Medicinal products are regulated differently according to their destination: Articles L5121-1 and seq of the Public Health Code (PHC) set up the legal framework on medicinal products for human use, which incorporated Directive 2001/83, and Articles L5141-1 and seq of the PHC govern medicinal products for veterinary use (which transposed Directive 2001/82).
The regulatory framework on medical devices (MD) is set out in Articles L5211-1 and seq of the PHC as well as in Articles R5211-1 and seq of the PHC, which incorporated the Medical Devices Directives 93/42/EC, 90/385/EEC and 98/79/EC. Medical devices can be distinguished from in vitro diagnostic medical devices (IVDR) and active implantable devices, which are regulated differently.
The current regulatory framework went through important changes with the implementation of two new Regulations on MD (2017/745) and IVDR (2017/746) on 25 May 2017, which will be fully applicable on 26 May 2020 (for MD) and on 26 May 2022 (for IVDR).
Regarding medicinal products for human use, the regulatory bodies are the EC, the Committee for Medical Products of Human Use (CHMP) of the European Medicines Agency (EMA) and the French National Agency for the Safety of Medicines and Health Products (ANSM).
Regarding medicinal products for veterinary use, the competent regulatory bodies are the EC, the Committee for Medicinal Products of Veterinary Use (CVMP) of the EMA and the French National Health Security Agency for food, the environment and work (ANSES).
Regarding medical devices, the competent regulatory bodies are the EC and the ANSM.
Decisions of the regulatory bodies (whether for medicines and medical devices) are administrative decisions, subject to an ex gratia/informalappeal that is addressed to the author of the challenged decision. In the event of failure of such an appeal, a judicial appeal can be exercised on grounds of misuse of power to the competent administrative court.
The ex gratia appeal can be submitted in the form of a letter, which shall state the facts and its legal grounds. Regarding the judicial appeal, the applicant shall be represented by a qualified attorney, have an interest in bringing proceedings and the capacity to act. The challenged decision must also be an administrative decision that is prejudicial and have legal effects on the applicant’s legal situation.
These procedures also apply for other regulated products.
EU legislation provides definitions of a medicinal product and a medical device. In case of doubt, where a product may fall within two different categories, the qualification of medicinal product shall prevail.
There is no official procedure for obtaining an official classification of a product in France, although the ANSM may provide some informal guidance.
Functional foods are regulated by Regulation 1925/2006 of 20 December 2006 on the addition of vitamins and minerals, and of certain other substances to foods, while nutraceuticals are regulated specifically by Regulation 2015/2283 of 25 November 2015 on novel foods.
Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect. They are defined as an intermediate category of medicated food and fall within Directive 2002/46/EC, transposed into French law by Decree No 2006-352.
Medicines and in vitro medical devices are only distributed by pharmacists, who retain a monopoly on such products through physical and online shops, although few exceptions exist (eg, contact lenses and accessories, Class I MD such as bandage or earplugs). Online shops shall only sell non-prescription medicines.
Clinical trials (whether on medicines or on medical devices) are regulated according to the level of risk the subject is exposed to. Interventional studies involving an intervention on the subject require the sponsor to obtain ANSM’s approval and a positive opinion from an Ethics Committee (CPP), which is composed of a group of scientists and non-scientists. For interventional studies involving low or no risk for the subject and non-interventional studies, although a positive opinion of the CPP is required, the ANSM shall only be informed of the performance of the trial. Should the clinical trial fall within the criteria outlined in one of the baseline methodologies implemented by the CNIL (National Commission for Information Technology and Liberties), the sponsor can go through a simplified procedure and submit a compliance commitment. Otherwise, the sponsor shall be authorised by the CNIL to collect and process data during the performance of the trial.
In 2020, interventional studies on medicinal products for human use are expected to fall within a new EU Regulation under which pre-approval and opinion of the CPP will be co-ordinated with other Member States' bodies. A unique authorisation and assessment procedure will also be implemented.
Sponsors shall obtain a research registration number. For interventional studies on medicines, sponsors must obtain that number in the EU database of clinical trials (EudraCT). For any other types of studies, they must seek a registration number on the ANSM’s website.
Sponsors shall then send an application file for authorisation and/or opinion, by electronic means or by mail, to the ANSM and/or the CPP, in accordance with the file formats provided for each type of trial. The evaluation process may last from 14 days to 88 days.
All clinical trials must be registered before starting on the register of the World Health Organization (WHO). In addition, all interventional studies conducted in the EU and the European Economic Area (EEA) must be registered on the EMA’s dedicated website no later than 21 days after the recruitment of the first subject. Some institutions also provide a list of clinical trials performed in specific therapeutic areas (cancer, rare diseases, hepatitis). The summary of the trial results is made available on these websites at the end of the study. Requests to release further documents can be made to the EMA in accordance with the ‘Transparency Regulation’; ie, Regulation (EC) No 1049/2001.
Online tools are not prohibited per se. However, the requirements in terms of information and consent of the subjects and data protection may seriously impair their usefulness. Moreover, all advertisement/communication used to invite subjects to participate in clinical trials and arrangements for information or advice shall be submitted and approved by the CPP. The procedures proposed for handling responses to the advertisement shall also be outlined.
Under Regulation 2016/679, the resulting data from clinical trials falls within the definition of sensitive data, which is considered as a specific category of personal data.
The resulting data may be transferred to a third party or an affiliate if the baseline procedure or the CNIL’s authorisation to collect and process such data allows it. In addition, the sponsor shall ensure that such affiliate or third party complies with the legal framework set out in Regulation 2016/679 (Article 44 and seq).
The creation of a database containing personal or sensitive data may be authorised without further requirements if (i) the database is not intended for a different purpose than the one under which the initial data collection was performed and (ii) the database should comply with the data retention period as agreed in the simplified procedures or in the CNIL’s authorisation.
In most cases, it will involve a modification of the initial authorisation or a new authorisation.
EU legislation provides a definition of medicinal products and medical devices. Guidelines tend to distinguish such products based on their principal intended actions. Hence, the medicinal product will have a pharmacological, metabolic or immunological action, whereas the principal intended action of a medical device will be physical or mechanical.
Medicinal products can be granted a marketing authorisation (MA) through four procedures (centralised, national, mutual recognition or decentralised), while medical devices shall be certified with the CE marking.
The ANSM or the EC grants the MA if the medicine is considered to have a favourable risk-benefit balance based on its quality, safety and efficacy. Should the medical device meet the performance and safety requirements, a CE marking is delivered by a ‘Notified Body’, which is authorised by the ANSM (ie, GMED).
Biological medicinal products have specific MAs dossiers and requirements; eg, application files for vaccines shall include a Vaccine Antigen Master File containing all relevant information concerning each of the active substances.
The initial period of validity of an MA is five years. The CE marking has a period of validity limited from one to five years.
Application for renewal must be filed at least nine months before the expiry date of the initial MA. A renewal has no time limit unless there are post-marketing surveillance issues. Guidelines are available for the different procedures on EMA and ANSM’s websites.
The MA can be revoked if the medicinal product is not commercialised within three years of its granting or if the product is not commercialised in France for three consecutive years.
