Medicinal product regulation and product liability in France: overview

A Q&A guide to life medicinal product regulation in France.

The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, patents, trade marks, and product liability.

For information on patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and competition law in France: overview.

To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool.

The Q&A is part of the global guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Alain Decombe and Sophie Pelé, Dechert LLP
Contents

Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

The French Public Health Code (FPHC) strictly regulates the manufacture, distribution and sale of pharmaceutical products. The Social Security Code regulates pricing and product reimbursement rates (total or partial) by the French healthcare system. "Soft law" guidelines, recommendation of therapeutic strategies, and so on, issued by the health authorities, also tend to play an increasing role in the regulation of public health in France.

Regulatory authorities

Pharmaceutical products are supervised by several health agencies, the roles and responsibilities of which should be reorganised and harmonized this year, following the adoption of a new Health Bill (Law 2016-41 of 26 January 2016 modernising the health system).

The National Agency for the Safety of Medicinal and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé) (ANSM) (http://ansm.sante.fr/)'s main areas of responsibility include:

  • Clinical trials.

  • Marketing authorisations.

  • Pharmaceutical establishment authorisations.

  • Advertising.

  • Pharmacovigilance.

  • Import and export of healthcare products.

The High health agency (Haute Autorité de santé, HAS) (www.has-sante.fr/portail/) also plays an important role in the organisation and regulation of the health system, notably through:

  • The scientific assessment of medicinal products, medical devices and procedures for price and reimbursement purposes.

  • Analysing the prescription of medicinal products and the use of medical devices or procedures and their efficiency.

  • Drafting medico economic recommendations relating to healthcare strategies.

  • Improving and supervising the quality of medical information to healthcare professionals and to the general public (the HAS is notably in charge of medical promotion activities certification).

  • Promoting healthcare best practices.

The Economic committee for health products (comité économique des produits de santé, CEPS), in the Ministry of Health, is in charge of negotiating pricing agreements with pharmaceutical companies.

 
2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

Biological medicinal products have been defined by Law no. 2007-248 of 26 February 2007. Biological products must obtain a MA granted by the European Medicines Agency (EMA) under the centralised procedure, which has exclusive jurisdiction over:

  • Biotechnological products.

  • New chemical compounds for the treatment of AIDS, cancer, neurodegenerative disorder, diabetes, auto-immune diseases and other immune dysfunctions, and viral diseases.

  • Treatment of rare diseases under Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency.

Certain provisions specifically apply to biosimilar products on a local basis. In particular, biological medicinal products do not meet the conditions for generic products, and therefore appropriate pre-clinical tests or clinical trials relating to the active ingredient or manufacturing process must be provided (Article R. 5121-28, FPHC).

Since the adoption of Law 2013-1203 of 23 December 2013, pharmacists can substitute, under certain circumstances, a biological medical product with a biosimilar product which belongs to the same biological group. In particular, the substitution must be limited to the first administration, while treated patients must not be switched from one biological product to another. However, the ANSM can revise its status report on biological and biosimilar products dated 2013 on the basis of updated scientific data. The implementation decrees of these provisions are expected in 2016.

Combination products are not subject to a specific regulation but, unlike in the US, they may be handled as variations to an existing MA, rather than treated as new pharmaceutical products.

 
3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

Medical devices and diagnostics are regulated under Articles L.5211-1 et seq. and R. 5211-1 et seq of the FPHC. Except for implantable active medical devices, they are divided into classes I, IIa, IIb and III depending on the level of risk they present for human health (Article R.5211-7, FPHC) in accordance with the classification rules laid down in a Decree dated 15 March 2010. A medical device cannot be placed on the French market unless it complies with the relevant essential requirements corresponding to its classification and bears the CE marking, except for clinical trials purposes.

In France, the manufacturers of medical devices or their agents, the distributors, importers or exporters of medical devices must declare their activity to the ANSM (Article L.5211-3-1, FPHC). In addition, since Law 2011-2012 of 29 December 2011, manufacturers of class IIb, III, implantable and in-vitro diagnostic devices must provide the ANSM with a copy of the instructions leaflet when their products are placed on the market.

The medical devices' operators are further subject to a material vigilance obligation (Article L.5212-1, FPHC).

Since the adoption of Law 2011-2012 of 29 December 2011, advertising regulation for medical devices has been strengthened (Articles L.5213-1 et seq. and R.5213-1 et seq. of the FPHC) and a prior authorisation is now required for the most dangerous products, the list of which is set out in a Ministerial Order of 24 September 2012.

Under French law, a computer software or mobile medical application might qualify as a medical device if and only if it is intended by its manufacturer for therapeutic or diagnosis purposes (Article L.5211-1, FPHC).

