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There is no question of the military being restricted to flying so many hours. It is about managing and planning the operation so that the availability of aircraft, flight crews, spares and logistics is managed coherently, taking into account the fact that we expect this to be a long campaign. This is about sustainability and managing our resources effectively. I say again that, if we require additional resources to do the job, they will be provided.
Baroness Dean of Thornton-le-Fylde: My Lords, I thank the Minister for repeating the Statement. It was certainly needed, because of the printed media, television and radio coverage over the weekend. From this side of the House, I entirely endorse the sympathies that we all have for the families of Corporal Thorpe and Lance Corporal Hashmi, together with the family of their interpreter. I hope that the five injured service personnel have a full and speedy recovery.
The Afghan operation received support from all round this House when it was announced. This weekend has clearly demonstrated concerns that a number of people rightly had about how hazardous it was going to be. We may well be faced with other sad stories ahead.
Many of us know the financial pressures that the MoD is under and we have just heard that this money does not necessarily come out of day-to-day budgets. Will the Minister confirm that, should our Armed Forces make a request for additional resources, they will receive not simply what they can get by with but what they absolutely need? We all know that our services have a culture of “can do, will do”, whether they are fully resourced or not. On this occasion, we must take that into account even more.
Finally, are steps being taken with the Government of Pakistan to see what they are going to do to further secure their borders? That is clearly a serious element of this operation.
Lord Drayson: My Lords, I am grateful to my noble friend for giving me the opportunity to confirm absolutely that we recognise that our forces have a “can do, will do” approach. That is why they are as good as they are. That will be matched by the absolute commitment that was given by No. 10 today, which was repeated in the other place and which I am happy to repeat in this House: if military commanders come to the conclusion that they require further resources, those resources will be provided.
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My noble friend also asked about border security. We must recognise that the border geography of the two countries presents a challenge to our Armed Forces, but it is a challenge that—in co-operation with our coalition partners and, most important, with the developing capability of the Afghans themselves—we will in time be able to address.
I note that I did not answer the part of the right reverend Prelate’s question on human rights progress. I shall give your Lordships one example of why our forces are there, providing security for the development of vitally important human rights in Afghanistan: women. Headmasters have been taken out of their schools and beheaded in front of their families and schoolchildren for the so-called crime of teaching girls. Let us look at this country’s progress: 87 women were elected as members of the 351-person National Assembly. In September 2005, despite the level of intimidation, 40 per cent of votes were cast by women. In March 2005, President Karzai appointed the first female governor, to Bamiyan province. More clearly than anything, that tells us what role our Armed Forces are playing in providing the muscle to allow proper governance and human rights to develop in the country.
Baroness Crawley: My Lords, I suggest that the Committee stage of the Legislative and Regulatory Reform Bill begin again not before 8.55 pm.
Paediatric Medicines
7.57 pm
Baroness Thomas of Walliswood rose to ask Her Majesty’s Government, in the light of the report of the European Union Committee on Paediatric Medicines: Proposed EU Regulation (20th Report, HL Paper 101), what steps they are taking to ensure that the proposed European Union regulation on medicinal products for paediatric use will meet satisfactory ethical standards on implementation, that the incentives proposed will be effective, equitable and proportionate and that the working of the regulation will be rigorously reviewed.
The noble Baroness said: My Lords, we are here to discuss our recent report on paediatric medicine. The Commission’s proposal for regulating medicinal products for paediatric use reached Sub-Committee G in December 2004, and by the summer of 2005 it was clear that the UK Government wanted to achieve the approval of the document by the end of the UK presidency.
