Distribution and marketing of drugs in France: overview
A Q&A guide to distribution and marketing of drugs law in France.
The Q&A gives a high level overview of distribution and marketing of drugs law, including pre-conditions for distribution; licensing; wholesale distribution; marketing to consumers; marketing to professionals and engagement with patient organisations.
To compare answers across multiple jurisdictions, vist the Distribution and Marketing of Drugs Country Q&A Tool.
This Q&A is part of the global guide to Distribution and Marketing of Drugs.
Pre-conditions for distribution
Under the Code of Public Health a medicinal product can only be sold and distributed in France if it has been:
Authorised for sale (marketing authorisation (MA)).
Registered (for homeopathic products sold under the generic name).
Authorised or registered in another state in the European Economic Area
Medicines authorised in another EU jurisdiction must have an import licence or a parallel import licence to be imported in France from another Member State, unless they have an EU-wide MA.
Unauthorised medicinal products without MA can be distributed through a compassionate use programme, the provisions of which were recently modified by the law on the improvement of medicines safety (the Bertrand Law) on 29 December 2011. The medicinal product must obtain a "temporary use authorisation", from the National Security Agency of Medicines and Health Products (Agence Nationale de Sécurité de Médicament et des Produits de Santé).
There are also exceptions to the authorisation requirement for medicines which are produced at a pharmacy and which are intended for a specific patient.
The Bertrand Law also authorises the French Drug Agency to impose a new indication to an already authorised product, in the event that the new indication is already in use in practice outside its official scope of indication. This is generally challenged by pharmaceutical companies. It is known as RTU (recommandation temporaire d'utilisation). In 2014, three examples of RTUs were officially recognised by the French Drug Agency.
A "temporary use authorisation" (ATU) allows early access to new promising drugs or to old drugs that are not covered by a marketing authorisation (MA) in France, when there is an unmet need. ATU is for treatment, prevention or diagnosis (not for investigation) of a rare or serious disease, when no satisfactory alternative method is available in France. There must be adequate proof of efficacy and safety and benefit must be anticipated for the patient. The patient must not be included in a clinical trial.
There are two kinds of ATU:
Nominative ATU. The nominative ATU is only for one patient, on a named basis, on the request and responsibility of the physician.
Cohort ATU. The cohort ATU is for a group of patients, for one indication. It is applied by the pharmaceutical company which commits to submit an MA.
In 2014, 18,000 patients were treated in the framework of nominative ATUs and 12,000 in the framework of cohort ATU.
To obtain a marketing authorisation (MA) for a drug, an application for an MA must be submitted to the National Security Agency of Medicines and Health Products (ANSM).
Four different procedures exist:
Mutual recognition procedure.
Decentralised procedure, where the ANSM is competent to grant the MA.
Centralised procedure for which the application is submitted to the European Medicines Agency (EMEA).
For additional details, see Distribution and marketing of drugs in the EU: overview.
For the national procedure, an application is needed for each single pharmaceutical formulation and strength. The application must follow the specific form supplied by the ANSM. Under Article R.5121-35 of the French Code of Public Health, the ANSM has 210 days to assess the application starting from the date where a complete application is filed. A technical and scientific evaluation of the data communicated by the company is carried out by the MA Commission from the ANSM. This assessment relies on criteria of quality, efficacy and safety of the medicinal product. If the requirements for authorisation are met, an MA is granted. The authorisation may be subject to conditions.
The ANSM cannot autonomously grant a national commission of marketing authorisation (Autorisation de Mise sur le Marché) (AMM) for a drug if it has already been authorised in another member state or if an AMM request has been submitted in one or more member states.
If a drug is already authorised for sale in another European Economic Area state, the mutual recognition procedure will apply and the National Security Agency of Medicines and Health Products (ANSM) must recognise this authorisation and grant an equivalent French one.
