council resolut decemb paediatr medicin product council european union recal high level health protect ensur definit implement commun polici activ commun action complement nation polici direct improv public health prevent human ill diseas obviat sourc danger human health note commun popul million peopl ag note treatment children characterist vari ag case treat adult medicin product administ child specif characterist term pharmaco kinet effect undesir effect medicin product intend children requir pharmaceut present ensur easi safe administr note larg number medicin product administ children assess specif paediatr meet criteria qualiti safeti effect requir case adult observ prescript medicin product children cover market authoris take account shortag paediatr pharmaco vigil data safeti popul group document monitor studi market recognis make paediatr medicin product involv difficulti pharmaceut develop clinic develop research develop cost amortis small number children affect disord ag bracket consid develop paediatr medicin product clinic trial involv children give rise specif ethic concern children benefit special protect consid member state face problem european approach offer advantag epidemiolog public health econom point view invit commiss make propos form incent regulatori measur support measur respect clinic research develop take account ethic aspect clinic trial children ensur medicin product children medicin product market fulli adapt specif popul group take account internation acknowledg standard protect minor regard medic scientif research