The Scottish Government appear to want—I think that we have to be very careful about the words that we use, as I said to the noble Lord, Lord Forsyth, in an intervention—to manipulate the way in which things will turn out in this referendum. It is very important to indicate clearly that separation is very different from any kind of devolution. As shown in the recent somewhat confusing vote regarding membership of NATO, the Scottish Government are going out of their way, in wanting to keep the Queen and in hoping to keep the pound, to try to make it appear that this separation, which will be drastic and irreversible, is no different from the vote that we had on devolution. It is completely different and we must keep saying that.

I referred to funding in an intervention, and I hope that we will get a reply. Again, there seems to be an attempt to manipulate or to try to make sure that the outcome moves in a particular direction, with funding coming from all sorts of sources for the yes campaign, particularly from overseas. We need to know that there will be a ruling, not advice, and to know exactly what the ruling will be and who will make it, so that there will be a level playing field.

Another issue that has appeared in social media—it was reported on Twitter—was that Alex Salmond said today, in an interview on Radio 4:

“The first job of the Scottish Parliament would be forming a constitution”.

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There is a misunderstanding of what would happen in the event of a yes vote, on which I think almost all of us here agree, although the noble Lord, Lord Wigley, has not spoken yet. An assumption is being made—an impression is being created—by the supporters of the yes vote that there would suddenly be independence. I hope that the Minister will indicate that it would be a long and difficult process in relation to issues such as the national debt and a whole range of others that will have to be negotiated.

A separate Scottish state could not be created until there had been legislation in this United Kingdom Parliament. Surely, there would have to be further legislation before there could be a separate Scottish state. The referendum is not enough. The detail would have to be worked out. There would have to be negotiations. Some people have suggested, and I hope that the Minister will comment on this, that there might need to be a further referendum on the acceptance of the negotiations at the end of that. I am not sure if that would be the position but it certainly seems arguable that that could be the position.

My main point relates to the report by the Select Committee on the Constitution, mentioned by the noble Lord, Lord Crickhowell. It covered a number of points. Paragraph 27 of the report states:

“It may be, therefore, that irrespective of the legal status of the MoA as a whole, different provisions within the MoA are capable of generating different levels or different kinds of legal or constitutional obligations or expectations”.

Paragraph 28 states:

“It cannot safely be said that the arrangements proposed put the matter beyond all legal challenge”.

My noble friend Lord Browne has already raised the question of legal challenge in relation to the wording of the question. I hope that the former Lord Chancellor, the noble and learned Lord, Lord Mackay, does not mind my saying, but earlier I had the opportunity of discussing this matter with him and he indicated that there may be options of legal challenge here as well. I do not think that it should be used as a threat in any way but we should alert people, the public generally and elected Members of the Scottish Parliament and the Scottish Government, to the dangers of that kind of thing.

Lord Crickhowell: While this question was left in the air, we were conscious that at the very least it might be another cause for substantial delay while the legal question was settled.

6 pm

Lord Foulkes of Cumnock: I think that that has reinforced the point.

I also want to raise the question of 16 and 17 year-olds, as I have done on a number of occasions. I do not think that people have realised—and certainly the Scottish Government have not realised—the practical problems of identifying and putting these 16 and 17 year-olds on the register. It has been estimated that there may only be a few thousand who are ultimately eligible to vote. We should ask the Scottish Government to tell us how they are going to do this. It has already been made clear that they will have to undertake and fund it; we should ask them how they are going to carry it out.

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Finally, one particular problem is that there is so much preoccupation with the referendum by the Scottish Government, the First Minister and Deputy First Minister, by members of the Scottish Cabinet and SNP Members of the Scottish Parliament—they are so preoccupied with the run-up to it and winning it—that other areas that we have devolved to them are being ignored. The health service is not being properly supervised and problems have already been raised. Some of our Labour colleagues in the Scottish Parliament have brought up these concerns. In education, housing, and social work, problems have been raised that are not being properly addressed. We should say to Members of the Scottish Parliament, and particularly to the Scottish Government, that a whole series of very important matters has been devolved to them and they should not let their preoccupation with the referendum and with trying to win it take their attention away from doing a good job in the areas already devolved.

Lord Steel of Aikwood: My Lords, when my noble friend Lord Forsyth began his speech he said to my noble friend the Minister that if he were on a charge of murder he would happily employ my noble friend as his defence counsel. I hope my noble friend is honing his skills because they may be needed. I get the impression that my noble friend Lord Forsyth has a completely unhealthy obsession with the First Minister of Scotland, and it is not one that I share. It may go back to the fact that they were at university together, but I thought that his otherwise powerful speech was spoilt by too many references to one individual of whom we should not be afraid.

Lord Forsyth of Drumlean: I am certainly not obsessed with the First Minister but I think it is legitimate to point out that when my noble friend talks about the Scottish Parliament and so on, we all know that the Scottish Parliament is completely dominated by the First Minister. None of the members of the SNP is able to say a word but by his leave. So it is important to realise that, when we think we are devolving power to the Scottish Parliament, we are talking about giving power to Alex Salmond because he calls the shots.

Lord Steel of Aikwood: My noble friend has just repeated the point I am trying to make—that he is totally obsessed by one individual. I agree with the noble Lord, Lord Browne, who pointed out that, whether we like it or not, the SNP secured the democratic mandate and this order enables it to carry that out and to hold the referendum. For that reason I support the order.

There are lessons to be learnt from the mistake—the misjudgment—that has been made to keep postponing the process to 2014. This has been mentioned by several other speakers. It is important to notice the difference between this situation and the one in Quebec: during the two years that we have been debating this issue, the support for independence has been going down, not up. This is extremely significant. I suggest that the reason it has been going down is that, quite apart from the 35 questions from the CBI which the noble Lord, Lord Nickson, referred to, there have been three major issues on which the Scottish Government

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have been found wanting. One already referred to is the legal advice—or rather lack of it—on joining the European Union.

I remember the SNP campaigning very strongly on independence in Europe—in other words, it was not only going to join the European Union, it was also going to sign up to the euro. That has suddenly disappeared: I cannot think why. The SNP is no longer advocating joining the euro. That uncertainty about the relationship of a future independent Scotland with the European Union—on which there was an interesting, long interview this morning on Radio 4—is one of the reasons why support has slowly withered away. The second reason, which is related to it—

Lord Reid of Cardowan: Will my noble friend give way? He has helpfully reminded me that there is another implication of that slogan, of course, because just as you can be independent in Europe you can be independent in the United Kingdom. What you are not is separate, which reinforces the points that we made earlier on.

Lord Steel of Aikwood: Indeed, I was going on to say that one of the other uncertainties that has been exposed during this prolonged debate is the question of what currency would be used. If the euro is out, and we are not having a separate Scottish pound because we are going to rely on the Bank of England, what sort of independence is that? So the second bit of unravelling has been on the whole issue of the financing of an independent Scotland.

The third—which has also been mentioned by others so I will not go into detail—is on Trident and the defence role of an independent Scotland. My party and I have long been opposed to the replacement of the Trident system—in fact we were opposed to the initial replacement of Polaris by Trident. That is at least a position of principle, even if people disagree with it. What is unacceptable is for the SNP to say, “We want rid of Trident, but we are quite happy if it goes to Devonport or Barrow-in-Furness or somewhere else”. That is not a credible position. Nor is the position, as the noble Lord, Lord Reid, pointed out earlier, of saying, “We would like to join NATO because that makes people feel comfortable, but we will not accept any of the obligations of joining”.

For all these reasons, the longer the debate has gone on—and I have argued before that that was a mistake because people would become bored by it and the uncertainty would not be good for Scotland nor for investment in Scotland—the more the support for independence has declined.

Among those of us who campaigned in the 1980s and 1990s for the restoration of the Scottish Parliament, there was an unspoken assumption that, if we got a Scottish Parliament and a Scottish Government, then the future Scottish Government and the future UK Government would collaborate in the interests of the people of Scotland. Indeed, it is fair to say that, in the first years of devolution, that did happen. Of course there were disagreements occasionally between the two Governments but basically they were both pursuing the best interests of the people of Scotland. I think the

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biggest single reason why support for independence has declined is that that does not appear to be the position of the SNP Government. Their position is not, “What can we do together with the UK Government to better the life of the people of Scotland?” It is rather, “What can we do to promote the SNP?”. That is a very different position.

During the Olympic Games, the Scottish Government hired the Army and Navy Club in London, at a cost of £400,000 of our taxpayers’ money, to entertain athletes and others visiting the Games: in fact, very few people went. They could have had Dover House for nothing—a substantial building, right in the centre of London, well known—but of course it belonged to the UK Government, so it did not suit the ideal of the SNP. That is a trivial example of what I am saying—that the motivation throughout has been what is in the best interests of the SNP.

I end with the question that everybody else has been raising about the decision on respecting the judgment of the Electoral Commission. Why is the SNP not willing to say now that it will accept that judgment? It is because it wants to promote the interests of the SNP. The more people realise this, the more the support for independence will continue to decline.

I support this order. I am not complacent about the outcome but I am confident that, because of this constant shifting of position by the Scottish Government, in the end people will say that they do not want to make that leap in the dark.

Lord Wigley: My Lords, every voice that we have heard so far has been a unionist voice. I realise that I may be in a small minority—perhaps even a minority of one—in this Chamber in wishing the people of Scotland well in their quest for independence; none the less, I wish to see a new relationship between the nations of these islands: a new partnership of free and equal self-governing nations co-operating with each other and with partners in the European Union and the wider world.

Today’s debate has involved a series of attacks on the SNP in general and on Alex Salmond in particular, as was mentioned by the noble Lord, Lord Steel of Aikwood, a moment ago. It may well cross the minds of noble Lords that it is a little strange that this House—one of the two Houses of the UK Parliament—does not have any voices from Scotland that represent nationalist aspirations, which is, after all, the driving force behind the forthcoming independence referendum.

I fully understand that the SNP has stuck resolutely to a policy of not putting forward nominations officially in the party name—as indeed did my party, Plaid Cymru, until five years ago. The experiences that my party suffered at the hands of a former Prime Minister may well have persuaded the SNP, which might be sympathetic to securing a voice in this Chamber, not to bother pursuing the matter. Noble Lords may well wish to ponder on the acceptability of a system whereby the leader of one party—albeit a Prime Minister—can determine whether another party, with MPs in the House of Commons, can be denied a voice in one of the two Chambers of the British Parliament.

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Lord McConnell of Glenscorrodale: I hope that the noble Lord, Lord Wigley, will accept that the only responsibility for this situation lies with the Scottish National Party itself. Many of us have argued that there should be representation in this Chamber. In particular, I have argued that Mr George Reid, the Presiding Officer who succeeded the noble Lord, Lord Steel, and who worked with me when I was First Minister, would be an excellent Member of this Chamber. However, because he rightly feels some loyalty to his former party and that party will not put him forward, he is not sitting here. That is wrong, but the responsibility for it lies entirely with the nationalist party, which will not make that decision.

Lord Wigley: I hear what the noble Lord says. Indications that I have had from Mr George Reid may be slightly different from the interpretation that the noble Lord has given. However, I have no doubt whatever that there were those within nationalist Scotland—not necessarily even members of the SNP—who would have been willing to serve the interests of their country in this House. Be that as it may, the fact that they are not here and therefore cannot participate in this debate is unfortunate. That is why I am contributing, although I have no authority to speak on behalf of the SNP and I certainly would not presume to do so. It is not for someone from Wales to tell the Scottish people what is best for them; nor indeed is it for those from England or Northern Ireland to do so. The decision on whether Scotland should be an independent country lies with the people of Scotland and Scotland alone. I am glad that the draft order before us today arises from the Edinburgh agreement, whereby it will be the Scottish Parliament and not Westminster that determines the date, franchise, question, referendum rules and campaign spending limits. The proposed arrangements for the referendum will be initiated by the Scottish Parliament. The Electoral Commission will then have an opportunity to give its views, and those views will be duly considered by the Scottish Parliament before a final decision is taken. That is the implication of the Edinburgh agreement.

I noted one important point in today’s debate relating to Scottish servicemen based overseas. I know that there are SNP MPs and MEPs who are also actively aware of this and I very much hope that a resolution of the issue can be found.

As I understand it, the resolution in the Scottish Parliament supporting this order was passed unanimously by that Parliament. I also understand that every one of the Westminster parties supports the order. This shows how Governments can work together to achieve a sensible outcome, and I believe that it is to the credit of both the Government of Scotland and the Government of the UK that this has been achieved. It is an indication that Governments can, indeed, work together harmoniously. I have no doubt that if Scotland becomes an independent country as a result of the referendum, there will be equally harmonious co-operation between the Governments in London and Edinburgh thereafter. There has been talk today of litigation and judicial reviews but that sits a little uneasily with the type of co-operation that I have just described.

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It is truly excellent that there should be such co-operation and that the referendum will be seen as “Made in Scotland”. That gives greater confidence that the outcome, whichever way it goes, will be acceptable to all the Scottish people as a democratic decision taken by the Scottish nation. I am sure that no one in this Chamber from outside Scotland would want to gainsay that or dispute the fact that this should be a decision for Scotland. To that extent, the noble Lord, Lord Reid, is quite correct that the referendum in Wales on providing further devolution is different from the question of independence and raises the question of whether referenda are really necessary for every small step of further devolution. That was not the case with the Scotland Act last year. There are, of course, implications for the rest of the United Kingdom, and no doubt these will be debated during the referendum campaign, as is right and proper. However, they are not issues that should delay the progress of the draft order before us today.

6.15 pm

Incidentally, I think it is a little disparaging towards Scottish voters to suggest that they may not understand that voting “yes” will deliver an independent state, even on the basis of the question that has been discussed.

In the spirit of the concordat which has led to the draft order coming before us, I humbly suggest that it is less than edifying to hear the personal attacks that have been made again today in this Chamber, and which were perhaps made yesterday as well, on the leader of the Scottish National Party, the First Minister of Scotland. Quite honestly, references to “no honesty, integrity or consistency”, allegations as to his honesty, and the suggestion today that he wants to rig a referendum and that distortion might take place are not, I believe, worthy of this Chamber and, perhaps more importantly, may not be conducive to the cause that noble Lords are promoting. It does no credit to the democratic process to resort to personal attacks, and I would suggest that it is also counterproductive.