 

Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?

The national healthcare system is in the hands of the Ministry of Health and Ministry of Economics.

As social security schemes are financed by contributions paid by employers, employees and other professionals, they are managed by professional union representatives. The healthcare budget is adopted annually by parliament under the Social Security Financing Act (SSFA). SSFA also determines the government's yearly public health objectives (for example, public campaigns addressing cancer, but also generic substitution targets).

 
5. How are the prices of medicinal products regulated?

The price of pharmaceutical products is generally freely determined by pharmaceutical companies. However, this is not the case for medicinal products reimbursed by social security schemes. The price of these products is determined after negotiations of a pricing convention between the pharmaceutical company and the CEPS. These negotiations take place on the basis of a three-year framework agreement agreed between the CEPS and the originator's trade union (LEEM). The pricing convention not only provides for applicable prices, but also contains various provisions relating to alternative payment schemes (pay for performance), rebates, and financial penalties. If no agreement can be reached between the CEPS and a given pharma company, the CEPS has the power and authority to unilaterally determine the maximum price at which a product will be reimbursed.

 
6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?

Reimbursement of pharmaceutical products by social security schemes depends on its degree of efficacy (Service Médical Rendu) which is evaluated by the Transparency Commission (Commission de la Transparence) of the Haute Autorité de Santé. The General Director of the French National Union of Health Insurance (Union Nationale des Caisses d'Assurance Maladie (UNCAM)) decides on the reimbursement rate (from 15% to 65%, or in certain circumstances 100%), which depends on the product's efficacy improvement, as compared to therapies that are already available.

Following a decree adopted on 2 October 2012, the Economic Assessment and Public Health Commission (another commission of the Haute Autorité de Santé) is required to perform medico-economic assessment of the reimbursed drugs, each time the financial impact for social security schemes is likely to be significant.

Community pharmacies are increasingly directly reimbursed by social security schemes, without patients to pay first (tiers payant) outside of a small franchise. The National Convention entered into between licensed pharmacists and French Social Security Authorities (Convention Nationale organisant les rapports entre les pharmaciens titulaires d'officine et l'assurance maladie) on 4 April 2012 (as amended from time to time, and lastly on 14 December 2015) has set up new compensation schemes for community pharmacists:

  • A dispensing fee (Honoraire de dispensation) intended to remunerate dispensation services (for example, verification of the prescription, control of risks factors and contraindication, and patient advice).

  • A performance-based remuneration (Rémunération sur objectifs) intended to promote general public health objectives (for example, development of generic medicines and chronic diseases management).

 

Clinical trials

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

In anticipation of the implementation of Regulation 536/2014, the ANSM has launched, on a voluntary basis, a pilot phase for sponsors willing to test the future new regimen and organisation of the clinical trials procedure, while still complying with Law no. 2004-806 of 9 August 2004 and Decree no. 2006-477 of 26 April 2006 which set out the rules applicable to clinical trials in France, including good clinical practices.

Authorisations

Clinical trials are subjects to a favourable opinion granted by public ethics committees (Comité de protection des personnes). In addition, clinical trials must then be authorised by the ANSM. The application for an opinion and for authorisation is filed by the sponsor of the clinical trial. The review of the application by the ANSM cannot exceed a time period of 60 days from the date of receipt. In the absence of a negative response within the 60–day period, the authorisation is deemed to be granted.

Consent

Risks to subjects of clinical trials must not be disproportionate to the potential benefit of the scientific research. Informed consent of the subject involved in the trial must be obtained prior to the inclusion, on the basis of certain information including:

  • Purpose of the trial and the procedures to be followed.

  • Foreseeable risks that could arise from the trial.

  • Reasonably expected benefits.

  • Opinion from the ethics committee.

In addition, the written consent form must be revised when new important information becomes available that may be relevant to the subject's consent, and may trigger a new opinion and authorisation, together with a new consent from concerned subjects.

Trial pre-conditions

The start of a trial is also subject to:

  • The subscription of insurance coverage to ensure adequate compensation for all damages or injuries arising from the performance of the trial.

  • If the site where the trial is expected to be performed is not usually used for the healthcare activities envisaged by the trial, a prior authorisation from the ANSM is necessary.

Procedural requirements

The sponsor must notify the ethic committee of all information concerning serious adverse drug reactions, and must report all adverse reactions to the committee and to the ANSM on a periodic basis. Within 90 days from its termination, the sponsor must notify the ANSM and the ethics committee of the effective date of termination of the trial. In addition, within one year from the termination, a final report of the research, including its results, must be sent to the ANSM.

