Medicines (Children) (Hansard, 20 July 1998)

§ Ms Jowell

[holding answer 1 June 1998]There is a newly established system for licensing medicines for the treatment of children in the United States of America. There have been recent amendments and proposed amendments to the already existing legislation which applies to the licensing of medicinal products for the treatment of all age groups.

In December 1994 the United States Food and Drug Administration (FDA) published the Final Rule on paediatric labelling. The Final Rule required applicants to examine their existing data for already approved drugs to determine whether there was enough information to permit a paediatric indication. If appropriate, applicants were to apply for the addition to their licence by April 1997. This rule has not been very successful in adding paediatric age groups to existing licences as the available data were generally inadequate.

In November 1997 the FDA Modernisation Act of 1997 was signed into law. Section 111 deals with paediatric studies of drugs. Where appropriate, studies are encouraged in children for all newly authorised drugs so that new medicines will be available for use in children. For certain already approved drugs (list published in May 1998) applicants will be required to carry out studies in paediatric age groups with the aim of obtaining a licence for use in children. The Act allows 6 extra months of market exclusivity for pharmaceutical manufacturers who conduct acceptable studies in children of drugs identified by the FDA for which paediatric information would be beneficial.

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There is also a proposed rule, published in August 1997, which would require manufacturers to conduct studies in children if requested to do so by the FDA. If the incentives in the Modernisation Act are successful this additional regulation may be unnecessary.

The spirit of these amendments is reflected in new European guidance on licensing medicines in children which came into operation in September 1997¹. The United Kingdom played a major role in developing this new guidance which strongly encourages the pharmaceutical industry to develop medicines for use in children. It states that clinical trials in children should be submitted to the regulatory authorities as soon as possible if a product is likely to be of benefit to children or widely used in that age group.

In the European Union there is no legal requirement to conduct studies in children although a change to the Directives may be considered if companies do not respond to the new guideline. There is no extra market exclusivity in the EU for applicants who conduct studies in children.

¹CPMP/EWP/462/95: Note for Guidance on clinical investigation of medicinal products in children.