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Trends and developments
Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?
On January 26 2016 France adopted the Law on the Modernisation of the French Healthcare System (2016/41), which introduced the following legal developments with regard to the pharmaceutical industry:
- A class action (referred to as a ‘group action’) enabling patients to file a collective claim in case of damage was introduced. The related implementing decree was published on September 27 2016 (Decree Related to the Class Action in Health-related Matters (2016/1249)) and the first group action was brought in early October 2016 by an association which defends those affected by an anti-convulsant product containing sodium valproate (also known as the Depakine case). Decree 2017/810 (May 5 2017) entered into force on June 1 2017 and created a non-judicial compensation procedure for the victims with the intervention of the agency overseeing cases concerning medical accidents (the National Office of Compensation for Medical Accidents, Iatrogenic Disorders and Nosocomial Infections). As a result, victims of drugs containing sodium valproate are able either to participate in the class action or choose the non-judicial compensation as provided by Decree 2017/810. In addition, Decree 2017/888 (May 6 2017) introduces a common base for all class actions in the fields of discrimination, environment, protection of personal data and health. To date, the number of group actions initiated in France is limited.
- The safety requirements for medicines and medical devices were increased by mitigating supply disruptions and strengthening the traceability of products.
- Access to health data was opened up to the public, in order to develop new services and facilitate research and innovation while ensuring individuals’ privacy.
- The transparency requirements were increased by extending the scope of the mandatory disclosure obligations regarding the links between healthcare practitioners and pharmaceutical companies.
France also modified its clinical trial legal framework by adopting the Ordinance concerning Research Involving Humans (2016/800) on June 16 2016, amending Law 2012/300 (known as Loi Jarde). On November 16 2016 the Implementing Decree concerning Research Involving Humans (2016/1537) was issued, bringing changes regarding:
- the modalities of carrying out research involving humans;
- the definitions applicable to the various research categories;
- the functioning of committees for the protection of persons (ethics committees); and
- the rules applicable to vigilance.
The European legal framework related to clinical trials is also subject to ongoing changes. The new Clinical Trials Regulation (Regulation 536/2014, April 16 2014) repealed Directive 2001/20/EC (April 4 2001); this new regulation provides a three-year transition period applicable to clinical trial applications submitted before the regulation came into effect on May 28 2016, and to those submitted within one year of this date if the sponsor opted for the previous system. In order to prepare for the implementation of the new clinical trial regulation, a pilot phase was undertaken, which ended on March 31 2017. The results of the pilot phase were encouraging, as the number of applications for clinical trials increased.
What is the primary legislation governing medicinal products in your jurisdiction?
The French healthcare sector is mainly governed by the Public Health Code. Numerous guidelines have also been issued by the National Agency for Medicines and Health Products Safety (ANSM) and industry associations, such as the Pharmaceutical Companies Association, whose guidelines apply to drug manufacturers, and the National Union of the Medical Technology Industry, whose guidelines apply to medical device manufacturers.
The sector is also subject to the EU legal framework and governed by various EU regulations and directives.
Are any legislative changes proposed or expected in the near future?
The healthcare sector is one of the most heavily regulated and is subject to continuously evolving national regulations, which are based on changing EU regulations.
Most French governments, regardless of their political association, have increased the scrutiny of the industry and the short-term evolution of legislation has reflected this trend.
The Law on the Modernisation of the French Healthcare System (2016/41), which was introduced on January 26 2016, aims to make health data available to the public. In this respect, the law established the National System of Health Information, a national health database that aggregates health data from multiple sources. The related implementing decree was adopted on December 26 2016 and effective since April 1 2017. A ministerial order adopted on March 22 2017 provides for specific security requirements in relation to the National System of Health Information and all information systems dealing with health data from the National System of Health Information.
The relationship between the industry and healthcare professionals is also undergoing changes. On the transparency side, an implementing decree relating to the extension of the scope of disclosure regarding the links between healthcare practitioners and pharmaceutical companies was adopted on December 30 2016 (Decree 2016/1939) and has been effective since the entry into force of the relevant order on March 26 2017. On the anti-gift side, Ordinance 2017/49 was adopted on January 19 2017, which aims to extend the scope of the anti-gift law of January 27 1993 (Law 93/121) and change the procedure relating to the prior submission of all agreements concluded with and hospitalities granted to healthcare professionals to the relevant national or departmental council. The new provisions will enter into force after the adoption of an implementing decree, no later than July 1 2018.
Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?
The main agency in this regard is the ANSM, which guarantees the safety of health products during their entire lifespan – from trial to market surveillance.
The National Authority for Health is an independent public scientific authority which contributes to the regulation of the healthcare system by:
- performing assessments;
- issuing recommendations; and
- rendering accreditations and certifications.
The Economic Committee for Health Products is an inter-ministerial body under the joint authority of the ministers responsible for health, social security and the economy. It is primarily responsible for determining the price of medicines.
The Shared Healthcare Information Systems Agency (ASIP), a department within the Ministry of Health, is the French digital health agency. It is responsible for assisting the development of e-health services. For example, in France, the hosting of personal health-related data can be performed only by an accredited health data host and such accreditation must be delivered by the ASIP. The abovementioned Law on the Modernisation of the French Healthcare System and the ordinance concerning the hosting of personal health-related data, dated January 12 2017, intends to replace this accreditation procedure with the requirement to obtain certification from the French Accreditation Committee. However, to date, no decree has been issued concerning this new procedure.
Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?
The French Competition Authority (ADLC) is the independent administrative authority in charge of enforcing competition law in France, although the French courts also have jurisdiction to rule over competition-related matters. For example, the Supreme Court recently confirmed (Cass, 15-10.384, October 18 2016) the ADLC’s decision that Sanofi-Aventis had abused its dominant position by denigrating generic competitors of its drug (Decision 13-D-11, May 14 2013).
However, contrary to other countries, the French pharmaceutical industry has not traditionally been subject to anti-bribery related monitoring, as there was no equivalent to the US Foreign Corrupt Practice Act or the UK Bribery Act. The recent adoption of the French Bribery Act may change this.
Data protection-related issues can also arise from pharmaceutical companies’ activities, particularly with regard to:
- conducting clinical trials;
- reporting adverse effects; and
- undertaking medical research.
Further, specific requirements apply to the hosting of personal health-related data. For example, in order to perform any telemedicine-related activity in France, data hosts must:
- be accredited with the French Agency for Digital Health; or
- work with an accredited data host – changes should be brought with the new certification procedure which will enter into force on the adoption of the relevant decree or no later than January 1 2019.
Moreover, when the General Data Protection Regulation comes into effect on May 25 2018, life sciences companies will be affected with regard to patient information and consent, and data protection impact assessments. This is a fundamental risk management resource which should allow life sciences companies in particular – which process sensitive data such as health data – to be aware of data processing activities that are likely to be high-risk and enable them to implement prevention measures in order to address those risks.
Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?
The Public Health Code provides a broad definition of ‘medicinal products‘, which encompasses all medicinal products, including homeopathic medicinal products, food supplements and traditional herbal medicinal products. The code does not exempt these products from being regulated, although they are regulated by a special regime.
What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?
Article L5124-3 of the Public Health Code provides that the manufacture of medicinal products is subject to manufacturing authorisation from the National Agency for Medicines and Health Products Safety (ANSM), which will be granted within 90 days from the examination of the manufacturer’s application (Article R5124-9 of the code). In France, pharmaceutical responsibility should lie with a nominatively designated person known as the chief pharmaceutical officer.
What is the fee for obtaining authorisation?
There is no fee associated with obtaining manufacturing authorisation.
What is the validity period for authorisation?
Manufacturing authorisation is granted once and has no pre-determined validity period. In other words, it is valid until the manufacturer ceases its activity or the ANSM withdraws the authorisation due to non-conformity with the applicable regulations.
How robust are the standard good manufacturing practices followed in your jurisdiction?
The EU regulatory framework has been broadened in light of the work of the International Conference on Harmonisation, which serves as international standards. France has strictly transposed this set of regulations into national law (Article L5121-5 of the Public Health Code and the Decision of the ANSM on Good Manufacturing Practices, updated on December 30 2016), which is therefore aligned with the international standards in terms of good manufacturing practices.
What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?
Carrying out medicinal product manufacturing without manufacturing authorisation is punishable by up to two years’ imprisonment and a fine of up to €150,000 (Article L5423-3 of the Public Health Code). Failure to apply the good manufacturing practices is punishable by up to two years’ imprisonment and a fine of up to €150,000 (Article L5421-1 of the Public Health Code). In both cases, companies can receive fines of up to €750,000. Other penalties that can be imposed on companies include the temporary or definitive prohibition of undertaking any activity relating to the infringement or debarment from public tenders. Further, the ANSM can suspend or withdraw manufacturing authorisation in case of non-compliance (Articles L5124-3 and R5124-15 of the Public Health Code).
