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Decree No. 2014-73 30 January 2014 On The Harmonisation Of Criminal And Financial Sanctions Applicable To Health Products And The Modalities Of Implementation Of Financial Sanctions

Original Language Title: Décret n° 2014-73 du 30 janvier 2014 relatif à l'harmonisation des sanctions pénales et financières applicables aux produits de santé et aux modalités de mise en œuvre des sanctions financières

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Summary

Partly repealed: lines 89 to 93 of the annexed table (Decree No. 2014-1608 of 26 December 2014).

Keywords

CODE OF THE PUBLIC HEALTH , CSP , PROFESSIONAL OF HEALTH , HEALTH PRODUCT , FABRICATION , MISE ON MARKING , MEDICAL DISPOSIBLE , MEDICAL DISPOSITORTURE


JORF no.0026 of 31 January 2014 page 1830
text No. 14



Decree No. 2014-73 of 30 January 2014 on the harmonization of criminal and financial sanctions for health products and the modalities for the implementation of financial sanctions

NOR: AFSP1328558D ELI: https://www.legifrance.gouv.fr/eli/decret/2014/1/30/AFSP1328558D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2014/1/30/2014-73/jo/texte


The public concerned: economic operators involved in the manufacture and marketing of health products, health professionals, the National Agency for the Safety of Medicine and Health Products, general direction of competition, consumption and repression of fraud, regional health agencies.
Purpose: harmonizing the penalties for health products and the modalities for the implementation of financial sanctions.
Entry into force: the text comes into force on 1 February 2014.
Notice: the text is part of the harmonization of the sanctions applicable to health products and the adaptation of the prerogatives of the agents and authorities responsible for detecting the breaches imposed by these sanctions and, in addition, to the regulatory level,Order No. 2013-1183 of 19 December 2013 relating to the harmonization of criminal and financial sanctions on health products and the adaptation of the prerogatives of the authorities and officials responsible for the failures. It provides the conditions under which regional health agencies and the National Drug and Health Products Safety Agency (ANSM) may impose financial sanctions. In addition, it adapts the penalties for contravening drugs, medical devices and in vitro diagnostic medical devices and creates a fifth-class contravention in the event of a failure to report pharmacovigilance, materialovigilance or reactovigilance by a health professional.
References: the Public Health Code Amended by this decree can be consulted, in its drafting, on the website Légifrance (http://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Social Affairs and Health,
See?Order No. 2013-1183 of 19 December 2013 relating to the harmonization of criminal and financial sanctions relating to health products and the adaptation of the prerogatives of the authorities and officials responsible for detecting violations;
Vu le Criminal codearticles 132-11, 132-15 and R. 610-1;
Vu le Public Health Code ;
Considering the advice of the National Drug and Health Products Safety Agency Technical Committee dated 2 December 2013;
The State Council (Social Section) heard,
Decrete:

Article 1 Learn more about this article...


In chapter V of title III of Book IV of the first part of the Public Health Code, after article R. 1435-36, a section 6 is added as follows:


“Section 6



“Implementation of financial sanctions


"Art. R. 1435-37. - I. ― On the basis of inspections conducted pursuant to the provisions of Article L. 1435-7, results of checks or evidence of breaches under Articles L. 5472-1 and L. 5472-2, the Director General of the Territorially Competent Regional Health Agency may initiate a financial sanction procedure against the authors of these breaches.
“II. ― The Director General of the Agency shall notify the natural or legal person concerned of the facts to justify the initiation of the sanction procedure and the breaches, the financial penalty incurred, and shall communicate to him the evidence justifying such breaches. He:
« 1° Provides the physical or legal person concerned with the submission of his or her written or oral submissions, with the indication of the possibility of being assisted by counsel;
« 2° Where appropriate, it remains to regularize the situation;
« 3° It remains to transmit to it the turnover of the financial penalty.
"It sets the person concerned a time limit that cannot be less than eight days to meet the requests mentioned in 1° to 3° above. When using the 2°, this period may be reduced in the event of an emergency.
"III. – At the end of the deadline, the Director General of the Regional Health Agency may impose a financial penalty.
"If the person concerned has not regularized the situation within the specified time limit, this penalty may be accompanied by a daily offence, which begins to run from the date of notification to the person concerned of the financial penalty and ceases to run on the day of regularization of the situation, if any, recognized by a new inspection.
"IV. ― The sanction decision is notified to the person concerned, by any means to give the person a certain date. It indicates the nature of the facts constituting the breach, the amount of the penalty imposed and, where applicable, the extent to which the offence is committed, the terms and conditions of acquittal, and the means and time limits of appeal.
"V. ― The financial penalty decision may be published on the agency's website for a period of time that may not exceed one month or, where applicable, until the regularization of the situation, if it has not occurred after that period. »

Article 2 Learn more about this article...


