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Paediatric R&D promise

Policy makers in the European Parliament should adopt the Commissionís proposal for legislation governing the use of medicines for children

Policy makers in the European Parliament should adopt the Commissionís proposal for legislation governing the use of medicines for children, which will help create a central role for Europeís pharmaceutical companies.

This encouragement comes from Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), who believes that Europe needs to catch up with other world regions where paediatric research has been incentivised.

ìOur children must be able to benefit from medicines tailored to their special needs. This must be achieved by restoring a strong pharmaceutical research and development presence for Europe,î he said.

Speaking of the ECís proposals to introduce a formal Regulation on Medicinal Products for Paediatric Use, he noted: ìHaving better medicines for children must be a common, high priority goal in the improvement of public health for EU authorities, Member States and society in general. Europe-based pharmaceutical companies that invest in high value-creating R&D support this long-awaited EU initiative.î

To date, medicines have been developed that help treat and/or cure diseases that afflict children, yet the technical, practical and ethical challenges of performing pharmaceutical research on children has hampered efforts.

The EC aims to stimulate paediatric R&D by introducing scientific and regulatory measures that will come with incentives for pharmaceutical companies working in and across Europe.

However, while in support of the initiative EFPIA has raised a number of concerns centring around timing issues and the interim period before such legislation can become concrete ñ ìnot before end of 2006 at the earliestî.

The Commissionís proposal will require that the results of all paediatric studies performed in compliance with an agreed investigation plan should be submitted when filing an application for marketing authorisation. Yet, EFPIA notes: ìProvisions on timing for submission of the paediatric results must not result in premature unwarranted testing in children, nor delay the availability of medicines for other populations.î

Another issue raised by EFPIA is that the expected date for the ECís proposal to come into effect must ìnot be a disincentive to conduct clinical studies on new medicines for children in Europe in the short termî.

With regard to the incentives for pharma firms to conduct paediatric R&D, EFPIA welcomes the proposed fixed-term extension of the duration of intellectual property protection, yet calls for it to be made product-specific, and hence not be curtailed by the limits of the Supplementary Protection Certificate.

Companies should also be provided with a six month fixed-term incentive ìas an absolute minimumî to undertake paediatric research, EFPIA adds.

ìThe adoption of the Commissionís proposal by the European Parliament and the European Council, and subsequently its implementation without delay by all EU-25 Member States is a key opportunity to improve childrenís health.î

30th September 2008

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