How are the distribution and storage of medicinal products regulated?
According to Article L5124-3 of the Public Health Code, the opening of a pharmaceutical business, regardless of its activity, is subject to ANSM authorisation. This means that both distribution and storage activities are regulated. The code requires manufacturers, operators, distributors, wholesalers and depositaries undertaking distribution and storage activity to obtain prior authorisation from the ANSM in this respect.
Import and export
How are the import and export of medicinal products regulated?
The import and export of medicinal products are subject to prior authorisation from the ANSM.
In relation to the export of medicinal products, Article L5124-11 of the Public Health Code requires exporters to apply for ANSM certification.
In relation to the import of medicinal products, Article R5121-108 of the Public Health Code requires importers to have:
- European marketing authorisation;
- parallel import authorisation;
- temporary authorisation for use;
- a qualification for a medicinal product to be used for authorised clinical research; or
- import authorisation obtained from the ANSM before commencing import operations.
Are parallel imports permitted in your jurisdiction?
Pursuant to Article R5121-115 of the Public Health Code, if a medicinal product has marketing authorisation in an EU member state, it can be granted parallel import authorisation by the ANSM in order to be sold in France if a similar medicinal product has also obtained marketing authorisation. ‘Similar’ means similar in terms of:
- the qualitative and quantitative composition of the products’ active substances;
- the pharmaceutical form of the products; and
- the therapeutic effects of the products.
Once parallel import authorisation has been granted, the importing company must immediately advise the marketing authorisation holder (Article R5121-124 of the Public Health Code).
Sale and purchase
What rules govern the dispensing, sale and purchase of medicinal products?
Medicinal products can be sold and purchased in France if they have obtained prior authorisation from the ANSM.
As explained above, medicinal products that have obtained prior marketing authorisation in another EU member state can obtain parallel import authorisation, which will allow them to be sold and purchased. The same applies to medicinal products that have obtained import authorisation. There are also special legal regimes for medicinal products that have obtained temporary authorisation for use or are to be used for authorised clinical research.
Are there any restrictions on the online sale and purchase of medicinal products?
Medicinal products can be sold and purchased online in France, provided that the following conditions are met (Articles L5125-33 and following and R5125-70 and following of the Public Health Code):
- The right to implement websites intended for the sale of medicinal products is reserved for pharmacists.
- Websites should be associated with a physical pharmacy.
- Only non-prescription medicines can be sold online.
- The creation of a website must be authorised by the Regional Agency of Health.
Pharmacists are responsible for the online dispensing of medicinal products and must comply with the rules of conduct applicable to the sale of medicinal products in pharmacies and the rules applicable to the dispensing of goods, which are detailed in the Order related to Good Dispensing Practices of November 28 2016.
Named patient supply
What rules govern named patient supply of pre-launch medicinal products?
In France, the exceptional use of medicinal products that do not have marketing authorisation and are not used in clinical trials is possible through the obtainment of temporary authorisation for use in advance of marketing authorisation. Temporary authorisation for use is granted by the ANSM and intended for medicinal products which can be used to treat serious or rare diseases when no appropriate treatment exists and the initiation of treatment cannot be deferred (Article L5121-12 of the Public Health Code).
The types of temporary authorisation for use available are:
- cohort temporary authorisation for use, which covers medicinal products of which the efficacy and safety of use are strongly presumed and which are intended for a group or sub-group of patients; and
- nominative temporary authorisation for use, which is issued for a single named person who cannot participate in a clinical trial and which is done so on request and under the responsibility of a prescribing physician.
Decree 2017/707, published on May 2 2017, stated that the maximum period to file a marketing authorisation following a temporary authorisation for use is one year from the date that the temporary authorisation was granted.
What is the authorisation procedure for conducting clinical trials in your jurisdiction?
Pursuant to Articles L1121-1 and L1121-4 of the Public Health Code, clinical trials can be carried out if they have:
- obtained a favourable opinion from the relevant committee for the protection of persons (an ethics committee); and
- been authorised by the National Agency for Medicines and Health Products Safety (ANSM).
How robust are the standard good clinical practices followed in your jurisdiction?