Lord Martin of Springburn: I agree with the noble Lord: we should not personalise this debate. The First Minister has a case to put the same as the rest of us, and we should not attack anyone—particularly the First Minister—on a personal basis.

Lord Wigley: I am very grateful to the noble Lord for that intervention. Certainly, not all speakers have done that. I noted the contribution of the noble Lord, Lord Browne, which was very constructive. It hit a tone that can help to ensure that there is no dispute on matters that are irrelevant to the central question. That central question is whether people want independence. No doubt there are arguments to be had on that and the other issues should be put to one side.

Lord Reid of Cardowan: I do not know whether the noble Lord is about to conclude but he has covered everything except one point. It is the main point here and concerns the nature of the question. Does he accept that under any referendum a leading question is an unfair premise on which to base a democratic decision?

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Lord Wigley: Yes, of course, I accept that without reservation. The point is whether the question that has been proposed is a leading question, and there will be differences of opinion on that. I have no doubt that the Electoral Commission will give its opinion on the question and of course the Scottish Parliament will take considerable note of what the Electoral Commission says. It would be strange if it did not. However, to suggest that the Scottish Parliament or any Parliament should automatically accept the ruling of a body such as this takes the issue much further. If we were to argue that Westminster should automatically, under any circumstances, always accept the suggestions put forward by the Electoral Commission, irrespective of whether the Government or indeed the whole Parliament agreed with it, that would be unacceptable here, and I suggest that it would be unacceptable in the context of Scotland as well.

Lord Reid of Cardowan: With respect, the noble Lord has set up a straw man. I did not suggest that every recommendation should be accepted. I suggested that if the question is deemed by the arbitration body, which is neutral, to be a leading question, you should make it plain in advance that you will accept that particular piece of advice. The noble Lord says that no one should ever do it, but perhaps I may say that I would do it. If a referendum were being proposed by any Government, including a Labour Government, which the Electoral Commission said was being skewed by a leading question, I would accept the arbitration of the Electoral Commission. The noble Lord implied that he would as well if the question was denoted by a neutral body as a leading question. The question that we have been asking is why that cannot be done by the First Minister and the SNP in Scotland.

Lord Wigley: I am very grateful to the noble Lord. If indeed the Electoral Commission were to come out and say in categorical terms that this is a leading question and is totally unacceptable, and that that is clear cut in its opinion, then that opinion must be taken on board by the Scottish Parliament. I have no doubt that it would take good note of any such recommendation. I have faith in the democratic process in Scotland. However, to say that whatever the Electoral Commission says, the Scottish Parliament must accept its ruling as opposed to the decision of elected representatives, is surely one step too far. Be that as it may, I support the draft order that is before us today. I hope that the House will give it a unanimous backing so that we can move forward to the next stage of this process and, ultimately, secure a referendum, whatever the outcome, that is a credit to democracy.

Lord Cormack: My Lords, the noble Lord, Lord Wigley, whom I am very pleased to call a friend, said that his would probably be the only voice advocating independence. Mine appears to be the only English voice in this debate today. We have heard two from Wales and the rest from Scotland. I particularly wanted to take part because this is not a Scottish issue. This is an issue that affects the whole United Kingdom. As I have said in this House before, we all have varied backgrounds, and it is very difficult to isolate the pure

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Scottish from the pure English. I consider my identity as English, and yet the background of my family is Scottish for centuries. My elder son lives in Scotland with a Scottish wife, and my two grandchildren go to school in Edinburgh. My son considers himself Scottish, so Scottish indeed that he acted as the election agent for the daughter of the noble Lord, Lord Steel—because he has gone Lib Dem—in a recent election.

Lord Steel of Aikwood: Successfully?

Lord Cormack: Yes, indeed, successfully. That, of course, in its simple way illustrates the fact that within this Chamber and within this country, there are very few of us who can say that we are wholly this, that or the other. It is therefore important that there be English voices in this debate. After all, England is by far the largest country in the union, and we will all be affected for generations to come if, on the anniversary of Bannockburn, the Scottish people vote to sever their links with the United Kingdom.

My noble friend Lord Forsyth made an absolutely splendid speech. He has been taken to task by one or two people for being too personal. I would like to dissociate myself from personal attacks but also to agree with the substance of what he said. I know Alex Salmond very well. I met him on the first day that he came into the other place. Quite by chance, my wife and I and our family found ourselves for successive years taking holidays on the beautiful island of Colonsay at the same time as Alex Salmond, and having many an agreeable conversation at the bar. He is an engaging man. Personally, he has many delightful qualities. However, he is one of the two most skilful politicians in the United Kingdom at the moment, the other being Boris Johnson. We underestimate his political skill, dexterity and ability at our peril. We must take him very seriously, and we cannot assume that the referendum will go the way that most of us in this Chamber would like it to go.

As I listened to my noble friend Lord Forsyth, and as he was almost convincing himself that he was wrong not to press this to a Division, so he was almost convincing me. Of course I accept his judgment and I will not attempt to divide the House. However, the agreement that was negotiated was not so much an agreement as a capitulation. The Prime Minister, for whom I have high regard, and the Secretary of State for Scotland had Mr Salmond running rings around them. They conceded far too much. It is a great pity that the Parliament of the United Kingdom in its two Houses will not have a greater say in these crucial decisions that will be taken. The Scottish Parliament will be judge and jury when it comes to deciding the question.

We all know what the question to the Scottish people is. It could be framed in the simple terms, “Do you wish to leave the United Kingdom?”. However, what is being proposed at the moment is certainly, as has been said, a leading question. It invites the answer that Mr Salmond would like. That is why over these next months—we have less than two years—it is important that the series of papers that has been referred to is

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produced not only by the British Government but by the cross-party alliance that is being spearheaded in Scotland by Mr Darling—an admirable choice, I believe. It must be spelt out to the Scottish people, whose decision this ultimately is—I am not one of those who advocates every citizen in the United Kingdom having a vote—just what they will be losing and what they will be leaving.

I was delighted that the question of the votes of Scottish service men and women, who serve our country, often in extremely dangerous circumstances, was brought up in this debate. They of all people, wherever they are temporarily domiciled, must have the opportunity to cast a vote on the future of the country for which they are prepared on a daily basis to lay down their lives.

It is going to be an extremely interesting and, I hope we can say, good-humoured period. However, the stakes are extremely high. The noble Lord, Lord McConnell, pointed to the dangers of bitterness creeping in. Of course, he did so with his background knowledge—knowledge that we all have—that of all wars, the bitterest are always civil wars. This will be a civil war of words, to a degree. It is crucially important that we try to keep it good-humoured. That is why, although it is right to talk about the political skills of our opponents, we do not seek to denigrate them personally as individuals.

I very much hope that there will be an opportunity during the coming 18 months for those of us who have Scottish links, Scottish roots and Scottish branches of our family to play a part in this debate. We need to say to the people of Scotland, “You are a fundamental and integral part of the United Kingdom, and we need you because we need each other”. The United Kingdom is far more than the sum of its individual parts, and there is no individual part that has made a greater contribution to our history and success as a nation than Scotland. We do not want to lose that.

There is no point in resurrecting all the arguments over devolution. I remember them well because I was in the House of Commons when the very first Scottish National Party Member, Donald Stewart of the Western Isles, came—he was a lovely man. I saw all this, and took part in debates in the early 1970s and throughout that decade. Big mistakes were made by both major political parties. The biggest mistake made by the Conservative Party was neglecting to recognise the reality of the first devolution vote. It failed because it did not clear a parliamentary hurdle but it indicated aspirations in the Scottish people. During those 18 years, I was one of a group who went to see Mrs Thatcher, as she then was, to beg that something be done: perhaps we should start having the Scottish Grand Committee sitting in Scotland regularly and frequently; or there should be a consultative assembly of Scottish local authorities. Sadly, she did not want to listen. That was a great mistake.

I will never forget travelling up to Scotland on the sleeper and having a dram or two with Donald Dewar in 1996. I said, “What would have happened, Donald, if we had done that in 1979 or 1980?”. “You’d have shot our fox”, he said, “but it’s far too late now”. We are, as they say, where we are. We have a United Kingdom. There are cracks and fractures and it is our duty collectively to repair them. I am sorry that the

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order is phrased as it is. I am sorry that so many concessions have been made, but those of us who believe in the United Kingdom all have a duty to fight for its integrity in the year ahead.

6.30 pm

Lord Kerr of Kinlochard: My Lords, my view of the Edinburgh agreement is closer to the noble Lord’s than that of the noble Lord, Lord Stephen. I scored the Edinburgh agreement a three-to-one win to the First Minister of Scotland. He seemed to lose on the number of questions but he won on the franchise, which is not a very important point; he won on the date, a more important point; and he won on the big point, which is the question itself. It is to that issue that I want to come back. I shall follow what was said by the noble Lords, Lord Sutherland of Houndwood and Lord Browne of Ladyton, and ask the Minister for a view on the internal wording of the Edinburgh agreement and its significance. I am referring to paragraphs 8 and 12.

In paragraph 8 we are told:

“Consistent with provisions in PPERA”,

the Electoral Commission will review the wording for its intelligibility. I do not know why these words are there but they worry me. Paragraph 12 has a straightforward reference to the PPERA, which gives the Electoral Commission responsibility for,

“commenting on the wording of the referendum question”.

What is the remit given to the Electoral Commission? The Constitution Committee’s excellent report—I am grateful to the noble Lord, Lord Crickhowell, for reading from it—shows that that committee, too, is nervous on that point. It says:

“We trust and believe that the Electoral Commission will be rigorous in assessing the question and will give candid and fearless advice on the wording proposed by the Scottish Government”.

It says that,

“the Electoral Commission will consider whether the referendum question … presents the options clearly, simply and neutrally … we would expect any departure from the Electoral Commission’s recommendations on the wording of the question to be robustly scrutinised. We hope that there will be no such departure”.

I share all those sentiments, obviously.

Why is the word “intelligibility” there? Why is it necessary to have the narrower definition of the role of the Electoral Commission? It is easy to envisage a question that is completely intelligible but also leading or misleading. I am nervous about the role of the Electoral Commission in this respect. I do not want to exaggerate the point. It would be resolved if the challenge of the noble Lord, Lord Sutherland, were accepted. We need to know the view of the Edinburgh Parliament in principle on what it would do—not when it has seen the language but its view of the language produced by the Electoral Commission.

Lord Crickhowell: The noble Lord’s question is particularly apposite as to why this limited reference was made when one considers that the Electoral Commission in 2009 set out the referendum question assessment guidelines, which included:

“Is the question written in neutral language, avoiding words that suggest a judgement or opinion, either explicitly or implicitly?”.

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That takes it much further than the question that has just been raised by the noble Lord.

Lord Kerr of Kinlochard: That is precisely the point that I am trying to make. Is the reference to “intelligibility” in some way limited to it or could it be construed in a court of law as in some way limiting the normal role of the Electoral Commission and its role envisaged in 2009?

Lord Elystan-Morgan: Is not the agreement made between the Prime Minister and the Scottish First Minister a gentleman’s agreement? It is not an international treaty, which can be made only between sovereign states. Although everything that the noble Lord says has every relevance in the moral context, in terms of legal consequence and strict constitutionality it must be the case that it is no more and no less than a gentleman’s agreement, binding, of course, as it is.

Lord Kerr of Kinlochard: That is where I was going, although I would like to hear the Minister’s answer to my question on how one reads paragraphs 8 and 12 together.

Lord Wallace of Tankerness: I wonder whether it would be helpful to do so now, as it has been raised. The word “intelligibility” is used because Section 104(2) of the Political Parties, Elections and Referendums Act 2000, passed by this Parliament, states, in relation to a referendum question, that the Electoral Commission,

“shall consider the wording of the referendum question, and shall publish a statement of any views of the Commission as to the intelligibility of that question”.

That is why the word, “intelligibility” has been taken from the statute and put into the memorandum. As the noble Lord rightly points out, the Electoral Commission set out in its 2009 guidance and guidelines, which I quoted when moving the Motion, how it intends to go about determining intelligibility. I hope that that clarifies why the word was used. The other matters to which the noble Lord referred, such as ease of understanding, lack of ambiguity and avoiding misleading voters, are part of the criteria that the Electoral Commission has indicated that it applies when undertaking the word, “intelligibility” in statute.

Lord Kerr of Kinlochard: I am grateful to the Minister and in some way reassured. It seems to me that we need to keep a close eye on this issue. I strongly agree with the challenge raised by the noble Lord, Lord Sutherland, but I think in his normal, consensual, non-polemical way, the noble Lord, Lord Reid of Cardowan, got it absolutely right. There may be a fox around, but the Scots are not chickens. They are not stupid. If there is an attempt to rig the question, and the advice from the Electoral Commission, speaking to its remit as described by the Minister, is dodged or not responded to positively, it would be a considerable down side with the electorate in Scotland. The question of the question is very important, but let us not exaggerate it. If it is not a straight question the Scots are even more likely to give it a very straight answer.

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Baroness Liddell of Coatdyke: My Lords, I rise at this stage in the debate because a woman always likes to get, if not the last word, at least something near to that and it has been a singularly male debate so far. I make that point quite deliberately. If you look at the polling in Scotland, you will discover that, in the course of this debate about separation, women have increasingly become in favour of the union and men have remained static. Whether that is about “Braveheart” or the football, I do not know. The other side of the coin is that women are concerned about jobs and their children’s future. They recognise that there are always those who suffer when there is divorce—and what we are talking about is divorce.

Let me be blunt. If the First Minister thought that there was a majority for the break-up of Britain, the referendum would have taken place by now. We proved in 1997, with the devolution referendum, how quickly a referendum could be done. What the First Minister is counting on is either boredom on the part of the electorate—and there is a very strong chance that that will happen—or complacency on the part of those who favour the union. That has been commented on a couple of times this evening. There is a risk of complacency. I am fed up with taxi drivers telling me that there is no way Scotland is going to vote for the break up of Britain. There is an assumption that it is in the bag. It is not.

