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My time is up. Manufacturers should be encouraged with further incentives to study those drugs that provide the greatest health benefit to children, including those that are not eligible for incentives in the current situation. I hope our report will influence further consideration of this situation.
8.17 pm
Baroness Howarth of Breckland: My Lords, as a member of the sub-committee, I add my tributes to the noble Baroness, Lady Thomas, and Gordon Baker. I am always totally amazed how even my modest comments can be turned into erudite recommendations. I have particular declared interests in children and health and I must say that the work on the report gave me equal proportions of satisfaction and dismay. I had satisfaction that, at last, paediatric medicines are being addressed, but dismay that, having reached the 21st century, there is still so far to go, although I am encouraged by the contribution of the noble Lord, Lord Turnberg, who seems to think that at least something is moving forward.
We have heard several times that children are not small adults. We heard from the excellent evidence of Sir Cyril Chantler that there are two major problems with the use of unlicensed medicines: how children's metabolism deals with the drug, and the effect on the child. The European Commission stated that 50 per cent to 90 per cent of all medicinal products used in the paediatric population have never been studied or authorised for use. Consequently, among the long list of problems outlined by Sir Cyril and well known to those dealing with children is the control of pain. Were the situations where children suffer to happen to adults, they would simply not be accepted. There would be a major campaign. We hope that our report will help the Government to take forward this important issue of paediatric medicine.
As with all pharmaceuticals, the need for rewards and incentives is a major driver. The noble Baroness, Lady Thomas, and the noble Lord, Lord Colwyn, have both outlined the issues; the noble Lord, Lord
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There is a similar issue with research where, under the directive, the European Medicines Agency will oversee and co-ordinate the tasks envisaged by the proposed directive, but the Royal College of General Practitioners questioned whether it would be best placed to provide the proposed scientific advice, which would be a significant undertaking. Unfortunately, the sub-committee was unable to judge from the evidence that we received whether the proposed funding framework would be adequate. What progress has been made in that area and on the need for a separate Community-funded programme of research?
The sub-committee was much exercised about the ethical considerations of consent. Although agreeing that the health and welfare of children must be the overriding priority for conducting paediatric trials, in her evidence the Minister drew a distinction between what she described as a properly informed decision and one that might be no more than what she called a whim.
We were troubled by that issue. I add my concern that children be consulted appropriately by those who understand how to communicate with them, not by those who have a vested interest in getting a particular answer. Anything that the Government can do to progress that would be most welcome.
In the short time available, I also mention labelling—a topic on which I spent much time as a member of the board of the Food Standards Agency. It is equally important that we get that right for children's medicine. We hope that the Government will be active at EU level and in the UK to ensure that products are labelled in a way that indicates their suitability for children, taking into account their size and development, and in a way that parents can understand and is distinctive.
If we get all that on track, it will be of little use if the Government do not get right the services for specialist paediatric groups—those services in which the medicines will be used. Stepping outside the brief of the sub-committee, I take this opportunity to urge the Government to speed up their major review of cardiac surgery for specialist care. I know that the Government have started that but, although Scotland, Wales and Ireland have already moved to a high level of care for all, rather than a postcode lottery, we in England still have no clear plan for central funding and standards.
I realise that the Minister may not be able to answer that point this evening; if he is not, could he write to me to explain how the proposed working party is progressing? Paediatric medicines will then have a proper context for progress.
8.22 pm
Lord Trefgarne: My Lords, may I speak for the children? I am the father of three and the grandfather
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I am very troubled by the arrangements for testing medicines on small children—and tested they must be, as my noble friend Lord Colwyn made clear. Medicines do not react in the same way for small children as they do for adults. It is no longer possible simply to prescribe a dose for an adult and then scale it down appropriately for a young person. That technique, which may have been widespread in the past, is now widely accepted as unacceptable.
There are real difficulties in testing drugs on small children. Despite what some of the evidence before the sub-committee suggested, I do not believe that it is really possible to obtain informed consent from a very young person. We were told that, in some circumstances, it was possible to obtain that consent from, say, only a 10 year-old child. I have grave doubts about that proposition. I know that the noble Baroness, Lady Howarth, thinks rather differently—she is, of course, an expert in these matters—but if I cast my own thoughts back to all those years ago, if I can, when I was that young, and more relevantly to my own children when they were that age, I do not think it is possible to obtain informed consent from a child of that age, especially if they happen to be ill, and even more so if they are very ill and we are offering them a medicine that is not properly trialled.
It is recognised that nowadays a large number of small children, especially very small children, are given medicines off-label—in other words, they are not adequately tested. Nor is it easy to obtain the consent of the parent to such things when, for example, the child is very ill. I ask your Lordships to consider how they would react if, their child desperately ill and they at the extremities of distress, they were asked to give consent to the use of an untried medicine. They would hasten to agree, would they not? I dare say I would have done so had I been in that circumstance. We have a very real difficulty. I am glad that the European Commission is addressing this problem, and I hope that the medical profession will take account of the serious difficulties that confront us in this matter.
