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Law No. 2011 - 2012 29 December 2011 On The Enhancement Of The Safety Of Medicines And Health Products

Original Language Title: LOI n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé

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Information on this text

Texts transposed

Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, with regard to pharmacovigilance, Directive 2001/83/EC establishing a Community Code for Human Drugs

Application texts

Summary

Amendment of the Public Health Code, Social Security Code, Intellectual Property Code. Amendment of Act No. 2006-686 of 13 June 2006 on transparency and security in nuclear matters: amendment of Article 13. Full transposition of Directive 2010/84/EU of the European Parliament and of the Council amending Directive 2001/83/EC on pharmacovigilance, establishing a Community Code on Human Drugs.

Keywords

STATUS OF THE PUBLIC HEALTH, CSP , CODE OF THE SOCIAL SECURITY , CSS , CODE OF THE INTELLECTUAL PROPERTY , STRENGTHENING , SANITIES , PRODUCTS OF HEALTH , TRANSPARENCE , USE , PRISE IN CHARGE , HORS AUTHORIZATION OF MISE ON MARKING , PHARMACOVIGILANCE , INFORMATION , PUBLICITY , LOGICIEL , AID TO PRESCRIPTION , AID TO DISPENSATION , COMPENSIVE MEDICAL DISPOSITIF , PROJECT OF THE EUROPEAN ,

Legislative records




JORF n°0302 of 30 December 2011 page 22667
text No. 1



LOI no. 2011-2012 of 29 December 2011 on strengthening the health safety of the drug and health products

NOR: ETSX1119227L ELI: https://www.legifrance.gouv.fr/eli/loi/2011/12/29/ETSX1119227L/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/loi/2011/12/29/2011-2012/jo/texte


The National Assembly and the Senate deliberated,
The National Assembly adopted,
The President of the Republic enacts the following legislation:

  • PART I: TRANSPARENCE OF INTEREST LINKS
    • Chapter I: Links of Interest Article 1 Learn more about this article...


      I. ― Title V of Book IV of the first part of the Public Health Code is amended as follows:
      1° The title is thus written: "Rules of ethics and health expertise";
      2° The title of Chapter I is thus written: "Links of Interest and Transparency";
      3° Article L. 1451-1 is as follows:
      "Art. L. 1451-1.-I. ― The members of the committees and councils serving with the ministers responsible for health and social security, the members of the cabinets of ministers and the leaders, executive and supervisory personnel and members of the collegial bodies, commissions, working groups and councils of the authorities and organizations referred to in Articles L. 1123-1, L. 1142-5, L. 1142-22, L. 1222-1, L. 1313-1, L.Article L. 161-37 of the Social Security Code, to theArticle 5 of Law No. 2001-398 of 9 May 2001 creating a French Environmental Health Safety Agency and theArticle 13 of Act No. 2006-686 of 13 June 2006 on transparency and security in nuclear matters are required, when taking office, to establish a declaration of interest.
      "This declaration is given to the competent authority.
      "It refers to the links of interest of any kind, direct or interposed person, that the declarant has, or has had for the five years prior to taking office, with companies, institutions or organizations whose activities, techniques and products fall within the scope of competence of the health authority in which he or she exercises his or her functions or the advisory body of which he or she is a member, as well as with the organizations or organizations or organizations
      "She is made public. It is updated on the initiative of the individual.
      "The presidents, directors and directors general of the proceedings referred to in Articles L. 1142-22, L. 1222-1, L. 1313-1, L. 1413-2, L. 1415-2, L. 1417-1, L. 1418-1, L. 3135-1 and L. 5311-1 of this Code, at the time of this Code,Article L. 161-37 of the Social Security Code, to theArticle 5 of Act No. 2001-398 of 9 May 2001 referred to above and to theArticle 13 of Act No. 2006-686 of 13 June 2006 referred to above are heard by Parliament before their appointment.
      "The persons referred to in this article shall not participate in the work, deliberations and votes of the bodies in which they sit only once the statement is signed or updated. They cannot, under the penalties provided for inArticle 432-12 of the Criminal Codetake part neither in the proceedings, nor in the proceedings, nor in the votes of those proceedings, if they have a direct or indirect interest in the matter examined. They are held in secret and at professional discretion under the same conditions as those defined inArticle 26 of Act No. 83-634 of 13 July 1983 the rights and obligations of civil servants.
      “II. ― Are also required to establish the declaration provided for in I, when they take office, the officials of the authorities and organizations mentioned in the same I whose missions or the nature of the functions justify it and which are mentioned on a list established by decree in the Council of State. » ;
      4° After L. 1451-1, an article L. 1451-1-1 is inserted as follows:
      "Art. L. 1451-1-1.-The advertisement of the sessions of the commissions, councils and collegial bodies of expertise referred to in Article I L. 1451-1 and which are consulted in administrative decision-making procedures is, as the case may be, organized by the Ministry of Health or by the authority, institution or body of which they report or from which they are placed.
      "For this purpose:
      « 1° Recording of debates and the preservation of such recordings;
      « 2° Without prejudice, if any, to the online broadcast of the audio-visual recording of the proceedings, the establishment of minutes containing the agenda, the record of the proceedings, the details and explanations of the votes, including minority opinions, and the free online dissemination of these minutes on the websites of the Ministry of Health or the authorities, institutions or organizations mentioned in the first paragraph. » ;
      5° Section L. 1451-2 is amended as follows:
      (a) In the first sentence of the first paragraph, the words: "members of advisory committees placed with ministers responsible for health and social security" are replaced by the words: "people referred to in Article L. 1451-1";
      (b) After the first sentence of the second paragraph, a sentence is inserted as follows: "The obligation under the first paragraph of Article L. 4113-13 is extended to the links with companies involved in the area of competence of the authorities and agencies referred to in Article L. 1451-1 I. » ;
      6° Chapter I is supplemented by articles L. 1451-3 and L. 1451-4 as follows:
      "Art. L. 1451-3.-The conditions for the application of this chapter, including the model and content of the declaration of interest, the conditions under which it is made public and its terms of filing, updating and conservation, are fixed by decree in the Council of State.
      "Art. L. 1451-4.-A decree in the Council of State sets out the conditions under which an ethical commission, established within each agency, controls the veracity of the information issued in the declaration of interest. » ;
      7° Chapter II becomes Chapter IV and Article L. 1452-1 becomes Article L. 1454-1;
      8° A chapter II is re-established as follows:


      “Chapter II



      “Health Expertise


      "Art. L. 1452-1.-Health expertise meets the principles of impartiality, transparency, plurality and conflict.
      "Art. L. 1452-2.-A charter of health expertise, approved by decree in the Council of State, applies to expertise in the areas of health and health safety at the request of the Minister for Health or at the request of the authorities and bodies referred to in Article L. 1451-1 I. It specifies the methods of choice of experts, the process of expertise and its relationship with the decision-making power, the concept of a link of interest, the cases of conflict of interest, the modalities for the management of potential conflicts and the exceptional cases in which it can be taken into account the work of experts with a conflict of interest.
      "Art. L. 1452-3.-People who are invited to provide their expertise in the areas of health and health safety to the Minister of Health, the committees and councils serving with ministers responsible for health and social security, the collegial bodies of the authorities and bodies referred to in Article I L. 1451-1 without being members of these commissions, councils or bodies shall file a statement of interest beforehand.
      "The model and the content of this declaration, the conditions under which it is made public, and its terms of filing, updating and conservation are set by the decree in the Council of State provided for in Article L. 1451-3. »
      II.-1. The second paragraph of Article L. 1123-3, the last paragraph of Article L. 1142-24-3, the penultimate paragraph of Article L. 1222-7, Article L. 1312-5, the first paragraph of Article L. 1313-9, Part II and III of Article L. 1313-10, the second paragraph of Articles L. 1413-11 and L. 1417-4, the second sentence
      2. Section L. 161-44 of the Social Security Code is repealed.
      3. The last paragraph of Article 5 of Law No. 2001-398 of 9 May 2001 creating a French Environmental Health Safety Agency is deleted.
      4. The first two sentences of the fourth paragraph of Article 13 of Act No. 2006-686 of 13 June 2006 on transparency and security in nuclear matters are deleted.