During the Scotland Bill deliberations in this House, I said—and I am not one for quoting myself but I quite like this quote—that we wanted a referendum without jiggery-pokery. As the noble Lord, Lord Forsyth, laid out in his excellent speech, what we are discussing this evening is the potential for jiggery-pokery. We have had a bit of it before—and this is not a personal attack. We have had obfuscation on the question of the legal basis of Scotland’s role in Europe; we have had a situation where Hansard in the Scottish Parliament has been altered; and we have had misleading figures given on further education, to name but three examples. This is a critical decision for Scotland and a critical decision for the rest of the United Kingdom. We owe it to all of the people of these islands to make sure that it is done on a sound and sustainable basis so that the day after the referendum each one of us can turn around and say that we won or we lost, and the other side accepts the decision.

I support much of what the noble Lord, Lord Forsyth, has said. I could not have followed him into the Lobby this evening, so I am glad he is not testing the opinion of the House, because I believe it would have led to delay. We have heard about the situation in Quebec, and I acknowledge what the noble Lord, Lord Steel, has said about the separation support going down, but a week is a long time in politics. Who knows what will happen between now and the referendum in 2014? It is critically important that we put aside petty divisions on these issues, which are much too big for the future of this country.

One very important issue that was raised by the noble Lords, Lord Reid and Lord Cormack, and others, is the question of allowing the vote to be made available to those in our Armed Forces. I do not know how they did it in 1945; they must have found a way to

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do it in 1945. Surely, it is not beyond the wit of a sophisticated democracy to find a way of giving our soldiers, men and women alike, the opportunity to vote in 2014, the year that marks the centenary of the First World War, when many of our families went to fight for a United Kingdom.

The challenge with the order that exists for us is to acknowledge, as a number of us have, that we should have been given an opportunity to debate these matters in this House. It should be recognised that we are a partnership. Those of us who sit in this House are unelected Members—but many of us have served our time at the other end of the corridor and have come from different parts of civil society in this country. We are entitled to a voice, and our colleagues at the other end of the corridor have a democratic right to that voice. It is unfortunate that they were not given that opportunity. I would say, particularly to the noble Lord, Lord Stephen, that the Prime Minister was either naive or misadvised in the terms that he agreed to in the Edinburgh agreement. The opportunity to get an agreement that allowed for no jiggery-pokery was there, and I am afraid that he dropped the ball—and it is not often that I use sporting analogies.

6.45 pm

I sum up in saying that I support the order. I think the position that we are in is flawed, but let us get on with it. Let us get this done and have a debate that is based on consensus and facts. The Government have a responsibility there. I asked previously if it would be possible to have some sort of independent arbiter to look at the facts that are increasingly being thrown around. Sometimes we hear from the First Minister facts that are issued as though ex cathedra that are often not subject to rigorous scrutiny. I support the order, I recognise much of what the noble Lord, Lord Forsyth, has said and I think we have had a good debate tonight. Please can we just now get on with it?

Lord Pearson of Rannoch: My Lords, I sense that the mood of your Lordships is to move towards the Front Bench speeches, so I shall speak briefly. I congratulate the noble Lord, Lord Forsyth, on another brilliant performance; I think he said it all. However, out of what he and other noble Lords have said, I would like to put two simple questions clearly to the Minister, as it will save me interrupting him when he comes to wind up.

Why did the Government not wait for the advice of the Electoral Commission before they brought forward this order? What was the hurry? Secondly, do the Government agree that the leading question, “Do you agree that Scotland should be an independent country?”, which other noble Lords have quoted, is not an acceptable question to put to the Scottish people?

Finally, I understand that for many Scottish politicians the whole prospect of a referendum and independence for Scotland is very agreeable to their political ambition and hubris. However, I fear that independence may have a very unhappy result for the people of Scotland. Therefore, I can only rely on the faith that I have in the Scottish people that they will not be that easily bamboozled when the time comes.

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The Earl of Mar and Kellie: My Lords, very briefly, and by way of introduction, I believe the referendum will lead to Scotland becoming a better democracy. The process we are involved in at the present moment, and the fact that the Edinburgh agreement was signed in Edinburgh, is a great improvement on what happened in 1921 after a ceasefire in July and fraught negotiations in Downing Street led to a treaty that people probably did not want to sign. The Westminster Parliament has made progress.

I am also mindful of the fact that the original treaty negotiations were held in London in the summer of 1706, and it is a curious phenomenon but the two sides were not allowed to meet. They had to negotiate from separate rooms, sending messengers to each other. We should make certain that we do not remain in that position. At the present moment, listening to the debate, it does slightly sound as though this House wants to talk to the Scottish Parliament without meeting its Members. I hope we can continue to make progress towards proper democratic discussion.

Lord Empey: My Lords, the noble Earl is concerned that people only met at a later stage in separate rooms. People in negotiations that I have been involved in have been in separate nations, separate continents and different places before we actually got together, so we are well versed in “proximity talks”, which I think was the phraseology that was invented to cover those circumstances.

We seem in this country, of late, to have developed referendumitis, because we are looking at a whole series of them now. Indeed, later this week, we may be offered a menu for further referenda. Not wishing to be outdone by the noble Lord, Lord Cormack, the sole English contributor to this debate, I felt it appropriate for my part of the world to make a few comments, because, as noble Lords have said throughout the debate, all of us would be affected one way or the other. However, the most important thing is that we are a union with component parts, and there is no doubt in my mind that the people of Scotland have a right to choose. The job of this Parliament is to ensure that the choice is fair and that the options are put to them clearly, as has been said many times before.

I will just deal with the order, because noble Lords will all have great sympathy with much of what the noble Lord, Lord Forsyth of Drumlean, has said today. However, I think that the noble Lord, Lord McConnell of Glenscorrodale, who is not in his place at the moment, put his finger on it. Whether we like it or not and whether this Parliament has had enough time to debate it or not—and I think it has not—the fact is that the Prime Minister and the First Minister have shaken hands. Quite frankly, any departure from that at this stage would have cataclysmic results on the implications and how that would be spun in the circumstances. It is done, and whether we like it or not, we have to work with it.

I will also deal with the point of breakdown. When we had our referendum—nearly 15 years ago, believe it or not—I had the task of being co-ordinator for the Ulster Unionist Party’s “yes” campaign. Not only were communities divided but so were families—husbands,

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wives, sons and daughters—and some of those scars have not yet healed. Let us be under no illusions but that the tone in which the debate is conducted is going to very important for the long-term relationships. People keep telling us today of the implications of the miners’ strike and the differences that arose there, and I know that both communities and individuals remained very divided.

Questions of this nature are extremely divisive, and constitutional questions, certainly where I come from, are exceptionally divisive. What we are witnessing at home at the moment is terribly sad. Sadly, Mr Gerry Adams of Sinn Fein, in his new year message, as reinforced in an article yesterday, is now trying to promote a referendum in Northern Ireland. Under the Belfast agreement, the only question, effectively, is, “Do you wish to be part of a united Ireland?”. Putting that particular, most divisive, issue front and centre as your main campaign for the next few years running up to 2016—the 100th anniversary of the rebellion in Dublin—is irresponsible to say the least in the present circumstances. When we should be talking about our economy and trying to get young people into work, I would have thought that talking about a referendum is the last place anybody wants to be. I deeply regret that.

With regard to complacency, I strongly endorse what the noble Baroness, Lady Liddell, has just said. If you have a 50% turnout, 33% can be 66%. You will get differential turnouts; I have seen it happen. If one side of the argument feels, “Ach, well it will be all right on the night”, but the diehards on whatever side of the argument come out, the percentages in an opinion poll are almost an irrelevance. It is who turns out on the day that matters.

I share the concerns about intelligibility and all these sorts of things. These arguments go over people’s heads. We have had three terms used in this debate already: “country”, “state” and “nation”. If you go and ask somebody for a definition, we all slip in and out of that language in our own parlance. As an Ulsterman looking across the channel at Scotland, to me, Scotland is a country. It has to be a country; if it were not, it would be part of the amorphous landmass of Great Britain. If it is not a country, why does it have its own law, traditions and different languages? Why does it have a history of attitudes, religion and a pioneering spirit and all that goes with that? Of course it is a country. I also think it is an independent country, because it has all those things, which define a country. However, if we get into an argument with somebody in the street about whether a country and a state are two different things, and if we have to go to the door arguing and trying to explain the difference between those things, I fear we are in some difficulty.

All I can say, with the experience that we have had, is that this will be divisive. We have to try to keep the best humour possible, as the noble Lord, Lord Cormack, said, but not underestimating the downsides and implications—and try to keep the argument as simple as possible. I sincerely hope that the people of Scotland will choose to remain within the union, because it would have huge implications for us if they did not. It is their decision, and I respect that, but the playing

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field has to be level, with nobody manipulating it, and the question asked has to be a genuine question that makes it clear that they are seceding from the United Kingdom. Anything less than that will leave an argument. There are still people in Northern Ireland today who do not accept the referendum result that we had, even though it was won with 71.5%. Because of our cross-community issues, people say, “Oh, well not enough of this group voted or of that group”. I can think of nothing worse or more corrosive than an argument over the process. I sincerely wish the people of Scotland well, but sincerely hope that the Government do not allow anybody to wipe their eye in the months ahead.

The Earl of Caithness: My Lords, as the noble Lord, Lord Empey, has said, words are important, and I come back to this word “independent”, or “independence”. I agree with my noble friend Lord Forsyth—on the hypothetical question that the Scottish Government would like to pose, I would very much like to vote yes because Scotland is, to me, an independent country now within part of the UK. I have been banging on about the use of the words “separate” and “separatism” rather than “independence”, and must ask my noble friend why the Government have used “independence” in the order. Proposed new Section 5A, under Article 3 of the order, refers to,

“the independence of Scotland from the rest of the United Kingdom”.

That only encourages the Scottish Government to continue using “independence” rather than “separation”. Why are the Government using that wording rather than saying, “Separate from the rest of the United Kingdom”? That would make what we are all talking about and what the Scottish Government actually mean much clearer.

I also echo what the noble Lord, Lord Pearson of Rannoch, said. I have been longing to ask the question, “Why have we got this order now?”. My noble friend Lord Forsyth said that the Electoral Commission has told him it needs 12 weeks to study the question and formulate its reply. That is in only three weeks’ time, but so much of this debate has been about what the Electoral Commission might have said or might not say. Why have we brought it forward this time? It has been a huge disservice to Parliament, and we have not had the sort of debate that we could have had. It leads one to ask the question put by the noble Lord, Lord Browne. If the Electoral Commission says, “No, that is a leading question”, what are the legal remedies if the Scottish Government persist with their proposed question?

7 pm

I want to raise an old chestnut of mine which nobody else has raised, and ask my noble and learned friend, Lord Wallace, what further negotiations he has had with the Scottish Government about allowing Orkney and Shetland to determine their own future? This is hugely important. If England, Wales and Northern Ireland are not allowed to consider what Scotland does, why should the rest of Scotland have any say in what Orkney and Shetland decide they want to do?

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I also hope my noble and learned friend will put Lord Steel’s mind at rest. He raised the question of the currency, and said that Scotland would have to look to the Bank of England in the event of independence. I hope the Government will make it absolutely clear that should Scotland wish to separate from the rest of the United Kingdom, it will not be allowed to use the same currency as the rest of the United Kingdom. If it did, it would be bad for Scotland and it would be bad for the rest of the United Kingdom. So let us lance that boil now. I hope my noble friend will make it absolutely clear that Scotland will not have the same currency in the event of a yes vote.

Lord McAvoy: My Lords, this has been quite a lengthy debate. Nevertheless, the contributions have been very weighty; there is much knowledge and wisdom in this House. I would like to draw your Lordships’ House back to why we are here. We are here because the Scottish National Party won an electoral mandate at the previous Scottish parliamentary election. I do not like it but I accept the result. It has the right to support and advocate a referendum. We in the Labour Party support this order and hope to get into the debate as soon as possible, rather than be distracted by the many issues that have been raised today.

The noble Duke, the Duke of Montrose, mentioned an ad hoc organisation that advocated devolution. The Labour Party, the Liberal Democrat Party, and almost the whole of civic Scotland joined that ad hoc organisation. The difference between what happened then and what is happening now is that there was a broad consensus throughout Scotland about the need for a Scottish Parliament. The Labour Party supported that and, with the help of the Liberals and others, we brought about devolution and the installation of a Scottish Parliament. As soon as you devolve power to the Scottish Parliament, that power is there and it would be foolish to argue and quibble about this and that when it clearly has a mandate and the democratic right to do what they are doing, within generally accepted conventions.

A number of your Lordships have mentioned, quite rightly, the flaws within the deal that came about between the Prime Minister and the First Minister. We feel that one or two things could have been negotiated a bit more firmly. Having said that, the deal has been made, that is what we have, and we should move on from that. Nevertheless, we should note some points. For instance, the Scottish Affairs Committee quite rightly said in its report last week that decisions in the Scottish Parliament should be achieved by consensus and not simply through the use of the SNP’s majority. I keep hearing the phrase “gold standard”. The consensus that we achieved in the 1980s over the issue of the governance of Scotland should surely be the gold standard. I do not want to denigrate anyone’s personality on this, because that is a distraction that will only damage the cause of those of us who support the union.

There are a lot of issues, such as that of granting votes to 16 and 17 year-olds. The Scottish Parliament has the power to do that. There should be a debate about it, but it should not be an issue that prevents or distracts us from scrutinising this order.

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On campaign finance and the wording of the question, the key phrase should be that the Scottish Government cannot be the referee and a player. Surely the Electoral Commission will act as an independent overseer of that process?

The point so ably made by my noble friend Lord Reid of Cardowan is that the Scottish people are not exactly backward at coming forward. I do not think we will be easily fooled; we will spot any chicanery or jiggery-pokery that may come from any party during this process. Sometimes, we in the political world can underestimate the acumen of the public, who keep an eye on politicians.

