> Definition and content

Therapeutic patient education (TPE) can be defined in several ways.

The World Health Organization (WHO) gave the following definition in 1996: “Therapeutic patient education aims to help patients acquire or maintain the skills they need to manage their lives with a chronic disease”.

In 2007, the French National Authority for Health (HAS) clarified the specific aims of therapeutic education:

– The acquisition and maintenance by the patient of self-care skills;

– The mobilization or acquisition of coping skills”.

Under the French law no. 2009-879 of July 21, 2009 on hospital reform and patients, health and territories (known as the HPST law), TPE is defined as being “[…] part of the patient’s care pathway. Its aim is to make patients more autonomous by facilitating their compliance with prescribed treatments and improving their quality of life. It is not enforceable against the patient and cannot condition the rate of reimbursement for his or her treatment or for drugs related to his or her illness”.

ETP, as provided for in the French Public Health Code, is divided into three distinct actions:

– Therapeutic patient education programs, which comply with national specifications, are implemented at local level after registration with regional health agencies (ARS). They are proposed to the patient by a healthcare professional and lead to the development of a personalized program;

– Accompaniment programs, which comply with national specifications, are designed to provide assistance and support to patients and their families in managing their disease;

– Learning programs are designed to help patients acquire the technical skills they need to use a medicine/Auto-administration. These programs are implemented by healthcare professionals working on behalf of an operator who may be financed by the company exploiting the medicine. The learning program is proposed by the prescribing physician to the patient. In this case, the ANSM authorizes their implementation, after consulting an approved patient association To this end, the manufacturer submits a training application, justifying the expected benefits for the patient.

> ETP objectives

ETP is based on an individualized approach, considering the specific characteristics of each patient. It involves close collaboration between the patient, healthcare professionals and often the patient’s family and friends. The aim is to foster an in-depth understanding of the disease, its implications and associated treatments. This approach encompasses not only the medical aspects, but also the psychological, social and environmental aspects of health.

– Understanding the disease: ETP enables patients to understand the mechanisms of their disease, their symptoms, treatments and effects. Better knowledge helps patients adhere to treatment and prevent complications.

– Skills acquisition: Patients learn to manage their treatment, recognize the early signs of complications and adopt healthy lifestyle habits.

– Autonomy and decision-making: ETP aims to reinforce patients’ autonomy by giving them the tools they need to actively participate in decisions concerning their health.

> Who can set up this type of program?

Healthcare professionals	Others	Legal entities
> Doctors and specialists: They play an essential role in defining therapeutic objectives and validating educational content; > Nurses: They are often on the front line in delivering education and educational follow-up to patients; > Pharmacists: They can help explain treatments and their dosage; > Psychologists or psychiatrists: They help patients manage the stress and psychological impact of their illness.	> Specialized educators: They are specifically trained to deliver TVE; > Expert patients: people living with the same pathology can share their experience and provide invaluable support.	> A healthcare establishment (public or private); > A collective practice structure (health center/health home/health cluster); > A health network; > An association; > The Assurance Maladie (health insurance) for health examination centers and the Sécurité Sociale Agricole (agricultural social security); > A mutual or other complementary insurance company; > A foundation; > A municipality.

> Manufacturers and their medicines, at the heart of TVE… but with less room for manoeuvre:

– Ever more innovative medicines

– Pathologies requiring increasingly advanced patient knowledge/technical gestures

– Image and communication issues, as well as the promotion of public health, may lead the laboratory to wish to support an ETP program especially when self-administering drugs.

In order to remain compliant, it is essential for manufacturers wishing to leverage the benefits of ETP to be aware of the roles and levels of involvement they are allowed to play.

Finally, implementing a TVE program without being authorized to do so is punishable by a fine of up to 30,000 euros.

> Conclusion

Therapeutic patient education represents a major evolution in the way we approach health and illness. In a world where it is becoming commonplace for patients to become experts in their own disease, they are a tool for them to understand, actively participate in their treatment and adopt health-promoting behaviors, while contributing to comprehensive, personalized care.