    • Chapter II: Benefits Article 2 Learn more about this article...


      I. ― After chapter II of Book IV title V of the first part of the Public Health Code, a chapter III is inserted as follows:


      “Chapter III



      "Benefits granted by companies


      "Art. L. 1453-1. - I. Companies that produce or market products referred to in Article L. 5311-1 II or provide services associated with these products are required to make public the existence of the conventions they conclude with:
      « 1° Health professionals under Part 4 of this Code;
      « 2° Health professional associations;
      « 3° Students destining themselves to the professions under Part 4 of this Code and the associations and groups representing them;
      « 4° Associations of users of the health system;
      « 5° Health facilities under Part 6 of this Code;
      « 6° foundations, scholarly societies and consulting companies or organizations involved in the product or benefit sector referred to in the first paragraph;
      « 7° News publishers, radio and television service publishers and online public communication services publishers;
      « 8° Software publishers for help with prescription and issuance;
      « 9° Legal persons providing the initial training of health professionals mentioned in 1° or participating in this training.
      “II. ― The same obligation applies, beyond a threshold established by decree, to all benefits in kind or in cash that the same undertakings provide, directly or indirectly, to persons, associations, institutions, foundations, societies, organizations and bodies mentioned in I.
      "III. ― A decree in the Council of State sets out the conditions for the application of this article, the nature of the information that must be made public, including the object and date of the conventions mentioned in I, as well as the deadlines and modalities for the publication and updating of this information. It also specifies the modalities under which the health professions are associated with this publication. »
      II. - Article L. 4113-6 of the same code is amended as follows:
      1° In the first sentence of the first paragraph, after the words: "the fact," the words are inserted: "for students destining themselves to professions under Part 4 of this Code and";
      2° In the same first sentence, after the word "book", are inserted the words ", as well as the associations representing them,"
      3° The second paragraph is supplemented by a sentence as follows:
      "It also does not apply to the benefits provided by agreements between students destining to the professions under Part IV of this Code and companies where these conventions are for research activities in the preparation of a degree. » ;
      4° The third paragraph is supplemented by a sentence as follows:
      "The same applies with respect to students destining themselves to the professions under Part 4 of this Code, for the hospitality offered, directly or indirectly, to the scientific events in which they participate, as long as this hospitality is of a reasonable and limited level to the main scientific objective of the event. » ;
      5° The first two sentences of the fourth paragraph are replaced by a sentence as follows:
      "All agreements between members of the medical professions or students destining themselves to the professions under Part 4 of this Code and the above-mentioned companies are, before their application, submitted for advice to the competent departmental council or, where their scope is interdepartmental or national, to the competent national council. » ;
      6° The same fourth preambular paragraph is supplemented by a sentence as follows:
      "The company is required to notify the competent ordinal proceeding if the agreement has been implemented. »

      Article 3 Learn more about this article...


      The Government shall submit to Parliament a report on the funding of health system user associations and their needs by 30 June 2012.

    • Chapter III: Penal sanctions Article 4 Learn more about this article...


      I. - Chapter IV of Book IV title V of Part I of the Public Health Code is supplemented by articles L. 1454-2 to L. 1454-5 as follows:
      "Art. L. 1454-2. - It is punishable by 30,000 € to fine the fact for the persons referred to in I and II of Article L. 1451-1 and Article L. 1452-3 to knowingly omit, under the conditions established by the same article, to establish or amend a declaration of interest in order to update the data contained therein or to provide false information that impairs the sincerity of the declaration.
      "Art. L. 1454-3. - Is punishable by 45,000 € to fine the fact for companies producing or marketing products referred to in Article L. 5311-1 or ensuring the benefits associated with these products knowingly to make public the existence of the conventions referred to in Article L. 1453-1, concluded with persons, associations, establishments, foundations, societies, bodies and bodies mentioned in 1° to 7° of the I of the same Article, as stated
      "Art. L. 1454-4. - For the offences referred to in this chapter, natural persons also apply the following additional penalties:
      « 1° The dissemination of the conviction decision and that of one or more releases informing the public of this decision, under the conditions set out in theArticle 131-35 of the Criminal Code ;
      « 2° The display of the decision, under the conditions and penalties provided for in the same article 131-35;
      « 3° The prohibition of civic rights, in accordance with the terms set out in article 131-26 of the same code;
      « 4° The prohibition of the exercise of a public service or a commercial or industrial profession, as provided for in section 131-27 of the same code;
      « 5° The prohibition to manufacture, condition, import and market the products referred to in Article L. 5311-1 of this code for a maximum of five years.
      "Art. L. 1454-5. - Legal persons declared criminally responsible, under the conditions provided for in theArticle 121-2 of the Criminal Code, offences under this chapter shall, in addition to the fine in accordance with the terms set out in section 131-38 of the same code, be liable to the penalties set out in 2° to 9° of section 131-39 of that Code. »
      II. - At the end of the first paragraph of Article L. 4163-1 of the same code, is added the reference: "and to Article L. 4221-17".
      III. - In the first paragraph of article L. 4163-2 of the same code, after the words: "this book" are inserted the words: "and for students destining themselves to the professions under Part 4 of this Code as well as for associations and groups representing them".

  • PART II: GOVERNANCE OF HEALTH PRODUCTS Article 5 Learn more about this article...


