This was made possible for member countries of the European Union by a European directive in 2011 (1). This stated that member countries must allow on-line sales of medicinal products to the public, whilst allowing them to prohibit mail-order selling of medication sold on prescription, either for reasons of public health or safety.
In France, the directive became an Order on 19 December 2012 (2) which authorized the on-line sales of medicinal products.
The primary goal is to combat fraud and counterfeit medication. Across the world more than 18,000 illegal sites for on-line sales of medicinal products have been identified and shut down. 3.75 million potentially lethal medications have been seized. In France, seizures by customs have increased by 290%. This figure is a very significant increase compared to the previous statistics released in 2011 (3). In addition, according to the World Health Organization (WHO), approximately 50% of medicinal products sold on the Internet are counterfeit. The regulation of pharmaceutical on-line sales had therefore become essential in order to ensure consumer safety.
Which medicinal products can be sold?
Initially, the Order limited the sale of on-line medicinal products to the category of medication known as “medicinal medication”, in other words medicinal products sold over the counter in pharmacies. Then, in a further development, restricting on-line sales to only one category of pharmaceutical products that required no prescription was suspended by a decision of the State Council (4). This thereby widened the on-line market to include all medicinal products that could be purchased without a mandatory medical prescription. As a result, over 3,500 referenced products can now currently be sold on-line.
France: who can sell medicinal products on the Internet?
Since the sale of medicinal products on-line must comply with public health and safety requirements, this market is not open to every sales channel on the web. Only pharmacies registered in France as licensed medicinal pharmacies can sell medicinal products on-line. The same goes for the managers of mutual pharmacies or rescue services who may sell exclusively to their members. It is mandatory for the internet site to be part of a medicinal pharmacy. Any termination of the pharmacy’s medicinal activity would automatically lead to the closure of its internet site. Pharmacists are responsible for the content of the internet site that they edit and the context in which the electronic sales of medicinal products are made.
In France the ‘Conseil national de l’Ordre des pharmaciens’ (National Council of the Order of Pharmacists) maintains a list of authorized on-line pharmacies. There are currently 32 on this list as of June 24, 2013.
Under what conditions can an on-line pharmacy be opened?
Firstly, pharmacists must be authorized by the Local Health Authority to which they are affiliated. Then they must inform their local Order of Pharmacists of the launch of their internet site within the15 days following authorization. Finally, French sites that are authorized to sell on-line medicinal products must display the following compulsory elements:
- contact details for the ‘ANSM’, the French national agency for the safety of medicinal and health products.
- links to the websites of the Order of Pharmacists and the French Ministry of Health.
- the European logo to be used by all member States of the European Union which relates to the electronic sales of medicinal products that is currently being established by the European Commission.
How is the situation being monitored and controlled?
Currently, the fight against illicit sales of medicinal products on the Internet is the result of international cooperation involving powerful agencies such as the International Institute of Research against Counterfeit Medicines (IRACM), Interpol and the World Customs Organization.
The Directive stipulates (5) that monitoring and control should be ensured by member States who must take all “necessary measures” so that counterfeiters incur “penalties that are stringent, proportionate and dissuasive.”
At a national level, the major player is ‘ANSM’, the French national agency for the safety of medicinal and health products which is involved in every stage from the production to the marketing of medicines. However, the ANSM’s main role is to monitor its territory. Up to now there has been no specific French organization established for the monitoring of the medicinal market on the Internet. The fight against fraud and counterfeit medication on the Internet is the result of collaboration between the OCLAESP (a centralized office that combats environmental hazards and risks to public health), the ANSM, and the services of the police, national gendarmerie and customs.
It is now essential that monitoring organizations should be established at a national level who would be fully specialized in internet surveillance. The ANSM needs assistance in its struggle against the sale of counterfeit medicines on Internet on French soil.
The Health Minister is shortly due to publish a decree defining best practice for sales distribution by electronic means. However, on May 15 2013 the French Competition Authority expressed its concerns about this ministerial order defining best practice (6), considering that the restrictions that it contains “are not warranted by public health considerations” and that they would limit the development of the on-line sales of medicinal products in France. In particular, according to the Authority, pharmacists should be able to propose medicines and parapharmaceutical products on the same internet site. The Authority equally takes issue with the compulsory alignment of sales prices on the Internet with products sold over the counter.
What sanctions can be imposed?
Pharmacists who fail to comply with regulations could face the temporary closure of their site plus the possibility of a fine. In addition, the distribution, marketing, offer of sale, act of sale or the importing of counterfeit medicinal products is punishable with 5 years imprisonment and a 375,000€ fine (7).
Both vigilance and swift action are required in order to identify internet sites selling illicit medicines. With the development of the legal sale of medicinal products on the Internet, there is even greater risk that consumers may be misled. Moreover, a survey indicated that 80% of French people were fearful that medication purchased on the Internet would be counterfeit (8), which clearly reflects the lack of consumer confidence as regards this new distribution channel.
This confidence will only be restored if there are adequate sanctions and appropriate surveillance. If a Google search is made for “on-line pharmacy” or “medicinal products on the Internet”, it becomes clear that illegal on-line pharmacies are still operational.
In theory, any advertizing for pharmaceutical dispensaries is illegal (9). In reality it is clear that on-line pharmacies do not hesitate to use tools for on-line advertizing or referencing such as Google Adwords.
As a start point, the use of a surveillance system for Google Adwords would appear to be essential in order to improve the monitoring and control of this market.
(1) Directive 2001/62/UE of the European Parliament and Council of June 8, 2011 having modified the prevention of the introduction of counterfeit medicinal products in the authorized supply chain, Directive 2001/83/CE of November 6 2001 that instituted a Community Code concerning medicinal products for human consumption.
(2) Order 2012-1427 of December 19 2012 confirmed by Decree 2012-15 of December 31 2012 and codified via articles L5125-33 and following, and R5125-70 and following of the Public Health Code.
(3) Source: internet site of the ‘Ordre des pharmaciens’.
(4) Referred Order of the State Council, February 14 2013 no 365459.
(5) Article 85, sixth quarter.
(6) Opinion no. 13-A-12 of 10 April 2013 on a draft resolution regarding good practice in the dispensation of medicinal products by electronic means published on May 15, 2013.
(7) Dispositions made by Order on December 19 2012 enforced by articles L5125-39 and L5421-13 of the Public Health Code.
(8) Survey by the ‘Pasteur Mutualité/Viavoice’ group on “the French and the sale of on-line medicinal products”. Sample of 1007 people, representative of the French population aged 18 and over, surveyed on February 28 and March 1 2013 by telephone.
(9) Articles L5125-31 and R5125-29 of the Public Health Code.