Reform

Current regulations have been amended by Law no. 2012-300 of 5 March 2012 organising research and clinical trials involving human subjects. The purpose of the law is to simplify and clarify the legal framework of research applicable to research on human subjects, and to ensure that non-interventional studies are subject to minimum requirements.

This new law determines three categories of studies which are subject to different rules, depending on the level of risks for the subjects:

  • Interventional studies.

  • Interventional studies that do not involve drugs and only involve minor risks and constraints for the subjects.

  • Non-interventional studies.

However, implementation decrees have not been published so far and, as a result, Law 2012-300 of 5 March 2012 is not yet applicable.

 

Manufacturing

8. What is the authorisation process for manufacturing medicinal products?

Application

Prior authorisation must be obtained to manufacture pharmaceutical products. Each manufacturing site must be authorised by the ANSM and any variation of an authorised site, technical equipment or the nature of the manufactured products or process must also be authorised or notified to the ANSM, depending on the importance of the variation. For instance, changes concerning the authorisation holder (corporate name or corporate form) or transfer of the authorised establishment to a new owner must be notified to the ANSM within one month following their implementation.

Conditions

Any pharmaceutical company that manufactures pharmaceutical products must:

  • Comply with quality and safety conditions, and good manufacturing practices (GMP).

  • Have a qualified pharmacist as head pharmacist (pharmacien responsable) involved in its management.

Restrictions on foreign applicants

There are no specific restrictions on foreign applicants.

Key stages and timing

Manufacturing authorisation is subject to the opinion of the relevant professional board of pharmacists and to an audit performed by ANSM inspectors. The decision must be given within 90 days of receipt of the application.

Fee

Initial authorisation is not subject to a fee.

Period of authorisation and renewals

Manufacturing authorisation is not subject to a time limit, but periodic inspections are performed by ANSM to monitor compliance with the terms of the authorisation, which may be suspended or withdrawn in case of breach of the terms of the authorisation, FPHC requirements and GMP.

Monitoring compliance and imposing penalties

Inspectors can take and analyse samples of manufactured products, and they can be authorised by a court to seize products.

The ANSM drafts an inspection report which is subject to the pharmaceutical establishment's comments prior to finalisation.

In case of breach of a manufacturing authorisation, or non-conformity with applicable regulations, the ANSM can require the establishment to implement corrective measures. The ANSM can also suspend the authorisation until full remediation. In addition, criminal prosecutions can lead to a maximum of two years' imprisonment and a fine of EUR150,000, or EUR750,000 if a legal entity is held responsible.

 

Marketing

Authorisation and abridged procedure

9. What is the authorisation process for marketing medicinal products?

Application

Pharmaceutical products cannot be placed on the market if they have not received a prior French or centralised MA. French MAs are granted by the ANSM. Any variation to the terms of the MA must be notified to or approved by the ANSM, depending on the nature and importance of the variation. MAs become null and void if the products have not been placed on the market within three years following the date they were granted.

Placing pharmaceutical products on the market without MA is subject to criminal sanctions of:

  • Up to five years' imprisonment.

  • A fine of up to EUR375,000 for individuals.

  • A fine of up to EUR1.85 million for legal entities.

Authorisation conditions

MAs are granted on demonstration of quality, safety and efficacy. The ANSM must reject the application if either the:

  • Risk-benefit balance is not favourable.

  • Therapeutic efficacy of the product is insufficiently substantiated by the applicant.

Under Law no. 2011-2012, the ANSM is entitled to:

  • Request the MA applicant or the holder, at any time, to provide comparative studies (that is, not only studies versus placebo, but also studies versus active comparator).

  • Grant a conditional MA, subject to the conduct of additional trials.

Key stages and timing

The application must contain all required administrative details and scientific information concerning the product (that is, the information listed in the summary of the product's characteristics, in particular the qualitative and quantitative composition of the product). After a scientific assessment, the application is examined by the ANSM Commissions and in particular by a commission of independent experts in charge of risk-benefit assessment (Commission d'évaluation initiale du rapport bénéfice risque des produits de santé).

During its review of the application, the ANSM can order any inspection, survey or test it deems necessary. The authorisation must be granted by the ANSM’s GM within 210 days from receipt of the completed application, but delay is not sanctioned, and silence is deemed a refusal.

Fee

The application is subject to a progressive fee (depending on the type of procedure or variation) up to a maximum of EUR50,000. In addition, each authorised pharmaceutical product is subject to an annual tax that cannot exceed EUR26,000. The tax is calculated on the amount of sales of each pharmaceutical product in the preceding financial year, excluding export sales.

Period of authorisation and renewals

MA is granted for five years. It is then tacitly renewed for an unlimited period of time unless the ANSM considers that additional monitoring is necessary. The pharmaceutical establishment must adapt the manufacturing and safety of its authorised product to the latest scientific knowledge.

