In France, the Public Health Code (FPHC) implements the definitions of and rules regarding healthcare products, and more specifically, the provisions relating to medical devices and medicinal products, in its Part V, in accordance with and by specifying the rules set out by the EU regulations.
Medical devices are regulated according to their purpose. They are notably governed by Article L. 5221-1 and Articles R. 5211-1 et seq of the FPHC. Specific rules apply to in vitro diagnostic medical devices.
The legal framework for medical devices has recently been amended by the revision of EU rules, in particular:
Both EU Regulations will be applicable from 26 May 2021 for medical devices and 26 May 2022 for in vitro diagnostic medical devices. The new rules have extended the scope of products covered and toughened the requirements and criteria for the design and manufacture of medical devices.
Medicinal products are regulated according to Articles L. 5121-1 et seq and Articles R. 5121-1 et seq of the FPHC, which transposed Directive (CE) No 2001/83.
In France, in response to the contaminated blood scandal, blood products are strictly regulated by the FPHC (Articles L. 1221-1 et seq and Articles L. 1271-1 et seq). Blood products come exclusively from volunteer blood donors. They comply with strict rules for donor selection, transportation, analysis, and storage, to guarantee the safety of the transfusion chain.
The French Blood Establishment (EFS), established in January 2000, has the monopoly, in France, on the collection, testing, preparation, and distribution of labile blood products (Articles L. 1222-1 to L. 1222-16 of the FPHC).
Cosmetics were first regulated by Directive No 76/68/ECC, which was transposed into national law in Articles L. 5131-1 to L. 5131-11, Articles L. 5431-1 to L. 5431-7, Articles R. 5131-1 to R. 5131-14, and Article R. 5431-1 and R. 5431-2 of the FPHC. The above-mentioned Directive has been replaced by Regulation (EC) No 1223/2009 on cosmetic products.
For several years, debate in France focused on the status of disinfectants used in the medical field. Depending on the manufacturer's claims, disinfectants may fall under the scope of Regulation (EU) No 528/2012, which came into force on 1 September 2013. The characterisation of disinfectants depends on the intended uses of the product, according to the French National Agency for the Safety of Medicines and Health Products (ANSM).
While disinfectants can be considered as medical devices when a medical device needs to be disinfected before use (such as contact lenses or endoscope disinfectants), claims such as "disinfection of medical devices" do not constitute an intended use that falls under the definition of medical devices. Moreover, product claims for general or multi-purpose uses are also considered as encompassing biocides (eg, disinfectants used to prevent the risk of transmission of environmental infectious agents).
Regulated by Regulation (EU) No 528/2012, all biocidal products require prior authorisation before being placed on the market, and the active substances contained in the biocidal product must be approved beforehand. Biocidal products are classified into 22 biocidal product types, grouped in four main areas (disinfectants, preservatives, pest control, and other biocidal products).
At the national level, biocides are governed by the legislation applicable to chemicals of the French Environmental Code. When they are chemicals or active substances, biocides are subject to the provisions on chemicals of Title I of the French Environmental Code.
Food and Nutrition Supplements
Food and nutrition supplements are regulated by Directive No 2002/46/CE relating to food supplements, transposed into French law by Decree No 2006-352 of 20 March 2006.
Software and mobile applications in the health field are currently undergoing a major boom, both in terms of their number and their diversity, particularly in terms of technological innovations.
If the medical app is considered as a medical device (or an in vitro diagnostic device (IVD)), the medical device regulations must be fully applied. Indeed, in line with Regulation (EU) No 2007/745, the French definition of medical devices includes "software designed to be used specifically for diagnosis or treatment purposes" (Article L. 5211-1 of the FPHC).
The status of the medical app is defined by its purpose as well as by its exploitation of any incoming data. The purpose is specified by the manufacturer and is also described in the instructions, labelling and promotional information.
Not all medical apps used in the health field fall under the status of medical devices.
To be considered as a medical device, the software must meet the following cumulative criteria:
Medical apps must also comply with the General Data Protection Regulation (EU) No 2016/679 (GDPR).
Wearables collect health data on a daily basis, which requires strict compliance with data protection legislation. Additionally, depending on the device, medical device regulations may apply.