    I. ― Section L. 5311-1 of the Public Health Code is amended as follows:
    1° The first paragraph is replaced by three subparagraphs:
    "I. ― The National Agency for the Safety of Medicine and Health Products is a state public institution, under the supervision of the Minister for Health.
    “II. ― The agency conducts an assessment of the benefits and risks associated with the use of human-purpose products and cosmetic products. It monitors the risk associated with these products and performs reassessments of benefits and risks.
    "The agency may request that clinical trials of drugs be conducted in the form of trials against active and placebo comparators. If the person who produces or operates a drug is opposed to testing against active comparators, it must justify it. » ;
    2° The beginning of the twenty-second preambular paragraph reads as follows: "III. ― The agency participates... (the rest without change). » ;
    3° The first sentence of the twenty-third paragraph is deleted;
    4° The twenty-seventh preambular paragraph is supplemented by a sentence that reads as follows: "The report includes the annual review of the reassessment of the relationship between the benefits and risks of human-use drugs referred to in Article L. 5121-8. » ;
    5° The last paragraph is deleted.
    II.-Article L. 5311-2 of the same code is amended as follows:
    1° The 3rd is supplemented by the words: "; it provides the scientific and technical support necessary for the development and implementation of public health plans";
    2° Added from 6° and 7° as follows:
    « 6° Encourages research, ensures coordination and, where appropriate, implements, in particular through conventions, patient monitoring studies and data collection of efficiency and tolerance;
    « 7° Access, upon request and under conditions that preserve the confidentiality of data with respect to third parties, the information necessary for the exercise of its missions that are held by any natural or legal person, without the possibility of the medical secrecy, professional secrecy or trade secrecy. »
    III.-Article L. 5312-4 of the same code is amended as follows:
    1° After the reference: "L. 5312-3", the words are inserted: "and in all cases where the public health interest requires it";
    2° After the words: "public opinion", the words "and health professionals" are inserted;
    3° It is added a sentence that reads as follows: "These measures and their cost are, if any, the responsibility of the natural or legal person responsible for the marketing, commissioning or use of the product(s) concerned. »
    IV.-A. ― The Public Health Code is amended to read:
    1° Article 12 to the end of the second paragraph
    2° In the fifth part of Book III, the words: "The French Health Safety Agency for Health Products" are replaced by the words: "the National Agency for the Safety of Medicine and Health Products".
    B. ∙ In 2° and in the first sentence of the ninth paragraph of Article L. 161-37, in the third paragraph, twice, and in the penultimate paragraph of Article L. 161-39, in the first paragraph of Article L. 162-4-2, in the second sentence of the first paragraph, in the third paragraph, twice, and in the last paragraph of Article L. 162-12-15, in the second paragraph-22 of Article first paragraphs of Article L. 165-5 of the Social Security Code, first sentence of the first paragraph of Article L. 221-10 of the Consumer Codeat the 7th I of Article L. 521-12 and the second paragraph of Article L. 521-14 of the Environmental Code and Article L. 234-2 of the Rural and Maritime Fisheries Code, the words: "The French Health Safety Agency for Health Products" are replaced by the words: "the National Agency for Safety of Medicine and Health Products".
    V.-After article L. 5312-4 of the Public Health Code, an article L. 5312-4-1 is inserted as follows:
    "Art. L. 5312-4-1.-The National Agency for the Safety of Medicine and Health Products shall, against natural or legal persons who produce or market products referred to in Article L. 5311-1 or provide benefits associated with these products, make administrative fines that may be accompanied by day-to-day damages, in cases provided for by law and, where applicable, by decree in the Council of State.
    "The agency shall pre-exist the natural or legal person concerned to present his or her observations, with the indication of the possibility of being assisted by counsel and to regularize the situation, if necessary, by matching this stay of a daily stay. In the event of a breach under the 7°, 10° and 11° of Article L. 5421-8, the agency may issue a ban on advertising, after the company concerned has been placed in residence.
    "The amounts of fine and burial are proportioned to the severity of the deficiencies found. They cannot exceed the amounts set out in Article L. 5421-9.
    "The fines referred to in this article are paid to the Public Treasury and are recovered as the claims of the foreign State to tax and the estate. »
    VI.-The title of book IV of the fifth part of the same code is thus written: "criminal and financial sanctions".
    VII.- Chapter I of title II of Book IV is supplemented by articles L. 5421-8 to L. 5421-11 as follows:
    "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 person who is licensed under section L. 4211-6 to ignore the obligation to implement a pharmacovigilance system in order to collect information regarding the risks posed by medications for the health of patients or for public health;
    « 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 a suspected adverse effect of refraining from reporting it without delay in the manner prescribed by regulation to the National Drug Safety Agency and Health Products. Where this breach is also subject to a financial penalty under section L. 5421-6-1, penalties may be accumulated within the maximum amount of one of the penalties incurred;
    « 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 or to maintain the presence of a responsible person on an ongoing basis;
    « 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° The fact that a company does not disclose a marketing stop, 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 health product concerned, or that it does not transmit the data requested by the agency within the time constraints of Article L. 5121-9-3;
    « 7° The fact for any person to advertise to the public or health professionals on the drugs referred to in Article L. 5121-12;
    « 8° 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 the same article L. 5121-12;
    « 9° The failure of the 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 Article L. 162-17-4-1 of the Social Security Code;
    « 10° 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 broadcast advertising to the public for medical devices reimbursed, supported or financed, even in part, by compulsory health insurance plans, with the exception of those listed in the list referred to in Article L. 5213-3;
    « 11° 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 broadcast an advertisement without having requested prior authorization under the conditions defined in section L. 5213-4;
    « 12° The fact for a wholesaler-retributor not to comply with public service obligations and not to ensure the continued supply of the national market, referred to in Article L. 5124-17-2;
    « 13° The failure of an exploiting pharmaceutical company to comply with the obligation of information of any risk of stock rupture or rupture under section L. 5124-6;
    « 14° The fact for the manufacturer of in vitro diagnostic medical devices or its agent as well as for any person who is engaged in the manufacture, distribution or importation of in vitro diagnostic medical devices to broadcast an advertisement without having requested prior authorization under the conditions defined in section L. 5223-3.
    "Art. L. 5421-9.-The National Medicine and Health Products Safety Agency may make an administrative fine against the perpetrator of a breach referred to in L. 5421-8.
    "This fine may be supplemented by a day-to-day violation that cannot exceed €2,500 per day when the perpetrator of the breach did not comply with his requirements at the end of the time limit set by a stay.
    "The amount of the fine given for the breaches mentioned in the same article L. 5421-8 cannot be more than 10% of the turnover made, within a million euros.
    "Art. L. 5421-10.-For the criminal offences referred to in this title, natural 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 or any other professional or social activity in the course of which the offence was committed, in accordance with the terms and conditions set out in section 131-27 of the same Code;
    « 3° The confiscation of the thing that served or was intended to commit the offence or of the thing that is the product of it, pursuant to section 131-21 of the same code.
    "Art. L. 5421-11.-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 the said Code. »
    VIII.-Article L. 162-17-4 of the Social Security Code is amended as follows:
    1° At the beginning of the tenth paragraph, the words: "When an advertising ban measure has been issued by the French Health Security Agency" are replaced by the words: "When an advertisement visa was withdrawn by the National Drug Safety Agency and Health Products";
    2° In the eleventh paragraph, the words: "prohibited advertising" are replaced by the words: "from the withdrawal of an advertising visa" and the words: "banning" are replaced by the words: "from the withdrawal of a visa";
    3° In the twelfth paragraph, the words: "the ban measure" are replaced by the words: "the withdrawal of an advertising visa";
    4° In the first sentence of the sixteenth paragraph, the words: "a ban measure" are replaced by the words: "a visa withdrawal".

    Article 6 Learn more about this article...


    The Public Health Code is amended to read:
    1° In the second sentence of the first paragraph of article L. 5122-15, the words: ", after notice of the commission provided for in the second paragraph of this article," are deleted;
    2° In the first sentence of the second paragraph of the same article, the words: "after notice of a commission and" are deleted;
    3° The 4th of Article L. 5122-16 is repealed;
    4° In the fifth paragraph of Article L. 5323-4, the words "Council and Commissions" are replaced twice by the words "Council, Commissions, Committees and Working Groups".

    Article 7 Learn more about this article...


