Key Benefits:
President of the Republic,
On the report of the Prime Minister and the Minister of Social Affairs and Health,
Having regard to the Constitution, including article 38;
Vu le Criminal code ;
Vu le Consumer code ;
Vu le Code of Criminal Procedure ;
Vu le Public Health Code ;
Vu la Act No. 90-1258 of 31 December 1990 amended in the form of companies of liberal professions subject to legislative or protected status and to companies of financial participation of liberal professions;
Vu la Act No. 2011-2012 of 29 December 2011 on strengthening the health safety of the drug and health products, including article 39;
Considering the advice of the National Drug and Health Products Safety Agency Technical Committee dated 2 December 2013;
The Council of State heard;
The Council of Ministers heard,
Order:
In article L. 5124-19 of the Public Health Code, the words: "independent or in the name" are replaced by the words: "independent and in the name".
Section L. 5125-39 of the same code is repealed.
Chapter I of Book IV II of Part 5 of the Code is amended as follows:
I. ― Section L. 5421-1 is replaced by the following provisions:
"Art. L. 5421-1.-The failure to comply with the rules of good practice defined in the context of the decisions or decrees taken under Article L. 5121-5 whose ignorance is likely to result in a serious risk to public health is punishable by one year's imprisonment and 150,000 € of fine. »
II. ― Section L. 5421-2 is replaced by the following provisions:
"Art. L. 5421-2.-I. ― The fact of marketing, carrying out the brokerage activity or distributing, in large or in detail, a pharmaceutical specialty, any other medicine manufactured industrially or according to a method in which an industrial process occurs, as well as any generator, kit or precursor as defined respectively at 8°, 9° and 10° of Article L. 5121-1, without an authorization to place on the market, a temporary authorization to use,
“II. ― is punishable by the same penalties for the purpose of carrying out, carrying out, disseminating or disseminating an advertisement on a pharmaceutical specialty, any other medicine manufactured industrially or by a method in which an industrial process occurs, as well as on any generator, kit or precursor as defined respectively at 8°, 9° and 10° of Article L. 5121-1, which has not been subject to a marketing authorization, a temporary authorization referred to
"III. – The penalties provided for in I and II are extended to seven years in prison and $750,000 in fine, when the offences provided for in the same paragraphs:
« 1° Are likely to result in a serious risk to human health;
« 2° Was committed in organized bands;
« 3° Was committed on a telecommunications network to an unspecified public;
« 4° Pharmaceutical establishments authorized pursuant to section L. 5124-3, brokers declared pursuant to section L. 5124-20, pharmacists of officin who hold the licence referred to in section L. 5125-4 and pharmacies for domestic use referred to in section L. 5126-5 of the same code. »
III. ― Section L. 5421-3 is replaced by the following:
"Art. L. 5421-3.-I. ― The fact of commercializing, carrying out the brokerage activity or distributing, either free or expensive, in large or in detail, homeopathic drugs mentioned in the 11th of Article L. 5121-1 or traditional herbal medicines referred to in Article L. 5121-14-1 that have not been the subject of a registration with the National Agency for the Safety of Medicine and of Health Products, or withdrew the agency
“II. ― is punishable by the same penalties for carrying out, carrying out, disseminating or disseminating an advertisement on homeopathic medicines referred to in the 11th of Article L. 5121-1 or traditional herbal medicines referred to in Article L. 5121-14-1 that have not been registered with the National Agency for the Safety of Medicine and Health Products, or whose registration with this agency has been refused,
"III. – The penalties provided for in I and II are increased to five years in prison and €375,000 in fine, where the offences provided for in the same paragraphs:
« 1° Are likely to result in a serious risk to human health;
« 2° Was committed in organized bands;
« 3° A telecommunications network was committed to an unspecified public.
« 4° Pharmaceutical establishments authorized pursuant to section L. 5124-3, brokers declared pursuant to section L. 5124-20, pharmacists of officin who hold the licence referred to in section L. 5125-4 and pharmacies for domestic use referred to in section L. 5126-5 of the same code. »
IV. ― Section L. 5421-4 is replaced by the following:
"Art. L. 5421-4.-The fact that any person who uses a drug or product does not disclose any new information in a manner that influences the assessment of the benefits and risks of the drug or product under section L. 5121-9-2 or does not transmit the data requested by the agency within the time limits provided by the agency under section L. 5121-9-3 is punished by two years' imprisonment and 150,000 €. »
V. ― Section L. 5421-5 is replaced by the following provisions:
"Art. L. 5421-5.-The act for any person who exploits a drug or produces not to communicate to the National Agency for the Safety of Medicine and Health Products any prohibition or restriction imposed by the competent authorities of any country in which the drug or product is marketed pursuant to section L. 5121-9-2 is punishable by two years of imprisonment and 150,000 € of fine. »
VI. ― Section L. 5421-6 is replaced by the following:
"Art. L. 5421-6.-The failure to comply with the requirement to inform the National Agency for the Safety of Medicine and Health Products of the cessation of the commercialization of a drug in another State and not to disclose to it the reason for this commercialization stop under section L. 5121-9-4 is punishable by two years' imprisonment and 150,000 €' fine. »
VII. ― Section L. 5421-6-1 is amended as follows:
1° The words: "Is punished by three years imprisonment and 45,000 € fine" are deleted;
2° After the words: "whose knowledge he has been" are added the words: "is punished by two years of imprisonment and 150,000 € of fine."
VIII. ― Section L. 5421-6-2 is replaced by the following provisions:
"Art. L. 5421-6-2.-The fact for any person who ensures the manufacture, operation, importation, export or wholesale distribution of blood-based medicines not to record the data to monitor it under the 14th of Article L. 5121-20 is punishable by two years imprisonment and 150,000 euros fine. »
IX. ∙ Section L. 5421-8 is replaced by the following:
"Art. L. 5421-8.-Constitutes a financial penalty breach:
« 1° The fact for any person operating a drug or product referred to in section L. 5121-1 or for any holder of the authorization provided for in section L. 4211-6 to ignore the obligation to implement a pharmacovigilance system, to manage the permanent record of the pharmacovigilance system and to conduct periodic audits;
« 2° The act for any person operating a drug or product referred to in section L. 5121-1 or for any licensee of the authorization provided for in section L. 4211-6 having been aware of an adverse reaction suspected of not reporting it to the authorities or competent bodies in the manner prescribed by regulation;
« 3° The fact for any person operating a drug or product referred to in section L. 5121-1 or for any holder of the authorization provided for in section L. 4211-6 of a measurer, in respect of pharmacovigilance, the obligation to transmit the updated periodic report of security or of continuous maintenance of the presence of a responsible person;
« 4° The fact for the applicant of a marketing authorization not to transmit within the required time the results of the studies referred to in the first paragraph of Article L. 5121-8;
« 5° The fact for the licensee of the marketing authorization not to transmit within the required time the results of the studies referred to in section L. 5121-8-1. Where this breach is also likely to be subject to a financial penalty under the 4° bis of Article L. 162-17-4 of the Social Security Code, penalties may be accumulated within the maximum amount of one of the penalties incurred;
« 6° Failure to comply with the rules of good practices defined in the context of decisions or orders made under Article L. 5121-5, excluding good practices of dispensation electronically;
« 7° The failure of any person to transmit to the National Agency for the Safety of Medicine and Health Products within the time limits of the information referred to in Article L. 5121-12 V;
« 8° The failure of a company to comply with the obligations set out in the second paragraph of Article L. 5121-14-3 when no agreements between the Economic Committee for Health Products and the company were concluded pursuant to theArticle L. 162-17-4-1 of the Social Security Code ;
« 9° The fact for the licensee of the marketing authorization not to comply with the obligation of motivated information of the National Drug Safety Agency and Health Products under section L. 5121-9-4;
« 10° The fact for any person involved in the manufacture, operation, importation, export or wholesale distribution of blood-based medicines, does not record the data for monitoring it under the 14th of Article L. 5121-20;
« 11° The fact that a company does not disclose a prohibition or restriction imposed by the competent authorities of any country in which the drug or health product is placed on the market, as well as any new information that may influence the assessment of the benefits and risks of the drug or the product concerned pursuant to Article L. 5121-9-2 or that it does not transmit the data requested by the agency within the time constraints of Article L. 5121-9-3;
« 12° Failure to recognize the obligations relating to labelling, notice and name of drugs and products. »
X. ― Section L. 5421-9 is replaced by the following:
"Art. L. 5421-9.-The attempted offence under articles L. 5421-2 and L. 5421-3 is punishable by the same penalties. »
XI. ― Section L. 5421-10 is amended as follows:
1° At 2°, after the words: "one or more professions governed by this code", are inserted the words: "a commercial or industrial profession, to direct, administer, manage or control in any way, directly or indirectly, for its own account or on behalf of others, a commercial or industrial enterprise or a commercial corporation";
2° At 3°, after the words "of the thing that is" are inserted the words "the object or".
