Use the Lexology Getting the Deal Through tool to compare the answers in this article with those from other jurisdictions.
In general terms, how is healthcare, including access to medicines and medical devices, funded in your jurisdiction? Outline the roles of the public and private sectors.
The French healthcare system is based on universal health protection. Every person who lives and works in France must contribute to social security. Individuals contribute to the health public insurance according to their income and benefit from total or partial reimbursements of medical costs.
Healthcare expenses are evaluated through an aggregate, called the Current Health Expenditures (DCS). It notably comprises of the Consumption of Medical Goods and Care (CSBM), which is subdivided into major risks (eg, hospitalisation and long-term disease) and minor risks (eg, optic and audio prostheses).
Both the public and private sectors contribute to healthcare funding - including through social security, state and local communities, complementary health cover organisms of the private sector (such as health mutuals and health insurance providers), and individuals. Schematically, the state contributes to prevention, training and the care of individuals in precarious situations.
Other funders mostly contribute to CSBM: major risks are principally funded by social security while minor risks rely on complementary health cover organisms. Individuals are responsible for the remaining part.
The private sector also has an important role in contributing to funding of research, training healthcare professionals, innovation, and managing private hospitals.
The reimbursement of health products and medical acts by social security is subject to the medicine, medical devices or acts being included in lists created by the Ministry of Health based on the product’s or act’s therapeutic rating, after being evaluated by the Commission of the High Health Authority (HAS). Complementary health cover from the private sector is optional, but results in more comprehensive reimbursements of medical costs.
In general terms, how is healthcare delivered in your jurisdiction? Outline the roles of the public and private sectors.
Healthcare is delivered in healthcare facilities (ie, hospitals or private practices) of variable capacity and competencies. In 2015, there were around 3,089 facilities, including 1,389 that were state-owned, 691 run by private non-profits, and 1,009 with private owners. Healthcare facilities are subject to different laws and regulations regarding their financing and organisation depending on their status. Public facilities are also subject to specific obligations under public tender regulations.
Delivery of healthcare involves different professions with regulated scope of intervention, for example, doctors, pharmacists, nurses and physiologists. Doctors have a monopoly over diagnosis, treatment and medical acts listed in specific nomenclature.
Identify the key legislation governing the delivery of healthcare and establishing the regulatory framework.
In France, most legislation is gathered into codes. Key legislation governing healthcare is contained in the Public Health Code (CSP). This contains both statute law and regulatory provisions governing the professions and the healthcare facilities that are entitled to deliver healthcare or medical goods, as well as the rules applying to healthcare products, healthcare industries and operators, and relationships between these actors and healthcare professionals - notably regarding transparency and anti-kickback rules.
Other provisions can be found in the social security code (CSS), public tenders regulation (Ordinance No. 2015-899), and commercial, civil and penal codes, for behaviour in the market, contracts and liability, and criminal offences respectively.
Moreover soft laws (ie, rules that are not legally binding but are indirectly enforceable, principally setting standards of conduct, eg, rules of good practices), issued by Ministry of Health, competent agencies (notably the National Agency for the Safety of Medicines and Health Products (ANSM) and HAS) and the director of ANSM must be taken into account.
Key principles and legislation can also be found in European legislation; notably in regulations and directives applying to clinical trials, medicinal products, medical devices and related good practices.
Which agencies are principally responsible for the enforcement of laws and rules applicable to the delivery of healthcare?
The Ministry of Health is concerned with the enforcement of laws and regulations applicable to healthcare, and supervises the implementation of the national health policy through the French Health Directorate (DGS) and the French Directorate General for Health Services (DGOS). The DGS and DGOS alert agencies and the Office of the Prosecutor of potential infringements of applicable rules.
The following organisations are principally responsible for enforcement of laws and have powers of control and sanction:
- regional health agencies (ARS): in charge of controlling hospitals as well as healthcare professionals’ work;
- regional prefects: these officials oversee the application of the national health policy;
- health insurance funds (CPAMs): these audit prescribers’ activity if fraud is suspected;
- professional organisations (eg, National Council for Doctors Order (CNOM) and National Council for Pharmacists Order (CNOP)): these ensure healthcare professionals meet ethical obligations; and
- the Office of the Prosecutor: investigates allegations of criminal offences.
