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The Government believe that the protection of those participating in clinical trials must be the overriding priority and believe that the safeguards laid down in the clinical trials directive and the measures in the new regulation provide a secure framework to ensure that the health, welfare and rights of children participating in clinical trials are protected. I reassure the noble Lord, Lord Trefgarne, that the clinical trial on a minor may be undertaken only if—and I give one example—the informed consent of the parents or legal representative has been obtained. Consent must represent the minor’s presumed will and may be revoked at any time without detriment to the minor. The explicit wish of a minor who is capable of forming an opinion and assessing this information to refuse participation or to be withdrawn from the clinical trial at any time is considered by the investigator. That is already provided for. I rather share the views quoted bythe noble Baroness, Lady Neuberger, of Cyril Chantler—to whom a number of noble Lords have paid tribute today and who has probably seen more children undergoing great suffering than any of us. I rather share his view that with appropriate creativity and patience we can secure informed consent from many more children than has often been the case. Certainly the clinical trials directive does nothing—quite the opposite—to ensure that we work hard at securing children’s consent in these often very difficult sets of circumstances.
Perhaps I may reassure the House that, in addition, the European Commission, in consultation with member states, is preparing a guideline on the ethics of conducting clinical trials in children. The commission intends to publish the draft guidance in the autumn for consultation before it is finalised and in place when the new regulation on medicines for paediatric use comes into force.
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This guideline, along with others that are being developed, will be important in setting out how the regulation will work in practice. I will mention the other guidelines later, but I can reassure the House unequivocally that the Government would not have supported a proposal with implications for conducting clinical trials in children if we were not absolutely convinced from all the expert advice we have received that this was the right thing to do.
A number of noble Lords mentioned incentives. The proposed incentives under the regulation stimulated much debate in Europe, but most people accept that incentives are necessary. The Government carefully considered the implications of the proposed incentives and agree that it is important to provide fair incentives to the research-based pharmaceutical industry to stimulate the necessary research. It was clear from the range in the commission’s impact assessment of the regulation and the Government’s partial regulatory impact assessment that it was not possible accurately to estimate the impact on the NHS at the present time. Because of this uncertainty, the Government felt it was important to make the case for a robust review of the economic and health benefits of the regulation, and this was agreed.
The European Commission will provide a general report within six years of the regulation entering into force. That will include a detailed inventory of all medicinal products authorised for paediatric use under the regulation and, if sufficient data have accrued, the commission will provide a report on the economic impact of the rewards and incentives along with an analysis of the estimated consequences for public health. If the data are insufficient to allow a robust economic and public health impact assessment at this stage there is the possibility of conducting a further review within 10 years of the regulation entering into force.
I can assure the House that the Department of Health will monitor the impact of the incentives. As set out in our response to the scrutiny committee’s report, we will also update the regulatory impact assessment once the data are available, and make this information available to the committee. I can certainly give the noble Baroness, Lady Thomas, the reassurance that she was seeking. I can also reassure her that we now accept that Article 95 of the treaty is an appropriate legal basis for the regulation.
As I mentioned earlier, specific guidance will be developed to underpin the regulation in a number of areas including, for example, the rules of procedure for the paediatric committee and guidance on the required format and content of an application for agreement of a paediatric investigation plan. The European Commission will have responsibility for developing the guidelines in consultation with the member states. Let me reassure my noble friend Lord Turnberg that the Government will ensure that all stakeholders, including healthcare professionals, parents, patient organisations and the pharmaceutical industry are able to provide input at the appropriate stages.
The UK led the development of European guidance on the conduct of pharmacovigilance in children. This
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The House will be aware of the extensive consultation on the regulation that was conducted by the European Commission, the Department of Health and the MHRA—the Medicines and Healthcare products Regulatory Agency. Consultation responses, including those from paediatricians and other healthcare professionals, indicated strong support for the new legislative framework. The Select Committee’s own inquiry and report on the regulation welcomed the proposed legislative framework. I cannot answer the question of the noble Baroness, Lady Howarth, on the cardiac working party, but I will certainly write to her.
In conclusion, I believe the proposal strikes the right balance between protecting public health through the development of properly tested and formulated medicines for children and assuring high-quality paediatric clinical trials in the UK. The proposal is long awaited, and we are pleased that the new regulation will become a reality in the very near future.
Lord Trefgarne: My Lords, before the noble Lord finally sits down, I should like to add my appreciation of the work of the Clerk to the Committee, Mr Gordon Baker, which I omitted to do during my earlier remarks.
Baroness Royall of Blaisdon: My Lords, I beg to move that the House do now adjourn during pleasure until 8.55 pm.
Moved accordingly, and, on Question, Motion agreed to.
[The Sitting was suspended from 8.50 to 8.55 pm.]
Legislative and Regulatory Reform Bill
House again in Committee on Clause 1.
Lord Goodhart moved Amendment No. 17:
The noble Lord said: Amendment No. 17 stands in my name and that of my noble friend Lord Maclennan. I am glad that we have not had another debate about your Lordships' House going into Committee and that we can get straight on with this.