XII. ― In section L. 5421-13, the 2° is replaced by the following:
« 2° These same offences were committed by licensed pharmaceutical establishments in accordance with Article L. 5124-3, brokers declared in accordance with Article L. 5124-20, pharmacists of officiency who hold the licence referred to in Article L. 5125-4 and pharmacists for domestic use referred to in Article L. 5126-5 of the same Code. »
XII. Sections L. 5421-6-3 and L. 5421-12 are repealed.
Chapter II of Book IV II of Part 5 of the Code is amended to read:
I. ― Article L. 5422-3 is reinstated as follows:
"Art. L. 5422-3.-Any advertisement within the meaning of section L. 5122-1 made with the public or health care professionals for a drug that is authorized under section L. 5121-12 shall be punished by one year's imprisonment and 150,000 € fine. »
II. ― Section L. 5422-5 is amended as follows:
1° In the first paragraph, the words: "37,500 euros" are replaced by the words: "one year's imprisonment and 150,000 €";
2° It is added a last paragraph as follows:
"Every non-institutional advertising campaign for vaccines carried out with the public is punishable by the same penalties, in breach of the obligations set out in article L. 5122-6. »
III. ― Section L. 5422-6 is replaced by the following:
"Art. L. 5422-6.-Any advertisement within the meaning of Article L. 5122-1 that has not obtained the visa under Articles L. 5122-8 and L. 5122-9 or that is made despite the suspension or withdrawal of the visa is punishable by one year's imprisonment and 150,000 € of fine. »
IV. ― Section L. 5422-8 is amended as follows:
1° The sum: "30,000 euros" is replaced by the sum: "one year's imprisonment and 75,000 €";
2° At 7°, the words "to that of ten per year and per recipient. are replaced by the words: "the number fixed by regulatory means. »
V. ― In article L. 5422-9, the words: "is punished by 37,500 euros of fine. are replaced by the words: "is punished by two years imprisonment and 75,000 € fine. »
VI. ― Section L. 5422-12 is amended as follows:
1° The words: "Is punished by 37,500 euros of fine" are replaced by the words: "Is punished by one year of imprisonment and 150,000 euros of fine";
2° The words: "Minister for Health. are replaced by the words: "Director General of the National Drug Safety Agency and Health Products. »
VII. ― Section L. 5422-14 is amended as follows:
1° The words: "in sections L. 5422-1 to L. 5422-13" are replaced by the words: "in this chapter";
2° The last paragraph is deleted.
VIII. ― It is added an article L. 5422-18 as follows:
"Art. L. 5422-18.-Constitutes a financial penalty breach:
« 1° Any advertisement relating to a drug that has not obtained the authorization referred to in sections L. 5121-8 and L. 5121-9-1 or the authorization for parallel importation under section L. 5124-13 or one of the records referred to in sections L. 5121-13 and L. 5121-14-1;
« 2° Any advertisement within the meaning of Article L. 5122-1 made to the public that has not obtained the visa referred to in Article L. 5122-8 or that is made despite the suspension or withdrawal of the visa;
« 3° Any advertisement within the meaning of Article L. 5122-1 made with health professionals who did not obtain the visa referred to in Article L. 5122-9 or that is made despite the suspension or withdrawal of the visa;
« 4° Any advertisement within the meaning of article L. 5122-1 made with the public for a medical prescription drug;
« 5° Any advertisements within the meaning of section L. 5122-1 made to the public for a drug refundable by compulsory health insurance plans, except in the case provided in the third paragraph of section L. 5122-6;
« 6° Any advertising within the meaning of section L. 5122-1 made to the public for a drug whose marketing authorization or registration includes public advertising restrictions due to a possible public health risk;
« 7° Any advertisements within the meaning of section L. 5122-1 made to the public or health professionals for a drug that is authorized under section L. 5121-12;
« 8° Any advertisement for generators, kits or precursors in ignorance of the provisions of Article L. 5122-13;
« 9° Any non-institutional advertising campaign for vaccines carried out in breach of the obligations under Article L. 5122-6. »
IX. Sections L. 5122-8-1, L. 5422-1, L. 5422-2, L. 5422-7, L. 5422-10, L. 5422-11, L. 5422-13, L. 5422-15 and L. 5422-16 are repealed.
Chapter III of Book IV II of Part 5 of the Code is amended as follows:
I. ― In article L. 5423-1, the sum: "30 000 euros" is replaced by the sum: "150 000 €".
II. ― Section L. 5423-2 is replaced by the following:
"Art. L. 5423-2.-The conduct of the drug brokerage activity referred to in section L. 5124-19, without having declared itself to the National Agency for the Safety of Medicine and Health Products under the conditions laid down in section L. 5124-20, is punishable by one year's imprisonment and 75,000 € fine. »