HAS also contributes to enforcement via certifying healthcare facilities and professionals, and quality controls.
Scope of enforcement
What is the scope of their enforcement and regulatory responsibilities?
Administrative bodies are in charge of supervising and controlling the delivery of healthcare. They contribute to enforcement by issuing interpretative guidelines, offering support to physicians, and investigating where malpractice is suspected and taking appropriate measures if needed (eg, suspensions or withdrawal of the right to practice medicine).
Within the agencies, qualified units conduct investigations into possible breaches of applicable laws and regulations. Depending on the findings, agencies may use their powers of sanction (see question 28) and inform the Office of the Prosecutor of possible breaches of criminal law. The Office of the Prosecutor has a dedicated section responsible for investigating criminal offences related to public health and prosecuting.
Regulation of pharmaceutical products and medical devices
Which agencies are principally responsible for the regulation of pharmaceutical products and medical devices?
The principal agency in charge of regulating pharmaceutical products and medical devices is ANSM. ANSM is an independent administrative body, entirely funded by the state. It is responsible for regulation of:
- medical devices;
- in vitro diagnosis medical devices;
- biological products of human origin (eg, blood components, tissues and cells);
- annex therapeutic products; and
- cosmetics and tattoo products (under article L5311-1 CSP).
Other institutions play a significant role, notably HAS, the Economic Committee for Health Products (CEPS) and the High Council for Public Health (HCSP).
Scope of enforcement
What is the scope of their enforcement and regulatory responsibilities?
ANSM authorises clinical trials and the marketing of products where required by law, controls advertising, and conducts some inspections, notably on manufacturing sites. It also centralises vigilance data and controls products’ benefits-to-risks ratios. To this end, ANSM has legal powers, notably health policing powers (see question 10). ANSM collaborates with other state agencies and European bodies. The general director of ANSM has specific missions, one of the most important being the issuance of rules of good practice guidance in the fields of manufacturing, laboratory practices, distribution and vigilance, and the taking of decisions regarding cleanliness.
Regarding other institutions, HAS conducts medico-economic evaluations prior to reimbursements and pricing (which is set by CEPS), assesses professional practices and takes part in the organisation of healthcare delivery. High Council of Public Health (HSCP) assists the Ministry of Health in its regulatory mission by providing its expertise.
Which other agencies have jurisdiction over healthcare, pharmaceutical and medical device cases?
The Ministry of Economy, via the General Directoriate for Competition, Consumption and Fraud Repression (DGCCRF), has jurisdiction over health product-related cases, as does the Competition Authority (France’s anti-trust authority).
Can multiple government agencies simultaneously conduct an investigation of the same subject? Does a completed investigation bar another agency from investigating the same facts and circumstances?
As long as agencies act within their respective legal frameworks, they can conduct investigations simultaneously and independently. It also may happen that different aspects of the same case are investigated several times. The authorities can also inform or mandate an agency on a matter falling under its scope of competency.
Collaboration may also be organised by law (eg, new anti-kickback laws obliges stakeholders to share information). For instance, in a recent major case concerning implantable medical devices that were found to be defective, while ANSM was completing an investigation, DGS mandated HAS’s National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) to reassess the products and alert the French National Cancer Institute on risks.
The Prosecutor’s Office may also decide to investigate a case. An administrative proceeding does not bar a prosecutor from investigating a case (article L5312-2 CSP expressly supports this).
Agencies are permitted to reach different conclusions on completing parallel investigations.
Regulation of pharmaceutical products and medical devices
What powers do the authorities have to monitor compliance with the rules on drugs and devices?
CSP provides authorities with large powers to monitor regulatory compliance, notably health policing powers. Health products suppliers can be investigated, including on-site inspections (from 8am to 8pm). If a company refuses access to the authorities, the visit has to be authorised by a judge and is conducted under his or her supervision. A decision allowing a visit can be appealed.
