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10.24 pm
The Parliamentary Under-Secretary of State for Health (Mr. John Hutton): I congratulate my hon. Friend the Member for Edmonton (Mr. Love) on his success in raising this matter for the House to consider tonight. The subject has been generating increasing interest and concern from both health professionals and the public. I welcome the opportunity afforded by this debate to consider the issue of medicines for children. I thank my hon. Friend for his thoughtful, considered and well-informed remarks.
I shall try to respond to all the points that my hon. Friend has raised, but first let me say that as a father myself, I sympathise deeply with the parents of all the children to whom he referred. No one expects to outlive his or her children, and there can be few more tragic events than the death, for whatever reason, of a dearly loved son or daughter. The pain and anguish in such circumstances I know, from my personal experience, to be immense, and I think that the thoughts of the House will always go out to those in that terrible position.
The treatment of children generally is an emotive issue, as well as an important area of service provision. The Government would be extremely concerned if any section of the public were exposed to treatment that was less well regulated or of poorer quality than that available to others, or denied treatment that should be available.
The role of the Government in ensuring that safe and effective medicines are available for the treatment of those of all ages is primarily regulatory, but the Government also have a role in providing industry and health professionals with advice and guidance. I shall say something shortly about the areas in which the Government can and do encourage those with the initiative to address this important issue, but the initiative for undertaking appropriate development work and conducting appropriate clinical trials rests with the pharmaceutical industry, which, once it is satisfied that a product should be marketed, submits its application to the regulatory authority for the appropriate licence.
It is worth pausing for a moment to note the historical perspective. Until quite recently--in the last 10 or so years--it was considered unethical to conduct the very clinical trials that would have helped to demonstrate the safety and efficacy of medicines for children, and ethical considerations remain an important factor.
For manufacturers seeking to license their products for use in the United Kingdom, the licensing authority currently consists of the Department of Health and the Ministry of Agriculture, Fisheries and Food. Responsibility for undertaking the appropriate assessment of new products and the monitoring of products already on the market resides with the Medicines Control Agency, which acts on their behalf. The agency is responsible for ensuring that medicines on the market in the United Kingdom are safe, of suitable quality and effective for the purpose for which they have been licensed.
The Government recently established the National Institute for Clinical Excellence, which is designed to ensure that every national health service patient in the country is given the most effective treatment available. It will identify best practice and help to spread it quickly, and it will advise doctors and nurses on which treatments work best for patients and the NHS and which do not.
My hon. Friend has expressed concern about the extent to which children may be being treated with medicines not specifically licensed for such use. It would, of course, be a matter of great concern if that led to children being given medicines in circumstances in which their use proves to be hazardous. The safety of all medicinal products licensed for use in the United Kingdom is continuously monitored by the Medicines Control Agency, via a voluntary reporting scheme involving doctors and pharmacists.
Mr. Paul Flynn (Newport, West):
In the last Parliament, I was informed by my hon. Friend's predecessor that the number of people dying from the effects of one widely available drug, paracetamol, had fallen from 57 to 48. Other sources--coroners' courts--showed that the actual number of deaths during the period concerned had been not 48 but 586. Is it not true that now, as then, there is huge under-reporting of deaths that have occurred as a result of the use of medicinal drugs, and that the present system does not depend on the reporting of side-effects and tragedies by doctors? It does not work: it vastly under-reports the number of tragedies.
Mr. Hutton:
I am not aware of the parliamentary exchanges that my hon. Friend had with my predecessor in another Administration. I also remind him that we are discussing medicines for children. I am not sure how many of the deaths that he mentioned were children's deaths.
Mr. Hutton:
I hope that my hon. Friend will forgive me if I make some progress, and deal with the points made by my hon. Friend the Member for Edmonton. However, I acknowledge the points that he made, and the seriousness with which he made them.
The yellow card adverse drug reaction scheme, to which my hon. Friend the Member for Edmonton referred, asks clinicians--both GPs and hospital doctors--as well as pharmacists and others to report any suspected adverse reactions to the MCA. Companies are obliged to submit individual reports of adverse reactions and periodic safety update reports containing information relating to suspected adverse drug reactions, drug usage and safety studies, as available, for MCA assessment at regular intervals throughout a product's lifespan.
The data are used to inform both the agency and the manufacturer of the safety profile of the product once it is in use in a wider section of the population than is possible under clinical trial conditions before licensing. Those reports are reviewed by experienced professional staff at the MCA before renewing product licences, a process that occurs every five years in the life of a pharmaceutical product.
My hon. Friend the Member for Edmonton specifically referred to adverse reaction reports for unlicensed medicines and off-label use. I should like to reassure him
that the well-established systems for monitoring the safety of marketed medicines cover all patient groups, including children and off-label usage. Clinicians have been reminded of that fact in a bulletin from the MCA, which went to doctors, dentists, pharmacists and coroners; it was issued in September 1997. Nevertheless, a more targeted approach to surveillance of medicines that are used by children is without question fully warranted.
