In new legislation for paediatric medicines which came into effect on 26 January 2007, the European Union (EU) has attempted to address several unresolved issues relating to children’s needs for medicines in Europe. This article reviews the legislation’s main proposals and makes some comparisons with equivalent legislation in the USA. We argue that the legislation suffers from several gaps and uncertainties in relation to the specific proposals and their intended aims. As the establishment of new legislation in this area offered the EU an opportunity to set some clear guidelines and objectives, and had the potential to go beyond the equivalent American rules, we thus see the proposals as something of a disappointment.
- European Union
- paediatric medicines policy
- research incentives
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Competing interests: None.
- Best Pharmaceuticals for Children Act
- Committee on Human Medicines
- European Federation of Pharmaceutical Industries and Associations
- European Generic Medicines Association
- European Medicines Agency
- European Union
- European Organization for Rare Diseases
- Food and Drug Administration
- Medicines and Healthcare products Agency
- Medicines Investigation for the Children of Europe
- National Institute of Child Health and Human Development
- National Institutes of Health
- Paediatric Committee
- Paediatric Investigation Plan
- Pediatric Research Equity Act
- Paediatric Use Marketing Authorisation
- Supplementary Protection Certificate