New French OTC rules by end of year

29 October 2007

The French government is to provide a boost to the stagnant self-medication market in France by authorizing the sale of certain non-prescription drugs on an over-the-counter basis in pharmacies. The country's Ministry of Health will draft a regulation before the end of this year to change the public health code (CSP) for approval by the State Council. The new regime would come into effect in first quarter of next year.

The Ministry has been consulting pharmacies, drugmakers and health care organizations to work out the fine detail of the new regulatory system. However, it is understood the existing pharmacy monopoly on drug distribution will be largely left untouched. The leading pharmacy federation (FSPF) has said these self-medication products will be clearly differentiated from those parapharmacy products sold in major retail outlets including supermarkets. Pierre Leportier, the FSPF's president, warned that "the patient must understand that these are medicinal products." One of the problems raised by the planned regulation will be defining which products are included. This will have to be set out by the health care products safety agency (Afssps). Exclusions are expected to include products containing codeine. There appears to be some confusion about items such as aspirin and paracetamol, which can be supplied on a non-prescription basis but are also reimbursable in some cases by the government's sickness benefit funds (CNAM).

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