However, the role of the operator of a medicine is regulated and requires a case-by-case analysis of each project.

In such a context, manufacturers have a role to play, while considering the regulatory complexity imposed by the system and the need to steer clear of the multiple risks associated with their highly regulated field of activity (promotional requalification, contact with patients, granting benefits to patients or healthcare professionals).

Article written by Zarine RAMJAUNY, Legal Advisor

Following the “Médiator” case and inspired by the Sunshine Act in the United States, the law of December 29, 2011, concerning the strengthening of health safety, known as the “Bertrand Law,” was passed.

This law establishes systematic transparency of links between health industries on one hand, and other actors in the health field on the other. This primarily includes healthcare professionals, but also students, learned societies, associations, media, etc.

The “transparency of links” system, which provides the general public with information on the relationships between health industries and members of the health system, is in line with the “regulation of benefits” system, which aims at the ethics of healthcare professionals. These two legislations interact with each other, with some subtle specificities that distinguish them.

Who is Affected by the System?

The following actors are concerned:

Types of Declaration and Publication

It is appropriate to publicly disclose retrospectively:

• Agreements: publication of all contracts made between laboratories and a health actor (for example: agreements with coverage of hospitality expenses (catering, transport, accommodation, registration fees at a congress));

• Service provision contracts (for example: remuneration for clinical expert work);

• Benefits exceeding 10 euros including taxes (for example, the granting of health product samples);

• Remunerations awarded (for example: remuneration of a healthcare professional for speaking at an event).
  
  
  

Commercial contracts are excluded.

The typology of benefits and agreements responds to precise definitions that have been clarified by the authorities.

The system requires that pharmaceutical companies, in particular, are obliged to publish information on the public database https://www.transparence.sante.gouv.fr, according to the following frequency:

• Publication twice a year:

• First calendar semester, i.e. from January 1st of year N to June 30th of year N: submission on the “transparency-health” website by September 1st of year N.

• Second half of the calendar year, i.e. from 1 July of year N to 31 December of year N: submission on the “transparency in health” website no later than 1 March of year N+1.

Thus, the general public can access the work links and professional relationships maintained between health industries and actors in the French healthcare system.

In parallel, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has also adopted the “EFPIA code of practice” to frame collaboration with Healthcare Professionals or their Organizations when conflicts of interest exist. This text is applicable to member companies.

ATESSIA supports its clients on all these questions.

Article written by Zarine RAMJAUNY, Junior Legal Consultant

Atessia assists its clients on a daily basis with the practicalities of implementing the French early access programs and compassionate use scheme, the subtleties of which require some explanation. 

This new system has been in place since 1^st July 2021 and is based on 2 access and reimbursement mechanisms:  

• Early access (AAP) 

The first is the early access scheme, dedicated to medicinal products that meet an unmet therapeutic need and are likely to be innovative. The pharmaceutical company submits an application for early access authorisation (AAP) to the French National Authority for Health (HAS) and, for medicinal products not yet authorised under marketing authorisation, to the French National Agency for the Safety of Medicines and Health Products (ANSM).  

These authorisations may apply to : 

– a medicinal product prior to obtaining marketing authorisation for the indication in question (Pre-marketing authorisation AAP = AP1),  

– a medicinal product which already has a marketing authorisation for the indication in question, prior to it being covered by the general health insurance system (Post-marketing authorisation AAP = AP2). 

Interestingly, the product may or may not have marketing authorisation for another indication. 

As indicated in the HAS doctrine, the granting of an AAP is reserved for specific medicinal products that meet the following 5 cumulative eligibility criteria: 

1. Efficacy and safety are strongly presumed in the indication in question  

2. The disease to be treated is serious, rare or disabling 

3. There is no such thing as “appropriate treatment” 

4. The treatment cannot be deferred 

5. The drug is presumed to be innovative. 

The authorities examine all these criteria separately, and quite strictly. 

