EGA Press Release

Friday, 2 September 2005

PAEDIATRIC MEDICINES:
WILL THE EUROPEAN PARLIAMENT GET IT RIGHT?

Next Wednesday, 7 September the European Parliament will vote in First Reading on an important piece of legislation designed to provide better medicines for children in the EU. In the words of Greg Perry, Director General EGA:

“The importance of establishing correct uses, doses and formulations of medicines for children is impossible to overstate. The European Commission’s proposed regulation on paediatric medicines is a significant step toward achieving this goal. However, our sector has major concerns in relation to the market exclusivity/SPC extensions for patented products and the EP report submitted to plenary fails to address them.”

The EP report sent to Plenary by the Environment Committee for vote next week has four main failings:

• It does not address the budgetary implications of the proposed 6-month SPC extension. While no price is too high to pay for a child’s health, many MEPS are still asking, “Why pay more than necessary?” Consequently, new amendments[1] reducing this proposed extension period have been submitted by MEPs for vote in Plenary. The EGA is urging MEPs to adopt these amendments as either three or four months of extra sales will more than cover the €1 million to €4 million cost for paediatric trials and will reduce the burden on national healthcare budgets. However, producers of patent medicines are fighting hard to protect the 6-month extension as it is worth more than €2 billion per year in extra sales.
• The report creates considerable new problems to market generics and for national healthcare purchasers to establish reliable budgets based on the availability of lower priced generics. This is because it introduces an amendment reducing the notification period required when applying for a paediatric extension from 2-years to a mere 6 months before expiry of the current exclusivity.[2] We are asking MEPs to reject this amendment.
• The report only partially succeeds in ensuring that manufacturers will not unfairly accumulate multiple rewards for a single investment in paediatric trials[3]. Significantly, amendments[4] addressing this weakness have been submitted to Plenary and if adopted will eradicate this major loophole in the current proposal.
• Finally, the report proposes to remove the obligation proposed by the Commission that the paediatric versions of patent products must be made available in all Member States in order to qualify for an SPC extension[5]. Removing this requirement will limit the number of countries — and indeed the number of children — that will benefit from better paediatric medicines. MEPs should reject this amendment.

Greg Perry adds, “Producers of lower-priced generic medicines are fast becoming the main suppliers of medicines in the EU. We urge MEPs to address the deficiencies in the EP Report to ensure that Europe’s children will truly benefit from better medicines and that affordable medicines will remain available to all citizens.”

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[1] Amendments 84, 89 and 91
[2] Amendment 68
[3] Amendment 52
[4] Amendment 75, 87, 88 and 90
[5] Amendment 51

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