Pediatric Psychopharmacological Research in the Post EU Regulation 1901/2006 Era

Abstract

Abstract. Although the use of psychotropic medications in child and adolescent psychiatry in Germany is on the increase, most compounds are in fact prescribed "off-label" because of a lack of regulatory approval in these age groups. In 2007, the European Parliament introduced Regulation 1901/2006 concerning medicinal products in pediatric populations, with a subsequent amendment in the form of Regulation 1902Regulation /2006. The main aim of this legislation was to encourage research and clinical trials in children and adolescents, and thus promote the availability of medications with marketing authorization for these age groups. Furthermore, initiatives such as the European 7th Framework Program of the European Union now offer substantial funding for pediatric pharmacological research. At a recent Congress of the German Society for Child and Adolescent Psychiatry and Psychotherapy (DGKJP), experts from the field and the pharmaceutical industry held a symposium with lay representatives in order to discuss attitudes toward, and experience with, pediatric psychopharmacology research in Germany since 2007. Several areas of concern were identified. The present paper derives from that symposium and provides an overview of these opinions, which remain crucial to the field. A wider discussion of how to facilitate psychopharmacological research in Germany in order to optimize the treatment and welfare of children and adolescents with psychiatric disorders is now warranted. Keywords

Unmet needs in paediatric psychopharmacology: Present scenario and future perspectives

“…To foster collaboration within and outside the EU, the EMA has also created "Paediatric Research Networks" (Enpr-EMA), involving the regulators, academia, the pharmaceutical industry, and patient associations (see below). Nonetheless, the fact that only one PUMA has been granted since 2008 indicates that this regulatory context may still not provide adequate incentives to the industry for the clinical development of offpatent drugs (Schmäl et al, 2014).…”

Psychopharmakologieforschung in der Kinder- und Jugend- psychiatrie – Entwicklungen, Herausforderungen, Perspektiven

“…Seit den 1990er-Jahren wurden in den USA und Europa regulatorische Maßnahmen ergriff en, um die klinische Forschung und Entwicklung von Medikamenten für Kinder und Jugendliche (qualitativ hochwertig, ethisch) zu fördern, die Zahl der Zulassungen zu steigern, Off -Label-Verschreibungen zu verringern und damit die Qualität der medikamentösen Therapie zu verbessern. (Kölch & Plener, 2016;Persico et al, 2015;Schmäl et al, 2014;Vitiello & Davico, 2018).…”

“…In Deutschland ist darüber hinaus zu beobachten, dass sich bei inter-/nationalen klinischen Entwicklungsprozessen nur eine begrenzte Anzahl von Zentren zu Studienteilnahmen bereitfi ndet (Schmäl et al, 2014…”

From Psychopharmacological Evidence to Clinical Practice: Unmet Needs in Child & Adolescent Psychiatry – Reflections on Kölch & Plener

“…Despite the existence of a range of nonpharmacological interventions and highly effective psychopharmacological treatment options, the quality of routine health care for children and adolescents with psychiatric disorders is characterized by various unmet needs and concerns [2,3]. Treatment research has focused primarily on acute treatment, yet many disorders, such as ADHD or early-onset depression, are frequently chronic or recurrent.…”