This system also requires concrete commitments from the laboratories, which should not be underestimated and which need to be weighed up with the parent company.  

• REGULATORY: The pharmaceutical company must undertake to submit a marketing authorisation application within 2 years for an AP1 or a registration application within one month of obtaining the marketing authorisation for an AP2. The timing of the application is therefore crucial to the project. 

• LOGISTICS: The pharmaceutical company makes the product available within 2 months of the granting of the AAP and ensures that it can supply the product to allow continuity of treatment for patients initiated throughout the AAP. At the end of the AP, the exploitant pharmaceutical company ensures the continuity of the treatments initiated for a minimum period of one year, of which 3 months are covered by health insurance.  

• FINANCIAL: The pharmaceutical company sets up a PUT-RD for data collection and the transmission of periodic summary reports. It funds the data collection withing the framework of an agreement signed with health establishments. 

• The pharmaceutical company is also required to support prescribers in entering and monitoring the collection of real-life monitoring data for the drug, by providing them with the necessary resources. 

Since the implementation of the AP scheme in July 2021, the HAS has published a positive report covering three years of application : 

• Two types of compassionate access  

This system covers two distinct cases, which have in common the fact that they concern a medicinal product used to treat patients suffering from illnesses for which there is no appropriate treatment, in a given therapeutic indication, without it being intended to obtain marketing authorisation in France. Applications are managed solely by the ANSM. 

1. 1^st mechanism: this compassionate access is requested for an unauthorised drug not available in France by a hospital prescriber for a named patient, provided that the ANSM is able to presume a favourable benefit/risk ratio for a serious, rare or disabling disease: this is an individual and nominative compassionate access authorisation (AAC). 

2. 2^nd mechanism: it is a framework for a practice, at the initiative of the ANSM, with a view to securing the practice of off-label prescribing of a medicinal product available in France, which has marketing authorisation for other indications, when it is the subject of well-established off-label prescribing on French territory : this is a compassionate prescribing framework (CPC). 

Exceptions to compassionate access have been made in the following cases: 

• Allowing nominative access to medicines in development for the indication: this is a “very early” compassionate access. 

• The LFSS for 2024 also provides for the possibility of granting compassionate access authorisations in the event of a refusal for early access on the grounds that the drug is not considered innovative enough. 

There are a number of eligibility conditions attached to the ANSM grant, which bring this scheme closer to early access and can be the gateway to it: 

• treatment cannot be postponed; 

• the patient cannot take part in any ongoing research; 

• the company responsible for exploiting the medicinal product must undertake to submit an application for early access program within 12 months of the first ‘compassionate pre-approval’ (18 months for rare diseases).  

Compassionate access schemes differ from early access programs in that their initiation does not rest with the manufacturer, who may be required to implement and fund a PUT-SP. 

Thus, the reform has brought greater predictability for manufacturers and continuity of access up to standard reimbursement. In return, pharmaceutical companies are bound by a number of commitments. 

According to the ANSM report, published in 2024, the use of compassionate access has been stabilising since the 2021 reform. In 2023, a relative decrease of 10% in compassionate access requests was observed. This decrease is partly linked to the granting of marketing authorizations for several Covid-19-related products, which had previously been the subject of numerous compassionate access requests. 

Moreover, the number of medicinal products available under this scheme has remained stable, with 373 made available in 2023. 

For these products, it may be necessary to appoint a pharmaceutical company to operate the medicinal product, in order to ensure import/distribution, pharmacovigilance, quality claims or medical information, as appropriate. 

Pharmaceutical companies now have several years’ experience of these new mecanisms, and the trends that are emerging show a willingness on the part of the authorities to make innovative medicines available to French patients and to respond to the personal situations of patients who have reached a therapeutic impasse. 

Article written by Lamya SAOUSSEN, Junior Regulatory Affairs and External Communication Advisor 

From a legislative point of view, the mutual recognition procedure is defined by the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. 

