Paediatric investigation plan (PIP)

The paediatric investigation plan is the research and development programme designed to generate the data needed to determine the conditions for authorising a medicinal product in the paediatric population. It was established by Regulation (EC) No 1901/2006, which entrusts its review to the Paediatric Committee of the European Medicines Agency (EMA). It is a condition for the validity of many marketing authorisation applications and, once completed, gives entitlement to rewards.

Scope of the obligation

The results of studies conducted in compliance with an agreed plan, or a decision granting a waiver or deferral, must be submitted with any application for authorisation of a medicinal product not yet authorised in the Union. The same applies to applications for a new indication, a new pharmaceutical form or a new route of administration of an authorised medicinal product, where that product is protected by a supplementary protection certificate or by a patent qualifying for such a certificate. Applications for generics, hybrids or biosimilars and bibliographic applications are exempt.

Drawing up and conducting the plan

The plan is in principle submitted no later than upon completion of the adult pharmacokinetic studies. The Paediatric Committee may grant a waiver, for example where the disease affects only adults, or a deferral of the paediatric studies so as not to delay authorisation in adults. The agreed plan may be modified during its implementation. When the marketing authorisation application is filed, the authority checks that the studies carried out comply with the plan, and the results are included in the summary of product characteristics (SmPC), even where they do not lead to a paediatric indication.

Link with rewards and litigation

Compliance with the agreed plan is the common condition for paediatric rewards, in particular the paediatric extension of the supplementary protection certificate. A statement of compliance must appear in the authorisation, and its absence or irregularity is a classic argument raised by generic manufacturers against the extension. Decisions on the plan may be subject to re-examination, then to an action before the General Court of the European Union. The Regulation also provides for financial penalties for breach of the obligations it imposes.

Key points

The paediatric investigation plan is negotiated early with the Paediatric Committee and determines both the validity of the marketing authorisation application and eligibility for rewards. Each modification of the plan should be tracked rigorously, and care taken that the statement of compliance appears in the authorisation. For a generic manufacturer, examining that statement is the first step in any challenge to a paediatric extension.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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