Telemedicine, a form of remote medical practice, was introduced into the FPHC over 20 years ago (Article L. 6316-1 and Articles R. 6316-1 et seq of the FPHC). It was amended by the Act of 21 July 2009 introducing hospital reforms and its implementing Decree (Decree No 2010-1229). In 2018, the French national security scheme allowed the reimbursement of telemedicine (Articles L. 6316-1 et seq of the FPHC). As France has extended the COVID-19 public health emergency until June 2021, telemedicine is fully reimbursed, and will be until new legislation is considered.
In France, Article R. 51232-86 of the FPHC provides for a general prohibition of any operation involving cannabis and its derivatives.
Nevertheless, the Decree of 22 August 1990 provides for an exception by authorising the farming, import, export and industrial and commercial use of the seeds and fibres of the Cannabis sativa L. variety if the following cumulative conditions are met:
In contrast, European legislation does not require that the use of cultivated hemp plants be limited to their seeds and fibres.
With the expansion of products containing CBD (cannabidiol with non-psychoactive effects), this restrictive regime was challenged before the CJEU, leading to a landmark decision finding the French regulations to be contrary to EU laws (CJEU, 19 November 2020, Case C-66318).
The debate focused on whether or not end products containing CBD could contain THC below 0.20%, even though CBD is extracted from the entire hemp plant and not solely from its fibre and seeds.
As of this date, the commercialisation of CBD is neither authorised nor prohibited in France. This uncertainty will force French legislation to come to a more definitive position; a French inter-ministerial mission "Mildeca" has just been launched to fight against drugs and addictive behaviour, on 26 March 2021. The report of the mission is expected by the summer of 2021, which could lead to legislation on CBD products.
Borderline products have the particularity of being on the borderline between medicines and other sectors. Progressively, EU laws have been enriched with new regulations to facilitate the distinction between medicinal products and, in particular, cosmetic products, medical devices, and food supplements.
Guidelines, issued by both the European Commission and various national authorities, on borderline issues between medical devices and medicines and between cosmetics and medicines have been published.
In borderline situations, the ANSM is responsible for deciding, on a case-by-case basis, on the classification of a product, taking into consideration its composition, its scientific properties, its mode of use, etc.
Borderline situations can also be clarified by the French courts, in cases where the classification of a product is being challenged.
The requirements for manufacturing entities prior to and after marketing of medical devices and related products, healthcare products and new products/technologies and digital healthcare products can be summarised as follows.
Prior authorisation must be obtained in order to manufacture medicinal products. Manufacturing sites must be authorised by the ANSM (Articles L. 5124-1 et seq of the FPHC).
Manufacturers of blood products are also subject to prior authorisation by the ANSM. Establishments carrying out transfusions must be approved by a decision of the ASNM. Moreover, any activity involving the preparation, storage, distribution, transfer, import or export of tissues, their derivatives, cells and cell therapy preparations from the human body, used for therapeutic purposes, is subject to prior authorisation from the ANSM.
Carrying out any preparation, conservation, distribution, or transfer with advanced therapy medicinal products prepared on an ad hoc basis (including experimental medicinal products) is also subject to prior authorisation from the ANSM.
Manufacturers of both medical devices (Article L. 5211-3-1 of the FPHC) and cosmetics (Articles L. 5131-2 and T. 5131-1 of the FPHC) are only subject to a declaration to the ANSM.
Finally, any person hosting personal health data in the context of prevention, diagnosis, care, social or medico-social healthcare must be certified as a health data hosting service provider in accordance with Article L. 1111-8 of the FPHC. The conditions of the approval are set by decree, after consulting the CNIL.
Manufacturing authorisations are subject to compliance with the Good Manufacturing Practice (GMP) guidelines, regulated at the EU level by Directive No 2003/94/EC and other good practice and practice guidelines in force according to the manufacturer's activity.
In addition, pharmaceutical companies manufacturing medicinal products must be owned by a pharmacist or a company in which a pharmacist participated in the management or board of directors. Pharmaceutical establishments must appoint a qualified person (the pharmacist in charge).
Examination of Application
The examination of the application may be subject to an inspection of the facility by an expert responsible for verifying the facility's ability to carry out its activities in compliance with the requirements in force, including the GMP guidelines.
