Children are the forgotten drug? That was the theme of a symposium, organized by the national Union of the pharmaceutical industry on October 5, 2000. Unfortunately, it can only respond positively to this question. Because the inadequate packaging and medicines designed for adults today are the common lot of the majority of the young patients. Where hope to tackle this problem by setting up a European regulatory urging industrialists to make paediatric drugs.
Large capsules difficult to swallow, tablets to be break into small pieces or crushed, it is every day that pediatricians must “tinkering” solutions to enable their small patients to take care of. When they do not, prescribe non-authorisation for placing on the market, a drug normally reserved for adults – with all the consequences you can imagine legally – when a complication occurs. In total, “three-quarters of drugs used in children and more than 90% of those who are employed in a hospital emergency have not been evaluated home”, says Annie Wolf, responsible for the Mission of orphan and paediatric medicines to the Ministry of employment and solidarity.
Not enough drugs against hypertension and pain
Many drugs are thus missing childhood such anti-ulcer, products anti-pain, anti-inflammatory, general anesthetics, and the antihypertensive.
If the usual antibiotics are numerous enough, the doctors taking care of children complain also does not have a sufficient amount of anti-infective injection. Finally, in the field of AIDS and cancer, the therapeutic arsenal isn’t as complete as one might wish.
Of constraints for pharmaceutical companies
This unsatisfactory situation arises that children, including toddlers, are not miniature adults. Due to their growth and the peculiarities of their metabolism, their body does often not use drugs in the same way as their elders. Legislation therefore requires manufacturers to achieve in their clinical studies by age group, for example, in neonates, infants, older children and adolescents. Specific rules are also required to packaging requiring safety plugs, miniaturized assay systems…
A market too small size
This legislation should protect children. In reality, she serves often, even if it is of course necessary to a strictly medical point of view. Pharmaceutical companies produce vaccines or drugs for common pediatric conditions such as infections ORL smoothly. But the development of paediatric medicinal products requires exceptional constraints: many studies must be carried out in sick children, sometimes against product inactive (placebo), before permission to deliver a medication in Pediatrics. This requires, in addition to investments, an agreement of the father and the mother of the little patients, not so easy to get.
A call to the European Health Ministers
Can we improve this state of affairs? Yes and by encouraging industry to develop research on drug use among children, with incentives. Currently, no regulation of this kind is planned in Europe. But, the French Government hopes that health ministers of the 15 Member States will vote at a scheduled meeting on 14 December, a draft resolution requesting the Commission European to propose a specific paediatric medicines regulation. Several associations of patients are pushing in this direction.
The carrot and the stick
This legislation could include both regulatory constraints and economic aid.Perhaps will draw its American equivalent, the Pediatric rule, applied to the United States since April 1999, requiring Pediatric data as soon as the number of children involved in a drug may exceed 50,000? By offering American manufacturers to help assemble their application record of placing on the market, offering them six months of exclusivity than the period provided for by the patent on adult forms and child forms of their products, this new law, still unique in the world, already did much change in the situation : approximately 300 cases of drugs have already filed in a few months.