might agree when it is explained to them. Those people can grasp a situation. Many of them want to help. I would not be against using them at all.

    My major concern is that it is wrong to use people who are incapable of saying "yes", just because they are there and have a certain condition. That is what is behind this amendment. If I withdraw this amendment, perhaps we may return to my great concern on this matter and try to seek better protection and another way of doing it.

    We look forward to the next round of debate. I will see what I can do to clarify the assumptions made by the noble Baroness. I would just stress that we believe in all sincerity that the safeguards that we have got, the conditions that are attached, the language that we use and the protocols that already exist are very robust, even compared with some of our international partners. The point made by the noble Baroness about science and society will be addressed in a later amendment in the name of the noble Lord. Lord Alton.

    I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [ Amendment No. 106 not moved.]

    In calling Amendment No. 107, I must advise the Committee that if it is agreed to I cannot call Amendments Nos. 108 to 110 inclusive because of pre-emption.

    [ Amendment No. 107 not moved.]

    moved Amendment No. 108:

    Page 17, line 39, leave out "or" and insert "and"

    The noble Baroness said: I can see that there is an argument for research to be carried out for "the greater good". However, I feel that we should not encourage a "we can so we will" attitude to research. Although the Minister has allayed some of my concerns, we must remember that in 60 years' time we will be judged on how we cared and protected the most vulnerable members of our society. Do we want to be remembered for legalising experimentation on people who lack capacity?

    If there is no potential to benefit the patient, no research or experimentation should be carried out on someone who lacks mental capacity, unless specific permission has been given in an advanced decision. If we include Clause 31(4)(b) without a "must have" subsection (4)(a), we cast doubts over the kind of society that we are. We are supposed to be a caring, compassionate and humane society. Let us keep it that way. I beg to move.

    Amendment No. 127 is grouped with Amendment No. 107, which was moved by my noble friend Lady Chapman. Perhaps I may say in parenthesis that I strongly support the sentiments that she has just expressed. During our previous debate, we had some discussion about the safeguards of the use of medical research ethics committees. Quite a lot of store has been placed on them, following the intervention made by the noble Baroness, Lady Carnegy.

    Before moving to the major argument that I want to put forward in favour of Amendment No. 127, it might be worth saying to the noble Baroness, Lady Andrews, that—given the kinds of concerns that my noble friend has just expressed—there are representative statutory organisations, such as the Disability Rights Commission, the Disability Rights Alliance and the groups that we have been hearing from during these proceedings. In addition to those people who already serve on the ethics committees, it might be worth the Government's while to think about including someone specifically from the Disability Rights Commission or one of its nominees to serve on such committees to act as a watchdog.

    I serve on my university's ethics committee. It looks at issues, such as the use of animals in experimentation. Under Home Office guidance, it is required that someone is there to put the case of whether the experiments are necessary or repetitive, and so on, which is the role that I perform on that committee. It seems to me that that would not be a bad model to have in this context. It might give some comfort to some of those who have expressed anxiety of the sort that we have heard in Committee.

    In the 23rd report of the Session 2003–04 of the Joint Committee on Human Rights, there was severe—I use that word deliberately—criticism of this Bill's proposals on medical research on the mentally incapacitated, as the noble Baroness, Lady Knight. rightly said at the conclusion of her earlier remarks. The Joint Committee pointed out that the provisions of the Bill do not match those of the European Convention on Human Rights and Biomedicine. The UK has not yet ratified the convention, but in relation to the provisions on research it does accept that it represents "longstanding international consensus", a phrase that the Government themselves have used.

    Among its many concerns, the Joint Committee has stated:
    "It seems to us, on initial consideration, that the introduction of the reference to there being reasonable grounds for believing that the research would be less effective if carried out only on persons with capacity is a significant dilution of the condition contained in the Human Rights and Biomedicine Convention, which states the requirement as a matter of fact rather than as a matter of reasonable belief.
    "We find it impossible to avoid the conclusion that the nature of the benefit from the research required in clause 31(4) of the Bill has the effect of lowering the threshold of when research will be permissible compared to the standards contained in the Convention. The absence of a reference to the potential benefit being 'real and direct' in clause 3I(4)(a)"—
    a point that we have just discussed—
    "the breadth of the test for whether the research is intended to add to the sum of general knowledge on the subject under clause 31(4)(b) and the absence of a structure in which it is only in exceptional cases that research may be conducted which does not have the potential to confer a direct benefit on the person concerned all amount to relaxations of the standards contained in the Convention".
    I shall quote a little further from the Joint Committee because we should take great account of these deliberations. They are obviously of huge importance and they reflect directly on the provisions now being considered:
    "We again consider, on an initial comparison of the two requirements, that the provision in the Bill is a much weaker requirement than that contained in the Convention".
    A few moments ago the noble Baroness, Lady Andrews, told us that the Government are satisfied that the position taken by the Bill is a stronger one. But that is not the position outlined by the Joint Committee on Human Rights. It says that it is a much weaker requirement than that contained in the convention. The report goes on to state:
    "The introduction again of a reference to `reasonable grounds for believing', the reference to 'negligible' rather than 'minimal', and the introduction of the qualification that the impact on the person's rights should not be 'significant', all in our view reduce the threshold for the carrying out of research on people lacking capacity, and therefore make it more likely that such research will be carried out in circumstances which are not contemplated by the Human Rights and Biomedicine Convention".
    It could not be clearer than that.

    Surely it is therefore incumbent on the Government to ensure, as the Joint Committee on Human Rights suggests, that the provisions on research are in accordance with internationally agreed standards.

    As the Joint Committee on Human Rights recognised in its most recent report, published only last week:
    "Securing the benefits of research for people who lack capacity is a legitimate aim, but pursuit of it must be accompanied by strict safeguards in order to be compatible with the rights of people lacking capacity".

    It is difficult to comprehend why a Bill which purports to safeguard the rights of the mentally incapacitated should allow research to take place on these people without their consent and without benefit to the person being experimented upon. Assurances from the BMA and others that everything will simply be all right and we just have to trust the researchers do not really wash with the general public, nor do I believe that they should do so with Members of the Committee.

    The Minister knows that I am unhappy with the principle of non-therapeutic research on the mentally incapacitated. It is a view that I expressed during the recent briefing that was kindly organised by Ministers, and I have also been in correspondence with the Government on the matter. It does not fit well with the overriding principle in the Bill that any acts done or decisions made on behalf of a person who lacks capacity must be in their "best interests".

    The fact that the research may be for the benefit of a wider section of society is arguably irrelevant. After all, if I am a person of full capacity and a doctor asks me whether I would be prepared to consent to tests, albeit not massively intrusive tests, which are not for my direct benefit but might benefit thousands of other people, as the law in this country currently stands—thank goodness—it is my right to say no. The idea that if I were incapacitated someone could make the decision for me is therefore deeply troubling.

    The Government have argued that they have departed from the language used in the European Convention on Human Rights and Biomedicine and the Helsinki Declaration principally because the Mental Capacity Bill is intended to cover a broader range of research than direct medical interventions on the person, extending also to health and social care research projects which may include accessing medical records or observation of the person in their care setting. Yet there is nothing in the Bill to make that explicit. As the Joint Committee on Human Rights has observed,
    "designing a single set of provisions which is designed not only to cover intrusive medical research but also other less intrusive types of research has the effect of diluting the standards applicable to the former type of intrusive research".

    No doubt the Government are studying the recommendations of the Joint Committee on Human Rights and I am sure that when the noble Baroness comes to reply, she will want to give at least an interim response. But I hope that the Government will feel able to be flexible and positive in their response to these recommendations. For some time now I have argued that the very fears that many hold about research, and which were so eloquently expressed by my noble friend Lady Chapman earlier, could be assuaged if the Government were to include in the Bill the words from the Helsinki Declaration: where research is being considered, the,
    "interests of science and society should never take precedence over considerations related to the well-being of the subject".

    It is in that regard that I draw the attention of the Committee to Amendment No. 127 in my name and that of my noble friend Lady Masham which states:
    "The clinician and health-care workers responsible for the care of P shall remain responsible for protecting the life and health of P and shall, at all times, ensure that P's life and health are protected during the course of research.
    "At all times, the life, health and well-being of P shall take precedence over the research [the Helsinki point] being carried out on P and, in the event of any danger to P's life, health or well-being, P must be withdrawn from the project unless his life, health and well-being can be protected by the research being undertaken in a different manner".
    Now that the Joint Committee on Human Rights has endorsed the standard outlined in my amendment, I hope that the Government will introduce on Report a suitable amendment incorporating that concept.

    6.45 p.m.

    I do not think it will come as a surprise to the noble Lord, Lord Alton, to learn that I have a lot of sympathy for his amendment. I like the idea that he expresses because it places emphasis on the role of the clinician, the person looking after the patient, to act as a sort of protector during research. That is absolutely critical.