In the case of risks to human health, safety or quality concerns, the regulatory bodies may modify, restrict or impose specific requirements in order for the product to be put on the market. They may also suspend or withdraw the product from the market.
The MA may be granted through four main procedures. MAs issued only allow the product in question to be marketed in the EU Member State(s) concerned, unless the product has been authorised via the centralised procedure. The CE marking can be obtained at a national level by a Notified Body and is valid within the EEA.
Applicants must submit data on the use of a medicinal product in children obtained in accordance with an agreed paediatric investigation plan. If the requirements of Regulation 1901/2006 are fulfilled, applicants may be then eligible for a reward.
Procedures for variation of MAs are classified according to the extent of the modification and their consequences on quality, safety and efficacy. Although minor modifications (type IA and IB) shall only be notified, major modifications (type II) and extensions shall be approved by the regulatory bodies.
A change of the MA holder shall be authorised by the ANSM on supporting documents. The transfer should be deemed accepted 60 days after the request has been made.
Patients may have access to medicines that are not yet authorised but have entered the authorisation application process provided that:
Temporary authorisations (ATU) may be delivered for a group of patients upon request of the manufacturer (compassionate use programmes) or on a named-patient basis upon request of a healthcare professional. Such possibility does not exist for medical devices outside clinical trials.
Pharmacovigilance is defined here as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long-term and short-term side effects of medicines. Technovigilance is defined here as the science relating to the detection, assessment, understanding and prevention of adverse incidents, particularly long-term and short-term side effects of medical devices.
Manufacturers of medicines are required to carry out pharmacovigilance and implement a risk-management plan to assess and minimise the risks linked to the medicine use. They should report any suspected drug-related adverse reaction and ensure the collection, recording and processing of such information. As part of the technovigilance, manufacturers of medical devices are required to report any incident or risk of serious incident and any recall of a product from the market.
Post-marketing obligations, including Phase IV trials, may be imposed as part of the granting of a centralised MA when there is no alternative treatment for the targeted disease and indication, and when the benefit-risk balance of the medicine is positive but needs to be reassessed based on complementary data.
The list of medicines under evaluation by the CHMP is available on the EMA’s website and includes international non-proprietary names and therapeutic areas. Pending applications for medical devices are not available publicly.
Following a positive opinion, a public assessment report is made public on the ANSM and EMA’s websites. Following a negative opinion, a refusal question and answer document and the refusal public assessment report are published.
There is no publication of any information of a commercially confidential nature or of sensitive information.
Directive 2011/62/UE and Delegated Regulation 2016/161 supplementing Directive 2001/83/EC set the safety features that shall appear on the packaging of medicines to fight against counterfeited and falsified medicines. This means that since 9 February 2019, the packaging of each medicine newly put into circulation shall have a data matrix with a unique identifier and an anti-tampering device for the purposes of allowing its identification and authentication. In France the non-profit organisation France MVO is in charge of the IT interoperability of the verification system.
The Ministry of Economy is specialised at the borders in the control of the flow of goods and shall verify all points of entry and exit of the territory and all the vectors of fraud. It also operates on storage sites and after customs clearance. Customs powers in the area of counterfeiting have been strengthened at the European level with the adoption of Regulation 2015/2424 and Directive 2015/2436 on counterfeit goods from and to third countries. As a precautionary measure, withholding of goods suspected of infringing an IP right can be carried out by customs services, upon prior filing of a request for intervention by the right-holder. A request can be filed for monitoring goods on the national territory and at the borders of another Member State.
For the hospital market, prices are freely set through bids. For the private market, the price is free on the non-reimbursable market. On the contrary, on the reimbursable market, the retail price is regulated and set by an agreement between the Economic Committee for Health Care Products (CEPS) and the company, or in the absence of an agreement, by the CEPS alone. Prices for OTC products are free. The maximum margins that can be applied by wholesalers and pharmacists are set out by law (order dated 4 August 1987 as amended). The price to be applied by the pharmaceutical company is calculated as a result of the application of these maximum margins to the retail price.
Most medical devices used in hospitals should be covered through the cost of the hospital stay related group (GHS). Price is freely negotiated between the company and the hospital-purchasing group.
Medical devices for personal use outside hospital can be reimbursed if the company requested to enter the reimbursable market through registration within the List of Reimbursed Products and Services (LPPR). The price is then determined the same way as for medicines.
Price and reimbursement are governed by the Security Social Code (Articles L162-16 and seq for medicines, and L165-1 and seq for medical devices).
An application for reimbursement must be submitted to the French Health Authority (HAS), which will assess the clinical benefit of the medicine or the service expected of the medical device. If that clinical benefit/service expected is proven sufficient, the HAS will then determine whether the product provides an improvement over other currently available therapies or products. The CEPS finally determines the price of the product based on this opinion.
Companies wishing to obtain a refund for an innovative medicine or medical device can request an early consultation to discuss with the HAS the foreseen criteria and methodology that may be used for the cost-benefit analyses. However, early consultations do not entail price negotiation.
Ex-factory prices of certain medicines (particularly innovative products) cannot be lower than the lowest price found in four other European countries, ie, Germany, Spain, Italy and the UK. Such stability is guaranteed for five years.
If the clinical benefit of a medicine or the service expected of a medical device is judged sufficient, the product may be included in a reimbursement list. The National Union of Health Insurance Funds (UNCAM) determines the reimbursement rate for medicines and an order of the Ministry of Health shall enforce the inclusion of the product on the list. The Pharmaceutical Innovation Funding Fund (FFIP) created by the Social Security Financing Act (LFSS) for 2017 outlining the expenses associated with the management of innovative medicines was abolished by the LFSS for 2019.
The greater the level of improvement in medical benefit of the medicine, the higher the cost treatment granted with regard to its ‘comparators’. A medico-economic assessment shall also be taken into consideration to determine the price of certain products that are judged innovative and have a significant impact on the health budget. In any case, when the level of improvement is considered non-existent, the reimbursement is possible only in the case of ‘a saving in the cost of treatment’.
Pharmacists are able to replace prescribed brand-name medicines with their generic equivalent. To facilitate such a replacement, general practitioners have been required since 2009 to write their prescriptions according to the international non-proprietary names, with a common name for each active substance. In addition, it is now mandatory to justify the mention of ‘non-substitutable’ with medical criteria. As from 1 January 2020, patients who refuse without such medical justification the generic equivalent will see their reimbursement limited to the price of that generic.
Subject to the ANSM’s authorisation, medicines can be promoted among healthcare professionals (HCPs) (Article L5122-9, PHC) as well as to the general public but in such case, only for non-prescription and non-reimbursed medicines (Article L5122-6, PHC).
Non-reimbursed medical devices and reimbursed medical devices, only when classified as category I or IIa, can be promoted to the general public (Article L5213-3, PHC). The promotion is otherwise authorised for the HCPs.
The medicines that can be promoted require the ANSM’s prior authorisation, known as a visa PM for HCPs and GP for the general public.
