EGA Press Release

Thursday, 8 September 2005

EP Vote on Paediatrics:
BETTER MEDICINES FOR CHILDREN WITH STRONGER SAFEGUARDS

Within the next few years EU pharmaceutical companies will begin developing more appropriate medicines for children following the European Parliament’s first reading vote yesterday on the proposed Regulation on Paediatric medicines.

“The importance of establishing correct uses, doses and formulations of medicines for children is impossible to overstate. This Regulation will provide a better environment with stronger safeguards against abuse than similar legislation in the United States”, says Greg Perry, Director General of the EGA.

These safeguards include the establishment of a Paediatrics Committee within the European Medicines Agency (EMEA) whose task will be to determine which medicines are of potential paediatric use and to require manufacturers to do the necessary research to develop a child formula. In addition, MEPs voted to allow 3rd party companies to take up production of a child product if an originator company discontinues it from the market.

In the off-patent sector where the paediatric need is greatest, the EP has introduced a facility for research funding. But to be effective, “This facility must be quickly and proactively integrated into the proposed 7th Framework Programme for Research”, says Greg Perry. Originator and generic pharmaceutical manufacturers could also be encouraged to develop child medicines in the off-patent sector by the promise of 10 years market exclusivity for new paediatric formulations of existing products.

In the on-patent sector, the EP voted to maintain the Commission’s proposed 6-month SPC/Patent extension as opposed to the alternative 3 to 6 month extension backed by the EGA and supported by 1/3 or MEPs. “We are disappointed by this decision as we believe our proposal was the fairest and most cost-effective form of extension”, stated Perry. On a more positive note, MEPs did pass an amendment to prevent “double awards” to industry for a single investment into paediatric research. MEPs also required the extension to be reviewed within 6 years to assess the cost implications on EU healthcare.

The EGA remains concerned, however, that an amendment passed by a tiny majority will allow originator pharmaceutical companies to wait until the final six months of an SPC to file for a paediatric extension. The EGA is also surprised that MEPs voted to remove the requirement for an on-patent child product to be marketed in all Member States to qualify for the extension, since this will reduce the availability of child medicines across the EU.

The proposal will now be sent to the Council of Ministers where it is expected to receive final approval under the UK presidency.

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