1. What is the problem with medicines for children?
There are comparatively few medicines on the market which are specifically licensed for the treatment of children or are available in suitable formulations.
2. Why has this happened?
Until relatively recently there has been a resistance to conduct studies of medicines used in the treatment of children. This was due to a number of factors including ethical concerns about, and the practical difficulties of, conducting trials in children.
3. Why are you taking action now?
New European legislation will help to resolve this problem. Unfortunately, it is taking longer than expected and so we have decided to take the initiative to move things forward. In addition many of the difficulties around conducting trials in children have been overcome and there is a greater acceptance of the need to test medicines in this population.
4. What action are you taking?
There are three strands to the strategy: information for patients/carers and health professionals; paediatric research; and regulatory actions. More information is available in the separate strategy document. The aim is to achieve better information about the use of medicines in children for prescriber, patient and carer, a measurable increase in the number of products appropriately labelled and formulated for paediatric use, a change in the attitude of the pharmaceutical industry, and to create positive conditions for the conduct of paediatric clinical trials in the UK.
5. Why can’t you just require the pharmaceutical industry to develop products for use in children?
There is currently no legislative requirement for companies to develop medicines for use in a particular patient population. The pharmaceutical industry is free to develop medicines for whatever therapeutic indication and patient population they choose. Commercial considerations predominate. This will change with the new EU legislation on medicines for children.
6. What is the European legislation?
The proposed European Regulation on medicines for children will establish a system of requirements and incentives aimed at increasing the availability of medicines specifically adapted and licensed for use in the paediatric population, increasing the information available to the patient/carer and prescriber about the use of medicines in children, including clinical trial data and increasing high quality research into medicines for children. More details are available on the European Commission website (external link).
7. Will the Government support the new European legislation?
The UK Government is very supportive of the aims of the new draft legislation. However, it will be important to ensure that the legislation strikes the right balance of costs and benefits for both the NHS and the pharmaceutical industry. In addition it must be practical and workable. It is expected that the legislation will not be finalised before 2006. It will be a priority for the UK presidency in the second half of 2005.
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