THEMATIC OBSERVATORY/ONLINE PHARMACIES: THE SITUATION IN FRANCE

Online Pharmacies: the legal uncertainties finally lifted

With the launch in November 2012 of two online pharmacies in France, controversy on the sale of drugs over the internet has been revived. While these internet sites are backed by existing pharmacies which guarantee the reliability of their products, given that they are subject to official French standards, there are many other websites offering products which have not been officially approved and which could potentially be illegal or hazardous.

According to the WHO, “more than 50% of drugs available for sale on the internet are believed to be counterfeits”.

On December 21st, 2012, in compliance with a European directive, an ordinance was published in the Official Journal of the French Republic. This authorizes the online sale of over-the-counter (OTC) drugs under certain conditions.

I. NOVEMBER 2012: PHARMACIES WHICH SELL MEDICINAL PRODUCTS ONLINE

Retrospective from November 2012

The online sale of parapharmaceutical products was authorized in France; in contrast, no text expressly prohibited the distribution via the Web of over-the-counter drugs with or without a prescription, i.e. prescribed and reimbursed or purchased directly for self-medication.

The doctrine acknowledged that no legal text prohibited the sale of these products online, and yet recognized that the juxtaposition of the legal texts prohibited de facto such sales.

In particular, the articles of the Code of public health imply that such sales must take place in the physical presence of both the buyer and the pharmacist, so that the latter can provide professional information and advice to the client. They also imply the definition of pharmacies as physical places.

I.1. A FIRST IN FRANCE

On the 14th of November, 2012, the pharmacy Grâce de Dieu in Caen commercialized medicinal products on its website pharma-gdd.com, where parapharmaceutical products had been available for purchase for the past year.

It is now possible to also buy over-the-counter (OTC) medicinal products from their website, as well as prescribed medicines; i.e. over 400 pharmaceutical and parapharmaceutical products.

In the case of prescribed medicines, patients can reserve the products on the pharmacy’s website, however they must come to the pharmacy in person, with their prescriptions, for delivery.

This initiative has spawned others: at the end of November 2012, the Bizet pharmacy in Villeneuve d’Ascq, near Lille, also launched online sales.

In addition to 300 brands of parapharmaceutical products, its site lasante.net sells 500 OTC drugs.

In parallel, a group of pharmacists launched an internet platform, 1001pharmacies.com which brings together twenty partner pharmacies selling their parapharmaceutical products on the internet.

I.2. ARGUMENTS IN FAVOR OF ONLINE SALES

For the pharmacists in Caen and Villeneuve d’Ascq, the online sale of drugs offers important services for both patients and pharmacists.

• Safety and advice

Online sales provide the safe delivery of drugs, offering the same quality of advice and oversight as physical pharmacies: automatic verification of quantities and possible conflicts between treatment courses. Before ordering drugs, the patient must confirm having read the instructions for use. At any time, clients can ask questions online or request to be called by a pharmacist.

The French Ministry of Social Affairs and Health has a list of online authorised pharmacies for patients.

• Combating counterfeit drugs

The French did not wait for the opening of online pharmacies to order drugs on the Internet, from abroad; however, these sales are far from safe.

• Intensification of competition

This online service is a way of reducing excessive prices set by some pharmacies.

• Access to medication

These services ensure that patients everywhere have access to medicinal products, including in areas where there are no pharmacies or doctors.

• Inevitable changes in pharmacies

Pharmacies have to adapt to new lifestyles. The online sale of drugs provides new services to patients as they can access the instructions for use of any given drug before purchasing it.

• Adapting to the European model

These online pharmacies follow the model of most European countries.

II. ARGUMENTS AGAINST

The online sale of drugs by pharmacies is highly controversial.

II.1. REACTIONS FROM PROFESSIONAL REPRESENTATIVES

The profession’s unions are unanimously against the sale of drugs on the Internet.

• Union des Syndicats de Pharmaciens d’Officine (USPO) [French pharmacists' Union]

During a meeting with the Minister of Health’s office at the end of November, 2012, the USPO requested that the ministry take a firm and rapid stance against the sale of drugs on the internet.

The union states that “health is not for sale”, and refutes the arguments of the cyber-pharmacies:

• Pharmacies are accessible in largely sufficient numbers, everywhere in France, including on holidays.

• For those who are house-bound, the Public Health Code provides for home deliveries.

• The attractiveness of buying over the Internet stems from a wish to avoid mandatory medical prescriptions and to obtain certain drugs illegally.

