12 September 2005: European boost for paediatric drugs



Legislation approved by the European Parliament on 7 September offers incentives for the development of much needed child-specific medicines in Europe, say experts. 

Parents have not been alone in feeling anxious when a child falls ill: physicians face difficult choices over medication, since they may be forced to prescribe a drug that has never been tested for paediatric use.

Doctors obliged to prescribe medicines for unlicensed use face the problem of dosage, given the variables of bodyweight and metabolism, and rates of absorption at different stages of child development.

Under the ruling, paediatric clinical trials will have to be considered when authorisation is sought for a new, general product. Products unlikely to be administered to children, such as drugs for Alzheimer's disease, will be exempted. 

Francoise Grossetete, the French MEP who is steering the draft through its parliamentary stages, told Chemistry World: 'Very little time will be lost in pushing through this important reform.'

She explained: 'At least 20 of the 25 EU member state governments are strongly in favour of the proposal - and industry commissioner GŁnter Verheugen accepts most of the Parliament's amendments. So I foresee enactment in 2006.'

Verheugen's proposal, published in September, 2004, echoes the US Best Medicines for Children Act 2001, which is credited with encouraging the development of 100 child-specific medicines.

New paediatric products will attract a bonus, six-month extension of patent protection, which the commissioner estimates could enhance profits by between $1 million and $11.25 million per product compared with the $5 million average cost of a trial.

The six-month extension represents a compromise, according to Grossetete. 'There was some lobbying for a 12-month extension, in line with a system adopted by Canada,' she said. 'But manufacturers recognise that we have to balance their interests against those of patients, health budgets, and the producers of generics.'

The London-based European Agency for the Evaluation of Medicinal Products (EMEA) will coordinate the new system.

A new EU programme, Medicines Investigation for the Children of Europe (MICE) will subsidise studies, particularly regarding out-of-patent medicines. Here, industry has no incentive to undertake fresh R&D. 

The Association of the British Pharmaceutical Industry (ABPI) calculates that unlicensed or 'off-label' prescribing applies to more than 90 per cent of medicines used in neonatal intensive care; 45 per cent of medicines used in general paediatric hospital wards, and 10 to 20 per cent of medicines prescribed for children by general practitioners. Arthur Rogers