Article L1424-3 CSP lists inspectors’ prerogatives during an on-site inspection, which include:
- collecting, when on site or by request, all information, justification and necessary documentation with regards to the inspectors’ objectives;
- obtaining communications by seizing all documentation from anybody, as long it is potentially useful for the inspection;
- accessing all software and data (including communications where necessary);
- collecting samples for analysis; and
- accessing individual medical data (this power is limited to inspectors that have valid medical licences).
Legal rights and procedural guarantees investigation authorities have to comply with balance these powers, except in cases of emergencies. In these situations, the contradictory principle (ie, the parties’ obligation to share evidence and supporting documents before pleading a case) can be bypassed.
Investigation time frames
How long do investigations typically take from initiation to completion? How are investigations started?
Investigations may result from deviations found during an inspection, or a request to investigate a matter from the Ministry of Health, the European Union or other competent agencies. A complaint or denunciation from patients or competitors, which are often made anonymously, may also lead to investigations.
Every year, ANSM sets out an inspection programme, often sector-focused (see question 19). This indicates ANSM’s priorities but does not bar ANSM from investigating other sectors and companies. Inspections may be announced or unannounced (ie, carried out without notice or after a very short notice period).
The duration of an investigation depends on its nature, the collaboration of interested parties, and the complexity and sensitivity of the case. On-site inspections generally take few days, but the decision process is much longer and can take months. Except for emergencies, when it is necessary to act without delay, agencies allow a reasonable period of time for interested parties to present their observations and may discuss these observations with the parties. They may also issue some requests that can lengthen the duration of the procedure.
Access to investigation materials
What rights or access does the subject of an investigation have to the government investigation files and materials?
The inspection report is a key element of the proceeding. This gathers all the elements noticed during the inspection and substantiates the authority’s decisions. Save in duly substantiated cases of urgency, the contradictory principle must be respected. Accordingly, inspectors must keep written minutes of on-site inspections, signed by all stakeholders. (A refusal by the investigated entity to sign is mentioned in the minutes.) Moreover, authorities must provide a preliminary report and grant a reasonable delay, not less than 15 days, to the investigated company to present its own observations. Except in restricted cases, the administration must also provide the investigated company with the elements supporting its decision or the projected decision.
If the administration refuses to grant access to documentation, the interested party can attempt an appeal before the Commission of Access to Administrative Documents (CADA).
With regards to ongoing criminal procedures, French law allows an incriminated person’s constituted attorney to access the procedure’s files. This right is strictly limited to an incriminated person’s lawyer and cannot be extended to third parties (eg, witnesses).
If pharmaceutical products or medical devices are made in a foreign country, may the authorities conduct investigations of the manufacturing processes in that other country?
The French authorities are competent to investigate foreign entities, including foreign sites manufacturing products intended for importing into France (subject to ANSM’s authorisation) as well as distributors or sub-contractors, notably with regards to quality control and vigilance requirements. ANSM’s general director may require documentation from foreign manufacturers.
In 2015, ANSM inspected 17 foreign raw materials manufacturing sites.
French criminal law addresses extraterritoriality and allows the Office of the Prosecutor to conduct some investigations on foreign manufacturers (see question 44).
Authorities cooperate with foreign agencies to conduct on-site investigations.
Through what proceedings do agencies enforce the rules?
Administrative bodies can use their policing powers (see question 10) to investigate companies and take action to protect public health.
In that respect, an administration can conduct on-site inspections and require, if necessary, the assistance of the police to this end. After providing a company with the opportunity to present its observations according to the contradictory principle (which does not apply if public health concerns justify acting without delay), the administration can sanction a company found to be in breach of the rules.
The interested party can appeal this decision before an administrative court.
Criminal proceedings are directed by the Office of the Prosecutor against individuals or companies, who are represented by their legal representatives. A prosecutor cannot make any sanctions against a company: the case has to be ruled on by a criminal court, and the incriminated party may raise an appeal before the Court of Appeal.
What sanctions and other measures can the authorities impose or seek in enforcement actions against drug and device manufacturers and their distributors?