“For the purposes of subsection (2), a financial cost or administrative inconvenience may result from the form of any legislation (for example, where the legislation is hard to understand)”.
When law is difficult to understand is an uncertain question, but, in any event, this subsection should be left out. Its intent seems to be to revise legislation so that it is easier to understand. Of course, all of us say, “And a good thing, too”. However, if one looks into this a bit more deeply, one will find, first, that the main problem with understanding legislation is not
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It is easy to say that existing provisions can be rewritten to make the law simpler and more accessible. That can be done. An example is the tax law rewrite programme—I have been involved with that for some years now. The tax law rewrite Bills go through the ordinary Bill procedure nominally, but they have the consent of all parties and are enacted after very brief debates.
However, my experience with the tax law rewrite programme shows that it is extremely difficult to rewrite legislation without to some extent changing it. In fact, many minor changes to the law have been incorporated in the tax law rewrite Bills, which are supported by detailed notes that explain what the changes are; if there is any significant change, it cannot be included. The orders that are to be made under this Bill are unlikely to have anything like such detailed notes and, further, they will probably be drafted by the departmental lawyers and not by the extremely able and highly specialised Parliamentary Counsel Office.
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One might also ask why it is that legislation is so difficult to understand. If it is difficult for lay people but not for lawyers, that is because of the use of technical language, excessive cross-referencing—so you have to chase up the cross-reference in different legislation—and so on. All those things make it difficult for lay people to follow, but they do not mean that the legislation itself is ambiguous or uncertain. The problem is that, with these technical Bills, which are sometimes drafted in old-fashioned language, you cannot put new wine into old bottles; you have to use consistent language throughout any particular area of legislation. That is why the tax law rewrite programmes have rewritten whole sections of the tax law. You have to use consistent language throughout, and the law needs a full rewrite.
If the problem is that it is difficult for lawyers to understand what the legislation means, that is almost inevitably because the legislation has been badly drafted or has failed to take into account what might happen in future, with the result that the legislation is uncertain and ambiguous and the courts have not solved the problem by giving a ruling on what it actually means. In those circumstances, I believe that solving the uncertainty or ambiguity is in practice really making new law, because what you are doing is
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This provision has nothing to do with deregulation; it is simply making the case for better drafting, and so should not be in this Bill. It is entirely different from the kind of deregulation that is clearly intended to be here. A considerable burden rests on the Government to establish a justification for this provision in the Bill. I beg to move.
Lord Jenkin of Roding: My Amendment No. 18 is grouped with the amendment that the noble Lord, Lord Goodhart, has spoken to. The noble Lord has far more expertise in this field than I could ever muster. I was brought up to believe that there could be no better Act of Parliament than the Sale of Goods Act 1893, which is completely clear, is totally understandable by everybody and has stood the test of time. Would that there were more legislation like that these days—but sadly, as the noble Lord has reminded us, that is not the case.
On the whole, I would not wish to remove the whole subsection, despite the strong arguments that the noble Lord has advanced. It seems to me that it should be possible to use the order-making power under this Bill to make sense of, and to reconcile, what might be a number of different statutory provisions without significantly altering their sense. I understand entirely the problem of rewriting Bills that may have been acted on, have had judicial interpretation and have stood the test of time, obscure though they may be. Nevertheless, in the interests of keeping the law up to date, this is a perfectly proper thing to do.
I take issue with the last few words of Clause 1(5),
With the greatest respect, I do not see that that adds anything of value to the preceding words. All the preceding words are saying is that,
Adding the words in parenthesis makes the subsection more obscure.
The courts may well have understood the measure in the past and, as has been said, have given their interpretation of it, and parties up and down the country may have acted on that interpretation. If one is arguing that the measure should be changed on the ground that lay people find the law difficult to understand, one will run into difficulties. I would not vote against the noble Lord’s amendment, which seeks to remove the subsection. If the Committee takes that view, I would certainly agree with it. But if the subsection is to remain in the Bill—I suspect that the Minister will argue that it should—I would argue very strongly that the words,
should be deleted. They add a note of informality that is inappropriate in legislation of this kind. If I may say so, it is a bad example and would be better left out.
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Lord Norton of Louth: I rise to reinforce the point made by my noble friend and to express sympathy with the argument advanced by the noble Lord, Lord Goodhart, of which I see the force. However, I agree with my noble friend Lord Jenkin about the words in parenthesis in particular, as they confuse the picture. My noble friend’s argument is that saying legislation is hard to understand renders the subsection itself hard to understand. But I am concerned about who finds it hard to understand. The relevant words may inject almost an element of mischief by inciting people to claim that something is difficult to understand as a way of avoiding a burden that may be placed on them. The measure creates more problems than it solves. Certainly, the words in parenthesis should come out, but I agree with my noble friend Lord Jenkin that not too much would be lost if the whole of subsection (5) came out of the clause.