• Over-the-counter drug courses must last less than a week; this is incompatible with delays in the delivery of products bought on the internet. Furthermore, costs are higher because of handling and delivery charges.

• Medical counsel to asses each patient’s situation is limited if not impossible over the internet.

• More than half of the drugs being sold on the internet are counterfeit. Online pharmacies give a false sense of security, which will heighten criminal activity.

• Health authorities who speak out against excessive drug consumption in France must not favor this unnecessary and hazardous new activity.

• Public authorities, with the collaboration of pharmacists, must reinforce best practices, i.e. proper treatment courses for first recourse drugs; they must not encourage drug consumption.

• Fédération des Syndicats Pharmaceutiques de France (FSPF) [Federation of French pharmacy trade unions]

In a press release, the FSPF stated that it is: “Opposed to the legalization of drug sales on the internet, including OTC drugs. The FSPF formally requests that the Ministry of Health uphold before the proper European instances each country’s right to prohibit, for reasons of public health, the sale of any drugs by mail-order” (27 November, 2012).

The union devoted the December issue of its magazine “Le pharmacien en France” [The pharmacist in France] to the online sale of drugs by pharmacies.

• Union Nationale des Pharmacies de France (UNPF) [National trade union of French pharmacies]

The UNPF “confirms its opposition to the sale of drugs on internet, stressing pharmacists’ duty to advise clients, and heightened risks due to counterfeit medicines”.

II.2. OPINIONS AND RECOMMENDATIONS

The various organizations representing the profession did not wait for the authorization of online sales of OTC drugs under certain conditions published in the Official Journal to speak out on the matter.

• The National Council of the Order of Pharmacists

In an interview published in the Quotidien du Pharmacien [The Pharmacist's Daily] (11/22/ 2012), Mrs. Isabelle Adenot, president of the Order of pharmacists declares: “The sale of drugs on the internet imperils both regulations and laws, all drafted to protect the patient”.

• Advertising:

“Pharmacists are prohibited from encouraging people to consume drugs”. “Displaying a box on a computer screen… is it advertising or information?”

• Advice:

Advice must be provided for any delivery of medicinal products.

“How can this advice be provided if the drugs are delivered via the internet?” If the answer comes by mail, “The confidentiality requirements of pharmaceutical advice are very difficult to respect”.

• Counterfeit drugs:

Internet sales also raise the issue of counterfeit drugs. “We know that the Web is a powerful accelerator of counterfeit drug sales”.

• Labeling:

“How can internet purchasers be sure that they are in contact with an actual pharmacy and pharmacist?”. The Order of pharmacists is currently working on “defining a labeling system”.

• Agence Nationale de Sécurité des Médicaments et des produits de santé (ANSM) [The National Security Agency for medicines and health products]

“The purchase of medicines on the internet poses health risks for consumers. To this day, the sale of drugs on the internet is not possible in France under the terms of the legal framework governing the sale and the dispensing of medicines”.

• Entreprises du Médicament (LEEM) [Pharmaceutical companies]

According to the LEEM, on-line sales are prohibited in France.

Contrary to other European countries, “French pharmacies are subject to regulatory constraints in advertising. To date, however, the Order of pharmacists has considered internet advertising as showcasing. French pharmacists may have their own website as an extension of their pharmacy, but essentially for health information and exchanges”.

• National Pharmacy Academy

It proposes that “the national order of pharmacists can direct the certification of internet sites for the sale of drugs in France, and can maintain a freely accessible register, enabling the public to check the status of any given website”.

III. LEGISLATION

III.1. IN FRANCE

The online sale of medicinal products is now authorized

On December 19, 2012, the Council of Ministers adopted an ordinance on the supervision of the sale of drugs on the internet and on the fight against counterfeit drugs. This text regulates the online sale of drugs by pharmacies. This possibility is restricted to pharmacists having obtained a license to create a physical pharmacy. Online sales are the full responsibility of the pharmacist, are restricted to OTC drugs, and are subject to the rules of ethics applicable to all pharmacies.

On December 21, 2012, this ordinance was published in the Official Journal of the French Republic.

It is supplemented by Decree 2012-1562 of December 31, 2012 on the tightening of security in the drug supply chain and the control over the sale of drugs on the internet.

Conditions governing the online sale of medicines:

• Online pharmacies must be linked to a physical pharmacy,

• Online sales must be conducted by a pharmacist having obtained a license to create a physical pharmacy,

• Online pharmacies must have the approval of the Regional Health Agency (ARS),

• Online pharmacies must be declared to the order of pharmacists following ARS approval,

• Online pharmacies may only sell OTC drugs,

• Online pharmacies must respect the rules of ethics applicable to physical pharmacies.