    I. ― The second paragraph of Article L. 5322-1 of the same code is replaced by nine paragraphs as follows:
    "The Board of Directors is composed, in addition to its Chair, of the following members:
    « 1° State representatives;
    « 2° Three members and three senators;
    « 3° Representatives of mandatory basic health insurance plans;
    « 4° Representatives of health professionals authorized to prescribe and dispense products mentioned in the same article L. 5311-1;
    « 5° Representatives of associations accredited under Article L. 1114-1;
    « 6° Qualified personalities;
    « 7° Representatives of agency staff.
    "The voting rights are divided for half among the members mentioned in 1° and for half among the other members of the board of directors. The president has a preponderant voice in the event of equal sharing of votes. »
    II.-The third paragraph of the same article L. 5322-1 is supplemented by a sentence as follows:
    "The Director General is appointed for a period of three years renewable once. »
    III.-After the third paragraph of the same article L. 5322-1, a sub-item reads as follows:
    "The Board of Directors sets out the direction of the agency's policy. It further deliberates on its programme of work as well as on subjects defined by regulation. »
    IV.-The title II of Book III of Part 5 of the Code is supplemented by a chapter IV as follows:


    “Chapter IV



    “Commissions


    "Art. L. 5324-1.-The agency shall make public the agenda and the records, together with details and explanations of the votes, including minority opinions, excluding any information of a nature of industrial or commercial confidentiality or relating to medical secrecy, meetings of the commissions, committees and collegial bodies of expertise referred to in I of Article L. 1451-1, whose notices shall base an administrative decision.
    "The modalities for the application of the first paragraph, including the conditions of advertising, are set by decree in the Council of State. »
    V.-Article L. 1413-8 of the same code is amended as follows:
    1° In the first paragraph, the words: "submitted under the conditions provided for in Article L. 5322-1" are deleted;
    2° After the first preambular paragraph, a sub-item reads as follows:
    "The board of directors includes, in addition to its president, half of the representatives of the state and half of the qualified personalities chosen because of their competence in the fields entering the missions of the institute and staff representatives. »

    Article 8 Learn more about this article...


    After Article L. 161-40 of the Social Security Code, an article L. 161-40-1 is inserted as follows:
    "Art. L. 161-40-1. - The National Agency for the Safety of Medicine and Health Products, in conjunction with the High Health Authority and the National Union of Health Insurance Funds, under the aegis of the Ministry of Health, implements an administrative and scientific database on treatments as well as on the good use of health products, which can be accessed and downloaded free of charge on the website of the Ministry of Health, intended to serve as a reference for the information of health This database meets the criteria set out in the quality charter of drug databases for prescription help software publishers candidates for the certification procedure provided for in Article L. 161-38.
    "A decree sets out the conditions for the application of this article, and in particular the conditions under which it is made available to the public free of charge. »

  • TITRE III : LE MÉDICAMENT À USAGE HUMAIN
    • Chapter I: Authorization to market Article 9 Learn more about this article...


      I. ― The second sentence of the first paragraph of Article L. 5121-8 of the Public Health Code is supplemented by the words: ", in particular, the obligation to conduct security studies or post-authorization effectiveness."
      II. ― After the same article L. 5121-8, an article L. 5121-8-1 is inserted as follows:
      "Art. L. 5121-8-1. - After the issuance of the authorization provided for in Article L. 5121-8, the National Agency for the Safety of Medicine and Health Products may, under conditions established by decree in the Council of State, require the holder of the authorization to do so, within a time limit that it specifies:
      « 1° Post-authorization security studies if there are concerns about the safety risks posed by an authorized drug;
      « 2° Post-authorization effectiveness studies where understanding of the disease or clinical methodology suggests that previous efficacy assessments may need to be significantly reviewed;
      « 3° A specific monitoring of the risk, its complications and its medico-social care, through a register of patients affected, when the medication, although removed, is likely to cause a serious adverse effect.
      "The studies mentioned in 1° and 2° are done at the closest to the actual conditions of care, that is, in comparison with the reference treatments available when they exist. »
      III. The first sentence of the fourth paragraph of the same article L. 5121-8 is amended as follows:
      1° The words: ", for justified reasons related to pharmacovigilance," are deleted;
      2° The word "extra" is replaced by the word "five".

      Article 10 Learn more about this article...


      After the same article L. 5121-8, an article L. 5121-8-2 is inserted as follows:
      "Art. L. 5121-8-2. - Registration on the list defined in section L. 1121-15 of clinical trials prior to the issuance of marketing authorization is mandatory. »

      Article 11 Learn more about this article...


      The last paragraph of Article L. 5121-9 of the Public Health Code is replaced by seven subparagraphs as follows:
      "The authorization provided for in Article L. 5121-8 is suspended, withdrawn or amended under conditions determined by decree in the Council of State, and in particular for one of the following reasons:
      « 1° The drug is harmful;
      « 2° The drug does not provide therapeutic results;
      « 3° The relationship between benefits and risks is not favourable;
      « 4° Speciality does not have the qualitative and quantitative composition declared;
      « 5° The licensee of the marketing authorization does not comply with the conditions set out in the same section L. 5121-8 or its obligations under sections L. 5121-8-1 and L. 5121-24.
      "The suspension, withdrawal or modification referred to in the fourth paragraph of this section and any refusal of the authorization provided for in section L. 5121-8 shall be made public without delay, at the expense of the licensee or the applicant for the marketing authorization, by any means permitting wide dissemination to the general public and health professionals and institutions. The refusal to make this decision is also made public under the same conditions at the expense of the agency. »

      Article 12 Learn more about this article...


      After article L. 5121-9-1 of the same code, articles L. 5121-9-2 to L. 5121-9-4 are inserted as follows:
      "Art. L. 5121-9-2. - The company or body operating a drug or health product shall immediately communicate to the National Drug and Health Products Safety Agency any prohibition or restriction imposed by the competent authority of any country in which the drug for human use is marketed and any other new information that may influence the assessment of the benefits and risks of the drug for human use or the product concerned. Where applicable, the National Drug Safety Agency and Health Products immediately conducts a reassessment of the relationship between the benefits and risks of this drug and all products with the same action mechanism or similar chemical structure.
      "Art. L. 5121-9-3. - In order to be able to continuously assess the relationship between the benefits and risks associated with the drug as defined in the first paragraph of section L. 5121-9, the National Drug Safety Agency and Health Products may at any time request the holder of the marketing authorization to transmit data demonstrating that this report remains favourable.
      "Art. L. 5121-9-4. - The licensee of the marketing authorization that stops the marketing of a drug in another state than France, while the product is still commercialized in France, must immediately inform the National Agency for Safety of the drug and health products and provide the reason for this marketing stop. »

      Article 13 Learn more about this article...


      I. ― The third paragraph of Article L. 5124-11 of the same code is supplemented by the words: "or whose marketing authorization has not been renewed for the same reasons".
      II. ― At the first sentence of the second paragraph of Article L. 5124-13 of the same code, after the reference: "L. 5121-8", the reference is inserted: "and to Article L. 5121-9-1".

      Article 14 Learn more about this article...


      After the first sentence of the first paragraph of Article L. 162-17 of the Social Security Code, a sentence is inserted as follows:
      "The application for the registration of a drug on this list is subject to clinical trials against therapeutic strategies, where they exist, under conditions defined by decree in the Council of State. »

      Article 15 Learn more about this article...


      The penultimate paragraph of Article L. 161-37 of the same code is supplemented by a sentence as follows:
      "The specialized commissions referred to in the same article L. 161-41 other than those established by the High Health Authority shall submit to Parliament annually an activity report mentioning, inter alia, the modalities and principles according to which they apply the criteria for the evaluation of health products for their care by health insurance. »

    • Chapter II: Limitation Article 16 Learn more about this article...


      Section L. 5121-1 of the Public Health Code is amended as follows:
      1° At 1°, after the word: "specified", the words are inserted: "because of the absence of a pharmaceutical specialty available with a marketing authorization, one of the authorizations mentioned in articles L. 5121-9-1 and L. 5121-12, a parallel import authorization or an import authorization issued to a pharmaceutical establishment as part of a stock shortage of a drug,
      2° In the first sentence of 2°, after the word: "adapted", the words are inserted: "with a marketing authorization, one of the authorizations mentioned in articles L. 5121-9-1 and L. 5121-12, a parallel import authorization or an import authorization issued to a pharmaceutical establishment as part of a stock shortage of a drug."

      Article 17 Learn more about this article...