I. ― AtArticle R. 5313-7 of the Public Health Code, the reference to section R. 1124-1 is replaced by the reference to section L. 1121-16.
II. ― Chapter II of Book III title I of Part 5 of the Code is amended as follows:
1° The single section becomes section 1;
2° It is added a section 2 as follows:


“Section 2



“Implementation of financial sanctions


"Art. R. 5312-2.-I. ― On the basis of inspections conducted pursuant to the provisions of section L. 5313-1, results of controls or evidence of breaches under sections L. 5471-1 and R. 5471-1, the Director General of the National Drug Safety Agency and Health Products may initiate a procedure for financial sanctions against the authors of these violations.
“II. ― The Director General of the Agency shall notify the natural or legal person concerned of the facts that warrant the initiation of the sanction procedure and the breaches, the financial penalty incurred and shall communicate to him the evidence justifying such breaches. He:
« 1° Provides the physical or legal person concerned with the submission of his or her written or oral submissions, with the indication of the possibility of being assisted by counsel;
« 2° Where appropriate, it remains to regularize the situation;
« 3° It remains to transmit to it the turnover of the financial penalty.
"It sets the person concerned a time limit that cannot be less than eight days to meet the requests mentioned in 1° to 3° above. When using the 2°, this period may be reduced in the event of an emergency.
"III. ― At the end of the deadline, the director general of the agency may impose a financial penalty.
"If the person concerned has not regularized the situation within the specified time limit, this penalty may be accompanied by a daily offence, which begins to run from the date of notification to the person concerned of the financial penalty and ceases to run on the day of regularization of the situation, if any, recognized by a new inspection.
"IV. ― The sanction decision is notified to the person concerned, by any means to give the person a certain date. It indicates the nature of the facts constituting the breach, the amount of the penalty imposed and, where applicable, the extent to which the offence is committed, the terms and conditions of acquittal, and the means and time limits of appeal.
"V. ― The financial penalty decision may be published on the agency's website for a period of time that may not exceed one month or, where applicable, until the regularization of the situation, if it has not occurred after that period. »

Article 3 Learn more about this article...


In chapter I of Book IV, Part 5, Title II, of the Public Health Code, an article R. 5421-1 was created as follows:
"Art. R. 5421-1. - The fact for physicians, dental surgeons, midwives or pharmacists to ignore the immediate reporting obligations of a serious adverse reaction suspected of being due to a drug or product within the meaning of 2° of section R. 5121-152 of which they were aware is punishable by the fine provided for fifth class contraventions. »

Article 4 Learn more about this article...


I. ― The title of Book IV of Part 5 of the Public Health Code is replaced by the following title: "Penal and Financial Sanctions".
II. ― In chapter I of Book IV title VI of Part 5 of the Public Health Code, a section 1 entitled "criminal sanctions" is created and in this section, which includes sections R. 5461-1 to R. 5461-3, sections R. 5461-1 to R. 5461-2 are replaced by the following:
"Art. R. 5461-1.-Is punishable by the fine provided for fifth class contraventions:
« 1° For a health facility, an inter-hospital union, a health cooperation group or an association referred to in R. 5212-12, not to designate a local materiality correspondent or not to communicate the name of that local correspondent to the Director General of the National Drug Safety Agency and Health Products;
« 2° For a health professional who has been aware of an incident or risk of an incident involving a medical device that has resulted in or likely to result in the death or serious deterioration of the health condition of a patient, user or third party, to refrain from reporting it promptly to the National Drug Safety Agency and Health Products.
"Art. R. 5461-2.-Recidivism of contraventions under section R. 5461-1 is repressed in accordance with sections 132-11 and 132-15 Criminal code. »
III. ― In chapter I of Book IV title VI of Part 5 of the Public Health Code, a section 2 entitled "Financial sanctions" includes section R. 5461-4 as follows:
"Art. R. 5461-4.-Constitutes a breach of financial penalty:
« 1° For the manufacturer of a medical device or its agent, not to make available to the Director General of the National Agency for the Safety of Medicine and Health Products the declarations of conformity and technical documentation established under the certification procedures, as well as the decisions and reports of the authorized bodies involved in these procedures, referred to in R. 5211-26;
« 2° For the manufacturer of a medical device or its agent, not to submit, upon request of the agents mentioned in Article L. 5431-1, the declarations of conformity and the technical documentation established in the course of the certification procedures, as well as the decisions and reports of the authorized bodies involved in these procedures, referred to in Article R. 5211-26;
« 3° For any person who has his or her head office in France and who has at least one of the activities mentioned in article R. 5211-65, to put on the market a class I medical device or a tailor-made medical device without making the declaration provided for in the first and fourth paragraphs of article R. 5211-65;
« 4° For any person with his or her head office in France who has at least one of the activities mentioned in article R. 5211-52, to put on the market a medical device fitted with CE marking and designed by the manufacturer to be sterilized before use without making the declaration provided for in the second paragraph of article R. 5211-65;
« 5° For any person who has his or her head office in France and who has at least one of the activities referred to in article R. 5211-67 to put on the market devices assembled to form a system or a necessary one, without making the declaration provided for in the second paragraph of article R. 5211-65;
« 6° For a manufacturer or agent referred to in R. 5212-13, not to designate a materialovigilance correspondent or not to communicate the name of that correspondent to the Director General of the National Drug Safety Agency and Health Products. »

Article 5 Learn more about this article...