8.25 pm
Baroness Neuberger: My Lords, I, too, thank my noble friend Lady Thomas for chairing the inquiry, and our remarkable Clerk, Gordon Baker, for his superb drafting of the report.
It is undoubtedly worth saying how wide the support has been generally for the regulation. Broadly speaking, the medical profession and others have really wanted it, as the noble Lord, Lord Turnberg, has made clear. As we have also heard, however, several issues concerned us. My noble friend Lady Thomas alluded to the fact that drugs are not tested on children, as did the noble Lord, Lord Colwyn, who commented that the pharmaceutical industry does not find it worthwhile
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The clinical trials directive requires that a person with parental responsibility, or a legal representative, must give informed consent to any trial involving a minor, whereas the explicit wish of a minor to refuse to participate or to be withdrawn from clinical trials “must be considered”. A clinical trial has to be designed to minimise pain and discomfort, fear and other foreseeable risks in relation to the disease and the developmental stage of the child concerned. We drew the attention of Professor Chantler, the chairman of Great Ormond Street Hospital, who gave evidence to us, to that statement. He was very firm about this. He argued, contrary to the view of the noble Lord, Lord Trefgarne, that,
- “one would be surprised how it is possible to find out what is in the child’s interest from the child’s point of view in very young children: you just have to find more imaginative ways of communicating with them. The notion that you would do something to a child that did not involve the child’s consent is not acceptable”.
He continued—I do believe it is worth quoting:
“Obviously there are occasions, I know, where doctors and nurses have to do things and the child does not want them done and the child may cry, but you pay a terrible price for that. I constantly as a paediatrician was upset by people saying to children, ‘This isn’t going to hurt.’ Of course it is going to hurt. Once you say it is not going to hurt and then stick a needle in them and they cry, two things have happened: one is the child has suffered pain which you might have been able to find a way of avoiding—and we are better at that now—but, perhaps more importantly, you have lost that child’s trust forever. It is a very serious matter to do something to a child that does not have the child’s consent. Participation in a trial, I think, would require the child’s consent as well as the family’s”.
Professor Chantler thinks that the guidance will need to be strong enough. We do not yet have that guidance. We await the guidelines and, like my noble friend Lady Thomas, we very much hope that the Government will watch this closely and ensure that the guidelines make it explicit that the child’s wishes have to be more than taken into account; they have to be recognised. But it is a complicated issue. We still live in a society where children’s views are often insufficiently taken into account. The first work—20 years ago—by Richard Nicholson showed, in research ethics committees looking at research on children, that consent was less likely to be given to research on children if a nurse was present, regardless of whether she spoke. It suggested that there were various people around who were quite prepared to carry on doing things that some of us now might not find acceptable. Children have views, so we have to clarify the extent to which the child’s view is to be taken into account.
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When the Minister came to speak to us, she was not worried that the child’s views must be considered, but wanted to draw a distinction between a properly informed decision by a child and one that might be no more than a “whim” on the day concerned. The noble Baroness, Lady Howarth, has already drawn our attention to that. There are two problems with it. The first is that adults are allowed to be subject to whims or fancies in consent to research; and so one has to ask why children should not be. Secondly, there is a real problem, on which Priscilla Alderson has been the great expert, about consent from children. What if the child has just had enough? Children who are very sick sometimes express the view that they have just had enough and want no more done.
We were much reassured by Sir Cyril Chantler and by the Minister’s assurances to us. However, until we see the regulations and guidance, and until we know that the database on research in children will be freely available, we cannot rest completely. Children’s interests must be taken into account. I hope that the Minister will be able to give us the Government’s reassurance on this matter.
8.31 pm
Lord McColl of Dulwich: My Lords, I must first apologise for being a few minutes late. My excuse is that I have just flown in from Montreal and am slightly disoriented. However, I thank the noble Baroness, Lady Thomas of Walliswood, for chairing this splendid committee and for coming to such sensible conclusions. It is good to acknowledge too the work of Sir Cyril Chantler, with whom I had the great privilege of working closely for many years at Guy’s Hospital. He is a most remarkable person.
I remember a couple coming to Sir Cyril with their child who was in renal failure. He not only carefully explained the situation to the parents but involved the child in the discussions. Afterwards, the parents were slightly embarrassed and said, “Doctor, we hope you don’t mind us asking the question, but before you begin treatment, could we take the child to Lourdes?”. Sir Cyril characteristically said, “No; that is absolutely fine. You see, we’re going to need all the help we can get”. The parents noticed that in the eyes of this great man there was a tear, and it was very helpful to them. Incidentally, the child went to Lourdes and no sooner had they arrived than they received a telegram saying “Come back. We have found a kidney”. A kidney transplant was carried out and the child was successfully treated. So it was a great end to that story.
We also dealt with the subject of whether a child should be informed of what is coming. One should never say, “This isn’t going to hurt”. Sir Cyril again comes to mind. My youngest child has a severe heart problem and hated the way in which doctors would say “This isn’t going to hurt you at all”, after which they would stick in a needle which would be extremely painful. So we hit on the bright idea of getting Sir Cyril always to take the blood from my daughter—which for years, as noble Lords can imagine, he did perfectly.
