Kinderarzneimittel: EP-Ausschuss will zusätzlichen Anreiz für Forschung schaffen

"Although some results of the committee's vote are not satisfactory," to the European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the research-based pharmaceutical industry operating in Europe, "the Committee showed broad support for a balance between the obligations for pharmaceutical companies to conduct often complex, costly and lengthy paediatric research and the need to stimulate paediatric research in Europe and innovation with their support for a proven, simple and effective incentive mechanism." EFPIA also urges the Parliament and the Council to "decide, without delay on an effective paediatric R&D infrastructure in Europe for the benefit of children."

European Generic Medicines Association (EGA) says that "adopting a six-month patent/supplementary protection certificate (SPC) extension for pharmaceuticals would generate up to two billion euros each year in unnecessary additional costs to Europe’s healthcare systems. Further, "the six month notification period would create a commercially impossible situation for manufacturers who have less expensive generic products under development for marketing immediately upon SPC expiry." EGA is also concerned over the vote in favour of removing obligations on a new paediatric product to be made available in all member states in order to qualify for the reward. This will, according to EGA, allow manufacturers to sell the new child formulations only in the more lucrative markets, thereby limiting the number of countries that will benefit from the better paediatric medicines. 

The European Economic and Social Committee (EESC) "hopes the Commission will soon draw up another proposal that focuses on the demand for pharmaceuticals, rather than on supply. The objective would be to create an operational tool that facilitates and encourages data collection and dissemination on the availability and use of medicines; setting up epidemiological and prescriptive use data bases as well as establishing guidelines through the increased involvement of health professionals and patient associations, thereby simultaneously extending the application of the open method of coordination to this sector."

Professor Jose Ramet, secretary general of the Confederation of European Specialists in Paediatrics (CESP)/ European Academy of Paediatrics: "Europe desperately needs more medicines which are proven to be safe for children. The proposed regulation is a welcome step forward, but it has to tackle head-on the need for strong and effective incentives to attract more competitive research and development to Europe."