Sanctions vary from injunctions to comply with the rules to fines and suspensions of authorisations or rights.
Article L5312-1 et seq. CSP notably allows ANSM to submit to specific conditions or suspend, among others, clinical trials, manufacturing, preparation, importation, exploitation, distribution, marketing, promotion, and delivery of a product suspected of presenting (under normal conditions of use or within predictable conditions of use) a danger to human health or that does not comply with legal and regulatory requirements. A suspension can cover any of the company’s activities. Such a decision may be published on the ANSM’s website and shared with other authorities (eg, CEPS).
In criminal proceedings, a company may be exposed to significant fines, up to five times of those applicable to individuals.
Complementary sanctions to the company may also be taken, such as the dissolution of the company, the exclusion from public tenders or the publication of the decision (eg, within the company’s offices, on its website or in sales sites).
Actions against employees
Can the authorities pursue actions against employees as well as the company itself?
Actions against employees are possible under French law, but are subject to restrictions. The employee must have intentionally committed an act of particular gravity that case law considers to be detached from their job functions. Case law generally considers crimes as detachable fault.
This doctrine of parallel action is particularly sensitive, as it often requires an employee to build his or her own defence. The company’s directors (and the responsible pharmacist in pharmaceutical companies) are usually the first to be effected by parallel action. Therefore, how power is delegated within the company is a key element to identify liability and qualify fault. Judges decide if a delegate meets all the requirements to be a suspect.
As healthcare professionals are subject to codes of ethics, responsible pharmacists, as well as other doctors and pharmacists working within a company, can be sanctioned by their professional organisations.
Defences and appeals
What defences and appeals are available to drug and device company defendants in an enforcement action?
During administrative proceedings, parties have the chance to present their observations, except in the exceptional circumstances of emergencies. In any case, defendants have the ability to formally address the authorities with their defences, should the procedure not respect rules or is questionable.
In cases when an administrative decision is issued, the interested party can attempt an amicable settlement. In cases of the defendant not receiving a reply or their offering being refused, the healthcare provider can appeal the decision before the competent court. In cases of duly substantiated urgency, the company can also introduce a summary procedure to have the decision suspended. In any case, the healthcare provider must prove the unlawfulness of the decision, demonstrating that the decision is vitiated by form (eg, there is a lack of competency of the authority or a lack of reasons for the decision) or because of its content (eg, a misinterpretation of the facts or misapplication of the law). Claims for damages are also possible, subject to the demonstration of harm or loss due to unlawful decision of the administration. Administrative appeals and claims must begin within strict legal deadlines (usually two months).
Professional bodies’ ethical proceedings are also subject to procedural rules and guarantees, and can thus be appealed. An appeal can be raised before the organisation’s national chamber should sanctions not comply with applicable rules.
In cases of criminal proceedings, the company can appeal each procedural decision before the competent instruction court and defend itself before the competent criminal court on the merit (ie, request a judge rule on the case).
What strategies should companies adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?
Usually when an enforcement action is initiated, the company has a very limited time to set up its defence, and inspectors expect quick and unequivocal answers. It is thus advisable to be prepared for such actions. This means that procedures at both the entity and group levels and responsibilities must be clearly identified and documented. Training and simulations may help the company’s readiness to face such actions. Based on our experience, lack of preparation can be detrimental to the company.
Once an action starts, the company should mandate a team - including staff responsible for regulatory, legal and business aspects of the company’s operations - to internally investigate the case without delay. Involving lawyers at the very beginning of the internal investigation (especially where criminal proceedings may be, or have been, initiated), is advisable to assess and, if necessary, minimise risk and to benefit from the from seizure legal privilege grants, as in France correspondence between a client and their attorney benefits from legal privilege while in-house correspondence does not.
The preparation of the defence must also consider the risk of exposure in the media from the very beginning.
Within pharmaceutical companies, according to the pharmacist ethical code, pharmacists must maintain trustful relationships with authorities and allow inspectors to complete their investigations. Violations of this obligation are punishable by sanctions. Experience of ANSM investigations demonstrates that inspectors appreciate cooperation from an investment company.