Since 2004, there has been a specific procedure for parallel imports. This procedure relates to the import of a drug from another EU member state in order to sell it in France where there is an identical drug which has obtained a marketing authorisation (MA). The parallel importer must notify the MA owner of its intention to import and must obtain authorisation from the ANSM within 90 days from the request. Silence on the part of the ANSM is considered an implicit rejection. In practice, the procedure is longer and can last almost a full year in some cases (for example, if the ANSM asks for information related to the pharmaceutical product from another national health authority in another jurisdiction).
A marketing authorisation (MA) obtained in France gives the MA holder the right to sell the authorised drug in France. The question of whether or not the medicinal product can be distributed in another country based on the French authorisation must be answered based on that country's law as there is no specific French legislation governing this issue.
The application fees depend on the procedure. Fees for obtaining a marketing authorisation:
Decentralised procedure: EUR50,000.
Mutual recognition procedure: EUR34,000.
National procedure: EUR34,000.
Up-to-date information on fees is available on the ANSM website (www.ansm.sante.fr).
Distribution to consumers
The following different classifications are made of drugs for distribution:
Non-prescription medicinal products.
Prescription medicinal products that can be:
exclusively for hospital use; or
reserved for certain specialist physicians.
These are also drugs which are reimbursable and those which are not.
In order to be permitted to sell prescription drugs to consumers, an authorisation is required. Only open care pharmacies can obtain such an authorisation. The authorisation is granted by the Regional Health Agency (Agence régionale de santé). The pharmacy must be owned by a pharmacist who is duly registered with the French Society of Pharmacists. Hospital pharmacies can also sell specific products to patients, in particular those suffering from AIDS or rare diseases.
Lastly, in the event that there is no pharmacist in a large area, medical doctors are allowed to sell pharmaceutical products but this situation is rare (see Question 10). However in all other situations, medical practitioners cannot give drugs to patients.
Over-the-counter medicinal products can only be distributed to consumers by pharmacies.
Authorised doctors have a general authority to prescribe drugs and medicinal products to patients. Dental surgeons and midwives have limited authority to prescribe medicinal products to patients.
Under the Code of Public Health (CSP), and since the law called Loi Hôpital, patients, santé et territoires from 21 July 2009 codified in the French CSP, pharmacists can renew prescriptions of certain drugs and medicinal products, after informing the physician.
Thanks to the Ordonnance of 19 December of 2012 and a decree of 31 December 2012, French law formally allows the distance selling of drugs. However, according to ethical rules, pharmacists must:
Provide information and advice to patients.
Personally carry out their business.
Verify the authenticity of the prescription and its duration.
The internet site must be run by a pharmacy (and not just a virtual pharmacist).
Only non-prescription medicines can be sold on these websites. The website must be authorised by the Regional Health Agency and the Council of Pharmacists must be informed by the retail pharmacist who wants to create the website. Retail pharmacists based in the EU but outside France are allowed to sell medicines through websites to French patients in France.
The French Society of Pharmacists, the National Security Agency of Medicines and Health Products and the Regional Health Agency are responsible for supervising the compliance of the Code of Public Health with the distribution activities regarding consumers.
Additionally, the Directorate General for Competition, Consumer Affairs and Prevention of Fraud (Direction générale de la concurrence, de la consummation et de la répression des fraudes), the government department responsible for fair competition, also regularly supervises pharmacies and pharmaceutical companies. The authorities can request, for example:
Access to information and documents.
Access to facilities used for the distribution.
They can also issue injunctions and prohibitions they consider necessary to ensure compliance. Fines for non-compliance are also imposed, with a maximum fine of EUR30,000 (EUR150,000 for a company).
In case of non-compliance, an authorisation to distribute drugs or medicinal products to consumers can be withdrawn. Additionally, anyone who distributes medicinal products to consumers without the necessary authorisation can face criminal charges.
