Young people can contribute to EMA committees for first time

The European Medicines Agency agrees principles for interactions between scientific committees or working parties and young people aged under 18 years.

European Medicines Agency building

The European Medicines Agency (EMA) has announced that for the first time patients and consumers aged under 18 will have the opportunity to contribute to the work it does.

The agency has agreed on principles that set out best practice for the interaction between scientific committees or working parties and young people.

The EMA said it recognised the importance of giving young patients and consumers a voice because they “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”.

Its working principles include discussion in small groups, provision of specific support, and use of appropriate language for young people. 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.

Case-by-case basis

According to the guidance, involving young people in the agency’s activities will be considered on a case-by-case basis when it is expected their views could enhance scientific discussions related to developing and assessing medicines for children and adolescents.

The EMA said young people were most likely to work with its Paediatric Committee (PDCO), but it said other of its committees including the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC), and the Scientific Advice Working Party (SAWP) could also benefit from their input.

The agency said that since it was established, it had 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.”

The EMA said the new initiative to involve young people in its activities is “not a major revamp of how we look at paediatric medicines, but rather a way of enriching stakeholder input”.

“It complements the work already ongoing in the PDCO and at the agency on this topic, and is an extension of the established engagement methodologies already in place for involving adult patient representatives in EMA’s work,” the EMA said.

Last updated
The Pharmaceutical Journal, Young people can contribute to EMA committees for first time;Online:DOI:10.1211/PJ.2017.20203260

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