• Online pharmacies must supply the following information and have the following characteristics:

• The ANSM contact details :

• A link to the websites of the National Order of pharmacists and the Ministry of Health,

• A Logo established at the European Community level certifying that the website meets all legal requirements,

NB. To conduct internet sales in France, foreign sites must meet all legal requirements, including the exclusive delivery of OTC drugs in France.

On February 15, 2013, the State Council decided to expand the number of drugs approved for sale on the Internet. The high court decided to suspend a section of the health code, effective on March 1, which would limit sales on the Internet to a list of 455 specialties. Decision of the State Council should open the online business in all non-prescription drugs, or about 3500 specialties.

France: Government reduces the sale of medicines online 26- 02- 13

Forced, after the decision of the State Council in mid-February to accept online trading of all non-prescription drugs, the government is drafting a code of “best practices” full of very restrictive measures . In the current version of this guide, pharmacists will be forced to charge the same price online and in their pharmacy. The medicines will be even more expensive on the internet since it will add the cost of delivery to the sales price.

Another daunting proposition for pharmacists who want to get on the Net: the requirement to have in stock in pharmacies, all products sold on the Internet. “These measures are very dissuasive” regrets Bruno Lasserre, President of the Competition Authority, which must give its opinion on the code of “best practices.”

The public body responsible for ensuring free competition and favorable sale online is launching a broad sector inquiry into the drug distribution chain.

Secure online sales

On their respective websites, the national order of pharmacists and the Ministry of Health will publish:

• The list of online pharmacies authorized by the appropriate director general of the Regional Health Agency (ARS).

• Information relating to proper legalization and the purpose of the authentication logo.

In the event of a breach of the rules established by the new legislation, the ARS may order the temporary closure of an internet site for a maximum duration of 5 months and impose an administrative fine, if necessary, accompanied by a daily penalty of 1,000 € per day maximum.

The implementation modalities relating to the electronic commerce of drugs by pharmacies have been clarified by a decree concerning in particular the framework of the sale of medicines over the Internet.

Reactions

The National Order of pharmacists quickly reacted to the authorization for pharmacists to sell OTC drugs on the internet. Isabelle Adenot, president of the Order, noted the government’s decision but stressed pharmacists’ responsibility and the risks associated with the sale of drugs on the Internet: “The permission for sale online was perhaps legally inevitable but it is inappropriate and dangerous to public health. As long as the perils are not addressed, the Order will persist in its opposition”. Finally, the Order called on all actors in the drug supply chain to make themselves heard.

The National Medical Order declared that it was a “brutal decision” with “more risks than advantages”. It emphasized in particular that “nothing can replace counsel on medications sold in a pharmacy, by pharmacists in person” and that awareness must be raised as to the major risks associated to the online sale of drugs:

• Iatrogenic risks,

• Risk of excessive drug consumption,

• No access to pharmaceutical records (non-use of the French health care card “Vitale”),

• Breach of confidentiality (use of unencrypted email messages)

• Risk of an increase in illegal pharmacies

May 15, 2013: the Competition Authority gave its verdict and urged the Minister of Health to revise the draft decree on best practices for the dispensing of drugs online.
The authority deemed that the proposed legislation contained “a vast number of prohibitions and restrictions not justified by public health considerations” and “sought to limit the development of the online sale of drugs by French pharmacists, and even dissuade them from using this sales channel”.

June 23, 2013 Publication of the decree laying down the best practices for the dispensing of drugs online.

These best practices can be summarised as follows:

Without prejudice to the ethical rules of the profession (professional secrecy, advertising, duty to advise, refusal to dispense drugs in the interest of the patient’s health), the following information is mandatory and must be easy to access on the website: name of the pharmacy and pharmacists, address of the pharmacy registered to sell, telephone and fax numbers, name and contact details of the web host, etc.

Hyperlinks to the websites of the National Order of Pharmacists and the Ministry of Health are required. They update the list of websites of authorised pharmacies and have a link to the ANSM website. However, hyperlinks to the websites of pharmaceutical companies are prohibited.

The site must have a specific section on the sale of drugs in order to distinguish these drugs from any other products sold by the pharmacist.

The site is a natural extension of the pharmacy, preventing supermarkets or platforms from creating their own sites.

- Patients should have access to a private space, called “My account”, to make purchases online and register on the website.

Discussion forums are prohibited. However, a dialogue between patient and pharmacist is required and can be located in the patient’s account space to maintain privacy.