Directive 2004/27/EC subsequently laid the foundations for the decentralised procedure. 

These two procedures are available for all marketing authorisation applications that do not fall within the mandatory scope of the centralised procedure. They are applicable whenever an applicant wishes to register its medicinal product in more than one Member State.  

1/ The Mutual Recognition Procedure (MRP) 

Article 28.2 of Directive 2001/83/EC, as amended, specifies the scope of this procedure: the principle is to extend a national MA already obtained in one of the EU Member States, to one or more other Member States in which the laboratory wishes to market its product. The referent state (or “RMS”), which granted the existing MA, manages the procedure. 

Once the evaluation procedure has been completed, the MAs are issued by each of the competent authorities of the member states concerned. 

Timetable 

After a possible upgrade of the MA dossier, the RMS sends the MA dossier and its assessment report, including the SPC, package leaflet and labeling, to the CMS 14 days before the start of the procedure.  

The concerned Member States must then recognize the authorization already issued by the RMS within 90 days (without clock-stop).  

The procedure may, however, end on Day 60 if the RMS has no further comments.  

The MA (including the SPC, package leaflet and labeling) is recognized by the CMS. 

This period is followed by a 30-day national closing phase to issue the national MA. 

If a Member State has objections to recognizing the dossier’s assessment report, summary of product characteristics (SPC), package leaflet and labeling, on the grounds of a potentially serious risk to public health (as defined by Article 29(1) of Directive 2001/83/EC), the dossier is referred back to the CMDh for further discussion. This procedure lasts 60 days. If the CMDh is unable to reach a decision within 60 days, the application is sent to the CHMP for arbitration (art. 29(4) of Directive 2001/83/EC). This procedure also lasts 60 days. 

2/ The decentralized procedure (DCP) 

This procedure differs from the MRP in two main points :  

• No marketing must first have been granted in the EU,  
• The dossier is submitted simultaneously in all Member States.  

In this case, the laboratory asks a member state to act as reference state (“RMS”) for the evaluation among the states in which it wishes to authorize its medicinal product. 

Timetable 

The RMS draws up a preliminary assessment report on the dossier submitted and the draft summary of product characteristics (SPC), package leaflet and labeling. 

This report is submitted to the CMS and the applicant for comments on Day 70 of the procedure. 

On Day 105 of the procedure, the clock stops to allow the applicant to submit answers to the questions raised by the Member States at the end of phase 1. 

When the answers have been submitted, the clock starts again on Day 106, and on Day 120 of the procedure, the RMS circulates at the same time an update of all documents (assessment report, SPC, package leaflet and labeling) to the applicant and the CMS. 

A second phase of Questions and Answers begins, and the procedure may be closed on Day 150 if all comments have been resolved.  

Otherwise, a new 60-day phase begins to finalize outstanding issues.  

The DCP therefore lasts a maximum of 210 days. This period is followed by a 30-day national closing phase to issue the national MA. 

As with the MRP, if there is no consensus between member states, the dossier is referred back to the CMDh for further discussion. This procedure lasts 60 days. If the CMDh is unable to reach a decision within 60 days, the application is sent to the CHMP for arbitration (art. 29(4) of Directive 2001/83/EC). This procedure also lasts 60 days. 

To sum up: 

MRP	DCP
Existing initial national MA	No MA granted in the EU
No choice of the RMS (national MA already existing th the EU)	The choice of the RMS is up to the applicant
Request a recognition by the other Member States	Simultaneous application to all member states: the RMS evaluates the dossier for the first time (as for the CMS)
Only one evaluation phase	Two evaluation phases
Decision within 90 days, or up to 150 days in the event of arbitration by the CMDh if no consensus can be reached between Member States.	Decision in 210 days (excluding clock-stop period), or up to 270 days in the event of arbitration by the CMDh if no consensus can be reached between Member States.
MA Dossiers identical in all member states
Principle of recognition of the evaluation of the Reference Member State (RMS) by the other Member States concerned (CMS)
The choice of the States involved in these procedures is up to the applicant
National closing phase of 30 days planned to issue the national MA
A European Public Assessment Report (PAR) for each medicinal product approved via the MRP/DCP is published in the directory « Mutual Recognition Index » by the RMS on the HMA website.