    While I have some problems with the exact wording used in the amendment, I like the idea behind it, but there may be a possible conflict with an advance directive if a clinician is responsible for protecting the life of a person against his advance directive. Some confusion may arise on that. However, I like the suggestion that the clinician looking after the patient must take some responsibility in this area.

    In Amendment No. 109 I approach this issue from a rather different angle from that of my noble friend in the last set of amendments because I do accept that there are circumstances when it is ethically justifiable to carry out research on someone who is mentally incapacitated, even though there is no prospect that the research will benefit them directly. I must make my apologies to my noble friend for taking a different view.

    It is a principle recognised in the European convention. I believe that that is quite right because without such research we would not be able to advance our knowledge of possible treatments for genetic disorders, to take but one example. A whole host of compelling examples could be cited in this category of research, such as the possible link between Down's syndrome and pre-senile dementia, research into the right amount of anaesthetic for patients who have suffered a bleed on the brain, and research into dementia and variant CJD. So, with great respect to my noble friend, I do not think that we can or should prohibit this type of research, provided that it is carried out only under very strict conditions.

    However, like the noble Lord, Lord Alton, what concerns me is that paragraph (h) is worded too loosely. The key requirement in the European convention is that this type of research should be "exceptional". It should,
    "have the aim of contributing, through significant improvement in the scientific understanding of the individual's condition … to results capable of conferring benefit to the person concerned or other persons … afflicted with the same … condition".
    I have abbreviated the quotation.

    Where in this clause of the Bill is the word "exceptional"? Where is there a mention of the words "significant improvement in scientific understanding"? The words are not there. The clause simply refers to,
    "knowledge of the causes or treatment of, or of the care of persons affected by, the same or a similar condition".
    That seems to be a much, much weaker formulation. I have to ask the Government why that is. Adding to the sum of general knowledge is not the same as contributing a significant understanding where the circumstances are exceptional. We need much more convincing answers from the Government than the ones they furnished on these issues to the Joint Committee on Human Rights.

    Perhaps I may ask the noble Earl whether one of the problems is that it is very difficult to forecast in advance whether a particular piece of research will be highly significant. When we embark on research, we set out on a journey.

    The noble Earl did not mention the safeguards contained in subsection (5). If subsection (4)(b) is the only reason that you can rely on research being authorised, and if you do not have the comfort of subsection (4)(a), you then have built-in the safeguards contained in subsection (5).

    We must have safeguards but we also have to reflect on the challenges which face eminent researchers who, in large regard, bring a strong and responsible ethos to the conduct of research. Some of the barriers which noble Lords have suggested researchers should go through may be very difficult for them to meet.

    I have no problem with the thrust of the safeguards in subsection (5); I think they are admirable. We shall come on to debate their detail in a while.

    I agree with the noble Lord that research is by its nature exploratory and that you cannot guarantee anything in advance. However, the convention states—and I cannot find fault with it in this respect that this type of research should have the aim of contributing through significant improvement in the scientific understanding of the individual's condition to results capable of conferring benefit and so on.

    So the aim should be there. It seems to me that that aim should be capable of being demonstrated to a research ethics committee. If a research ethics committee is satisfied that, in good faith, a research team has that aim and that the research is capable of producing that kind of result, I have much less problem. I do not think that that is an unobtainable thing to ask of a research team. It is not asking the research team to commit itself to absolute certainty in advance; it is stating that the research involved should not be a tinkering at the edges of something that is of no material gain to medical knowledge but that it should be something significant. The word "significant" is an important addition to the wording.

    I am grateful for the opportunity to explore some other aspects of these issues, particularly in relation to the research defined in subsection (4)(b). The previous amendments allowed us to debate the relationship between the potential and direct benefits of research. These amendments drive the debate further, as the noble Lord, Lord Alton, said, because they are specifically concerned with research that provides new scientific knowledge. The noble Lord went on to describe the ways in which that can bring benefits.

    I can see why noble Lords have raised concerns about this clause because, in a sense, it is furthest away from the concept of the individual benefiting. In Clause 31(4) and (5) This is expressed in terms of research that is intended to provide knowledge of the causes or treatment of, or the care of, persons affected by the same or a similar condition.

    But, because it is further away from the notion of individual benefit, we have put stricter safeguards around it. There must be grounds for believing that the research will contain minimal risk to the person—that is a unique condition—and that anything done will not interfere with a person's freedom or privacy in a significant way or be unduly invasive or restrictive. Those are very specific criteria which attach only to this particular class of research.

    It will perhaps be helpful if I briefly describe the kind of research that might be covered. It could, for example, include interventional research—which is sometimes misleadingly called therapeutical research—where the intention is to do something different in the person's treatment or care and to compare it with other approaches or standard best practice. Another category is observational research and studies to understand what is happening to a person or his condition and what might have been the underlying cause; or, in a social research context. how he goes about his daily life and his relationship with family and carers. Although it is a slightly academic framework it can provide a huge range of specific direct and indirect benefits.

    So that is the context in which we are operating. If we had not permitted observational research we might, for example, have lost out on understanding the genetics of the defective gene PKU. Years ago we made the surprising discovery that a simple genetic error of metabolism meant that infants who ate a normal diet suffered major developmental impairment and developed severe learning difficulties. Understanding the genetics of that gene by studying those with the impairment led to the simple screening test called the Guthrie infant heel prick that all babies are now offered routinely. It is an extremely effective way of preventing a devastating condition.

    The question is—I am sure we would all say yes to this—whether it is wrong to conduct research involving those without capacity even if there is no guarantee that there is a direct benefit to them. As I have said, the safeguards are higher for this class of research. Researchers have to convince a research ethics committee of three main safeguards: that what will be done relates to the person's condition and the causes of impairment; that it could not be done as effectively by involving those who might consent; and that the research is to provide knowledge of the causes or treatment of people with the same or similar learning disability.

    As I have said, it has to involve negligible risk. "Negligible" means the same as "minimal", which is exactly the same as the terminology that appears in international instruments such as the Council of Europe Biomedicine Convention.

    Amendment No. 109 seeks to remove the whole of subsection (4)(b) while leaving subsection (5) in its place. In answering the questions raised by the noble Earl, perhaps I may use the language of the convention itself. Why have we framed this in the way it has been framed? Part of that question has been answered by my noble friend Lord Hunt when he explained the difficulty of determining what is "significant".

    Why do we not use the term "exceptional" and follow the Biomedicine Convention? I understand that the convention does not state that subsection (4)(b)-type research is permitted only in exceptional—that is to say, rare—circumstances. In fact, it states that there is an exception to the general rule, which is about the subsection (4)(b)-type of research. The convention explanatory notes, I understand, refer to this as a supplementary condition. So it may be that we are struggling with a misapprehension about what "exceptional" means in this context and what the convention is designed to do. It is an ambiguity trap which we have fallen into. To be quite clear about it, I would prefer to write to noble Lords and spell it out in more detail, so that the supplementary information can be put on the record.

    We are concerned about the effect that Amendment No. 109 would have. It would remove the whole of subsection (4)(b) while leaving subsection (5) in its place. In effect, an ethics committee would require any research to he minimally invasive. We would be outlawing a huge range of research on that basis, which is one reason why we cannot accept the amendment. However, I will return to that point when I deal with the amendment of the noble Lord, Lord Alton.

    The noble Baroness, Lady Chapman, has proposed replacing "or" with "and", thus linking the requirements of subsections (4)(a) and (b). That would require research to be of direct benefit to the person without capacity and to provide new knowledge. Again, that would extend the very strict safeguards in subsection (5) to subsection (4)(a), and for all the reasons that I have given, it would have the unfortunate effect of significantly restricting the scope of research that may provide a benefit to the person without capacity.

    7 p.m.

    On Amendment No. 127, and the issue of the JCHR, we believe that the arguments we put forward in our first response still hold. We are talking about a different class of research in the UK and we have a broader definition of health in the Bill. Of course we are considering how we are best able to respond to this; we will have some things to say about these very difficult and sensitive issues.

    The amendment would place on the face of the Bill a positive duty of care on the part of researchers. It is a laudable aim, with which we are fully in agreement. This is a standard professional duty of care, required by the Government's framework for research, and it sits within the international definitions.

    The Helsinki Declaration is constantly being revisited. It was clarified most recently in 2004. It says:
    "In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society".
    That is precisely what the noble Lord, Lord Alton, has asked us to put in the Bill. Paragraph 10 says:
    "It is the duty of the physician in medical research to protect the life, health, privacy and dignity of the human subject".

    Those principles appear in relation to clinical trials. We are very sympathetic to the need to consider some elements. We wish to consider how we might see some of those fine principles on the face of the Bill. It would have to he very clear to whom the duty fell—that is what we have to establish correctly. There would need to be a limit to what researchers were responsible for and to what extent they could be expected to have regard to all the dangers that a person who is part of a research project might encounter. The amendment does not recognise that duty of care and suggests that the researcher shall "at all times" protect the person's life and health. There is a complex relationship between clinical research and treatment.