Both the declaration and the authorisation procedures must be done online up to 60 days before any activity. Manufacturing authorisations are given within 90 days of receipt of the application.
Initial authorisations are not subject to any fees.
Period of Authorisation and Renewals
Authorisations are granted for an unlimited period of time, but inspections may be carried out by the ANSM, which may lead to suspensions or withdrawals in the case of breaches of authorisations, FPHC requirements or the GMP guidelines.
Inspections aim at assessing the compliance of manufacturers with good practice and other standards in force for an activity. Technical investigations may also take place. Inspectors can analyse samples and can be authorised by a court to seize products.
Inspections are concluded by an inspection report stating any deviations from required standards. The inspection report is drawn up during a process in the presence of all the parties, which includes a preliminary report to the operator. The report concludes that the site is compliant or allows appropriate decisions to be taken in the event of non-compliance.
Inspections can lead to administrative being measures taken by the ANSM including injunctions, suspensions, the withdrawal of authorisation or the approval of financial penalties.
To the best of our knowledge, there are no specific obligations regarding corporate social responsibility, the environment, and sustainability throughout the product life cycle. This being said, the majority of manufacturers have published measures that they plan on implementing in order to improve their position on social responsibility, the environment, and sustainability.
Specific requirements in respect of advertising and product claims relating to (i) medical devices and related products, (ii) healthcare products and new products/technologies, and (iii) digital healthcare products can be summarised as follows.
Legislation Regulatory Authorities
Advertising medical devices and healthcare products is strictly regulated by the FPHC. The general provisions of the French Consumer Code on unfair and misleading practices (Articles L. 121-1 to L. 121-1) and on comparative advertising (Articles L. 122-1 to L. 122-7) are also applicable. The ANSM provides guidelines and general recommendations on its website.
Advertising medicinal products and medical devices is subject to prior authorisation (an "advertising visa") or certification. It must comply with the marketing authorisation or certification and the therapeutic strategies recommended by the French National Authority for Health (HAS). Products must be presented in an objective manner, promoting their proper use and advertising must not be misleading or endanger public health and/or consumer safety.
Advertising requirements vary depending on the audience (general public or healthcare professionals), the prescription and reimbursement of the products concerned.
The FPHC provides for penalties for non-compliance with advertising regulations of up to EUR750,000 and two years in prison for the legal representative and up to five times more, in terms of fines, for the companies involved.
Advertising biocides is strictly regulated by the French Environment Code (Articles L. 522-18 to L. 522-19 and Articles R. 522-16 to R. 522-17). Decree No 2019-642 of 26 June 2019 specifies the categories of biocides for which commercial practices such as discounts or rebates are prohibited. In addition, Decree No 2019-643 of 26 June 2019 provides the categories of biocidal products for which commercial advertising to the general public is prohibited. It also sets out the requirements for advertising aiming at professionals. Non-compliance with advertising rules is punishable by a level five contravention.
Advertising for food supplements and cosmetics is not subject to prior authorisation by the ANSM. Nevertheless, the advertising must not mislead the consumer. The labelling, presentation and advertising must not attribute properties for the prevention, treatment, or cure of a human disease to the product, as this would risk the product being considered as a medicine by the regulators. For food supplements, references to the rate or extent of weight loss are prohibited.
For all products, the use of French language is compulsory (Law No 94-665 dated 4 August 1994). The main objective of the Toubon Act is to protect French consumers, as well as to preserve the French language, and promote French culture. A failure to comply with the Toubon Act exposes the professional to various risks including a fine of EUR3,750 per non-compliant product.
Before being placed on the market, medical devices and healthcare products may be subject to prior authorisations.
Marketing Authorisations and Similar Measures
Medicinal products must receive prior authorisation, which must be either centralised or national. The authorisation can either be granted by a national authority or, at the European level, by the European Medicines Agency (EMA).
For medicinal products intended to be marketed across the EU, access to the market must be obtained either by the centralised procedure of the EMA (Regulation No 2309/93/ECC, modified by Regulation No 726/2004/EC) or through the mutual recognition procedure (Directive No 2001/83/EC modified by Directive No 2004/27/EC) and since 2005, through the decentralised procedure (Directive No 2004/27/EC).