Subcontracting all or part of the sale of drugs over the internet to a third party is prohibited, except for the design and maintenance of the site.

Seeking listing in search engines or price comparisons against payment is prohibited.

The way in which the drugs are presented must be clear and not misleading. The only information that may appear is the trade name, therapeutic indications, dosage form, the number of dose units and prices, precautions for use and photos of packaging as sold in the pharmacy.

The price shall be clear and legible, in euros including VAT, and the site must state that this does not include delivery.

- Delivery is made by the pharmacists and is their responsibility. However, patients are entitled to pick up their orders themselves.

A health questionnaire must be completed before the first order.

The conditions for hosting websites and French data protection legislation must be followed.

The maximum amounts that may be dispensed are consistent with the duration of treatment. There is no minimum quantity of purchase.

The delivery of drugs is conditional to increased security in the French public health code (home delivery of medicines).

The right of withdrawal (which must be clearly displayed) is not applicable given the specificity of drugs and to guarantee the integrity of the supply chain.

July 12, 2013
The decree of June 23rd comes into effect. All non-prescription drugs can be sold on the internet.

Now 4,000 drugs can be sold over the internet without a prescription.

On July 29, 2013, the website 1001pharmacies.com, which seeks to group pharmacies together on its website and create a platform, challenged the decree before the Council of State and especially the fact that the site is a natural extension of a physical pharmacy.

August 2013: bombshell
The Council of the Order of Pharmacists lodged a complaint against 11 e-commerce websites suspected of selling counterfeit drugs and posing as French pharmacies after recovering expired domain names, the goal being to suggest that the sites are an extension of a physical French pharmacy. One website was also copied, its address, www.viagra-pfizer-france.com, serving to deceive patients as to the origin and source of the product.

October 1 st, 2013: database of medicines on line

Since October 2013, the Ministry of Social Affairs and Health has put on line a public database of medicines: medicaments.gouv.fr. This base includes data from the national safety agency: Agence nationale de sécurité du médicament et des produits de santé (ANSM), from the High health authority: Haute autorité de santé (HAS) and from the Health insurance (CNAMTS). They give information on the French authorized pharmaceutical specialties or drugs which the end date of marketing is less than 2 years. Medicines are scrutinized.

This web site is part of the continuous march of information initiative and awareness that the Ministry launched following the first cyberpharmacies published in July 2013. The access to the base is free. This site is not only dedicated to the fight against counterfeit medicines but is also a complete tool on all the medicines. For sure the French patients will now be better informed and aware in drugs and in their misuse.

This base is supposed to evolve following requests and according to the suggestions coming from healthcare professionals or from patients themselves that the Ministry will receive.

List of authorised online pharmacies

The list of French pharmacies authorised to sell drugs on the internet is available on the Ministry of Health website.

The Ministry of Health plans to add a logo on all pages of websites selling drugs to guarantee their legitimacy. This system will be enforced in 2013.

In early September 2013, 67 online pharmacy websites were listed as authorised by the regional health authorities, with only 9 in the Paris area. On January 23rd, 2014, the number of authorized on-line pharmacies amounts to 86 (or 22% more than 5 months earlier), among which only 13 in Paris area.

III.2. IN OTHER EUROPEAN COUNTRIES

• Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts

This Directive on distance selling provides that a Member State may ban, in the general interest, the marketing on its territory of medicinal products.

• The “DocMorris” Judgment

According to the “DocMorris” Judgment (11 December, 2003) by the Court of Justice of the European Communities (ECJ), “the Member States may not prohibit the sale of non-prescription medicines on the Internet “, thus, the court notes that a Member State may prohibit the distance selling of prescription medicines. The problem with sales on the internet is that prescriptions may not be mandatory for some drugs in all countries, while being so in the country of delivery. In fact, the DocMorris Judgment does not actually bear on the general principle of selling drugs on the internet, but rather addresses the question of the cross-border sale of drugs over the internet.

As in the Delattre and Monteil Judgments of March 21, 1991, the court highlights that Community law has not been harmonized as to the rules governing sales to end consumers. It notes that a pharmacy monopoly can be justified on the grounds of protecting the lives and health of the public, and poses two criteria: account must be taken of the “real dangers which they may present to public health, and of the possible errors into which they might lead an averagely well-informed consumer.”

• The Directive 2011/62/EU of the European Parliament and of the Council of June 8, 2011 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products

This directive relating to falsified medicinal products which also provides for the sale of medicinal products via the internet was published in the Official Journal of the European Union in July, 2011.

