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Mr. Dalyell rose in his place and claimed to move, That the Question be now put.
Question put, That the Question be now put:--
The House divided: Ayes 11, Noes 0.
Tellers for the Ayes:
Tellers for the Noes:
It appearing on Report of the Division that fewer than 40 Members had taken part in the Division, Madam Speaker declared that the Question was not decided in the affirmative.
Motion made, and Question proposed, That this House do now adjourn.--[Mr. Robert Ainsworth.]
Mr. Andrew Love (Edmonton)
rose--[Interruption.]
Madam Speaker:
Order. Those hon. Members who are leaving will please do so or resume their seats. [Interruption.] How churlish! An hon. Gentleman has the Floor.
Mr. Love:
I am grateful for the opportunity to raise the subject of licensing medicines for children, as I believe that it is a very important, if somewhat neglected, issue. I hope in a small way to put that right tonight. I know that the matter is of interest to hon. Members on both sides of the House, as more than 100 colleagues from all parties have shown their support for early-day motion 365, which I tabled a few weeks ago. That motion calls for the Government to
I first looked into this issue as a result of a tragic case in my constituency. Through it, I made contact with the parents of other children who had died following medical treatment and also with Professor Choonara, of Derbyshire children's hospital, who has carried out much of the research into this matter. From his research, I learned, to my amazement, that 25 per cent. of all drugs given to children in hospitals are not licensed for that purpose and that 36 per cent. of all children in hospitals receive drugs in that way.
In addition, a more recent study showed that the figure for newborn babes admitted as patients is even higher: 65 per cent. of all treatments are either unlicensed for that purpose or prescribed off-label, and 90 per cent. of them receive such treatments. I remind the House that those drugs are either totally unlicensed for human administration or licensed solely for use on adults, yet they are still regularly given to children.
My amazement and concern were clearly shared by the Select Committee on Health, whose report "The Specific Health Needs of Children and Young People" was published in February 1997. The Committee's report states:
In my attempt to raise this issue, I have received support from general practitioners and paediatricians, and I express my gratitude to them for that. The present system--or, rather, the lack of one--simply leaves doctors to sink or swim with their own clinical knowledge and judgment. Although that may be sufficient for many doctors to prescribe the correct drug and the appropriate dosage, for others it may not be. I have in mind particularly the GP who is not a specialist in child health, but is expected to take responsibility for prescribing a drug of which he has little knowledge. The point is that, without a proper licensing system, we have no way of independently and scientifically assessing those treatments.
I emphasise that I am simply calling for children to be treated in the same way as adults--as individuals entitled to the best medical treatment available. A doctor's clinical judgment must be based on the information available. A substantial part of that information is provided by drugs manufacturers, after full and rigorous clinical trials on a given treatment. If that is what we expect and receive as adults, why should we not expect and provide the same for children?
This is an issue of consumers' rights and, as such, it is of great concern to the Consumers Association, which has campaigned hard for some time. I believe that paediatricians and GPs should be required to inform patients and, in cases involving children, parents when an unlicensed or off-label drug is given. I look forward to hearing my hon. Friend the Minister's views.
A further consequence of unlicensed and off-label prescribing is the apparent inability to monitor adverse reactions to particular dosages of a drug. The Medicines Control Agency is able to track any adverse reactions as a licensed drug is used and, if necessary, amend the instructions on how it should be administered. When a product is used outside the licence, such monitoring and feedback simply cannot happen, as there is no on-going mechanism within which it can take place.
I would argue, therefore, that children are disfranchised in that process. They have to rely much more heavily than adults on unlicensed and off-label treatments and the treatments that they are given are not subject to the monitoring and on-going review of licensed medicines. Nevertheless, adverse reactions to off-label and unlicensed treatments exist, and I expect that in some cases they are reported to the Medicines Control Agency and the Committee on Safety of Medicines. When I asked the Minister about that, his response was:
The Government are funding a pilot research project into adverse medical reactions in children in the Trent region. The project has been running for six months and funding of £38,000 has already been committed. However, I understand that Trent region is happy to back the research for a further three years, conditional on the Medicines Control Agency funding its share. So far, the agency appears to be unwilling to commit itself. Already,
however, the project has shown signs of success, with a 100 per cent. increase in the reporting of adverse reactions in the first six months.
It is also significant that, in June, the Royal College of Paediatrics and Child Health will produce the first national formulary to include data on drugs prescribed for children. It will be funded by the Nuffield Foundation as a one-off edition and will be sold commercially to raise funds for future editions. However, it is hoped that the Department of Health will fund future editions, to be published and updated regularly. To date, the Department has not said that it wants to take on that role. Will the Minister comment?
The use of unlicensed and off-label treatments is not a new problem; it has been recognised and addressed by the United States and the European Union. From April this year, pharmaceutical companies in the United States will be compelled to provide information about the effects of their drugs on children if such a use is likely. Significantly, for such information to be required, the use on children needs only to be "likely". In written questions, I asked the Secretary of State whether the Government would look at the US system. I hope that the Minister will elaborate tonight on that basis.