The promotion and advertising of reimbursed medical devices that are classified category I or IIa are post-controlled when directed to the general public. Promotional materials of non-reimbursed medical devices are subject to the ANSM’s pre-approval only in cases where the medical devices are included on “the list of medical devices presenting a significant risk to human health”, namely products of filling skin depressions.
As for the HCPs, the promotional materials for the medical devices (whether refundable or not) are subject to pre-approval only in cases where the medical devices are on the above-mentioned list (eg, implantable cardiac defibrillators and breast implants).
The ANSM is the competent authority to deliver authorisations and to sanction in the event of infringement.
Infringements of advertising rules can be subject to:
Any third party, including a non-competing third party, may take legal action as long as it has legal capacity and interest.
See 5.4 Sanctions or Provisional Safety Measures above.
In principle, the director general of the ANSM gives the person concerned an opportunity to present his or her observations within a time limit that may be no less than one month and in the case of an emergency, can suspend the visa for up to three months. The decision to ban an advertisement shall take effect three weeks after its publication in the official journal.
Article L4113-6 of the PHC provides for a general principle of prohibition of advantages/benefits, in kind or in cash, granted or proposed to the HCPs by pharmaceutical companies. This principle is subject to some exceptions, such as hospitality being offered, directly or indirectly, at events for purely professional and scientific purposes, or at promotion events. In such case, these benefits shall be subject to written contracts and pharmaceutical companies are required to publish various mandatory information, including the compensations/allowances, the (direct and indirect) beneficiaries and the precise purpose of the agreement on a public website.
For each advantage exceeding EUR10, the following elements shall also be made public:
The publication is made in French, on the public website (transparence.sante.gouv.fr) in accordance with the operating conditions mentioned under Article L1453-1 of the PHC. The entry into force of a revised Anti-Gift law is pending and shall be applicable upon publication of the implementing texts, expected in the third quarter of 2019.
The most common infringements committed by manufacturers are breaches of the Consumer Code provisions with regard to misleading or comparative advertising. The ANSM often issues decisions banning advertising that fails to fulfil the provisions of the MA, or that constitutes indirect advertising that was not previously authorised pursuant to the law.
Any advertising for health products shall comply with the provisions of the Consumer Code, which prohibits deceptive marketing practices (Articles L 121-1 and seq) and illicit comparative advertising (Articles L 122-1 and seq).
The advertising shall not create any confusion with another product, brand, trade name or other distinctive feature of a competitor and shall not be based on allegations, indications or presentations that are false or likely to be misleading.
Furthermore, any advertising that compares products by identifying, whether implicitly or explicitly, a competitor or such products offered by a competitor is lawful only if:
Medical apps fall within Regulation 2016/679 on data protection. Depending on their intended purposes, some of them may be considered as medical devices or in vitro diagnostic medical devices. They shall then be regulated by the Medical Devices Directives, at least until the Medical Devices Regulations are fully applicable (see part 1 question 1).
According to recent case law, a medical app shall be considered as MD or IVDR under three cumulative conditions:
Apps ensuring the patient treatment is taken adequately or used in sports practice do not fall in this scope.
Telemedicine is governed by Articles L63116-1, R6316-1 and seq of the PHC, which apply alongside common principles (eg, deontology). With some exceptions, the physician should be the primary care physician. The free and informed consent of the patient shall be obtained for any act of telemedicine.
Although the use of a mobile device is not prohibited, it shall meet the regulatory requirements, which are (i) the use of a video exchange (ensuring the identity of physicians and patients) and (ii) the connection to a secure solution (eg, a link) that may be only accessible via a laptop or a tablet (securing the consultation and data processing).
Online websites promoting medicines or medical devices shall comply with the general principles of advertising (see above). Provided that companies comply with these rules (which entails in practice access restriction and content adapted to the public), advertising or promotion shall be clearly identified as such. The editor (eg, the companies) shall also be clearly identified. The content shall not be misleading and respect certain file formats. With some restrictive exceptions and under specific conditions, advertising on social networks is prohibited. Guidelines are available on the ANSM website.
Electronic prescription is allowed by Law No 2004-810 under some conditions. The prescriber must be identified, the e-prescription must have been established, transferred and stored under conditions that guarantee its integrity and confidentiality, and a clinical examination of the patient should have been carried out beforehand, except in exceptional emergency cases. Furthermore, an experimental project called PEM2D is under way in several departments.
Only non-prescription medicines can be sold on the internet through physician online shops. Very few exceptions to pharmacists’ monopoly exist (eg, anti-parasitic for animals, some class I medical devices such as bandages or contact lenses). See Regulatory framework - question 7.
Since 2004, patients can request the creation of a unique and electronic medical record, which is not mandatory. Articles L1111-8 and seq and R1111-9 and seq of the PHC regulate the hosting of health data by electronic means. The data host requires a certificate of conformity, which is delivered by a certification body. The data hosting contract must contain some mandatory provisions, as set up in Article R1111-1 of the PHC.
Manufacturing plants of medicinal products shall be authorised by the ANSM, whereas manufacturers of medical devices or their representatives shall declare their activities and the medical devices they manufacture to the ANSM.
The declaration for medical devices and the application for authorisation to manufacture medicinal products can be sent by registered mail or by electronic means, with acknowledgement of receipt. Application for an authorisation shall be made at least 60 days before any operation.
The scope of the declaration and the authorisation will be determined by the manufacturer’s application or by its declaration. However, any modification of the scope of the activities shall be reported to the ANSM.
There is no period of validity of such authorisation.
As manufacturers, wholesalers of medicines shall be authorised, while establishments engaged in wholesales of medical devices must report their activities and the products they distribute. Distributors shall comply with the Good Distribution Practices. The process for the authorisation or declaration is the same as for manufacturers (see the question above).
See 1.7 Different Categories.
Articles L5121-8 and seq, and R5121-108 and seq of the PHC govern the import and export of medicinal products.
Articles L5211-3 and seq as well as Articles R5211-12 and seq of the PHC regulate imports and exports of medical devices, while Articles L5221-2 and seq as well as Articles R5221-8 and seq of the PHC govern imports and exports of in vitro diagnostic medical devices.
The ANSM is the regulatory body competent for imports or exports of medicines and medical devices. The ANSM has a greater role on imports and exports of medicines (upon authorisation, with some exceptions) than for medical devices (upon declaration). The assessment and delivery of the CE marking for medical devices is also delegated to a Notified Body (ie, GMED).
Only pharmaceutical establishments can act as the importer of record, provided that they are authorised by the ANSM (with some exemptions – see 9.4 Prior Authorisations). For certain controlled substances (eg, toxins, narcotics), an additional authorisation may be required.
Such establishments can act as importers of record, provided that they report their activities and the products they import to the ANSM.
Imports of pharmaceuticals require import permits, which are delivered by the ANSM. Import permits may be delivered for an import within three months or for several imports within a year for a predefined quantity.
Medical devices can only be imported if they are CE marked and importers shall report to the ANSM their activities and the products they import.