The EU regulatory framework has been broadened in light of the work of the International Conference on Harmonisation, which serves as international standards. France has strictly transposed this set of regulations into national law (Decree 2006/477, dated April 26 2006, and the Decision of the ANSM on Good Clinical Practices, dated November 24 2006), which is therefore aligned with the international standards in terms of good manufacturing practices.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
In applying a former version of Article L1121-15 of the Public Health Code, the ANSM established a public register of clinical trials. Only information on biomedical research for which an application for marketing authorisation has subsequently been issued is published in the register.
While this register is still available, the Ordinance concerning Research Involving Humans (2016/800), dated June 16 2016, amended Article L1121-15 of the Public Health Code, which now provides that research involving humans and the results must be published in a public register in accordance with the decree. In that respect, the Decree concerning Research Involving Humans (2016/1537) was adopted on November 16 2016, although it provides no further clarification regarding this new version of the register for research involving humans.
What are the informed consent obligations with respect to clinical trial subjects?
Pursuant to Article L1122-1-1 of the Public Health Code, informed consent must be obtained from the subject of a trial before his or her inclusion. This includes the provision of comprehensive information on the trial, including its:
- expected benefits; and
- foreseeable constraints and risks.
Consent must be given freely and in writing. Where the person is incapable of giving written consent, it can be given by a ‘trusted person’ (Article L1111-6 of the Public Health Code) – namely, a person designated by a subject where he or she is unable to express his or her consent or the person’s legal representative or relative – on the condition that such person is independent from the investigator or sponsor.
What are the insurance requirements for clinical trials?
Pursuant to Article L1121-10 of the Public Health Code, all interventional studies require the sponsor to obtain prior insurance coverage, in order to ensure adequate compensation of damages or injuries arising from the study.
What data protection issues should be considered when conducting clinical trials?
The legal framework relating to data protection issues with respect to the conduct of clinical trials was amended by the Law on the Modernisation of the French Healthcare System (2016/41) on January 26 2016. The processing of personal data in the healthcare sector for research, study or evaluation purposes must be authorised by the National Commission of Informatics and Civil Liberties (CNIL). The CNIL must also authorise:
- research involving humans, after the relevant committee for the protection of persons (a French ethics committee) has rendered its opinion; and
studies and evaluations not involving humans, after the Expert Committee on Health Research, Study and Evaluation has given its opinion. This new committee was created by law on January 26 2016 and replaced the former Consultative Committee for the Processing of Health Research Data – 21 members were appointed to the committee following a ministerial order adopted on May 5 2017.
The CNIL can also request an opinion from the newly created National Institute of Health Data on the public interest dimension of the research, study or evaluation that requires the processing of personal data.
In order to simplify the authorisation procedure, the CNIL has issued standard methodologies. In particular, the CNIL adopted reference methodology MR-001 for interventional studies and, on July 21 2016, reference methodology MR-003 for non-interventional studies.
What is the marketing authorisation procedure for medicinal products in your jurisdiction?
Pursuant to Article L5121-8 of the Public Health Code, a medicinal product can be placed on the market if marketing authorisation is obtained beforehand. In this respect, an application for marketing authorisation must be submitted to the National Agency for Medicines and Health Products Safety (ANSM) or the European Medicines Agency (EMA).
The different types of procedure for obtaining marketing authorisation are as follows:
- The centralised authorisation procedure, according to which pharmaceutical companies submit a single marketing authorisation application directly to the EMA in order to market the medicinal product throughout the European Union on the basis of a single marketing authorisation. The centralised authorisation procedure is mandatory for certain types of medicinal product – such as medicinal products intended for cancer or neurodegenerative diseases – and optional for others.
- If a company wishes to obtain marketing authorisation in several EU member states for a medicine that is outside the scope of the centralised procedure, it may use the decentralised procedure.
- Another available procedure for medicinal products is the mutual recognition procedure, whereby marketing authorisation granted in one EU member state can be recognised in others. This procedure differs as it applies to medicinal products that already have marketing authorisation at the time of application.
- There is also the national procedure, whereby an application for marketing authorisation is granted by the ANSM.
What criteria are considered in granting marketing authorisation?
The criteria taken into account by the ANSM in granting marketing authorisation are the product’s quality, safety and efficacy. The ANSM will examine whether the risk-benefit balance is favourable to patients and whether the new medicinal product presents a benefit-risk ratio which is at least equivalent to that of medicinal products already on the market.
What is the fee for obtaining marketing authorisation?
