824 - Cancer: Drugs (Answered)

Jim Shannon
To ask the Secretary of State for Health, what discussions he has had with his EU counterparts on reviewing EU legislation on access to cancer drugs for children.

George Freeman

The European Union Regulation on Paediatric Medicines has been successful in increasing the number of medicines authorised to treat diseases that affect children and it has led to an overall increase in the number of paediatric clinical trials in the United Kingdom and across Europe in many therapeutic areas, including oncology.

However, it is recognised that the system of class waivers for adult conditions, which was intended to prevent unnecessary studies in children, may have acted as a disincentive for the development of medicines to treat rare paediatric cancers. Medicines regulators are aware of this issue and have been taking steps to encourage development of more medicines for paediatric-specific conditions in the oncology field and other therapeutic areas, within the existing legislation.

They are reviewing anti-cancer paediatric investigation plans (PIPs), which are required by the legislation for new medicines, on the basis of mechanism of action and are reviewing the class waivers in this area. UK representatives are strongly supporting this on-going work at a European level to widen access to clinical trials for medicines for rare diseases, including cancer, in children and will continue to press for changes to the system of class waivers in collaboration with European Medicines Agency, which issues decisions on PIPs and other European regulators. The review of the class waiver system is close to completion and publication is expected in the next few months.