If the product has not been marketed during a three-year period, the corresponding MA is automatically withdrawn.

Monitoring compliance and imposing penalties

The ANSM can monitor compliance with MAs through periodic inspections and surveys at any pharmaceutical site. ANSM inspectors are authorised to take and analyse samples of manufactured products and can seize products upon judicial authorisation.

In case of breach of an MA, the ANSM can require justifications and corrective measures from the MA holder. The MA holder has the right to defend itself by following a written appeals procedure. If the holder does not remedy the breach or the ANSM still believes it is not complying, the ANSM can either:

  • Suspend MA for up to one year.

  • Withdraw the authorisation.

  • Impose an administrative penalty for any breach of obligations described in Article L5421-8 of FPHC.

 
10. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?

Other conditions

Pharmaceutical companies:

  • Must inform the ANSM before any decision to suspend marketing of the product(s).

  • Provide the ANSM with information on any circumstances likely to involve suspension of marketing.

In addition, for products of major therapeutic interest (the shortage of which could create a public health issue), they must prepare plans to describe in advance how they would address potential shortage issues.

Post-marketing commitments and pharmacovigilance obligations

Only authorised pharmaceutical companies (exploitant) are allowed to market and promote pharmaceutical products in the French market. The exploitant must appoint internally a local representative for pharmacovigilance who must reside in France, whose contact details must be notified to the ANSM.

In addition to providing the ANSM with a periodic report of all information concerning adverse reactions in relation to its product, under Law no. 2011-2012 and Ordinance 2013-1183:

  • The exploitant must inform the ANSM immediately of any prohibition or restriction imposed by competent authorities of any other country on the product. In case of breach of this obligation, ANSM can impose an administrative fine that cannot exceed 10% of the company's turnover (Article L. 5421-8 11, FPHC) (within the limit of EUR1 million) and a daily penalty of up to EUR2,500 for each day of delay (Article L. 5 471-1, FPHC). Further, any failure to comply with such reporting obligation can involve a criminal fine of up to EUR150,000 and up to two years' imprisonment (Article L. 5421-5, FPHC).

  • The exploitant must provide the ANSM with any new information likely to influence the evaluation of the benefits and risks of the product. If it fails to do so, ANSM can impose an administrative fine (Article L. 5421-11°, FPHC).

  • The ANSM will be able to require the exploitant to conduct post-authorisation studies on the safety and efficacy of its product.

 
11. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? What information can the applicant rely on?

The ANSM can grant MAs through an abridged procedure, whereby the applicant is exempt from providing the pharmacological, toxicological and clinical data in three main situations:

  • Generics of a pharmaceutical product authorised for no less than ten years in France or another EU member state. However, reference products benefit from protection periods (that is, data protection of eight years and marketing exclusivity for up to three additional years), where the MA application was submitted after 30 October 2005 (Directive 2004/27/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Second Amendment Directive)).

  • Pharmaceutical products making reference to the file of another pharmaceutical product already authorised, provided that:

  • the two products have the same qualitative and quantitative composition; and

  • the MA holder for the reference medicinal product consents to the use of data and information contained in the reference product's file.

  • Those with well-established medicinal use, with efficacy recognised by detailed scientific literature.

A pharmaceutical product is deemed to be the generic of another product if:

  • It has the same qualitative and quantitative composition in active substances.

  • It has the same pharmaceutical form (various oral forms are deemed having the same form).

  • Its bioequivalence with the reference medicinal product has been shown by appropriate bioavailability studies.

The period of time required for establishing "well-established medicinal use" must be at least ten years from the first use of that substance as a medicinal product in the EU (Directive 2001/83/EC on the Community code relating to medicinal products for human use (Code for Human Medicines Directive)). If reference is made to a well-established medicinal use, the documents submitted by the applicant must refer to all relevant literature, taking into account pre- and post-marketing studies and published scientific literature.

 
12. Are foreign marketing authorisations recognised in your jurisdiction?

The mutual recognition procedure allows for the recognition in France of MAs granted in other EU member states. Under this procedure, the MA holder can submit an application to the ANSM for the pharmaceutical product's approval in France. The holder must inform the member state that has issued the authorisation (reference member state) of this application and the reference member state must forward the assessment report to the concerned member states. Within 90 days of receipt of the assessment report, the ANSM must either:

  • Recognise the decision of the reference member state.

  • Consider that the medicinal product may present a risk to public health.

If required, a conciliation procedure can be initiated before the EMA.

In addition, the Code for Human Medicines Second Amendment Directive establishes a new decentralised procedure for simultaneous applications in the EU. These provisions were transposed into French law in December 2007.