The main elements of the proposal were, first, a package of rewards and incentives to encourage the pharmaceutical industry to test products for use in children across the European Union and to develop and/or adapt them to paediatric use. Secondly, the European Medicines Agency would appoint an expert paediatric committee to oversee and assess paediatric investigation plans for developing medicinal products for children. Thirdly, a European clinical trials network would be set up to foster communication and collaboration on paediatric studies throughout the EU. Fourthly, authorisation procedures would be
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Sub-Committee G appreciated the potential value of encouraging the clinical testing of medicines for paediatric use across the EU market. However, there were ethical and practical concerns and a decision was taken to undertake a brief inquiry. We received a wide range of evidence from interested parties including, most helpfully, from Professor Sir Cyril Chantler, the chairman of the Great Ormond Street Trust. We also saw the results of the consultation carried out by the Healthcare Products Regulatory Agency. We also had a good deal of correspondence and a very useful evidence session with the then Minister of State at the Department of Health, the right honourable Jane Kennedy MP, and her officials.
As our report shows, we were convinced that there was a real and urgent need for this regulation. More than half of all the medicines currently given to children and 90 per cent of those given to newborn babies have never been tested for that use. Furthermore, not only can the results of tests of medicines in adults not be extrapolated reliably for their use in children, but children can react very differently to drugs according to their age, among other factors. Many drugs are formulated in a way that does not suit children—in particular, very young children. Moreover, the pharmaceutical industry can find it relatively unrewarding to do the necessary but expensive research needed to produce or adapt medicines for children’s use because the market is relatively small and complicated. Meanwhile attempts by member states to encourage it to do so have not been successful.
But we concluded that the proposed package of rewards and incentives, although based on a successful scheme in the United States, was something of a leap in the dark. Under the scheme, pharmaceutical companies can expect an extension of the sole right of sale of their product if they do the research required to prove the product’s efficacy in treating children. But we could not judge with confidence whether the proposed regulation would have the desired result, whether the manufacturers would be insufficiently, reasonably or even excessively rewarded and what the effect on health service budgets would be. We also understood that some member states opposed any delay in the release of medicinal products to the generic manufacturers, who are significant players in new member states in eastern Europe.
As the December 2005 Council meeting approached, it was clear that member states were ready to approve the proposal. We were aware of the weight of professional opinion in this country that the proposal should be implemented as soon as possible. We concluded that it would not be sensible to stand in the way of such an agreement and, exceptionally, agreed to lift scrutiny in advance of publication of the report. Political agreement was secured by the UK presidency at that Council meeting.
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Two issues still concerned the committee. The first was whether the guidelines for the detailed application of the regulation really would take on members’ concerns about the consent of minors, the rights of children and their parents, the proper publication of all the research projects in a transparent way and product information and labelling. The second was the legal base for the new regulation. On the matter of guidelines, we had been partially reassured by meeting the officials dealing with the details under comitology procedure. They clearly understood the committee’s concerns and assured us that these matters were being pursued by them in committee. It was also agreed by the Minister that, as a condition of lifting scrutiny, officials would brief Sub-Committee G on the development of the guidelines once the regulation was adopted and that the Government would hold the Commission to its commitments to give a full review of the working of the regulation and on access to the database. The Minister further agreed that when the operation of the regulation came under review—which might be in six or 10 years’ time—our successors would be briefed on the practical operation of the guidelines. I hope the Minister can confirm tonight that that approach still reflects the Government’s intentions.
I now turn to the matter of legal base, which is always of importance to the Select Committee. There was some concern that the Government, despite their judgment that the proposed legal base—Article 95 of the EC Treaty—was not appropriate, were preparing to give political consent to the regulation so long as they lodged a minute statement officially recording their objection. We understand that that was done and that several relevant rulings have since been given by the ECJ. Can the Minister bring us up to date on this matter?
After the report had been published, a final and unexpected coda to our deliberations was provided by the representations from the Association of the British Pharmaceutical Industry to the effect that the amount of time allowed for companies to make application for the right to conduct tests was insufficient, particularly in the years immediately following implementation of the regulation. We understand that a European Parliament common position to that effect was adopted on June 1. We also understand that the Government endorse that position, and it would be helpful if the Minister could explain the latest position.
