French Public Health Code
In forceThe limited company called "Laboratoire Français du fractionnement et des biotechnologies" carries out research, production and marketing activities for medicinal products for human use, in particular medicinal products derived from blood, medicinal products that can be substituted for medicinal products derived from blood and health products derived from biotechnologies. The majority of its capital is held by the State, its public establishments or other companies or bodies belonging to the public sector.
Its activities relating to the manufacture of blood-derived medicinal products for the French market, derived from the fractionation of plasma, are carried out exclusively by a subsidiary, within the meaning of article L. 233-1 of the French Commercial Code, created for this purpose.
The majority of the capital of this subsidiary is held, directly or indirectly, by the State, its public establishments or other companies or bodies belonging to the public sector.
Only this subsidiary may manufacture medicinal products mentioned in article L. 5121-3 of the present code from blood or its components collected by the Etablissement Français du Sang.
This subsidiary gives priority to fractionating plasma derived from blood or its components collected by the Etablissement Français du Sang. In order to meet national needs, in particular those relating to the treatment of rare diseases, it distributes the medicinal products derived from it as a priority on French territory.
When this subsidiary manufactures blood-derived medicinal products for the French market, it does so using blood or its components collected under the conditions defined in article L. 1221-3, except when medicinal products equivalent in terms of therapeutic efficacy or safety are not available in sufficient quantities to meet health needs or when their manufacture requires the use of specific plasma that does not meet the conditions of the same article.
It may subcontract some of the stages involved in the manufacture of these medicinal products. However, medicinal products intended for the French market, manufactured by this subsidiary, are released under the control of its responsible pharmacist.
The Etablissement français du sang may not hold any direct or indirect shareholding in the public limited company "Laboratoire français du fractionnement et des biotechnologies" or in companies controlled by the latter, within the meaning of article L. 233-3 of the French Commercial Code.