Medical devices are subject to a CE marking granted to the manufacturer if the latter complies with the European requirements regarding the quality and safety of the device.
Depending on the device's risk category, the ANSM must be notified and then issues a certificate of conformity allowing the manufacturer to manufacture and market the device (Certificat de conformité). The CE marking is valid for one to five years. Applications for renewal must be made nine months before the expiry date of the initial marketing authorisation. Furthermore, the authorisation can be automatically withdrawn if the product is not marketed in France for three consecutive years.
Marketing authorisations are also needed to market biocide products (Regulation (EU) No 528/2012). This takes place in two consecutive steps. First, the active substance is assessed: if the regulatory criteria are verified in terms of efficiency and risks, the substance can be approved. The second step is the authorisation of each product. In France, the authorisation is granted by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES). The marketing authorisation includes an assessment of the biocidal product's efficiency and the risks for humans and the environment that are related to its use.
Not all healthcare products are subject to authorisation. Manufacturers of cosmetics must put together a file including a human health assessment of the product considering the toxicological profile of the substances used in its composition and the level of consumer exposure. This file must be available to the ANSM at any time.
Food and nutrition complements must be declared to the General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF), in accordance with the requirements of Articles 15 and 16 of Decree No 2006-352. The manufacturers must comply with the regulatory provisions, once the product has been placed on the market, in terms of consumer safety and information. The DGCCRF receives and processes, on average, more than 1,000 such declarations per month.
In France, marketing authorisations are granted by the ANSM (autorisation de mise sur le marché/marketing authorisation). National marketing authorisations are granted for a period of five years, renewable without time limits. Fees for marketing authorisations are set out in the French General Tax Code and are subject to a progressive fee up to EUR50,000.
Marketing authorisations are granted if the benefit/risk ratio is favourable and if the therapeutic efficiency of the product is sufficiently proven by the applicant.
As part of their post-marketing commitments, manufacturers of medicinal products must appoint an internal representative for pharmacovigilance, whose contact details must be notified to the ANSM.
Manufacturers of medicinal products must also provide a periodic report to the ANSM of any reaction to their products. They must also report any prohibition or restriction imposed by a competent authority of any country on the product. Manufacturers of medical devices must report any incident or risk of serious incident and any recall of a product from the market.
The COVID-19 pandemic has pushed the French government to announce that it will work on having essential medicines and medical devices manufactured in France in the coming years, in order to achieve national productive autonomy in such products.
In parallel, the Court of Justice of the European Union ruled that a medicinal product not subject to medical prescription in one member state may not be placed on the market in another member state unless that member state, has also granted its marketing authorisation (Case C-178/20, 8 July 2021). This decision will not ensure the free movement of medicinal products in the European Union and it will be interesting to monitor how the national authorities of the member states will implement such a ruling.
The national authorities constantly monitor healthcare products, with the aim of continuously verifying that the benefit/risk balance remains positive after the product has been placed on the market, and reinforcing, if necessary, the safety of healthcare products through corrective measures and recalls.
The national authorities are also in charge of the safety of the products through pharmacovigilance (for medicines), cosmetovigilance (for cosmetics), materiovigilance (for medical devices), reactovigilance (for in vitro medical devices), and nutrivigilance (for food supplements).
National authorities usually carry out inspections on manufacturing sites in order to check whether the regulations are correctly applied. Inspections can lead to administrative measures, from injunctions to suspensions of activity and financial penalties to force manufacturers to comply.
In France, medical devices and healthcare products are regulated by several health agencies. Their roles and responsibilities were aligned by Law No 2016-41 of 26 January 2016.
The main regulatory authorities are the following.
The regulatory authorities perform regular investigations and controls.
They monitor the products being placed on the market and their conclusions are sent to the competent ministry, which can order appropriate measures if and when necessary.
These authorities have been granted more and more powers, including the ANSM, which grants access to healthcare products in France on behalf of the State and ensures their safety throughout their life cycle. Its powers were extended by Law No 2011-2012 of 29 December 2011.
The ANSM monitors clinical trials as well as the manufacture, distribution, marketing, import/export, advertisement, and sale of health products and conducts investigations on manufacturing sites. The ANSM is also in charge of the safety of the products through pharmacovigilance, cosmetovigilance and materiovigilance.