 

Parallel imports

13. Are parallel imports of medicinal products into your jurisdiction allowed?

Parallel imports are permitted under the FPHC, but are subject to a renewable five-year authorisation granted to the importer by the ANSM. The authorisation is granted provided that:

  • The product has been granted MA in France.

  • The imported product is identical to the authorised product in the following ways:

    • qualitative and quantitative composition of active substances;

    • pharmaceutical form; and

    • therapeutic effects.

Authorisation can be refused for public health reasons, but not for intellectual property rights (IPR) reasons. Under the principle of exhaustion of rights conferred by a patent or trade mark (épuisement des droits), the holder of an IPR protected by law cannot rely on that right to prevent the import of a product that has been marketed in another EU member state by the holder itself (or with its consent). However, this principle does not apply if there are legitimate reasons for the trade mark holder to oppose the commercialisation of the product as it would result in an alteration to the trade mark, because the nature of the product has been changed or impaired after being put on the market.

 

Restrictions on dealings with healthcare professionals

14. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

Pharmaceutical companies that produce or market products or services reimbursed by social security schemes are prohibited from granting free advantages, directly or indirectly, to HCPs (Article L. 4113-6, FPHC). However, pharmaceutical companies can provide advantages or compensation to HCPs in the form of:

  • Advantages granted in the context of research and scientific evaluation activities and reasonable compensation for services performed by the HCPs.

  • Hospitality offered in the context of scientific or promotional congresses, provided that it takes the form of a written contract which must be submitted to the relevant professional bodies for review and opinion prior to its execution.

The distribution of free samples is also limited. Pharmaceutical companies can provide free samples to HCPs only on request and during the two first years following product launch. The number of samples is limited to four samples of a given product per professional and per year.

Gifts or donations to a medical institution to finance research activities or training of HCPs are acceptable provided that the pharmaceutical company makes a specific declaration to the regional health agency (agence regionale de santé, ANSM) and these gifts or donations do not provide any individual advantage to HCPs (that is, they are intended for collective use only). However, gifts to associations representing HCPs' professional interests are prohibited by Law no. 2011-2012.

 

Sales and marketing

15. What are the restrictions on selling medicinal products? Are there specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?

Article L.4211-1 of the FPHC provides for a list of healthcare products which can only be sold by pharmacists (Monopole pharmaceutique), including all medicinal products for human use.

Articles R.5121-82 and 83 of the FPHC further provide that medicines classified as reserved to hospital use can only be dispensed by hospital practitioners.

Directive No. 2011/62/EU (Falsified Medicines Directive) related to the sale of medicinal products on the internet has been implemented into French law by Ordonnance No. 2012-1427 of 19 December 2012 and Decree No. 2012-1562 of 31 December 2012, complemented by a ministerial Decree (Arrêté) published on 20 June 2013 fixing the Good Dispensation Practices of medicinal products on the internet. In France, the following restrictions apply to the sale of medicinal products on the internet:

  • Only non-prescription medicinal products can be sold on the internet.

  • The internet website must be operated by a retail pharmacy and authorised by the competent Agence Régionale de Santé (ARS).

The Good Dispensation Practices set out by ministerial Decree provide for further restrictions relating to the content and operation of the website and limits the quantity of medicinal products that can be ordered on the internet. However, on 16 March 2015, the French Supreme Court (Conseil d'Etat) declared this ministerial Decree invalid on the ground that it exceeds the limits of the ministerial powers and a non-updated version has been adapted since then.

 

Advertising

16. What are the restrictions on advertising medicinal products?

Legislation and regulatory authority

Medicinal product advertising in France is regulated by the following:

  • Provisions of the FPHC concerning the promotion of pharmaceutical products.

  • Guidelines issued by the ANSM.

Although the ANSM guidelines are not legally binding, French courts consider they must be taken into account by pharmaceutical companies.

Restrictions

Advertising for medicinal products must strictly comply with the product's MA, and also with the HAS' recommendations on some therapeutic strategies. The FPHC distinguishes between advertising directed to the general public and advertising directed to HCPs.

Advertising directed at the general public:

  • Is not generally allowed, if the product is subject to prescription or is reimbursed by social security.

  • Is allowed for other medicinal products, provided prior authorisation has been granted by the ANSM.

All medicinal product advertising must contain objective information and be consistent with appropriate use (bon usage) of the product. More specifically, advertising directed at HCPs must contain both:

  • Information set out in Article R. 5122-3 et seq. of the FPHC.

  • All relevant information for professionals to form their own opinion of the therapeutic worth of the product.

