Regulation and Paediatric Drug Trials: Patents, Plans, and Perverse Incentives

TitleRegulation and Paediatric Drug Trials: Patents, Plans, and Perverse Incentives
Publication TypeJournal Article
Year of Publication2011
AuthorsGaifulinay, R
JournalResearch Ethics
Date Published2011
Publication Languageeng
Keywordschildren , Cost , cost-effectiveness , developing/transition , Drug , EUROPEAN , exploitation , incentives , paediatric , PATENTS , Pediatrics , Pharmaceutical , Publication , requirements , unlicensed/off , US
AbstractThe facilitation of tight regulatory frameworks necessary to ensure that new drugs are safe and effective have yet to be effectively applied within the paediatric population. Utilization of unlicensed and off-label drugs in children results in a variety of problems ranging from inefficacy, adverse reactions and in some cases death. This ethically questionable behaviour has led the European government to legally force pharmaceutical companies to propose paediatric applications and carry out clinical studies at early stages of drug development. The new European Paediatric Regulation implemented in 2007 opens a new era of paediatric drug development and will offer the opportunity to vastly improve children's health. However, this brighter outlook for the paediatric community might encourage potentially unethical behaviour in a pharmaceutical industry that finds itself in economically unstable times.The article records the gradual evolution of the US Paediatric Exclusivity Plan and the underlying principle of the newly introduced European Paediatric Regulation. It discusses some of the potential drawbacks and detrimental consequences of implementing the new European regulation, and the prospects of avoiding these by critically evaluating the difficulties experienced by the US. 
NotesGaifulinay, Riana 1; Affiliation: 1: University College London; Source Info: Jun2011, Vol. 7 Issue 1, p51; Subject Term: PHARMACEUTICAL research; Subject Term: DRUG development; Subject Term: PEDIATRICS; Subject Term: PATENTS; Subject Term: COST effectiveness; Subject Term: PHARMACEUTICAL industry; Author-Supplied Keyword: children; Author-Supplied Keyword: cost-effectiveness; Author-Supplied Keyword: developing/transition countries; Author-Supplied Keyword: European Paediatric Regulation; Author-Supplied Keyword: exploitation; Author-Supplied Keyword: incentives; Author-Supplied Keyword: Paediatric Investigation Plan; Author-Supplied Keyword: patents; Author-Supplied Keyword: publication bias; Author-Supplied Keyword: requirements; Author-Supplied Keyword: unlicensed/off label drug use; Author-Supplied Keyword: US Paediatric Exclusivity Plan; NAICS/Industry Codes: 541710 Research and development in the physical, engineering and life sciences; NAICS/Industry Codes: 325410 Pharmaceutical and medicine manufacturing; NAICS/Industry Codes: 414510 Pharmaceuticals and pharmacy supplies merchant wholesalers; NAICS/Industry Codes: 424210 Drugs and Druggists' Sundries Merchant Wholesalers; NAICS/Industry Codes: 541110 Offices of Lawyers; NAICS/Industry Codes: 541199 All Other Legal Services; NAICS/Industry Codes: 325412 Pharmaceutical Preparation Manufacturing; NAICS/Industry Codes: 541712 Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Number of Pages: 7p; Document Type: Article