Illegal exercise of pharmaceutical activity is considered as a criminal offence and is punishable by two years imprisonment and a fine of EUR30,000. A pharmacist who does not comply with his or her deontological obligations can face a ban on practising.
Wholesale distribution of drugs or medicinal products is governed by French legislation. Wholesale distribution of drugs or medicinal products is permitted for companies with a wholesale trade authorisation granted by the National Security Agency of Medicines and Health Products (ANSM).
When applying for an authorisation, the pharmaceutical company must demonstrate that it has the ability to fulfil the requirements set out in the Code of Public Health, for example, that the wholesale authorisation holder must have appropriate facilities and a qualified person, who is a pharmacist in France, responsible for the safety and the quality of the medicinal products. In the last couple of years, some wholesale authorisations have been withdrawn by the ANSM, because the wholesales did not comply with French legislation.
The National Security Agency of Medicines and Health Products (ANSM) is responsible for supervising compliance with provisions regarding wholesale distribution from the Code of Public Health. The ANSM can, for example, demand access to information and documents necessary for the supervision as well as demand access to facilities used for the distribution. The ANSM can also issue injunctions and prohibitions necessary to ensure compliance. Fines for non-compliance might also be imposed.
Decisions on injunctions and prohibitions can be appealed with the Administrative Court located where the distribution facility is established. Since the Mediator case in 2011, in which it was considered that the previous healthcare agency did not verify pharmaceutical entities by being rigorous enough, the ANSM has been increasingly rigorous in its control of pharmaceutical companies.
Some wholesalers, the authorisations of which were withdrawn because they did not comply with the national mandatory law governing pharmaceutical wholesalers, brought the case before the court, but without success.
The French Drug Agency can also order injunctions against pharmaceutical wholesalers, which are published on the French Drug Agency website. The company must comply with the injunction. If not, the authorisation can be withdrawn.
Almost 50 injunctions have already been issued in 2014 and half of 2015.
In case of non-compliance, the wholesale trade authorisation can be withdrawn (see Question 17). Additionally, anyone who pursues wholesale trade without the necessary authorisation can face criminal charges and be punished by a maximum fine of EUR30,000 (for individuals), and up to EUR150,000 for companies (legal persons), as well as two years in prison for individuals.
The French Drug Agency can also decide injunctions against pharmaceutical wholesalers, which are published on the French Drug Agency website. Almost 50 injunctions have already been issued in 2014 and half of 2015.
Drug advertising is only possible for drugs which are authorised for sale in France.
All advertising must comply with the provisions of the marketing authorisation and the therapy guidelines recommended by the French Health Authority (Haute Authorité de Santé). It must present the drug objectively and encourage proper use. It must not be misleading and must not adversely impact the protection of public health.
Further to this basic provision, the Code of Public Health also provides detailed rules on drug advertising based on whether the advertising is destined for professionals or the general public.
Limits to marketing activities
The National Security Agency of Medicines and Health Products (ANSM) and the National Agency for the Safety of Health Products) (Agence française de sécurité sanitaire des produits de santé) before the setting up of the ANSM, have always been very rigorous in their control of advertising and have regularly to prohibited specific advertisements.
Advertising of prescription drugs must not be aimed towards the general public, with the exception of campaigns for vaccination against human infectious diseases. Since the new law on medicinal products on 29 December 2011, all advertising is subject to prior authorisation.
Additionally, the general provisions from the French Consumer Code regarding advertising, which are applicable to advertising of all kinds of products and services, including drugs, set out a general requirement that all advertising must be fair towards consumers, and must be in French. The Consumer Code also sets out specific rules on, among other things, misleading advertising, comparative advertising and special offers.
The National Security Agency of Medicines and Health Products has issued guidelines clarifying and specifying the rules governing the advertising of medicinal products for human use in France.
Although not legally binding, the guidelines are widely recognised by the pharmaceutical industry and applied by courts. Those guidelines include prohibitions on, among other things, advertisement of prescription drugs to the general public, off-label advertisement and pre-launch marketing. They also list rules with respect to for example, authorised support for advertising, misleading or incomplete information and disguised advertisements.
