Since 2 January 2013, the e-commerce of medicinal products has been authorized in France.
This small revolution is a result of the implementation of the European Directive 2011/62/EU, of the 8 June 2011, which was transposed into French law by the Order n°2012-1427 of 19 December 2012 relating to the reinforcement of security of the medicinal product’s supply chain, the regulation of the sale of medicinal products on internet and to the fight against medicinal products fraud. It was supplemented by the decree n°2012-1562 of 31 December 2012 and the Bylaw of 20 June 2013, known as the code of good practices.
This new form of delivery is regulated by articles L.5125-33 to L.5125-41 and R.5125-70 to R.5125-74 of the French Public Health Code, and only concerns medicinal products sold over the counter (OTC products), i.e. those which are not subject to a prescription. Medicinal products subject to prescription are thus excluded.
Pharmacists have obtained their main objective: their monopoly has been conserved and the creation and exploitation of websites for the sale of medicinal products is therefore reserved for pharmacists. Indeed, such websites are considered to be the “virtual extension” of pharmacies. The physical pharmacy must have a license for the website and if it ceases its activity, its website will be shut down.
In order to guarantee the same level of quality and services as in a traditional pharmacy, the delivery of medicinal products by internet is done in accordance with the pharmacist’s duty of information and advice. From the selection of the medicinal product by the client to its delivery, the pharmacist must personally and effectively control the medicinal product’s validity and quality.
Therefore, as stated in the decision of 20 June 2013 (point n°3), before the validation of an order pharmacists must ask clients to fill in a questionnaire (age, weight, sex, any medical treatment, allergic records, pregnancy…) and offer the possibility of an interactive discussion with them. If it seems necessary, the pharmacist can refuse the delivery of the medicinal product.
Other factors, essentially concerning the maximum quantities authorized for sale, the presentation of online medicinal products, its publicity, the methods of conservation of the online data, the preparation of the orders and their delivery are also regulated by the Decision of 20 June 2013.
The website is the full responsibility of the pharmacist who is subject not only to the classic ethical and professional rules, but who also has to respect the good delivery practices enacted in the Decision.
In the eventuality that the rules cited above are not respected, the French regulatory authority, ANSM (the National Agency for the safety of Medicine and Health Products) can deliver an administrative fine, along with a daily penalty up to 2.500 euros (article L.5438-1 & 2 French Public Health Code).
Additionally, the creation of a website is subject to the authorization of the French Regional Health Agency (ARS in French). According to article L.5421-12 of the French Public Health Code, if the pharmacist creates a website against the Agency’s decision, he can risk up to two years of imprisonment and a 30.000 euros fine, which can be multiplied fivefold for legal entities (article 131-38 French Penal Code).
As soon as pharmacists receive the French Regional Health Agency’s agreement, they must inform the “Ordre National des Pharmaciens” (National Pharmacists Association), which keeps a record of the list of all the authorized websites and to which the public has access from the association’s website (www.ordre.pharmacien.fr/ecommerce/search).
Finally, if falsified medicinal products are sold (fake or falsely labelled medicinal products), article L.5438-4 of the French Public Health Code establishes that the pharmacist can be imprisoned up to 7 years, and be given a 750.000 euros fine, in addition to the fine applicable to legal entities.
One year after the start of this practice, the National Pharmacists Association listed 94 authorized websites, whilst a French investigation company (IFOP) estimated that only 4% of French people had bought medicinal products online, and that only 30% considered to do it.