III. ― In sections L. 5423-3 and L. 5423-6, the sum: "30 000 euros" is replaced by the sum: "150 000 €".
IV. ― Section L. 5423-4 is replaced by the following:
"Art. L. 5423-4.-Not respecting the export ban of a drug issued by the National Agency for the Safety of Medicine and Health Products pursuant to section L. 5124-11 is punishable by five years imprisonment and a fine of €375,000. »
V. ― Section L. 5423-5 is replaced by the following provisions:
"Art. L. 5423-5.-The failure of a wholesaler to comply with the public service obligations defined under section L. 5124-17-2 is punishable by two years imprisonment and 150,000 € fine. »
VI. ― After Article L. 5423-7, an article L. 5423-8 is created as follows:
"Art. L. 5423-8.-Constitutes a financial penalty breach:
« 1° The fact that a pharmaceutical company operating a drug does not immediately inform the National Agency for Safety of the drug and health products of any action it has undertaken to suspend its marketing, remove it from the market or remove a specified lot or not indicate the reason for such action under section L. 5124-6;
« 2° The fact for a pharmaceutical company operating a drug or product not to comply with the obligation of information of any risk of rupture of stock or any rupture that it has under section L. 5124-6;
« 3° The fact for a pharmaceutical company operating a drug or product subject to the marketing authorization provided for in section L. 5121-8 not to disclose the date of marketing of the drug or produced at the National Drug Safety Agency and Health Products;
« 4° directing a company with at least one pharmaceutical establishment without having a delegated pharmacist within the meaning of Article L. 5124-2 in each pharmaceutical establishment;
« 5° The fact that a wholesaler-retributor does not comply with the public service obligations defined under Article L. 5124-17-2;
« 6° Failure to address the National Drug and Health Products Safety Agency, by March 31 of the current year, the statements referred to in section L. 5121-18, or to make an incomplete or inaccurate declaration;
« 7° The fact for a responsible pharmacist or a delegated pharmacist not to personally practise his profession;
« 8° The act for a responsible pharmacist or a delegated pharmacist not to be assisted and, in the event of a temporary absence or if the pharmacist is prohibited from exercising, not to be replaced under the provisions of Article L. 5124-4;
« 9° Exporting a drug without complying with the provisions of section L. 5124-11;
« 10° Failure to know the rules of advertising for companies and pharmaceutical institutions established by decree in the Council of State pursuant to the provisions of Article L. 5124-18. »
Chapter IV of Book IV II of Part 5 of the Code is amended to read:
I. ― Section L. 5424-1 is replaced by the following provisions:
"Art. L. 5424-1.-The opening, operation or transfer of an informal without the holder of the licence pursuant to section L. 5125-4 or despite the suspension or withdrawal of the latter is punishable by one year's imprisonment and 75,000 € fine. »
II. ― Section L. 5424-2 is replaced by the following provisions:
"Art. L. 5424-2.-Constitutes a breach of financial penalty as follows:
« 1° To open, operate or transfer an informal without the licensee of the licence referred to in section L. 5125-4, or despite the suspension or withdrawal of the latter;
« 2° To cede a license independently of the trade fund to which it relates;
« 3° To assign an informality other than a mutualist pharmacy, before the expiry of a five-year period from the date of notification of the licence order except in the event of force majeure defined in Article L. 5125-7;
« 4° Not to surrender the licence to the regional health agency when the offence is finally closed;
« 5° Not to respect the rules relating to the creation, transfer of the informals or the minimum conditions of installation determined by decree in the Council of State pursuant to the 1st of Article L. 5125-32;
« 6° To create or redeem an open-ended informal for less than three years, individually or in society, without being a pharmacist of French nationality, or a national of one of the Member States of the European Union or of any of the other States parties to the agreement on the European Economic Area, and without being a holder of the French diploma of a doctor in pharmacy or pharmacistol or of any of the titles and certificates provided in articles L. 4221-5
« 7° After the death of a pharmacist, for his spouse or heirs, to maintain an open informality without complying with the provisions of Article L. 5125-21;
« 8° Not to respect the rules relating to advertising in favour of pharmacy deposits, set by decree in the Council of State pursuant to the provisions of Article L. 5125-32. »
III. ― Section L. 5424-3 is replaced by the following provisions:
"Art. L. 5424-3.-Constitutes a financially sanctioned failure for a pharmacist:
« 1° Not to be the owner of the offence of which he is the owner or owner or co-owner of several officines. However, these provisions are not applicable to cases provided by the Act of 31 December 1990 relating to the exercise in the form of companies of liberal professions subject to legislative or regulatory status or whose title is protected;
« 2° To exploit an informal by exercising another profession in violation of Article L. 5125-2;
« 3° To exploit an informal without medication being prepared by or under the direct supervision of a pharmacist;
« 4° To provide a masterful or official preparation with one or more substances that are not used for these preparations;
« 5° To dispense simple drugs, chemicals or preparations that do not meet the specifications described in the pharmacopoeia;
« 6° To sell secret remedies;
« 7° Prepare preparations that may pose a health risk without the authorization provided for in Article L. 5125-1-1;
« 8° Not to comply with the rules relating to the labelling of preparations defined by regulation pursuant to Article L. 5121-20;
« 9° Not to exercise his profession personally;
« 10° Not to be replaced regularly when he is absent from the officin he holds;
« 11° Do not have the number of pharmacists who must attend for the exercise of his profession because of the importance of his turnover;
« 12° Not to participate in the custody or emergency service under the conditions set out in Article L. 5125-22;
« 13° To open its informality during a guard or emergency service, while it is not itself a service, without holding it open throughout the service. »
IV. ― Section L. 5424-4 is replaced by the following provisions:
"Art. L. 5424-4.-Constitutes a breach of financial penalty as follows:
« 1° To sell the drugs and products referred to in Article L. 5121-8 at a higher price than that derived from the price regulations;
« 2° To sell to the public drugs, products or objects referred to in Article L. 4211-1 through commission houses, purchasing groups and establishments owned or administered by persons not holding any of the diplomas referred to in Article L. 4221-1;
« 3° To deliver drugs, in a pharmacy informal, without bearing the badge corresponding to its pharmacist or person legally authorized to assist him, contrary to the provisions of Article L. 5125-29;
« 4° To solicit orders from the public;
« 5° To receive orders of medicines and other products or objects referred to in Article L. 4211-1 through brokers;
« 6° Distributing drugs and other products or objects referred to in Article L. 4211-1 to their homes, the order of which was obtained through brokers;
« 7° For any person other than a pharmacist or his or her attendant, to place an order outside the offence in a package not in accordance with the provisions of Article L. 5125-25;
« 8° To dispense blood-derived drugs without recording the data to monitor it under the 14th of Article L. 5121-20;
« 9° For one of the pharmacists mentioned in Article L. 5125-33, to ignore the rules applicable to the electronic commerce of medicines set out in chapter V bis of Part II of Book I of Part 5 of this Code and the rules of good dispensation practices referred to in Article L. 5121-5. »
V. ― In article L. 5424-6, the sum: "30 000 euros" is replaced by the sum: "150 000 €".
VI. ― In L. 5424-9, the sum: "3 750 euros" is replaced by the words: "one year in prison and 75,000 € in fine. »
VII. ― In L. 5424-10, the sum: "30,000 euros" is replaced by the sum: "75 000 €".
VIII. ― Section L. 5424-13 is replaced by the following provisions:
"Art. L. 5424-13.-The fact that a pharmacist does not exercise his profession personally is punished by 75,000 € fine. »
IX. ― In L. 5424-14, the sum: "3 750 euros" is replaced by the sum: "75 000 €".
X. ― Sections L. 5424-5, L. 5424-7, L. 5424-8, L. 5424-11, L. 5424-12 and sections L. 5424-15 to L. 5424-18 are repealed.
In article L. 5425-1 of the same code, the words "six months of imprisonment and 7 500 euros of fine" are replaced by the words "two years of imprisonment and 150,000 € of fine".
Chapter VI of title II of Book IV of Part 5 of the Code is thus amended:
I. ― Article L. 5426-1 is amended as follows:
1° In I, the words: "two years of imprisonment and 30,000 euros" are replaced by the words: "five years of imprisonment and 375 000 €";
2° III and IV are replaced by the following:
"III. ― The penalties mentioned in I and II are extended to seven years in prison and $750,000 in fine, when:
« 1° The offences under the first paragraph were committed in organized gangs;
« 2° These same offences were committed on a telecommunications network to an unspecified public;
« 3° These same offences were committed by licensed pharmaceutical establishments in accordance with Article L. 5124-3, brokers declared in accordance with Article L. 5124-20, pharmacists of officiency who hold the licence referred to in Article L. 5125-4 and pharmacists for domestic use referred to in Article L. 5126-5 of the same Code. »
II. ― The chapter is supplemented by articles L. 5426-2 to L. 5426-4 as follows:
"Art. L. 5426-2.-Constitutes a financial penalty breach:
« 1° Distributing or assigning free or expensive gene therapy preparations or xenogenic cell therapy preparations without authorization or when the authorization is suspended or withdrawn;
« 2° preparing, retaining, distributing, yielding, importing and exporting gene therapy preparations or xenogenic cell therapy preparations without respecting the rules of good practices defined in the context of decisions or decrees taken under Article L. 5121-5;
« 3° Importing or exporting gene therapy preparations or xenogenic cell therapy preparations without the authorization referred to in Article L. 5124-13;
« 4° Preparing, retaining, distributing, assigning, importing or exporting these same products without the authorizations provided for in sections L. 4211-8 and L. 4211-9.