I. ― In chapter II of Book IV, Part VI, Part 5, of the Public Health Code, a section 1 entitled "criminal penalties" is created and in this section, which includes sections R. 5462-1 to R. 5462-3, sections R. 5462-1 to R. 5462-2 are replaced by the following provisions:
"Art. R. 5462-1.-Is punishable by the fine provided for fifth-class contraventions:
« 1° For a health facility, an inter-hospital union, a health cooperation group using in vitro diagnostic medical devices or a blood transfusion facility referred to in R. 5222-10, not to designate a reactovigilance correspondent or not to communicate the name to the Director General of the National Drug Safety Agency and Health Products;
« 2° For a health professional who has been aware of a failure or deterioration of an in vitro diagnostic medical device that could cause adverse effects on the health of people, to refrain from reporting it promptly to the National Drug Safety Agency and Health Products.
"Art. R. 5462-2.-The recidivism of contraventions under section R. 5462-1 is repressed in accordance with sections 132-11 and 132-15 Criminal code. »
II.-In chapter II of Book IV title VI of Part 5 of the Public Health Code, a section 2 entitled "Financial sanctions" includes section R. 5462-4 as follows:
"Art. R. 5462-4.-Constitutes a financially sanctioned violation:
« 1° For the manufacturer of an in vitro medical diagnostic device or its agent, not to make available to the Director General of the National Agency for the Safety of Medicine and Health Products the declarations of conformity and technical documentation established under the certification procedures, as well as the decisions and reports of the authorized bodies involved in these procedures, under the conditions referred to in R. 5221-18;
« 2° For the manufacturer of an in vitro medical diagnostic device or its agent, not to submit, upon request from the agents referred to in Article L. 5462-1, the declarations of conformity and the technical documentation established in the certification procedures and the decisions and reports of the authorized bodies involved in these procedures, under the conditions referred to in Article R. 5221-18;
« 3° For a manufacturer or agent referred to in R. 5222-11, not to designate a person in charge of reactovigilance or not to communicate the name to the Director General of the National Drug Safety Agency and Health Products. »

Article 6 Learn more about this article...


Book IV of the fifth part of the Public Health Code is supplemented by title VII, as follows:


“ITTRE VII



« IMPLEMENTATION OF FINANCIAL SANCTIONS



« Single Chapter



"Financial penalties imposed by the National Drug Safety Agency and Health Products
"Art. R. 5471-1. - I. The Director General of the National Drug and Health Products Safety Agency may impose a financial penalty against the perpetrator of a breach referred to in sections R. 5461-4 and R. 5462-4.
“II. ― The amount of the penalty imposed may not exceed €15,000 for a natural person and 5% of the turnover realized during the last fiscal year, within the limit of €100,000 for a legal person, for the breaches mentioned:
« 1° to 1° and 2° of article R. 5461-4;
"2° At 1° and 2° the article R. 5462-4.
"III. ― The amount of the penalty imposed may not be greater than €15,000 for a natural person and 15% of the turnover made during the last fiscal year for the product or group of products concerned, within the limit of €100,000 for a legal person for the breaches mentioned in the 3°, 4° and 5° of section R. 5461-4.
"IV. ― The amount of the penalty imposed may not exceed 150,000 € for a natural person and 10% of the turnover made during the last fiscal year, within the limit of 1,000 000 € for a legal person, for the deficiencies mentioned:
« 1° At the 6th of article R. 5461-4;
« 2° At 3° of article R. 5462-4.
"V. ― Financial sanction decisions may be published on the agency's website under the conditions set out in section R. 5312-2.
"VI. ― The agency may award this financial penalty when the perpetrator of the breach did not regulate the situation after the time limit set by a daily stay that cannot be superior:
« 1° A €1,000 per day for breaches provided for in 1° to 5° of article R. 5461-4 and 1° and 2° of article R. 5462-4;
« 2° A €2,500 per day for breaches provided for in the 6th of Article R. 5461-4 and the 3rd of Article R. 5462-4. »

Article 7 Learn more about this article...


The provisions of this Decree come into force on 1 February 2014.

Article 8 Learn more about this article...


The guard of the seals, Minister of Justice, and the Minister of Social Affairs and Health are responsible, each with regard to it, for the execution of this decree, which will be published in the Official Journal of the French Republic.


Done on January 30, 2014.


Jean-Marc Ayrault


By the Prime Minister:


Minister of Social Affairs

and Health,

Marisol Touraine

The guard of the seals,

Minister of Justice,

Christiane Taubira


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