I have tried to give an overview of our report. I am confident that other members of the sub-committee will be able to fill out many of the details. It was a piece of work to which every member brought real personal commitment and knowledge. I am delighted that this debate has attracted speakers who were not members of the committee. I cannot close without thanking the committee secretary, Gordon Baker, and his staff for all their support. As Mr Baker may have to leave us before another of these occasions occurs, I should put on record our very real appreciation of his hard work, cheerful disposition and impressive drafting skills that have been of such immense service to the committee and to all its members.
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8.06 pm
Lord Turnberg: My Lords, I congratulate the noble Baroness, Lady Thomas of Walliswood, and her committee on a thorough, commendable and—dare I say?—readable report. I also congratulate her on her excellent introduction.
I find it remarkable that although we go through such an elaborate and robust system of testing drugs before they are used in adults, many drugs given to children have not been tested in children at all. Before a new drug can be given to an adult, it has to go through several phases of trials to assess its safety and efficacy in treating the disease for which it is prescribed. However, the practice in children, more often than not, has simply been to scale down the adult dose according to weight and age on the basis that a child is just a small adult and ignoring the fact that a child’s metabolism may be quite different from that of an adult. The reason for that is that very few drugs have been tested in children, so unfortunate paediatricians have to rely on their experience and prescribe off licence or not prescribe at all. Every day, paediatricians face the dilemma of whether it is more unethical to prescribe a drug that has not been tested or to deny treatment to a sick child. They do not have the comprehensive information on risks and benefits that would allow them to make an informed judgment. For example, 90 per cent of drugs used in the very emotive group of patients—the neonatal babies in intensive care—are unlicensed or off-label medicines. Therefore, the new EU regulations that are designed to encourage the testing of drugs in children are welcome. Indeed, they are essential.
The regulation follows fairly closely changes introduced in the United States that were shown to be effective in increasing the number of drugs tested. I understand that some 30,000 children in the US have been entered in clinical trials. This is an extremely sensitive area because no parent wishes to see his child used as a guinea pig, but if that idea is followed through to its logical conclusion, every child becomes a guinea pig if the drugs have not been tested properly. It can be argued that not to do proper studies in children is unethical. The answer lies in sensitive and carefully managed systems of consent and extreme care with safety issues, which are covered by ethics committees. The evidence is that these issues can be fully taken into account with due care. One study by the National Perinatal Epidemiology Unit in Oxford retrospectively questioned 100 parents of neonatal babies who had been in a controlled trial of extra-corporeal membrane oxygenation. They were asked whether they had had any qualms about their babies being involved in the trial and none said that they regretted it, even though some babies in this group of extremely ill neonates had died. So it can be done, and with carefully conducted controlled trials it is now possible to treat so many forms of childhood leukaemia so well and new ways of treating childhood asthma have become possible. So I am sure that the new EU regulation, which offers some important inducements to the pharmaceutical industry, will be well received. Although it may be a great leap of faith, we have the evidence of some success, at least, from the American experience.
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Paediatricians are now well set up to undertake trials in the UK with children in a sensitive and highly ethical way. The guidelines from the Royal College of Paediatrics and Child Health, which have been helpfully appended to the report, give some confidence. They describe how it is possible to obtain consent from a child who is able to give consent, and recommends that that should be the normal course, and only if the child is unable to give consent—too young—should parental consent triumph.
It will be important for government guidelines to be constructed in such a way as to give reassurance to parents and children as well as to paediatricians, and that they ensure full transparency. They should also encourage rapid and wide dissemination of results so that drugs which are shown to be of value can be used as soon as possible, and those that are not can be avoided.
Finally, this regulation is welcomed by paediatricians and I hope that the Government will move quickly so that it can be adopted.
8.10 pm
Lord Colwyn: My Lords, I thank the noble Baroness, Lady Thomas, for her chairmanship of the committee and the way she introduced the debate this evening, Gordon Baker for his advice and guidance, and Sir Cyril Chantler for his expert opinions. The problem of funding complete trials of adult medicines used for children means that thousands are being prescribed “off-label” therapies that have not been licensed for such use.
Paediatricians and paediatric pharmacists are faced with the difficulty of prescribing and supplying medicines for children without the support of clinical trial evidence, which is available for adult medicines from the specification of product characteristics supplied by the manufacturer.