"Art. L. 5426-3.-For the criminal offences referred to in this chapter, physical persons also apply the following additional penalties:
« 1° The display or dissemination of the decision, under the conditions and under the penalties provided for in theArticle 131-35 of the Criminal Code ;
« 2° The temporary or final prohibition to practise one or more professions governed by this Code, a commercial or industrial profession, to direct, administer, manage or control in any form, directly or indirectly, on its own behalf or on behalf of others, a commercial or industrial enterprise or a commercial corporation or any other professional or social activity on the occasion of the year in which the offence was committed, in accordance with the terms and conditions set out in section 131-27
« 3° The confiscation of the thing that served or was intended to commit the offence or of the thing that is the object or the product thereof, pursuant to section 131-21 of the same code.
"Art. L. 5426-4.-Legislatures declared criminally liable under the conditions provided for by theArticle 121-2 of the Criminal Code, offences defined in this chapter shall, in addition to the fine in accordance with the terms and conditions prescribed by theArticle 131-38 of the Criminal Code, the penalty provided in 2° to 9° of article 131-39 of the same code. »
Chapter II of Title III of Book IV of Part 5 of the Code is amended as follows:
I. ― Section L. 5432-1 is replaced by the following provisions:
"Art. L. 5432-1.-I. ― It is punishable by five years' imprisonment and a fine of €375,000 in a regulated activity not to comply with the provisions made under section L. 5132-8:
« 1° Setting the conditions of production, transport, import, export, detention, offer, assignment, prescription, issuance, acquisition, and use of drugs, plants, substances or preparations classified as veneers;
« 2° Prohibiting operations related to these plants or substances;
« 3° Prohibition of prescription or incorporation in preparations, certain veneer plants or substances or specialties that contain it, or setting the specific conditions for the prescription or issuance of such preparations.
"In all cases provided for in this article, the courts may order the confiscation of seized plants or substances.
“II. ― The penalties mentioned in I are extended to seven years in prison and 750,000 € in fine, when:
« 1° The facts were committed in organized bands;
« 2° When the supply, assignment or acquisitions were committed on a telecommunications network to an unspecified public;
« 3° The facts were committed in order to facilitate, by any means, including by order or issue of complacency, misuse or abuse as defined by regulation, drugs, plants, substances or preparations classified as poisonous. These provisions are not applicable in the event of a prescription of a pharmaceutical specialty not in accordance with its marketing authorization when the conditions laid down in Article L. 5121-12-1 are met. »
II. ― The chapter is supplemented by articles L. 5432-2 to L. 5432-5 as follows:
"Art. L. 5432-2.-I. ― It is punishable by five years' imprisonment and 375 000 €'s fine for anyone, to manufacture, import, export, transport, offer, give, acquire, hold, use illegally or to be issued by means of fictitious or complacent orders:
« 1° Substances, plants or preparations listed in lists I and II or classified as psychotropic substances referred to in Article L. 5132-1;
« 2° Drugs referred to in section L. 5111-1, where these drugs are listed in lists I and II referred to in section L. 5132-1 or where they are not registered contain one or more substances or preparations listed in the same lists.
“II. ― The penalties mentioned in I are extended to seven years in prison and 750,000 € in fine, when:
« 1° The facts were committed in organized bands;
« 2° Where the supply, assignment or acquisitions have been committed on a telecommunications network to an unspecified public.
"Art. L. 5432-3.-The attempted offence under articles L. 5432-1 and L. 5432-2 is punishable by the same penalties.
"Art. L. 5432-4.-For the criminal offences referred to in this chapter, physical persons also apply the following additional penalties:
« 1° The display or dissemination of the decision, under the conditions and under the penalties provided for in theArticle 131-35 of the Criminal Code ;
« 2° The temporary or final prohibition to practise one or more professions governed by this Code, a commercial or industrial profession, to direct, administer, manage or control in any form, directly or indirectly, on its own behalf or on behalf of others, a commercial or industrial enterprise or a commercial corporation or any other professional or social activity on the occasion of the year in which the offence was committed, in accordance with the terms and conditions set out in section 131-27
« 3° The confiscation of the thing that served or was intended to commit the offence or of the thing that is the object or the product thereof, pursuant to section 131-21 of the same code.
"Art. L. 5432-5.-Legislatures declared criminally responsible under the conditions provided for by theArticle 121-2 of the Criminal Code, offences defined in this chapter shall, in addition to the fine in accordance with the terms and conditions prescribed by theArticle 131-38 of the Criminal Code, the penalty provided in 2° to 9° of article 131-39 of the same code. »
Article L. 5434-1 of the same code is amended as follows:
1° In the first paragraph, the references: "L. 5422-1 to L. 5422-6" are replaced by the references: "L. 5422-5 and L. 5422-6";
2° In the second paragraph, the words: "Articles L. 5422-1, L. 5422-3, L. 5422-4 and 2° of Article L. 5422-6" are replaced by the words: "Article L. 5422-6".
Chapter VIII of Title III of Part IV of Part 5 of the Code is amended as follows:
I. ― Section L. 5438-2 is replaced by the following provisions:
"Art. L. 5438-2.-The act for the manufacturer, importer or distributor of excipients as defined in section L. 5138-2 to carry out its activity without having made a declaration to the National Agency for the Safety of Medicine and Health Products under the conditions set out in section L. 5138-1 is punishable by one year's imprisonment and 75,000 € of fine. »
II. ― In L. 5438-3, the sum: "30 000 €" is replaced by the sum: "150 000 €".
III. ― In section L. 5438-6, the reference "L. 5438-2" is replaced by the reference "L. 5438-4".
IV. ― Section L. 5438-7 is replaced by the following provisions:
"Art. L. 5438-7.-For the criminal offences referred to in this chapter, physical persons also apply the following additional penalties:
« 1° The display or dissemination of the decision, under the conditions and under the penalties provided for in theArticle 131-35 of the Criminal Code ;
« 2° The temporary or final prohibition to practise one or more professions governed by this Code, a commercial or industrial profession, to direct, administer, manage or control in any form, directly or indirectly, on its own behalf or on behalf of others, a commercial or industrial enterprise or a commercial corporation or any other professional or social activity on the occasion of the year in which the offence was committed, in accordance with the terms and conditions set out in section 131-27
« 3° The confiscation of the thing that served or was intended to commit the offence or of the thing that is the object or the product thereof, pursuant to section 131-21 of the same code. »
V. ― After article L. 5438-7, an article L. 5438-8 is inserted as follows:
"Art. L. 5438-8.-The legal persons declared criminally responsible, under the conditions provided for in theArticle 121-2 of the Criminal Codein addition to the fine in accordance with the terms set out in section 131-38 of the same code, the penalties set out in paragraphs 2 to 9 of section 131-39 of this Code shall apply. »
Chapter IX of Title III of Book IV of Part 5 of the Code is amended as follows:
I. ― Article L. 5439-1 is amended as follows:
1° The first paragraph is preceded by the words "I" and the words "three years imprisonment and 45,000 € fine. are replaced by the words: "five years' imprisonment and a fine of €375,000. » ;
2° The article is supplemented by the following provisions:
“II. ― The penalties mentioned in the previous paragraph are extended to seven years in prison and 750,000 € in fine, when:
« 1° The offences under the first paragraph were committed in organized gangs;
« 2° These same offences were committed on a telecommunications network to an unspecified public. »
II. The chapter is supplemented by articles L. 5439-2, L. 5439-3 and L. 5439-4, as follows:
"Art. L. 5439-2.-The attempted offence under Article L. 5439-1 is punishable by the same penalties.
