1 April 2013Jurisdiction reportsAurélia Marie

Online sale of drugs now possible

As a result, from January 2, 2013, owners of a pharmacy can make retail sales online of certain medicinal drugs. Prescription drugs, veterinary drugs and any medication not freely accessible to the consumer remain excluded.

Electronic commerce in medicines is strictly regulated and the creation of a website for selling medicinal drugs is conditional on the physical existence of a pharmacy (Articles L 5125-34 to L 5125-41 of the French Public Health Code). The pharmacist must also obtain permission from the Regional Health Agency and inform the Order of Pharmacists of his intent to sell online.

The website 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 to an administrative fine.

The first online offerings obeying those regulations were supposed to take place from March 2013, but the French press had already reported pharmacies offering drugs online.

In France, the sale of prescription medicines remains the preserve of pharmacies, and distribution channels for medicines are very tightly controlled. However, the new French provisions are consistent with the Directive of June 8, 2011, which provides that selling online is permitted “without prejudice to national laws which prohibit the offering for distance sale to the public of prescription medicines ...”.

“ELECTRONIC COMMERCE IN MEDICINES IS STRICTLY REGULATED AND THE CREATION OF A WEBSITE FOR SELLING MEDICINAL DRUGS IS CONDITIONAL ON THE PHYSICAL EXISTENCE OF A PHARMACY.”

They are also consistent with the judgment of the Court of Justice of the EU (CJEU) of December 11, 2003, which had admitted as a grounds for restricting the sale of medicines 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”.

These rules should be borne in mind not only by French consumers, but by any natural or legal person, even outside France, who is in the business of selling medicines online to France.

Actually, all legal or natural persons legally installed and authorised to sell products to the public in a member state of the EU in the context of e-commerce activity of medicines 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 medicines approved for sale online in that country.

A professional who wants to start selling medications online will also have to comply with all statutory provisions relating to the creation of a website and assume responsibility for all of its contents, as he is considered the publisher of the site. In addition, the ordinance authorises him, in the framework of dispensing medicines 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 is also intended to prevent the introduction of falsified medicinal products into the legal supply chain. A falsified medicinal product is defined as any medicine containing a misrepresentation of its identity, including its packaging and labelling, its name or its composition, its source, or its history (Article 5111-3 of the French Public Health Code).

Therefore, manufacture, trade, distribution, advertising, offering for sale, sale, import and export of such products will be punished by a fine, ranging from €375,000 to €750,000 ($488,000 to $975,000), and imprisonment of five to seven years.

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