Abstract
The EU' s Paediatric Medicines Regulation will come into effect on 26 January
2007. Its main aim is to increase the availability of properly tested and
authorised medicines for paediatric use.
Patented products will be required to be studied in the paediatric population
whenever the manufacturer applies for a marketing authorisation, whether for
initial approval or for a line extension. As a reward, they will receive a six
month extension of their supplementary patent certificate. The requirement
will be waived if the product is not suitable for paediatric use, and may be
deferred in order not to delay the approval of adult indications.
Orphan products must also comply with the paediatric study requirements. Their
reward will be a two year extension to their ten years of market exclusivity.
For off-patent products, there are incentives for voluntary studies, rather
than requirements and rewards. The Paediatric Use Marketing Authorisation will
give ten years of data exclusivity for off-patent medicines that obtain a
paediatric indication, while the EU' s Paediatric Study Fund will support
paediatric research into commercially unattractive medicines.
All paediatric trials should comply with an agreed Paediatric Investigation
Plan, which will be approved and monitored by the new Paediatric Committee to
be set up within the European Medicines Agency. Paediatric studies of patented
and orphan products that comply with the PIP will qualify for the SPC
extension even if the trial results do not support a paediatric use;
off-patent products will have to successfully develop a paediatric indication
to receive the ten years of data protection.
For the industry, the Regulation will be most advantageous for R&D-based
companies. This report calculates that cost to European healthcare systems of
delayed generic entry due to the six-month SPC extension could exceed €1
billion. Generic companies face a loss of market share, although the offpatent
incentives offer some consolation.
The Regulation was fiercely debated, with the six-month SPC extension proving
particularly controversial. It is likely that there will be calls for a
reduced extension period for blockbuster drugs when the Regulation is reviewed
six to ten years after it enters into force.
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