    The amendment does not take due heed of the other protections in the Bill. It does not, for example, recognise that under Clause 42, ill treatment or neglect are criminal offences.

    We have some misgivings about the requirement to withdraw the person from research if there is a danger to a person's life, health or well-being. The amendment has some potential pitfalls. However, despite those concerns, let us take this away and look at what we can do to pursue the principles which the noble Lord has very eloquently outlined. I will read very carefully what he said about his amendment in the context of the Helsinki Declaration.

    I have gone at rather a fast pace, and there may be questions I have not addressed, but I can write to the noble Lord.

    I, for one, am extremely grateful for the way in which the noble Baroness has responded to the arguments I advanced earlier. I guess that my noble friend Lady Chapman, will reply, as the person who moved the lead amendment in the group. However, I am very pleased at what the noble Baroness has said and look forward to corresponding with her between now and Report.

    I thank the Minister for that answer. I ask her to go away and think again because a lot of organisations are extremely worried about this part of the Bill. I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [ Amendment No. 109 not moved.]

    moved Amendment No. 110:

    Page 17, line 40, after "causes" insert ", diagnosis"

    The noble Earl said: As it currently reads, Clause 31(4)(b) appears to exclude research on diagnostic issues. The noble Baroness gave an example of such research earlier. Magnetic resonance imaging of the brains of people with learning disabilities has been found to pick up co-existing schizophrenia. A further example is that of imaging and neurological studies to detect prion disease such as variant CJD.

    The amendment is a very simple one, designed to rectify what appears to be an omission. I beg to move.

    I have a very simple answer, too. Research into new and better diagnostic methods is important, and we are clear that the Bill covers that. Clause 31(4) allows research to be approved if it is intended to provide knowledge of the causes or treatment of, or the care of persons affected by, the same or a similar disorder. In the interpretation in Clause 60, on page 33, the definition of "treatment" includes a diagnostic or other procedure. I hope that that helps the noble Earl.

    Researchers and RECs have an obligation under the Bill to have regard to and comply with the code. We will be consulting on the code of practice later and will look at the best ways of bringing this range of interpretations to people's attention. We will also seek help from the research groups. There are terms in the Bill which will become clearer in the code of practice—this is one of them.

    I am most grateful to the noble Baroness. I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [ Amendment No. 111 not moved.]

    moved Amendment No. 112:

    Page 18, line 1, after first "the" insert "additional"

    The noble Earl said: In Clause 31(5)(a), the term "risk" fails to make clear that it is the extra risk of participating in research that must be minimal. The patient may already face considerable risks by virtue of the condition that he or she is in. I am suggesting, at the prompting of a number of bodies, including the MRC, the Wellcome Trust, the Royal College of Physicians and the Academy of Medical Sciences, that the word "additional" should be inserted before "risk" in line 1 of page 18. I beg to move.

    I understand the concerns underlying the proposal. We should be clear that the risk referred to is the extra risk associated with taking part in research. Even if not taking part in a research project, a person may already face certain risks because of his or her underlying condition. We feel that the Bill is sufficiently clear on this point. It refers to,

    "the risk to P from taking part in the project",
    so we see no need to amend it.

    To take one example, research to monitor the levels of oxygen in the brain can improve survival in patients with head injuries. Research involving an additional oxygen probe in the same cranial incision used for the clinically necessary purpose of monitoring cranial pressure may provide valuable knowledge. In this case, the risk associated with the research would come from using a new type of probe, which I think we would agree would be negligible, rather than from the cranial incision.

    Including the word "additional" would change the effect of the subsection significantly. We believe it could even have the unintended effect of requiring research ethics committees to look beyond just the risk of participating in the project to the person's general prospects of survival.

    We agree that the important factor in looking at the additional quantum of risk is between taking part and not taking part in research. I realise that that is not the noble Earl's intention, but there is a real danger that the amendment could lead to a situation whereby a maverick researcher could seek protection behind the severity of a person's underlying condition. He or she may seek to argue that the person's prognosis is so bleak that any additional risk to him or her from taking part in a highly risky project is likely to be negligible. This would have the perverse effect that the more seriously at danger a person is from his or her condition, the more risky the research project could be within the meaning of the Bill. That is not something that we want to achieve. Our advice has been to think very seriously about the implications of that and what it might mean in the way I have described. Although the amendment looks innocuous, we are advised that it could confer some accidental disbenefits. I ask the noble Earl to consider that and to withdraw his amendment.

    That was a very helpful reply. I will indeed consider what the noble Baroness said as it is clearly undesirable to have any perverse effects from an amendment such as this. I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    moved Amendment No. 113:

    Page 18, line 4, at beginning insert "unduly"

    The noble Earl said: There is a concern in the scientific community that the word "significant" in Clause 31(5)(b)(i) will be difficult to interpret or apply in practice. I suggest, at the instigation of the MRC, the Wellcome Trust and others, that we should substitute the word "unduly" for the phrase "in a significant way". The difference may not seem all that material but the word "unduly" is the word used in the next paragraph—I believe appropriately—and it carries with it the notion of proportionality rather than an absolute measure, which may not be easy to measure at all. I beg to move.

    We are committed to ensuring that people who lack mental capacity should not be denied the benefits that can be obtained through carefully regulated research. We have spoken at length this afternoon about the importance of safeguards and the need for them to be as strong as possible. Clause 31(5)(b) is very clear—the research must not interfere with the person's freedom or privacy in a significant way.

    The Joint Committee on Human Rights has been considering the matter and we value its views. We have explained the meaning of "significant way" in this context. It welcomed the clarification of the drafting and in particular our intention that any interference with a person's privacy or freedom of action should be kept to a minimum. The committee goes on to say that in its opinion it would be clearer to substitute "material" for significant, so that the protection requires that anything done to, or in relation to, the person who lacks capacity will not interfere with their freedom of action or privacy in a material way. This is something we are looking at with interest. Although we have not come to quite the same conclusion as the research community, we are looking at the terms, as I say. Therefore, emboldened by the expert views of the Joint Committee, I am bound to say that we do not think the amendment proposed achieves what we and the Joint Committee want. Having looked at this carefully, we feel that changing this to use the word "unduly" would weaken the protections, which I know is not the noble Earl's intention. It would imply that any interference would not be undue—that is, would not be justifiable in view of the aim of the researchers. We have set the test at a low level; that is to say, interference must be kept to a minimum. The noble Earl's amendment would change that. We need to think carefully about that word.

    To give an idea of the context in which we are arguing, let us consider an example that has been used in another place of a researcher who may want to observe how a person with learning disabilities solves an abstract puzzle. He or she may need to do so in a way that means the person is not distracted by the presence of the researcher. To achieve that a two-way mirror may be used. That might be said to be a minimal interference with the person's right to privacy. But suppose the researcher wanted to study the sexual behaviour of the person with a learning disability or how that person bathed or undressed. We believe that filming those intimate moments does not constitute minimal interference but rather a gross intrusion. Many people would hold that view. We need to be careful not to accept a provision which might allow a well intentioned researcher to argue to a research ethics committee that this was not an undue interference—the matter turns on the notion of what is undue—because the aims of the research were vitally important.

    I hope that with that clarification and bearing in mind what I said about the word "material", the noble Earl will withdraw his amendment.

    7.15 p.m.

    Once again I am grateful to the Minister for her full reply which largely persuades me that the amendment I have proposed is wrong. However, I shall reflect further. I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [ Amendments Nos. 114 to 116 not moved.]

    Clause 31 agreed to.

    Clause 32 [ Consulting carers etc]:

    moved Amendment No. 117:

    Page 18, line 37, at end insert "(subject to the following subsection)"

    The noble Earl said: In moving Amendment No. 117 I wish to speak also to Amendment No. 118. These amendments are, I hope, self-explanatory and were suggested to me by the Making Decisions Alliance. Having said that, the MDA did not draft them, I did, and I apologise for the technical defect in Amendment No. 118, which refers to a deputy consenting to the research. Technically, a deputy would not do that even under the terms of the Government's proposals. Consent does not enter into this part of the Bill. However, if the Minister is kind enough to overlook that mistake, I hope that I may explain what lies behind the amendments. They are intended to ensure that where the opinion of a deputy is being sought on whether research may be carried out on someone, and the research is not of a kind that is likely to benefit the patient, that deputy is eligible to be a consultee only if he or she is also a close relative of the patient.

    This is one of those amendments about achieving the right balance in what are quite a complex set of provisions, and I admit that it is a very fine balance. But we need to look at the broader context. The type of research falling under Clause 34(3)(b), which is the research I am concerned about here, is not the kind that is likely to provide direct benefit to the patient. The sensitivities are therefore considerably greater, and we can see these added sensitivities reflected in the wording of the European convention which permits research of this nature only in exceptional circumstances, as we have just debated. The safeguard in this clause of the researcher having to consult a person close to the patient before being allowed to proceed, is a good one, the rationale surely being that only a close relative or friend or carer will be in a position to know what the patient's beliefs, wishes and feelings are—for example, whether the patient is the kind of person who has an altruistic outlook on life, or whether he is not.