      I. ― After the word "execution", the end of the second paragraph of section L. 5125-1-1 of the same code is as follows: "by a pharmacy of preparations other than those mentioned in the first paragraph, which may pose a health risk and whose list is fixed by order of the Minister for Health, is subject to authorization by the Director General of the Regional Health Agency. »
      II. ― After the same article L. 5125-1-1, an article L. 5125-1-1-1 is inserted as follows:
      "Art. L. 5125-1-1-1. - The Director General of the Regional Health Agency suspends or prohibits the execution of preparations, other than those referred to in Article L. 5125-1-1, where the offence does not comply with good preparation practices or performs preparations in dangerous conditions for public health.
      "The Director General of the Regional Health Agency suspends or withdraws the authorization for the exercise of the subcontracting activity referred to in section L. 5125-1 or that referred to in section L. 5125-1-1 where the officin no longer complies with good preparation practices or performs preparations under dangerous conditions for public health.
      "With the exception of an emergency, the pharmacist of an offence concerned is in a position to present his observations prior to the action provided for in this section. »

      Article 18 Learn more about this article...


      I. ― After article L. 5121-12 of the same code, an article L. 5121-12-1 is inserted as follows:
      "Art. L. 5121-12-1. - I. A pharmaceutical specialty may be subject to a prescription not in accordance with its marketing authorization in the absence of an appropriate drug alternative with a marketing authorization or a temporary use authorization, subject to:
      « 1° That the indication or conditions of use considered have been the subject of a temporary recommendation of use established by the National Drug and Health Products Safety Agency, this recommendation may not exceed three years;
      « 2° Or that the prescriptor considers it essential, in view of the data acquired from science, the use of this specialty to improve or stabilize the patient's clinical condition.
      “II. ― Temporary recommendations of use referred to in I are made available to prescriptors.
      "III. ― The prescriptor informs the patient that the prescription of the drug specialty is not consistent with its marketing authorization, the absence of appropriate drug alternatives, the risks involved and the constraints and benefits likely to be brought by the drug and refers to the order: "Prescription excluding marketing authorization".
      "He informs the patient on the conditions of health insurance coverage of the prescribed pharmaceutical specialty.
      "He motivates his prescription in the patient's medical file.
      "IV. ― Temporary recommendations of use referred to in I are established after information from the licensee of the marketing authorization.
      "Temporary recommendations of use are elaborated in conditions established by decree in the Council of State. With regard to rare diseases, the agency referred to in Article L. 5311-1 develops temporary recommendations for use, including on the work of health professionals taking care of these pathologies and, where appropriate, the results of therapeutic tests and national diagnostic and care protocols.
      "These recommendations are accompanied by a collection of information on the effectiveness, adverse effects and actual conditions of use of specialty by the holder of the marketing authorization or the undertaking that exploits it, under conditions specified by an agreement with the agency. The agreement may include the licensee's commitment to file, within a specified period of time, an application to amend that authorization. »
      II. ― Article L. 162-4 of the Social Security Code is supplemented by a paragraph to read as follows:
      "For the pharmaceutical specialties mentioned in the 1st, the inscription of the mention: "Prescription excluding marketing authorization" provided for in Article L. 5121-12-1 of the Public Health Code does not indicate their non-refundable character. »

      Article 19 Learn more about this article...


      After itArticle L. 5121-1-1 of the Public Health Code, are inserted articles L. 5121-1-2 and L. 5121-1-3 as follows:
      "Art. L. 5121-1-2. - The prescription of a pharmaceutical specialty mentions its active principles, designated by their international common name recommended by the World Health Organization or, if not, their denomination in the European or French pharmacopoeia. In the absence of such denominations, it mentions their usual common denomination. It can also mention the fantasy name of the specialty.
      "Art. L. 5121-1-3. - Any holder of an authorization to market a drug or any operator of that drug is required, within one year of the promulgation of the drug Act No. 2011-2012 of 29 December 2011 on strengthening the health safety of the drug and health products, making available to the public on its website the designation of the active ingredients of this medication according to their international common name recommended by the World Health Organization or, if not, their name in the European or French pharmacopoeia. »

      Rule 20 Learn more about this article...


      In the third paragraph of article L. 5125-23 of the same code, after the word "prescription", the words "only handwritten" are inserted.

      Article 21 Learn more about this article...


      After article L. 162-17-4 of the Social Security Code, an article L. 162-17-4-1 is inserted as follows:
      "Art. L. 162-17-4-1. - I. The conventions referred to in Article L. 162-17-4 may include the commitment of the company or group of companies to implement means to limit the observed use of drugs outside the indications of their marketing authorization when this use does not correspond to recommendations of the competent health authorities.
      "These means include specific information actions implemented by the company or group of companies in the direction of prescribers.
      "II. ― In the event of a failure of a company or group of companies to an undertaking under I, the Economic Committee for Health Products may issue, after they have been put in a position to present their observations, a financial penalty against that company or group of companies. The penalty is re-conductable each year, under the same conditions, in the event of the persistence of the breach.
      "The amount of this penalty may not exceed 10% of the non-tax turnover made in France by the company or group of companies for the drug(s) subject to the undertaking subscribed during the twelve months preceding the finding of the breach. The amount of the penalty is determined based on the severity of the breach.
      "The penalty is recovered by the organizations referred to in section L. 213-1 designated by the Director of the Central Agency for Social Security Agencies. Its product is assigned to the basic health insurance plans as defined in Article L. 162-37. The appeal against the decision making this penalty is an appeal of full jurisdiction.
      "The rules and time limits of procedure and the methods of calculating the financial penalty are defined by decree in the Council of State. »

    • Chapter III: The delivery of drugs Article 22 Learn more about this article...


      After article L. 5121-14-1 of the Public Health Code, an article L. 5121-14-2 is inserted as follows:
      "Art. L. 5121-14-2. - I. Without prejudice to changes, suspension or withdrawal of marketing authorizations, the National Agency for the Safety of Medicine and Health Products may, in the interest of public health, prohibit the prescription and issuance of a pharmaceutical specialty and remove it from the market under conditions determined by decree in the Council of State, and in particular for one of the following reasons:
      « 1° Speciality is harmful;
      « 2° The drug does not provide therapeutic results;
      « 3° The relationship between benefits and risks is not favourable;
      « 4° Speciality does not have the qualitative and quantitative composition declared;
      « 5° Inspections on speciality or intermediate components and products of manufacture have not been conducted or any other requirement or obligation relating to the granting of the manufacturing authorization has not been met.
      “II. ― The agency may limit the ban on the issue and the withdrawal of the market to the only batches required.
      "For a pharmaceutical specialty that has been banned or has been withdrawn from the market, the agency may, in exceptional circumstances and for a transitional period, authorize the issue of speciality to patients who are already treated with it, under conditions determined by decree in the Council of State.
      "III. ― The decision in I shall be made public without delay, at the cost of the licensee of the marketing authorization, by any means permitting wide dissemination to the general public and to health professionals and institutions. The refusal to make this decision is also made public under the same conditions at the expense of the agency. »

      Article 23 Learn more about this article...


      I. ― For public health reasons, the Minister for Health, the National Drug and Health Products Safety Agency and the National Health Watch Institute can access anonymous drug-related data that are hosted in the pharmaceutical file referred to in the Health Care Watch.Article L. 1111-23 of the Public Health Code.
      II. ― After the first sentence of the second paragraph of the same article L. 1111-23, a sentence is inserted as follows:
      "In the same conditions, pharmacists in a pharmacy for internal use can consult and feed this file. »
      III. ― On an experimental basis and for a period of three years from the publication of this Act, doctors may consult with their medical records in certain health facilities and in the care of patients.
      A decree issued after the advice of the National Commission for Informatics and Freedoms and the National Council for the Order of Pharmaceuticals sets the conditions for the application of this experiment, and in particular the modalities for the designation of establishments subject to experimentation.

