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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
3 July 2006 : Column 89
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”.
- “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 that, in research ethics committees looking at research on children, 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
3 July 2006 : Column 93
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.
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.
3 July 2006 : Column 95
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.]
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