Exemptions apply to:
Specific restrictions may be imposed for well-defined therapeutic categories of products (eg, vaccines, narcotics, psychotropic drugs, gene and cell therapy products, clinical trial products and medicinal products used in biomedical researches). The EU product classification system provides a classification for all products under a tariff code that includes information on the duty rates, applicable protective measures, external trade statistics, import and export formalities, and other non-tariff requirements. The classification includes:
The Council Regulation (EEC) No 2658/87 of 23 July 1987 and the Commission Implementing Regulation (EU) 2018/1602 of 11 October 2018 set up the EU product classification system.
The exportation of intangibles, such as software and technology, including know-how, can be controlled by Regulation (EC) No 428/2009 on dual-use items or Council Directive No 93/42/EEC, which includes in the definition of medical devices “any instrument, apparatus, appliance, material or another article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer.”
Regulation (EC) No 428/2009 requires dual-use items to be subject to effective control when exported from or transit through the EU, or delivered to a third country as a result of brokering services provided by a broker resident or established in the EU. In France, the Dual-Use Goods Service (SBDU) is the competent authority for such control. Annex I of the Regulation as amended incorporates the common list of such dual-use items, which includes biological materials, toxins, genetically modified organisms, pathogens, chemical products and equipment to handle this type of product.
A new type of trade agreement (ie, bilateral or regional agreements) that tend to reduce non-tariff barriers are currently signed between the EU and industrialised third countries; for example, the CETA (EU-Canada), the TAFTA/TTIP (EU-US) and the JEFTA (EU-Japan).
The EU pronounces the embargoes on behalf of the French territory, through the EC’s Directorate General of the Treasury. These embargoes can lead to low circulation of health products depending on the degree of restriction. There is currently an import ban on goods from Crimea and Sevastopol that has been extended until 23 June 2019.
Article L611-1 and seq of the Intellectual Property Code (IPC) set up the legal framework on patent.
Most issues regarding patent law concern illicit agreements or disputes between generic and originator companies.
There are no patentability requirements specific to medicines or medical devices. However, some features may apply to life sciences (eg, methods of surgical or therapeutic treatment and diagnostic methods cannot be patentable as well as a number of other biological processes).
Second and subsequent medical uses of a known product are recognised as patentable, provided that said use is novel and inventive.
The principle of the patentability of second medical uses was also extended for claims drawing their novelty from a method of administration, a new class of patients, as well as from new dosage regimes, provided that the patentability requirements are met.
The scope of protection of a second patent for a new therapeutic use will be limited to the said use of the product. Therefore, an infringement would be demonstrated if the product is manufactured or offered for this particular medical use.
A supplementary protection certificate (SCP) can be requested from the Patent Offices, which will extend the duration of the protection granted by the initial patent up to five years plus six months in the case of studies with a view to paediatric use.
A SCP shall be granted if:
A third party may bring an action for a declaration of invalidity of the certificate before the competent tribunal.
Patent infringements consist of:
Threat of infringement is actionable if there is an imminent infringement of IP rights.
Defences to patent infringement include:
Compulsory licences are available to manufacture and export pharmaceutical products to countries in need of such products. The ministry in charge of IP can also implement such regime for medicinal products and medical devices in the event of health or competition issues. Such provision, whose rationale lies essentially in its deterrent effect, has never been applied.
The right-holder or the exclusive licensee can bring proceedings for patent infringement, unless the licence agreement says otherwise.
Such dispute falls within the exclusive competence of the president of the Tribunal de grande instance of Paris and of the Paris Court of Appeal. An appeal before the Supreme Court is possible in accordance with ordinary law.
A request for seizure for counterfeiting usually precedes most patent infringement actions as it enables the finding of solid evidence before any proceedings. The interlocutory proceedings, which are faster and allow interim measures, are usually favoured. Substantive proceedings can be brought later but are necessary to obtain compensatory damages.
Invalidity of the patent is an available defence and can be raised by a counterclaim.
Prelaunch declaratory action is available for bona fide companies that wish to ensure their activities will not infringe a patent under Article L615-9 of the IPC.
Prelaunch declaratory action remains optional for generic companies.
The authorisation procedure does not directly address patent linkage. When the period of data exclusivity expires (ie, eight years following the granting of the MA) generic companies can apply for an MA. However, the generics cannot be launched on the market before the period of marketing exclusivity (ie, 10 or 11 years) and prior to the expiry of the patent(s) without the consent of the proprietary rights (Article L5121-10, PHC). Be that as it may, in the Lundbeck case of 8 September 2016, the General Court ruled that the presumption of a patent validity “cannot be equated with a presumption of illegality of generic products validly placed on the market which the patent holder deems to be infringing the patent.”
A counterfeit can trigger the civil and criminal liability of the counterfeiter, which can expose the counterfeiter to a fine of EUR7,500 up to EUR750,000. Customs withholding may also be applicable (see also 3.9 Available Border Measures).
Trade marks used for medicines must avoid any confusion with the International non-proprietary names or with other medicines. They should not mislead the consumer about the qualities or properties of the product. The ANSM will assess medicines trade marks on the basis of restrictive recommendations.
Various conditions are required for the lawfulness of parallel imports:
The Court of Justice has recently applied the same principles to parallel imports of medical devices.
The trade dress or design of medicines or medical devices can benefit from the protection of designs and models, unless:
Design rights are a useful and relatively inexpensive way to protect life sciences products, especially medical devices.
Data exclusivity, which prohibits the application for a generic MA, shall last eight years following the granting of the originator MA.
The marketing exclusivity that prevents the placing on the market of the generic product lasts ten or 11 years (ie, the originator obtained during the eight years following the granting of its MA a new therapeutic indication that brings a major advantage) following such granting.
Recently, strategies denigrating generics or hindering their market entry are practices that have been acknowledged as unilateral anticompetitive practices by the French Competition Authority (FCA) (Decision No 13-D-11 of 14 May 2013; 13-D-21 of 19 December 2013; 17-D-25 of 20 December 2017) and the French courts (Decision of 18 October 2016; 11 January 2017). In 2018, the FCA sanctioned wholesale distributors of veterinary medicines and their professional body for setting up several cartel agreements (Decision No 18-D-15 of 26 July 2018).
To date, there has been no French case law concerning pay-for-delay agreements.
Over the past years, the FCA has been developing case law on intimidation or denigrating strategies implemented to prevent the entrance of generic competitors on the market, which includes misuse of regulatory procedures.
The FCA acknowledged the effect-based approach. In Decision No 13-D-11, the FCA ruled that questioning the bio-equivalence and substitutability of generic competitors of Plavix® was not only having likely effects but also proven effects on competition and consumers by modifying the behaviour of HCPs.
Depending on the territorial scope of the practices, the EC and the FCA may deal with cases on their own initiative or through interested private parties. Proceedings before the FCA start with examining the admissibility of the referral and continue with the analysis of the conditions of competition in the specific market. The FCA may order interim measures, order the parties to change their conduct within a certain period or under special conditions, or sentence companies up to 10% of their worldwide turnover. Executive Order No 2017-303 of 9 March 2017 encourages private enforcement by transposing Directive 2014/104/EU of 26 November 2014 on certain rules governing actions for damages under national law for infringements of the competition law provisions of the member states and of the EU.
Companies can also engage in civil proceedings before a competent tribunal to seek relief and damages. Parallel litigations are common to exercise greater pressure.
