The draft regulation on paediatric drugs presented
by the European Commission in autumn 2004 centres on the financial
concerns of pharmaceutical firms and on technical measures intended
to meet these concerns. It leaves the initiative entirely in the hands
of drug companies and neglects the overriding public health objective,
which is to provide every possible means of treating children better.
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The Medicines
in Europe Forum welcomes the EU initiative aimed at making appropriate
drugs available for children and their caregivers. The Forum has
closely examined the draft regulation on paediatric drugs presented
by the European Commission in autumn 2004.
The draft regulation
mentions several measures aimed at encouraging the funding of paediatric
drug development:
drug substances protected by patents or by supplementary
protection certificates: a "paediatric investigation plan"
must be submitted at the same time as the marketing application
(except for drugs that do not concern children); the data protection
is automatically extended if the plan is implemented, even if authorisation
for paediatric use is not granted;
drug substances that are no longer protected: creation of
a specific marketing authorisation for paediatric use, with major
rewards in terms of the duration of data protection.
However, as
usual for a draft proposed by the Enterprise Directorate-General
of the European Commission, the project centres on the financial
concerns of pharmaceutical firms and on technical measures intended
to meet these concerns. It leaves the initiative entirely in the
hands of drug companies and neglects the overriding public health
objective, which is to provide every possible means of treating
children better.
If the draft
regulation on paediatric drugs were to be adopted as it currently
stands, it would result in a paediatric medicines market that fails
to meet the needs of those children lacking new treatments, and
would also increase paediatric consumption of useless and risky
drugs.
The Medicines
in Europe Forum considers that the text must be refocused on the
initial public health objective, which is to improve the health
of all children in the European Union. A thorough inventory of real
needs must be conducted by an independent, publicly funded authority,
in order to orient research efforts most efficiently. Research incentives
must be available to both the public and the private sector. The
initiative must not be left simply to the goodwill of private drug
companies. The rules of the game must be clear, so as to avoid abuse
and misappropriation of incentives and funds. Rewards must be proportional
to spending on research and development of really needed drugs.
Pharmacovigilance must be reinforced in the paediatric clinical
trial setting.
©Medicines in Europe Forum January 2005
europedumedicament@free.fr
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