      Article 24 Learn more about this article...


      I. ― Section L. 5123-2 of the Public Health Code is amended as follows:
      1° In the first paragraph, the reference: ", L. 5121-12" is deleted;
      2° After the first preambular paragraph, a sub-item reads as follows:
      "The drugs subject to the authorizations referred to in section L. 5121-12 may be purchased, supplied, supported and used by public authorities without being listed in the first paragraph of this section. »
      II. ― On an experimental basis, from April 1, 2012 to December 31, 2013, a drug that was subject to a temporary authorization for use referred to in theArticle L. 5121-12 of the Public Health Code and receives a marketing authorization may, from the date on which the temporary authorization ceases to produce its effects or the date on which the National Drug and Health Products Safety Agency has ceased to issue the said authorizations, be purchased, provided, supported and used by public authorities until a decision has been made, under its marketing authorization, on its entry to the list mentioned in paragraph 2 first or second paragraphs of Article L. 162-17 of the Social Security Code, and no later than seven months after the granting of the marketing authorization.
      The provisions set out in the first paragraph of this II shall cease to apply if no application for registration on the list referred to in first paragraph of Article L. 5123-2 of the Public Health Code has not been filed, for the drug considered, within the month following the granting of its marketing authorization.
      The Government shall submit to Parliament, as part of the review of the Social Security Financing Bill for 2014, a report on the review of the experiment under the first paragraph of this II, including its impact on the expenses and good use of the products concerned. This report covers data for the period from 1 March 2012 to 1 April 2013. It may propose legislative developments arising from this assessment, which will ensure the proper use of these drugs and the control of the cost of their care by the community in this transitional period.

      Rule 25 Learn more about this article...


      Title II of Book III of Part VI of the Public Health Code is supplemented by a chapter VI as follows:


      “Chapter VI



      "Medical centers and mobile care teams
      Military Health Service


      "Art. L. 6326-1. - The medical centres of the military health service and their mobile teams are among the elements of the military health service referred to in Article L. 6147-9. The latter may, as part of their priority mission referred to in Article L. 6147-7, issue, free of charge and under the responsibility of a doctor or pharmacist, the medicines and medical devices and, where appropriate, the medical devices for in vitro diagnosis necessary for their care.
      "The medical centres of the military health service are provided free of charge by the health-resource facilities of the armed health service referred to in Article L. 5124-8.
      "The conditions for the application of this article are determined by decree in the Council of State. »

    • Chapter IV: Temporary authorization for use Rule 26 Learn more about this article...


      I. ― Article L. 5121-12 of the Public Health Code reads as follows:
      "Art. L. 5121-12.-I. ― Sections L. 5121-8 and L. 5121-9-1 do not constitute an obstacle to the use, on an exceptional basis, of certain drugs intended to treat serious or rare diseases, in the absence of appropriate treatment, where the implementation of the treatment cannot be delayed and one of the following conditions is met:
      « 1° The efficacy and safety of these drugs are highly presumed in the light of the results of therapeutic tests to which it has been carried out for an application for marketing authorization that has been filed or that the interested company undertakes to file within a specified period of time;
      « 2° These drugs, if imported, are prescribed, under the responsibility of a physician, to a patient named and unable to participate in biomedical research as long as they are likely to be beneficial to him and that their efficacy and safety are presumed in the state of scientific knowledge. The prescribing physician must justify that the patient, his or her legal representative or the trusted person he or she has designated under section L. 1111-6 has received information appropriate to his or her situation on the absence of therapeutic alternatives, the risks incurred, the constraints and the benefit likely to be brought by the drug. The procedure is included in the medical file.
      “II. ― The use of the drugs referred to in I is permitted, for a limited period, possibly renewable by the National Drug Safety Agency and Health Products, at the request of the holder of the drug's operating rights in the case provided for in 1° of I or at the request of the prescribing physician in the case provided for in 2° of the same I.
      "III. ― An application under 2° of I is admissible only if one of the following conditions is met:
      « 1° The drug was the subject of an application under 1° of the same I;
      « 2° The drug was the subject of an application for a marketing authorization referred to in Article L. 5121-8 or a request for a marketing authorization issued by the European Union pursuant to Regulation (EC) No. 726/2004 of the European Parliament and the Council of 31 March 2004 establishing community procedures for authorisation and monitoring with respect to drugs for human use and veterinary use, and establishing community procedures for authorization and monitoring for drugs for human use and veterinary use, and
      « 3° Clinical trials are conducted in France or a clinical trial application has been filed;
      « 4° The licensee shall, within a period determined by the agency, file one of the applications referred to in 1° and 2° of this III.
      "In the event of rejection of one of these applications, the authorization referred to in 2° of the I granted on its basis is withdrawn for the therapeutic indications requested in the application.
      "IV. - By derogation from the provisions of the III, an authorization requested under 2° of the I may be granted in one of the following cases:
      « 1° When, in the condition of available therapeutics, serious consequences for the patient are highly likely;
      « 2° When the drug has been subject to a marketing stop, if the requested therapeutic indication is different from that of the authorization of the drug that has been subject to that stop and there are strong presumptions of efficacy and safety of the drug in the requested therapeutic indication;
      « 3° If, in the requested therapeutic indication, the holder of the drug's operating rights was denied an application for a drug referred to in 1° of I or if an application for clinical trial authorization referred to in III was refused, provided that the patient and the practitioner were informed of the reasons for refusal of the application and subject to an individual benefit to the patient.
      "V. ― Unless granted in accordance with IV, the authorization is subject to the conclusion, between the agency and the holder of the drug's operating rights, of a protocol of therapeutic use and the collection of information concerning efficacy, adverse effects, actual conditions of use and the characteristics of the population benefiting from the drug as authorized.
      "This collection of information includes people belonging to populations not or insufficiently represented, in relation to the populations brought to use these drugs, in the therapeutic tests to which a request for a marketing authorization was made.
      "For medicines authorized under the same IV, the prescribers shall transmit to the agency, upon expiry of the authorization and, if applicable, on the occasion of each renewal, data for the follow-up of treated patients. The nature of these data is specified by the authorization.
      "These authorizations may also be subordinated by the National Agency for the Safety of Medicine and Health Products to the establishment of a protocol for therapeutic use and information gathering.
      "VI. - The authorization referred to in II may be suspended or withdrawn if the conditions set out in this section are no longer met or for public health reasons. »
      II. – In the first paragraph of Article L. 1121-16-1 and in the fourteenth paragraph of Article L. 1123-14 of the same code, the reference: "a" is replaced by the reference: "1° of the I".

    • Chapter V: Support without market authorization Rule 27 Learn more about this article...


      The first paragraph of Article L. 162-17-2-1 of the Social Security Code is thus amended:
      1° The first sentence is replaced by two sentences as follows:
      "If there is no appropriate alternative, any pharmaceutical specialty subject to a temporary recommendation of use under Article L. 5121-12-1 of the Public Health Code, any product or service prescribed outside the scope of the goods and services refundable for the treatment of a long-term condition that meets the conditions set out in Article L. 322-3 of this Code or Speciality, product or service must be included in a notice or recommendation relating to a category of patients formulated by the High Health Authority, after consultation with the National Drug Safety Agency and Health Products for the products mentioned in theArticle L. 5311-1 of the Public Health Code, with the exception of pharmaceutical specialties already subject, in the therapeutic indication concerned, to a temporary recommendation of use provided for in article L. 5121-12-1 of the same code. » ;
      2° At the beginning of the third sentence, the words "The Order" are replaced by the words: "In agreement, if any, with the temporary recommendation of use mentioned above and the related agreement between the company and the National Agency for Safety of Medicine and Health Products, the Order".