A public consultation was launched on 18 October 2018 by the FCA to collect input from stakeholders on a wide range of activities, including retail pharmacies, wholesalers and biological laboratories. This could pave the way for a change in legislation as regards, eg, the rules on capital ownership of retail pharmacies and biological laboratories that are today the most restrictive in the EU, and online sales of medicinal products. The final report of the FCA is expected in the first quarter of 2019.
General contract law principles laid down in the Civil Code providing that relations should be driven by good faith, loyalty, mutual co-operation and consistency apply to all types of agreements. Competition law may also apply if the operations qualify as a concentration or the agreements produce restrictive anti-competitive effects. Commercial law, interpreted by case law, lays down the rules related to payment terms, non-competition clauses and termination or non-renewal of contractual agreements. Financial regulations and guidelines from the French Financial Markets Authority (AMF) may also apply in some cases. IP law sets out some principles that companies should take into account (eg, moral rights, publication of the licence agreement and IP infringement).
Different techniques might be used to bridge the valuation gap between the buyer and seller, such as earn-out clauses (ie, indexation of a portion of the acquisition price to the future performance of the target company), escrows/holdbacks (ie, setting aside a portion of the purchase price until some post-closing condition has been satisfied), locked box mechanism (ie, agreement on a fixed price, not subject to post-closing adjustments, based on the financial statements of the target at a certain date prior to closing), share/asset swap (ie, exchange of one equity-based asset for another/exchange of fixed and floating investments).
The main purchase clauses in an acquisition agreement are price adjustment, earn-out or locked box mechanism.
Several deal protection provisions are customary under French law, including representations and warranties covering the business, status, accounts, assets, operation of the company as well as employment matters, indemnification clauses, security provided for warranty claims and certain types of non-compete clauses. Complex transactions often involve preliminary agreements such as confidentiality letters, exclusivity agreements and letters of intent, which also provide some legally binding provisions such as confidentiality, exclusivity and terms relating to the payment of a break fee.
A concentration shall be notified to the FCA under three cumulative conditions:
Share purchase agreements are known to trigger lower transfer taxes than asset purchase agreements. Asset deals induce transfer taxes of 3% of the purchase price or the market value of the business up to EUR200,000 and 5% for the portion exceeding this threshold, while share deals trigger transfer taxes of (i) 0.1% for the shares of a joint stock company (société anonyme) or simplified joint stock company (société par actions simplifiée), or (ii) 3% for the shares of a private limited liability company (société à responsabilité limitée). Asset deals concerning the transfer of immovable property trigger the application of a 5.09% to 5.80% transfer tax rate on the sale price (plus notary fees) depending on the location of the property. Share deals concerning predominantly real estate companies (where real estate represents more than 50% of the total assets of the company) trigger a transfer tax that amounts to 5%.
No statutes enable the licensee to terminate the licence agreement in the event of insolvency proceedings of the licensor. Contractual provisions may be implemented in the licence agreement to address such situations. It shall be decided whether such agreement should be terminated, keeping in mind that the royalty fees obtained from the licensee may prevent him from doing so. If the licensor’s business is sold, the licence agreement should be transferred to the purchaser.
Aside from the legal framework provided by the French Criminal Code in connection with corruption and influence-peddling, the relationship between pharmaceutical companies and HCPs has been subject to strict regulations that have intensified over the past years. The entry into force of a revised Anti-Gift law is pending and shall be applicable upon publication of the implementing texts, expected in the third quarter of 2019.
In the event of an investigation, it is crucial to have set up in advance a specific operational organisation with the persons to intervene on behalf of the company. The objective is to ensure the proper conduct of operations and show the authority that the company agrees to co-operate in good faith. The biggest challenges will particularly lie in being able to identify quickly the documents deemed confidential, monitoring the relevance of the documents requested and the inventory of the documents seized, as well as checking carefully the contents of the minutes. Companies shall immediately assess the possibility of lodging appeals against the orders that may have been issued before or during the operations.
Beyond such official investigations, internal investigations should be carried out as soon as there is a reasonable suspicion of non-compliance with due consideration of the reaction expected not only from administrative/judicial authorities but also employees. The company has no choice but to react promptly and qualify the facts in such way as to put an end to bad practices by safeguarding the best interests of the company.
In June 2018, the French Supreme Court upheld the decision of the Paris Court of Appeal and sentenced several companies of the dental sector to a EUR135,000 fine for offering and providing several illicit benefits to HCPs. In January 2019, the Court of Appeal of Besançon confirmed a judgment and sentenced a pharmaceutical company for a similar infringement.
The special features of investigations in the life sciences industries lie in the thoroughly regulated environment (both upstream and downstream) in which they operate and the close and long-term relationships that are developed with a limited number of stakeholders (ie, wholesalers, pharmacists, HCPs and regulatory bodies). Conflict of interest situations are likely to be more frequent. Drawing a line between what is allowed and what is prohibited, and complying with the fast-paced regulatory changes may be more challenging.
As regards the liability for medicines and medical devices, two specific legal regimes may apply. Under Article L1142-1 of the PHC, HCPs and hospitals may be liable for the damages caused by a health product furnished or used during an act of prevention, diagnosis or care. Under Directive 85/374, transposed by Law No 98-389 of 19 May 1998, manufacturers can also be found liable for damages caused by a defective product they put on the market.
Both legal regimes are strict liability regimes. Furthermore, the liability for defective products is an exclusive regime excluding other applicable liability regimes based on a similar legal ground. In addition, the prerequisites and conditions of both legal regimes differ greatly (ie, period limitations, existence of a minimum threshold, the defendant and defences).
The defective product must be a movable good, which was put on the market by the manufacturer after 21 May 1998 (ie, the entry into force of the transposing law). Although the liability regime for a defective product does not cover damages to goods that are less than EUR500 (franchise), it covers any type of bodily injury without limitation.
As for the conditions of liability, the plaintiff must prove the damage, the defect of the product and a causal link between the damage and the defect.
Under Directive 85/374, the producer(s) of the finished product, any component part or any raw material shall be primarily liable for any loss or damage caused by a defective product regardless of any contractual relationship. Liability shall be extended to the persons who imported the product into the EU and companies presenting themselves as the manufacturer by affixing their name, trade mark or any other distinctive features on the product.
Where the manufacturer(s) cannot be identified, the seller, the renter or any other supplier of the product may be liable if he or she fails to provide the claimant with the identity of his or her supplier or the actual manufacturer within three months upon receipt of the victim’s claim. If the product cannot be identified, each supplier of the product shall be in principle treated as its producer. European judges have clarified that a service-provider using the defective product does not fall within the scope of this standard.
The traditional standard proof of causation lies in the proof of an actual, direct and certain causal link. The certainty of the causal link should be understood as a scientifically proven causal link between the defectiveness of the product and the occurrence of the damage.
Due to the major difficulties faced by patients trying to prove the necessary scientific evidence, case law has admitted ‘proof by presumption’, provided that these presumptions are ‘serious, specific and consistent’. Several elements are taken into account: the acquired scientific data on any potential causal link, the time between the occurrence of the damage and the date the medicine was taken, as well as the absence of other potential causes. To some extent, these presumptions can also be used to prove the intake of the alleged medicine.
