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.

Position Statement by the Medicines in Europe Forum
On the draft regulation prepared by the European Parliament and European Council on medicines for paediatric use

Summary
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.

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