Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The 2017 EC Report on the Paediatric Regulation - A critical analysis of stakeholder positions ***

Sebastian Fischer (Abschlußjahr: 2018)

Summary
On 26 January 2007, the 'Paediatric Regulation' came into force in the European Union (EU). It aimed to foster research and development on paediatric medicines to increase their availability and avoid off-label use of medicines in paediatric patients. The legislator chose a double approach of incentivising and requiring pharmaceutical companies to present paediatric clinical data for new drug applications. As required by the Regulation, 10 years after its implementation a major evaluation of its effectiveness towards these aims was conducted by means of a report by the European Commission (EC) towards the European Parliament and Council. In order to prepare this report, a public consultation involving relevant stakeholder groups such as regulators, patients, healthcare professionals, industry and payers was held.
This work aims to disentangle the complicated web of interlocked by the interests of aforementioned stakeholder groups. As a basis the Commission’s final report and the preceding public consultation that provides a rich resource to analyse different viewpoints on the Paediatric Regulation. Whereas a generally positive influence of the Paediatric Regulation on the availability of medicines for children could be ascertained, several pivotal issues of paediatric legislation became obvious. For example, not all therapeutic areas and paediatric patient populations are equally well addressed by research stimulated by the Regulation. A discussion of reasons and possible solutions for these shortcomings along with a personal comment conclude this work.
Pages: 40, Annexes: pages: 58