    So to say, as it does in Clause 32(7), that a deputy may be one of the categories of people who can be consulted over permission to proceed with this type of research is rather odd. A deputy may or may not be someone close to the patient and may or may not know him well. If he is not, or does not, I do not see how he can possibly be in a position to make a judgment of the kind that the clause invites him to make.

    I am therefore proposing that while a deputy may indeed be consulted for permission to proceed. he or she will at the same time have to be a close relative as well. I hope that the Minister will appreciate the rationale behind the amendment. I beg to move.

    I air what I think is a legitimate concern about this amendment. The noble Earl, Lord Howe, and I have mostly been in agreement on the MDA amendments, along with other Members of the Committee. However, what happens if a person who lacks capacity does not have anyone who falls into the categories named in Amendment No. 118?

    Let us take another possibly real-life situation. What if the person who lacks capacity has someone and that is the person whom he would wish to trust with this sort of decision? I do not disagree with the noble Earl, Lord Howe, when he says that it is of the utmost importance that someone who is close to the person and knows and understands his wishes should be involved. I think that the noble Earl used the word "friend", but that word is not in the amendments. Let us say that someone was raised in a family of Jehovah's Witnesses but had discontinued his subscription to that belief and moved on. Would this amendment mean that his blood relations, for example, would have the power to overrule his wishes?

    I think that there is a parallel in the mental health legislation that is currently being debated. I am sorry that the noble Lord, Lord Carter, is not in his place. I think that the phrase used in that legislation is something about "a nominated person". The intention of that provision is to widen the category of those whom people can nominate to take decisions for them.

    That is my only concern. I agree with the thrust of what the noble Earl is trying to do and believe that it is very important. I am concerned only about the exclusivity of the category of person.

    I am grateful to the noble Baroness for making some of the comments that I shall make and for doing so more briefly than I will be able to do. And far from overlooking the noble Earl's mistake in the amendment, I did not even see it. So I cannot blame him for anything.

    The question of who should or should not be consulted is a very important one. Consultees will have to consider what is involved in the research project and what the person without capacity feels about it. Those are very important responsibilities. Obviously, they will have to know about the aim of the research. It is important, therefore, that the noble Earl has drawn our attention to the issue of research that is slightly distant to the direct benefit element. Consultees will need to know about the procedures involved, the risks and any inconvenience, and then give advice on whether the person without capacity should take part and on the person's beliefs, values, likely wishes and feelings, and, of course, whether the person has made any advance decisions.

    I am very sympathetic to what noble Lords have said. It is extremely important that the consultee knows the person well enough to be able to give advice on that sort of information. Much more often than not, the relationship is likely to be one of carer, spouse, partner or close family member. However, that may not always be the case. That is why we cannot arbitrarily rule out someone who knows the person better than anyone else simply because he is what we call a deputy. It is very important that he knows the person well and is concerned about the person's welfare. That is why we state in Clause 32(2) that the person consulted must not be acting in a professional capacity or for payment. That would, for example, rule out a solicitor who might be handling financial affairs for an unbefriended person.

    However, we believe that it is unlikely that the courts would explicitly grant a deputy powers in relation to research. So we do not want to rule out the possibility, for example, that a health and welfare deputy could be consulted. A deputy, or an attorney, may often be a parent or a spouse, who will know the person better than anyone else. For that reason, as I said, the Bill states that it does not automatically follow that someone cannot be consulted simply because he has been appointed as a deputy or has lasting powers.

    We have again run into the problem of the list—the curse of the list. The problem, by definition, is that we risk excluding people, as the noble Baroness said. The issue is who is best placed to make a decision and how to draw up a list. What about a step-child, for example, or a step-sibling, cousin, great-niece, partner who is not a registered civil partner or friend who acts as a carer? Any of those might be very suitable to act as the deputy but they would all fall outside the amendment and automatically be excluded. There may therefore be the unintended consequence of denying a relative or partner any direct say in that involvement.

    However, we sympathise with the concerns. We have already made a commitment to amend the code of practice on this point. In particular, we will make it clear that a deputy who had no relationship with, or knowledge of, the person who lacks capacity before his appointment as deputy should not be consulted about participation in research. So although I cannot meet the entire spirit of the amendment, I hope that my comments will reassure noble Lords.

    I am grateful to the Minister for her reply and to the noble Baroness, Lady Barker, for her remarks. Yes, I concede that the list of relations is arbitrary. The list could probably be varied without countering the point of principle too greatly, but it would still be a list and would therefore offend the noble Baroness. So I am sure that if I bring this point back at Report stage, it will not be in the form of a list. But I think, perhaps, the noble Baroness has said enough to persuade me that I should not take that action in that she has very helpfully told the Committee that the code of practice has reflected the point at issue.

    Of course, what troubles me is that a court deputy who is not someone close to the patient is the only type of consultee—potentially, on the face of the Bill at least—who is not close to the patient. That makes a nonsense of the requirement in Clause 32(4)(b), which says that the researcher must ask the consultee the question about "P's wishes and feelings". It does not say that whoever is being consulted has to give an informed answer, though that is clearly what it implies. But it does not actually say that.

    So it is absolutely essential for the code of practice to be firm on this point. I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [ Amendment No. 118 not moved.]

    moved Amendment No. 119:

    Page 19, line 3, after "if" insert "the research involves no invasive action in relation to P beyond that which may be required for his care or treatment and either—"
    The noble Earl said: In moving Amendment No. 119 I shall speak at the same time to Amendments Nos. 121 and 122. Clause 32 is all about the obligation placed upon a researcher to consult the carer or someone close to a mentally incapacitated patient whenever they are proposing to carry out research on that patient.

    However, there are some circumstances in which the clause absolves the researcher from that obligation to consult, and these are set out in subsections (8) and (9). If the patient needs urgent treatment and the researcher judges that it is also necessary to pursue the research as a matter of urgency, he need not consult a friend or relative or carer of the person if to do so would be impracticable. Instead he must consult a doctor who is not concerned in P's treatment or care. If it is not reasonably practicable to do that either, he can go ahead anyway, so long as he is acting within the parameters already laid down by the research ethics committee or other approving body.

    That opens up, it seems to me, a number of quite big questions. Are we really saying that no matter what sort of research it is, the researcher can go ahead with it without consultation of any kind? I would challenge that idea. What happens if the research involves invasive procedures? What if it is not research that has any potential to benefit the patient?

    I do not say that we should be too restrictive, but what matters above all in these circumstances, surely, is the added risk to the patient by virtue of the research going ahead. If risk is too subjective a concept for a researcher to assess on his own—particularly in the time available for him to take the decision—then perhaps a better and more practicable benchmark would be the degree of invasiveness that the research involves. That is what I am suggesting in Amendment No. 119. 1 am saying that the degree of invasiveness entailed by the research should be no greater than that entailed by the care and treatment that P is receiving. I do think that that would inject a rather better balance to these provisions which are otherwise too open-ended.

    Amendment No. 122 deals with another instance of open-endedness here. Subsections (8) and (9), as I have said, absolve a researcher in certain circumstances from having to consult anyone at all. However, the clause says nothing about the need to consult after the event, and there ought to be that obligation. Furthermore, if the person consulted says that P would not have wished to take part in the research, that should be the end of the matter; P should be withdrawn from the project without further ado. Just because it has not been practicable to consult a carer or whoever prior to embarking on the research is no reason not to consult them at the earliest possible moment thereafter and abide by what they say.

    In Amendment No. 121, where a doctor is consulted about the possibility of including an incapacitated person in a research project, what counts for the protection of the patient is that that doctor should not be involved in any way in the research project; in other words, that he should have no conflict of interest. The clause as it stands leaves open the possibility of conflict of interest. I cannot see the logic of saying that the doctor who is consulted may not be involved in P's treatment or care; indeed that is precisely the category of doctor who ought to be consulted, as he or she will be able to make a much better assessment about how appropriate it is to include P in the study. Can the Minister enlighten us on the thinking behind this provision? I beg to move.

    7.30 p.m.

    I shall speak to my Amendment No. 120. Subsection (9)(a) of the clause applies in an emergency situation where it is not possible to get immediate agreement from the categories of individuals laid out in earlier provisions of Clause 32. In this case, it allows researchers to seek the agreement of a registered medical practitioner. However, the wording specifically excludes the patient's own doctor—the one who is caring for the patient is excluded. This seems a little odd, as the noble Earl has suggested, because I suspect that many, if not most, patients would be glad if it was their own doctor who was asked for agreement. He is likely to know more about them than another doctor who happened to be passing by.

