New EU approach to medicines for children viewed by Hogan & Hartson

It has been estimated that more than 50% of medicines used to treat children in Europe have not been tested for use in this population, neither have they been authorized for use in the care of young people. On January 26, new European Union legislation on medicines for children entered into force.

The Pediatric Medicines Regulation aims to balance the ethical issues raised by conducting trials on children with concerns arising from treatment with products which have not been tested on them and the effects, both positive and negative, of which have not been assessed, say Elisabethann Wright and Susan Clements of UK law firm Hogan & Hartson, who review the new legislation and its implications. The Regulation aims to increase the development of medicines that are intended to treat children, to encourage research into drug for use in treating this population and to improve the quality and quantity of information available in this area. All pharmaceutical companies seeking to sell their medicines in the EU have an interest in this legislation, whether or not the products are intended to treat children. Indeed, applicants for marketing authorizations for new medicines and line extensions at EU and EU member state level must comply with its stringent requirements. The requirements apply irrespective of whether or not the medicinal product for which authorization is sought is intended to be administered in children. However, they do not apply to generic products, biosimilars, hybrids, products containing substances acknowledged to have well-established medicinal use and herbal and homeopathic medicines.

The Regulation is also of particular interest to pharmaceutical companies seeking to develop off-patent medicinal products for use in children. Indeed, it provides for a new type of approval called a Pediatric Use Marketing Authorization. The Regulation imposes an extensive system of requirements on companies and provides for penalties for non-compliance. However, it also offers rewards and other incentives.