In 1995, the EU established guidance on the clinical investigation of medicinal products in children, which came into effect in September 1997. I understand that the Government played a major role in developing that guidance, so I presume that the Minister is familiar and broadly sympathetic with its content. As it is guidance and not a directive, it does not compel member states or drugs companies to do anything. Nevertheless, I draw the House's attention to its opening lines:
I understand that research will soon be published in The British Journal of Clinical Pharmacology, which looks at practice in licensing at the time the EU guidance was formulated. That research highlights the need for pharmaceutical companies and enforcement agencies to undergo a change in attitude to effect the necessary change in the licensing process.
As compliance with the EU guidance is entirely voluntary, drugs companies have little incentive to apply to license their products in that way. However, a joint British Paediatric Association and Association of the British Pharmaceutical Industry working party was set up and recommendations were made to address the unsatisfactory situation. My concern is that, although those recommendations are worthy in themselves, they are worth little without action to implement them. Experience of the commercial sector suggests that drugs companies ultimately follow the profit motive. Indeed, I understand that they are requesting extended intellectual property rights to encourage the industry to follow the guidance.
Significantly, the US Government have tried such a carrot-and-stick approach--compelling drugs companies to provide information about the effects of their drugs on
children, but also offering them the financial incentive of a six-month extension to their patents in exchange for comprehensive paediatric data. Have the Government evaluated the benefits of such a system in the UK?
There is a need for the Government to step in to regulate a situation where the other parties are unwilling or unable to act. The use of unlicensed and off-label treatments in children merits such intervention. I would add also that both the pharmaceutical industry and the medical profession could have addressed the issue some years ago, so any accumulated costs are due to years of inaction.
The reasons for a specific licensing system for children are clear. Physiologically, children and babies differ considerably from adults. I refer again to the EU guidance, which states:
The only sensible way forward is to follow the recommendations in the European guidance and to establish clinical trials for drugs that are likely to be used on children. Of course, the participation of any child in such trials would have to be with the full consent of the parents concerned and, where appropriate, with the informed consent of the child. Such a process would have to be carefully monitored at every stage, and any adverse reactions speedily evaluated and treated.
I recognise that the notion of testing on children can, in itself, be seen as alarming because the last thing that anyone would want is to put a child through any kind of hazardous process. However, I believe that this is infinitely better than what we have at present--a hit-and-miss system in which all children are potential guinea pigs without their knowledge or the knowledge of their parents. There is a responsibility on the Government to recognise the need for the education of parents and the wider public about the very good reasons for a proper testing process.
There is an irony here, in that the Medicines Act 1967--which introduced the licensing system--came as a result of the thalidomide disaster, a drug which directly affected children, yet the present system effectively excludes children from the licensing process. That cannot continue to be justified.
Finally, I draw the House's attention to the main reason for this debate--the human cost of not taking any action. Lexie McConnell was nine years old when she died in November 1992. Her immune system collapsed following a steroid overdose after she had been given doses licensed only for use on adults. Lexie was being treated by a specialist at the John Radcliffe teaching hospital in Oxford for a relatively minor eye injury, yet her treatment still went tragically wrong.
AYES
Benn, Rt Hon Tony
Corbyn, Jeremy
Dalyell, Tam
Galloway, George
Gerrard, Neil
Mahon, Mrs Alice
Marshall-Andrews, Robert
Simpson, Alan (Nottingham S)
Smith, Llew (Blaenau Gwent)
Wareing, Robert N
Wise, Audrey
Mr. Bill Michie and
Mr. John McDonnell.
NOES
Mr. Mike Hall
Mr. David Jamieson.10.8 pm
"take steps to strengthen the regulatory system in the UK, and establish a satisfactory system for testing and licensing treatments for use on children."
I repeat that call tonight.
"the current system in regard to the testing and licensing of medicines for use by children is unacceptable."
The Department of Health is quoted in the report, responding to those concerns by acknowledging that that "unsatisfactory" situation exists. The report goes on to say:
"The Department and the Medicines Control Agency consider that children should have timely access to safe and effective medicines which have accurate, scientifically justified prescribing information".
I should make it clear that unlicensed and off-label prescribing can bring benefits to some patients, and I am not seeking to deprive children of beneficial treatments, but I believe that those treatments should be administered after a rigorous testing and licensing process. Off-label
prescribing may also lead to under-dosing of worthwhile treatments, thus depriving children of the full benefits of a drug.
"there is no centrally held record of suspected adverse reactions to medicines."
Perhaps he could tell the House tonight what happens to any information that is received. Is it filed, or simply disposed of because no mechanism exists to process it?
"Children should not be given medicines which have not been adequately evaluated for use in that age group. There is a responsibility, shared by applicants and the competent authorities, to ensure that children have timely access to safe and effective medicines which have accurate, scientifically justified, prescribing information."
What steps are the Government taking to monitor the application of the guidance to establish which products are licensed in accordance with the guidance and from which drugs companies?
"The effects of many medicinal products on children may differ considerably from those observed in adults, even when dosage has been adapted to body weight or body surface area."
Drugs affect children differently in terms of side effects and the way in which a child's body absorbs and processes a drug. That must be recognised in the licensing system. Evaluating the suitability of any given drug for children is, therefore, a far more sophisticated process than, for example, simply taking the adult dosage of a given drug and halving it.
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