    Furthermore, it is conceivable, according to the wording here, that one of the researchers who was medically qualified could provide the agreement. That is not excluded, but clearly it would be wrong. The researcher should not be in a position to give himself or herself permission to do the research. My amendment removes the idea that the patient's own doctor cannot provide the agreement, and it inserts the safeguard that it cannot be the researcher who gives agreement for the research to be done. There is a potential problem if the researcher also happens to be the clinician in charge of the patient. We need something else to cover that situation which is not covered in any of the amendments. We may have to think about that.

    The amendment proposed by the noble Earl, Lord Howe, Amendment No. 121, would achieve more or less the same objective as my amendment and spells out more clearly that the researcher should not be involved in giving permission. I am certainly not wedded to my own form of words. With regard to Amendment No. 119, I wonder whether it would be necessary to insert this amendment specifying the type of research if Amendment No. 120 or Amendment No. 121 were accepted, since we would then have the safeguard that the researcher himself or herself could not give approval.

    I am concerned that some research in the emergency situation would be prevented by Amendment No. 119. I give the example of patients in cardiac arrest who have been shown to have an improved survival rate if artificial cooling is given during the arrest. That is now part of standard care. We would not know that if that research, which is relatively invasive, had not been done. I hope that Amendment No. 119 is obviated by either Amendment No. 120 or Amendment No. 121.

    The example given by the noble Lord about cardiac arrest research is research that might well benefit the patients themselves, in which case it would not be caught by my amendment.

    When it was first tried it had only potential to affect the patients. We did not know whether it would.

    I support the amendment because the clause as it stands might open a door to researchers. We all know that keen researchers can get completely carried away with their research and perhaps forget the interests of the patient. We need some safeguards here.

    We are all agreed that emergency treatment research is an important part of the Bill, and we all want to get this right. I will make a few remarks of context before dealing with the amendments. The clauses as they stand recognise that some research inevitably takes place in situations where a person is temporarily incapacitated as a result of a sudden trauma, such as a car accident, stroke, or a serious infection. It is important that such people can have urgent medical attention. It is also sometimes the case that vital research can be done in these situations to understand what changes the body undergoes during the first few moments after the event.

    In such cases of urgency the next of kin, to use a simple term, is often not with the person when the emergency happens. In such circumstances, the researchers need alternative arrangements for seeking the agreement to P's involvement in the study. This may be a doctor who has no responsibility for treating the person, or it may be another person, if that has been agreed in advance with the research ethics committee. Once the need for urgency has passed, the researchers must, under Clause 32(10), follow the normal arrangements for consent to continue in the research, or consultation with the next of kin if the person still lacks capacity.

    The effect of Amendment No. 119 is greatly to limit research to non-invasive procedures that do not go beyond those required for P's treatment and care. While I understand the reasoning behind this amendment, I fear that it will prevent a good deal of vital research. It could be argued that this amendment would mean that if the researchers required a few millilitres of blood that is slightly more than that necessary for P's clinical care they would not be permitted to take it, because that would be additionally invasive. Perversely, it may also prevent the research procedures that are likely to improve P's survival or recovery.

    I am aware of some research that involves using an experimental probe to measure oxygen levels in the brain of those who have experienced major head injuries. The research uses the same skull incision that is made for the clinically necessary purpose of measuring brain pressure. Initial findings suggest that maintaining correct oxygenation of the brain is important in promoting recovery. However, under this amendment it would be considered to be unlawful as it is invasive and goes beyond what is necessary for P's care.

    On Amendment No. 122, I am again grateful to noble Lords for attempting to specify clearly in the Bill the steps that a researcher must take as soon as possible after the emergency passes. It is, of course, accepted by all researchers that the next of kin must be identified as soon as possible, given information about any research, and asked for their views on whether P should remain in the trial. Researchers must respect that view and, if necessary, withdraw P from the research. This is already the effect of the provision in Clause 32(10), which says that the researcher cannot continue to rely on the emergency provisions for longer than is necessary. If he has reasonable grounds for believing that it is not necessary to take action as a matter of urgency he must, retrospectively, consult with a carer and respect their views. While I agree with the steps outlined in the amendment, with respect, they do not take sufficient account of the alternative scenarios that I have mentioned.

    For example, it might be the case that shortly after the emergency the person regains sufficient capacity to give or withhold their consent in the normal manner, or they may make it known that they do not wish to continue in the research. The researcher may become aware of the existence of a previous statement of wishes that affects the research. In those circumstances, he would be obliged, under Clause 33, to respect these views. I hope that noble Lords will accept my assurances that the Government want to strike a balance between protecting vulnerable people while permitting important medical research. I hope that noble Lords will be reassured by what I have said.

    I have a good deal of sympathy with Amendments Nos. 120 and 121, which attempt to widen the category of doctor who might agree to P's involvement in emergency research. We had already sought to achieve that by means of Clause 32(9)(b), which allows much flexibility in deciding who may agree, provided that the research ethics committee approves the proposed approach when deciding whether to approve the research.

    The clauses recognise that some research takes place in the kinds of situations of urgency that I mentioned. However, I accept that Members of the Committee think that they do not go far enough. We already have provisions that might enable an attending emergency healthcare worker—perhaps a paramedic—to make an initial decision to include a person with a heart attack in a trial of better ways of performing heart massage. In such cases, the decisions need to be made in seconds, not minutes, and a doctor may not always be on hand.

    In that regard, it is worth noting that we have announced a consultation on a possible amendment to the clinical trials regulations to provide for emergency research where it is not possible to get consent from a legal representative. I raise that again because the Government feel that we have to make the final arrangements for research in emergencies under the Bill and the clinical trials regulations absolutely consistent. That is important to enable trusts to implement properly the necessary systems for those to be consulted and agree or give consent to a person being included in research or a clinical trial in an urgent situation. It was with that in mind that we sought the ability to produce guidance on the appropriate local approaches to the matter. We have included in Clause 32(3) a provision for the Secretary of State to issue guidance on nominating a person who may be consulted on research involving a person without capacity in such circumstances.

    I accept that there is more work to be done in the area, but we want to make everything consistent between the clinical trials regulations, the Bill and the code of practice. I therefore suggest that we take away Amendments Nos. 120 and 121 and come back on Report with a considered view on the matter, to try to meet the concerns expressed on them.

    I am sure that I speak for the noble Lord, Lord Turnberg, as well as myself in thanking the Minister, particularly for his positive response on Amendments Nos. 120 and 121. That is extremely helpful. I was also greatly helped by the Minister's full answers on the other two amendments to which I spoke. I shall reflect carefully on what he said. I beg leave to withdraw the amendment.

    Amendment, by leave, withdrawn.

    [ Amendments Nos. 120 to 122 not moved.]

    Clause 32 agreed to.

    I beg to move that the House do now resume. In doing so, I suggest that the Committee restart not before 8.45 p.m.

    Moved accordingly, and, on Question, Motion agreed to.

    House resumed.

    Parliamentary Constituencies (Scotland) Order 2005

    7.43 p.m.

    rose to move, That the draft order laid before the House on 14 December 2004 be approved [4th Report from the Joint Committee].

    The noble Lord said: My Lords, my right honourable friend the Secretary of State for Scotland received the fifth periodical report of the Boundary Commission for Scotland on 30 November last year. He laid the report and a draft order before Parliament on 14 December. By doing so, he was fulfilling his obligation under the Parliamentary Constituencies Act 1986, which required him,
    "as soon as may be",
    after he had received the Boundary Commission's report to lay it before Parliament, together with a draft of an Order in Council for giving effect, with or without modifications, to the report's recommendations.

    As I have indicated, the report was laid two weeks after its receipt. I recall during the debates last year on the then Scottish Parliament (Constituencies) Bill that some noble Lords were of the view that the Government were dragging our feet with regard to the Boundary Commission reporting on the new Scottish constituencies, and that it was our intention to delay the reduction of the number of Scottish representatives at Westminster until after the next election. We made it very clear during those debates that that was not the case. The Boundary Commission is entirely independent of government. It was a matter for it alone to decide when, within the legislative framework, it would report to my right honourable friend the Secretary of State. I trust that the very short time taken to lay the commission's report and the draft order implementing its recommendations proves the Government's integrity and the truth of our previous statements on the matter.

    Before turning to the details of the order, I thank the Boundary Commission for Scotland—that is, the deputy chairman, the right honourable Lady Cosgrove, and her fellow commissioners, Professor Gavin McCrone and Dr Elspeth Graham, together with their expert advisers and secretariat—for its work in delivering its fifth periodic report. As noble Lords will be aware, it was a much more extensive and radical review than previous ones, and its recommendations are of very significant consequence.

    The draft order gives effect—I stress that it does so without modifications—to the recommendations made by the Boundary Commission in its report. As noble Lords will be aware, implementing the recommendations will reduce the number of Members of Parliament representing Scottish constituencies from 72 to 59. The boundary changes affect only constituencies for elections to the Westminster Parliament.