Marketing to consumers
There is an explicit prohibition on the advertising of prescription-only and reimbursable drugs or medicinal products to the general public, with the exception of vaccination campaigns against human infectious diseases if they are on a specific list, and cessation-smoking aids.
Additionally, the marketing authorisation or the registration must not include any prohibition or restriction due to a possible risk for public health, in particular where the drug cannot be used without the involvement of a physician for the diagnosis, commencing or monitoring of treatment (Article L.5122-6, Code of Public Health ( CSP)).
All drug advertising to the general public is controlled before its publication and an authorisation called "visa GP" must be granted by the National Security Agency of Medicines and Health Products.
There are no specific restrictions under French law regarding the kinds of marketing activities to consumers that are permitted. However, all marketing activities must comply with the restrictions outlined in the Code of Public Health and the National Security Agency guidelines.
However, correspondence which is necessary to answer a specific question on a medicinal product or information about human health is not considered as an advertisement and is not controlled.
Free samples of drugs or medicinal products that have been authorised for sale in France must only be provided to persons qualified to prescribe the product, or to pharmacists of hospital pharmacies, on request only. The sample must not be larger than the smallest pack available on the market. The sample must be similar to the medicines and must bear the words "free samples".
Special offers to consumers such as "buy-one-get-one-free" constitute promotion and are therefore not permitted regarding prescription-only medicinal products. The Code of Public Health also prohibits pharmaceutical companies from distributing medicines to patients.
Internet advertising of medicinal products is subject to the same rules as advertising in any other French media. The Code of Public Health and the National Security Agency of Medicines and Health Products (ANSM) guidelines on advertising are therefore also applicable to advertisements published on the internet or on social media.
Additionally, the ANSM has issued a Charter for Communication on the Internet by Pharmaceutical Industries on the interpretation of provisions on advertisement of medicinal products in relation to the internet.
The National Security Agency of Medicines and Health Products (ANSM) and Directorate General for Competition Consumer Affairs and Prevention of Fraud are responsible for supervising marketing activities. The ANSM can demand access to information and documents necessary forsupervision as well as demand access to facilities. The ANSM can also take action in case of non-compliance.
The ANSM can issue a prohibitive injunction subject to fines upon non-compliance. Decisions by the ANSM can be appealed before the administrative courts.
The normal sanction under the Code of Public Health (CSP) for failing to comply with the rules governing advertising is a prohibitive injunction subject to fines for non-compliance of up to EUR37,000 and two years in prison (EUR187,500 for a company).
The CSP provides for several remedies and sanctions, depending on the nature of the violation. The specific rules deal with misleading advertisements, the absence of authorisation or the distribution of free samples to consumers, which are punishable by a maximum fine of EUR30,000 (EUR150,000 for legal entities) and two years imprisonment.
Advertisement for reimbursed or prescription medicinal products is punishable by a maximum fine of EUR37,500 (EUR187,500 for legal entities). Most cases regarding pharmaceutical companies' advertising of medicinal products are handled by the National Security Agency of Medicines and Health Products.
Marketing to professionals
There are no specific restrictions under French law in respect of what kinds of marketing activities are permitted with regard to professionals. However, all marketing activity must comply with the restrictions outlined in the Code of Public Health and the National Security Agency of Medicines and Health Products Guidelines.
The Code of Public Health contains provisions called the "anti-gift law" according to which pharmaceutical companies are forbidden to make any gifts to health professionals. The new law on medicinal products from 29 December 2011 has extended this prohibition to medical students. However, the anti-gift law does not apply when:
The amount of the gift is reasonable (up to EUR60).
A contract has been signed for a clinical trial (or research activity in general).
For hospitality offered for scientific events.
