The European Ombudsman has recommended that the European Medicines Agency (EMA) ensures adequate transparency in its decisions regarding the Paediatric Regulation.
To ensure the protection of children's health, Regulation (EC) No 1901/2006 (the Paediatric Regulation) has been adopted in the European Union. In accordance with the Regulation, pharmaceutical companies are required to present an approved paediatric investigation plan (PIP) when applying for marketing authorisations for new medicinal products.
However, the Regulation also gives EMA the authority to grant a waiver for the requirements, either for classes of medicinal products, or product specific waivers.
The draft recommendation from the Ombudsman concerns EMA's procedures for granting such waivers.
Two pharmaceutical companies submitted a complaint over EMA's decision not to grant a product specific waiver for the complainants' medicinal product, despite granting such waivers to the competitors who marketed similar products of the same class.
The Ombudsman made a thorough examination of EMA's evaluation procedures. The Ombudsman considers that EMA in this specific case failed to ensure adequate transparency of the process through which the decision was reached, and failed to provide adequate reasons for the decisions.
In the view of the Ombudsman, it is necessary for EMA to document future assessments of all waiver applications. This should be done to ensure consistent and complete reasoning in the decisions. The Ombudsman has also recommended that EMA commits to drafting guidelines aimed at assisting the Paediatric Committee.
Furthermore, the Ombudsman recommends that EMA should disclose decisions and their annexes regarding the Paediatric Regulation.
EMA has been given a deadline until 30th September 2012 to give a reply.
The full decision is available on the Ombudsman's website, and can be found here.
About the authors:
Inga Kaasen is an attorney-at-law and partner at the Norwegian law firm Grette. She also holds a PhD. in biotechnology. She is the leader of Grette's Life Sciences team, and has extensive experience with patent disputes, pharmaceutical law, IP transactions and R&D agreements.
Håkon Austdal is an associate at the Norwegian law firm Grette. He also holds a Bachelor of Pharmacy. He is a member of Grette's Life Sciences team, working with patent disputes and pharmaceutical law.
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