EFHG Congress: EU Regulation on Paediatric Medicines Brings More Safety

10. Oktober 2006, 00:00

An international panel of experts at the 9th European Health Forum Gastein (EHFG) in Bad Hofgastein assessed the new...

An international panel of experts at the 9th European Health Forum Gastein (EHFG) in Bad Hofgastein assessed the new EU Regulation on Paediatric Medicines extremely positively. However, the panel also stressed that much more needs to be done to achieve the overall goal of making standards of safety and effectiveness equivalent to those for adult medications.

To summarize, Peter Stephens of IMS Health, a leading provider of business intelligence and strategic support for the pharmaceutical and healthcare industries, said that “the regulation is a significant development in children’s medicines but it is simply a starting point. We need to ensure that the incentives to manufacturers actually work in practice, we need to develop effective tools for paediatric drug safety and it is essential that there is collaboration between all parties if medicines are to be prescribed, dispensed and administered without error.” 

According to the experts at the EHFG, the EU’s largest congress on health policy, the main challenges for improvement of paediatric medicines are:

  • The areas of competency of the Paediatric Use Marketing Authorisation (PUMA) need to be clarified if the financial opportunities are to outweigh the financial risks;

  • Further work on the coordination of research is essential if the potential of cross country studies is to be realised;

  • Longitudinal studies are particularly essential to the safe use of drugs and this in turn means greater use of computerisation in health care systems;

  • Consistency in interpretation of the Data Protection Directive across member states is essential if sufficient information is to be gathered on adverse drug reactions;

  • A practical approach needs to be found to ensure that there is a common understanding between patients, researchers, policy makers and health care professionals concerning the vital need for research and the appropriate management of disease;

  • This information needs to be tailored in particular to the needs of the patient and should harness the power of the media to develop trust and thus effective treatment and clinical trial recruitment;

  • Health care professionals should work together collaboratively in multidisciplinary clinical teams and this in turn requires a more structured approach to training and practice.
In cooperation with and under the responsibility of Eastbusiness, the business information service for Central and Eastern Europe

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