Regulatory authorities also have legal powers, especially policy powers. The CEO of the ANSM can order administrative injunctions, financial sanctions, or measures such as recalls and the suspension of authorisations.
Several regulatory authorities can carry out investigations jointly. They usually have joint and complementary powers. Regular exchanges of information and experience are part of the co-operation, which is usually regulated. For instance, cosmetics are regulated by both the ANSM and the DGCCRF.
The ANSM is the main entity responsible for monitoring compliance with the requirements of the FPHC. Both criminal and civil penalties are provided for in the event of failure to comply with the laws and regulations applicable to medical devices, vitro diagnostic devices, medicines, cosmetics, biomaterials, etc.
The FPHC provides for criminal sanctions faced by entities failing to comply with the law and regulations (Articles L. 5411-1 to L. 5472-3 of the FPHC).
Criminal penalties relating to the provisions on advertising medicinal products (Articles L. 5422-3 et seq of the FPHC) and medical devices (Article L. 5461-1 of the FPHC) are punishable by a year in prison and a EUR150,000 fine.
In addition, the placing on the market of products subject to suspension or prohibition measures by the ANSM can lead to a maximum prison sentence of two years and a fine of up to EUR150,000 (Article L. 5451-1 of the FPHC).
The ANSM can also impose financial penalties on those responsible for the breaches of the provisions provided by the FPHC (Articles L.5421-8, L.5422-18, L.5423-8, L.5461-9, L.5462-8, R.5461-4 and R.5462-4 of the FPHC). This concerns various infringements, from advertising to marketing.
The amount cannot exceed 10% of the turnover achieved, up to a maximum of EUR1 million, and EUR150,000 for a natural person. A daily penalty may be added which cannot exceed EUR2,500 per day if the person responsible for the breach has not complied with their requirements by the end of the period set by a formal notice.
In 2020, the ANSM registered a total amount of EUR 1,269,235 of financial penalties.
Product liability claims can be pursued under tort law, contract law or product liability for defective products law.
Tort liability can be sought by any plaintiff where compensation is claimed for damage that does not result from the manufacturer's breach of a contractual obligation.
According to Articles 1240 and 1241 of the French Civil Code, the plaintiff must prove:
Strict Product Liability for Defective Products
Product liability for defective products is governed by Articles 1245 et seq of the French Civil Code and derives from Directive No 85/374/EEC on liability for defective products. It is applied whenever a product is considered unsafe. The producer is held liable for damages caused by its defective product whether or not the parties entered into an agreement. A product is considered as defective when it does not provide the safety which a person is entitled to expect (Article 1245-3 of the French Civil Code).
There are two types of contractual claims available: the breach of contractual provisions and the statutory warranty against hidden defects.
Under contract law, the plaintiff must establish a fault, a loss and causal link between the breach and the loss (Article 1231-1 of the French Civil Code). A party that does not comply with its contractual obligations or is late in performing them commits a fault. One of the main obligations of a producer is to deliver products free of any defects. Consequently, if a contracting party can demonstrate that the producer failed to comply with this obligation by delivering a defective product, it is entitled to claim damages.
Article 1641 of the French Civil Code provides that the seller is liable when a defect that is not apparent at the time of the sale renders the product unfit for the purpose for which it was intended or diminishes its usefulness to such an extent that the buyer would not have acquired it or would not have paid the same price for it if they had known about the defect. This allows the end user to sue the producer even after the expiration of the limitation period for filing a standard contractual claim.
In civil matters, the jurisdiction of French courts results from the defendant's domicile in France according to Article 42 of the French Code of Civil Procedure. This principle has been extended to cross-border cases (French Supreme Court, 1st Civil Chamber, 14 March 2006, No 05-13.820).
The jurisdiction of the French courts may also result from the location of the plaintiff's domicile. In regard to Article R. 631-3 of the French Consumer Code, the consumer is given a choice: to either bring the case before the French court of the place where they resided at the time when the agreement was entered into, or the French court of the place where they resided at the time when the damage arose.
Article 18 of Regulation (EU) No 1215/2012 allows the consumer to "bring proceedings against the other party to a contract either in the courts of the member state in which that party is domiciled or, regardless of the domicile of the other party, in the courts for the place where the consumer is domiciled".