Moreover, according to the French Criminal Code, any person who gives, promises, or offers any improper remuneration to an employee in respect of his services, can be held guilty of bribery.
Under the National Security Agency of Medicines and Health Products Guidelines, a number of media is authorised such as booklets, posters, agendas. Survey or observational studies are also authorised as long as they are compliant with the marketing authorisation of the product, and are scientifically useful.
There are no specific rules on the number of times professionals might be targeted by sales representatives. However, the Economic Committee for Medicinal Products (Comité Economique des Produits de Santé) (CEPS) has published a Charter containing detailed rules regarding how such contact might be made. In practice, the infringement of the Charter means that CEPS will reduce the medicine's price.
Legislation regarding sales representatives' visits was modified in 2011 by the Bertrand Law in order to further control this practice. The Bertrand Law provides that such visits carried out in health institutions must be done only collectively to a number (the precise number is yet to be published) of health professionals (and not only one as was the case under previous law), under the conditions set out in an agreement concluded between each health institution and the employer of the health professional. This limitation does not deal with sales representatives' visits concerning medicinal products reserved for hospital use and those reserved for prescription-only medication. The law also provides that these mechanisms will eventually be extended to community-based medicine.
However, these new provisions concerning sales representatives' visits are not applicable as such because to date the implementing orders have not been published. Procedural requirements will be defined in a state order (arrêté). Currently, these provisions are subject to controversy because their implementation raises a certain number of questions, and it seems unlikely that they will really be applicable as they are currently. It is even more unlikely that they will be applicable to community-based medicine.
Provision of hospitality
The accepted level of benefits which might be provided to professionals is very low in France and great care must therefore be taken when hospitality is offered to health professionals. The prohibitions on bribery and under the French Criminal Code are also applicable to the offering of hospitality.
According to the anti-gift law, all hospitality offered to physicians attending meetings arranged by a company selling reimbursed medicinal products must be of such a kind and on such a scale that there is no risk that the recipients will let themselves be influenced thereby in the execution of their professional duties. The choice of location for an event must be reasonable in relation to the purpose of the event.
The body representing pharmaceutical companies (Les Entreprises du Médicament) (LEEM) and the French Society of Practitioners (Conseil national de l'ordre des médecins) (CNOM) have published some guidelines regarding the anti-gift law. Generally, companies cannot arrange or provide financial support for events held abroad unless it is justified in relation to the purpose of the event. The airplane ticket must be an economy class ticket except for travel exceeding five hours. Moreover, the choice of location for an event must be reasonable, which implies that locations that are known for leisure activities or other activities such as winter sports, motor and golf competitions, must be avoided. Hospitality agreements must be communicated to the CNOM for its opinion. Two month's notice is required for the opinion. In practice, in 2014 and 2015, the CNOM issued many unfavourable opinions concerning hospitality.
Written information must contain at least the following data:
The name of the medicinal product.
The name and address of the company responsible for the marketing of the medicinal product.
Its dosage form and, if required, its strength.
Names of its active ingredients, stated by a generic name, as well as quantities of such ingredients.
Marketing authorisation number.
A balanced statement of the product characteristics, including particulars of pharmacological group or other accepted group affiliation and indication or area of indications.
Potential drug interaction and side effects.
Required warnings or limitations applicable to the use of the medicinal product.
The status of the product and if the product is part of the social security benefits system (including possible restrictions) and the sale price.
If the advertisement contains quotations, numerical data or diagrams taken from a scientific study, or makes a comparison between drugs that are based on such a study, reference must always be made to the documentation. It must also state the date of the establishment or revision of the advertisement material. The information provided must be correct, up-to-date, verifiable and as detailed as possible in order for the recipient to get an opinion of the product's value for treatment. The National Security Agency of Medicines and Health Products applies rigorous controls of advertising.
The National Security Agency of Medicines and Health Products Guidelines provide for rules on comparisons with other medicinal products. They state that comparisons between effects, active ingredients and costs of treatment, among others, of drugs must be objectively and truthfully presented and give a fair overall picture of the compared products. This means among other things that the medicinal products must:
Have the same properties.
