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The EU’s new paediatric medicines legislation: serving children’s needs?
  1. Govin Permanand1,
  2. Elias Mossialos1,
  3. Martin McKee2
  1. 1
    LSE Health and European Observatory on Health Systems and Policies, London School of Economics and Political Science, London, UK
  2. 2
    European Centre on Health of Societies in Transition and European Observatory on Health Systems and Policies, London School of Hygiene and Tropical Medicine, London, UK
  1. Govin Permanand, LSE Health and European Observatory on Health Systems and Policies, London School of Economics and Political Science, Houghton Street, London WC2A 2AE, UK; g.permanand{at}lse.ac.uk

Abstract

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
  • legislation
  • research incentives
  • obligations

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Footnotes

  • Competing interests: None.

  • Abbreviations:
    BPCA
    Best Pharmaceuticals for Children Act
    CHMP
    Committee on Human Medicines
    EFPIA
    European Federation of Pharmaceutical Industries and Associations
    EGA
    European Generic Medicines Association
    EMEA
    European Medicines Agency
    EU
    European Union
    Eurordis
    European Organization for Rare Diseases
    FDA
    Food and Drug Administration
    MHRA
    Medicines and Healthcare products Agency
    MICE
    Medicines Investigation for the Children of Europe
    NICHD
    National Institute of Child Health and Human Development
    NIH
    National Institutes of Health
    PDCO
    Paediatric Committee
    PIP
    Paediatric Investigation Plan
    PREA
    Pediatric Research Equity Act
    PUMA
    Paediatric Use Marketing Authorisation
    SPC
    Supplementary Protection Certificate

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