ATESSIA supports laboratories throughout the registration process: from the registration strategy to the draft and submission of the marketing authorization applications. 

Article written by Fabien MEDINA, Pharmaceutical and Regulatory Affairs Senior Advisor. 

*ANSM : Agence Nationale de Sécurité du Médicament et des produits de santé (competent authority for medicines and health products) 

Law No. 2023-451 dated June 9, 2023, which aims to regulate commercial influence and combat abuses by influencers on social media platforms, not only defines the concept of an “influencer”, but also introduces the notion of an “influencer’s agent”.

What is an Influencer?

Influencers are any “(…) natural or legal persons who, for a fee, mobilize their reputation among their audience to disseminate content to the public via electronic means. Their goal is to promote either directly or indirectly, goods, services or any cause. They engage in the activity of commercial influence through electronic means” (Article 1).

Examples include a patient, a healthcare professional or a person with a strong reputation.

What is an Influencer Agent?

” I. – An influencer agent’s role is to represent, for a fee, either natural or legal persons engaged int the activity of commercial influence through electronic means as defined in Article 1. This representation involves liaising with other natural or legal persons, and if relevant, their representatives, to promote goods, services or any cause, also for a fee.

II. – Individuals who undertake the activity defined in Section I of this article must take all necessary measures to safeguard f the interests of those they represent, to avoid situations that might lead to conflicts of interest and to ensure their actions align with the stipulation of the current law  (Article 7).

What are the Law’s Obligations?

Supervision of Sponsored Content:

This law creates an obligation for influencers to report any sponsored content. Specifically, any promotion of goods, services or a cause of any kind carried out by an influencer must systematically include the mention “Advertising” or “Commercial collaboration”. This mention must appear clearly, legibly and identifiably on the influencer’s image or video, whatever its format and for the entire duration of its broadcast.

• Supervision of Published Visuals:

Images should be labelled as “Retouched Images” if they undergo processing to slim or thicken a silhouette or modify face appearance.;

Images should be labelled as “Virtual images” if any artificial intelligence process has been used to generate or modify a face or silhouette.

• Supervision of Dropshipping Activities:

Influencers are obliged to provide the buyer with all pre-contractual information related to a distance sales agreement. This includes the identity of the supplier and confirmation of product availability. Failure to provide this information can result in influencers being held accountable.

What is Prohibited?

Direct or indirect promotion of the following products and services is prohibited:

• Aesthetic procedures, processes, techniques, and methods referred to in Article L. 1151-2 of the French Public Health Code, as well as interventions referred to in Article L. 6322-1 of the same code (including aesthetic medical devices (DMs) listed in Annex XVI of Regulation 2017/745 MDR);
• Procedures, processes, techniques, and methods presented as comparable to, preferable over or substitutes for therapeutic procedures, protocols, or prescriptions;
• Products considered as nicotine-based that can be consumed and are made, even partially, of nicotine.
  
  

What are the Penalties?

Violators may face a fine of up to 300,000 euros and a prison sentence of up to 2 years. To ensure consumer protection, a dedicated team has been set up within the DGCCRF (a French authority, Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes), and reports can be submitted via the Signal conso website.

Existing sanctions are reinforced and graduated. The following acts are punishable:

• Failure to indicate the advertising nature of a video or photo posted by an influencer is now considered a misleading commercial practice;
• Promotion of a prohibited or regulated product carries the same penalties as online advertising;

Additionally, the authorities have been granted a new power of injunction with penalties. This allows them to compel an influencer to remove non-compliant content or for platforms to suspend the influencer’s account promptly.