Recent enforcement activities
What have the authorities focused on in their recent drugs and devices enforcement activity and what sanctions have been imposed?
Owing to recent critical liability cases, authorities have reinforced their control, notably upon health products considered as a risk. ANSM’s programme for 2018 announced inspections of:
- vaccine, tissue and cell manufacturing;
- prostheses used for prolapses;
- distribution of dental implants;
- manufacturers of class III medical devices (eg, internal pacemakers and breast implants);
- wrinkle-reduction products;
- cosmetics products intended for professional use; and
- pregnancy pictograms.
The latest sanctions were post-investigations injunctions issued to pharmaceutical companies to resolve discrepancies and suspensions of the marketing of medical devices.
Are there self-governing bodies for the companies that sell pharmaceutical products and medical devices? How do those organisations police members’ conduct?
Both the pharmaceutical and the medical devices sectors have major active trade unions. Majors ones are Leem for drug industrials, National Union of the Medical Technologies Industry (SNITEM) for medical devices sector, In Vitro Diagnostic Industry Union (SIDIV) for in vitro diagnostic medical devices, and the Association of Professionals of Dentistry Manufacturing and Distribution (COMIDENT) for dental sector.
These groups all issue recommendations and code of conducts their members are committed to respect. Furthermore, international codes of conduct may apply to member companies (eg, those of the European Federation of Pharmaceutical Associations and Industries (EFPIA) and MedTech).
Sanctions, from reprimands to exclusion, may be taken, but are rare.
Relationships between healthcare professionals and suppliers
What are the rules prohibiting or controlling the financial relationships between healthcare professionals and suppliers of products and services?
Independence is one of the key principles of medical ethics. It commands doctors to refuse anything (eg, remunerations, gifts or other benefits) that might compromise their judgement in favour of suppliers of products and services. Professional orders can sanction healthcare professionals who disrespect these professional duties.
The French anti-kickback law notably prohibits healthcare professionals (as well as students intending to qualify as healthcare professionals, healthcare professionals’ associations, and public officials within health authorities and agencies) from obtaining, directly or indirectly, advantages from companies marketing health products listed in question 6 and persons performing health services. The CSP penalises these companies and those offering such advantages. However, this principle has exceptions, which are detailed in the CSP and are strictly interpreted. For example, remuneration of a service is not considered an advantage and may thus be acceptable under certain circumstances detailed by the CSP.
Financial relationships between healthcare professionals and suppliers of products and services may also fall under the scope of general criminal law provisions, in particular, those dealing with corruption and bribery.
The transparency regime obliges life science companies to disclose some information on these financial relationships and advantages granted (see question 22).
How are the rules enforced?
Any agreement concluded with a healthcare professional, including payment or any advantage granted, must be declared to the relevant professional body prior to granting the advantage or performing of the service and made public through a specific portal (see question 23).
In breaches of the rules on financial relationships and reporting requirements, both parties can be sanctioned with prison sentences (two years for the offeror and one year for the beneficiary) and significant fines (€150,000 for the offeror and €75,000 for the beneficiary, plus 50 per cent of the expenses incurred by the practice constituting the offence - that fine may be five times higher for companies).
Professional organisations may also suspend healthcare professionals’ licences to practise for up to 10 years.
What are the reporting requirements on such financial relationships? Is the reported information publicly available?
Reporting requirements include the following:
- The submission of contracts to healthcare professionals’ organisations prior to implementation. New legislation, which is expected to be applicable as of publication of a decree by end of 2018, reinforces the control of financial relationships by requiring a declaration or prior authorisation should the value exceed a certain amount to be defined by the decree.
- Publication of conventions by the entity granting remuneration or advantages (including details of remuneration and advantages exceeding €10) through a dedicated portal. This data is made available on a public website, Base Transparence Santé.
Regulation of healthcare delivery
What powers do the authorities have to monitor compliance with the rules on delivery of healthcare?
By law, the opening of healthcare facilities is subject to specific authorisation from the territorially competent ARS, which has powers of control upon the facility’s operation (article L6122 and seq. CSP). The ARS can conduct inspections and is granted wide powers in this regard.