    • Chapter VI: Pharmacovigilance Rule 28 Learn more about this article...


      I. ― After chapter I of title II of Book I of the fifth part of the Public Health Code, a chapter is inserted I bis as follows:


      “Chapter I bis



      « Pharmacovigilance


      "Art. L. 5121-22.-The purpose of pharmacovigilance is to monitor, evaluate, prevent and manage the risk of adverse reaction resulting from the use of drugs and products referred to in L. 5121-1.
      "Art. L. 5121-23.-The National Drug and Health Products Safety Agency ensures the implementation of the pharmacovigilance system to conduct the scientific assessment of all information, to examine options for preventing or reducing risks and, if necessary, to take appropriate action. It defines the directions of pharmacovigilance, animates and coordinates the actions of the various stakeholders, ensures compliance with the monitoring procedures and participates in the activities of the European Union in this area.
      "Art. L. 5121-24.-Any company or agency operating a drug or product referred to in section L. 5121-1 is required to comply with its pharmacovigilance obligations and, in particular, to implement a pharmacovigilance system as well as to record, report and monitor any suspected adverse effects of being due to a drug or product referred to in the same article L. 5121-1, of which it is aware and
      "Art. L. 5121-25.- Physicians, dental surgeons, midwives and pharmacists report any undesirable effects suspected of being due to a drug or product referred to in article L. 5121-1 of which they are aware.
      "Other health professionals, patients and approved patient associations may report any adverse reactions suspected of being due to a drug or product referred to in the same article L. 5121-1 of which they are aware.
      "Art. L. 5121-26.-The rules applicable to pharmacovigilance on the drugs and products referred to in Article L. 5121-1 are determined by decree in the Council of State, including its organizational arrangements as well as procedures for the detection, collection and analysis of signals and procedures for the monitoring and return of information to the persons referred to in Article L. 5121-25. »
      II. ― The 13th of section L. 5121-20 of the same code is repealed.
      III. ― Article L. 5421-6-1 of the same code is as follows:
      "Art. L. 5421-6-1.-Is punishable by three years' imprisonment and 45,000 €' fines for any person operating a drug or product referred to in section L. 5121-1 or for any person who is licensed under section L. 4211-6 to ignore the reporting obligations of a serious adverse effect suspected of being due to that drug or product of which he or she has been aware. »

    • Chapter VII: Information and advertising on human drug use Rule 29 Learn more about this article...


      I. ― The second paragraph of Article L. 5122-2 of the Public Health Code is supplemented by the words "as well as the therapeutic strategies recommended by the High Health Authority".
      II. ∙ Article L. 5122-3 of the same code is supplemented by a paragraph as follows:
      "Advertising for a drug is prohibited when this drug is subject to a reassessment of the relationship between benefits and risks following a pharmacovigilance report. Health professionals are informed by the operator of the re-evaluation medication conducted under this paragraph. This information must be consistent with that provided by the National Drug Safety Agency and Health Products. »
      III. ― In the first paragraph of Article L. 5122-5 of the same code, after the reference: "L. 5122-8", is inserted the reference: ", L. 5122-9" and the reference: "to articles L. 5122-9 and" is replaced by the words: "to article".
      IV. ― The third to the last paragraphs of Article L. 5122-6 of the same code are replaced by four paragraphs as follows:
      "By derogation from the first paragraph, advertising campaigns for drugs referred to in Article L. 5121-2 or for vaccines subject to medical or repayable prescription may be directed to the public.
      "Non-institutional advertising campaigns to the public for vaccines referred to in the third paragraph of this article shall be permitted only if the following conditions are met:
      « 1° They are on a list of vaccines established on public health grounds by order of the Minister for Health, after the advice of the High Council for Public Health;
      « 2° The content of these advertising campaigns is in accordance with the opinion of the High Council for Public Health and is clearly identified with the mandatory minimum statements determined by this body. These references are reproduced in extenso, are easily audible and legible, according to the support of the advertising message concerned, are without reference and are in accordance with characteristics defined by decree of the Minister for Health. »
      V. ― Article L. 5122-9 of the same code is as follows:
      "Art. L. 5122-9. - Advertising for a drug to members of the health professions authorized to prescribe or dispense drugs or to use them in the exercise of their art is subject to prior authorization from the National Agency for the Safety of Medicine and Health Products known as "Advertising Notice".
      "This visa is issued for a period that cannot exceed the duration of the marketing authorization for drugs subject to this authorization.
      "In the event of a breach of articles L. 5122-2 or L. 5122-3, the visa may be suspended in the event of an emergency or withdrawn by a reasoned decision of the agency.
      "Any publicity to health professionals for vaccines is clearly identified and without reference to in-depth recommendations of the opinion of the High Council for Public Health. »
      VI. ― After the same article L. 5122-9, an article L. 5122-9-1 is inserted as follows:
      "Art. L. 5122-9-1. - Visa applications under Article L. 5122-9 are made on a schedule and for a period determined by a decision of the Director General of the National Drug Safety Agency and Health Products. »
      VII. ― Section 5 L. 5122-16, section L. 5422-3 and section L. 5422-4 of the same code are repealed.
      VIII. ― Section L. 5422-6 of the same code is amended as follows:
      1° In the first paragraph, after the word "public", the words "or health professionals" are added;
      2° At 2°, the reference: "to article L. 5122-8" is replaced by the references: "to articles L. 5122-8 and L. 5122-9".
      IX. ― The third part of article L. 5422-11 of the same code is as follows:
      « 3° Who has not been the subject of the advertising visa provided for in Article L. 5122-9 or which is carried out despite the decision to suspend or withdraw it made under the same article. »
      X. ― After the d of section L. 613-5 of the Intellectual Property Code, it is inserted a d bis as follows:
      "(d bis) To the acts necessary to obtain the advertising visa mentioned to theArticle L. 5122-9 of the Public Health Code ;".

      Rule 30 Learn more about this article...


      I. ― Experimental and for a period not exceeding two years, information by demarcation or prospecting for health products mentioned inArticle L. 5311-1 of the Public Health Code, except for medicines reserved for hospital use and those with initial or non-prescribing hospital prescription as well as products referred to in section L. 5211-1 of the same code, carried out in health facilities may only take place before several health professionals, under the conditions defined by agreement between each health institution and the employer of the person concerned, whose terms are defined by order of the minister responsible for health taken after notice of the High Authority.
      Prior to 1 January 2013, the Government submits to Parliament a report on the experiment under the first paragraph, based on an assessment conducted by the High Health Authority. This report may propose legislative developments arising from the balance sheet, particularly with regard to the sustainability of the provisions in question and their possible adaptation to city medicine.
      II. ― Article L. 162-17-8 of the Social Security Code is amended as follows:
      1° The second paragraph is supplemented by a sentence as follows:
      "For this purpose, the Economic Committee for Health Products can set quantified annual targets for the evolution of these practices, if applicable for certain pharmaco-therapeutic classes or for certain products. » ;
      2° Three subparagraphs are added:
      "The Economic Committee for Health Products may establish, after the company has been put in a position to make its observations, a financial penalty against the company that has not complied with the decisions of the committee referred to in the second paragraph taken against it. The amount of the penalty may not exceed 10% of the non-tax turnover made in France by the company for the last fiscal year ended for the product(s). The penalty is determined on the basis of the severity of the breach.
      "The penalty is recovered by the organizations referred to in section L. 213-1 designated by the Director of the Central Agency for Social Security Agencies. Its product is assigned to the basic health insurance plans as defined in Article L. 162-37. The appeal against the decision making this penalty is an appeal of full jurisdiction.
      "The rules and time limits of procedure and the methods of calculating the financial penalty are defined by decree in the Council of State. »

      Rule 31 Learn more about this article...