    The Explanatory Note attached to the draft order explains its effect. Article 2 of, and the schedule to, the order set out and describe the 59 new constituencies into which Scotland will be divided.

    My Lords, the noble Lord is right that the Explanatory Note says that the schedule sets out a description of the constituencies. Could he use his good influence to see that the schedule is reprinted in a more comprehensible manner? I shall give one example. For Rutherglen and Hamilton West Burgh constituency, the description is:

    "The area of the South Lanarkshire Council other than those parts in the Dumfriesshire, Clydesdale and Tweeddale County Constituency, the East Kilbride, Strathaven and Lesmahagow County Constituency and the Lanark and Hamillton East County Constituency".
    I do not call that much of a description that anyone could be expected to understand. It is entirely negative.

    My Lords, I am grateful to the noble Lord for that intervention, which I shall deal with when I reply to the debate.

    The order will come into force the day after it is made. However, that will not affect any parliamentary election until a proclamation is issued by Her Majesty summoning a new Parliament, or affect the make-up of the House of Commons until the dissolution of the present Parliament. If your Lordships approve the draft order, it will swiftly be submitted to Her Majesty in Council for final scrutiny. If the Privy Council should also give its approval, the intention is that the order will come into effect before the middle of February.

    It may be helpful if I remind noble Lords of the background to the order. The Government accepted at the outset of consideration of devolution that the introduction of devolved government for Scotland would remove the need for special consideration for Scottish representation in the United Kingdom Parliament. That was an integral part of the devolution settlement. Therefore, under the Scotland Act 1998, the Boundary Commission for Scotland was required in its next review of parliamentary constituency boundaries to use the same electoral quota as for constituencies in England. The previous quota for Scotland was around 55,000 electors per constituency. In the recent review, that rose to just under 70,000, as in England. The Boundary Commission started its fifth periodical review in June 2001 and completed its work on the Westminster boundaries in December 2003.

    The Scotland Act provided that once the commission had reviewed these parliamentary constituencies, it then had to look at the regional boundaries for the Scottish Parliament, since these were built from the Westminster constituencies. As required by the Scotland Act, a reduction in the number of MPs would have led to a consequential reduction in both constituency and regional list members of the Scottish Parliament. However, following the consultation that showed overwhelming support for retaining 129 MSPs, as noble Lords will recall, the Government introduced legislation to retain the existing size of the Scottish Parliament. That legislation, the Scottish Parliament (Constituencies) Act, received Royal Assent in July last year.

    My Lords, I am grateful to the Minister for giving way and I apologise for interrupting him but, given that he said that the consultation had "overwhelming" support for retaining the numbers of MSPs at 129, can he remind me how many people expressed that view?

    My Lords, I do not remember in detail the number of people who expressed that view, but I do remember that we had a long and detailed debate on this matter last year, when the number who responded from all those who were consulted was revealed to the House and is in Hansard. I hope that by the time I respond to the debate, I shall have some firmer information than I am able to give at the moment.

    The passage of the Scottish Parliament Constituencies Act meant that the Boundary Commission was no longer required to review the regional boundaries for the Scottish Parliament. It was then in a position to work towards completing its report. As I have indicated, that was presented to my right honourable friend the Secretary of State at the end of November last year. However, it is important to point out that since the proposals for the new Scottish constituencies for Westminster have been in the public domain for over a year since December 2003, the political parties and electoral administrators have had some considerable time to plan the changes that will need to be in place for the next general election.

    The Boundary Commission announced at the outset of its review that it would use existing local government electoral wards as the basic building blocks for the construction of constituencies. Although the legislation did not require this, the Boundary Commission believed that it would not be appropriate to ignore the structure of those electoral arrangements. The commission concluded, after consideration of all the critical factors in constituency geography, that the number of Scottish constituencies should be reduced from 72 to 59. There followed an extensive public consultation and the statutory inquiry process on the proposed parliamentary constituencies. The political parties in Scotland represented at both the Westminster and Scottish Parliaments were kept fully informed by the commission of its proposals.

    Once he had received the commission's report, my right honourable friend the Secretary of State reflected carefully on whether to exercise his power under the Parliamentary Constituencies Act 1986 to modify any of the recommendations. He concluded that the report should be implemented in full without modification. He reached that conclusion on the following basis: the Boundary Commission is fully independent; it weighed up all the representations received with considerable thoroughness and systematic analysis; it conducted statutory inquiries, as was required, where significant representations were made against its original proposals; and it revised many of its initial recommendations, either as a result of the statutory inquiries or on the basis of the representations submitted. Evidence of those four points will be found in the fifth periodical report of the Boundary Commission for Scotland.

    Inevitably, as was made clear by the range of representations submitted to the commission and its inquiries, not everyone agreed with all the Commission's conclusions. Other valid structures are possible. That is in the nature of an exercise such as this. However, we are firmly of the view that the Boundary Commission has exercised judgment and proper discretion and that it carried out its duties transparently and conscientiously, with full public consultation, as required by law. In particular, we endorse the commission's view that, having regard to the significant changes to the constituency geography, as a consequence of the reduction in the number of constituencies, its conclusions are fair and consistent across Scotland.

    I shall not attempt to go through the detail of the report or the order and I hope that noble Lords will not do so either. But in the light of the points mentioned above, I trust that noble Lords will accept that it would not have been appropriate for the Government to adjust any of the commission's recommendations.

    As noble Lords will be aware, the passing of the order will mean that in future there will be different boundaries—in some cases very different—between Westminster and Holyrood constituencies. During the passage of the Scottish Parliament (Constituencies) Bill last year, a number of your Lordships raised concerns about the consequences of that development. It may, therefore, be helpful if 1 remind your Lordships of the work of the Commission on Boundary Differences and Voting Systems which my right honourable friend the Secretary of State set up in July last year, under the chairmanship of Professor Sir John Arbuthnott.

    That commission is currently examining the issue of boundary differences and the consequences of having in the near future four different voting systems for elections in Scotland—for the European Parliament, Westminster, Holyrood and local government. Issues on which the Arbuthnott commission has been asked to make recommendations include the pattern of electoral boundaries in Scotland, arrangements between elected representatives to provide the best service to their constituents and the method of voting in elections to the Scottish Parliament.

    The commission started work in September 2004 and aims to report to my right honourable friend the Secretary of State by the end of this year. I hope noble Lords are aware that it launched a public consultation document on 18 January, which set out a series of important questions on the matters within its remit. Copies of that document are available in the Library and I understand have also been sent separately to each Scottish Peer in this House. I am sure that we will have an opportunity for a detailed debate on the Arbuthnott commission's report after it is published.

    In conclusion, I assure noble Lords that we are satisfied that the Boundary Commission has followed all due procedures in reaching its conclusions and in making its recommendations. In those circumstances, I do not believe that it is for us to take issue with the independent assessment of how the new parliamentary constituencies for Scotland are made up. We need now to complete the parliamentary and other processes to implement the Boundary Commission's report. I beg to move.

    Moved, That the order laid before the House on 14 December be approved [4th Report from the Joint Committee].—(Lord Evans of Temple Guiting.)

    8 p.m.

    My Lords, first, I offer my thanks to the Minister for bringing this order before your Lordships' House in reasonably quick time. I also add my thanks to the members of the Boundary Commission for producing such a comprehensive, if at certain points controversial, rethink of the Scottish constituencies.

    We are finally dealing with the much foreseen reduction in the number of the Scottish Westminster parliamentary seats, which was such a feature of the debates when we discussed the Scotland Bill all those years ago. By the order that the Minister referred to a few minutes ago, we are fortunately—or unfortunately—relieved of the worries concerning the seats of the Scottish Parliament. I do not envy Ministers when, every time we deal with this subject, they have to repeat how, at the time of the Scotland Act 1998 on the Scottish Parliament, they made it clear that their intention was to keep the composition of the Parliament under review, as the Government Minister did in another place on 24 January this year.

    Noble Lords who were here at the time of the Scotland Bill will no doubt remember how we spent what is counted as 18 days—and, if my memory serves me correctly, that also included nights—considering that legislation. So far as I can tell, there was some slight wavering in the Government's determination by the noble Lord, Lord Sewel, on Report, but it was only on the final day, when we entered ping-pong in the consideration of Commons amendments on 17 November 1998, that the Minister, having spent two columns of Hansard arguing that Scottish parliamentary constituencies should always be the same as those for Westminster, suddenly remembered at col. 1195 to put in the critical phrase:
    "The opportunity would not be lost, at some time in the future—on the basis of practice—to reopen this question".—[Official Report, 17/11/98; col. 1195.]
    If that counts as making it clear, I shall be watching the small print rather more carefully in future.