Article 1635bis AE of the General Tax Code provides the fees to be paid for a marketing authorisation application, which are as follows:
- €50,000 for applications made by way of the decentralised procedure in which France is the reference member state;
- €34,000 for applications made by way of the decentralised or mutual recognition procedure in which the reference member state is not France; and
- €34,000 for applications made by way of the national procedure.
What is the validity period for marketing authorisation?
Marketing authority is granted by the ANSM for a five-year period, which can be renewed tacitly, without any limitation of duration, unless the ANSM decides to renew the authorisation on the basis of a re-evaluation of the positive therapeutic effects of the medicinal product with regard to the risks (Article L5121-8 of the Public Health Code).
What are the consequences of failure to obtain marketing authorisation?
According to Article R5121-42 of the Public Health Code, an ANSM decision refusing marketing authorisation must detail the applicable legal remedies and appeal period. An ANSM decision constitutes an administrative decision under French law and, as such, may give rise to proceedings before the French administrative court with jurisdiction.
The marketing of a medicinal product for which marketing authority has not been obtained is punishable by up to five years’ imprisonment and a fine of up to €375,000 for individuals or €1,875,000 for companies (Article L5421-8 of the Public Health Code). Other penalties can also be imposed on companies, such as a temporary or definitive prohibition against undertaking an activity relating to the infringement or debarment from public tenders.
What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?
In France, pharmacovigilance procedures aim to monitor, evaluate, prevent and manage the risk of an adverse reaction resulting from the use of medicinal products (Article L5121-22 of the Public Health Code). Pharmacovigilance involves the reporting of suspected medicinal product-related adverse reactions, including in case of overdose, misuse, abuse and medication errors (Article R5121-150 of the Public Health Code).
Pharmacovigilance is coordinated between the National Agency for Medicines and Health Products Safety (ANSM), regional pharmacovigilance centres, healthcare practitioners and pharmaceutical companies. The latter have an obligation to collect and assess information relating to adverse effects, with a view to prevent and mitigate risks and must, if necessary, take appropriate measures (Article L5121-24 of the Public Health Code).
What data protection issues should be considered when conducting pharmacovigilance activities?
According to the data protection law, when implementing a pharmacovigilance system, companies must file a notification with the National Commission on Informatics and Civil Liberties (CNIL) before carrying out any data processing operations. In order to simplify the standard procedures, the CNIL issued the unique authorisation procedure (AU-013) on March 20 2014, which can be used for data processing relating to pharmacovigilance and is less cumbersome and time consuming for companies.
Pricing and reimbursement
Are there rules governing the pricing of medicinal products in your jurisdiction?
The rules governing the pricing of medicinal products depend on whether medicinal products are provided in the community or in hospitals.
The pricing of medicinal products bought by and provided in hospitals can be freely determined (Law 87/588, dated July 30 1987). However, an increasing number of exemptions apply.
For medicinal products provided in the community, there is a distinction depending on whether the products are reimbursed under social security schemes. If they are not reimbursed, the price can be freely determined, whereas if they are reimbursed, the price must be determined through an agreement between the pharmaceutical company and the French Economic Committee for Health Products. In such cases, the price is determined by considering elements such as the level of improvement in medical benefit.
What is the structure for state reimbursement of medicinal product costs?
The decision as to whether a product should be included in the list of reimbursable products is made by the Ministry of Social Security on the basis of an assessment of the medical benefit of each therapeutic indication. If this is insufficient in relation to other available medicinal products, the product cannot be included in the list of reimbursable products (Article R163-1 of the Social Security Code). Depending on the medical benefit of each therapeutic indication, the reimbursement rate varies between 15%, 30%, 65% and 100%.
Advertising and labelling
How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?
Article L5122-1 of the Public Health Code defines ‘advertising’ as any form of information, including canvassing, prospecting or providing incentive, aimed at promoting the prescription, delivery, sale or consumption of medicinal products. Drug advertising is permitted only for drugs which have obtained marketing authorisation (Article L5122-3 of the Public Health Code).
The rules on the advertisement of medicinal products are divided into:
- general rules;
- rules pertaining to advertising directed at healthcare professionals; and
- rules pertaining to advertising directed at the general public.
Advertising directed at healthcare professionals must receive so-called ‘visa PM’ authorisation from the National Agency for Medicines and Health Products Safety (ANSM) before publication (Article L5122-9 of the Public Health Code). Advertising directed at the general public is also regulated and so-called ‘visa GP’ authorisation must be obtained from the ANSM before its publication. Only the advertisement of non-prescription medicines that are not reimbursable through the social security system are permitted (Article L5122-6 of the Public Health Code).