The defendant can always argue that these presumptions are not sufficiently solid and/or consistent to prove the link of causality (Supreme Court, 18 October 2017, No 14-18118) or that the burden of proof is disregarded.
In respect of defences, manufacturers can oppose the information already given through the summary of the product characteristics (SPC) and the package leaflet. They may also challenge the casual link between the damage and the defect of the product.
Furthermore, Article 1245-10 of the French Civil Code (FCC) provides several grounds of exoneration for the manufacturer:
Article 1245-10 5° of the FCC provides exoneration for the manufacturer if they can prove that the defect results from compliance of the product with mandatory regulations issued by the public authorities.
Ifit is demonstrated that the plaintiff was indeed exposed to the alleged active substance that was put on the market by several pharmaceutical companies, each of them shall be jointly and severally liable, unless one of them demonstrates that their product is not the cause of the damage. This solution was first introduced by the Distilbène case.
The burden of damage is ruled by a case-by-case approach. However, the liability was traditionally assessed in the light of the seriousness of each pharmaceutical company’s misconduct and when there was a similar fault, there was an equal share of the liabilities. Most recently, the market share liability seems to be favoured as more equitable.
Under the law of 19 May 1998, the rights conferred upon the injured person against the producer shall be extinguished upon the expiry of a ten-year period from the date on which the product was put into circulation, unless the injured person has, in the meantime, instituted proceedings against the producer. According to case law, in the case of serial products, the date of commercialisation shall be that of the batch.
Moreover, a limitation period of three years applies to proceedings for the recovery of damages. The limitation period begins to run the day the plaintiff becomes aware, or should reasonably have become aware, of the damage, the defect and the identity of the producer. The three-year limitation period shall be included within the ten-year period during which the liability of the manufacturer can be sought.
There is no specific channel or proceedings under which a claim for information against the manufacturers or the public authorities can be made (bearing in mind that in any case the ANSM has a duty to monitor medicines and inform the public while the manufacturer must provide extensive information on the product; eg, conditions of use, gravity and frequency of the adverse events).
In the context of the regime on defective products, the plaintiff can request from the supplier of the product the identity of the manufacturer. Adverse events may also be reported to the regulatory body by HCPs.
The damages potentially recoverable against the manufacturer mainly concern the impairment of physical integrity (death or injury) and all the resulting damages, whether or not they have economic consequences. They also include damage to goods and property. However, the damages caused to the product itself fall outside the scope of Directive 85/374.
In French civil law, damages are limited to compensation, which exclude any type of punitive damages.
Damages that have not materialised yet are not recoverable. However, courts have acknowledged that damages can be recovered from the exposure to a risk, which was called ‘anxiety prejudice’ (eg, prejudice resulting from the awareness of being a carrier of a potentially dangerous medical device; Paris Court of Appeal, 12 September 2008).
With respect to the French principle of full compensation for loss and damages, there is no maximum limit of damages available for one claimant (even in the case of class actions). The same applies for the damages that a manufacturer may owe to the victim.
A general trend shows that civil and criminal litigations, driven by the adoption of the class-action mechanism, have been increasing within the healthcare sector over the past few years.
Be that as it may, the Supreme Court overruled on 26 September 2018 a judgment and held that when the adverse reactions are too significant in comparison with the benefits expected, the product should be considered as ‘defective’, regardless of any reference to these side-effects on the leaflet. In another case dated 10 October 2018 involving the PIP breast implants, it has been acknowledged that the Notified Body that previously certified a device found defective could be held liable.
The trial is held by a judge or several judges, depending on the proceedings.
Unless a court’s order requires a party to do so, there is no disclosure obligation for documents or other evidence for the parties.
To date, there have been no material discussions related to potential changes in the legal regime on defective products.
Regulation (EU) 2016/679 on data protection (also known as the General Data Protection Regulation, or GDPR) governs privacy and data protection. It was incorporated by the Law of 22 June 2018 into Law No 78-17 of 6 January 1978, which has historically regulated privacy and data protection. Two decrees of 20 October 2005 and 1 August 2018 as well as an order of 12 December 2018 were taken to define further the conditions of implementation of the amended Law of 1978.
The CNIL applies and enforces the privacy and data protection framework by imposing administrative sanctions. Infringement of the privacy and data protection legislation can also constitute a criminal offence, which can be ordered by the criminal courts.
Sensitive personal data includes genetic data, biometric data or data concerning health (eg, genetic, biometric or health data such as information related to an individual, results from medical tests, information related to the subject’s medical history).
By way of derogation, processing (whether electronically or on paper) of health data is allowed if:
Should the said processing be allowed, it must be carried out on a legal ground pursuant to Article 6 of the GDPR (consent of the data subject, compliance with a legal obligation, vital interest of the subject incapable of consent, etc).
In addition to the mandatory European legal framework and while most preliminary formalities disappeared with the GDPR, France has strengthened the requirements related to processing of health data by deciding, for example, that data processing for reasons of public interest in the area of public health remains subject to prior formalities (ie, statement of compliance or prior approval). Several provisions of the PHC may also be applicable as regards the interoperability and security standards (L1110-4-1, PHC), the hosting of health data (L1111-8 and R1111-8-8, PHC), the availability of health data (L1460-1, PHC), or the prohibition to transfer or commercially exploit the said health data (L1111-8, PHC and L4113-7, PHC).
The CNIL may issue to the controller or the processor warnings, or order them to comply with the data subject’s requests, to communicate a personal data breach to the data subject, to make the rectification or erasure of personal data or restriction of processing, to suspend the data flows to a recipient in a third country or an international organisation, or to bring processing operations into compliance subject to a fine.
The CNIL has the authority to impose a temporary or definitive limitation, or ban on processing, to withdraw a certification or to order the certification body to withdraw it and to impose an administrative fine. Such a fine can go up to EUR20 million or, in the case of an undertaking, up to 4% of the total worldwide annual turnover of the previous financial year (whichever is higher).
Criminal sanctions may also be imposed by the competent courts. Depending on the offences, infringements can be sentenced with up to five years of imprisonment and a EUR300,000 fine.
Cloud platforms fall within the GDPR framework provided (i) the processing activities are related to the offering of goods or services to data subjects within the EU or (ii) the processing activities are related to behaviour monitoring of data subjects within the EU.
As data controllers, cloud computing customers must be able to meet their obligations and choose providers that guarantee the implementation of security and confidentiality measures.
In this regard, a comprehensive risk analysis and a detailed and personalised service agreement is strongly encouraged.
Sensitive health data may be stored in cloud platforms provided that all the stakeholders comply with the GDPR requirements. Specific French provisions also impose additional requirements such as certification of the health data host as per Articles L1111-8 and R1111-9 of the PHC.
In 2018, the laws concerning health and pharmaceutical industries were the focus of many developments. In this context, the year is marked by different trends, as set out below.
More and More Shortages
In 2017, more than 500 essential drugs were reported to be out of supply, a 30% increase from 2016. The number of drug shortages reached a record high in 2018, and drug unavailability problems can now be considered chronic.
