Life Sciences 2021 Comparisons

Last Updated March 22, 2021

Contributed By Intuity

Law and Practice

Authors



Intuity was founded in 2005 and groups specialised lawyers in the pharmaceutical and life sciences industries, combining high-quality legal skills, in-depth knowledge of the industry and scientific backgrounds to provide a multidisciplinary approach. Intuity's lawyers are the privileged partners of major national and international companies in human health, the veterinary sector and medical devices. The firm's key practice areas include the following: market access, healthcare regulation and general compliance, competition/distribution, product liability, commercial litigation, commercial contracts, review of promotional material, data protection/electronic communication, tenders and public procurement, corporate administration, and company secretariat support. In terms of life sciences, Intuity intervenes on every issue related to pharmaceutical law and healthcare products or borderline products: medicinal products, medical devices, dietary supplements, cosmetics, and biocides.

Medicinal products are regulated differently according to their destination. Articles L5121-1 and seq as well as R5121-1 and seq of the Public Health Code (PHC) set up the legal framework on medicinal products for human use, which incorporated Directive 2001/83. Articles L5141-1 and seq as well as R5141-1 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 applicable on 26 May 2021 (for MD) and on 26 May 2022 (for IVDR).

Medicinal Products for Human Use

Regarding medicinal products for human use, the regulatory bodies are:

  • the European Commission (EC);
  • the Committee for Medical Products of Human Use (CHMP) of the European Medicines Agency (EMA) – in order to carry out its scientific evaluations and assessments for the Agency, it acts in total independency and guarantees the accuracy and validity of its opinions through a peer-review; and
  • the French National Agency for the Safety of Medicines and Health Products (ANSM), a public administrative establishment placed under the supervision of the Ministry of Health.

Medicinal Products for Veterinary Use

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 – its opinions are issued in total independency and guaranteed through a peer-review; and
  • the French National Health Security Agency for food, the environment and work (ANSES), a public administrative body placed under the supervision of the Ministries of Health, Agriculture, Environment, Labour and Consumer Affairs.

Medical Devices

Regarding medical devices, the competent regulatory bodies are the EC and the ANSM.

With the exception of preparatory acts, decisions of the regulatory bodies authorising or refusing the marketing of a medicinal product, relating to the coverage by the health insurance or the fixing or modification of the price of a medicinal product are subject to an appeal for excess of power before the competent administrative court.

The same applies for the fixing of the price or tariff of medical devices listed in the LPP.

The Economic Committee for Health Care Products (CEPS) decisions that concern conventional remittances and financial penalties are administrative decisions that might be subject to an ex gratia/informal appeal 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.

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. 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 2021, 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 the database is not intended for a different purpose than the one under which the initial data collection was performed and 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.

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:

  • the medicine treats a rare or serious disease;
  • no appropriate treatment is available on the market; and
  • the treatment cannot be postponed
  • the medicine is deemed effective and safe to use.

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.

In addition, the ANSM can regulate prescriptions that do not comply with the MA, subject to the following conditions:

  • there is a therapeutic need, and
  • the benefit/risk ratio of the medicinal product is presumed to be favourable

Early Access and Compassionate Access Schemes

The Social Security Financing Act for 2021 removes these two derogatory benefit regimes and replaces them with the "early access" and "compassionate access" schemes.

The early access scheme provides for the same four conditions as the ATU with an additional criterion: only medicines presumed to be innovative will be eligible for early access.

The compassionate access mechanism is intended for medicines that are not necessarily innovative nor intended to obtain a MA in the indication concerned but which respond satisfactorily to a therapeutic need. Only medicines that are not the subject of research involving the human person for commercial purposes will be eligible for this scheme.

The new provisions should be effective by 1 July 2021 at the latest.

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 concerned medicines to fight against counterfeited and falsified medicines. This means that since 9 February 2019, the packaging of each concerned 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 French order of 26 February 2021 on good practices in the dispensing of medicinal products in retail, mutual and mine rescue pharmacies, fully incorporates in its provisions the role of pharmacists in the fight against the falsification of medicinal products.

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.

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 4 Manufacturing of Pharmaceutical and Medical Devices).

See 1.3 Different Categories of Pharmaceuticals and Medical Devices.

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.

Only pharmaceutical establishments can act as the importer of record, provided that they are authorised by the ANSM (with some exemptions – see 6.3 Prior Authorisations for the Importation of Pharmaceuticals and Medical Devices). 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 medicines 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.

