Study on the economic impact of the Paediatric Regulation, including its rewards and incentives : executive summary

The Paediatric Regulation was enacted in the European Union in 2007 to encourage development of suitable medicine for children, promote high quality research, improve the information available on the use of medicines in children, and to prioritise the therapeutic needs in this group. The current study is aimed at providing a review of the economic impacts of the Regulation since it entered into force until the end of 2015. This study covers the following dimensions: Analysis of the regulatory costs to the pharmaceutical industry for meeting legal obligations Analysis of the economic value of the rewards/ incentives to the pharmaceutical industry Overall assessment of the rewards/ incentives to the pharmaceutical industry Analysis of the direct and indirect social and economic benefits Exploratory high-level cost-benefit assessment providing estimates of the broad economic impacts The regulatory costs analysis aimed to capture and assess all the costs incurred by the sponsors of paediatric clinical trials within the scope of Paediatric Investigation Plans (PIPs). Cost estimates were based on a consultation of PIP and waiver applicants by means of a survey questionnaire and follow-up interviews. The total cost of the Paediatric Regulation incurred to industry is estimated to be €2,106m per year or €16,848m for the years 2008-2015. The annual cost estimate includes €2,103m PIP-related compliance costs and €3.6m costs for waiver applications. On average, the estimated costs made in relation to in-vitro studies and animal studies and the development of a paediatric formulation are relatively lower than the costs of Phase II and Phase III paediatric clinical trials, and some of the other R&D costs incurred in relation to the PIP, such as pharmacokinetics and pharmacodynamics studies. The variation in cost is also dependent on the number of modifications to the PIP, the number of clinical studies, the number of paediatric subjects, the duration of the PIP, and therapeutic area.