The wording of the question should be clear, unambiguous and thoroughly tested by the Electoral Commission. Like others, I should like to see the Scottish National Party commit itself to accepting the decision of the Electoral Commission vis-à-vis the wording. The noble Lord, Lord Empey, and other noble Lords who mentioned this were right: if we have bitter disputes over this, the bitterness will continue and the result will not be regarded as legitimate. It is absolutely essential that we get legitimacy for that result, whatever it is, and that it should be accepted by all.

A number of your Lordships have rightly mentioned the quality of the contribution and amendments of the noble Lord, Lord Forsyth. A number of my colleagues have stated they agree with much of his position. As I am a bit of a bureaucrat, one of the things I am concerned about is the practicality of the timeline. It is clear that, although October 2014 seems a long time away, the processes that need to be gone through before then are nevertheless considerable and time-consuming. If any of these timeline targets are not met, the process will be delayed, which would be dangerous. It will seem that obstruction by Westminster has caused the delay, which would be fatal to the cause of those of us who support the union.

Devolution means devolution. I am afraid that is sometimes hard to accept and something that we do not like. The Scottish people decided that they wanted devolution. I accept it, and it should be accepted.

My noble friend Lady Liddell made the point—far better than I am making it so far—by warning that we should not allow ourselves to be distracted by all the niggly points that have annoyed us. We have picked fault here and picked fault there. I do not say that the niggles, doubts and criticisms are not justified, but let us solve them; let us deal with them, get them out of the way and get on with campaigning. The people of Scotland are looking for a campaign where the issues are discussed, not individual personalities. We can then go to the real core of what would happen to Scotland if it separated from the rest of the United Kingdom. I do not mean that as a negative point or to frighten the people of Scotland by saying that Scotland cannot or would not exist without the rest of the United Kingdom. Of course we could: we could be economically viable and we could be a separate state. But we should say to people that we do not want to be separate—to separate from England, Wales and Northern Ireland, a union that has served us all well, especially in two world wars.

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Again, I echo my noble friend Baroness Liddell. Let us get these issues dealt with. Yes, let us deal with them and debate them, but the sooner we get on to this campaign the better.

Lord Wallace of Tankerness: My Lords, I thank all those who have taken part in this debate. I thank also my noble friend Lord Forsyth for moving his amendment which has stimulated so much debate, although I suspect that, even without it, we would have had a considerable debate on the issue. I understand from my noble friend Lady Garden that there have been some 20 contributions, including an Englishman, a Welshman, a Northern Irishman and, regrettably, only one woman.

Lord Crickhowell: There were two Welshmen.

Lord Wallace of Tankerness: I offer my sincere apologies to my noble friend Lord Crickhowell. It has been a very passionate debate. As the noble Lord, Lord McAvoy, said, this is not necessarily where we want to be. I do not think that anyone here has advocated a referendum or, certainly, independence. Nevertheless, we recognise and respect the outcome of the Scottish election of May 2011 and the manifesto commitment of the Scottish National Party to have a referendum.

I welcome the fact that the noble Lord, Lord Browne, supported the view that the process was being done properly. I thank my noble friend Lord Crickhowell as a member of the Constitution Committee for his contribution. I am grateful not just for the most recent report of that committee on this matter but for the report which the committee produced in February last year following the consultation which the United Kingdom Government launched. In that report, the Constitution Committee welcomed the proposal,

“that a section 30 order be made to confer on the Scottish Parliament clear competence to legislate for a referendum on Scottish independence”.

From that flow a number of the issues which have been dealt with in this debate. It is also fair to point out that, in its most recent report on the referendum, the committee stated:

“We welcome the fact that the Agreement reached between the two Governments accords with our previous recommendations. The question of legislative competence is addressed, it is intended that the referendum will pose a single question on independence, and the Electoral Commission will play the lead role in advising on the referendum”.

That is why I cannot accept the argument that the outcome of the negotiations was weak, as it has been described by some noble Lords. As the Scottish Affairs Select Committee in the House of Commons said:

“The Secretary of State and his team are to be congratulated on their willingness to compromise and reach a consensus with the Scottish Government so that the referendum can be held on a basis to which all can consent”.

The noble Lord, Lord McConnell, mentioned the evidence that he gave to both the United Kingdom Government’s consultation and the Scottish Government’s consultation, where he said:

“I hope that both the Scottish Government and the UK Government will be willing to compromise on all of the key issues to ensure we have a clear outcome in a referendum and an outcome that is accepted by everyone as the fair result of a fair campaign”.

That is what we sought to do.

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The noble Lord, Lord Reid, said, quite fairly, that of huge significance was the fact that it was a single question. I would certainly find myself in some difficulty if I was to come before the House today trying to defend an order or a process that had led to an outcome where there could be more than one question—the so-called multi-option referendum. As the noble Lord rightly said, there is a world of difference between a referendum where one part of the United Kingdom wishes to secede from the United Kingdom, which is a matter, as successive Governments have accepted, for that part of the United Kingdom, and one where there is to be a different relationship within the United Kingdom, with further powers being devolved. That is an important distinction and it is why I am very glad indeed that what we bring before the House today is an order which will provide for a single-question referendum.

It is inevitable in these circumstances that we come to the role of the Electoral Commission. The noble Lord, Lord Kerr, asked about the wording in paragraph 8 of the agreement, which contains the reference to “intelligibility”. I hope that I indicated why that word was used—it is a statutory word, if you like—but of equal importance is the way in which that has been interpreted by the Electoral Commission. Mr John McCormick, who is the Electoral Commissioner for Scotland, said on 9 November, when the Scottish Government submitted their question:

“We will assess the referendum question to see whether voters find it clear, simple and neutral. If it isn’t, we’ll say what needs to be done”.

I shall come to the issue of the question in a moment, because the other issue, as my noble friend Lord Crickhowell said, is the role of the Electoral Commission. Paragraph 12 of the agreement, also referred to by the noble Lord, Lord Kerr, sets out the role of the Electoral Commission in referendums. It states:

“Both governments agree on the importance of the referendum being overseen in an impartial way by bodies that can command the confidence of both sides of the campaign. The Electoral Commission is responsible for overseeing referendums held under PPERA. PPERA gives the Electoral Commission responsibility for: commenting on the wording of the referendum question; registration of campaigners; designating lead campaign organisations; regulating campaign spending and donations; giving grants to lead campaign organisations; publishing guidance for permitted participants; reporting on the referendum process; the conduct of the poll; and the announcement of the result”.

Paragraph 14 of the agreement states:

“Both governments agree that the Electoral Commission should fulfil all these functions in respect of the independence referendum, with the exception of the conduct of the poll”—

which will be done by an electoral management board which has already been established for local elections in Scotland and it is widely agreed across that parties that that should continue—

“and announcement of the result, and the giving of grants”.

The reason why the giving of grants is excluded is that the Scottish Government propose that there will be no grants of public money to the lead campaigns. That is the nature of the oversight by the Electoral Commission which has been proposed.

On foreign donations, it is proposed—

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Lord Forsyth of Drumlean: Before the noble and learned Lord leaves the topic of the Electoral Commission—

Lord Wallace of Tankerness: I am going to come back to it.

Lord Forsyth of Drumlean: Well, perhaps, when he comes back to it, he can answer the question whether it was ever part of the British Government’s negotiating position to require the Scottish Government to accept the advice of the Electoral Commission on the question.

7.15 pm

Lord Wallace of Tankerness: I certainly intend to deal with that. It is a fair question which has been echoed across the Chamber in this debate.

Donations from overseas are dealt with by paragraph 28 of the agreement, which indicates that the rules under PPERA will apply. PPERA states that donations of more than £7,500 must be recorded and declared publicly and that donations of more than £500 require individuals to be registered in the United Kingdom. It is intended that these rules will apply in this referendum and the agreement has set that out. In other words, it is the same rules as are agreed under PPERA.

Lord Foulkes of Cumnock: Does that mean that more than £500 can be donated to the campaign from people in England?

Lord Wallace of Tankerness: I understand that that would be the case, yes.

My noble friend Lord Forsyth asked why broadcasting and mailshots were included in the order whereas other issues were not. The simple answer to that is that broadcasting and the Royal Mail are outwith the competence of the Scottish Parliament. Legislation brought forward by the Scottish Parliament cannot deal with these issues unless competence has been transferred. That particular part of the order transfers competence in order for the broadcasting arrangements and mailshots to be dealt with.

My noble friend and many other noble Lords asked about the nature of the question. Numerous people have found flaws with the question of whether Scotland is a country, a state or a nation, as the noble Lord, Lord Sutherland, made clear. I do not stand here to defend the question that has been put forward. It is not my job to defend it; nor would I wish to defend it. It is important that that should be a matter for the Electoral Commission, which is why it has been asked to advise.

The United Kingdom Government recognised in their consultation paper that the Electoral Commission’s role in referendums was to consult on the intelligibility of the proposed question and to report to the UK Parliament. We would have come under considerable pressure and criticism if it had been suggested that the Scottish Parliament should be treated in a different way. I will pick up on this point, because it is quite central to a lot that has been said in this debate. I will not go into the personalities, but we know the ability

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of not only the leader of the Scottish National Party, but in many ways the Scottish National Party itself. One thing that they have quite excelled at—those of us who have been around Scottish politics know this only too well—is their ability to nurse a grievance and to milk a grievance. That is what the noble Lord, Lord McAvoy, said about the timing of this. We do not want to give them another sense of grievance. If we had proposed that the Scottish Parliament was in some way to be treated in a lesser way with regard to a question after it had gone to the Electoral Commission than the United Kingdom Parliament was treated, we would have given them cause for a grievance.

The noble Lord, Lord Reid, was absolutely right to point out that this is a question which will come back to haunt them if they choose to ignore the advice of the Electoral Commission. I know that my noble friend Lord Forsyth said that he did not want this to be two years of picking on points, but it would be quite legitimate, if an attempt was made to put a biased question, for that to be pointed out and for the political consequences of that to be reaped. However, I would not wish, and what we have sought to avoid—and have successfully sought to avoid—is a two-year campaign in which the United Kingdom Government and Parliament are in the dock because we somehow or another have tried to rig the referendum. That is why it is so crucially important that we do not give, and we have not given, any opportunity for the Scottish Government to cry foul and say that we are somehow rigging the situation.

In an interesting article by John Rentoul in the Independent in November of last year, in which he praised my right honourable friend the Secretary of State for Scotland, he said:

“This sudden removal of the London Government from the see-saw meant that Salmond lost his balance. When Cameron went to Edinburgh in February to announce that he would not try to stop the Scottish National Party holding a referendum, Salmond found that the great London counterweight, against which his career had been built, had been taken away”.

It is important that we do not give that opportunity, or that excuse, for a grievance to be mounted. That is one of the main reasons—a key reason—why we are dealing with this in the same way as we would deal with a question in a UK referendum that had been legislated for by the UK Parliament.

That answers the question about the referee and the player. I take the point made by the noble Lord, Lord Sutherland, who came forward with a question himself. It is up to people with an interest to make their views on this known to the Electoral Commission. Clearly it would not be appropriate from the Dispatch Box to determine the agenda of the Scottish Parliament, but I rather hope that Members of the Scottish Parliament will note what has been said about them having an opportunity to debate this issue.

I will make one further point on this, which was made by the noble Lord, Lord McConnell, and was echoed by the noble Lord, Lord Empey. Lots of harsh words could, and almost certainly will be, exchanged in the next two years, and there is potential, as the noble Lord, Lord McConnell, said, for a nasty taste to be left in the mouth. That is why there is a responsibility on the Scottish Government and the Scottish Parliament

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to ensure that the question that is asked is not a source of that sour taste in the mouth. Just as we have sought, as a United Kingdom Government and a United Kingdom Parliament, to produce a scheme and process that will not allow anyone at the end of the day to cry foul—“It wasnae fair”—it is also incumbent on the Scottish Government and, above all, on the Scottish Parliament to ensure that when they devise the rules, procedures and indeed the questions for this referendum, they do not give anyone the opportunity at the end of the day to say “It wasnae fair”. It is important that the outcome of this referendum is decisive and properly recognised as having been fair and properly arrived at by the people of Scotland when they cast their votes in 2014.

Lord Pearson of Rannoch: My Lords, is the Minister about to leave the Electoral Commission in his remarks, or will he address the two questions that I, and the noble Earl, Lord Caithness, put to him?

Lord Wallace of Tankerness: I had indicated that I would not defend the question that had been put forward. It would be appropriate for the Electoral Commission to indicate that. I was asked about time; as was indicated by the noble Lord, Lord McAvoy, there is a timeline. My noble friend Lord Forsyth suggested that the legislation for the referendum would not come until after the White Paper. My understanding is that if this House, and subsequently, the Privy Council, approve the order next month, the Bill will be presented to the Scottish Parliament in March. The Bill cannot in fact be presented to the Scottish Parliament until such time as this order has been approved, which is why the timing of it is as it is.

The important point with regard to the question is that what has been done by this order, in transferring the legal competence to the Scottish Parliament, is such that the nature of the question and the advice of the Electoral Commission will go to the Scottish Parliament. It is not proper, and it would fuel that sense of grievance, if somehow or another we said “We’ll give you the competence to legislate for this, but only provided that we can write or prior-approve the question for you”. That would lead to a very strong sense of grievance, and would put us, who want to argue the case for our United Kingdom, on the back foot in many of the ensuing debates.

I very much hope that common sense will prevail, and that the sense of achieving a decisive outcome will prevail with the Scottish Government and Parliament. As the noble Lord, Lord Reid, indicated, they will pay a very serious political price if they do not do so.

Lord Forsyth of Drumlean: Does the Minister really mean that it was right for the Electoral Commission not to give its advice to this House and the other place on the intelligibility of the question proposed by the Scottish Parliament, and that it would be wrong for us to comment on it? If we had had the Electoral Commission’s advice today—it must be provided by 1 February—quite a long time would have been saved, because we would have known what the position was. Surely we have not got to the position where we are so afraid that what we are doing will be misrepresented that we cannot do our work. Of course we cannot

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decide the question, but surely it would have been entirely appropriate for us to have the opportunity to comment on the question in the light of the independent advice from the Electoral Commission.

