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"Aesthetic medicine associations in France are lobbying for a change in the AMM regulations, to extend the list of doctors who can use botulinum toxin for aesthetic purposes in private practice."
Botulinum toxin has been used for medical purposes since 1975, but it is in the field of aesthetic medicine that botulinum toxin has seen a real revolution. In 2002, botulinum toxin, marketed under the name BOTOX, was approved by the Food and Drug Administration (FDA) for the treatment of wrinkles.
According to Montesquieu, “Freedom is the right to do what the laws allow”. When it comes to botulinum toxin regulation in Europe, freedom differs depending on the country in which the doctors are based.
Botulinium Toxin is distributed exclusively through pharmacies or approved suppliers, who deliver it directly to authorized practitioners. Because of its status as a prescription-only medication, online sales and direct delivery to the public are prohibited1. In France, eight botulinum toxin-based specialties have received marketing authorization, five of which are intended for aesthetic medicine: ALLUZIENCE, AZZALURE, BOCOUTURE, LETYBO and VISTABEL 2. Their use is reserved for professionals authorized to prescribe them, such as those specializing in plastic, reconstructive and aesthetic surgery, face and neck surgery, maxillofacial surgery, dermatology, ophthalmology and ENT, in accordance with article R.5121-80 of the French Public Health Code.
Physicians must prove that they are licensed in one of the six specialties listed. Otherwise, they are not authorized to prescribe or administer these medications and may face disciplinary and/or criminal sanctions3.
The National Medical Council (Ordre national des médecins) has reiterated this principle on numerous occasions. Firstly, in a 2021 decision, a doctor was banned from practicing medicine for one year for having performed botulinum toxin injections for aesthetic purposes “whereas such acts are reserved for doctors specializing in plastic and reconstructive surgery, maxillofacial surgery, face and neck surgery, cervico-facial surgery, dermatology and otorhinolaryngology.4”
In 2019, the National Medical Council sanctioned a doctor with a one-month ban on practice, of which fifteen days were suspended, for having promoted botulinum toxin injections for wrinkles on his website, even though he was not authorized to perform them, as these procedures are forbidden to general practitioners5.
In fact, article R.4127-1 of the French Public Health Code6 prohibits doctors from offering unjustified risks to patients.
Furthermore, if authorized doctors help unauthorized doctors to obtain it, they may be held liable for misuse of the regulations. Disciplinary and/or criminal sanctions may be required 7.
Aesthetic medicine associations in France are lobbying for a change in the AMM regulations, to extend the list of doctors who can use botulinum toxin for aesthetic purposes in private practice.
In the UK1, Belgium and Spain, regulations governing the use of botulinum toxin for aesthetic purposes are based on specific requirements concerning the competence of practitioners. According to the Summary of Product Characteristics (SPC) for medications containing botulinum toxin, treatment must be administered by “suitably qualified doctors with good experience of treatment and using appropriate equipment”.
These countries offer greater flexibility than French legislation in terms of prescribing and performing botulinum toxin-based aesthetic treatments.
In the UK, a specially-trained nurse can also inject botulinum toxin.
In Italy, only neurologists, rehabilitation doctors, orthopedists and ophthalmologists with proven experience in the use of botulinum toxin are authorized to prescribe and administer this treatment.
