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Mr. Ian Bruce (South Dorset): Further to that point of order, Mr. Deputy Speaker. I, too, was in Westminster Hall today. I must admit that I did not smell anything, but perhaps I had left when the hon. Member for Linlithgow (Mr. Dalyell) arrived.

The hon. Gentleman asked you, Mr. Deputy Speaker, to make representations to Madam Speaker. Two debates took place in Westminster Hall this morning. One concerned post offices, and a good many people were interested and wanted to sit in the Public Gallery; the other dealt with petrol retailing, and a large number of petrol retailers had come to listen. In fact, the public area was not sufficient for the number of people who turned up. Only a few could go in at a time, for half an hour at a time, so no one had a chance to hear the whole debate. Perhaps that too could be mentioned in your representations.

Mr. Deputy Speaker (Mr. Michael Lord): I suggest that concerns about ventilation and housekeeping should be directed to the Serjeant at Arms. Hon. Members with concerns about management and arrangements generally in the new Chamber should contact the Chairman of the Modernisation Committee.

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Medicinal Product Testing in Children

5.7 pm

Mr. Andrew Love (Edmonton): I beg to move,

The purpose of the Bill is to strengthen the licensing system relating to medicines that are likely to be prescribed for children, in response to growing concern about the widespread use in that context of off-label and unlicensed treatments. It may surprise hon. Members to learn that drugs routinely given to children are either not licensed for that purpose, or off-label: that is, they are prescribed in a way that is not in accordance with the instructions on the label regarding age, indication, dose or route of administration. It is no fault of the clinicians; rather, it is a direct result of deficiencies in the licensing system as it stands.

United Kingdom research published in the British Medical Journal in 1998 found that 25 per cent. of drugs were either off-label or not licensed for that purpose, although one in three children in hospital received drugs in that way. For babies admitted as patients, the figures are even higher: 65 per cent. of off-label or unlicensed treatments were given to nine out of every 10 infant patients, many of whom had been born prematurely.

The Government have acknowledged that the issue needs to be addressed. Indeed, the last Government played a leading role in the drafting of existing European guidance, which came into force in September 1997. The opening lines state:

Guidance, however, cannot ensure that medicines will be adequately evaluated, or that prescribing information will be made available to clinicians. Indeed, no one monitors whether the guidance is being followed.

A Europe-wide study published in this week's British Medical Journal shows the scale of the problem. Sixty-seven per cent. of children who were admitted to hospital in five different European countries over four weeks received unlicensed or off-label treatments. Nearly half the prescriptions were either unlicensed or off-label. Surprisingly, in the main those were routine treatments, prescribed extensively to children.

My Bill would begin to deal with that problem by establishing a proper licensing system for new medicines that are to be used for children. Britain should take a lead by placing a statutory duty on the pharmaceutical industry to supply paediatric data on new products when their use on children is likely.

I must acknowledge the cost implications of the extended testing that would have to be carried out to improve the information available to doctors when prescribing specifically for children. To ensure compliance with the spirit as well as the letter of my Bill, some incentive should be considered that would recognise the additional costs that will inevitably be borne, thereby guaranteeing accurate and timely paediatric data.

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Since April last year, a reformed system has been operating in the United States. Although it is still relatively early days, indications are that the United States pharmaceutical industry is rising to the challenges and providing adequately evaluated medicine for children in particular age groups.

I stress that the Bill would not deprive children of beneficial off-label and unlicensed treatments. It would simply regulate and evaluate new products coming on to the market to improve the paediatric information that is available to doctors when they prescribe drugs to children. As product licences are reviewed every five years, potentially the new system could be extended to drugs that are already on the market.

Worryingly, as drugs are prescribed in an unlicensed or off-label fashion, no formal mechanism has been established for notifying, collating or processing adverse drug reactions. Indeed, doctors are unlikely to report adverse reactions because they feel vulnerable, having prescribed a drug that is off-label or unlicensed. We do not know the extent or impact of adverse reactions.

Many people will be alarmed at the thought of testing medicines on children, but that, in effect, is what is happening every day in the health service. Under the present system, all children are potential guinea pigs when they enter hospital or see their general practitioner, yet neither children nor parents are aware of it. It is a hit-and-miss and, sometimes, hazardous system. Seriously ill children may be receiving inadequate doses of life-saving drugs, while others may be receiving worryingly high and potentially harmful doses of inappropriate treatments.

It is recognised that children's bodies absorb and process drugs differently from adults. Dosages cannot be based simply on a child's size, weight, body surface area or age. That is why specific, rigorous studies are important. With a closely monitored clinical study, properly designed and structured, as recommended by the existing European guidance, any adverse reactions and failure to respond to treatment would be speedily picked up and dealt with.

I stress that only children who would directly benefit from the drug--those already ill or being treated--would be involved in the testing. In addition, with modern non-invasive techniques, it would be possible to carry out trials with minimum discomfort to children. Of course, every study would have to have the full consent of parents and, where appropriate, of the child, too.

Proper medical trials would make the system far safer than at present, where drugs are prescribed with inadequate information. Currently, doctors are left to sink or to swim with their limited clinical knowledge and judgment. That is particularly the case for GPs or junior doctors who are not specialists in paediatric medicine, but are expected to take responsibility for prescribing to children. They should have the benefit of rigorous testing, carried out by acknowledged experts, to ensure that their prescribing is soundly based. Under the Bill, existing European guidance on the conduct of drug trials would be rigorously and ethically applied.

The Bill calls for children to be treated in exactly the same way as adults. In one important respect, children are no different from adults: they are individuals entitled to the best medical treatment available. Under the current system, they are effectively disfranchised. Ironically,

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the Medicines Act 1968, which introduced the current licensing system, was a direct result of the thalidomide tragedy--a drug that directly affected children. My Bill would be an important step towards dealing with the deficiencies in the current Act that are already widely acknowledged by everyone involved in prescribing medicines to children.

I am particularly pleased to have the opportunity to introduce the Bill today, as it coincides with the re-opening of the Bristol Royal infirmary inquiry. The inquiry will be focusing on making recommendations that could help secure high-quality care across the national health service, and licensing medicines specifically for children is particularly pertinent to achieving that goal.

My Bill has the support of the Consumers Association, the Royal College of Nursing and academic medical opinion. I am pleased to say that it also has cross-party support, which demonstrates that hon. Members on both sides of the House recognise the need for change. Such change would significantly improve the licensing system for children's medicines and potentially benefit a very large number of children in the United Kingdom.

Question put and agreed to.

Bill ordered to be brought in by Mr. Andrew Love, Ms Julia Drown, Mr. John Austin, Audrey Wise, Mrs. Eileen Gordon, Dr. Vincent Cable and Mr. David Amess.

Medicinal Product Testing in Children

Mr. Andrew Love accordingly presented a Bill to make provision for the clinical testing and licensing of new medicinal products that are to be used for the treatment of children: And the same was read the First time; and ordered to be read a Second time on Friday 3 March, and to be printed [Bill 45].

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