Pediatric extension (of an SPC)

The pediatric extension is a legal mechanism that allows the protection conferred by a Supplementary Protection Certificate (SPC), which itself extends a pharmaceutical patent, to be extended by six months. Its purpose is to encourage laboratories to conduct specific clinical studies on the pediatric population (infants, children, adolescents), in order to guarantee the safety and efficacy of medicines for these vulnerable groups.

Conditions for obtaining a Paediatric Extension

1. Paediatric Investigation Plan (PIP):
   The laboratory must have carried out the paediatric studies in accordance with the PIP approved by the European Medicines Agency (EMA).
2. Marketing Authorization (MA):
   The medicinal product must have a MA that includes paediatric data in its Summary of Product Characteristics (SPC).
3. Valid Supplementary Protection Certificate (SPC):
   The pediatric extension only applies to a medicine that already has an SPC.

Benefits of the Pediatric Extension

• Extension of profitability: It offers an additional 6 months of exclusive commercial protection, thus delaying the arrival of generics.
• R&D incentive: Encourages investment in pediatric studies, which are often costly and complex.
• Public health impact: Ensures that medicines are adapted to the specific needs of children.

Limitations

• The 6-month period is fixed and non-extendable
• The laboratory must demonstrate that all regulatory conditions have been strictly adhered to.