Do any special rules apply to online advertising of medicinal products?
The abovementioned general rules provided for in Article L5122-1 of the Public Health Code are applicable regardless of the advertising media. If an ANSM visa has already been granted for printed material, it is not necessary to apply for additional visas for different types of media, including online advertising, provided that the advertising is strictly similar to that which has been approved. The ANSM issued specific guidelines on advertising published on the Internet in 2014.
What are the packaging and labelling requirements for medicinal products?
Labelling requirements are set out under Article 5121-138 and following of the Public Health Code. There is a distinction between internal and external packaging (also called ‘secondary packaging’). Internal packaging refers to packaging that is physically in contact with the medicinal product, whereas external packaging refers to packaging in which the medicinal product is placed, but which is not in direct contact with the medical product. The ANSM has also issued guidelines on packaging.
How is the promotion of off-label use regulated?
Off-label use of medicinal products is permitted if:
- a recommendation for use has been issued by the ANSM in order to secure the off-label use of the medicinal product; and
- the prescribing physician believes that the off-label use of the medicinal product is indispensable to improving or stabilising the patient’s medical condition.
Pursuant to the charter relating to the promotion of medicinal products, pharmaceutical companies can give notice of the existence of a recommendation for use. However, such information must be separate from any promotional process and must be validated by the ANSM.
Relations with healthcare professionals
Gifts and incentives
What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?
The rules applying to the provision of gifts, discounts and other incentives to healthcare professionals are established in Law 93/121 of January 27 1993, known as the Anti-gift Law, and Law 2011/2012 of December 29 2011, known as the Sunshine Act.
Article L4113-6 of the Public Health Code provides that healthcare professionals cannot receive a direct or indirect advantage, in kind or in cash, from companies manufacturing or marketing health products that are reimbursed under the Social Security Scheme, except:
- certain advantages included in an agreement relating to research activities or scientific evaluation; and
- certain hospitalities offered at promotional or professional and scientific events.
Before they are concluded or granted, the above agreements and hospitalities must be submitted for prior approval to the relevant national or departmental council of the healthcare professional’s workplace, in order for it to assess whether the remuneration for services and hospitalities are reasonable and limited to the sole scientific and professional purpose of the event. This procedure will soon be extended to companies manufacturing health products that are not reimbursed by the social security scheme. It will also be changed into a declaration/authorisation procedure, depending on the value of the advantages or hospitalities. The new provisions are provided by Ordinance 2017/49 of January 19 2017 and will enter into force after the adoption of an implementing decree (by July 1 2018 at the latest).
In addition, pharmaceutical companies must disclose certain information on a public state portal. Both recent and past years’ changes concerning the content of the disclosure have resulted in significant complexity for pharmaceutical companies with regard to meeting their disclosure obligations.
Pursuant to the Law of January 26 2016 and the implementing decree published on December 28 2016, all remuneration above €10 contained in agreements concluded with healthcare professionals must be disclosed. Previously, only the existence of the agreement and its nature had to be published.
In 2015 and 2016 the Directorate General of Health recommended that the fees and remunerations should be retroactively published (from 2012). However, the French Pharmaceutical Companies Association noted in its July 2017 guidelines that, in practice, companies have different ideas regarding how to implement this retroactive publication.
How can a liability claim for a defective medicinal product be brought?
The liability regime for defective medicinal products is governed by the general liability regime applicable to defective products provided for in Articles 1245 to 1245-17 of the Civil Code.
The plaintiff must bring a judicial action to seek compensation for damages caused by a defective medicinal product. It is a strict liability regime which requires the following elements to be established:
- a defect;
- damage; and
- a causal link between the defective product and the damage suffered by the plaintiff.
France has also introduced class actions in the health sector. The implementing decree was published on September 27 2016 (the Decree on Health-related Class Actions (2016/1249)) and allowed for such class actions to be brought as of September 28 2016.
According to the procedure of health-related class actions, only associations of healthcare system users can introduce an action. The class action is aimed at compensating individuals placed in a similar or identical situation with regard to bodily injuries, in the event that these are caused by the same health product manufacturer or supplier.