Medicines of vital importance, named medicinal products of major therapeutic interest, dispensed in hospitals and medicines for daily use sold in pharmacies are both affected by these stock shortages.
Shortages are costly for healthcare facilities, which are forced to purchase high-cost substitutes, and they also lead to lost opportunities in patient treatment. To remedy these situations, France has developed and strengthened its legal system in recent years, with new obligations for both wholesalers and pharmaceutical companies.
Indeed, law No 2016-41 of 26 January 2016 on the "modernisation of our healthcare system" imposes an obligation on pharmaceutical companies to supply the national market in an appropriate and continuous manner, and to prevent and overcome any supply difficulties.
For medicinal products of major therapeutic interest for which discontinuation presents a serious and immediate risk, this obligation includes the implementation of shortage management plans. For medicinal products of major therapeutic interest for which a shortage does not present a serious risk to patients, alternative solutions must at least exist to deal with shortages.
It is up to pharmaceutical companies to determine the medicinal products of major therapeutic interest for which a shortage poses a serious and immediate risk. This may be an issue as, in the end, the implementation of shortage management plans or alternative solutions is the exclusive responsibility of the pharmaceutical companies.
Wholesalers are now responsible for ensuring a continuous supply to the market in order to cover the needs of patients. In addition, the export sale of medicines on the French Medicine Agency list of medicinal products of major therapeutic interest which are out of stock or at risk of being out of stock is prohibited.
Health professionals have also taken action. The College of Pharmacists has established an alert platform, called "DP-Ruptures", which enables pharmacies to send reports to manufacturers concerning drugs that have been unavailable for more than three days. The system does not prevent stock-outs, but it should reduce the length of time drugs are absent from pharmacy inventories.
The French Medicine Agency recently fined a pharmaceutical company for non-compliance with the obligation to supply the national market, which is not the usual basis for the financial sanctions it imposes.
More Major Sanctions from the French Health Authority
Since 2015, the French Medicines Agency has had the power to impose financial penalties. Over the past three years, the main financial penalties imposed against pharmaceutical manufacturers have generally concerned advertising control and the marketing of health products.
However, a financial penalty decision of 28 December 2018 issued by the French Medicines Agency sanctioned a pharmaceutical company because it did not set up any shortage-management plans for its product, which was a medicinal product of major therapeutic interest for which a shortage presented a serious and immediate risk to patients, and it did not provide alternative solutions to deal with this situation.
This decision is significant, firstly because the fine amounts almost to EUR350,000 and secondly because it is the first decision based on the obligation to set up shortage-management plans. This decision is in line with the conclusions of a recent Senate information report on the shortage of medicines and vaccines, which expressly mentions that "the failure of an operator to fulfil its obligations to provide alternative solutions [and] measures provided for by a PGP [...] may give rise to financial penalties imposed by the ANSM," and that "any failure by laboratories to supply the market in an appropriate and continuous manner, in particular by not allowing wholesalers-participants to fulfil their public service obligations, shall be financially sanctioned."
In light of the many previous decisions of the ANSM, the responsibility for supply disruptions seemed to have previously concerned wholesalers almost exclusively, as part of their public service obligations, but recent developments on this public health subject demonstrate that pharmaceutical companies also bear an effective responsibility in this area that some might consider excessive. Pharmaceutical companies and wholesalers must, in any case, give even greater consideration to these risks and maintain or implement appropriate tools internally.
The financial penalties imposed by the ANSM on pharmaceutical companies no longer solely concern non-compliance with advertising rules.
More Constraints Concerning Personal Data
The impact of the General Data Protection Regulation (GDPR), which came into effect on 25 May 2018, is wide ranging in the health sector and causes some difficulties, particularly with regard to clinical trials and the concept of Healthcare Data Host.
In France, the data protection law of 1978, adapted to the GDPR in June 2018, still allows the French Data Protection Authority (CNIL) to regulate the processing of personal health data through reference documents. Commitment to comply with these methodologies exempts the data controller – generally the sponsor of the research – from having to apply to the CNIL for authorisation of the processing.
These reference documents are specific to France but they could inspire other European countries because of their usefulness in explaining the relationships between the various regulations. However, in the context of research involving the human person, despite the GDPR, Member States have a margin of manoeuvre, allowing them to take a stricter approach in this area.
It is in this shifting context that the CNIL published the new reference documents in the Official Journal in July 2018, updated from the GDPR. In particular, the publication of the MR-01 reference document relating to the processing of personal data, in the context of research in the health sector with the obtaining of the patient's consent, sheds light on the practical application of the GDPR to patient information notes.
Indeed, putting these patient information notes in perspective not only with the new GDPR obligations but also with current clinical trial regulations raises important practical questions, including (i) the link between the period for which personal data is kept and the period for archiving the permanent clinical trial file required by national laws and by the regulation on clinical trials for medicinal products, which will soon enter into force; (ii) the possible increase in the number of information notes to be signed by the same patient in order to be included in a clinical trial; (iii) the procedures for informing persons under medical treatment in the context of an ongoing study and possible referral to the ethic committees for this additional information; and (iv) the sensitivity of ethics committees in France (CPP) or in another country to which the information notes are submitted, particularly with regard to the balance to be struck between ethics and the constraints of the new personal data protection rules.
Clinical research actors must therefore be attentive to the prompt updating of their patient information notes and, more broadly, their clinical research contracts in France and Europe.
The fact that the French clinical trials regulation is more and more complex may hinder the role of France in research. In 2018, France is behind the USA, the UK and Germany in terms of the number of performed clinical trials, decreasing little by little in the ranking.
Another difficulty is related to the notion of "Healthcare Data Hosting", which is a particular French notion. Indeed, it is difficult to articulate this notion with the new European regulation on personal data.
New Legal Opportunity for Business: the Case of Telemedecine
In France, the legal framework surrounding telemedicine activities has changed rapidly in recent months.
A quick look at the internet shows that many recent websites offer patients the possibility to treat their illnesses through remote medical consultations. Depending on the websites, the patient chooses the method by which he or she wishes to contact a physician: in writing, by phone or by video.
Indeed, the French authorities seem to be more lenient with respect to telemedicine activities.
Under French law, telemedicine is defined as "a form of remote medical practice using information and communication technologies." Several remote medical acts fall into the scope of telemedicine. More specifically, a remote consultation ("teleconsultation") is a form of telemedicine that aims to "enable healthcare professionals to give remote consultations to patients. A healthcare professional may be present with the patient and, if necessary, assist the medical professional during the remote consultation."
Before 14 September 2018, a contractual arrangement with a French authority was mandatory prior to any implementation of telemedicine activities in France. The purpose of this agreement was to determine the objectives and procedures for carrying out the teleconsultation activity, within the framework of a regional organisation that guarantees the quality and safety of care. Since 14 September 2018, there are no longer prior formalities to be carried out with the French authorities in order to implement telemedicine activities.
In addition, it is now possible for patients to be reimbursed by the French social security system for remote consultations. Indeed, from 15 September 2018, remote consultations performed through videos can be reimbursed – under certain conditions – by the French social security system.
