Paracetamol: The end of the reign of Doliprane.

The drug agency should authorize the systematic replacement of brand-name drugs containing paracetamol by their generic equivalents.

Although they have been marketed in France for about thirty years, Doliprane, Dafalgan, and other Efferalgan cannot be replaced by generic paracetamol in pharmacies. An exception in the French drug landscape should soon end at the request of the competition authority.

In France, pharmacists are authorized to replace "originator" drugs (original form) with a generic equivalent as soon as they appear in a directory drawn up by the national drug safety agency (ANSM), which is regularly updated. This practice aims to reduce health insurance expenses, as generics are often less expensive than branded products. Once the registration has been recorded in the Official Journal, the pharmacist can proceed with the substitution without asking for the patient's authorization. If the latter opposes it, he cannot benefit from the third-party payment and must advance the part reimbursed by Social Security. Only the words "non-substitutable," written by hand by the doctor on the prescription, allow this rule to be avoided.

Sales Champions

The ANSM confirmed Tuesday to Le Figaro to launch the procedure for registering paracetamol-based specialties in the generic directory in early December. This applies to 500 mg and 1000 mg tablets and capsules, but not syrups or suppositories. The initiative responds to a request from the Competition Authority, which was surprised in July by the different treatment of paracetamol, "while the patents of these specialties have nevertheless fallen into the public domain for a long time," we read. in the report. The authority also stressed that "paracetamol is legally substituted everywhere in Europe, except for France."

The lack of systematic substitution of these products is all the more surprising given that paracetamol specialties are the best-selling drugs in France. Doliprane, produced by the Sanofi laboratory and representing half of the market, is the 5th most reimbursed drug by Health Insurance, for a total cost of 276 million euros in 2012, up 20% compared to the previous year. The other major player in the market is the Bristol Myers Squibb laboratory, which produces Dafalgan and Efferalgan, or around 35% of paracetamol sales.

Cheaper in some European countries

An explanation emerges from reading an exchange between a senator and the Minister of Health in 2002, i.e., the same year paracetamol specialties should have entered the generic directory. Ambroise Dupont, elected from Calvados, challenged the government on the "serious consequences for the paracetamol industry" of the "directory of generic drugs." doliprane "represents 95% of the activity of the Lisieux plant, and according to the Aventis Pharma group, the inclusion of paracetamol in the generic register would lead to a significant drop in sales that could range from 30% to 50%. The estimated 40% drop in site activity could lead to the outright closure of the plant and therefore a loss of 150 direct jobs, not to mention the economic benefits for the region," summed up the elected official. The Minister replied that "all precautions [would] be taken,

The following year, paracetamol specialties were not entered in the generic register. Still, the selling price of this drug, reimbursed by Social Security and therefore controlled by the State, was lowered. However, a box of 8 tablets of 1000 mg of Doliprane or Dafalgan now costs 1.95 euros, which is higher than in other European countries.