Lord Wallace of Tankerness: My Lords, a number of questions are rolled up into that. First, that is not the obligation of the Electoral Commission—there is no statutory duty or anything else for it to provide the answer by 1 February. I cannot remember which noble Lords made the point that your Lordships’ Constitution Committee had produced a report in a relatively short period of time, so why could the Electoral Commission not do the same?

The task of the Electoral Commission, among other things, is to go out and sample the question, which is not something, with all due respect, that the Constitution Committee intended to do, and neither would we expect it to do so. There is, therefore, a piece of work to be done in testing the question for its intelligibility, whether it is leading or misleading, whether it is neutral or whether it can be understood by those who will be asked to answer it in the referendum. I do not believe, therefore, that there was somehow some obligation on the Electoral Commission to rush that. I can hear the criticisms now if people thought that it had in some way been rushed.

Neither my noble friend nor any other noble Lord will be inhibited from commenting on the report of the Electoral Commission, which will be published and very much in the public domain. I will come to the noble Lord, Lord Sutherland, in a moment. There is no doubt that it is a matter for the Scottish Parliament to determine. There will be every opportunity for voices to be expressed as to what the Scottish Parliament should do in the light of the advice from the Electoral Commission.

Lord Sutherland of Houndwood: Simply as a matter of fact, the Electoral Commission has advised me that it will publish its report early in February.

Lord Wallace of Tankerness: That is helpful. However, it is important to understand that there is a body of work that it ought to do, and is doing, before it publishes that advice.

The question has been raised about the franchise. As I indicated to my noble friend the Duke of Montrose, it is a matter of primary legislation for the Scottish Parliament. If it chooses to extend the franchise to 16 and 17 year-olds, issues will arise out of that; it will need to ensure that the proper protection is given to minors whose names would appear on a roll. That would be the responsibility of the Scottish Parliament in any legislation which it brings forward.

I do not believe that that is the thin end of the wedge. If only legislation passed by the Scottish Parliament was, we would have proportional representation by single transferable vote for English local authority elections, but I have not seen a great rush in the Westminster Parliament to follow the Scottish Parliament in that constitutional development

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Several noble Lords, including the noble Lord, Lord Reid, my noble friends Lord Stephen and Lord Cormack, and the noble Baroness, Lady Liddell, posed an important question about the vote for service personnel. The position is that the members of the Armed Forces and their spouses or civil partners are entitled to vote in elections, provided that they are registered to vote either by means of a service declaration or as an ordinary voter. Members of the Armed Forces will be able to vote in the referendum if they are on the register in Scotland either as a result of an address in Scotland or a qualifying address showing a connection to Scotland, such as service accommodation in Scotland; an address in Scotland where they would be living if they were not in the services; or an address in Scotland where they have lived in the past. The same rules apply to spouses and civil partners of members of the Armed Forces.

On the specific point raised by the noble Baroness, Lady Liddell, service personnel who are overseas at the time of the referendum who would otherwise be eligible to vote will be able to vote by post or by proxy. I understand that the Electoral Commission and the Ministry of Defence run an annual electoral registration campaign to inform personnel and their families in units around the world about such voting matters. I will certainly talk to colleagues in the Ministry of Defence in the next round of prompting of information to ensure that they remind service personnel of the referendum.

Lord McConnell of Glenscorrodale: My Lords, will the Minister check very carefully that that information campaign is timed to coincide with the period during which service personnel would require to register to qualify to vote in 2014? The timescales may well be such that they would miss deadlines. We would all appreciate an assurance that such checking will happen.

Lord Wallace of Tankerness: That is an important point, and I take it on board. It is also important to make clear that service declaration, to which I referred, is now valid for five years, following legislation that took effect in March 2010. Those who have already made a service declaration which gets them on to the Scottish register will have that for the five years after March 2010, so they will certainly have it for the time of the referendum.

Lord Reid of Cardowan: I am grateful to the Minister for that. Knowing how bureaucracy can ensure that the best laid plans gang aft agley, can he ensure that there is a distinct recognition in the Ministry of Defence that this is different from the normal, annual registration, for this reason: you have go to every serviceman and woman? From what he said, there may well have to be a process to identify those who have the qualifying criteria of having had a residence in Scotland, and so forth. If that process is not started early, we will find, as we did many years ago, before we brought in the new regulations, that for purely bureaucratic reasons, servicemen and women and their families are not adequately informed—especially, as my noble friend Lord McConnell said, in time. That process has to

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start now. It is quite a big job weeding out, if you like, or identifying people, rather than applying a carte blanche regulation for everyone.

Lord Wallace of Tankerness: My Lords, the noble Lord makes an important point. I will certainly ensure that his comments and the general sense of the House is drawn to the attention to the Ministry of Defence. No doubt Questions can be asked to ensure that we live up to that.

Finally, my noble friend Lord Forsyth quite properly said that there should be no room for complacency. That was echoed by other noble Lords, including the noble Baroness, Lady Liddell, and the noble Lord, Lord Empey. I could not agree with them more. I have said—although I do not think it was from the Dispatch Box—that the biggest enemy that those of us who wish to remain part of the United Kingdom have is complacency. We must guard against it, not simply because I want to win—I want to win very convincingly indeed. I certainly take the point about differential turnout made by the noble Lord, Lord Empey, and very much believe that we should guard against complacency.

My noble friend Lord Forsyth and the noble Baroness, Lady Liddell, asked about information. I suspect that we will not get a completely neutral arbiter, although some bodies are producing evidence from a more neutral point of view. The noble Lord, Lord Nickson, who I think is a former chair of CBI Scotland, appropriately raised the pertinent questions that CBI Scotland is addressing to the Scottish Government.

The Government have made it clear that we will be publishing material to provide information, not least about the number of jobs provided by the defence industry and what benefits being part of the United Kingdom bring to Scottish security. It will also set out facts, which are perhaps currently unknown or often just taken for granted. In that regard, it will include the importance of our position in the world. Scotland is part of the United Kingdom which punches much above its weight in terms of our population and because of our history, to which Scotland has contributed. It will talk about the protection of our citizens. It will talk about the many economic benefits to the United Kingdom.

The first of those papers will be published in the next few weeks, and we will publish further papers throughout 2013. I hope that that brings important information, which we will all be able to use in our arguments for the furtherance of the United Kingdom.

My noble friend Lord Forsyth and I were both elected to the other place 30 years ago this year, and I have known him all that time. We have disagreed about a number of issues, not least Scotland’s constitutional future, but I have always respected where he comes from on that and the important issues that he has raised this afternoon. One issue on which we can join together is that it is very important that we join together people right across this Chamber who believe that Scotland is better as part of the United Kingdom and the United Kingdom is better with Scotland in it; that we share a common heritage; that we share common social bonds; that we have a shared cultural heritage with, fundamentally, shared political values; and that

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we can defend them much more effectively in an uncertain and challenging world when we are working together. It is in that spirit that I want to argue that case, and I urge your Lordships to approve the order.

Lord Forsyth of Drumlean: My Lords, what a wonderful debate we have had. It is pretty clear to me that there is a consensus in all parts of this Chamber— bar one, if I may say so—about the need to have a referendum campaign that is seen to be fairly conducted and where there is no dispute about the result at the end of the day.

As I said at the beginning, I do not propose to divide the House. I think that that would be a huge error on my part, because it might give the impression that we are not as united as we are on these matters. However, I say to my noble and learned friend—we have been friends for a long time, if opponents, which we are not now, although we were earlier in the week; it is very difficult to work out what the nomenclature of this week should be—that he has taken a risk, a gamble, on being able to ensure that we get a decent question and proper rules for the referendum. I am prepared to withdraw my amendment and back his judgment. If it turns out to be wrong, he can expect some very vigorous debates in future. I beg leave to withdraw my amendment.

Amendment withdrawn.

Amendment to the Motion

Tabled by Lord Forsyth of Drumlean

As an amendment to the Motion in the name of Lord Wallace of Tankerness, at end to insert “and regrets that debate in Parliament on the draft Order is taking place before the publication by the Electoral Commission of its advice on referendum campaign funding and on the proposal from the Scottish Government that the referendum question be ‘Do you agree that Scotland should be an independent country?’, advice which is required to be published by 1st February”.

Amendment to the Motion not moved.

Motion agreed.

Health: Medical Innovation

Question for Short Debate

7.39 pm

Asked By Lord Saatchi

To ask Her Majesty’s Government what steps it proposes to take to encourage best practice in medical innovation.

Lord Saatchi: My Lords, I express my gratitude to the usual channels for allowing the time for this debate. I have introduced the Medical Innovation Bill into your Lordships’ House. I will not be covering the details of that Bill in this debate; Second Reading will

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follow at some point in the year and we can discuss them then. However, this debate may illuminate the context of the Bill and give your Lordships’ House an opportunity to consider the whole complex question of what best practice is in innovation, particularly the application of research and knowledge to patient treatment.

In opening this debate among the judicial and medical experts in your Lordships’ House who have devoted a lifetime to this subject—compared to my own brutally short experience—a certain humility is appropriate. It will be my privilege to hear many noble Lords who are among the great innovators of our time. I particularly thank my noble friend and his team at the Department of Health for their wisdom; Dame Sally Davies, the Chief Medical Officer, for her viewpoint; the Secretary of State himself for making improved survival rates his key priority for healthcare; and the many patient groups, academics and practitioners who have contributed their thinking.

The Prime Minister himself has encouraged British medical innovation in the context of the global race, and the document on diffusion of innovation in the NHS by my noble friend, himself Minister for innovation, is, if he will allow me to say so, a model of agenda-setting by a government department.

Buoyed up by Bertrand Russell’s view that simplification is not always obfuscation and often serves to crystallise the issues, I will attempt first a simple description of the need, and then a specific suggestion of what steps your Lordships may consider to meet that need. I will concentrate on the most emotive word in the English language—cancer—and hope to draw wider conclusions from this area. To express the need, I am helped by an unexpected source, the Father of the House in another place. In his tribute to Her Majesty the Queen on the occasion of her Diamond Jubilee, he used a striking phrase:

“There is nothing more inspiriting in the whole world than a beautiful woman”.—[Official Report, 07/3/12; col. 852.]

I can amend that. There is no more distressing thing in the whole world than a beautiful woman being reduced to a sparrow.

Unfortunately, here is the status quo. A woman is told that her tests are “normal” and to come back in 12 months. She is removed from her home 12 months later and cut and drilled until she loses half her body weight. Wires and tubes are attached to her throat, nose, stomach and vagina. Drugs are given to her that cause nausea, vomiting, diarrhoea and fatigue. They open the path for fatal infections to enter the woman’s body and reduce her body’s defences against such infection. The woman is left for dead, and sooner or later the woman dies. The “process”, as it is called, involves scenes that would not be permitted in a Hollywood horror movie.

I hope that that is a fair description of the need for medical innovation. The screening techniques for such a cancer are inadequate; no reliable early detection method is available, and even if it was, it would improve the overall survival statistics but not the date of death. The treatment regimes, when provided—that is, the drugs, the cycles of their administration and the surgical

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procedures—are 40 years old. They are also ineffective; cancer quickly develops resistance. Not surprisingly, the survival rate for such cancers is the same as it was 40 years ago—in other words, nought; and the mortality rate is the same as it was 40 years ago—that is, 100%.

This disease is relentless, remorseless and merciless. Its treatment is medieval, degrading and ineffective. Why are we so forsaken? It is said that cancer is so complex that it is beyond the judgment and understanding of the human mind to comprehend its variables. Therefore, through ignorance, we kill people unnecessarily.

If that is true, it is not through lack of trying. Scholars in cancer have long sought general rules about the world as robust as the laws of physics and to verify statements, propositions and putative facts by the results of empirical studies. Unfortunately, it has not worked out quite like that. Instead, we find the stubborn fact that, after 2000 years of human progress, cancer is still outside Newton’s universe where physical laws govern reality.

In the natural sciences, even though, as Popper says, the closest approach to proof is just a succession of unsuccessful attempts at falsification, we can nevertheless make statements in the natural sciences, perhaps without finality but with a certain degree of probability. If I drop these papers, they will fall to the ground. Tomorrow the sun will rise. In cancer, though, the record seems to show that once we express opinions or beliefs or attempt to offer explanations, descriptions or predictions, then error, doubt and uncertainty come to the fore. In cancer you hear it said that, “Every case is different” and, “There is always hope”. Such well meaning sentiments are not science. There is no hope that if I drop my papers they will not fall. These statements are meant to bring cheer to the desperate, but instead the effect is the opposite. They bring despair—the dread revelation that cancer is a realm in which science has yet to achieve sovereignty.

In the end, all attempts to place cancer medicine within the canons of scientific objectivity have failed. There remains an irremediable tentativeness about the logically perplexing question of what is the cause or cure for cancer. Cancer science has not yet found its Newton. Why? There is a powerful deterrent to innovation at the heart of the current system. Economists would call it a systemic failure. Current law is a barrier to progress in curing cancer. Under present law, any deviation by a doctor from standard procedure is likely to result in a verdict of guilt for medical negligence. Current law defines medical negligence as deviation from standard procedure. As innovation is deviation, though, non-deviation is non-innovation. In this way, the fear of litigation for medical negligence is a roadblock to innovation in cancer treatment. The present pre-eminence in law of the standard procedure provides no inducement to progress. The self-interest of medical practitioners, as defined, for example, in doctors’ insurance policies, means that innovation—that is, deviation—is a form of self-harm.

In Clark v MacLennan, an important test case in 1983, the significance of departing from an approved mode of practice was treated by the trial judge, J Pain, as having the effect of reversing the burden of proof, so that once the plaintiff established a deviation the

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defendant had to disprove an inference of negligence. I quote Crawford v Board of Governors of Charing Cross Hospital, 1953:

“The practitioner who treads the well-worn path will usually be safer, as far as concerns legal liability, than the one who adopts a newly discovered method of treatment”.