The information must be accurate, up to date, verifiable and exhaustive. The price of the product (if determined by the authorities), the daily cost of the treatment and its reimbursement by social security schemes must be mentioned in any promotional material directed at HCPs. Under Law no. 2011-2012 advertising directed at HCPs must be submitted to the ANSM for prior authorisation (promotional visa, as provided for by Article R 5122-12 of the FPHC) following a strict schedule of four time-windows opened for submission. The advertising materials are deemed authorised within two months following the last day of the window for submission, unless the ANSM issues a decision of refusal.

Violations of these provisions regulating advertising of medicinal products can incur criminal penalties of:

  • Up to one year of imprisonment.

  • Fines of up to EUR150,000 for individuals.

  • Fines of up to EUR750,000 for legal entities.

In addition, the ANSM can impose an administrative penalty up to 30% of the company's turnover (up to a limit of EUR1 million).

Internet advertising

In addition to the above restrictions, the advertising of medicinal products on the internet is subject to specific recommendations that have been adopted by the ANSM and professional organisations. In particular, the ANSM and the Professional Association of the Pharmaceutical Industry in France (les enterprises de médicament) (LEEM) published the Charte pour la communication et la promotion des produits de santé ( médicaments et dispositifs médicaux) sur Internet et le e-media (updated in April 2014), which contains recommendations applicable to the promotion of medicinal products on the internet. However, these recommendations are not binding on pharmaceutical companies.

 

Data protection

17. Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

Under French Data Protection Law No. 78-17 of 6 January 1978 as amended (the Law), health personal data qualify as sensitive data and cannot in principle be the subject matter of a processing. The Law however provides for a certain number of exceptions under which such health personal data can be collected and processed:

  • Article 8 II, 6° allows the processing of health personal data for therapeutic or diagnosis purposes by healthcare professionals to whom professional secrecy rules apply.

  • Chapter IX of the Law provides for an authorisation scheme applicable to health personal data processed for research purposes. This Chapter applies to clinical research.

  • Chapter X provides for an authorisation scheme, applicable to health personal data processed for care and prevention activity assessment purposes.

  • Article 25 II of the Law allows the French Data Protection Authority (CNIL) to implement standard authorisations for health personal data processing sharing the same purpose and concerning the same categories of data and data recipients. On this basis, the CNIL implemented a reference methodology MR-001 for clinical trials meeting certain common conditions and a standard authorisation AU-013 concerning health personal data processing for pharmacovigilance purposes. If the data processor complies with all the conditions laid down hereof, a declaration of compliance with MR-001 or AU-013 is sufficient and no further authorisation is required;

 

Packaging and labelling

18. Outline the regulation of packaging and labelling of medicinal products.

Legislation and regulatory authority

The packaging and labelling of pharmaceutical products is subject to specific regulations provided by the FPHC (for example, Article R. 5121-137 et seq.). The ANSM controls compliance of pharmaceutical products' packaging and labelling.

Information requirements

All packages and leaflets are part of the MA granted by the ANSM. The following information must appear on, among other things, the outer packaging of pharmaceutical products:

  • Name of the medicinal product.

  • Qualitative and quantitative composition in relation to active substances.

  • Pharmaceutical form and contents by weight.

  • Route of administration.

  • List of excipients.

  • Expiry date.

  • Special storage precautions.

  • Instructions for disposal of unused medicinal products or waste materials.

  • Authorisation number and manufacturing batch number.

  • Special warnings.

If the required information is not on the outer packaging, it must be on the inner packaging. The information must be legible, understandable and indelible.

Other conditions

The information must appear on packaging in French and in Braille. Other languages can be used, provided identical information appears in all languages.

In accordance with Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products which has been transposed into French law (Article R. 5121-138-1, FPHC), reimbursable and prescription-only medicines have to be fitted with authenticity features, enabling distributors to verify the authenticity of the medicine and to identify individual boxes.

 

Product liability

19. Outline the key regulators and their powers in relation to medicinal product liability.

In France, the main bodies in charge of ensuring medicinal product quality and safety are the following:

ANSM

The ANSM is in charge of:

  • Decisions relating to the marketing authorisations and temporary use marketing authorisations (ATU) of medicinal products.

  • Sanitary alerts and vigilance.

  • Co-ordinating the national pharmacovigilance scheme.

  • Controlling the advertising for medicinal products.

  • Issuance of best practice recommendations with respect to medicinal products.

  • Authorisation and supervision of pharmaceutical establishments.

Its powers were extended and reinforced through Law 2011-2012 of 29 December 2011. Since then, the ANSM is notably in charge of supervising the off-label use of medicinal products through the temporary use authorisations (RTU) scheme. It can request additional clinical and non-clinical data from marketing authorisation holders and impose the conduct of post-marketing authorisation studies.