Judges and supervisory authorities will tailor penalties according to the severity of the act.

What About Drugs and Medical Devices?

The promotion of medicines to the general public is regulated by the French Public Health Code. With the exception of class I or IIa medical devices, the promotion of a drug, medical device or IVDD to the general public based on a recommendation from people who, through their reputation, can encourage the consumption of the product in question, such as influencers on social networks, is already prohibited by the Public Health Code.

Need assistance in managing influencer communication under contract with your laboratory? Our expert consultants are available to discuss your concerns.

Article written by Zarine RAMJAUNY, Junior Legal Consultant

Promotional visit for medicinal products in France refers to promotional interactions with healthcare professionals (HCPs) conducted by authorized collaborators from the pharmaceutical industry. 

The structural reform of health insurance established by the law of August 13, 2004, resulted in the first Charter of Medical Visit. The objective was to better regulate the commercial and promotional practices of laboratories that could harm the quality of care (creation of Article L.162-17-8 of the Social Security Code). 

Since 2008, the scope of the charter has been broadened to include prescribers practicing in health institutions, and not just those from private practices. The latest version of the Charter, dated October 15, 2014, is now titled the “Charter on information provided for the promotion of medicinal products through prospecting or canvassing ” 

. All pharmaceutical companies with an authorization to open as an ”Exploitant”, and having signed an agreement with the CEPS (reimbursable medicines) must undertake to comply with the Charter declined in a reference framework drawn up by the Haute Autorité de Santé (HAS), the latest version of which in force dates from March 2017, as well as the Q&As that followed and notably the latest dated March 20, 2025 .  

It is the practical application procedure of the Charter, and it is based on this procedure (certification reference system) that certifying bodies, accredited by the French Accreditation Committee (COFRAC), certify companies for their promotional activity. This procedure has two parts: one dedicated to the certification of the activity performed by the “Exploitant” companies themselves, on their own or in co-promotion, as well as the requirements that these companies must meet in the event of outsourcing all or part of their promotional activity. The second part is dedicated to the certification of the promotional activity performed by subcontracting companies. 

Companies subject to this system must implement a quality management system that can sustainably meet the requirements of the Charter and its reference system: 

Chapter 1: Definition, implementation and monitoring of the quality policy for this activity (internal audit, annual quality review, management of CAPAs, management of promotional documents, etc.). 

– Chapter 2: Initial/induction/continuing training and knowledge assessment of promotional employees (7 regulatory themes and 2 scientific themes), random assessment and individual training pathways. 

– In chapter 3: Compliance with ethical rules vis-à-vis patients, healthcare professionals, competitor companies, one’s own company and health insurance, including French anti-gift Law and RGPD regulation ( March 2025 Q&As update). 

– In chapters 4 and 5: Co-promotion and use of subcontractors (contract, responsibility and organization and monitoring). 

Pharmaceutical companies must prepare for annual certification audits (N: certification, N+1 surveillance, N+2 surveillance, N+3 renewal audit), regularly review their quality management system, and monitor the activities of all cross-functional functions involved (marketing, regulatory affairs, medical, field staff: MSL and promotional staff, etc.). The challenges include ensuring regulatory compliance of promotional activities, which are one of the strategic pillars of the company’s business, and making a clear distinction between promotional activities and medical and scientific activities.   

Medicines are not the only products concerned: the quality charter for the professional practices of persons responsible for the presentation, information or promotion of medical devices for individual use, health products other than medicines, and any associated services, published in the French Official Journal on March 8, 2022, and whose application guidelines are due to be published at the end of 2025, will apply simultaneously to the multi-product laboratories concerned and to medical device companies (“quality charter for professional practices for reimbursable products and services”). 

The March 2025 Q&As update the notions of early access and compassionate use, as well as RGPD and French anti-gift Law, in a referential that celebrates its 8th anniversary this year. 