In the standard Butterworth text on medical negligence, the authors Nathan and Barrowclough expressed in 1957 the following view, still applicable today, concerning deviation from accepted modes of practice and the ethics of new treatment research and experimentation:

“Medical men cannot be permitted to experiment on patients (Slater v Baker and Stapleton) (1767) ... On the other hand the courts will not press this proposition to a point where it stifles initiative and discourages advances in techniques … a line must be drawn between the reckless experimentation with a new and comparatively untried remedy or technique, and the utilization of a new advance which carries with it unforeseen dangers and difficulties”.

I hope that we can agree with Lord Diplock, who was looking for a better balance to be struck between therapeutic innovation and therapeutic conservatism. He warned of the dangers of so-called defensive medicine:

“Those members of the public who seek medical or surgical aid would be badly served by the adoption of any legal principle that would confine the doctor to some long-established, well-tried method of treatment only, although its past record of success might be small, if he wanted to be confident that he would not run the risk of being held liable in negligence simply because he tried some more modern treatment, and by some unavoidable mischance it failed to heal but did some harm to the patient. This would encourage ‘defensive medicine’”—

that is his phrase—

“with a vengeance”.

I am looking carefully at the time and will therefore bring these remarks to a close. Your Lordships will agree that optimal care is evidence-based care. Evidence-based medicine is therefore standard procedure for the protection of patients. However, as your Lordships are well aware, cancer is the least evidence-based disease of all. There is great uncertainty: either the evidence does not exist or, if it does, it is not clear what it means. Innovation is therefore more appropriate in cancer treatment and the consequences of not innovating are greater—poor life quality, followed by death.

I shall end with this. What can your Lordships’ House do—that is the point of this debate—to encourage the drive towards medical innovation, on which my noble friend has made such a great contribution? The advance of science depends upon the free competition of thought and thus upon freedom; that must come to an end if freedom is destroyed. Are the intellectual problems of cancer insoluble? I do not think so. What is more inspiring, apart from a beautiful woman, than the quest by scientists to explain the world; to find satisfactory explanatory theories—simple theories—and to test them? One of them will cure cancer. We should rise to our feet to applaud the great cancer doctors and scientists, many of them in this House, who are striving by their own best lights to serve the community. Let us erect statues in their honour or build bridges in their name, or parks, or avenues, or airports. Let us encourage them, not frighten them.

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7.51 pm

Lord Winston: My Lords, it is both a responsibility and a privilege to be the first speaker after the deeply moving speech from the noble Lord, Lord Saatchi. He carries the respect of the whole House for tabling this debate and has our thanks for the way that he phrased what he said. I feel that my own contribution will be paltry by comparison, but I thought that it would be interesting to look quickly at my own career and think of seven points in it where innovation was an issue. Our excellent Minister sitting on the Front Bench cannot be expected to be responsible for trying to improve innovation in the health service. This is a colossally difficult issue; I will explain why I think so.

The first thing I want to refer to briefly is my involvement in the early days of microsurgery of the fallopian tube. First, that project, which led to about 50 publications, would not have been possible today because the Medical Research Council grant that I got would not be awarded with the current competition. Secondly, it is fair to say that I would not have got an animal licence to practise a surgical procedure, rather than to do it experimentally. There is a neat difference now in how the regulation is. Throughout, there are at least eight issues that conflict to make innovation difficult. One is regulation; one is infrastructure; one is governance; one is industry and its involvement; one is the internal market, supported by both the Labour Party and the Conservative Party; one is clinical training; another is teamwork. Lastly and most importantly, there is the cultural environment. I will come to one other issue at the end, if I may.

The infrastructure for my work with the fallopian tube would not be possible now because I had access then to a workshop in a district general hospital, where Dennis Melrose was producing extracorporeal circulation pumps to improve heart surgery. That is almost unthinkable now. One of the greatest difficulties I had was in getting industrial support for making the microsurgical needles. I could not find a single industry in this country that would make the needles. We made needles with our own hands, under a microscope, that were so fine and delicate that they did not fall to the ground. Unlike the noble Lord’s papers, they actually floated on the air. Eventually, we found a German company which then captured one-third of the world’s ophthalmic market with those needles. There is a message in that innovation.

With regard to trying to translate that surgery into the female pelvis, the big problem now would be governance. What also followed was the issue of having training in teamwork around, to persuade surgeons to work as a team. That has become more difficult now because of the internal market. It is very difficult to prove that a surgical procedure works and is innovative, because it is more difficult to collect the cases together within a health service structure. We have all faced this difficulty for quite a long time. It is not the responsibility of any one Government.

The same thing applies, to some extent, to laparoscopic surgery. I think I was one of the first people to operate using a laparoscope in this country. There would now

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be a problem with governance; it would be considered risky and unwise, and would take much longer to innovate.

With the present regulatory system, it would also be impossible to see in vitro fertilisation—your Lordships probably know that I have certainly more than dabbled in that—on the books in the way that it is now. It would be very difficult to transfer an egg that you fertilise outside the body into a human patient. It would certainly take much longer to get permission to do that. That is one of the issues. In my own unit, we made a whole series of improvements. We improved the culture media. We demonstrated, for example, the given knowledge that glucose in the medium was poisonous to human embryos but not to any other animal that was experimented on. We could not change those media now, given the current regulatory framework. Even the little changes that one could make—the fact that tungsten light is dangerous to embryos, for example—become increasingly difficult.

I could go on and on but I do not want to spend more than a few minutes and my time is almost up. It would now take much longer to get permission for things such as embryonic detection of genetic defects. I have to declare an interest as somebody who launched a biotech company. One of the problems with that company, which might change the whole field of transplantation with the use of pigs’ kidneys, hearts and livers, and possibly pigs’ lungs, is that it took us more than a year and a quarter to get an animal licence to practise and do the work on just six pigs. It was quite difficult to get the rodent licence before that as well.

I want to say one final thing. The first experiment I ever did was as a result of fraud in my unit. I was asked to go in and troubleshoot by repeating an experiment. It was pure serendipity that we found that there was probably something wrong, with an infection in the vagina of women that might lead to the possibility of a virus being involved. We now know, of course, that the virus is very well established but I did not know what it was at the time. That was a long time ago but one of the issues with true innovation is that serendipity is extremely important. What we can perhaps best all do together is to see how we might improve the culture in which we do our medicine.

7.57 pm

Lord Willis of Knaresborough: My Lords, I begin my remarks by echoing the comments of the noble Lord, Lord Winston. I have been a parliamentarian in both Houses for some 16 years now and I do not think I have ever heard a more moving, considerate or emotive speech than that of my noble friend Lord Saatchi. I thank him for it. In so doing, I have to say that some of the issues that he and the noble Lord, Lord Winston, have raised—and that others will raise—are ones that the Minister, with his responsibilities, can begin to address. Last night, I was responsible for hosting a reception for Children with Cancer UK, an organisation that has been running for 25 years and which began because, 25 years ago, childhood leukaemia killed eight out of 10 children who suffered from it. Now, 80% of children survive it. That happened through innovation—through the very things that the noble

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Lord, Lord Winston, mentioned and which others will mention—so there is hope. I would want to give my noble friend that element of hope.

My frustration is with many of our scientists’ inclinations. The means to deliver novel or experimental treatments to patients earlier exists. It is not something that does not exist and, quite frankly, it does not require further legislation. With the support of government and an excellent UK life sciences strategy, we have the means to do exactly what my noble friend wants to see. We do not need more legislation; we need action. We need regulators and funders to recognise that, while their approaches are fine for established research pathways and large populations of patients, they are hopelessly inadequate for new and experimental treatments on small, stratified populations.

There is progress. Both the conditional approval scheme and the named patient scheme are important in the toolbox of clinicians who want to try novel and untried treatments but, frankly, they are rarely used. Indeed, perhaps the Minister, when summing up, can say how often they are used and for what purpose. Perhaps, too, he could tell us what progress is being made on the early access scheme, championed in the UK Life Sciences Strategy, which would allow access to drugs earlier than the current regime permits, especially where the compounds under consideration represent possible therapies where few alternatives are available. Currently, the Government’s ambition for this scheme is two to five drugs per year. Does the Minister really feel that that should be the height of this strategy’s ambition?

Perhaps offering more promise, as the Science and Technology Select Committee heard in relation to its regenerative medicine inquiry, is the issue of adaptive licensing, an initiative that also appeared in the UK life sciences strategy. Adaptive licensing offers a flexible approach whereby regulators, clinicians, patients, the research community and industry are jointly involved in assessing the risks of a given experimental treatment so that a proportionate level of regulation can be determined for the release of novel drugs to patient groups. This proportionate approach recognises, as we move to more targeted therapies for smaller populations where traditional clinical trials will be of limited use, that this approach offers an alternative, more appropriate assessment of patient risk and benefits; but, again, where is the urgency or ambition? The expert group that was set up by the MHRA to look at adaptive licences has met only once, in October 2012. Frankly, if that is the rate of progress, it will be years before we see this opportunity realised.

Finally, I come to regulation and regulators, a topic to which I know many noble Lords will return later. When the Academy of Medical Sciences produced its report in 2011, the Government promised simplified, more unified and smarter regulation. The setting up of the Health Research Authority would herald a new dawn for those who see the regulatory burden—particularly for scientists, clinicians and SMEs working at the edge of discovery—as an obstacle to progress. Far from achieving that aim, the HRA appears to have become a very expensive national ethics service. If anything, regulation has become more complex and

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more bewildering. Indeed, as one expert witness revealed yesterday to our committee, “It is only accessible if you know where to look”.

Clinicians hoping to use new therapies to save the lives of cancer patients do not have the time, and often do not have the resources, to meet the demands of well meaning regulators and their plethora of never-ending hurdles set up to ensure patient safety. That is the real challenge. Without a more agile, unified and flexible regulatory system, which puts patients at its heart, all attempts to move novel and often untried treatments into patients will fail. In that case, we will fail my noble friend in his cause.

8.03 pm

Baroness Masham of Ilton: My Lords, I thank the noble Lord, Lord Saatchi, for asking this question so movingly. I feel honoured to be taking part in this debate with such experts. Having a cousin who is research-minded and is a professor, now living in Australia, I want to raise a few points that we have discussed.

Many Britons see their clinical research careers take off after they leave the UK. Some of this is due to the internationalisation of medicine and the growing awareness of how valuable exposure to overseas best practice can be during specialist training. It is a two-way street, so some of the UK’s best specialists come from overseas.

It seems that clinical research comes a poor second after the pressing needs of an overloaded health service have been met. From clinical medical student through resident positions, specialist registrar training and on to first consultant position, it seems difficult to find the time and support for clinical research and development. Apart from a few fortunate centres, where seniors have managed to establish a strong funding stream for R&D, resulting in research fellow appointments, research support staff and so on, there seems to be a poor match between the R&D effort and the acute medical front line. More regional expert centres should be better funded. Steps seem to be needed to recognise where there is already established leadership and to make use of it.

Innovation in healthcare and innovation in clinical research have a symbiotic relationship. Without research there can be no innovation, as there will be no evidence base with which to inform clinical practice. Without that clinically proven innovation being acted on, we will see no advance in clinical practice, no improvement in patient outcomes and less incentive for clinical research to be carried out.

There seems to be frustration from some bodies involved in innovation. For example, Innovation, Health and Wealth promised to:

“launch a national drive to get full implementation of”,

oesophageal Doppler monitoring,

“or similar fluid management monitoring technology, into practice across the NHS”.

This is an admirable policy, but again reality is not living up to intention. Not only is that implementation drive delayed; it has been scaled back. The NHS is also allowing the inclusion of technologies similar to

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ODM that do not have adequate backing through clinical research and have not been evaluated by NICE. Allowing unproven technology to be on an equal playing field with technology that has been through the rigours of clinical research is both unfair and uncompetitive. It will also result in worse outcomes for patients, lost productivity, fewer savings for the NHS and reduced incentives for clinical research to be carried out in the UK.

Will the noble Earl look again at the ODM implementation plan to ensure that the benefits to both patients and the NHS are realised through proper consideration being given to clinical research? There are so many complicated rare conditions that need new ways of treatment. When medical innovation has come up with the answer, it is vital that patients get the correct treatment for their condition. Nothing is more frustrating for the developers of a treatment and for the patients than when commissioners will not pay, thus holding up treatment and ongoing development.

It is heartening to witness the great support that so many people give to medical research and innovation through charities.

8.08 pm

Lord Ribeiro: My Lords, I add my thanks to my noble friend Lord Saatchi for bringing this debate on a matter that is very personal to him. I chair the research panel of the Pelican Cancer Foundation based in Basingstoke. One of our members, Professor Bill Heald, pioneered a new technique for removing rectal cancer in the early 1980s. Total mesorectal excision, or TME, reduces the incidence of a recurrent tumour in the pelvis after surgery. Despite many publications, presentations and lectures on his technique, it was not adopted in the UK. The Scandinavians, however, were more convinced of the benefits, and Professor Heald developed a national training programme with them, which was adopted in the Netherlands, Norway and Sweden in the early 1990s. It became part of routine practice, resulting in improved outcomes for rectal cancer patients. It was to take another 10 years before TME became accepted as a routine procedure and best practice in the UK, despite it having been first pioneered in England.

So how can we speed up the take-up of new procedures? How can we accelerate translational research? In 2007, the national cancer action team and the Department of Health introduced the LAPCO training programme for teaching laparoscopic colorectal surgery. The Royal College of Surgeons promoted and delivered the programme through its new skills centres and, now, through specialist hospitals throughout England. This initiative proved so successful that I was recently asked to give a keynote lecture in the United States to offer our experience of teaching and disseminating laparoscopic colorectal surgery to the surgical community, and our methodology for assessing skills and accrediting competence to practise the procedure. The invitation letter said:

“It is my understanding that the UK has done this in a more proactive and safe fashion than we have in the States”,

an acknowledgment that central direction, as occurred with TME in Scandinavia and now with LAPCO, can produce best practice and innovation.