"Art. L. 5439-3.-For the criminal offences referred to in this chapter, physical persons also apply the following additional penalties:
« 1° The display or dissemination of the decision, under the conditions and under the penalties provided for in theArticle 131-35 of the Criminal Code ;
« 2° The temporary or final prohibition to practise one or more professions governed by this Code, a commercial or industrial profession, to direct, administer, manage or control in any form, directly or indirectly, on its own behalf or on behalf of others, a commercial or industrial enterprise or a commercial corporation or any other professional or social activity on the occasion of the year in which the offence was committed, in accordance with the terms and conditions set out in section 131-27
« 3° The confiscation of the thing that served or was intended to commit the offence or of the thing that is the object or the product thereof, pursuant to section 131-21 of the same code.
"Art. L. 5439-4.-Judicial persons declared criminally responsible under the conditions provided for in theArticle 121-2 of the Criminal Codein addition to the fine in accordance with the terms set out in section 131-38 of the same code, the penalties set out in paragraphs 2 to 9 of section 131-39 of this Code shall apply. »
The title V of book IV of the fifth part of the same code is amended as follows:
I. ― The title V is replaced by the following title: "Chart V. ― National Drug Safety Agency and Health Products".
II. ― Section L. 5451-1 is replaced by the following:
"Art. L. 5451-1.-Est punished by two years imprisonment and 150,000 € fine, as follows:
« 1° To continue, with respect to the products concerned, activities that have been subject to any of the suspension or prohibition measures provided for in sections L. 5312-1, L. 5312-1-1 and L. 5312-2;
« 2° Failure to comply with the specific conditions or restrictions that may be made in the public health interest in the limitation, issuance, administration or use of products under section L. 5312-1;
« 3° Not to carry out measures for the removal, destruction of the product or dissemination of warnings or precautions of employment decided or ordered under section L. 5312-3. »
Chapter I of Book IV title VI of Part 5 of the Code is amended to read:
I. ― After Article L. 5461-1, it is created a section 1 entitled "Criminal sanctions" comprising sections L. 5461-2 to L. 5461-8.
II. ― Section L. 5461-2 is amended as follows:
1° In the first paragraph, the words: "three years of imprisonment and 45,000 euros" are replaced by the words: "two years of imprisonment and 150,000 €";
2° The second paragraph is deleted.
III. ― It is created an article L. 5461-2-1 as follows:
"Art. L. 5461-2-1.-The failure of a manufacturer or agent to inform the National Agency for the Safety of Medicine and Health Products of any recall of a medical device to which he conducts under the conditions referred to in section L. 5212-2 is punishable by two years imprisonment and 150,000 € fine. »
IV. ― Section L. 5461-3 is amended as follows:
1° The first paragraph is preceded by the words "I" and the words "is punishable by two years of imprisonment and 30,000 euros of fine. are replaced by the words: ", or a medical device not in accordance with the essential requirements mentioned in the same article or whose conformity certification is no longer valid, is punished by five years' imprisonment and a fine of €375,000. » ;
2° The article is supplemented by the following four paragraphs:
“II. ― The penalties mentioned in the previous paragraph are extended to seven years in prison and 750,000 € in fine, when:
« 1° The commercialized medical device is likely to cause a serious risk to human health;
« 2° The offences under the first paragraph were committed in organized gangs;
« 3° These same offences were committed on a telecommunications network to an unspecified public. »
V. ― In article L. 5461-4, the sum: "30 000 euros" is replaced by the sum: "150 000 €";
VI. ―It is created an article L. 5461-4-1 as follows:
"Art. L. 5461-4-1.-The fact, for manufacturers of medical devices or their agents, as well as for any person engaged in the manufacture, distribution, import or export, even incidental, of medical devices, not to make the declaration provided for in section L. 5211-3-1, is punishable by one year's imprisonment and 75,000 € of fine. »
VII. ― Section L. 5461-5 is amended as follows:
1° The word: "operations" is replaced by the words: "to bonds";
2° The words: "planned to" are replaced by the words: "in application of";
3° The sum: "30,000 euros" is replaced by the words: "two years imprisonment and 150,000 €".
VIII. ― Section L. 5461-6 is replaced by the following:
"Art. L. 5461-6.-The fact, for manufacturers of medical devices or their agents, as well as for any person who engages in the distribution or importation of medical devices, to carry out, carry out, disseminate or publicize an advertisement of medical devices subject to prior authorization when the National Agency for the Safety of Drugs and Health Products has not issued, refused to issue, suspended or withdrew that authorization, shall be punished by a year of imprisonment. »
IX. ∙ Section L. 5461-7 is replaced by the following:
"Art. L. 5461-7.-For the criminal offences referred to in this chapter, physical persons also apply the following additional penalties:
« 1° The display or dissemination of the decision, under the conditions and under the penalties provided for in theArticle 131-35 of the Criminal Code ;
« 2° The temporary or final prohibition to practise one or more professions governed by this Code, a commercial or industrial profession, to direct, administer, manage or control in any form, directly or indirectly, on its own behalf or on behalf of others, a commercial or industrial enterprise or a commercial corporation or any other professional or social activity on the occasion of the year in which the offence was committed, in accordance with the terms and conditions set out in section 131-27
« 3° The confiscation of the thing that served or was intended to commit the offence or of the thing that is the object or the product thereof, pursuant to section 131-21 of the same code. »
X. ― Section L. 5461-8 is replaced by the following:
"Art. L. 5461-8.-The legal persons declared criminally responsible, under the conditions provided for in theArticle 121-2 of the Criminal Codein addition to the fine in accordance with the terms set out in section 131-38 of the same code, the penalties set out in paragraphs 2 to 9 of section 131-39 of this Code shall apply. »
XI. ― After Article L. 5461-8, a section 2 is created as follows:
“Section 2
"Financial penalties
"Art. L. 5461-9.-Constitutes a financial penalty breach:
« 1° The fact, for the manufacturer, importer or distributor of a device that 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 a patient's health condition, user or third party's health, to refrain from reporting it promptly to the National Drug Safety Agency and Health Products under the conditions provided.
« 2° The failure of a manufacturer or agent to inform the National Agency for Safety of the drug and health products of any recall of a medical device to which it operates under the conditions laid down in section L. 5212-2;
« 3° Import, market, commission or use of a medical device without the certificate referred to in section L. 5211-3, or a medical device not in accordance with the essential requirements mentioned in the same article or whose compliance certification is no longer valid;
« 4° The commissioning of a category of medical device referred to in Article L. 5211-4 without the communication of the data provided for in this article;
« 5° The failure of the operator to submit a medical device to the maintenance obligations and quality controls provided for under section L. 5212-1;
« 6° The fact, for the manufacturer of medical devices or its agent, as well as for any person engaged in the manufacture, distribution or importation of medical devices, to carry out, cause, distribute or cause public advertising to the public for medical devices reimbursed, supported or financed, even in part, by the mandatory health insurance plans, with the exception of those listed in section L. 5213-3;
« 7° The fact, for the manufacturer of medical devices or its agent, as well as for any person who engages in the distribution or importation of medical devices, to carry out, carry out, disseminate or publicize an advertisement of medical devices subject to prior authorization when the National Agency for Safety of Medicine and Health Products has not issued, refused to issue, suspended or withdrew that authorization referred to in section L. 5213-4;
« 8° The fact, for the manufacturer of medical devices or its agent, as well as any person who engages in the manufacture, distribution, import or export, even incidental, of medical devices, not to make the declaration provided for in section L. 5211-3-1. »
Chapter II of Book IV II of Part 5 of the Code is amended to read:
I. ― After the article L. 5462-1, a section 1 entitled "Criminal sanctions" includes sections L. 5462-2 to L. 5462-7.
II. ― Section L. 5462-2 is replaced by the following provisions:
"Art. L. 5462-2.-The fact, for the manufacturer or its agent, the importer or distributor of an in vitro medical device that has been aware of a failure or alteration of an in vitro medical device that could cause adverse effects on the health of persons, to refrain from reporting it without delay to the National Agency for the Safety of the Drug and Health Products is punished by two years of imprisonment. »
III. ―It is created an article L. 5462-2-1 as follows:
"Art. L. 5462-2-1.-Est punished by two years imprisonment and 150,000 € fine:
« 1° The fact, for a manufacturer or its agent, that it does not inform the National Agency for Safety of Medicine and Health Products of any recall of an in vitro medical device to which it conducts under the conditions set out in section L. 5222-3;
« 2° The failure of a manufacturer or agent to provide, at the request of the National Drug and Health Products Safety Agency, any information that is relevant to the implementation of health protection measures in respect of patients pursuant to the provisions of section L. 5222-3. »
IV. ― Section L. 5462-3 is amended as follows:
1° The first paragraph is preceded by the words "I" and the words "is punishable by two years of imprisonment and 30,000 euros of fine. are replaced by the words: ", or an in vitro diagnostic device that does not comply with the essential requirements mentioned in the same article or whose conformity certification is no longer valid, is punished by five years' imprisonment and a fine of €375,000. » ;
2° The article is supplemented by four following paragraphs as follows:
“II. ― The penalties mentioned in the previous paragraph are extended to seven years in prison and 750,000 € in fine, when:
« 1° The medical device for commercialized in vitro diagnosis is likely to cause a serious risk to human health;
« 2° The offences under the first paragraph were committed in organized gangs;
« 3° These same offences were committed on a telecommunications network to an unspecified public. »
V. ― An article L. 5462-4 is drafted as follows:
"Art. L. 5462-4.-For any person who engages in the manufacture, marketing, distribution, import or export of an in vitro diagnostic medical device, the failure to make a declaration to the National Agency for the Safety of Medicine and Health Products, referred to in Article L. 5221-3, is punishable by one year's imprisonment and 75,000 € of fine. »
VI. ―It is created an article L. 5462-5 as follows:
"Art. L. 5462-5.-The fact, for manufacturers of in vitro diagnostic medical devices or their agents, as well as for any person who engages in the distribution or importation of in vitro diagnostic medical devices, to carry out, carry out, disseminate or publicize an advertisement of in vitro diagnostic devices subject to prior authorization when the National Agency for the Safety of Medicine and Health Products has not issued, has refused to issue, »
VII. ―It is created an article L. 5462-6 as follows:
"Art. L. 5462-6.-For the criminal offences referred to in this chapter, physical persons also apply the following additional penalties:
« 1° The display or dissemination of the decision, under the conditions and under the penalties provided for in theArticle 131-35 of the Criminal Code ;
« 2° The temporary or final prohibition to practise one or more professions governed by this Code, a commercial or industrial profession, to direct, administer, manage or control in any form, directly or indirectly, on its own behalf or on behalf of others, a commercial or industrial enterprise or a commercial corporation or any other professional or social activity on the occasion of the year in which the offence was committed, in accordance with the terms and conditions set out in section 131-27
« 3° The confiscation of the thing that served or was intended to commit the offence or of the thing that is the object or the product thereof, pursuant to section 131-21 of the same code. »
VIII. ―It is created an article L. 5462-7 as follows:
"Art. L. 5462-7.-The legal persons declared criminally responsible under the conditions provided for in theArticle 121-2 of the Criminal Codein addition to the fine in accordance with the terms set out in section 131-38 of the same code, the penalties set out in paragraphs 2 to 9 of section 131-39 of this Code shall apply. »
IX. ― After Article L. 5462-7, a section 2 is created as follows:
“Section 2
"Financial penalties
"Art. L. 5462-8.-Constitutes a financial penalty breach:
« 1° The fact, for the manufacturer or its agent, the importer or distributor of an in vitro diagnostic device that has been aware of a failure or alteration of an in vitro diagnostic medical device that could cause adverse effects to the health of persons, to refrain from reporting it without delay to the National Drug Safety Agency and Health Products under the conditions set out in section L. 5222-3
« 2° Importing, placing on the market or putting in service an in vitro medical device without establishing or establishing the certificate referred to in section L. 5221-2, or an in vitro medical device that does not comply with the essential requirements mentioned in the same article or whose conformity certification is no longer valid;
« 3° The fact, for a manufacturer or its agent, that it does not inform the National Agency for Safety of Medicine and Health Products of any recall of an in vitro medical device to which it conducts under the conditions set out in section L. 5222-3;
« 4° The failure of a manufacturer or its agent to provide, at the request of the National Drug Safety Agency and Health Products, any information that is relevant to the implementation of health protection measures in respect of patients pursuant to the provisions of section L. 5222-3;
« 5° The fact, for the manufacturer or its agent, the importer and distributor not to keep all the information necessary for the recall of in vitro diagnostic medical devices, in accordance with the provisions of Article L. 5222-3;
« 6° The fact for the manufacturer of in vitro diagnostic medical devices or its agent, as well as for any person who engages in the distribution or importation of in vitro diagnostic medical devices, to carry out, carry out, disseminate or publicize an advertisement of in vitro diagnostic medical device subject to prior authorization when the National Agency for the Safety of the Drug and Health Products has not issued, refused to issue, suspended or withdrew the aforementioned authorization.
« 7° The fact, for any person engaged in the manufacture, marketing, distribution, import or export of an in vitro diagnostic medical device, does not make the declaration to the National Agency for the Safety of Medicine and Health Products referred to in section L. 5221-3. »
Book IV of the fifth part of the same code is supplemented by title VII as follows:
“ITTRE VII
« IMPLEMENTATION OF FINANCIAL SANCTIONS
“Chapter I
"Financial penalties imposed by the National Drug Safety Agency and Health Products
"Art. L. 5471-1.-I. ― The National Agency for the Safety of Medicine and Health Products may impose a financial penalty against the perpetrator of a breach referred to in sections L. 5421-8, L. 5422-18, L. 5423-8, L. 5426-2, L. 5438-1, L. 5461-9 and L. 5462-8, except where the breach is committed in connection with a retail distribution of health products.
“II. ― The agency may include this financial penalty of a daily breach that cannot exceed €2,500 per day when the perpetrator of the breach did not comply with its requirements at the end of the time limit set by a stay.
"III. ― The amount of the penalty imposed for the breaches mentioned in 1° to 11° of Article L. 5421-8, at 4° to 10° of Article L. 5423-8, as well as in articles L. 5426-2, L. 5438-1, at 8° of Article L. 5461-9 and at 7° of Article L. 5462-8 shall not be greater than 150,000 € for a natural person and
"The amount of the penalty imposed for the breaches mentioned in the 12th of Article L. 5421-8, in Article L. 5422-18, at 1st to 3rd of Article L. 5423-8, at 1st to 7th of Article L. 5461-9 and at 1st to 6th of Article L. 5462-8 shall not be greater than 150,000 € for a natural person and at 30% of the last
"In case of findings of one of the breaches mentioned in the 1st to 3rd of Article L. 5422-18, at the 6th and 7th of Article L. 5461-9 and at the 6th of Article L. 5462-8, the agency may issue a ban on the advertisement concerned by the breach, after the company concerned has been put in place.
"IV. ― The agency may decide to publish the financial penalty decisions issued under I of this article on its website.
"Art. L. 5471-2.-Where a financial penalty imposed under this book is likely to accumulate with a criminal fine imposed on the same facts on the perpetrator of the breach, the overall amount of fines and financial penalties imposed does not exceed the highest legal maximum.