According to the recent changes from December 2018, the next step would be to give a role to pharmacists, who will be able to assist the patient during a remote consultation. The pharmacist will be required to have a closed room in his or her pharmacy to carry out this activity, in order to ensure the confidentiality of exchanges and the privacy of patients.
These recent developments are being carried out under the watchful eye of the French medical board, which closely monitors compliance of these new activities with physicians' ethical obligations as defined by the French public health code.
It also seems that more and more companies, including pharmaceutical companies, want to develop their telemedicine activity along with their historical business.
More Constraints for Pharmaceutical Companies for their Relationships with Healthcare Professionals
Introduced by Ordinance No 2017-47 of 19 January 2017 on the benefits in kind offered by persons manufacturing or marketing health products or services, the new Anti-kickback Statute has been in force in France since 1 July 2018. This new statute significantly reforms the scope of the Anti-kickback Statute.
Indeed, the former Anti-kickback Statute targets healthcare companies that sell products or services reimbursed by the French social security system, while the new Anti-kickback Statute will apply to healthcare companies that sell reimbursed and non-reimbursed healthcare products.
Healthcare companies are prohibited from granting forbidden benefits in kind to healthcare professionals such as physicians, dental surgeons, pharmacists, nurses, masseur physiotherapists, chiropractors, osteopaths, psychotherapists, students entering the health professions listed above, associations of healthcare professionals, or students and civil servants acting in the health sector.
In this context, forbidden benefits in kind means any type of advantages/benefits granted to healthcare professionals, such as gifts, free travel and meals, and excessive fees paid for services rendered.
Benefits in kind are prohibited, except for the following:
According to the new Anti-kickback Statute, healthcare companies must draft written agreements concerning the hospitality granted to healthcare professionals, the payment of services rendered within the context of scientific evaluation and research, or the payment of grants or donations.
Then, healthcare companies must contact the competent healthcare professional board, and either make a prior declaration for the implementation of the agreements or request prior authorisation. It is a key change, compared with the previous system.
Moreover, the new Anti-kickback Statute implements new penalties, such as one year's imprisonment and a fine of EUR75,000 for people who received forbidden benefits in kind, and two years' imprisonment and a fine of EUR150,000 (which may be increased to 50% of the expenses incurred for the practice constituting the offence) for healthcare companies that provide benefits in kind.
2019 began with a judgment confirming the application of the French Anti-kickback Statute in the pharmaceutical sector.
The Besançon Court of Appeal upheld and increased the sentences handed down in November 2017 by the Lons-le-Saunier criminal court in a case involving two pharmacists, employed by a pharmacy, who had received numerous gift vouchers from suppliers subject to the Anti-kickback Statute.
The judgment in question called for a suspended sentence of one year's imprisonment for one of the pharmacists and a fine of EUR40,000 for one of the suppliers. The Court of Appeal's decision also significantly increased the amount of compensation to be paid by the two salaried pharmacists for the moral prejudice of the pharmacy and its owner.
The introduction of the French Sunshine Act in 2012 was intended to ensure greater transparency and improve public information on the existence of relations and links of interest between companies and healthcare professionals.
As a result, healthcare companies that produce or market healthcare and cosmetic products intended for human beings, whether reimbursed by the Social Security or not, which fall under the scope of competency of the French Healthcare Agency must disclose on a public website processed by the ministry of health any benefits in kind granted to healthcare professionals and other targets.
General information must be disclosed on the internet, such as the identity of the grantor and the grantee, the date of signature of the agreement and the termination date, the agreement's precise purpose according to an official typology, whether or not the agreement's purpose is related to promotional or scientific events or congresses, the organiser, the name, date and place of the event, and the total amount of an agreement. Moreover, remuneration that amounts to EUR10 or more must be disclosed on the same website.
Transparency beneficiaries that fail to disclose the precise purpose, date, direct beneficiary and final beneficiary, and the amount of the agreements, remuneration and benefits granted may be ordered to pay a fine of EUR45,000.
Increase of Pressure on Pharmacies in Terms of Liability
In the area of health products, the class action was created in France by the Touraine law of 26 January 2016. This new French class action procedure has many features in common with the procedure in place since 2014 for consumers.
The purpose of the group action is to compensate the personal injuries suffered by several users of the health system placed in a similar or identical situation. These injuries must be caused by professional misconduct and must involve a health product. This may include, for example, people who have undergone treatment in hospital or who have been prescribed drugs by doctors. The health products in question are defined in a non-exhaustive list contained in the Public Health Code, and may include drugs and devices used by health professionals to diagnose or treat diseases, but also blood products, contraceptives, contact lenses and cosmetics.
In France, many actions are initiated before the civil or administrative courts due to defective products and especially defective medicines or medical devices. These were the well-known Mediator or PIP cases, which have been the subject of a French television broadcast exposing the responsibility of the ANSM for matters of adverse events. These actions were not subject to the new class action as they were initiated before the Touraine law entered into force.
However, in May 2017, the first class action in the field of health was launched, in the Depakine case. This was followed by another class action in June 2018, which was finally filed in the Levothyrox case by more than 4,000 complainants. In this case, patients complain of "lack of information and prejudice of anxiety," and respectively claim a lump sum compensation of EUR10,000. The case was heard by the first circuit court of Lyon last December and the decision is still awaited.
Other Key Trends in the Health Sector in 2018
Creation of hybrid medicines
The Social Security Financing Law for 2019 (in French the "LFSS") allows the creation, by 2020, of a new repertoire of so-called "hybrid medicines", thus allowing the replacement of pharmaceutical specialities by hybrid medicines, which would have a very negative financial impact on some French pharmaceutical companies.
According to the legislator, these products are specific generic medicines whose authorisation is based partly on the results of clinical trials of the reference medicine and partly on new data, and which "generally have an advantage for patients by providing a useful variation compared to the reference medicine: a new dosage form, which is easy to use for some patients or a new packaging which is more suitable for certain situations of use."
From a health and safety point of view, it therefore seems impossible to exclude the risk that the replacement of a medicine by a radically different hybrid medicine could modify the results of a treatment. As a result, it is impossible to exclude a risk to the health of patients associated with replacement by hybrid medicines.
Increase in mergers and acquisitions in the pharmaceutical industry
2018 was marked by major acquisitions in the pharmaceutical industry.
One of the explanations for this increase was the tax reform in the United States in late 2017. In 2018, pharmaceutical companies benefited from reduced taxes on profits made abroad, and their tax rates were lowered. In this context, pharmaceutical companies had more margins to acquire other pharmaceutical companies.
Another reason for pharmaceutical companies making acquisitions is that patents for several biological products are nearing their end dates.
2018 began and ended with two major acquisitions. In January, the French group Sanofi acquired US biotech company Bioverativ, which specialises in the treatment of blood diseases, for EUR9.3 billion, and then acquired Belgian biotech company Ablynx for EUR3.9 billion. At the end of the year, UPSA, which is famous for its Donormyl, Fervex and Efferalgan products in particular, was acquired by the Japanese laboratory Taisho Pharmaceutical.
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