The Ministry of Health and HAS also perform controls based on indicators jointly defined with the General Inspection Body of Social Affairs (IGAS). Controls are delegated to ARS agents regarding infection events and patients’ medical files held by clinical practices.
If a complaint is made professional organisations can ask healthcare professionals for information to assess their practices’ compliance with deontological rules. They do not have any specific investigation powers as professional organisations apply the rules of administrative proceedings.
In case of criminal proceedings, a prosecutor has the right to perform investigations that are delegated to police agents and officers (including raids under the supervision of a judge and the collection of data and any available document or information).
Investigation time frames
How long do investigations of healthcare providers typically take from initiation to completion? How are investigations started?
The duration of investigations into healthcare professionals vary from months to years, depending of the number of incriminated people and companies and the complexity of the case. From our experience, the investigation phase can easily last more than two years.
Investigations can be based on a complaint from a competent authority, a ministry or a patient. In the newly amended anti-kickback law, the cooperation between police agents, a prosecutor, ANSM and DGCCRF is legally organised.
Access to investigation materials
What rights or access does the subject of an investigation have to the government investigation files and materials?
See question 12.
Through what proceedings do agencies enforce the rules?
At the end of the contradictory proceeding administrative bodies can enforce the rules by making decisions on the basis of the inspection’s results that must be applied by hospitals (except in case of public health threat, article L6122-13-1 CSP). The ARS director can deliver an injunction on a hospital requiring them to comply with legal requirements or even suspend its authorisation to perform patients’ care.
Regarding healthcare professionals, professional bodies can enforce the rules by taking administrative judicial decisions following administrative proceedings.
What sanctions and other measures can the authorities impose or seek in enforcement actions against healthcare providers?
If a deviation is found during an inspection, an ARS director can impose an injunction requiring a healthcare provider to comply with legal and regulatory requirements by a deadline. The director may even suspend or totally or partially withdraw authorisation to perform patient care. Such administrative decisions can be challenged before a competent administrative court. If the ARS director identifies that there are no more compliance issues, he or she can decide to end his or her measures. Otherwise, the director can make a final decision after getting an opinion from a Regional Health and Autonomy Conference (an advisory body that works alongside the ARS) that can be appealed.
Regarding healthcare professionals, professional bodies, following administrative proceedings, can make judicial decisions ordering blame, or a suspension or the withdrawal of the right to practice.
In case of criminal proceedings, a prosecutor will seek the imposition of financial penalties or imprisonment.
Defences and appeals
What defences and appeals are available to healthcare providers in an enforcement action?
See question 17.
What strategies should healthcare providers adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?
The precautions mentioned question 18 are relevant, as well as in matters of enforcement actions directed against healthcare providers.
A strategy should also include the healthcare providers’ insurers.
Recent enforcement activities
What have the authorities focused on in their recent enforcement activity and what sanctions have been imposed on healthcare providers?
Recently, most of the investigations conducted by authorities concerned fraud in social security claims. These investigations are mostly directed against healthcare professionals and do not concern healthcare facilities.
Are there self-governing bodies for healthcare providers? How do those organisations police members’ conduct?
Healthcare professionals (notably doctors, nurses, pharmacists and physical therapists) must be registered with professional bodies or a competent authority. These organisations assess the compliance of their members’ professional practices with deontological rules. They can investigate complaints brought by patients or authorities and conduct administrative proceedings, potentially leading to sanctions such as blame, or a suspension or the withdrawal of the right to practice. Such decisions can be challenged before competent courts.
Professional bodies can also bring complaints against healthcare professionals before a criminal court, in the case of criminal offences, and inform administrative authorities.
Remedies for poor performance
What remedies for poor performance does the government typically include in its contracts with healthcare providers?
Health authorities can request compliance with good practice and any other standard of certification. They can also request training, regular self-inspections and audits, and new inspections from their agents to verify compliance with applicable laws and regulations.
ARS and designated hospitals can also sign performance agreements relating to the improvement of patient care, attractivity and operational effectiveness.
Causes of action
What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law?
