In addition, there will also be a new designation, the Paediatric Use Marketing Authorisation, which will provide 10 years’ patent protection for companies that carry out paediatric clinical trials of off-patent drugs.
Currently, more than 50 per cent of medicines have not been tested in clinical trials in children, and subsequently are not licensed for paediatric use. This is due both to concerns about the ethics and safety of conducting trials in children and because they represent a small market.
The EU said the new rules would increase the availability of fully researched, developed and authorised drugs for children.
Clinical trials in children will be supervised by a new expert group, the Paediatric Committee, which will operate under the auspices of the European Medicines Agency. There will also be moves to improve the robustness of pharmacovigilance for medicines in children, and an EU-wide network of investigators and trial centres will be set up with the capability to conduct paediatric trials.
At the same time, the potential commercial opportunities for companies to develop paediatric drugs will be listed in an inventory of the therapeutic needs of children.
In return companies will have to submit a paediatric investigation plan when they file for drug approvals for adults. There will be waivers for drugs that are unlikely to benefit children and a system for allowing paediatric testing to be deferred if this would delay authorisation of treatments for adults.
Brian Ager, Director General of the European Federation of Pharmaceutical Industries and Associations, said the new legislation would allow Europe to reclaim a central role in innovative drug development worldwide and, “Catch up with other world regions where the necessary framework for paediatric research has been implemented to meet the needs of the patient population.”