Brussels 'disappointed' by low take up of child medicine authorisation system

Published: 5-Oct-2012
Regulatory

Launches a public consultation about impact of the regulation


The European Commission (EC) has admitted being ‘disappointed’ by the low take-up of a special European Union (EU) Paediatric Use Marketing Authorisation (PUMA) designed to encourage the development of medicines for children.

Introduced by the EU’s paediatric regulation (EC) No 1901/2006, only one PUMA authorisation has been issued since the legislation came into force. This is despite it offering 10 years of data and market exclusivity to any new off-patent product developed exclusively for children.

In a consultation report on the performance of the regulation, the Commission added: ‘Neither industry nor academic networks have responded to this opportunity as widely as the regulation intended and aimed for. It would seem that the incentive of data and market exclusivity does not work for those products, or market opportunities are currently considered insufficient to outweigh the inherent economic risks of pharmaceutical development.’

The EC has launched a public consultation about the regulation’s impact, in which it asks for reasons why this low take-up has happened.

Among other questions asked, the Commission requests comments on articles 45 and 46 of the law, where companies are required to give to regulators data on the safety or efficacy of medicines authorised for treating children. This has enabled regulators to assess and issue guidance on whether 140 active substances should be used in paediatric medicines. It said since 2008 more than 18,000 study reports on roughly 2,200 medicinal products had been submitted ‘revealing the large amount of existing paediatric information available at company level’. This has been assessed through ‘an impressive work-sharing project.

The consultation will feed into a 2013 report. Comments should me made by 28 November to sanco-pharmaceuticals-D5@ec.europa.eu.

Meanwhile, the European Medicines Agency (EMA) has released a discussion paper on how children and young people’s views and comments could be used in its market approval assessments of paediatric medicines.

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