“Chapter II
“Financial penalties imposed
by the Regional Health Agency
"Art. L. 5472-1.-I. ― The Director General of the Territorially Competent Regional Health Agency may, in the areas under his jurisdiction, impose a financial penalty against the perpetrator of a breach referred to in Articles L. 5424-2 to L. 5424-4 and, where the breach is committed in the course of a retail distribution of health products at the 6th of Article L. 5421-8, at L. 5426-2
“II. ― It may include this financial penalty of a daily breach that cannot exceed €2,500 per day when the perpetrator of the breach did not comply with its requirements at the end of the time limit set by a stay.
"III. ― The amount of the financial penalty provided for in I of this section may not exceed €150,000 for a natural person and 10% of the turnover realized during the last fiscal year, within a million euros, for a legal person.
"IV. ― The Director General of the Regional Health Agency may decide to publish the financial sanction decisions issued under this section I on the website of the Regional Health Agency.
"Art. L. 5472-2.-I. ― In the event of a breach of Article L. 5424-4, the Director General of the Territorially Competent Regional Health Agency may after, except in the event of an emergency, have placed in place within a time limit that the Director General of the Regional Health Agency may not be less than eight days, the author of the failure to comply with his or her requirements and submit his or her observations:
« 1° Pronouncing the temporary closure of the electronic drug business website for up to five months;
« 2° Pronouncing a financial penalty against the perpetrator of the breach and, if applicable, including the fine of a daily offence that cannot be more than €1,000 per day when the perpetrator of the offence did not comply with his or her requirements after a period of time fixed by a stay.
“II. ― The amount of the financial penalty may not exceed 30% of the turnover made by the pharmacy as part of the e-commerce activity during the last fiscal year, within a million euros.
"III. ― When, at the end of the closing period of the website, the pharmacist did not comply with the applicable rules, the Director General of the Regional Health Agency may make a new closure under the same conditions.
"IV. ― The regional health agency shall inform the board of the competent order of the implementation of the procedure provided for in this section.
"The Director General of the Regional Health Agency may decide to publish the financial penalties and temporary suspension decisions of the electronic drug trade websites issued under I of this article on the website of the Regional Health Agency.
"Art. L. 5472-3.-Where a financial penalty imposed under this book is likely to accumulate with a criminal fine imposed on the same facts to the perpetrator of the breach, the overall amount of fines and financial penalties imposed does not exceed the highest legal maximum. »
Chapter I of title II of Book IV of the first part of the same code is thus amended:
I. ― Section L. 1421-1 is amended as follows:
1° After the first preambular paragraph, a sub-item reads as follows:
"They may resort to any qualified person, designated by the administrative authority on which they depend. This person can accompany them during their checks. It may be aware of any document or element necessary to carry out its mission or expertise, including medical data if the person is a doctor or pharmacist, under the conditions set out in section L. 1421-3. » ;
2° In the second paragraph, which becomes the third, the words "to be assisted by experts appointed by the competent authority and" are deleted and the words "the experts" are replaced by the words "the qualified persons".
II. ― Section L. 1421-2 is replaced by the following provisions:
"Art. L. 1421-2.-For the purpose of carrying out their duties, the officers referred to in section L. 1421-1 may operate on the public highway and enter between 8 a.m. and 20 a.m. in the premises, places, facilities and means of transport in which the provisions they control apply. They may also enter outside these hours when access to the public is authorized or when an activity is underway. Where the occupant refuses access, the occupant may be authorized by the judicial authority under the conditions laid down in Article L. 1421-2-1, without prejudice to the implementation of the penalties provided for in Article L. 1427-1.
"When the premises, places, facilities and means of transportation referred to above are also for use in housing, these controls may only be carried out between 8 a.m. and 8 p.m., and after authorization by the judicial authority under the conditions laid down in Article L. 1421-2-1. »
III. ― In the IV of Article L. 1421-2-1, after the words "two witnesses" are inserted the words "required for this purpose by them."
IV. ― Section L. 1421-3 is replaced by the following:
"Art. L. 1421-3.-The officers referred to in Article L. 1421-1 may collect, on site or on summons, any information, justification or document required for the controls. They may require the communication and obtain or take a copy, by any means and on any medium, or make the seizure of documents of any kind, in a few hands that they are located, to facilitate the fulfilment of their mission and the provision of the necessary means to carry out their verifications. For the control of computer-based operations, they have access to the stored software and data, as well as the clear return of information to facilitate the fulfilment of their missions. They may request a transcript by any appropriate processing in documents directly usable for the purposes of the control.
"They can take samples. The samples are analyzed by a state laboratory, the National Drug and Health Products Safety Agency or by a laboratory designated by the Director General of the Regional Health Agency or, where the control was carried out on behalf of the National Agency for the Safety of Medicine and Health Products, the Biomedicine Agency or the National Agency for Health Safety of Food, Environment and Labour.
"People with medical quality have access to any individual medical data required to carry out their duties in accordance with the provisions of section 226-13 of the Criminal Code.
"Pharmacists have access to any individual medical data necessary for the performance of their duties relating to the exercise of the pharmacy and the products referred to in Article L. 5311-1 in accordance with Article 226-13 of the Criminal Code. »
I. ― In section L. 1418-2 of the same code, the reference to section L. 1426-1 is replaced by the reference to section L. 1427-1.
II. ― In article L. 1427-1 of the same code, the words "six months of imprisonment and 7 500 euros of fine" are replaced by the words: "one year of imprisonment and 75,000 € of fine".
Section 4 of Chapter V of Title III of Book IV of Part I of the Code is amended as follows:
I. ― Article L. 1435-7 is amended as follows:
1° The last sentence of the first paragraph is replaced by a sentence as follows:
"The second and third paragraphs of Article L. 1421-1 are applicable, if any, to qualified persons who assist them. » ;
2° In the second paragraph, the words: "French Food Safety Agency" are replaced by the words: "National Health Safety Agency for Food, Environment and Labour".
II. ― It is supplemented by two articles L. 1435-7-1 and L. 1435-7-2 as follows:
"Art. L. 1435-7-1.-The Director General of the Territorially Competent Regional Health Agency may impose, against natural or legal persons, financial sanctions that may be accompanied by daily offences, in cases provided for by law and, where applicable, by decree in the Council of State.
"If necessary, they may remain the same people to regulate the situation.
"The director general of the agency shall pre-examine the individual or legal person concerned with the presentation of his or her observations, with the indication of the possibility of being assisted by counsel.
"The amounts of the financial penalty and the amount of the penalty are proportionate to the severity of the breaches. They shall take into account, where appropriate, the reiteration of penalties within two years of the date on which the first sanction decision has become final.
"The financial sanctions and the breaches referred to in this article are paid to the Public Treasury and are recovered as the claims of the State that are foreign to tax and the domain.
"The terms and conditions for the application of this article are provided by decree in the Council of State.
"Art. L. 1435-7-2.-For the sole purpose of detecting offences under articles L. 5421-2, L. 5421-3, L. 5421-13, L. 5432-1, L. 5432-2, L. 5438-4, L. 5461-3 and L. 5462-3 the Public Health Code, when committed by using an electronic means of communication, the inspectors of the regional health agency authorized under conditions specified by decree of the Ministers of Justice, the Interior and responsible for health may, without being criminally responsible for these acts:
« 1° Participate under a pseudonym in electronic exchanges;
« 2° To be in contact with persons who may be the perpetrators of these offences;
"3° Acquire products or substances.