Exemptions apply to:

  • medicines imported by individuals for personal use in the context of a prescription and for a maximum treatment period of three months;
  • medicines imported for the needs of a sports team by the responsible physician;
  • medicines authorised in France and compliant with the French MA;
  • medicines with a temporary authorisation for use (ATU);
  • medicines necessary for the performance of authorised biomedical research;
  • registered homoeopathic and traditional herbal medicinal products, presented in accordance with their registration;
  • medicines coming from an EU member state and stored in an authorised pharmaceutical establishment, which are only intended for export outside the EU; and
  • medicines in external transit or that use the national territory for internal exchanges into the EU.

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.

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 Harmonised System (HS), which is a nomenclature developed by the World Customs Organization (WCO);
  • the Combined Nomenclature (CN) (HS Codes with further EU subdivisions); and
  • the Integrated Tariff (TARIC), which provides information on all trade and tariff measures applicable in the EU (ie, pharmaceutical goods are under Chapter 30).

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.

A new type of trade agreement (ie, bilateral or regional agreements) that tend to reduce non-tariff barriers are signed between the EU and industrialised third countries; for example, the CETA (EU-Canada), the TAFTA/TTIP (EU-US) and the JEFTA (EU-Japan).

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).

The pricing of reimbursable medicinal products and medical devices is regulated and set by a convention between CEPS and the company. The process takes into account various criteria set out in article L162-16-4 and L165-2 of the Social Security Code.

Depending on the price in Germany, Spain, Italy and the UK (defined as reference countries because of their comparable market size), the retail price/insurance tariff may be adjusted or revised by the CEPS.

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".

The Economic and Public Health Evaluation Commission (CEESP) assesses the efficiency of a medical device if it claims an improvement of the required level of service (ie, major, significant or moderate) and is likely to have a significant impact on health insurance expenditure.

This evaluation consists of determining the interest for the society in the new product compared to those existing by comparing the means employed (ie, the cost) with the results obtained.

Finally, a specific package allows for the exceptional and temporary coverage of a particularly innovative medical device, subject to the completion of a relevant study aimed at providing missing clinical or medico-economic data. This coverage is decided by the publication of a specific decree by the Minister of Health, following the opinion of the High Authority for Health (HAS).

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. Since 1 January 2020, patients who refuse, without medical justification, the generic equivalent will see their reimbursement limited to the price of that generic.

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 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices).

According to recent case law, a medical app shall be considered as MD or IVDR under three cumulative conditions:

  • their intended purpose is medical (eg, diagnostic, treatment);
  • they are able to produce a patient-tailored result; and
  • they perform analyses from the collected and processed data, and are not limited to storage, communication or searches in a database.

Apps ensuring the patient treatment is taken adequately or used in sports practice do not fall in this scope.

Telemedicine is governed by Articles L6316-1, 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 the use of a video exchange (ensuring the identity of physicians and patients) and 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.

Order No 2020-1408 of 18 November 2020 implementing electronic prescription aims to develop the practice of prescriptions issued in a dematerialised manner.

It authorises healthcare professionals in private practices to prescribe care, products or services in a dematerialised manner and to transmit it through teleservices provided by the health insurance system. After an experiment focusing on medicines’ prescriptions, e-prescription will be widespread step by step by the end of 2024, with a series of tests for each type of prescription and procedure.

Finally, it will make it possible for patients to access such prescriptions from their shared medical record (DMP). See 8.6 Electronic Health Records.

Only non-prescription medicines can be sold on the internet through physician online shops. No specific regulation exists for online sale of MDs. Pursuant to the application of the Treaty on the Functioning of the European Union and Regulation (EU) 2017/745, the principle is the free distribution of medical devices bearing the CE marking, with the exception of those subject to a monopoly (ie, optics, hearing aids, in vitro diagnostic devices, prostheses and orthoses).

Since 2004, patients can request the creation of a unique and electronic medical record, which is not mandatory. Such electronic medical record has never been able to deploy due to multiple obstacles. The law on the modernisation of the health system of 26 January 2016 and the implementing decree of 4 July 2016 renewed the objective of an introduction of the medical record, renamed "shared medical record" (DMP) whose implementation is carried out by National Health Insurance Fund (CNAM) (Article L1111-14 of the PHC).

In order to protect sensitive data, the law provides a framework for the activity of hosting providers.

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 R1111-11 of the PHC.

Article L611-1 and seq of the Intellectual Property Code (IPC) set up the legal framework on patents.

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.

SCP shall be granted if:

  • the said product has not been the subject of an SCP;
  • the product is protected by a basic patent in force in the member state;
  • a valid MA has been granted for the said product;
  • the said MA is the first to place the product on the market; and
  • the application for a SCP is made six months upon the granting of the first MA.