Citizens can bring civil or administrative actions in cases of damage owing to a situation induced by non-compliance with regulations or laws. Such damage can arise from the patient’s medical care (eg, an error by a healthcare professional in the prescription of the treatment or the diagnosis - ‘professional fault’) or from the use of a medicinal product or a medical device. A citizen can also bring a claim before a Conciliation and Indemnification Commission (CCI) to get compensation from a designated person or, in cases of medical hazard, from a national compensation fund.
If a citizen suffers from an infringement of criminal law, he or she can also introduce a criminal action or become a party in a pending proceeding.
More informally, a citizen can inform administrative authorities of any violation of laws and regulations or alert the media.
Framework for claims
What is the framework for claims of clinical negligence against healthcare providers?
According to article L1142-1 CSP, the liability of healthcare providers, including professionals and the facility concerned, for their activities involving diagnosis and care is a fault-based. Facilities are liable for damages due to nosocomial infections, unless they prove the infection was caused by an external cause.
The CCI’s procedure was created to compensate patient’s medical injuries should the patient’s damages be serious enough. The patients only have to send a request form (cerfa no. 12245*03) and provide supporting exhibits. An attorney is not mandatory for these proceedings. Expert investigations are then ordered and the case is heard by CCI. If CCI retains the liability of the healthcare professional, its insurer must offer the patient compensation for the damages within four months. (See question 37.) Acceptation closes the case and the patient then loses his or her right to raise the claim before a court.
The patient can always bring his or her case before administrative, civil or criminal courts during CCI proceedings, or afterwards if they did not accept the compensation offered. The court the case is heard by depends on the public or private status of the healthcare facility and the nature of the alleged fault. In most of clinical negligence cases expert investigations are requested or ordered by a judge before a decision is made, in order to identify the circumstances of the incident and assess the patient’s damages.
How and on what grounds may purchasers or users of pharmaceuticals or devices seek recourse for regulatory and legal infringements?
Producers of pharmaceuticals and medical devices are responsible for damages caused by defective products or by a fault.
A ‘defective product’ is one that does not provide the safety a user can legitimately expect when used as reasonably expected and following the information provided by the manufacturer (article 1245 et seq. Civil Code). The manufacturer may be liable regardless of whether it complied with existing norms. However, if the default results from imperative rule, then the producer cannot be held strictly liable.
Defective product liability does not preclude the application of other systems of contractual or noncontractual liability based on other grounds, such as a fault or a warranty in respect of latent defects. Should regulatory and legal infringement not qualify a defect, the claimant can always invoke a fault.
The burden of proof to show the product’s was defective, the producer’s fault, the injury, and the causal relationship between the product and the damages is on the patient. Expert investigations are usually ordered to provide the judge details and explanations about the product, the causes of the damage, and to assess the damages.
Are there any compensation schemes in place?
There are no official compensation scales in place in France. However, there are some, such as that run by the National Office for Compensation of Medical Accidents (ONIAM), the Dinthillac Nomenclature, and the compensation scale used by the Courts of Appeal. These do not bind judges, who remain free to go far beyond or below recommended compensation levels to fully compensate the prejudice, but as the scales reflect jurisprudence they provide defendants with relatively good estimations of legal risk.
Class and collective actions
Are class actions or other collective claims available in cases related to drugs, devices and provision of care?
2016 Loi Touraine introduced class actions in the CSP with restrictive conditions (article L1143-1 CSP). Class actions must be conducted by a patient association and must aim to exclusively compensate physical injury, including mental injury. According to French tradition, no punitive damages can be ordered. As of today, because of the specific requirements and the duration of proceedings, class actions have seen limited use in France. Rather, patients sue jointly but through individual procedures, which allows them to obtain compensation of all the prejudices they may have endured due to use of drugs, devices or provision or care.
Are acts, omissions or decisions of public and private institutions active in the healthcare sphere subject to judicial or administrative review following a complaint from interested parties?
