Done the children forget of the medicine?

Home

Are the children forgotten them of the medicine? Such was the theme of a symposium, organized by the national union of the pharmaceutical industry October 5, 2000. Unfortunately, one can only answer positively this question.

Because the maladjusted conditionings and the medicines conceived for adults are today the common share of the majority of the young patients. From where the hope to remedy this problem while establishing an European regulation inciting the industrial to manufacture pediatric medicines.

Big difficult capsules to swallow, tablets that one must break in small pieces or must crush, it is every day that the pediatricians "must tinker" some solutions in order to allow their small patients to take care of itself/themselves. When they don't prescribe, out authorization of marketing, a medicine normally reserved to adults - with all consequences that one can imagine on the legal plan - when a complication occurs. To the total, "the three quarters of the medicines used at the children and more of 90% of those that are used in the setting of a hospitalization in emergency didn't value at home, indicate Annie Wolf, responsible of the mission of the orphan and pediatric medicines to the ministry of the employment and Solidarity.

Not enough medicines against hypertension and the pain

Many medicines miss thus at the child such the anti-ulcerous, the anti-pain products, the anti-inflammatory, the general anesthetics and the anti-hypertenseurs.

If the usual antibiotics are numerous enough, the physicians taking in charge of the children complain otherwise about not to have a sufficient quantity of anti-infectious injectable. Finally, in the domain of the AIDS and the cancer, the therapeutic arsenal is not as complete as one could wish it.

Of heavy constraints for the pharmaceutical businesses

This dissatisfactory situation ensues because the children, notably quite the small, are not in anything of the adults in miniature. Because of their growth and the particularities of their metabolism, their organism doesn't often use the medicines like their eldests. The legislation imposes to the industrial therefore to achieve at home of the clinical studies by age group, for example, at the newborns, the infants, the bigger children and the teenagers. Some specific rules also impose themselves for the conditionings requiring plugs of security, of the systems of dosages miniaturized.

A market of too weak size

This legislation should protect the children. Actually, it often goes against them, even though it is of course necessary of one point of strictly medical view. The pharmaceutical laboratories manufacture without problem of the vaccines or medicines planned for frequent pediatric affections as the ENT infections. But the development of pediatric medicines imposes exceptional constraints: numerous studies must be done at sick children, sometimes against inactive product (placebo), before getting the authorization to deliver a medicine in pediatrics. It requires, besides not so easy important investments, an agreement of the father and the mother of the small patients, to get.

A call to the European ministers of Health

Can one improve this state of fact? Yes and while encouraging the industrial to develop some research on the usable medicines at the children, thanks to measures incitatives. Currently, no regulation of this type is foreseen in Europe. But, the French government hopes that the ministers of the Health of the 15 member states will vote, at the time of a meeting foreseen next December 14, a project of resolution asking the European Commission to propose a specific regulation on the pediatric medicines. Several associations of patients make pressure in this sense.

The carrot and the stick

This legislation could include the authorized constraints and the helps of economic order at a time.

Will it be inspired maybe by its American equivalent, the Pediatric rule, applied to the United States since April 1999, demanding to collect pediatric data as soon as the number of children concerned by a medicine risks to pass 50 000? While proposing the American industrial to help them to bring up their file of marketing demand, while offering them six months of exclusive rights more than the length foreseen by the patent on the adult shapes and on the shapes children of their products, this all new law, even unique to the world, already made a lot evolve the situation: about 300 files of medicines have been deposited already in some months.

2009-02-18