According to this new text, “The public should be assisted in identifying websites which are legally offering medicinal products for sale at a distance to the public” (Art 25).

The directive finally states that: “Member States should be able to impose conditions justified by the protection of public health upon the retail supply of medicinal products offered for sale at a distance” (Art 24).

The Member States had eighteen months to transpose these new rules into national law, i.e. until the end of December 2012.

To conform to European legislation, France therefore had to take a stance to define the legal framework for the sale of drugs on the Internet.

This was done on 21 December with the publication in the Official Journal of the ordinance authorizing the on-line sale of OTC medicines by approved pharmacists.

• Situation in other European countries

Internet sales in Europe

Currently, European countries have their own system for the online sale of drugs. Eventually, one site will group together those websites authorised across Europe.

IV. FURTHER INFORMATION

• Medicine with optional prescription: 455 presentations in the date of the 31st January, 2013

• Free access products in alphabetical order (Meddispar – National Order of Pharmacists) in French: click here

• Produced in free access by categories and classes (Meddispar – national Order of the pharmacists) in French: click here

• Notice: the list of medicine with optional prescription is also available and regularly updated on the site of the ANSM at the following address (in French): click here

• Legislative texts

• Contentious ruling from the Council of State on the online sale of drugs
On July 17, 2013, the Council of State interim relief judge was requested to suspend the application of the provisions of the ordinance of December 19, 2012 on the tightening of security in the drug supply chain, the control over drugs on the internet and the fight against drug counterfeiting, inserting articles L. 5125-34 and L. 5125-36 into the French public health code.Information available at:click here

• Order of June 20, 2013, published in Official Journal No. 0144 of June 23, 2013 Regarding best practices for the dispensing on drugs online.

Coming into effect on July 12, 2013.

• Opinion 13-A-12 of April 10, 2013 of the Competition Authority, published May 15, 2013 Unfavourable opinion on a draft decree from the Minister of Social Affairs and Health on best practices for the dispensing of drugs online. Information available at: click here

French Public Health Code:• Article L.5125-33, created by Ordinance 2012-1427 of December 19, 2012 – art. 7
On online trading of drugs by pharmaciesInformation available at:click here

• Article R.5125-70, created by
The pharmacy’s online trading website is established or operated by pharmacists referred to in Article L. 5125-33, registered under sections A, D and E of the National Order of Pharmacists.Information available at:click here

• Ordinance No. 2012-1427 of December 19, 2012
Relative to strengthening security of the supply chain of drugs, to oversight of the sale of drugs on the internet and fighting against drug falsification.
Official Journal of the French Republic on December 21, 2012Information available at the following address: click here

• Official Journal of the European Union 7.1.2011
Text of Directive 2011/62/EU of the European Parliament and of the Council of June 8, 2011
Amending directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal productsInformation available at the following address:click here

• Judgment of the Court in the preliminary ruling in Case C-322/01
So-called “DocMorris” Judgment of 11 December, 2003
Court of justice of the European Communities (ECJ)Information available at the following address:click here

• Articles and reports

• “Risques liés à l’achat de médicaments sur Internet” [Risks related to buying medicinal products over the internet]
National Security Agency of medicines and health products (ANSM, formerly AFSSAPS)Information available at the following address:click here

• “Flou sur le net – Profitant du vide juridique, des pharmaciens se lancent dans la vente d’OTC sur Internet” [Haze on the net - Taking advantage of the legal vacuum, pharmacists begin selling OTC drugs on the internet]
12/2012
“Le pharmacien de France” ["The pharmacist of France"] magazine of the Federation of pharmaceutical Trade Unions of France (FSPF).Information available at the following address:click here

• “Internet: pas de vente de médicaments dans l’attente d’un label français” [Internet: no drug sales until there is a French label]
05/06/2011

• “La vente de médicaments en ligne sur internet” [The online sale of medicines via the internet]
01/2011Information available at the following address: click here

• Les entreprises du médicament (LEEM) [Pharmaceutical companies] Information available at the following address:click here

• “Vente de médicaments sur internet: propositions de modification du Code de la santé publique” [Sale of drugs on the internet: proposals for amendment of the Code of Public Health]
Médecine et droit 2009, No. 95 [Medicine and Law]Information available at the following address: click here

• “La vente de médicaments à partir de sites Internet” [The sale of medicines via internet sites]
11/12/2007

• National Academy of Pharmacy Information available at the following address:click here

• “La légalité de la vente en ligne de medicaments” [The legality of the online sale of drugs]
Julie Munier
2003/2004Information available at the following address: click here