In addition, it can access, on request, any information held by a natural or legal person, for the performance of its duties (subject to confidentiality).

ONIAM

The ONIAM is a publicly funded organisation in charge of the indemnification of victims of defective health products and medical incidents. Together with local indemnification conciliation committees, it plays an important role in the amicable settlement of health related litigation.

 
20. Are there any mandatory requirements relating to medicinal product safety?

The FPHC provides for various criminal sanctions and financial penalties for non-compliance with mandatory requirements relating to medicinal products (Articles L.5421-1 et seq. of the FPHC).

The Law (Ordonnance) No. 2013-1183 harmonised the criminal financial penalties applicable to breaches of mandatory requirements relating to medicinal products. The quantum of several penalties was increased by this Law. For example:

  • Failure to comply with GMP triggering a serious risk to public health is now punished by up to one year's imprisonment and a fine of EUR150,000 (previously a fine of up to EUR3,750).

  • Failure to report any information to the ANSM which is likely to impact on the risk/benefit assessment of the medicinal product is now punished by two years' imprisonment and a fine of up to EUR150,000 (previously a fine of up to EUR3,750).

  • Failure to report a serious adverse event is now punished by two years' imprisonment and a fine of up to EUR150,000 (previously three years' imprisonment and a fine of up to EUR45,000).

In addition, non-compliance with the following mandatory requirements is punished by financial penalties up to 10% of the company's turnover and up to EUR150,000 for a natural person:

  • Failure by the marketing authorisation holder/operator (exploitant) to implement a pharmacovigilance system, a permanent pharmacovigilance system masterfile and to perform periodic pharmacovigilance reports.

  • Failure by the marketing authorisation holder/operator (exploitant) to report an adverse drug reaction to the competent bodies.

  • Failure by a marketing authorisation holder to report to the ANSM the results of the post-authorisation studies imposed on it at the time of granting of the marketing authorisation.

  • Failure by a marketing authorisation holder to immediately inform the ANSM of any action taken in France or in any European member state, with the view of suspending or stopping the commercialisation of a medicinal product, requesting the withdrawal or the non-renewal of the marketing authorisation for this product.

  • Failure to inform the ANSM of any interdiction or restriction imposed by any competent authority where the product is authorised.

  • Failure to comply with the labelling and packaging obligations relating to the medicinal product.

In addition to these financial penalties, the ANSM can impose the payment of daily penalties up to EUR2,500 in case of non-compliance with the ANSM's requirements within a certain timeframe.

 
21. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.

Legal provisions

Liability can arise under tort, contract and defective products liability law. Under tort law, a fault can result from an act or omission. The claimant must establish:

  • A fault.

  • An injury.

  • A causal link between the fault and the injury.

Under contract law, a party to a contract is liable for the damage caused by the non-performance of its contractual obligations, unless it proves the non-performance resulted from an external cause. Courts have also established specific obligations, such as to deliver the product, a safety obligation, a counsel or advice obligation and a guarantee against latent defects (for example, latent defects that make the product improper for its intended use).

Defective product liability stems from Directive 85/374/EEC on liability for defective products (old Product Liability Directive), which was implemented in France by Law no. 98-389 on 19 May 1998 and established a specific defective product liability regime.

In addition, claimants can also pursue pharmaceutical companies under criminal law. A manufacturer of a dangerous product can be liable for involuntary homicide or infliction of an involuntary injury resulting in the victim's total incapacity for more than three months.

Substantive test

Under tort liability, the claimant must give evidence of an existing fault, an injury and a causal link between fault and injury. Fault can be negligence in the conception or manufacture of the product.

Under contract law, the claimant must prove either that:

  • The product does not comply with the contract or was affected by a manufacturing vice or defect that made it improper for its intended use.

  • Information delivered concerning the product was incomplete.

Under defective product liability, the product is considered to be defective when it does not provide the safety that a person is legitimately entitled to expect. The claimant must give evidence of the actual damage, the defect in the product and the causal link between the damage and the defect.

 
22. Who is potentially liable for defective medicinal products?

Under tort liability, any person can be liable provided that a fault, an injury and a direct causal link are proven. However, the manufacturer is generally liable.

Under contract law, the supplier (for example, the physician, pharmacist or hospital) usually bears responsibility for the default or defect (except for safety obligations where the manufacturer can also be responsible).

Under defective product liability, the principle is that the producer, when acting in a professional capacity, bears ultimate responsibility for the defect. A producer is defined as any of the following:

  • The manufacturer of a finished product.

  • The producer of any raw material.

  • The manufacturer of a component part.