In France, a distinction is made between procedural costs that are necessary for the lawsuit (dépens) and other expenses such as legal fees (frais irrépétibles).
In accordance with Article 696 of the French Code of Civil Procedure, the winning party may recover all the procedural costs listed in Article 695 of the French Code of Civil Procedure, in particular the fees of court-appointed experts, the expenses of witnesses and service fees.
All other costs, such as legal fees, are governed by Article 700 of the French Code of Civil Procedure, which states that the court will order the party bearing the court costs, or failing that the losing party, to pay the other a sum determined by the court corresponding to the costs incurred that are not included in the procedural costs. The court assesses, on a case-by-case basis, the amount that would be fair to grant, considering equity or the economic position of the paying party and the amount of damages granted (generally, no more than EUR20,000).
In France, decisions of regulatory bodies can be challenged before the administrative courts for abuse of power, except for preparatory acts.
Mass litigation is becoming common in France. Such cases are a challenge for defendants as plaintiffs often present these cases as one large case with the same evidence for all plaintiffs, without that evidence being personal and showing specific damage. However, procedurally, these cases should be treated as individual cases, each of which could be tried individually. Defendants need to insist on this point to stand a chance and avoid a general sentence being ruled against them.
The first class-action mechanism was introduced in France by the Hamon Law of 17 March 2014, which came into force on 1 October 2014, allowing what are known in France as group actions. The scope of this group action was limited to consumer and competition law breaches only. This mechanism can only be launched by a specific and limited list of consumers' associations which must find at least two people suffering from similar damage.
By the Law dated 26 January 2016, the group action mechanism was extended to the field of healthcare products and cosmetics (Article L. 1143-1 of the FPHC). Following this extension, the Depakine case (a claim relating to an anti-epilepsy drug prescribed to pregnant women despite the risk of birth defects) was brought before the French courts for the first time.
The purpose of this specific group action is to enable users of the health system and consumers using cosmetics to obtain compensation for losses resulting from physical injury, including in product liability matters. It can be launched against manufacturers, suppliers and service providers using health products (including pharmaceuticals and medical devices). The particularity of this mechanism in this field is that it would allow physical injury to be compensated and it applies to products placed on the market even before the Law came into force.
At the EU level, on 24 November 2020, the European Parliament passed a Directive on representative actions for the protection of the collective interests of consumers. The Directive establishes a right of collective redress across the EU (injunctive relief and other redress measures) for qualified entities. It covers all infringements of EU laws that are harmful to the collective interests of consumers, in a variety of areas including health.
There are no mandatory alternative dispute resolution (ADR) steps to submit a dispute before the French courts.
However, the parties may agree by an agreement to submit their dispute to prior mediation and conciliation. French courts would then uphold provisions and a claimant referring the matter to the courts directly will be exposed to a ruling of inadmissibility. Indeed, only when parties have failed to reach a settlement during conciliation can the dispute be referred to the courts.
As of 1 January 2021, Article 54 of the French Code of Civil Procedure provides that any summons must justify the steps taken by the plaintiff to reach an amicable resolution of the dispute.
Civil litigants may bring civil or administrative claims in cases of damages in relation to product safety compliance. Civil litigants may also report to any regulatory authority any violation of law or regulations.
In the case of criminal law infringements, citizens may also bring criminal actions or join pending actions.
The French Act No 2020-105 of 10 February 2020 against waste and for a circular economy aims at achieving zero single-use plastic by 2040, and the end of micro-plastic by 2024. Moreover, by 2022, the sale of certain medicines in pharmacies will be done individually in order to avoid wasting medicine.
In April 2017, the EU revised the regulatory framework for medical devices and in vitro medical devices. It includes the EU Regulation on medical devices (No 2017/745) and the EU Regulation on in vitro diagnostic medical devices (No 2017/746).
This new EU regulatory framework redefines the responsibilities of economic operators, modifies the classification system for medical devices, provides new requirements for post-marketing surveillance and new transparency requirements, among other provisions.
Most provisions of the EU Medical Devices regulation were to apply from 26 May 2021. Due to the pandemic, the European Parliament handed down a decision postponing the beginning of its application by a year. The final date of any transitional period remains 26 May 2024.