    When this order was introduced in the other place, the Minister expressed the hope that it would come into effect by the middle of February, and I am most grateful to the Minister for telling us that that is still the case. In addition to the outline that he gave us, I should be interested to know what stage has been reached with the returning officers, who are having to implement the new structure, and how much more time they will require to comply with the boundary changes. After that, it would be of great interest to know the earliest possible date that these boundaries could be used for an election.

    The fun is, of course, only just beginning, and the Minister touched on that. It really will not be all that long until we find ourselves at the year 2007 and the next election for the Scottish Parliament, when we shall be back contesting on the old boundaries with the 72 constituencies.

    It seems slightly ironic that a Government who appear to be so sensitive on the question of voter turnout at elections and have had Bills before this House to try to increase participation should face the voters with such a mass of alternatives. I wonder whether they have made any assessment of the effect that that, in itself, is likely to have on the turnout.

    As the Minister pointed out, the Government are aware of the potential chaos that all these arrangements have thrown up, and they have appointed Professor Arbuthnott to chair the inquiry that the Minister outlined. How does one deal with an electorate with four different voting systems and three different approaches to what constitutes a democratic constituency?

    I was grateful to receive, when I came to the House last night, a copy of the consultation document that Professor Arbuthnott and his committee have been circulating. At paragraph 1.6, it points out that in 2007 there will also be the usual local government election and that that will be conducted on the single transferable vote system. The great value of that, he maintains, will be to preserve the direct link between the voter and his or her ward representatives—something that he believes should be sustained at each level of government.

    Is the Minister aware that when Professor Arbuthnott was being interviewed on "Good Morning Scotland" on 18 January, he was questioned on this subject and his remarks were interpreted to imply that his committee was inclined to favour the single transferable vote for all Scottish elections? Can the Minister inform the House whether that is a position that the Government have put to his committee or whether, in this aspect, all the options are being kept open? Can the Minister also tell us whether the Government themselves will be submitting views to the committee?

    The greatest curiosity that this whole exercise throws up is the impression given that, in this Government's view, Westminster MPs are dispensable but MSPs are not. In the final analysis, my party welcomes the order and sees it as a logical part of the devolution process.

    My Lords, I, too, am ready, willing and, indeed, enthusiastic about extending to the Minister gratitude for the way that he introduced the order. I am also grateful to the Boundary Commission for the work that it has done. It is right to recognise in this debate just how significant a change this is in the Scottish political geographical landscape.

    Concerns have been expressed all along about the impact of devolution on the structure and representation of Scotland in the Westminster Parliament. However, the settlement, adumbrated in the debates on the Scotland Bill, was clearly a package, and it is right that the Government have fulfilled the foreseen steps to reflect the appropriate decisions to reduce the number of Members in Westminster to take account of the new responsibilities of the Scottish Parliament and its Members. Indeed, it was the right time to change the pattern so that the electoral quotas in England would be broadly the same as those north of the Border.

    It is important that there has been a slight variation, to which I do not think either the Minister or the noble Duke referred, from the strict translation of the English quota to Scotland. The Boundary Commission recommended that the number should be increased from 57, which would have been the strict application of the quota, to 59, reflecting, as it is entitled to do under Rule 4 of the rules for the redistribution of seats, the considerable sparsity of population in the north Highlands, in particular, and the inaccessibility of the Northern Isles and Western Isles. This results in not an equalisation of the electors in all the Scottish constituencies, but a compromise arrangement which is entirely defensible and reflects the geographical realities. We have a spread of electorates from as high as 78,675 in Linlithgow and Falkirk East to around 22,000 in Na h-Eileanan an Iar. This carries forward the disparities which have long existed, but, as I have said, it is defensible.

    The work that has been done by the Boundary Commission on this occasion has been exemplary. It is important that the public have an awareness of the lengths to which it has gone to ensure transparency and to ensure that the views of objectors were properly considered. It is of course provided by law that these things be done, but when such massive changes are being made, there would have been opportunity for considerable disgruntlement and even suspicion of misfeasance. That has been largely obviated by the manner in which the commission has done its work. It held 23 meetings on reviews and 20 local inquiries, with a large number of objections by many different parties in different areas being reflected in the final recommendations of the Boundary Commission. It has given this method of reaching conclusions a very good name, and of course it was entirely right that the Government should seek not to exercise their power to modify the recommendations but simply to reflect them in the order before us.

    A further anxiety on the part of the public has been the prospect that the process might be so protracted that it would not be possible to implement the changes appropriate to take account of the devolution package in time for the general election. I suppose that it has to be said that that anxiety cannot be entirely removed unless and until the Prime Minister announces a date for the general election beyond the implementation of the order. It now seems that that is highly probable and that the order will take effect in the next couple of weeks.

    I also would be interested to know about the steps that have been taken by returning officers to prepare the ground for the changes. They certainly have had notice of what is going to happen for long enough to take suitable measures and to make preparations. Certainly, the political parties have been noticing what has happened, and I believe that in most places candidates have been selected on the basis of the new constituency boundaries. It looks as though all this will be given effect without let or hindrance and, most importantly, without great public disturbance or anxiety. That is something of a triumph for a delicate operation of this kind, for which all those who have been involved deserve our thanks and appreciation.

    My Lords, I do not want to detain the House, but I congratulate the Government on the order. I have a certain empathy with the Secretary of State for Scotland. When I was the Secretary of State, I too had to bring forward a Boundary Commission order that made it pretty well impossible for me to win my constituency. I suspect that the present Secretary of State may be in the same position. It is a real testament to public duty in our country that Secretaries of State can do that with a smile on their face and in time for the next general election. I am tempted, however, to say to the Minister that, while I accept that there should be reduction in the number of Members of Parliament coming to Westminster from Scotland in line with the Scotland Act, I worry about the position of Members of Parliament who find their constituencies overwhelmed by MSPs. The failure of the Government to complete the second part of the bargain and reduce the number of MSPs is of considerable concern.

    When you were elected in the past—it was certainly the case when I was a Scottish Member of Parliament—you did not care whether people had voted for you or not. After the election, you were there to represent their interests and put their case to Ministers, sometimes perhaps with a certain reticence, but none the less, that was the duty. There are now several MSPs—some on lists, some elected and some not representing what will be the geographical area and therefore that identity which comes from Members of Parliament. All will receive generous secretarial and constituency allowances, using them to compete, sometimes on a party basis, for the favour of the electorate. Whereas in the past when Mrs Bloggins went to see her MP she would have been treated in a non-political manner, we now have Members of the Scottish Parliament competing with each other saying that the Liberal, or the SNP, or the Tory will do better for her. That is wasteful of public funds and undermines the position of the Member of Parliament.

    8.15 p.m.

    I am also very concerned about those Westminster MPs who will now have larger constituencies. It seems that the way in which the Scottish Parliament is operating is putting a greater burden on those Members of Parliament. I hesitate to use the phrase in front of the noble Lord, Lord Sewel, but it seems that Sewel Motions are now being used for matters that are of serious concern in Scotland. I do not wish to go on at length, but I shall give one example about which I am sure that noble Lords have had letters from the Scottish Police Federation. There is a proposal to bring the chief constables in Scotland under political control for the first time. There is a proposal to set up a new agency that will have powers for people who are not members of the Scottish police force to operate in Scotland. These are major constitutional changes and, so far as I can see, they are not even going to be debated in the Scottish Parliament.

    That legislation will be debated in the House of Commons and Scottish Members of Parliament will be expected to carry the burden of that legislation, as will this House. Yet Members of the Scottish Parliament continue in significant numbers. I am not going to embarrass anyone by suggesting that we should make them one and the same on this occasion. However, the Government need to think about how Scottish interests are going to be represented in this House and in the other place, particularly if more legislation is going to be subject to Sewel measures, which are often not properly debated in the House of Commons before they come to this place. It is very undesirable.

    Something else has changed. It is deeply worrying that when Scottish MPs do their duty and speak, they are largely ignored by the media in Scotland. They focus on the Scottish Parliament and MPs find it extremely difficult to do their job, to raise interest and to be seen to be active on behalf of their constituents. Living, as I do, in Scotland and reading the press on both sides of the border, it is increasingly apparent that the media do not report Scottish affairs down here. The effect of this great devolution proposal has been the marginalisation of Scotland and the reduction in Scottish interest in matters that are of great interest to constituents.

    So I welcome the order, but I regret the fact that the number of MSPs was not also addressed and that the Government seem so complacent about the effect of devolution on Scottish interests, the integrity of the United Kingdom and the ability of people in Scotland to be seen to play a key role in it.

    My Lords, I do not want to follow the noble Lord, Lord Forsyth. down the rather extraneous byways that he has been talking about. However, he made a point about Scottish matters not being reported promptly and he is a very good example of that. The last time that he made a speech in this place, it was discovered by the Scotsman three or four weeks later, which then led with it on the front page.

