EU Paediatric regulation - (EC) No 1901/2006 entered into force on 26 Jan 2007. Its purpose was to improve the health of children in the EU by facilitating the development of safe and effective medicines making sure they are ethically researched, authorised appropriately and by improving the availability of information on the use of medicines for children. Before this regulation, many medicines authorised in Europe were not studied adequately or authorised in children.
One important change was the introduction of the Paediatric Committee (PDCO) which became responsible for the assessment of the content of Paediatric Investigation Plans (PIPs), which describe how a medicine should be studied in children, as well as waivers and deferrals. In the last 5 years, there is a steady number of PIPs agreed and request for PIP modifications analyzed, as presented in the figure below.
*Source: EMA 2019 Annual Report
There are several rewards and incentive for the development of the paediatric medicines for children in the EU:
Six months' supplementary protection certificate (SPC) extension – Medicines that were authorized in the EU with the results from the paediatric trials (according to a PIP) included in the product information are eligible for an extension of their SPC by six months. This is the case even when the studies' results are negative. SPCs are granted on the “active” patent, i.e. cannot be granted on “expired” patents. Therefore, a careful calculation on when the patent expires, when the PIP must be over as well as when all required procedures to update the SPC must be over must be performed. In 2018, 24 active substances benefited from the six-month extension. More detailed list of companies that received the SPC extension and in which countries is available in this document: https://ec.europa.eu/health/sites/health/files/files/paediatrics/2018_annual_report.pdf
For orphan medicines intended for use in children additional two years of market exclusivity is granted in addition to the existing ten-years awarded under the EU orphan regulation. In 2018, 1 (one) orphan medicinal product has benefited from a two-year extension of their respective market exclusivity.
PUMA offers automatic access to the centralized procedure, 10 years of market protection, partial fee exemption and authorisation under the same name and branding as the authorised medicine containing the same active substance, if the marketing authorisation holder is the same. As an example, 2 (two) new PUMAs were granted in 2018.
Completion of the PIP is necessary to obtain the rewards provided by the Paediatric Regulation. Information on Agency decisions on PIPs (and waivers) is made public. It is also worth mentioning that the Agency publishes the Annual report in which companies that failed to comply with the regulation are listed (the latest report is for 2018 and can be found here: https://ec.europa.eu/health/sites/health/files/files/paediatrics/2018_annual_report.pdf).
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