Drug Treatment in children

House of Lords adds voice to call for European wide regulation on children's medicine

January 2006

The UK Parliament's House of Lords has added its voice to calls for the introduction of European-wide regulation on children's medicines.

In its response to proposals put forward by the European Commission (EC), the House of Lords described the need for a coordinated European response as, 'overwhelming and urgent'.

However, the Lords has also expressed some ethical concerns about how aspects of the proposals might work in practice. In essence, the EC wants to:

• increase the development of medicines for use in children;
• ensure that medicines used to treat children are subject to high-quality research and are appropriately authorised for use in children;
• improve the information available on the use of medicines in children;
• achieve these objectives without putting children through unnecessary clinical trials and in full compliance with rules governing the use of such trials.

So, the EC proposal combines procedures to regulate clinical trials of medicines for use in children with incentives designed to encourage the pharmaceutical industry to develop and submit for approval medicines specifically developed for the treatment of children.

Publishing its response in January 2006, the Lords said it was particularly keen to ensure that the proposed clinical trials of medicines will be acutely sensitive to the particular problems involved in gaining informed consent from children.

It has recommended that guidelines covering the trials should have in place an agreed definition of informed consent, tackle instances of conflict which may arise if parents and children disagree on whether consent should be given, and make a distinction between a child agreeing to take part in trials because they want to please rather than because they have genuinely understood the implications of what is being asked of them.

The Lords also wants assurances built into the guidelines that any treatment keeps the individual child's welfare as the prime objective so that medicines are given on the basis of each patient's need rather than for their use as a potential marker for the treatment of others.

The Lords has further recommended that the guidelines are kept up to date with changes in medical and scientific thinking.

Commenting on other aspects of the proposals, the Lords supports the setting up of a Clinical Trials Database and recommends that its contents be made publicly available to all those involved in testing medicines on children. The Lords recommends that all details of drugs testing should be included even where clinical trials are halted so that as much information as possible is stored.

The importance of clear labelling is stressed by the Lords committee. The risks of using medicines on children without taking full account of the instructions for their proper use, such as correct dosage, must be made plain on all products which may be used on children.

The use of the European Medicines Agency (EMEA) as the umbrella body responsible for implementing the proposals is generally supported although the membership, funding and day to day running of it should be kept under regular review, says the Lords committee.

The Lords has called for the adequacy of the framework for funding research into children's medicines to be properly investigated and assessed once the new regulations come under review.

The Lords also accepts that while not perfect, the structure of rewarding and providing incentives to European pharmaceutical companies to develop children's medicines is a compromise that needs to be made in the short term to get the wheels in motion.

The Lords report states: "We conclude that they (the package of incentives and rewards) are essentially a leap of faith: it is impossible to judge from the information we have been given whether these arrangements are likely to provide the necessary incentives to industry, whether they are likely to be equitable and proportionate, or whether they may give rise to excessive profits, penalise the health services of member states or create unacceptable disadvantages for the manufacturers of generic products."

The Lords has requested that an economic review of the proposals be undertaken within six years of their implementation to assess their full impact. If this cannot be done, the Lords wants sound reasons sought as to why not and assurances that such a review will be take place at the earliest possible opportunity.

Click here for a full copy of the House of Lords report

Charity campaigners welcome launch of new guide to child medicines

September 2005

Fantastic step forward for paediatric care

Action Medical Research has welcomed the launch on the 20th September 2005 of the British National Formulary (BNF) for Children, calling it a 'fantastic step forward'.

We have been campaigning since 2000 for better, evidence-based guidelines to help doctors prescribe safe and effective doses of drugs for children.

Around 40 per cent of the medicines given to children have never actually been tested on children, and for new-born babies the figure is 65 per cent.

Calculating safe dosage levels for young patients

In the absence of clear guidelines, GPs and hospital doctors have relied on their best professional judgements when determining the optimum dosage of some drugs for young patients.

Back in 2002 Action Medical Research announced the findings of its study into the use of 10 drugs that are commonly prescribed to hospitalised children, but which are unlicensed or untested for young patients.

While most doctors selected doses that were appropriate and safe, the study found evidence that in some cases doctors were giving doses that were too low to control the patients' symptoms.

This important study demonstrated the urgent need for better testing of drugs for children, and for improved prescribing guidelines.