No similar decision has been handed down by the European Parliament regarding the EU In Vitro Diagnostic Regulation, which will apply from 26 May 2022.
Other than these, no reforms are currently under consideration in France concerning healthcare products.
The healthcare product sector has been particularly impacted by the withdrawal of the United Kingdom from the European Union on 30 March 2019. The EU and the UK have agreed on the terms of a detailed post-Brexit Trade and Cooperation Agreement, which became effective on 1 January 2021 (TCA).
The end of the transition period on 1 January 2021, during which EU law continued to apply in the UK, requires companies dealing with the UK to comply with the many changes in terms of health regulations and custom formalities. The medical devices and healthcare products sectors are now facing a dual regulatory system (in terms of manufacturing licences, marketing authorisation, labelling, etc).
In terms of customs formalities, the withdrawal of the UK from the EU has had the effect of re-establishing borders for goods. Companies now have to comply with customs formalities to trade with the UK. Advance clearance procedures exist and should be used by companies in order to not delay the supply of health products to the market.
The medical devices and healthcare products sectors are directly concerned by the impact of COVID-19. All players in the healthcare system, including manufacturers, are on the front line in the fight against the pandemic. In this unprecedented context, the government issued emergency law No 2020-293 on 23 March 2020 declaring a state of health emergency, enabling the Prime Minister to take measures by decree to guarantee public health. The state of health emergency ended on 1 June 2021, after several laws had extended it.
Many measures were taken during that time, including emergency approvals of medicines and medical devices. Restrictions were taken in order to ensure that appropriate medicines were made available to patients to eradicate the public health threat (Article L. 3131-15 of the FPHC). Many manufacturing sites have also been requisitioned to meet the increased demand for personal protective equipment. Many luxury industry players produced masks and hydroalcoholic gels, the 3D printing industry created protection for caregivers in hospitals. Moreover, adjustments to the execution of public procurement contracts were made.
With the multitude of healthcare products that have been developed and produced during this unprecedent period, the issues to be faced in the near future lie in the area of product liability. Indeed, the design, manufacturing, testing, and approvals of the pandemic emergency differ from the usual process, in response to the urgency of the situation and the high demand. This is likely to lead to significant legal issues in the future.
The health and medical devices industry has been subject to a significant number of changes recently, with important case law developments. This can notably be explained by the COVID-19 pandemic and the increasing scrutiny that the authorities have subjected this industry to due to public pressure and the realisation of its national importance.
The entry into force, on 26 May 2021, of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices provided for a new legal framework for manufacturers, distributors and also for notified bodies. The transition period which started in 2017 should have lapsed on 26 May 2020 but, because of the COVID-19 pandemic, an additional year was granted to the industry by the European Commission. This Regulation is obviously at the heart of the medical device and healthcare product industry, so as to fully adapt their business model to this new set of rules. Businesses operating in France are of course concerned.
More specifically, in France, the developments that this article will discuss are of a varied nature and not necessarily linked to each other. This diversity demonstrates, in the authors' view, the complexification of the legal issues faced by the healthcare and medical devices industry, which is currently undergoing wholesale change.
Regulation of Pharmaceutical Sales
An interesting development is a decision by the French Council of State (Conseil d'Etat) of 17 March 2021 which has lifted, since 17 May 2021, the ban on pharmacists using paid referencing to increase their visibility on the internet in order to sell online. This decision is recognised as representing a deep shift in the selling of health products in France given that today – out of the 21,000 pharmacies operating in France, only 720 would have a website and 400 would be conducting online sales – therefore representing only 1% of the turnover according to the French competition authority. This decision is in line with the Court of Justice of the European Union's position dated 1 October 2020.
Also affecting pharmacies, on 26 March 2021, the French National Agency for the Safety of medicines and health products (ANSM – Agence nationale de sécurité du medicament et des produits de santé) has published the list of pharmacies which can sell cannabis for medical use. This was a step taken right before the French Supreme Court (Cour de Cassation) ruled, on 23 June 2021, that products containing CBD (as opposed to the ones containing THC) are legal in France.
In parallel, the more stringent anti-gift regulation dated 15 June 2020 entered into force on 1 October 2020. This new Anti-gift Act reduces even more the capacity for manufacturers to participate in the training of health professionals. There are now very strict rules on the amount that manufacturers can grant to health professionals when it comes to dining, hotels, subscriptions, etc, regulated through a new prior authorisation system. There is also increased transparency with the obligation to publish any gifts that have been received.
