Regulation on Medicinal Products for Paediatric Use (Regulation EC No 1901/2006)

Background

Currently, more than 50% of the medicines used to treat children in Europe have not been tested or authorised for this purpose. Most medicines prescribed for children are simply reduce doses of adult medicines prescribed "off-label" by physicians. Previously, very few medicines have been developed specifically for children, principally for economic reasons. This is about to change.

Following a proposal from the Commission in September 2004, the European Parliament and the Council have reached a final agreement on a Regulation on children's medicines. The Paediatric Regulation enters into force on 26 January 2007, i.e. 30 days after publilcation in the Official Journal of the European Union.

Requirements

There will be a requirement, at the time of making a marketing authorisation application, for data on the use of the medicine in children, resulting from an agreed paediatric investigation plan ("PIP"). There will be a system of waivers from the requirement for medicines unlikely to benefit children, and a system of deferrals to ensure medicines are tested in children only when it is safe to do so and to prevent the requirements delaying the authorisation of medicines for adults.

There is an obligation to include either the results of studies on children or a decision (issued by the European Medicines Evaluation Agency (EMEA)) on a waiver or on a deferral in applications for marketing authorisation. This is required for the validation of new applications for marketing suthorisation. This obligation commences 18 months after entry into force of the Paediatric Regulation, i.e. as of 26 July 2008.

In applications for variation or extension of an existing marketing authorisation concerning a new indication, pharmaceutical form or route of administration, the same obligation commences 24 months after entry into force of the Paediatric Regulation, i.e. as of 26 January 2009. This requirement applies to authorised medicinal products which are protected by a supplementary protection certificate (SPC), or by a patent which qualifies for the grant of an SPC.

Rewards

An incentive for compliance with the requirement comes in the form of a six month extension to the SPC, whatever the outcome of the paediatric studies, if information arising from a completed PIP is incorporated into the Summary of Product Characteristics (SmPC). The extension to the SPC will apply to the entire product range having that active ingredient; it will not be limited to the paediatric use. Off-patent products and products not benefiting from an SPC will not be able to take advantage of this provision.

Orphan medicines will benefit from two years of market exclusivity in addition to the existing ten years awarded under the EU orphan regulation. Finally, a new type of marketing authorisation, the Paediatric Use Marketing Authorisation (PUMA), is brought into existence. The PUMA brings ten years of data exclusivity for peadiatric studies on off-patent products.

Limitations

An application to extend a relevant SPC must be filed not later than two years before the normal expiry of the SPC. This deadline is extended to six months before normal SPC expiry for a transitional period of five years from the implementation of the legislation.

Impact on Businesses

This new legislation will clearly have an impact on pharmaceutical companies in both the research-based and generic sectors. It is estimated that the SPC extension will allow the research-based sector to make an additional profit of 1 - 10 million per product. It is also estimated that the generic sector will benefit from the availability of PUMAs to develop exclusive paediatric formuations of off-patent medicines.

The first applications for extensions to SPCs under the Regulation are not expected before 2008/2009. However, those who advise in the area of supplementary protection certificates will obviously need to be aware of the changes before then. This is especially the case when, for example, calculating the earliest potential date of generic competition/market entry.

For further information contact:

Kirk Gallagher

DISCLAIMER: This bulletin is intended to provide information of a general nature and is provided solely for the interest of the reader. Nothing in these pages constitutes legal or other professional advice.

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