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One conflict which has been discussed is whether children can really give consent. There are of course two sides to it. As my noble friend Lord Trefgarne pointed out, it is hard to imagine how the parent of a child who is desperately ill or perhaps dying feels when a doctor asks, “Do you mind if we try out this new drug on your child?”. But in this day and age we simply have to involve both the parents and the child in the decision-making process. So the more expert we get at communicating with the young, the easier this process becomes.
Perhaps I may emphasise what was said by the noble Lord, Lord Turnberg. Drugs have different effects on children. Surprisingly, adults are sometimes more sensitive to a drug than are children. A larger dose of belladonna is required for children.
Once again I apologise for being late and I want to express my thanks to the noble Baroness, Lady Thomas of Walliswood, for this splendid report.
Lord Colwyn: My Lords, before the Minister replies, perhaps I may say that it would have been extremely useful to have been told that the noble Baroness, Lady Finlay, was not going to speak in the debate. When I rang the Whips’ Office at 10 o’clock this morning while giving an anaesthetic in Harley Street, I was told that I had nine minutes in which to speak. When I spoke to my own Whips’ Office this afternoon I was told that I had seven minutes, and when I came into the debate this evening I found that I had five minutes. But now the Minister has all of 20 minutes in which to reply, while I have had to cut major sections of my speech. It is very unsatisfactory.
Baroness Royall of Blaisdon: My Lords, perhaps I may respond to the noble Lord’s point. As is normal in such circumstances, about two speakers were scratched before the noble Baroness herself was due to speak and the usual channels were informed. I am terribly sorry. In future I shall ensure that other noble Lords are informed, but we were not told that the noble Baroness had been scratched until after the noble Lord had himself spoken in the debate.
Baroness Finlay of Llandaff: My Lords, perhaps I may speak very briefly. I was stuck on the M4 because of a four-car accident, but I tried to get here as fast as I could. I ran up the stairs to join the debate, but realised that it would have been impolite to speak.
Perhaps I may take a moment to address the differences in neonates at term and the even greater differences in preterm neonates. I hope that the Minister will tell us how he intends to inform the public that the culture of research needs to change so that people understand that there are good outcomes from good research and that everyone benefits.
8.37 pm
The Minister of State, Department of Health (Lord Warner): My Lords, noble Lords will be pleased to know that I am not going to speak for 20 minutes; even I recognise that you can have too much of a good thing. I am pleased to have the opportunity to
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I should like to make it clear at the outset that the Government have been supportive of legislation in this area for a number of years and welcome the efforts made by the Commission to progress this regulation. It was a key priority during the UK presidency last year and I am pleased that political agreement was achieved during our presidency. The Government have been concerned for many years about the lack of medicines authorised and formulated specifically for paediatric use for the reasons mentioned by a number of noble Lords this evening. Because of our concerns, we took steps at the national level within the existing regulatory framework: first, to produce in the short to medium term an increase in appropriately labelled and formulated medicines for children; and, secondly, to increase information on the paediatric use of medicines for prescribers, carers and patients through the children’s British National Formulary. I should add that this is probably one of the most useful things I have done as a Minister. There may not have been many of them, but the BNF was one of them. Thirdly, we have ensured that appropriate standards are met for the conduct of clinical trials of medicines involving children.
However, the Government have always considered that a pan-European legislative solution was required to address the current situation. The regulation responds positively to concerns expressed by all member states, including the UK. We were not alone in wanting to address this issue. We recognised the need for a regulatory approach that includes both incentives and requirements to ensure that new medicines along with medicines already on the market meet the specific needs of the paediatric population while also ensuring that children are not subjectedto unnecessary clinical trials or delaying the authorisation of medicines for adults. That second issue has been around for some time and has had to be addressed and dealt with. I am very pleased to report that a Second Reading agreement was reached on the regulation in the European Parliament on 1 June 2006. This means that the regulation will come into force later this year.
One important outcome of the regulation—indeed, one of its objectives—will be an increase in the number of clinical trials in children. Some people, understandably, have expressed concerns about involving children in clinical trials. But let us be clear: if a medicine is to be used in children, the only way of determining whether it will be beneficial and safe is by conducting clinical trials in children, as my noble friend Lord Turnberg so clearly expounded. These trials in children will make an important contribution to public health by providing the scientific base for authorising new essential medicines, particularly for
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In recognition of the importance of clinical trials in children, the Government launched the Medicines for Children Research Network last year to provide a world-class health service infrastructure to support high-quality trials of medicines for children. We want to do this job well and that is why we have involved the experts in this network.
A number of noble Lords have raised issues around the ethical considerations. Involving children in clinical trials clearly raises a number of ethical issues. I should like to emphasise that the Government attach the greatest importance to ethical standards, an area which I know is of particular interest to the House not only in this debate but more generally. The rules governing the conduct of clinical trials are both detailed and specific. The paediatric regulation contains a range of measures specifically to safeguard those participating in paediatric clinical trials. These are over and above the high standards introduced by the clinical trials directive to protect minors. The directive requires that ethical and procedural criteria specific to children are in place before entering them into a trial.
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