On 29 September 2004 the European Commission adopted a proposal for a regulation on medicinal products for paediatric use.
More than 50% of the medicines used to treat children have not been tested and authorised for use in children. This means a doctor writing a prescription for a child for an untested, unauthorised product, cannot be sure the medicine will be truly effective, what dose is appropriate or exactly what the side effects may be.
According to the European Commission, market forces have failed to stimulate adequate development of medicines for children, requiring the intervention of public policy to address this failure.
The key elements of the new proposal are:
a new expert committee within the European Medicines Agency to assess and agree companies’ testing plans;
a requirement at the time of marketing authorisation applications for data on the use of the medicine in children (plus a system of waivers from this requirement for medicines unlikely to benefit children and a system of deferrals to ensure medicines are tested in children only when it is safe to do so and to ensure the requirements do not delay the authorisation of medicines for adults);
a reward for studying medicines for children of 6-months extension to the supplementary protection certificate - in effect, six-month patent extension;
increased safety monitoring for children?s medicines and compulsory submission by industry of existing studies in children;
an EU inventory of the therapeutic needs of children and an EU network of investigators and trial centres to conduct the studies required;
a system of free scientific advice for the industry, provided by the European Medicines Agency.
The text of the proposal, an impact assessment study and other background documents can be downloaded from a dedicated page on the website of the Enterprise Directorate-General.
Council and European Parliament Conclusions
Following the vote of the European Parliament in September 2005, the Council reached a common position on the 09 December 2005, different from the European Parliament.
Following negotiations, the Parliament and the Council reached a final agreement in May 2006.
The new regulation therefore states the following:
the establishment of a Paediatric Committee within the European Medicines Agency, which will be responsible for the assessment and agreement of paediatric investigation plans;
a six-month extension of patent protection for medicinal products if: all the measures included in the agreed paediatric investigation plan are complied with; the product is authorized in all Member States, and relevant information on the results of studies is provided in the product information.
a new type of marketing authorization for paediatric use proposed for medicines whose patents have expired (but which have been specifically developed for use in children) - this affords the products ten years of data protection;
pharmaceutical firms have to present a "paediatric investigation plan" (a research and development programme aiming at guaranteeing the necessary data for those who require paediatric treatment);
“justified derogations" from the requirement, for firms to present the results of paediatric studies at the same time as human pharmaco-kinetic studies in adults, if the development of medicines for children could hamper the development of medicines for adults;
a special logo to be affixed on medication boxes which benefit from a paediatric guideline.