"In penalty of nullity, these acts cannot have the effect of inducing others to commit an offence. »
Title I of Book III of Part 5 of the Code is amended as follows:
I. ― After L. 5312-1, an article L. 5312-1-1 is inserted as follows:
"Art. L. 5312-1-1.-When it appears, on the occasion of a decision to suspend or prohibit an activity relating to a product or group of products taken by the National Drug Safety Agency and Health Products pursuant to section L. 5312-1, that all or part of the activities of the natural or legal person concerned shall be carried out under conditions that have a proven risk to human health, the agency may make a decision
"With the exception of an emergency, the suspension decision referred to in the first paragraph may only intervene after the physical or legal person has been given the opportunity to present his or her observations.
"If at the end of the suspension period referred to in the first paragraph, the person concerned has not taken the measures to eliminate the risk, the agency may, after a new inspection, issue a new suspension under the same conditions. »
II. ― Section L. 5312-4-1 is amended as follows:
1° In the first paragraph, the words "administrative fines" are replaced by the words "financial sanctions";
2° After the first preambular paragraph, a sub-item reads as follows:
"If necessary, it can put these same people in place to regulate the situation. » ;
2° The second paragraph that becomes the third is replaced by the following:
"The agency shall pre-examine the physical or legal person concerned to present his observations, with the indication of the possibility of being assisted by counsel. » ;
3° In the third paragraph, which becomes the fourth, the word "a fine" is replaced by the words "financial sanction" and the last sentence is replaced by the following sentence: "They take into account, if any, the reiteration of the penalties imposed within two years of the date on which the first sanction decision became final. » ;
4° In the last paragraph, the word "finals" is replaced by the words "financial sanctions and infringements";
5° It is added a last paragraph as follows:
"The terms and conditions for the application of this article are provided by decree in the Council of State. »
III.-After article L. 5312-4-2, an article L. 5312-4-3 is inserted as follows:
"Art. L. 5312-4-3.-When on the occasion of an inspection, the National Drug and Health Products Safety Agency finds that there is no compliance with the laws and regulations applicable to the activities and products referred to in section L. 5311-1, it may enjoin the person concerned to regularize the situation within a specified time frame. This injunction occurs after the person concerned has been given the opportunity to present his or her observations. This person may be assisted by counsel or represented by an agent of his or her choice.
"The injunction is published on the agency's website until the situation has been regulated. »
IV. ― In the first paragraph of section L. 5313-1, after the words: "laws and regulations" are inserted the words: "in particular the application of the rules of good practices defined by decision of the National Agency for the Safety of Medicine and Health Products or by order of the Minister for Health pursuant to this Code, as well as standards concerning medical devices, transposing the harmonized European standards whose references have been published in the Official Journal of the French Republic".
V. ― After Article L. 5313-2, an article L. 5313-2-1 was created as follows:
"Art. L. 5313-2-1.-For the sole purpose of detecting offences under articles L. 5421-2, L. 5421-3, L. 5421-13, L. 5432-1, L. 5432-2, L. 5438-4, L. 5461-3 and L. 5462-3 of the Public Health Code, where they are committed by using an electronic means of communication, the inspectors of the agency referred to in Article L. 5412-1 authorized under conditions specified by decree of the Ministers of Justice, the Interior and responsible for health may, without being criminally responsible for these acts:
« 1° Participate under a pseudonym in electronic exchanges;
« 2° To be in contact with persons who may be the perpetrators of these offences;
"3° Acquire products or substances.
"In penalty of nullity, these acts cannot have the effect of inducing others to commit an offence. »
Title I of Book IV of Part 5 of the same code is amended as follows:
I. ― Section L. 5411-1 is amended as follows:
1° The words: "public places" are replaced by the words: "open places to the public";
2° After the words: "activities and products referred to in Article L. 5311-1" are inserted the words: ", as well as the provisions of Title II of Book I of the Consumer Code when the offence relates to one of these products".
II. ― Section L. 5411-2 is amended as follows:
1° The words: "according to their establishment" are replaced by the words: "following their closure";
2° It is supplemented by a final paragraph, as follows:
"The offences and breaches are found by minutes, which are held to the contrary. »
III. ― In section L. 5411-3, the words: "in accordance with their establishment" are replaced by the words: "within their closure."
IV. ― After article L. 5411-3, he created an article L. 5411-4, as follows:
"Art. L. 5411-4.-When looking for or finding an offence referred to in section L. 5411-1, the inspectors referred to in section L. 5411-1 are entitled to identify the identity of the person they control. If the person refuses or is unable to justify his or her identity, they shall immediately report to any territorially competent judicial police officer, who may then conduct an identity check under the conditions provided for inArticle 78-3 of the Code of Criminal Procedure. In this case, the period provided for in the third paragraph of the same article 78-3 is short of the identity statement. »
V. ― The title of Chapter II is replaced by the following title: "Chapter II. Inspectors of the National Drug Safety Agency and Health Products."
VI. Sections L. 5412-1 and L. 5413-1 are amended as follows:
1° After the words: "to the products mentioned in Article L. 5311-1", the words are inserted: "and to the provisions of Title II of Book I of the Consumer Code when the offence relates to one of these products";
2° The words "and L. 5411-3" are replaced by the words ", L. 5411-3 and L. 5411-4".
VII. ― The first paragraph of Article L. 5414-1 is replaced by the following paragraphs:
"The agents mentioned to the 1° of Article L. 215-1 of the Consumer Code have the right to seek and detect offences under the laws and regulations relating to the activities and products referred to in Article L. 5311-1:
« 1° Medical devices;
« 2° Medical diagnostic devices in vitro;
« 3° Products intended for the maintenance or application of contact lenses;
« 4° Non-corrective eye lenses;
« 5° Cosmetic products;
« 6° Tattoo products.
"For this purpose, they have the powers provided for under Book II of the Consumer Code. »
VIII. ― In section L. 5414-2, the reference to section L. 1426-1 is replaced by the reference to section L. 1427-1.
In the second paragraph of sections L. 5431-1 and L. 5462-1 of the same code, the reference to section L. 5411-3 is replaced by the reference to section L. 5411-4.
Title XIII bis of Book IV of the Legislature of the Code of Criminal Procedure is supplemented by article 706-2, as follows:
"Art. 706-2-2.-In order to find out the offences mentioned in the articles L. 5421-2, L. 5421-3, L. 5421-13, L. 5426-1, L. 5432-1, L. 5432-2, L. 5438-4, L. 5439-1, L. 5451-1, L. 5461-3 and L. 5462-3 the Public Health Code, andArticle L. 213-1 of the Consumer Code where the offence relates to one of the products mentioned in theArticle L. 5311-1 of the Public Health Codewhere they are committed by an electronic means of communication, to gather the evidence and to search for the perpetrators, officers or judicial police officers acting during the investigation or on a rogatory commission may, if they are assigned to a specialized service and specially authorized to do so under conditions specified by order, proceed to the following acts without being criminally responsible:
« 1° Participate under a pseudonym in electronic exchanges;
« 2° To be in contact with persons who may be the perpetrators of these offences;
« 3° To extract, acquire or maintain by this means data or content, products, substances, levies or services and, more generally, evidence or data on persons likely to be the perpetrators or accomplices of these offences.
“With the penalty of nullity, these acts cannot be an incentive to commit these offences. »
The provisions of this Order come into force on February 1, 2014.
The Prime Minister, the Minister of Justice, the Minister of Social Affairs and Health and the Minister of the Interior are responsible, each with respect to him, for the application of this Order, which will be published in the Official Journal of the French Republic.
Done on 19 December 2013.
François Hollande
By the President of the Republic:
The Prime Minister,
Jean-Marc Ayrault
Minister of Social Affairs
and Health,
Marisol Touraine
The guard of the seals,
Minister of Justice,
Christiane Taubira
The Minister of the Interior,
Manuel Valls