    My Lords, I am grateful to the noble Lord, but he does the Scotsman an injustice. It carried a front-page story saying that I called for Scottish MPs to sit in the Scottish Parliament and here and for the 129 MSPs to be got rid of. It said that I made the speech in the House of Lords last month, in December 2004. In fact, I made the speech in December 2003, so 13 months later it reported it as a front-page story. That is the point that I am making. It seems that people in Scotland are not aware of what is going on down here and vice versa.

    My Lords, I was making a different point, which was that the noble Lord's speeches are always slightly dangerous but they eventually surface north of the border.

    However, I rise to make a simple point on what the Minister said. He is quite correct that, as things stand, this order will come into effect very soon and we assume that the general election will be fought on the new boundaries. To my mind, it is then wholly unsatisfactory to expect the next Scottish Parliament elections to be fought on the old constituencies. I plead with the Government to make sure that the Arbuthnott commission, which is now sitting, does its job thoroughly and speedily. I also plead with them to give effect to whatever proposals the commission makes. If the Government have the will to do so, the proposals could be implemented before the next Scottish Parliament elections, so that we do not have the ludicrous situation where people in Scotland are voting on constituencies that no longer exist. The Government ought to be determined to do that, if at all possible.

    My Lords, I shall not detain the House too long. I welcome the report. It has caused an enormous amount of discussion. The House should realise how very great the changes are. In the part of the country where I live it has involved considerable upheaval, and we are not the only part.

    The work is by no means over. Everybody has been talking about the Arbuthnott commission. That is where the fun and games will now be because the Arbuthnott commission has to fit 129 Members of Parliament into 59 constituencies, and to do so by readjusting the voting system. It clearly has to readjust it because the number of list MPs will have to change in some way in order to do the calculation.

    It is a great pity that this whole thing was not thought out before the Scotland Act passed through Parliament. I have not the smallest doubt that the outcome would have been very much better if it had all been part of the plan. Now that it is being carried out in this stage-by-stage way, it will be difficult to get the issue right. My mind boggles when I read the consultative report of the complications that the commission will have to sort out.

    I want to ask the Minister one question. These changes are much greater than usually occur at the time of a Boundary Commission. Let us suppose that the general election is postponed until getting on for a year from now, which it could be, and there is a by-election, or perhaps more than one by-election. Presumably, judging by the Explanatory Notes and what the Minister said, the by-election will be fought on the old boundaries. Yet where I live and I think in most parts of Scotland—I have been deeply involved in this—the political organisations have been rejigged. There are new political associations and new candidates all based on the new boundaries. What will happen if there is a by-election? Will chaos ensue? It seems to be a terrible prospect. That is perhaps one reason why the Government should hurry up and have their election. However, they may not be able to judging by the way things are going. I shall be interested to hear what the Minister has to say about that.

    My Lords, I join other noble Lords in welcoming the order and, following the noble Lord, Lord Maclennan, pay tribute to the work of the Boundary Commission, the Secretary of State and the political parties in Scotland for handling in a mature and sensible way what is a major revision of electoral representation in Scotland. The matter could have been extremely sensitive and divisive. It brings credit to all the parties involved.

    The noble Lord, Lord Forsyth, said that he had to bring forward similar recommendations which led to his eventual departure from the House of Commons. In at least some ways that was the making of the noble Lord, Lord Forsyth. I do not know whether a similar fate will befall the present Secretary of State; I certainly hope and trust not.

    Perhaps I may look forward. Comment has been made on the Arbuthnott commission. It seems to me that this is not just a Scottish issue. If the Arbuthnott commission—no one knows its thinking; I recognise that it is at a very early stage—comes forward with a major change to the electoral system in Scotland, that would inevitably have implications for the debate on electoral systems in the United Kingdom generally. So, the Arbuthnott report is not a purely domestic Scottish issue; it is a United Kingdom issue and the debate should be at a United Kingdom level.

    My Lords, this has been a wide-ranging short debate. Perhaps "wide-ranging" is code for a debate that very often strayed beyond and well off the subject of the order tonight—but, so what? In my limited experience, every time that the word "Scotland" appears on the Order Paper, we revisit the whole concept of devolution, and we have done so briefly this evening.

    First, I shall answer the two interventions on my opening speech. The noble Lord, Lord Steel, asked whether the schedule could be reprinted in a more comprehensible manner. I regret to say that the order must be passed as drafted. I have a rather long explanation of why it was crafted in the form that it was, which I shall pass to the noble Lord after the debate, and not read it now, but our solicitors believe that it is the most convenient way to draft the order. All the wards in each constituency are set out in full in the Boundary Commission report, but the noble Lord's point was well taken.

    The noble Lord, Lord Forsyth, questioned my view that there is overwhelming support for maintaining the size of the Scottish Parliament and asked for evidence of that. As I said, we discussed it at great length last year. We received about 280 responses to the Scotland Office consultation. As with everything, it is quality rather than quantity that is the determining factor. Many came from significant bodies and organisations and all political parties. Only the Conservative Party argued against keeping 129 MSPs.

    I shall touch on the point made by the noble Lord, Lord Forsyth, about the number of MSPs, which was debated very fully last year. This is not the moment to revisit that. I am delighted that my noble friend Lord Sewel was sitting behind me to make his points about Sewel Motions, which I am sure have been taken on board. With great respect, we have before us tonight a fairly well defined order. Although many matters are connected to the order that we could discuss, time forbids us from going into great detail.

    My Lords, I feel that the Minister is rapping my knuckles. That matter is entirely relevant. The Government propose to reduce the number of Members of Parliament from Scotland at Westminster in the other place. At the same time, more and more devolved measures are passing through Westminster because of the use of Sewel Motions. So it is entirely appropriate for me to say that, if the Government's policy is to have a devolved assembly or parliament in Edinburgh, it is rather odd if we arc reducing the number of MPs who can speak for Scotland when more and more business is being transacted here at Westminster under Sewel Motions and not in Edinburgh, where we have all those MSPs.

    My Lords, perhaps I may make what I hope is a helpful intervention. I sometimes wish that I had somehow copyrighted the term Sewel Motion, in which case I could have retired even earlier from the University of Aberdeen than I did. It is a fact that the Scottish Parliament set up under its Procedures Committee an inquiry into the use of Sewel Motions—interestingly, considering them not just from the Edinburgh but the Westminster end. I am sure that the noble Lord, Lord Forsyth, would be welcomed if he wanted to give evidence to that inquiry.

    My Lords, I was not attempting to rap the knuckles of the noble Lord, Lord Forsyth; I should not have the nerve. I was simply pointing out that very few things discussed in this House are self-contained. Everything leads to other matters. I was suggesting as politely as I could that we ought to concentrate on the order in hand and leave its implications and connections in other areas to a later debate. Obviously, we will have many more discussions on orders for Scotland and other Scottish matters.

    8.30 p.m.

    The noble Duke, the Duke of Montrose, asked a number of questions, which I shall attempt to answer. There was one practical one: do the local authorities in Scotland have enough time to make the practical arrangements necessary for the next election? Electoral administrators in Scotland have been kept fully apprised of the Boundary Commission's proposals for Westminster constituencies. The final recommendations were published in 2003. The Scotland Office will work closely with returning officers in the planning of elections.

    In some areas, a constituency crosses two or three local authority boundaries. The returning officers for those will be appointed by the Secretary of State for Scotland immediately after this order has been made. No debate and no decision are required in this House. I hope to reassure the noble Duke that preparation has been made. If there were an election in May—I have no idea about that—there is every confidence on both sides of the Border that it could be handled well and efficiently.

    The noble Duke, the Duke of Montrose, asked about the Arbuthnott commission's position on introducing the single transferable vote for Scottish Parliament elections. As I indicated in my opening remarks, the Commission on Boundary Differences and Voting Systems, under the chairmanship of Professor Arbuthnott, is examining the issue of boundary difference and the consequences of having in the near future four different voting systems for elections in Scotland.

    A number of noble Lords mentioned the Arbuthnott commission. The commission is there for noble Lords to give evidence to; it wishes to hear from them. In response to an earlier question, the Government will not give evidence because it would not be appropriate, given that the commission will report to the Secretary of State. Although it is to report to the Secretary of State, the commission is independent of government, as its remit makes absolutely clear.

    My Lords, I am most grateful to the Minister for giving way. Does he know when the commission hopes to report?

    Yes, my Lords, the commission hopes to report by the end of this year.

    All the practical arrangements seem to be in hand. In constituencies that have changed considerably, the relevant returning officers are well ahead in ensuring that things go well and efficiently.

    The noble Lord, Lord Maclennan, made the point that the Boundary Commission did not quite rely on the English quota of the electorate. I agree that this was entirely defensible and, as the noble Lord said, within the rules. It takes proper account of the Scottish geography and population, but it was not precisely the same.

    My Lords, is the Minister clear in his own mind that Professor Arbuthnott does not have any prejudice about the single transferable vote?

    My Lords, I have no evidence, no feeling, that Professor Arbuthnott and his commission—he will not be the only person handli