Better Medicines for Children … Affordable Medicines for All
GROSSETÊTE REPORT ON PAEDIATRIC MEDICINES
(PE 357.553)
Will the EP Get it Right?
Children First
Everybody wants better medicines for children. The importance of ensuring the proper uses and establishing safe doses of adult medicines for children is impossible to overstate. And when the life of a child is at stake, everyone agrees that no price is too high for an effective treatment.
On the Right Track
The European Commission's proposal on paediatric medicines is a major step in the right direction. For example, the regulation will require companies to perform studies and trials to determine which patented medicines are apt for treating children, and to establish safe and effective paediatric dosage regimes. In addition, the European Parliamentary Committee for Environment, Public Health and Consumer Protection has voted to introduce research funds to promote the development of off-patent medicines for child use, which is especially needed to ensure academic research and clinical work by hospitals.
Why pay more than necessary?
One heavily disputed part of the draft regulation is the six month market exclusivity extension for patent products. While it’s true that no price is too high to pay for a child’s health, many MEPs and EU governments have been asking themselves, “Why pay more than necessary?” Why provide six months extra market exclusivity when three or four months of extra sales would cover the €1 million to €4 million cost for paediatric trials? If maintained, this six-month extension will cost Europeans up to €2 billion per year, as higher priced pharmaceuticals will have longer market exclusivity, and access to lower priced generic products will be delayed.
3 or 4 months of extra sales will more than cover the cost of paediatric trials.
Committee Vote Needs Review
In July, after first rejecting the six-month proposal, the parliament narrowly adopted the proposed six month extension in committee, but only because MEPs failed to agree on any of the shorter alternatives. The committee also adopted amendments to reduce the notification periods of patent extensions and to reduce obligations on manufacturers to market child patent products in all countries. And the committee failed to ensure totally that companies were not rewarded twice for the same trials and studies. These amendments will need to be reviewed seriously during the September plenary.
Towards a Successful Regulation
A truly successful Regulation must provide more and better medicines for children throughout the EU. It should compensate manufacturers fairly. And it must maintain reasonable medicines prices for everyone else. The EGA is working with policy makers to adopt an effective Regulation on paediatric medicines which will indeed provide...
Better Medicines for Children and
Affordable Medicines for All.
To Get it Right ...
Adopt a more reasonable SPC/Patent Extension period than the proposed 6 months. 3 or 4 months extra sales are enough to recover investments in paediatric trials.
Adopt Amdts 89, 91, 92, 93 (3+3 months)
Maintain the Commission’s 2-year notification period for a new paediatric use instead of the 6-month period proposed in ENVI Committee.
Reject Amendment 68
Avoid granting “double awards” for a single investment.
Adopt the complete
“Non-cumulative Amendment”
Adopt Amdts 52, 75, 87
Ensure paediatric medicines are available to children in all EU Member States.
Reject Amendment 51
Further Info ...
PRESS RELEASE: 2 September 2005: PAEDIATRIC MEDICINES:
WILL THE EUROPEAN PARLIAMENT GET IT RIGHT?
PRESS RELEASE 13 July 2005: EP VOTES COSTLY PATENT EXTENSIONS, REDUCES PHARMA OBLIGATIONS TO PROVIDE CHILDREN’S MEDICINES
Background Documents and Position Papers
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