A third party may bring an action for a declaration of invalidity of the certificate before the competent tribunal.

Patent infringements consist of:

  • manufacturing, importing, exporting, transhipping, placing on the market, offering, using, or stocking the product for such purposes covered by a patent without the consent of the patent-owner;
  • using the process that is the subject matter of the patent or, when the third party knows, or it is obvious in the circumstances, that the use of the process is prohibited without the consent of the patent-owner, offering the process for use; and
  • offering, putting on the market or using a product obtained directly by a process that is the subject matter of the patent, or importing or stocking the product for these purposes.

Threat of infringement is actionable if there is an imminent infringement of IP rights.

Defences to patent infringement include:

  • the acts were performed privately and for non-commercial purposes;
  • the acts were performed for experimental purposes relating to the subject matter of the patented invention;
  • the extemporaneous preparation for individual cases in a pharmacy of a medicine in accordance with a medical prescription, nor acts concerning the medicine so prepared;
  • the performance of studies and tests required to obtain an MA for generics or biosimilars (Bolar exception); and
  • the acts necessary to obtain the advertising visa mentioned in Article L5122-9 of the PHC.

The existing legislative framework concerning forced licences includes compulsory licenses (judicial licenses) and ex officio licences (administrative licenses). The ministry in charge of IP can specifically implement such regime for medicinal products and medical devices in the event of health or competition issues. Such procedure, 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, ten or 11 years) and prior to the expiry of the patent(s) without the consent of the proprietary rights (Article L5121-10, PHC).

A counterfeit can trigger civil and criminal liability, 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 Border Measures to Tackle Counterfeit Pharmaceutical and Medical Devices).

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.

The trade dress or design of medicines or medical devices can benefit from the protection of designs and models, unless:

  • the design is contrary to the law or public order;
  • the drawing or model relates to a computer program;
  • the design has characteristics that are exclusively imposed by the technical function of the product to which it relates; and
  • the shape of a product is imposed by the need to be associated with another product.

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 eleven 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.

This applies to biological medicinal products.

In response to COVID-19, an emergency law was first adopted in France on 23 March 2020. It introduced a new Chapter in the PHC, entitled State of health emergency.

Such new provisions allow the French government to declare a state of health emergency on all or part of French territory. This state of health emergency enables the Prime Minister to take measures by decree to guarantee public health.

These measures include the requisition of persons, goods and services necessary to preserve public health (see 11.9 Requisition or Conversion of Manufacturing Sites), all necessary measures to ensure appropriate access to medicines needed to face the public health threat (see 11.5 Import/Export Restrictions or Flexibilities as a Result of COVID-19), temporary measures to control the prices of certain necessary products and any other measures restricting the exercise of economic activities. 

Such measures must be "strictly proportionate to the health risks involved and appropriate to the circumstances of the time and place" and "shall be terminated without delay when they are no longer necessary". In addition, compensation for requisitions is governed by the Code of Defence.

Successive laws were adopted to extend the state of health emergency. As long as it is maintained in France (as it stands, this will be until 1 June 2021), these provisions will remain applicable.

On 20 March 2020, the ANSM published a communication, further updated following the course of the epidemic, on ongoing clinical trials in France. This communication, addressed to clinical trials sponsors, calls for a re-evaluation of the relevance of ongoing or new clinical trials.

Exceptional measures provided by the ANSM for ongoing medical trials included the possibility to suspend ongoing trials, change of research location, collection of information through teleconsultation and home delivery of experimental treatments.

The intended aim of the ANSM, through these special measures, was to give priority to trials involving patients infected with COVID-19.

To achieve said objective, fast-track procedures before ethical research committees (CPP) and ANSM benefit to COVID-19 researches granted with the label of "national research priority" by an ad hoc committee (CAPNET), which is based in particular on a scientific and methodological evaluation carried out by the scientific council of the REACTing consortium. To support this effort, the EMA offers a fee waiver and a fats-track procedure for scientific advice.

Several measures have been provided for the renewal of medicinal products benefiting from compassionate use (ie, nominative or cohort temporary authorisations for use (ATUs)), not reserved for hospital use and prescribed as part of a chronic treatment. In the same vein, the ANSM has granted a cohort ATU to allow continued access on national territory to the antiviral medicinal product remdesivir indicated for the treatment of the COVID-19 virus.

The new Chapter on the state of health emergency specifies that any measures necessary to enable patients to be provided with appropriate medicines to eradicate the health disaster may be taken.