Be clearly specified (including the complete name and generic designation, if necessary).
The comparison must also give a comprehensive and fair picture of the properties compared, with efficacy and safety criteria.
For drug marketing, the Code of Public Health (CSP) prohibits offering or promising a bonus or financial or material advantages to persons authorised to prescribe or dispense them, except where this is of negligible value.
Such arrangements can in certain circumstances have competition law implications, and there are also restrictions regarding discounts in respect of medicinal products included in the national reimbursement scheme.
In detail, the French Code of Social Security provides that a 2.5% decrease is allowed to pharmacists for prescription drugs and 40 per cent for generic products, since the law of 23 December 2013 and Order of 22 August 2014.
According to the CSP, free samples of medicinal products that have been authorised for sale in France can only be provided to persons qualified to prescribe the product, or to pharmacists of hospital pharmacies, on their request.
The sample can only be supplied during the first two years after the product is marketed and in response to a written request, which has been signed and dated. The request must be kept and filed by the company. The company must also carefully check that the person sending the request is authorised to prescribe or dispense medicinal products.
Only one packet of the smallest size must normally be supplied on each occasion and the number of samples of each product each year to the same recipient must be limited. The implementation decree of the Bertrand Law states four products a year per doctor. The sample must be marked with "free sample". It is not permitted to distribute free samples of medicinal products listed as narcotics by the National Security Agency of Medicines and Health Products.
Sponsorship of professionals
Financial support to the healthcare sector, although not prohibited, is a sensitive issue in France, particularly since the publication of the new law on medicinal products, and great care must be taken in order not to challenge the integrity and independent relationship between the pharmaceutical industry and the medicinal profession. The offer to sponsor must never be addressed to individual physicians, but must always be targeted to and approved by the employer or principal concerned. Any sponsoring must be clearly documented in writing.
The National Security Agency of Medicines and Health Products and also the Directorate General for Competition, Consumer Affairs and Prevention of Fraud are responsible for supervising marketing activities regarding professionals. They are entitled to conduct investigations and transmit their report to the prosecutor who will decide whether a case will be brought before the court.
The French Society of Practitioners can also take action in cases of non-compliance and can order temporary suspension of physicians from practising for a period of ten years.
The court can impose a maximum fine of EUR75,000 and a temporary ten-year suspension from practising against doctors, and a fine of EUR375,000 against pharmaceutical companies. The National Security Agency of Medicines and Health Products can prohibit any advertising campaign and the Economic Committee for Medicinal Products is also allowed to fine pharmaceutical companies.
Engagement with patient organisations
There are no specific restrictions in respect of what kinds of activities are permitted. However, any activity must comply with the rules provided under the Code of Public Health (CSP). According to the CSP and guidelines published by the LEEM, agreements between a patient organisation and a pharmaceutical company must always be made in writing and be available to third parties. Financial support can only be given for special projects or activities, on the condition that the co-operation must be conducted in such a manner that the parties' independent positions in relation to each other cannot be questioned.
The pharmaceutical company must declare to the French Health Authority (HAS), before 30 June of each year, the list of patient organisations that they support and the amount of this support. The information is published by the HAS. Some pharmaceutical companies also work with patient associations through patient following programmes.
Lastly, all the links of interests between patient organisations and pharmaceutical companies must also be disclosed by the latter on a specific and public Ministry of Health website.
At the present time, the French Ministry of Health and the French Parliament are preparing a significant bill concerning the health sector. Among the main aspects, there are provisions governing class actions and access to health data owned by the French Social security. They are not supposed to impact directly the distribution and promotion of drugs.
Olivier Lantres, Partner
Professional qualifications. Legal advisor, qualified in French law; Doctor at law
Areas of practice. Pharmaceutical and healthcare law.