But with all this:  

What can they give to doctors, and what should they give to them? What can a KAM or MSL say? And above all, what messages should be delivered in relation to the therapeutic indications of the MA, early access or compassionate use, and off MA, taking into account the therapeutic strategy established by the HAS? How should we discuss the results of clinical trials? How to declare a congress with a speaker? Can a MSL train field associates? Can a delegate do referencing? 

ATESSIA can help you with your internal audits, subcontractor audits, preparation for certification audits, drafting procedures or training (7 regulatory topics) for your field teams. 

Sandrine De Sousa, Senior Consultant Compliance & Quality of External Communications 

For more information

🌐 https://www.atessia.fr/fr/accueil/

Get in touch!

👤 Géraldine BAUDOT-VISSER

✉ hello@atessia.fr

📞 +33 764 273 693

The Chief Pharmaceutical Officer also called Responsible Pharmacist (RP) is a key role , essential to the organization of any pharmaceutical laboratory involved in the manufacture, exploitation and distribution of medicinal products for human use in France.

The Chief Pharmaceutical Officer ensures  the quality of the medicine and the safety of the patients. Their position, functions, and assignements are defined by the regulations. Their skills are validated by their peers based on practical experience. Their responsibilities are numerous. They must maintain their freedom of judgment and hold pharmaceutical authority within their structure. They can delegate some activities and must be replaced in case of absence.

Positions, functions and Assignements

The Chief Pharmaceutical Officer has a statutory position within a pharmaceutical establishment (manufacturer, operator, depositary or wholesaler-distributor).

They  organize and supervise all pharmaceutical activities: manufacturing and batch release, advertising, information, pharmacovigilance, follow up and withdrawal of batches, distribution, import and export, storage and transport.

The responsibilities attributed to the RP are broader than those of the qualified person within the European Union (directive 2001/83/EC, article 48). They have a personal responsibility for all pharmaceutical activities, unlike the qualified person who exercises operational responsibility for the activities they are responsible for (batch release, follow up and recall of batches, pharmacovigilance).

Their status as well as their functions and assignements are defined in the Public Health Code (Code de la Santé Publique CSP) in articles R.5124-16 to R.5124-41.

Validation of Skills and Practical Experience

Their skills and practical experience are validated by the National Council of the Order of Pharmacists. Decree No. 2022-324 of March 4, 2022, recently modified the terms of the practical experience required for the RP (CSP Articles R.5124-16 à R.5124-18).

The RP is appointed by the competent corporate body of the company and then declares themselves to the competent authority: the ANSM*.

The Responsibilities of the RP

The responsibilities of the RP are of three types:

• Legal and criminal liability
• They are a member of the management of the company.
• They are the main contact of the Health Authorities.
• They arepersonally responsible for the compliance of the pharmaceutical establishment with the Public Health Code.
• Disciplinary responsibility
• Respect for professional ethics
• Compliance with their deontologic obligations
• Civil liability

The RP shares civil and criminal liability with the manager(s) of the company.

Freedom of Judgment and Pharmaceutical Authority

Like any pharmacist, the RP preserves their freedom of professional judgment in the exercise of theirfunctions (CSP Article R.4235-3).

They have authority over all pharmaceutical staff (CSP Article R.5124-36) and appoints the delegate pharmacist(s).

Delegation and Replacement

The RP can delegate some pharmaceutical activities. The delegate pharmacist is bound, within the limits of their delegation, to the same obligations as the RP (CSP Article R.4235-68).

In the event of absence, the RP is replaced by an interim responsible pharmacist (CSP Article R.4235-70). The IRP then has the same functions, assignements, and responsibilities as the RP during the replacement period.

ATESSIA supports Chief Pharmaceutical Officer in the performance of their duties: regulatory intelligence, CMC support, advertising, pharmacovigilance, activities related to regulatory affairs and quality assurance, and offers Interim Responsible Pharmacists registered at the Pharmacists Council.

