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Involving young people in EMA activities
New principles give a voice to patients and consumers under age 18
The European Medicines Agency (EMA) has agreed on principles for involving patients and consumers under the age of 18 in the activities of its scientific committees and working parties.
Young patients and consumers can make an important contribution to EMA’s committee discussions on medicines by sharing their experience and perspectives of living with a disease or condition. These working principles set out best practice for the interaction between scientific committees or working parties and young people under 18 years old, for example, discussion in small groups, provision of specific support, use of appropriate language, etc. They also address issues such as obtaining parental consent, protection of personal data and the privacy of the young patients.
The principles define what input young people could contribute and suggest options on how best to capture their opinions. The document also establishes a process for identifying, supporting and consulting with young people.
According to the new principles, involving young people in the Agency’s activities will be considered on a case-by-case basis when it is expected that their views could enhance scientific discussions related to the development and assessment of medicines for children and adolescents.
The key forum in which young people could participate in the Agency’s activities would be its Paediatric Committee (PDCO), but experience has demonstrated that the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the Scientific Advice Working Party (SAWP) can also benefit from this input when these groups review medicines for children.
Since its creation, the Agency has engaged in dialogue with patients, consumers and carers. They are involved in almost all areas of the Agency’s activities. However, one area where interaction had not yet been established was the option to consult with people under the age of 18.
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