Best Practices for the Online Sale of Medical Drugs in France

27 September 2013

Anne-Charlotte Le-Bihan, Enora Baron

The online sale of medical drugs has been officially authorised in France following an ordinance of December 19th, 2012 (the "Ordinance") and its regulatory decree of December 31, transposing Community Directive No. 2011/62/EU of June 8th, 2011.

A decree of June 20, 2013 published on June 23, 2013 specifies the operating conditions of websites selling medical drugs. This decree, which came into force on July 12, 2013 places strict rules on these sites.

The website must be operated by a registered pharmacist owning and running a physical pharmacy. The website is a virtual extension of the pharmacy. The site must be authorised by the territorially competent Director of the Regional Health Authority (Agence Régionale de Santé). The French Chamber of Pharmacists must also be informed. The e-pharmacy website must contain information establishing a link between the site and the pharmacy’s owner. The site must have hyperlinks to the websites of the French Chamber of Pharmacists and the Ministry of Health which maintain an up-to-date list of authorised pharmacy websites.

The Ordinance allows for access to the online sale of medical drugs, but only those that are not subject to mandatory medical prescription and that are sold over the counter. However, over the counter drugs represent a residual share of medical drugs that are not subject to mandatory medical prescription. This substantially limits the earning potential of an e-pharmacy.  On February 14, 2013, the French Administrative Supreme Court, in an expedited proceeding, suspended the application of this limitation to over the counter medical drugs due to the fact that the EU Directive covers all medical products that are not subject to mandatory prescription. We have to wait until the French Administrative Supreme Court rules on the substance of the Ordinance to determine the fate of this limitation.

As required by the French Competition Authority, the decree establishes that an e-pharmacy site can sell medical drugs alongside other products (cosmetics or medical devices).  A specific section must be dedicated to the sale of medical drugs.

It is recommended that the name of the pharmacist and perhaps even the pharmacy name be made part of the website’s domain. The site must not contain any hyperlinks to pharmaceutical companies’ websites. Discussion forums are prohibited. Subcontracting to a third party is prohibited except for the design and technical maintenance of the site.  However, these services cannot be provided by companies that produce health products. Paying search engines and price comparison sites for indexation is prohibited.  Information on medical drugs that may appear on the website is exhaustively enumerated by the Ordinance. Price is determined by the pharmacist; it is displayed inclusive of VAT and exclusive of delivery charges

Upon the first order, the patient must fill out a questionnaire. The site must suggest that the questionnaire be updated whenever a new order is placed. The site must provide interactive communication between pharmacists and patients (e-mails or instant messaging). In addition, the site must have a private personal space that logs patients’ orders and their interactions with their pharmacist.

The decree establishes maximum recommended delivery amounts in order to prevent overmedication. Similarly, no minimum order can be imposed. Given the specificity of health products, patients have no withdrawal right. The lack of the withdrawal right must be clear and legible to the patients before the confirmation of their order.

Conclusion. The implementation of medical drug online sales has not been without tribulations. France has caught up with its European counterparts, which, for the most part, have already accepted the online sale of medical drugs not subject to a mandatory prescription.