To that end, in addition to the regular reporting arrangements, we have supported an initiative in Trent region--my hon. Friend the Member for Edmonton referred to it--specifically to encourage reporting of adverse drug reactions in the use of medicines in the treatment of children. That scheme has been operating for a little under a year. However, it is reassuring to be able to report that, within the time frame of the project, no major safety issues have been reported.
I am happy to be able to reassure my hon. Friend, and I hope he will recognise, that, in the very act of committing funding to the project, the Government have signalled their determination and willingness to find ways in which to improve the current system. If the scheme proves to fulfil that need in the best way, subject, obviously, to a full and proper evaluation, we shall continue to fund it.
My hon. Friend referred to the work of the Royal College of Paediatrics and Child Health on a national formulary to include data on drugs prescribed for children. He asked a specific question about funding for future editions of the formulary. As far as I am aware, the Department has received no application to fund a future edition, but, if any such request were made, the Department would be very willing to consider the proposal.
My hon. Friend might be aware--I am sure that he is--that the formulary will cover some 300 medicines commonly used in the treatment of the paediatric population. It will include medicines specifically licensed for such use and medicinal products that are not currently licensed for use in the treatment of children, where advice on the appropriate indications and dosage use for different age groups based on other research findings and evidence has been compiled by the joint committee. It is hoped that the formulary will be issued to the health service by the committee in May or June. I am sure that that will be an important and welcome development.
I turn to the specific question of availability of licensed medicines for use in the treatment of children. It is true to say that a sizeable proportion of medicines is available and formally licensed for use in the treatment of many illnesses that can occur in the paediatric population. Indeed, some products have been developed specifically for such use.
There are other products for which specific clinical trials of a product have not been conducted in the paediatric population, but where the manufacturer and the licensing authority have no reason to suppose that its safety and efficacy will be such that it should not be used in the treatment of children. Such products cannot and should not be defined as "unlicensed" for use in the treatment of children.
A further category of products is those where the terms of the licence and the patient leaflet may state that use in children is not for use in the paediatric population. Those medicines can indeed be described as "unlicensed" for such use. Nevertheless, there are circumstances when the
use of such medicines may, in the view of a clinician, be justified and, indeed, necessary. In any circumstance where a doctor prescribes for a patient, he or she must assume the responsibility for that action.
In the case of treatment of children with unusual conditions, GPs will usually seek the advice of specialists before prescribing treatment with products that are unlicensed or will have to be used "off-label". Such specialists build up a body of knowledge and expertise in the treatment of children's illnesses and have developed treatment regimes to respond to them. There is also a significant volume of published and experimental data available and schemes are in place which make that information available to prescribers of medicines in the paediatric population.
The wide availability of so-called "specials" manufactured commercially and by the NHS has developed in part as a response to the needs of those specialists. Although such products may not have been subjected to assessment of safety, quality and efficacy by the MCA, manufacturers are required to hold a "specials" licence, to have suitably qualified persons responsible for production and quality control and are subjected to inspection by the agency. Their use is carefully monitored by prescribers, and much of the body of information and advice available to those prescribing for children has been compiled from experience gained in practical usage of those, and formally licensed, medicinal products.
I turn now to the question of what additional action could be taken to improve the availability of medicines licensed specifically for the treatment of the paediatric population. I know that that is a matter of especial concern to my hon. Friend the Member for Edmonton and the parents of the child to whom he referred. The Government share the view of those who have expressed their concerns that a wider range of properly assessed and licensed products for use in the treatment of children of all ages should be available.
My hon. Friend raised a point about the very real value of the use of some of those medicines and I agree with him that, important as this debate is, it must not deprive children of the benefits that use of such medicines can bring. We expect that the pharmaceutical industry shares this view. We would like to see them working constructively with the MCA to provide appropriate data to support inclusion of relevant information in the licence. That will ensure that clinicians have access to clear information about the use of their products in the treatment of the paediatric population. Such information also needs to be available in the patient leaflet for the parent or carer.
So far, I have spoken only of the UK's regulatory position. However, much of the legislation that underpins medicines control in the UK now derives from European directives. While that has contributed significantly to improved standards of regulation throughout Europe, it does also mean that any change to the legislation--for example, any proposal that increased the data required from the pharmaceutical industry on use of their products in the paediatric population--would need to be widely discussed and agreed Europe-wide.
Such discussions have already been initiated and there is already a European guideline which the UK played a leading role in developing, which makes it clear that if a product is likely to be used on children, the regulatory
authorities such as the MCA will expect data to be presented from clinical trials in the appropriate age group. The principles set out in the guideline are also being taken forward at an international level through the International Conference for the Harmonisation--the ICH--of technical standards for the registration of medicinal products. The aim is to have an agreed guideline to be adopted throughout the EU, Japan and the USA. However, that is only a guideline and does not have the force of law, as my hon. Friend the Member for Edmonton
acknowledged. In the USA, a similar initiative has met with only limited success in encouraging the pharmaceutical industry there to conduct appropriate clinical trials. I can reassure my hon. Friend that we will be looking at the US experience very carefully.
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