Cabinet Beau de Loménie
France has now incorporated into French law the European Union Directive 2011/62/UE 8 June 2011 amendingDirective 2001/83/EC on the Community code relating to medicinal products for human use, by enacting an Ordinance of 19 December 2012 supplemented by Decree No. 2012-1562 of 31 December 2012. Thus, as from 2 January 2013, owners of a pharmacy can make retail sales online of: "certain medicinal drugs that can be presented to the public via direct access". Therefore prescription drugs, veterinary drugs and any medication not freely accessible to the consumer are excluded.
Electronic Commerce in medicaments was defined by this Ordinance in Article L. 5125-33 of the French Public Health Code as "the economic activity in which the pharmacist provides or ensures retail at a distance and by electronic means and delivery to the public of medicinal products for human use and, to this end, provides health information”.
This activity is strictly regulated and the creation of a website is conditional on the physical existence of a pharmacy (Articles L 5125-34 to L 5125-41 of the French Public Health Code). The requesting pharmacist must obtain permission from the Regional Health Agency and inform the Order of Pharmacists of his intent to sell online.
The site itself must have certain minimum information on each page (contact details of the National Security Agency for Medicines and Health Products, a link to the website of the National Order of Pharmacists and the Ministry of Health, a common logo to be introduced at Community level but which is still to be created).
Any breach of these rules may result in sanctions ranging from temporary closure of the site (for a maximum of five months) up to an administrative fine, which may be accompanied by a maximum penalty of 1000 euros per day. The amount of the administrative penalty may not exceed 30% of the revenue generated by the pharmacy in the course of its "online selling" business, and is capped at one million euros.
The first online offerings obeying those regulations were supposed to take place as from March 2013, but theFrench press has already reported pharmacies offering drugs online.
In France, the sale of prescription medicines remains exclusively for pharmacies and distribution channels for medicaments are very tightly controlled. However, the French provisions are consistent with the Directive of 8 June 2011, which provides in Article 85 quater 1 that selling online is permitted "without prejudice to national laws which prohibit the offering for distance sale to the public of prescription medicines...". They are also consistent with the judgment of the Court of Justice of the European Union (ECJ) of 11 December 2003, which had admitted as a grounds for restricting the sale of medicaments on the Internet and for justifying a ban on sales in some cases, "the need to check effectively and responsibly the authenticity of prescriptions (...), and to ensure that the medication is given to the owner of the prescription".
While all the Member States of the European Union must implement the Directive into their national law, Article L. 5125-40 of the French Public Health Code (implementing Article 85 quarter a) of this Directive) should retain the attention not only of French consumers, but of any natural or legal person from a country of the Union and with the business of selling medicaments online.
This provision states that all legal or natural persons legally installed and authorized to sell products to the public in a Member State of the European Union in the context of e-commerce activity of medicaments intended for a person established in France must comply with the provisions of the State of destination, including limiting its French sales to the list of medicaments approved for sale online in that country.
A professional who wants to start selling medication online will of course have to make sure to comply with all statutory provisions relating to the creation of a website and assume responsibility for all of its contents as he shall be considered to be the publisher of this site. In addition, the Ordinance authorizes him, in the framework of dispensing medicaments to the public by electronic means, to provide health information online. He must, however, be particularly careful not to overstep that notion of information: advertising of medicines is strictly regulated in France and requires authorisation when it is directed at the general public (Article 5122-8 of the French Public Health Code).
Finally, the Ordinance of 19 December 2012 was also intended to prevent the introduction of falsified medicinal products in the legal supply chain: a falsified medicinal product is defined as any medicament containing a misrepresentation of its identity, including its packaging and labeling, its name or its composition, its source, or its history (art 5111-3 French Public Health Code).
Thus manufacturing, trading, distribution, advertising, offering for sale, sale, import and export of such medicaments will be punished by a fine and imprisonment: ranging from 375 000 to 750 000 euros fine and five to seven years of imprisonment.