EU’s EMA ready to involve under 18s in some of its activities

The European Medicines Agency (EMA) has decided to give children and adolescents a voice in some activities of scientific committees and working parties.

The EMA has recognised that under 18 year olds can make an important contribution to the agency’s discussions on medicines by sharing their experience and perspectives of living with a disease or condition as a patient or consumer.

Working principles set out best practice for the interaction between scientific committees or working parties and young people, for example:

  • Discussion in small groups
  • Provision of specific support
  • Use of appropriate language, etc
  • Obtaining parental consent
  • Protection of personal data
  • Privacy of the young patients.

The document also describes what input young people could potentially give and a procedure for working with young people.

Young people will be involved in the agency’s activities when it is considered that views could add value to scientific discussions on the development and assessment of medicines for children and adolescents.  As such the Paediatric Committee (PDCO) is likely to be the primary group to engage under 18s, but the Committee for Medicinal Products for Human Use (CHMP), Pharmacovigilance Risk Assessment Committee (PRAC) and Scientific Advice Working Party (SAWP) will also involve youngsters when beneficial.  The EMA, committee members and rapporteurs will decide on a case-by-case basis when it would be beneficial to consult children and the format of the consultation.

Young patients, consumers and carers will be chosen by the Agency’s network of patient and consumer organisations, specifically those who have experience working with young people.  The Patients and Consumers Working Party (PCWP), together with EnprEMA and the other EMA eligible patient/consumer organisations, are working to build contacts with youth groups across Europe.

Click here to read the full announcement and access the ‘Principles’ document.