Medical Device Innovation – Transitional Support
We could not miss out on addressing innovative medical devices, this field being subject to great expansions. The decree of 23 February 2021 introduces the possibility of transitional support for certain products and services with a view to their registration on the list of products and services reimbursable through the French Health Insurance/Social Security system.
Transitional support is a system for providing care for presumed innovative health products which have a therapeutic or disability-alleviating purpose and which fall within the scope of the list of products and services reimbursable by French Health Insurance. It allows them to be reimbursed for one year while waiting for traditional support via the list of products and services reimbursable through French Health Insurance.
Three prerequisites must be met for a device to be eligible for this transitional support: (i) the medical device must have the CE marking, (ii) it must not already be covered as part of hospitalisation benefits, and (iii) the manufacturer must undertake to submit a request for inclusion in the list of reimbursable products and services for this medical device within 12 months of their request for transitional coverage.
The process is meant to be fast. The files are to be assessed within 45 days, following which an opinion on the five eligibility criteria defined by the decree of 23 February 2021 is published. These criteria are meant to assess the potential of the technology for each medical indication covered by the medical device.
AI in Healthcare Technology
This new step taken by the French High Health Authority (HAS – Haute Autorité de la Santé) follows the update of its guides for submitting reimbursement requests for medical devices that use machine learning and/or artificial intelligence back in October 2020. This guide, which is available on the HAS' website both in French and in English, explains all the questions which manufacturers have to answer.
PIP Implant Litigation
Finally, a summary of the main recent developments in the field of medical devices could not miss out on the decision rendered by the Paris Court of Appeal on 20 May 2021 concerning the Poly Implant Prothesis (PIP) breast implant case. In this decision, the Court condemned the certification body TUV Rheinland to pay EUR3,000 in damages to the 2,500 plaintiffs involved. This decision is notably the result of a decision of the Court of Justice of the European Union dated 16 February 2017 in which the Court stated that "the notified body is not under a general obligation to carry out unannounced inspections, to examine devices and/or to examine the manufacturer’s business records. However, in the face of evidence indicating that a medical device may not comply with the requirements laid down in Directive 93/42, as amended by Regulation No 1882/2003, the notified body must take all the steps necessary to ensure that it fulfils its obligations under Article 16(6) of the directive and Sections 3.2, 3.3, 4.1 to 4.3 and 5.1 of Annex II to the directive" and that "in the procedure relating to the EC declaration of conformity, the purpose of the notified body’s involvement is to protect the end users of medical devices. The conditions under which culpable failure by that body to fulfil its obligations under the directive in connection with that procedure may give rise to liability on its part vis-à-vis those end users are governed by national law, subject to the principles of equivalence and effectiveness".
This is a case, together with the new Regulation on medical devices mentioned above, that has and will undoubtedly completely change the approach of certification bodies, not only when it comes to the control and the approval of medical devices, but also for all other types of products. Indeed, it should not be forgotten that TUV Rheinland was here found liable despite the fact that the criminal liability of the manufacturer was recognised, including on the ground that its behaviour was dismissive and aimed at misleading its certification body, the authorities and the patients.
The change in certification bodies' behaviour will also result in a change in how manufacturers will have to conduct their business. Documentation will become key as the industry now has no excuse but to anticipate potential claims against it. It should therefore be ready to document all the steps taken to ensure the safety and compliance of the products placed on the market. Manufacturers should develop, if they have not already done so, automated processes whereby information is recorded at each stage of the development of the device and alerts are sent to the operators when an update, audit or review should be conducted. For those who cannot implement such a burdensome system, one can already predict that new companies will be created with the purpose of taking over these tasks on behalf of manufacturers.
In light of the above-mentioned trends in the medical devices and healthcare products industry in France, it is fair to say that we can expect more to come with a complexification of regulation and of the relationship between different actors in the industry, and in particular between the certification bodies and the manufacturers, in a context where innovative medical devices and new types of products are thriving. The key question is whether the fear of liability and high damages which might be borne or the push to place diversified and new products on the market will win out.