Patent Term Incentives to Improve Paediatric Medicines

During September 2005, the European Parliament (EP) had first reading of a proposed regulation to ensure that medicinal products for use on children are fully studied and formally approved for use in such age groups (see page 2 of our August 2005 IP Review).

The proposed system offers a fixed 6-month extension to the Supplementary Protection Certificate (SPC) of a patented medicinal product. To obtain this extension, the application for marketing approval of the medicinal product must include the results of all studies in accordance with a paediatric investigation plan (PIP). This PIP must be agreed by a Paediatric Committee within the European Medicines Agency.

The "opinion" of the EP after first reading was to support the majority of the proposed regulation. Most importantly, the EP supported the fixed 6-month extension period for the SPC. The EP also suggested amendments to the proposed regulation; many of these were aimed at shortening procedures and administrative delays and to improving transparency.

At this stage, the next legislative step is for the European Council to decide which proposed amendments to adopt and which to reject. Once the Council has reached a "common position", the regulation will be sent to the EP for a second reading. If the EP supports the proposed regulation at this stage (which is likely due to the nature of the suggested amendments), the regulation could come into force by late 2006.