If the producer is unknown, the seller or any professional supplier is responsible for defective products under the same conditions as the manufacturer, unless it discloses the name of its supplier or producer, within three months of notification by the claimant.

 
23. What defences are available to product liability claims? Is it possible to limit liability for defective medicinal products?

Under contract law, valid defences are that the defect or fault arose as a result of:

  • A force majeure (Act of God).

  • An external cause (third party action).

  • The buyer's own fault.

Under tort liability, the defendant must prove that the defect or fault arose as a result of external causes or conduct of the victim (that is, fault or consent of the victim). Under defective product liability, the producer is not responsible if it can prove one of the following:

  • It did not place the product into circulation.

  • The defect that caused the damage did not exist at the time the product was placed into circulation or the defect arose after it was put into circulation.

  • The product was not manufactured for distribution or sale.

  • The state of scientific or technical knowledge at the time the product was placed into circulation was not such as to enable the discovery of the defect (except for injuries caused by pharmaceutical products using compounds from human bodies, such as blood).

  • The defect was due to compliance of the product with mandatory provisions or regulations emanating from public authorities.

In addition, the producer of a component is not responsible if it can prove that the defect in the component is attributable to the design of, or the directions given by, the producer of the product in which the component has been fitted.

 
24. How can a product liability claim be brought?

Limitation periods

The common law time limit for bringing an action for bodily damage or injury is ten years from the date when the cause of action arose.

A specific time period is provided for the contractual guarantee against latent defects. Liability claims must be brought within two years of discovery of the defect (Article 1648, Civil Code).

Under defective product liability, the limitation period is ten years after the product was put into circulation. Proceedings for damages based on defective product law are time-barred after three years from the date on which the claimant became aware, or should have become aware, of the damage, defect and identity of the producer.

Class actions

Class action procedures specific to the health sector have been introduced into French Law by the Health Bill of 26 January 2016. Registered consumer associations can bring legal proceedings in all courts for compensation for damages of a similar nature sustained by a bodily injured group of patients, the cause of which is attributed to the same manufacturer's or HCP's fault.

A judge will firstly rule on this fault, the group of victims concerned, and the body injuries admitted. The judgment will then open rights for patients to opt-in, within a time frame determined by the judge of between six months and five years. The victims still have their individual rights to sue for injuries that do not fall within the scope of the class action.

 
25. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?

Under tort and contract law:

  • Monetary damages resulting from material damage are recovered if the damage is certain, direct and foreseeable. This includes loss incurred, as well as missed gain or loss of opportunity.

  • Damages for bodily injuries are also recoverable.

  • Remedies for moral damage are also recoverable, but are difficult to evaluate. However, the Supreme Court validated on 28 January 2016 indemnification for "anxiousness damage" for patients treated with Mediator who are facing the anxiousness of being sick at a later stage, albeit not at present.

Under defective product liability, compensation is limited to all damages resulting from harm to a person or goods other than the defective product itself.

Punitive damages do not exist under French law. Under French civil law, damages awarded to the claimant by French courts must exclusively compensate the harm suffered (that is, they must not enrich the claimant).

 

Reform

26. Are there proposals for reform and when are they likely to come into force?

A substantive reform has been implemented by the Health Bill dated 26 January 2016 but the substantive aspects of it remain to be seen, either through publication of the following decrees, or the ordinances the government is authorised to make to further simplify or amend the health system.

 

Contributor profiles

Alain Decombe

Dechert LLP

T +33 1 5757 8080
F +33 1 5757 8081
E alain.decombe@dechert.com
W www.dechert.com

Qualified. Paris, 1992

Areas of practice. Corporate and healthcare law; international M&A; commercial transactions including life sciences.

Recent transactions

  • Advising the shareholders of a French biotechnology company in the sale of 100% of the shares of the company to a Swiss pharmaceutical group.
  • Advising a French leading pharmaceutical company in the acquisition of a group of French health services companies.
  • Advising a British pharmaceutical group in an exchange of strategic assets and the creation of a joint-venture with a Swiss pharmaceutical group.

Sophie Pelé

Dechert LLP

T +33 1 5757 8098
F +33 1 5757 8081
E sophie.pele@dechert.com.com
W www.dechert.com

Qualified. Paris, 2006

Areas of practice. Regulatory healthcare law.

Recent transactions

  • Representing a Swiss-based pharmaceutical company before the Administrative supreme court against various administrative decisions relating to the authorisation of off-label use of one of its products.
  • Assisting a US-based pharmaceutical company in the negotiation of a pan-European promotion and distribution agreement with a French based company.
  • Advising a French biotech in the negotiation of a contract manufacturing agreement for the development and production of a gene therapy.

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