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For a national programme of laparoscopic colorectal surgery for cancer, we will need about 460 surgeons trained in the technique. This is because we have a large NHS caseload, and it is required to meet the NICE guidelines on laparoscopic bowel resection. We currently have half that number. We need to be able to release doctors and surgeons to train innovative procedures. This requires incentives, the support of the base hospital when they have to go away to learn techniques, recognition of their efforts through clinical excellence awards—which I am pleased to say have been reinstated—and other marks of recognition. These efforts definitely show that you can improve the outcome for patients, and the benefit to them is real.

In a report in 2001, From theory to theatre: Overcoming barriers to innovation in surgery, the Royal College of Surgeons recommended that surgical trainees should be encouraged to participate in ongoing research and to work with multidisciplinary teams. With the support of CMO Dame Sally Davies, who was mentioned earlier, the Royal College of Surgeons has committed to funding five surgical trial centres from 2013, with the aim of recruiting thousands of patients for these trials. As surgeons, we are often criticised for not getting involved in randomised control trials; the comic opera referred to as “surgeons trying to do research” perhaps refers to this.

It is necessary today for us to carry out these trials because the number of trials carried out in surgical discipline comprises less than 10% of those done in cardiology. The trials units will provide expertise to develop multi-centre surgical trials, offer technical support and speed up the delivery of clinical trials. As surgeons, we are trying.

In order to speed up the process, from theory to theatre, it is vital that we involve patients in decisions about innovative treatment. Patients must understand the potential risks so that they are able to give full, informed consent. The process for doing this is in place—we have study design, ethical approval and patient involvement—but it needs to be expedited. We all know how long it takes to get approval to start a new trial. It is important that we do not have to wait the length of time that Professor Heald in Basingstoke did to introduce a procedure which has clearly saved many patients’ lives.

8.14 pm

Lord Rennard: My Lords, I first declare my interest through the work that I do with the British Healthcare Trades Association, as in the register. However, the issue that I was asked to raise in this debate is specifically about the provision of insulin pumps.

I am one of the 2.9 million people in this country already diagnosed with diabetes. As a type 2 diabetic, I was first told that my treatment would only be in the form of tablets, but in common with many people who are diagnosed at a relatively early age with what they used to call “mature onset diabetes”, I found that after 10 years or so I also needed insulin injections every day. Now, as our understanding of dealing with diabetes grows, I am advised by my excellent diabetes specialist

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nurse that I may well need an insulin pump in another 10 years or so in order to be able to maintain good control of my condition.

The prevalence of diabetes is growing, and the period of time over which people need treatment is growing substantially. I am, therefore, concerned that many people with diabetes, who might benefit considerably from the provision of insulin pumps, do not currently find them available on the NHS. A survey not very long ago showed that the average rate of insulin pump provision for people with type 1 diabetes in this country was 3.7%, compared with the then 12% benchmark recommended by NICE and in comparison with other countries, such as the USA, where such provision is estimated at 35%, and Sweden, France and Germany, where it is estimated at 15-20%.

Good diabetes management is, of course, crucial to reducing diabetes-related complications, such as hypoglycaemic episodes and potentially fatal conditions such as heart disease and strokes. Greater use of technologies such as insulin pump therapy can deliver much better outcomes for patients. It can also help to reduce cost savings for the NHS by improving diabetes control, reducing primary care contacts, and reducing hospital admissions and hospital outpatient contacts.

However, the provision of insulin pumps is very patchy and inconsistent. Many healthcare professionals are not trained in supporting patients on insulin pump therapy and, as a consequence, are reluctant to recommend it as a treatment option. The position seems much better in Scotland. The Scottish Government announced in February 2012 that they would invest over £1 million to deliver insulin pumps to patients with diabetes. Over the next three years, their NHS boards will increase the number of insulin pumps available to under-18s, in addition to tripling the number of pumps available across Scotland.

Patients must of course be given accurate information about self-managing their condition, which should include advice on insulin pumps as a treatment option. It is imperative that healthcare professionals are trained in supporting patients to use insulin pump therapy.

8.17 pm

Baroness Morgan of Drefelin: My Lords, I congratulate the noble Lord, Lord Saatchi, on securing this debate. I, too, found his introduction moving, so I thank him for that.

I declare an interest as chief executive of the medical research charity Breast Cancer Campaign and, perhaps more importantly for this debate, honorary president of Cancer52, an alliance of more than 60 organisations—many of which are very small and unstaffed—working to address the issues faced by those with less common cancers who make up 52% of UK cancer deaths, including ovarian cancer.

The promotion of a vibrant research environment is absolutely essential for the development, evaluation and take-up of new medical innovations in our NHS. Research and innovation are vital if we are to ensure better outcomes for cancer patients, which is why I am so proud that we in this House worked hard and successfully to ensure that duties to promote research

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and innovation were included in the Health and Social Care Act 2012. It is now equally essential to make sure that these duties are embraced by the new NHS structures as they take up their responsibilities in the coming months. I know that there is much debate about how that will happen.

I turn to an issue that is of concern to many patients: the use of drugs which are off-patent and not licensed for a particular indication, but which could be helpful in new and innovative ways. This is a little related to concerns that the noble Lord, Lord Saatchi, has raised through his Private Member’s Bill. Many noble Lords will have seen the news yesterday about proposals from the National Institute for Health and Clinical Excellence to recommend the use of the drugs tamoxifen and raloxifene for the prevention of breast cancer in high-risk patients. The barrier to using tamoxifen for chemoprevention in the UK arises from the fact that the drug is now off-patent and its original licence does not cover the use of tamoxifen for chemopreventive purposes, despite the drug being licensed for this indication in the United States for a number of years. Because existing UK legislation only allows the original owner of the drug to seek to change the indication—even when a drug is off-patent and there is therefore no incentive for the drug company to seek a change at this stage—this means that medical professionals who may wish to prescribe the drug for their patients must do so outside the existing licensing agreement. This is a significant disincentive and we could argue that it is stifling innovation.

Indeed, the draft guidelines issued by NICE yesterday are clear. They state that the prescriber of these drugs should follow the General Medical Council’s good practice in prescribing medicines and take full responsibility for their decision. This means that medical professionals must clearly document that the patient, or whoever has the authority to give consent on the patient’s behalf, has provided informed consent to receive the drugs for chemopreventive purposes.

Although the NICE guidelines are designed to circumvent this problem and make health professionals more comfortable with prescribing these particular drugs for chemoprevention, the best way to eliminate any remaining doubts for prescribers would be for a new avenue to obtain licences for new indications for drugs where there is a clear evidence base of clinical benefit and when they are off-patent. Therefore, would the Minister tell us what avenues the Government are exploring for closing this existing shortfall in the current legislation? Have the Government perhaps explored any possibilities for public bodies such as NICE to seek new licences for off-patent drugs where the manufacturer has no incentive to do so? He might want to write to me on this, but it would be very interesting to hear how this kind of innovation—which is looking at existing medicines and discovering how they might be used in different ways in different conditions —could be made a more nimble, innovative process.

8.22 pm

Baroness Finlay of Llandaff: My Lords, I, too, congratulate the noble Lord, Lord Saatchi, for having described, in a very moving and clear speech, the reality and the

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horror for patients of illness and treatment, and the difficulty that many patients and their families face while in the shock of realising that life is not as they hoped it would be and has changed in an instant.

The noble Lord, Lord Saatchi, has highlighted the push and pull of the dilemma of innovation in medicine. We have a push from research councils to innovate; we have a push in academic medicine, principally in secondary care in specialist services, to innovate, to think and to instigate new trials; and we have a push from industry to come up with developments. However, we have a pull, which is a risk-averse system that is frightened of taking the decision to go with something that looks as if it might be high-risk or to go with the unknown. It is that tension between the push and pull that I think we are caught in the middle of today. Perhaps this debate is really timely, because we need to think about how we should handle that.

I was involved in some of the early trials to which the noble Lord, Lord Willis, referred, of children with leukaemia. I remember some of the children who were in the arms of the failing drugs; I remember them as if it were yesterday. I can see in my mind’s eye the room and the face of the child who then died and having to talk to those parents. However, it was through those trials, through every child taking part, that the face of childhood leukaemia has completely changed. I sincerely say, thank God that it has, because there was a terrible toll before those trials were properly instigated.

Another problem for patients, when they are faced with a disease for which there does not seem to be a conventional treatment on offer, is that in desperation they go off and try to find their own treatment and therapy. It is worth remembering that about half, or possibly more than half, of patients with malignant disease of any type seek help and treatments outside of conventional medicine, going for complementary or alternative medicine—often taking treatments for which there is no evaluation. Some years ago, it was a great difficulty for my team to cope with people who were coming in and saying that they were taking shark’s fin. The ecological disaster, the cruelty to sharks and the total lack of evidence of any efficacy made us come up with a form of words that we could use to dissuade patients from ever even thinking along those lines and discuss with them their use of alternative therapies or medicines. Some things that they pinned great hope on really had no benefit.

I also congratulate the noble Lord, Lord Saatchi, on having focused our minds on the patient in the context of themselves as a person and their whole family. He put me in mind of a patient I had at one time who was in exactly that situation. She was a young woman with a rare disease who was clearly dying. We discovered that her children had been fundraising at the school gate for a treatment that they had found on the internet. This treatment had been shipped over from America and she wanted it given to her. There was no evidence base that I could find for it, and I discussed it at length with her and her family, documenting everything—pages and pages of documentation of those conversations. She knew she was dying but she wanted to try it because she knew that her family could live afterwards if she tried it; but if she had not done so, they would

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not have been able to. Therefore, I undertook to take the whole responsibility on myself for administering it, equipped myself with drugs for every adverse event that might occur, and gave her one dose. There was no adverse effect but there was no benefit either, but after her death her children, who had fund-raised at the school gate, were able to cope better and were glad that she had at least tried it.

We have a system in medicine called the N of 1 trial, which is underused and should be used, particularly where we have rare conditions and genetic disorders, and where we could document and should be documenting what we do. There is a problem, though, for those who instigate such trials in getting them published. I would like to address the publication difficulty in my closing remarks—the difficulty of pooling all the little bits of information that can come from different aspects of medicine.

I think that the N of 1 trial will have an increasing place as we get further into rare genetic conditions and personalised medicine, but the NHS, with its push to embrace research as a core component, is going to have to look at a kind of buffer zone for funding the additional bits of work that need to go along with doing that properly. We also need to have good publication of negative results and we need to publish all the results, including all the adverse effects, when trials fail. Unless all of those emerge, we really will not know the full picture and what we are dealing with.

I make a plea that in this push-pull with which we are faced in medical innovation, there is a real push to have a repository for the results of some of these N of 1-type studies, and a repository for negative results and those that are currently going unpublished.

8.28 pm

Lord Ryder of Wensum: My Lords, I congratulate my noble friend on the clarity and strength of his speech. I am conscious of the medical distinction of many noble Lords here tonight; I participate as a layman.

For the past eight years I have chaired the Institute of Cancer Research, an organisation driven by innovation. The institute, a college of the University of London, employs about 800 scientists from more than 40 countries. According to the Times Higher, we came top of the most recent research assessment exercise. We prize a global-leading drug discovery unit and are proud that over the past six years alone, 16 of our drugs have been nominated as candidates for development. Two months ago, an innovation debate took place at the Royal Society. Professor Paul Workman, head of cancer therapeutics at the institute and the RSC’s entrepreneur of the year, was a speaker. He argued that, although we are making strides against cancer, we are failing to convert our knowledge into outcomes. To be precise, our knowledge of the genomes of cancer cells should be allowing us to develop targeted therapies for patients—what is known as personalised medicine.

There are many reasons why we are not advancing at greater speed. Biotech companies are diminishing because venture capitalists demand profits in three years, when in our sphere it is often a struggle to

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achieve results within a decade. Pharmaceutical companies should be switching from blockbuster drugs to personalised medicines targeted on small patient groups based on cancer genes, but we suffer from the fact that these pharmaceutical companies are also enduring an era of change, which is typified by the theme of next month’s Pharma Summit in London—namely, “Should pharma cut its losses and get out of R&D?”.

How can we turn our knowledge into targeted drugs? How can we bridge this innovation chasm? The commendable Strategy for UK Life Sciences, which was produced by the Government, urged us to develop infrastructures that connect academics, industry, investors, clinicians and the NHS. Thanks partly to a long-standing relationship with our sister organisation, the Royal Marsden Hospital, that is our model. It has worked well for years in terms of innovation and outcomes. It is vital for it to be taken up in as many places and as many fields as possible.

We also require more investment in drug discovery and development carried out by non-profit groups, especially early-stage drug projects that are too risky for industry and can be advanced quickly only in the lab and with patients. In addition, we require further re-evaluation of regulations and pricing. Patients must have earlier access to drugs. I am told by institute clinicians working in the Royal Marsden that the European clinical trials directive handicaps their work and impedes innovation. The Minister will know that, unfortunately, clinical trials carried out in the UK, as a percentage of the world total, have fallen from 6% to 1.4% during the past 10 years.

Drug discovery and development is the UK’s leading innovation-based business. It is the UK’s most successful manufacturing industry in terms of the surplus it provides for the balance of payments. However, expenditure does not necessarily correlate with inventiveness. I have always upheld the Schumpeter line that innovation is the critical part of economic change, yet Governments have a duty to create the right climate for innovators, and they have plenty yet to do.

8.33 pm

Baroness Warwick of Undercliffe: My Lords, when I read just before Christmas the cri de coeur of the noble Lord, Lord Saatchi, about the lack of progress in finding cutting-edge treatments for cancer, I had huge sympathy, which has been reinforced by his passionate speech today. I remember a similar sense of anger, frustration and bewilderment at the lack of speedy diagnosis and then effective treatment of my mother’s cancer, albeit some years ago now.

I hoped that the science would move on. I knew how good our scientists and our clinical researchers were, so there was no question in my mind that our scientists could produce results so long as they were given the means and the encouragement to do so. Sadly, the improvements have been patchy and, in some cases, stubbornly resistant. A few months ago, I noted in a debate on pancreatic cancer that there had been virtually no change in treatments over the past 20 years, although it is about not just drugs but early diagnosis and access to surgery.