French law provides persons affected by a decision taken by a public institution or a private institution invested with a public service mission, to administrative recourse if some conditions are met (see question 17). Depending on the nature of the initial procedure, an administrative judge can withdraw the decision, modify its contents, and grant damages. There are no dedicated procedures concerning other decisions from private institutions. Interested parties have to demonstrate that the decision is vitiated by form or content, causes damages, or qualifies as a criminal offence to substantiate a claim.
Are there any legal protections for whistleblowers?
2016 Loi Sapin II introduced legal protection for whistleblowers into French law, subject to conditions related to their status (see question 41), a procedure to be respected (see question 42) and the divulging of information being necessary and proportionate to the goal of protecting concerned interests.
If these conditions are respected, the whistleblower can benefit from:
- protection of his or her identity, which remains confidential;
- enhanced protection against sanctions his or her employer might take because of the alert; and
- penal irresponsibility (ie, immunity from prosecution) for disclosing information protected by law (this does not apply if the information relates to national defence, confidential medical information and legal privileged information).
Within pharmaceutical companies, responsible pharmacists have the legal obligation to report to ANSM, notably in case of persistent disagreements with the company’s management board on the application of legal and regulatory requirements aiming at protecting public health.
Does the country have a reward mechanism for whistleblowers?
The legal definition of ‘whistleblower’ implies that they must act from goodwill and without any interest other than protecting the public interest. Consequently, the French state and legal system does not financially reward whistleblowers. However, they can benefit from protection. Should they have been involved of a criminal act, they may also benefit from clemency (eg, a discharge or a reduction of a sentence).
Are mechanisms allowing whistleblowers to report infringements required?
Under applicable law, reports of infringements must follow three steps:
(i) The employee must make an internal report. Since January 2018, companies with more than 50 employees have a legal obligation to set up a dedicated whistleblowing procedure.
(ii) If the company does not respond, the whistleblower may alert the appropriate authority.
(iii) If the authority does not take any action nor respond, a whistleblower may make alert the public by any means.
In cases of serious and imminent risk, a whistleblower can directly go to step (ii) or (iii).
Support in carrying out this process can be requested from an independent administrative authority, the Defender of Rights.
Prior consultation with an attorney is, of course, recommended.
Cross-border enforcement and extraterritoriality
Cooperation with foreign counterparts
Do prosecutors and law enforcement authorities in your country cooperate with their foreign counterparts in healthcare cases?
Prosecutors and agencies do cooperate with their foreign counterparts, a fortiori within the European Union where cooperation results from regulation. With other countries, bilateral treaties guarantee mutual recognition and assistance.
In what circumstances will enforcement activities by foreign authorities trigger an investigation in your country?
Enforcement activities by foreign authorities may require participation of French authorities within the context of cooperation. It may also lead to the opening of an investigation in France should the facts fall under the scope of French law (see question 45), but, following the principle of non bis in idem, the investigated party has not been sanctioned for the alleged act yet (article 113-9 Penal Code).
The proceeding is initiated by prosecutors who have the power to evaluate and decide whether to investigate, after receiving a complaint by a victim or an official denunciation from the foreign authority (article 113-8 Penal Code).
Pursuing foreign entities for infringement
In what circumstances will foreign companies and foreign nationals be pursued for infringements of your country’s healthcare laws?
French criminal law applies to the facts committed totally or partially in French territory (including complicity) as well as acts committed by French nationals or on French subjects abroad. Some provisions expressly address the extraterritoriality of French healthcare law (eg, the rules of good practice of distribution). Therefore, foreign nationals’ and companies’ acts may fall under French healthcare law and they may be consequently fined.
Update and trends
What are the authorities’ enforcement priorities likely to be in the coming year? Are there any noteworthy cases pending? Are there any current developments or emerging policy or enforcement trends that should be noted?
The French legal framework applicable to healthcare providers and industries has been recently revised, notably with a new anti-gift regime. New laws and regulations are to be enacted within the coming year in view of new European regulations regarding medical devices.
Recent major product liability cases and the issuance of rules regarding good practice applicable to pharmacovigilance suggest that ANSM will reinforce its controls on related matters. It is noticeable that French authorities tend to rationalise their inspection process and reinforce cooperation at both national and international levels.