Lord Borrie: I am an enthusiast for the Sale of Goods Act 1893 and its wonderful clarity, at least as much as the noble Lord, Lord Jenkin of Roding, is. I was a little puzzled by the argument advanced by the noble Lord, Lord Goodhart. I thought that he was saying that we did not need to worry about law that was hard to understand because there were other more important problems—for example, the proliferation of laws, the need for consolidation and other such matters.
But if law is “hard to understand”, to use the words in the Bill, that seems to me an example of administrative inconvenience that it might be desirable to change by regulatory order under the Bill. I understand Members of the Committee saying—I would join them—that there are other more important things to do, but the measure is concerned with getting rid of burdens and administrative inconveniences, and one example is given here. If Members of the Committee are saying that they do not like an example being given, and that that is unnecessary, it is rather like the argument advanced earlier by the noble Lord, Lord Peyton of Yeovil, in which he wanted to get rid of certain words because he thought that they were not essential. I refer to the words in the Bill following the word “sanction”. But if it adds clarity, why get rid of the measure?
Lord Desai: I would say one small thing. I have been in your Lordships' House for 15 years and I have never yet understood a Bill on my first reading of it. I am not illiterate—I have many degrees—but it is very hard to understand laws. If I have difficulties, people who have to abide by those laws have lots of difficulties. We should do whatever we can do to reduce those difficulties.
Lord Norton of Louth: I will respond to both noble Lords. The logic of what the noble Lord, Lord Desai, has just said is that all legislation is a burden. That brings us back to the problems inherent in this Bill. Regarding the comments of the noble Lord, Lord Borrie, I thought that the argument was not that the words are superfluous, but that they might inject an element of ambiguity into the provision and that that was why they should be removed.
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Lord Kingsland: I shall speak to Amendment No. 55 in this group. Amendments Nos. 67, 71 and 73 are consequential on that amendment.
Amendment No. 55 reflects a recommendation of the Delegated Powers and Regulatory Reform Committee to remove subsections (3) to (5) of Clause 4. Those subsections exempt provisions that restate statute or which codify a rule of law from the protections contained in subsection (2). Subsection (5) of Clause 1 enables a power to be used to consolidate and rewrite primary legislation. So, subsections (3) to (5) of Clause 4 should be read with subsection (5) of Clause 1 in mind.
I agree with everything said by the noble Lord, Lord Goodhart, in speaking to his Amendment No. 17. As the committee pointed out, the definition in subsection (5) of Clause 1 allows the power to be used for rewriting and consolidating primary legislation. In other words, it is a paving power. The question for the Committee is whether the order-making powers are appropriate for the consolidation of statutes.
The Delegated Powers and Regulatory Reform Committee interprets “restates”—the word used in the Bill—as meaning “consolidation”. The committee set out, in paragraph 66 of its report, how Parliament has already set up by statute and standing order fast-track mechanisms to deliver primary legislation for certain purposes, including consolidation. The committee cites, as an example, the Education Act 1996, which was passed in four minutes on the Floor of your Lordships' House and in one minute on the Floor of another place.
The committee goes on to note:
“That Parliament currently requires a bill for such restatement is significant in considering whether to delegate to Ministers the more substantial power to simplify the law”.
The point made by the committee is constitutional. It is saying that primary legislation, not secondary legislation introduced by an order made by Ministers, should be used to simplify the law.
Government Amendment No. 61 attempts to redefine the meaning of “restates”. It is helpful, in as much as it clarifies that restating an enactment relates only to matters of form and arrangement. But it still does not address the principle at stake here, that primary legislation is the appropriate way for legislation to be consolidated or rewritten. The fact that there are already adequate procedures in place to achieve that aim, coupled with the constitutional principle of the inappropriateness of attempting to use the order-making powers in this way, should, I hope, make the Government reconsider what they are trying to do with subsection (5) of Clause 1.
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Lord Bassam of Brighton: I want to deal with the amendments as a group, but I shall deal with each in turn. Amendment No. 17 relates to the ability to consolidate legislation by order, but I shall turn to Amendments Nos. 67, 71 and 73, which relate to the provisions in Clauses 5, 6 and 7 for orders that restate legislation. I shall then turn to Amendment No. 55, and Amendment No. 61.
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Orders under Part 1 will be able to cut red tape by removing or reducing unnecessary burdens and ensuring that regulatory activities are exercised in a way that is proportionate, accountable, consistent, transparent and targeted in line with our policy. As well as providing that orders can remove or reduce burdens, such as financial costs or obstacles to productivity, Clause 1(5) makes it clear that orders could be used to consolidate or restate the law without changing its meaning, where to do so would itself be reducing or removing a burden. That might be where, for example, the legal rules on a particular subject were scattered through numerous pieces of legislation or where legislation was drafted in a way that was very inaccessible.
Amendment No. 17 would remove Clause 1(5) and cast doubt over whether orders could be used to remove burdens resulting from the form of legislation. Amendment No. 18 would remove the words,
That would make it less clear what is meant by “a financial cost or administrative inconvenience resulting from the form of legislation” and may cast doubt over whether changes that make the law easier to understand can be delivered under Clause 1.
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