The class action procedure is divided into two phases. During the first phase, an association will sue a manufacturer on the basis of an existing regime, such as the abovementioned product liability regime. Once a French court has ruled that the manufacturer or professional is liable for the injuries suffered, the judges will also determine the criteria for other patients to join the group and decide on the publicity measures in that respect. Patients have between six months and five years to join the group. The second phase will consist of individual procedures before the same court that found the manufacturer or professional liable. The parties can also agree to a mediation phase at the beginning of the proceedings.
Which parties can be held liable for a defective medicinal product?
Under Article 1245-5 of the Civil Code, a producer does not have to be a professional and may be:
- the manufacturer of the finished product or a component part;
- the producer of the product’s raw material; or
- the party whose distinctive sign is affixed to the product or which imports the product into the European Union for sale purposes.
If the producer cannot be identified, the distributor or another professional supplier will be liable for the defect under the same conditions as a producer would be, unless the distributor or other supplier names its own supplier or producer within three months from the date on which it received notice of the victim’s subpoena (Article 1245-6 of the Civil Code).
What remedies are available to successful claimants?
Successful claimants can be compensated for:
- damages relating to bodily injuries;
- monetary damages – on the conditions that they are certain, direct and foreseeable – including:
- present and future health-related expenses;
- recovery costs;
- loss of income;
- a functional deficit; and
- costs relating to third-party assistance in relation to basic living needs; and
- moral damages, such as those relating to:
- endured suffering;
- disfigurement or discomfort; and
- the diminution of quality of life.
Exclusion and limitation
On what grounds can liability be excluded?
Article 1245-10 of the Civil Code provides that a producer is liable unless it proves, for example, that:
- the defect did not exist when it put the product into circulation;
- the product was not intended for sale or distribution; or
- the state of scientific and technical knowledge at the time of circulation did not allow the defect to be detected.
A producer’s liability may be reduced or excluded if the damage was the fault of both a defect in the product and the victim or a person for whom the victim is responsible (Article 1245-12 of the Civil Code).
What preventive steps can be taken to limit liability?
As the product liability regime is mandatory under French law, no contractual arrangements can be made to prevent its applicability, as the regime supersedes any contrary contractual arrangement.
As a result, clauses that seek to eliminate or limit liability for defective products are valid only if they concern damage to property and relationships between professionals. Otherwise, they are forbidden and will be deemed to be null and void (Article 1245-14 of the Civil Code).
Compliance and enforcement
What measures are in place to enforce the laws governing medicinal products?
The National Agency for Medicines and Health Products Safety is vested with the power to inspect and monitor pharmaceutical companies’ activity, as part of its mission is to guarantee the safety of health products during the entirety of their lifespan – from trial to market surveillance (Article L5412-1 and following of the Public Health Code).
In addition, various fines can be imposed on companies that fail to comply with the applicable rules (Article L5421-1 and following of the Public Health Code). Other penalties can also be imposed on companies, such as a temporary or definitive prohibition against undertaking an activity relating to the infringement or debarment from public tenders.
What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?
Concerning falsified medicinal products, the European Union has strengthened patient and consumer protection by adopting the Directive on the Prevention of the Entry into the Legal Supply Chain of Falsified Medicinal Products (2011/62/EU).
Further, France adopted the Bribery Act (Law 2016/1691) on December 9 2016, which broadly applies to all industries, including the pharmaceutical industry.
In practice, the new law established the National Anti-corruption Agency, which will have various responsibilities, including monitoring the implementation of specific compliance programmes that are newly imposed on companies that have at least 500 employees and an annual turnover of more than €100 million.
Failure to implement such a compliance programme could result in the National Anti-corruption Agency imposing penalties, including a fine of up to €1 million for legal persons.
In addition to the transparency requirements resulting from the French Sunshine Act, which sets forth disclosing obligations of the so-called ‘links of interest’ between life sciences companies and healthcare practitioners, the new Bribery Act now imposes the disclosure of links of interest with lobbyists. An implementing decree was published on May 9 2017 regarding the register of lobbyists. Since July 1 2017 lobbyists have been required to register on an online State Portal. From January 1 2018 to April 30 2018, lobbyists must disclose their identity and the scope of their lobbying activities for 2017.
However, there is still uncertainty with regard to the precise scope of public officials falling under the scope of the law, as well as the question as to whether contacts with the National Agency for Medicines and Health Products Safety, National Authority for Health and the Economic Committee for Health Products within the framework of mandatory administrative procedures would be covered by the law.