The EMA has decided to include patients and consumers under the age of 18 in the activities of its scientific committees and working parties. The EMA believes this patient group can make a significant contribution to their committee discussions on medicines by sharing their unique experiences and perspectives of living with a disease or condition.
The EMA has issued a set of working principals which outline best practice for the interaction between scientific committees or working parties and young people under the age of 18 years of age. These include discussion in small groups, provision of specific support, use of appropriate language etc. Obtaining parental consent, data protection and the privacy of the young patients is also included in the working principals. They also define the type of input this patient group can contribute and suggests options on how best to capture the feedback. They also include a process for identifying, supporting and consulting with young people.
This patient group will be included in the agency’s activities on a case by case basis, such as when their input could enhance scientific discussions related to the development and assessment of medicines for children and adolescents. They are expected to participate in the EMA’s Paediatric Committee (PDCO) as well as the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Scientific Advice Working Party (SAWP) when they discuss medicines for children.
Historically, the EMA has involved patients and consumers in its meetings, however involving young adults and children under the age of 18 is a new venture and the EMA hopes to benefit the wider public from their involvement.