Children are the forgotten drug? Was the theme of a symposium, organized by the national Union of the pharmaceutical industry on October 5, 2000? Unfortunately, we cannot respond positively to this question. Because inadequate packaging and drugs designed for adults today is the common lot of the majority of the young patients. Where hope to remedy this problem by setting up a European regulation encouraging industry to pediatric medicines.
Large capsules difficult to swallow, tablets that should break into small pieces or crushed, it is every day that pediatricians should “Tinker” solutions to enable their small patients health care. When they do not prescribe off authorization on the market, a drug normally reserved for adults – with all the consequences that one can imagine legally – when a complication arises. 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 assessed home”, said Annie Wolf, responsible for the Mission of the Ministry of employment and solidarity orphans and pediatric drugs.
Not enough drugs against hypertension and pain
Many drugs are thus in children such anti-ulcer, pain, anti-inflammatory, general anesthetics products and the antihypertensive. If the usual antibiotics are quite numerous, physicians taking children complain also did not have a sufficient amount of anti-infective injection. Finally, in the field of AIDS and cancer, the therapeutic arsenal is not also complete that one would wish.
Severe constraints for pharmaceutical firms
This unsatisfactory situation stems from the fact that children, including toddlers, are really miniature adults. Their growth and the particularities of their metabolism, the body often does not use drugs in the same way as their elders. The legislation must therefore be for manufacturers to achieve their clinical studies by age, for example, in infants, infants, older children and adolescents. Specific rules are also required to packaging requiring safety plugs, assays miniaturizes… systems
A market too small
This legislation should protect children. In reality, the served often, even if it is of course necessary to a strictly medical point of view. Pharmaceutical manufacture without any problem of vaccines or drugs for common pediatric conditions such as ear infections. But exceptional constrains the development of pediatric medicines: many studies must be carried out in sick children, sometimes against the inactive product (placebo), before obtaining the authorization to issue a pediatric medicine. This requires, in addition to investment, an agreement of the father and the mother of the small patients, not so easy to obtain.
A call to European Ministers of health
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 type is planned in Europe. But, the French Government hopes that health ministers of the 15 Member States will vote, a planned meeting on 14 December, a draft resolution requesting the Commission European propose specific pediatric medicines regulation. Several associations of patients are pressure in this sense.
The carrot and the stick
This legislation could include both regulatory constraints and economic aid. Perhaps will build on its American equivalent, the Pediatric rule, applied to the United States since April 1999, require Pediatric data as soon as the number of children affected by a drug may exceed 50 000? For American industry to help get their application on the market record, giving them six months of exclusivity more than the duration prescribed by the patent on the adult forms and child forms of their products, this new Act, yet unique in the world, has already made the situation: approximately 300 cases of drugs were already filed in a few months.