At least one unlicensed or off-label drug is received by 11 per cent of children treated at home by their GP, 67 per cent of children in hospitals across Europe,70 per cent of children in paediatric intensive care and, as we have heard from the noble Lord, Lord Turnberg, 90 per cent of babies in neonatal intensive care.
A study by the University of Liverpool found that 6 per cent of children had suffered adverse reactions to an off-label medicine, and French research has suggested that the risk of serious side effects is up to three times higher.
The use of off-label and unlicensed drugs to treat children is widespread and occurs in medical and surgical wards as well as with critically ill children. Off-label use occurs more frequently—drugs are being used in children at ages for which they have not been licensed and evaluated—at doses greater than that recommended by the manufacturers and for indications outside the terms of the product licence.
The committee’s conclusion is that there is an overwhelming and urgent need to take effective action at European level to govern clinical trials in children and the authorisation of medicinal products for paediatric use with the minimum delay.
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The EU regulation recognises that paediatric licensing is essential for all categories of medicines for children. This includes new medicines yet to be authorised, existing medicines under patent protection and those where patent protection has expired. It attempts to use both obligation and incentives and rewards to achieve this.
Children are subject to many of the same diseases as adults and, as would be expected, are treated with the same drugs. The absence of paediatric testing and labelling causes significant risks for children. Inadequate dosing information exposes them to adverse reactions that could be avoided if such information were provided in product labelling. The absence of paediatric testing and labelling may also expose children to ineffective treatment through under-dosing or may deny them the benefit of therapeutic advances because physicians choose to prescribe existing, less effective medication because of insufficient paediatric information about a new medication.
The medical community has shown increased concern about the lack of information for over 20 years. My own experience within a dental environment has shown me that different drugs work in different ways at different ages. Children are defined as “someone under 19”. It seems obvious to me that the pharmaceutical companies should ideally provide information about how drugs work in several stages of childhood. A drug will have a variable effect on a neonate, a newborn infant, a one to four year-old, a four to 10 year-old, a 10 to 13 year-old and a 13 to 19 year-old, but they are all classified as “children”.
It is difficult enough for pharmaceutical companies to undertake adequate phased testing of drugs for adults. To have to evaluate a medicine for the six additional categories that I have listed would take many years and bear a disproportionate cost, perhaps even making it impracticable to consider the use of the drug for children.
The impact assessment of the proposed EU regulation estimated that to deal with the increased number of applications, the EMEA budget would have to be increased by between 67 to 150 per cent, or €130 million to €195 million, the cost to the pharmaceutical industry being about €4 million per product.
It is proposed that medicines and products covered by existing patents, or granted market exclusivity by supplementary protection certificates under existing EMEA authorisation procedures, shall be entitled to a six-month extension of the market exclusivity and an additional two years’ market exclusivity to which orphan medicinal products are entitled under existing EMEA authorisation procedures, making 12 years in all.
Ten years of data protection for new paediatric studies would also be granted to off-patent medicinal products developed specifically for use in children. Products developed under this provision would be granted paediatric use marketing authorisation. Historically, this has been successful in the USA, which introduced the “paediatric rule” and the “paediatric exclusivity” provisions, adopted in 1998 and 1997 respectively. This legislation provides six months’ exclusivity in return for conducting paediatric studies and has been highly effective in generating paediatric
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Some categories of drugs and some age groups remain inadequately studied despite these new incentives, but suggestions have been made for modifications to the paediatric exclusivity provision that may address these gaps.
For some products and for some age groups the incentives provided have not produced proposals to conduct paediatric studies. The incentive is not adequate for old antibiotics and other drugs lacking market exclusivity or patent protection because these products are not eligible for any exclusivity under the current paediatric exclusivity provision.
While the incentive provided by paediatric exclusivity provision has been adequate for many products, it has naturally tended to produce paediatric studies on those products where the exclusivity has the greatest value, and not on those which no longer have patent protection or exclusivity, or small markets.
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