Article written by Christelle PETIT, Pharmaceutical Affairs Advisor and Director.

*ANSM : Agence Nationale de Sécurité du Médicament et des produits de santé (competent authority for medicines and health products)

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Securing the distribution of medicines represents an unprecedented challenge for public health. Although France has always benefited from a particularly secure drug distribution system and a strict legislative framework from the health authorities, the risk of falsified drugs is increasing on a global and European scale.

Faced with this major challenge, Directive 2011/62/EU of the European Parliament and of the Council of June 8, 2011 introduced the serialization system, which details were subsequently specified by Commission Delegated Regulation (EU) 2016/161 of October 2, 2015, in order to strengthen the safety of the distribution chain of medicinal products and to fight against their falsification. The obligations relating to the serialization of medicinal products and anti-counterfeiting devices are applicable since February 9, 2019.

Now 4 years after the entry into force of the European regulation, let’s look back at the implementation of the serialization system.

As a reminder, the serialization device is composed as follows:

• A tamper-evident device for all drugs, affixed by the manufacturer and verified by the pharmacist to check the integrity of the product before dispensing (e.g. transparent adhesive tape);
• A unique identifier (UI) on each box of mandatory prescription medication, affixed by the manufacturer and scanned by the pharmacist before dispensing to the patient (datamatrix).

The serialisation system contributes to the implementation of a European system to fight against the introduction of falsified medicines by providing additional security to guarantee the authenticity, safety and quality of medicines on the territory of the European Union. It completes the existing batch traceability by authenticating each box at the time of dispensing.

The implementation of this system required the collective commitment of all the stakeholders in the drug supply chain (manufacturers (CMOs) and Exploitants/Marketing Authorization Holders, wholesalers and distributors, pharmacies and hospitals, software publishers, etc.), as well as the Ministry of Solidarity and Health, the French National Agency for the Safety of Medicines and Health Products (ANSM) and the regional health agencies (ARS).

Indeed, this new system has required organizational changes at all levels, from drug production to delivery to the patient: adapting production lines to implement the unique identifier and the anti-tampering device, adapting the IT systems of all drug professionals, setting up governance bodies at national (NMVO) and European (EMVO) level, adapting procedures, etc.

The question of ultimate responsibility for implementing serialization has been the subject of numerous debates, which have now been settled, with the central issue of downloading unique identifiers at the time of manufacture and the possible outsourcing of this activity. The introduction of the OBP portal registration requirement and fees to finance the infrastructure of national (NMVS) and European (EMVS) repositories systems has also had an impact on the drug chain stakeholders.

WHAT ABOUT THE IMPLEMENTATION OF SERIALIZATION IN PHARMACIES IN FRANCE?

Serialisation is a regulatory obligation for all pharmacies. Indeed, such a system can only operate with the participation of all pharmacies in the Member States in order to ensure that no falsified box is delivered to a patient in the European Union.

This obligation, which came into force on February 9, 2019, was reminded in the Order of February 26, 2021 on good dispensing practices for medicinal products in order to make the obligations incumbent on all pharmacists under European regulations more visible in a text of national scope.

However, to date, despite the health crisis and the strong mobilization of pharmacists, the connection of pharmacies to the system has been delayed and remains insufficient in France. As of February 6, 2023, only 17,901 pharmacies (86.2%) were complying with their obligations to serialize their medicines, with a target of 100% by December 31, 2022.

Given France’s considerable delay in implementing effective verification of the serialization system in pharmacies, a bill was adopted by the Senate on December 14, 2022, defining the financial penalties that may be imposed on pharmacy holders in the event of non-compliance with the obligation to deactivate the unique identifier.

On the page dedicated to serialisation in pharmacies on its website, the Ministry of Health stresses the importance of reaching this 100% objective as soon as possible to guarantee better safety and traceability of medicines for all French people.

Article written by Amélie NICOLAS-VERLEY, Regulatory and Pharmaceutical Affairs Advisor