Regarding medical devices, some of these products have been granted access to the market, prior to obtaining a CE mark (see also 11.4 Flexibility in Manufacturing Certification as a Result of COVID-19).

Through an order dated 18 May 2020, and in the context of COVID-19, the French government has authorised, by way of derogation, the use of in-vitro diagnostic medical devices that do not have a CE mark in order to allow a sufficient number of medical biology examinations to be carried out.

In order to benefit from this derogation, manufacturers must meet several cumulative conditions. These conditions consist of a declaration to the ANSM, a validation by a national reference centre (CNR) and being the subject of a mandatory publication on the site of the Ministry of Health. 

More generally, in accordance with European provisions, the ANSM authorises, upon duly justified request, the placing on the market and putting into service within the French territory of a specific device for which the conformity assessment procedures have not been applied, but whose use is in the interest of public health or the safety or health of patients.

The emergency law of 23March 2020, taken in response to COVID-19 introduced Article L3131-15 in the PHC.

It allows under paragraph 9 the Government, by regulatory decree and for the purpose of guaranteeing public health, to take all necessary measures to ensure that appropriate medicines are made available for patients in order to eradicate the public health threat.

Under these provisions, the French Government took a regulatory decree on 11 May 2020 that banned exportations of hydroxychloroquine and specialities containing the lopinavir/ritonavir combination by the wholesalers. Such a decree was revoked on 27 May 2020.

As for imports, the ANSM published a list of imported medicines needed to treat patients in intensive care units.

In order to face the emergency of the health situation in France, these products were not labelled in French, as it is usually done.

The “Health Data Hub” has been created by a ministerial order of the 29 November 2019. Its aim is to allow the health sector to use the potential of artificial intelligence by providing researchers with health data from French public health organisations.

Through a ministerial order of 21 April 2020, the French Government has issued an early launch of the Health Data Hub to facilitate the management of health emergencies and improve knowledge on COVID-19.

Only data necessary for the pursuit of a public interest purpose in relation to COVID-19 are allowed and for the duration of the state of health emergency.

In addition to the compulsory licences pronounced by the Judicial Court, the French legislation provides for three types of ex-officio licences that can be granted by decision of the public authorities for general interest reasons: ex-officio licence in the interest of public health, in the interest of economic development or for the needs of national defence.

None of these licences appear to be adapted to the current situation because of their stringent conditions.

It is therefore understandable that the government preferred to resort to the emergency measures of the law of 23 March 2020 and in particular to the new Article L3131-15 of the Public Health Code.

In order to compensate for the high risks taken by manufacturers due to the unprecedented context of vaccines production and limited time to observe side effects, advance purchase agreements provide for member states to indemnify the manufacturer for liabilities incurred under certain conditions.

The emergency law of 23 March 2020 taken in response to COVID-19 introduced Article L3131-15 in the PHC.

Paragraph 7 of this Article allows the government to order by regulatory decree and for the purpose of guaranteeing public health, in territorial constituencies where a state of health emergency has been declared, the requisition of all persons, goods and services needed to face the health emergency.

The government issued an Order No 2020-319 on 25 March 2020 adapting the rules for the award procedure or execution of public procurement contracts in order to deal with the COVID-19.

These measures were implemented to the extent that they were necessary to deal with the consequences of COVID-19 and applied to contracts in progress as of 12 March 2020 until 23 July 2020 included.

In particular, this Order allows:

  • an adjustment of the procedures in progress, in particular with regard to the competitive tendering of candidates;
  • an extension of contracts that are expiring, but for which a new competitive bidding procedure cannot be organised; and
  • the possibility for the buyer to have recourse to a third party to perform the service which cannot be delayed, even in the case of an exclusivity clause.

The Order also provides financial support to companies which have difficulties in executing public contracts due to the health crisis. This is reflected in particular by the possibility to extend the execution period, provided the context allows it, the absence of all or part of the contractual penalties and the possibility of receiving financial support.

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Intuity was founded in 2005 and groups specialised lawyers in the pharmaceutical and life sciences industries, combining high-quality legal skills, in-depth knowledge of the industry and scientific backgrounds to provide a multidisciplinary approach. Intuity's lawyers are the privileged partners of major national and international companies in human health, the veterinary sector and medical devices. The firm's key practice areas include the following: market access, healthcare regulation and general compliance, competition/distribution, product liability, commercial litigation, commercial contracts, review of promotional material, data protection/electronic communication, tenders and public procurement, corporate administration, and company secretariat support. In terms of life sciences, Intuity intervenes on every issue related to pharmaceutical law and healthcare products or borderline products: medicinal products, medical devices, dietary supplements, cosmetics, and biocides.