Policy issues
*Child Health
Off Patent Medicines for Children
Since most medicines used to treat the children of Europe have not been tested and are not authorised for use in children: the health and therefore quality of life of the children of Europe may suffer from a lack of testing and authorisation of medicines for their use. A study programme to develop and test off patent medicines for children in new formulations is now part of the Seventh Framework Programme. It is based upon a list of paediatric priorities for off patent products devoid of commercial interest, drawn up by a group of experts in paediatrics at the European Medicines' Agency (EMA), the Paediatric Committee (PDCO), for which studies would have to be publicly funded. Priority issues include the clinical seriousness and absence of therapeutic authorised alternatives, taking into particular account the need for neonatal treatment, where such needs are most acute. Another factor is a demonstration of therapeutic interest from published reviews, especially from prior clinical trials in children of pharmacokinetics data, efficacy or safety. Funded projects are expected to seek a Paediatric Use Marketing Authorisation (PUMA) as part of the project work plan. In view of numerous advantageous services offered at a substantial discount by the European Medicines' Agency (EMA), the topic is of particular interest to SMEs, from whom most successful projects originate.
Adverse Drug Reaction Research
Emerging issues in drug safety demonstrate the need for largeŽscale studies to capture somewhat rare but nevertheless potentially lifeŽthreatening events that may be associated with serious or unpredictable long-term effects. These may only emerge when a product or class of products has been on the market for some time and where different standŽalone databases and other similar resources exist in several centres that contain the necessary data on both exposure and medical outcomes. Such issues are a matter of grave public concern and funded project(s) generate new knowledge on potentially life threatening drug adverse events that affect different body systems. The results of this research allows for evidence-based regulatory and treatment decisions to be made.
FP6
ANGIOSTOP: Novel Anti-angiogenic Treatment for Cancer, Arthritis and Ocular Neovascularization based on Inhibition of Placental Growth Factor (PlGF)
BMC: Bispecific Monoclonal Antibody Technology Concept
DEZNIT: Design of zinc metalloenzyme targeted drugs using an Integrated Technology approach
DIALOK: Development of Innovative Assays and Locally acting therapies aiming at critical Kinases in hepatic and renal fibrosis
EUMAPP: European Union Microdose AMS Partnership Programme
EURO-PHARMACO-GENE: Design of targeted Gene Pharmaceutics using self-assembling functional entities
GENDEP: Genome-Based Therapeutic Drugs for Depression
NANODRUGS:
PRIOMED:
PRO-KINASE:
RESPECT: Relating expectations and needs to participation and empowerment of children in clinical trials
SAGE: SME-led Antibody Glyco-Engineering
TEDDY: Task-Force in Europe for Drug Development for the Young
FP7
EPOC: European paediatric oncology off-patent medicines consortium
LOULLA AND PHILLA: Development of 6-mercaptopurine and Methotrexate oral liquid formulations for the maintenance treatment of Acute Lymphoblastic Leukemia in children
NEOOPIOID: No pain during infancy by adapting off-patent medicines
NEUROSIS: Efficacy and safety of inhaled budesonide in very preterm infants at risk for bronchopulmonary dysplasia
O3 K: Oral off-patent oncology drugs for kids
SOS: Safety of non-steroidal anti-inflammatory drugs
TINN: Evaluation of antibiotics (ciprofloxacin and fluconazole) for the treatment of infections in preterm and term neonates
Maria Helena Baptista Palhares
Iiro Eerola
Alexandru Sorin Costescu