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There are many reasons why progress has been less speedy than we might have hoped. The noble Lord, Lord Saatchi, has identified one important area—the effect of medical negligence claims and the risk-averse culture that they generate—and I wish him good speed with his Private Member’s Bill.

Another area often cited as a brake on innovation is regulation. I declare an interest as chair of the Human Tissue Authority. I want to offer some thoughts on how regulation might be a force for good and need not stifle innovation. It is vital that all bodies involved in the health service do all that they can to facilitate high quality medical innovation. Innovation in medicine leads to improved healthcare and quality of life, and can have significant economic benefits.

Sir David Nicholson’s recent report, Innovation, Health and Wealth, provides us with a clear picture of what needs to change if we are to encourage further innovation in medicine and healthcare. In his report, Sir David makes a passing reference to regulation as a “top-down pressure” on innovation but, importantly, he does not identify regulation as one of his six,

“barriers to innovation in the NHS”.

No one doubts that regulation has value in providing assurance for quality, safety and efficacy, and regulation can sometimes be a driver of innovation. None the less, and notwithstanding the exclusion of regulation from Sir David’s six barriers, it is clear that some regulation, if it is excessive, complex, unclear or inflexible, can impede innovation. I believe that we should review all healthcare regulation in terms of design, implementation and enforcement, to ensure that unnecessary barriers are removed. The regulators should be challenged and, just as importantly, should challenge themselves to ensure that they are not creating barriers to innovation.

I shall finish with a few words about the approach to regulation used by the Human Tissue Authority. Of particular relevance to this debate is our remit relating to the use of human tissue for patient treatment and the development of regenerative medicines, where we work very closely with the Medicines and Healthcare products Regulatory Agency. The HTA is very supportive of research and ensures that effective regulation supports good practice and high-quality science which, in turn, leads to improved healthcare.

There is no doubt that some of the regulation in this area is complex, primarily because the science itself is complex, as is the legislation underpinning that regulation. Complex does not have to mean burdensome, however. At the HTA we believe that a key role of a regulator is to provide clarity and to support organisations in working through the quality and safety regulations. I urge the Minister to reinforce the point that, if done well, regulation can yield significant benefits. It provides assurances about quality and that products can be used safely for patient treatment. It promotes faith in the efficacy of products. Will the Minister confirm that regulators should be committed to doing all that they can to support innovation in medicine? This is certainly true at the HTA, and I hope that the Minister will encourage all regulators in the sector to have such an enabling approach.

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In my last few seconds, I should like to raise a related topic. I learnt this morning of a proposal in the European Parliament that the minimum duration of a medical training programme should be increased to six years. This could have serious consequences for graduate-entry programmes in the UK. Medical schools will probably not be able to recruit arts graduates, and surely we need creative people in the profession if we want to be more innovative, especially when evidence shows that they make as good doctors as do science graduates. Will the Minister take this back to his colleagues and ask them to do all that they can to prevent the requirement being increased in this way before the vote on 24 January?

8.38 pm

Lord Patel: My Lords, I thank the noble Lord, Lord Saatchi, for initiating this debate and for presenting it so movingly. This ought to be the start of such debates. It ought not to be the last debate we have on this subject. I hope he will remain committed to leading us in future debates.

Some of the treatments the noble Lord described, particularly for some cancers, are medieval and this continues to be the situation for some cancers. Treatment for pancreatic cancer, to which the noble Baroness referred and of which both my mother and my mother-in-law died, remains the same. However, there is hope. Some novel and innovative treatments are now being tried out, such as molecular tagging of drugs to get at cancers that are not amenable to conventional treatment. There is also nanomedicine for targeting tumours that are not responsive to current treatments. There are other technologies that I will come to which could be used to target tumours that are not receptive to radiotherapy.

We should also be slightly more optimistic in this country about where our science is today compared with 10 years ago. For instance, we have had 12 Nobel Prize winners in medicine and physiology since 2001. We have to go back to 1998 for the previous one. Not only that, we have Nobel Prize winners in allied disciplines, such as Sir Venkatraman Ramakrishnan who won the chemistry prize in 2009 for his isolation of the structure of life science-related diseases.

We now have a commitment from the Government to investing in science and having strategies in life sciences and other fields. We should give credit for that. We hope that innovations will come but we must also ensure that regulation is proportionate and is not bureaucratic. We must always keep an eye on that.

There is also the question of investment in translational medicine. One example is in the field not of drug therapy but in cell therapy where big pharma will not invest and small countries do not have the money to do early translational research. There are many examples. One is the use of embryonic stem cells as a therapy for age-related macular degeneration. Currently, the first-phase translation of that is being funded through research councils and charities. The Government should be funding early-phase translation. What plans do the Government have to help with this?

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I come now to technological advances and I use the example of focused radiotherapy which is often referred to as “cyberknife”. Of course it is not a knife: it is focused radiotherapy. You cannot use conventional radiotherapy for targeting tumours because you will do more harm to normal cells. Currently, to make that available to a patient who is not amenable to conventional treatment, the doctor will have to ask for finances from commissioners or PCTs. They do not have the expertise to know whether that is indicated for that patient or not, and they may or may not fund it. The Government should be commended for accepting in the Health and Social Care Act that all NHS organisations must have an awareness of research, but it is difficult to find money to fund an expensive, one-off treatment. However, that is sometimes the only thing that is available to the patient. We should support such technologies and make sure that whenever we find that they are not supported, we do something about supporting them. Will the Minister confirm that he will expect commissioners to look at such treatments and innovations in a more favourable way and provide the funding that individual patients require? These treatments are expensive.

I again thank the noble Lord, Lord Saatchi, for initiating this debate. We should debate some of these issues at length at the Second Reading of his Bill and I wish him luck with that.

8.44 pm

Lord Kakkar: My Lords, I, too, thank the noble Lord, Lord Saatchi, for having introduced this important debate with so much courage and with such intellectual power. In doing so, I declare my interests as Professor of Surgery at University College London, as Chair for Clinical Quality in our academic health sciences centre, UCL Partners, and as an active clinical researcher.

Innovation is absolutely at the heart of improving clinical practice and outcomes for our patients. It is only right that patients, their relatives and the public expect the profession and government to do all they can to ensure, first, that the research necessary to develop innovative treatments and diagnostic strategies is promoted at national and local levels, and that, once we become aware of innovation—be it through research in our own country or anywhere else in the world—it is quickly identified, adopted and placed in clinical practice. Her Majesty’s Government have placed a particular emphasis on this. Driving a research commitment in the Health and Social Care Bill for the first time, ensuring an obligation on the Secretary of State for Health to promote research and development in the NHS, was an important statutory development. We have the commitment of funding through the National Institute for Health Research, the biomedical research centres and their associated units, and the academic health science centres, which all promote early-phase, experimental and clinical research in our healthcare system.

However, Her Majesty’s Government have also recognised the problem of adopting the findings of that innovation and diffusing it more broadly across the healthcare system and across larger proportions and populations of patients. The recent report, Innovation, Health and Wealth, has identified the need for the development of academic health science networks with

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a clear obligation to ensure that high-impact innovation is quickly adopted and diffused across populations and healthcare systems, and that the recognised therapies that have been shown to have important clinical benefit and are approved by NICE through its guidance mechanisms are applied more broadly across populations for which we are responsible.

We have also heard in this debate that there are important hurdles to innovation in our healthcare system. These hurdles are regulatory, they are potentially legal and they are cultural in terms of the way that clinical practitioners and others work in the National Health Service and healthcare systems more broadly.

With regard to regulation, I should like to ask the Minister about one particular problem that we have heard about today—the European clinical trials directive. I know that Her Majesty’s Government are involved in negotiations at the European level to overcome some of the problems associated with this directive, which has been damaging to clinical research in our country. Is the noble Earl able to give an update on the progress that has been made there and on what changes might be made to this regulation in the future?

With regard to the legal problem, the noble Lord, Lord Saatchi, identified case law which suggests that there may be anxiety in clinicians’ minds about innovating when it comes to the individual patient in front of them. This may indeed be a very important problem and something that needs to be addressed. As we have heard in this debate, it needs to be addressed in a sensitive and careful way to ensure appropriate innovation and to ensure that clinicians who are in a position to innovate do so effectively but that any deleterious effect is not allowed to take place.

Then there is the question of culture. This is particularly important because much of the debate today has focused on what the views of clinicians and researchers, the healthcare system and indeed the Government may be on innovation. However, we must also look at innovation from the patients’ point of view, as well as that of their relatives. They are right to expect that when they need it most, innovation, wherever it is, is responsibly applied to the management of their case. In all the important work to drive innovation, and the research and development of biomedicine that has been achieved in our country so far, we must be sensitive to the fact that we may not be meeting the expectations of patients—our fellow human beings—when they are at their most vulnerable, and therefore more may need to be done to drive an improved culture for the adoption of innovation and the improvement of practice in our country.

8.49 pm

Lord Turnberg: My Lords, it is clear that we are all enormously grateful to the noble Lord, Lord Saatchi, for introducing this very timely debate. It was impossible not to be moved by his remarkable personal story, and I respect and admire the motivation that lies behind his desire to see the best possible treatments being made rapidly available for patients. He has certainly stimulated a wide-ranging debate.

I declare an interest as a trustee of the charity Ovarian Cancer Action and as a one-time practising clinician. We have heard from a number of noble Lords

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about the time-consuming, bureaucratic regulatory pathway that new drugs have to go through, and we should do something about that—I hope that the noble Earl might comment. However, I want to concentrate on how it might be possible to bypass this normal route to approval, and to give patients a drug that has just come out of research. I shall limit myself to cancer patients.

We know that the Government are committed to embedding research in the NHS, although we are a little way off delivering fully on that holy grail across the whole of the NHS as yet. However, it is the case that novel candidate drugs for cancers are being developed all the time, and are being used for patients in many major centres around the country. At the Cancer Research laboratories that we heard about, the Christie hospital in Manchester, the Beatson Institute in Glasgow and centres in most other cities new drugs are being developed all the time. The £200 million cancer fund has been invaluable in making them available for patients. What will happen to this funding when the source dries up, as I believe it might? It is a tragic fact that, despite some remarkable advances, there remain many cancers that have proved terribly resistant. Ovarian and pancreatic cancer, for example, creep up on patients with vague symptoms or none at all, so that diagnosis is often made too late.

The point is, however, that as novel treatments become available, they can be and are being tried. Of course, there are strict conditions. Novel treatments can be given to individual patients only during clinical trials or on a named patient basis, where patients are made fully aware of the risks and dangers as well as the fact that the treatment may or may not help them. They must give their informed consent. Then, the best conditions for giving the treatment must be available. Those involved in the research, who understand the possibility of adverse side effects, should be available, as should the laboratory facilities to monitor the patient’s response. These are the conditions under which it is reasonable to give novel treatments, and they are just the ones that are provided by the NHS in our major cancer centres around the country.

It should be clear, too, from all of this that it is difficult to provide these conditions outside major centres, particularly in private hospitals where the expertise may not be available. Consultants there are often on their own, and do not have the full back-up that would give them confidence. They may feel vulnerable and unwilling to take the risks to which they would be exposed. Furthermore, private funders may be quite unwilling to fund untried treatments or the extra tests needed to monitor the patients.

I come to the problem described by the noble Lord, Lord Saatchi. It is clear that we do not currently lack the ability to try out novel treatments within the NHS, and I have described the best conditions under which they should be and are being given. However, there are problems of continuing funding, with particular difficulty in private hospitals and in some district general hospitals which lack the facilities. In those hospitals, doctors and their patients need to be made aware of the limitations that exist. When the possibility of a novel treatment arises, patients should be offered the prospect of transfer to a centre where the relevant research is going on and the treatment is being given.

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This debate has been invaluable in setting out a set of problems that really deserve our attention. The need to be able to speed through the availability of novel therapies is vitally important, and we must do something about the regulatory burden. However, so far as the use of innovative treatments is concerned, I am not yet convinced that we need a new law to achieve what we want. We should concentrate on spreading information about what novel treatments are emerging across the whole of the service, what treatments are available in our cancer centres, and ensuring the rapid transfer of patients to those centres.

I very much look forward to the noble Earl’s response and I hope that he will say something about many of the other problems mentioned today, such as streamlining regulation, availability of cancer funds and replacement of those funds by some other source. I believe that we owe an enormous debt of gratitude to the noble Lord, Lord Saatchi, for raising the debate, and for giving me my moment in the sun on the Front Bench.

8.55 pm

The Parliamentary Under-Secretary of State, Department of Health (Earl Howe): My Lords, my noble friend Lord Saatchi introduced this debate most compellingly and very movingly, and I thank him for bringing a subject of such importance to us and one on which your Lordships have considerable expertise, as this debate has amply shown.

Let me start, as many speakers have done, by focusing on the NHS. The unique and integrated nature of the health service has brought many advantages. Since the NHS was established in 1948, innovation has brought incalculable benefits for patients. Treatments have been improved, as has health policy. Inequalities have been reduced. Productivity has been increased. However, while the NHS is recognised as a world leader at invention, the spread of those inventions within the NHS has often been too slow, and sometimes even the best of them fail to achieve widespread use. It still takes an estimated average of 17 years for only 14% of new scientific discoveries to enter day-to-day clinical practice. This is not acceptable. Patients have the right to expect better health, better care and better value from their NHS.

We need to make sure that our staff can get the best, transformative, most innovative ideas, products and clinical practice spread at pace and at scale so that every patient benefits. That cannot happen without innovative minds working with the best resources in a creative and supportive environment. As the noble Lord, Lord Winston, reminded us so powerfully, research is an essential part of the innovation pathway. The Government’s investment in basic health research through the Medical Research Council underpins invention, and our investment in applied health research through the NIHR underpins evaluation. Translation of research is also vital for innovation to progress along the pathway. I hope that the noble Lord, Lord Patel, will be pleased to know that the Government are investing a record £800 million over five years in a series of NIHR biomedical research centres and units. These are translating scientific breakthroughs into better treatments for patients.

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