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

Research Ethics

RianaGaifulinay¹ 

关键词: unlicensed/off label drug use;    children;    US Paediatric Exclusivity Plan;    European Paediatric Regulation;    Paediatric Investigation Plan;    requirements;    incentives;    patents;    developing/transition countries;    exploitation;    cost-effectiveness;    publication bias;   

DOI  :  10.1177/174701611100700204

学科分类：医学（综合）

来源: Sage Journals

【 摘 要 】

The 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...

【 授权许可】

CC BY