      After section L. 5121-14-1 of the Public Health Code, an article L. 5121-14-3 is inserted as follows:
      "Art. L. 5121-14-3. - The undertaking that operates a pharmaceutical specialty contributes to the good use of the latter by, inter alia, ensuring that the specialty is prescribed in accordance with its market authorization referred to in Article L. 5121-8 and, where applicable, temporary recommendations of use referred to in Article L. 5121-12-1, of its temporary authorization of use referred to in Article L. 5121-12, of its registration referred to in Articles 5121-13
      "It shall take all information measures that it considers appropriate to the attention of health professionals under Part IV of this Code when it finds requirements not in accordance with the proper use of this specialty as defined in the first paragraph and shall promptly notify the National Drug Safety Agency and Health Products. »

    • Chapter VIII: Limitation and dispensation aid software Rule 32 Learn more about this article...


      Article L. 161-38 of the Social Security Code reads as follows:
      "Art. L. 161-38.-I. ― The High Health Authority establishes the procedure for certification of health-related computer sites.
      “II. ― It also sets out the procedure for certification of medical prescription aid software that met a set of rules of good practice. It ensures that the rules of good practice specify that these software incorporate the medico-economic recommendations and advice identified by the High Health Authority, allow to prescribe directly as a common international name, to display the prices of the products at the time of prescription and the total amount of the prescription, to indicate the belonging of a product to the directory of the generics and contain information regarding their designer and the nature of their financing.
      "This certification procedure participates in improving drug prescription practices. It ensures that software complies with minimum requirements in terms of safety, compliance and efficiency of the prescription.
      "III. ― The High Health Authority establishes the procedure for certification of dispensation aid software. It ensures that these software ensures the translation of the active principles of drugs according to their international common name recommended by the World Health Organization or, if not, their denomination in the European or French pharmacopoeia.
      "This certification procedure participates in the improvement of official dispensation practices. It ensures that dispensation aid software complies with minimum requirements in terms of safety and compliance with the exemption.
      "IV. ― Certifications under I to III are implemented and issued by certifying bodies accredited by the French Accreditation Committee or by the competent body of another Member State of the European Union certifying compliance with the rules of good practice enacted by the High Health Authority.
      "These certifications are made mandatory for any software which at least one of the features is to offer assistance in the editing of medical prescriptions or aid in the dispensation of drugs under conditions provided by decree in the Council of State and no later than 1 January 2015. »

    • Chapter IX: Public Health Studies Rule 33 Learn more about this article...


      After chapter I of title II of Book I of the fifth part of the Public Health Code, a chapter I is inserted as follows:


      “Chapter Ier ter



      “Public Health Studies


      "Art. L. 5121-28. - When conducting vigilance and epidemiology studies involving, inter alia, the products referred to in Article L. 5311-1 makes it necessary to have access to the national inter-regime information system of health insurance referred to in Article L. 5311-1Article L. 161-28-1 of the Social Security Code or extraction of its data, access or extraction may be authorized by a public interest group established for this purpose between the State, the High Health Authority, the National Drug Safety Agency and Health Products, the Health Care Watch Institute and the National Health Insurance Fund of Employee Workers. This public interest group is governed by the Act No. 2011-525 of 17 May 2011 simplification and improvement of the quality of law.
      "The authorization is granted based on the purposes of these studies and the contribution they are likely to make, by their scientific quality and in respect of the protection of personal data, including medical secrecy, public health or the efficiency of health insurance expenses.
      "The public interest group referred to in the first paragraph may carry out vigilance and epidemiology studies, including the products referred to in Article L. 5311-1. It may also initiate tenders for the conduct of studies, provided that they are not funded by one or more companies producing or marketing products referred to in the same section L. 5311-1 or providing services associated with these products.
      "An activity report describing the results of the studies conducted and making recommendations is presented annually to Parliament.
      "A decree in the Council of State, taken after the advice of the National Commission of Computer Science and Freedoms, sets out the modalities for the application of this article. »

  • PART IV: MEDICAL DISPOSITIF Rule 34 Learn more about this article...


    I. ― Title I of Book II of Part 5 of the Public Health Code is supplemented by a chapter IIIandi written:


    “Chapter III



    « Advertising


    "Art. L. 5213-1.-I. ― An advertisement for medical devices within the meaning of section L. 5211-1 means any form of information, including demarcation, prospecting or incentive, which aims to promote the prescription, issuance, sale or use of these devices, with the exception of information provided as part of their duties by pharmacists managing a pharmacy for internal use.
    “II. ― are not included in the scope of this definition:
    « 1° Labelling and instructions for medical devices;
    « 2° Correspondence, if any, with any non-advertising document required to answer a specific question on a particular medical device;
    « 3° Information on warnings, precautions of employment and adverse effects identified in the materialovigilance as well as sales catalogues and price lists if there is no information on the medical device;
    « 4° Information on human health or human diseases, provided there is no even indirect reference to a medical device.
    "Art. L. 5213-2.-The advertisement defined in section L. 5213-1 covers medical devices that comply with the obligations set out in section L. 5211-3.
    "The advertisement objectively defines the product, if any, its performance and compliance with the essential safety and health requirements, as attested by the certificate referred to in the same article L. 5211-3, and promotes its good use.
    "Advertising may not be misleading or pose a risk to public health.
    "Art. L. 5213-3.-Can not be advertised to the public any medical devices supported or financed, even in part, by compulsory health insurance schemes, except for medical devices with a low risk to human health, the list of which is set by decree of ministers responsible for health and social security.
    "Art. L. 5213-4.- Advertising of certain medical devices with a significant risk to human health, the list of which is determined by order of the Minister for Health is subject to prior authorization issued by the National Drug Safety Agency and Health Products.
    "This authorization is issued for a period of five years renewable.
    "This authorization may be suspended or withdrawn by reason of the agency's decision.
    "Art. L. 5213-5.-The National Agency for the Safety of Medicine and Health Products may, under the conditions set out in section L. 5312-4-1, retain the person concerned to withdraw the advertisement, to present his observations and to regularize the situation, if necessary, by setting this condition in place. It may impose a ban on advertising, after the company concerned has been put in place.
    "Art. L. 5213-6.-This chapter does not apply to products referred to in sections L. 5134-1 and L. 5134-2.
    "Art. L. 5213-7.-The modalities for the application of this chapter are set by decree in the Council of State. »
    II. Chapter I of Book IV, title VI of Part IV, is supplemented by articles L. 5461-6 to L. 5461-8 as follows:
    "Art. L. 5461-6.-Is punishable by two years imprisonment and 30,000 € fines 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 or disseminate:
    « 1° An advertisement of a misleading nature or nature to pose a risk to public health;
    « 2° An advertisement of a medical device subject to prior authorization when the National Drug and Health Products Safety Agency did not issue, refused to issue, suspended or withdrew that authorization.
    "Art. L. 5461-7.- Individuals guilty of the offences defined in this chapter shall also be liable to the following additional penalties:
    « 1° The dissemination of the conviction decision and that of one or more releases informing the public of this decision, under the conditions set out in theArticle 131-35 of the Criminal Code ;
    « 2° The display of the decision, under the conditions and penalties provided for in the same article 131-35;
    « 3° The final closure or for a period of not more than five years of establishments or one or more of the establishments of the company that have been used to commit the offence under the conditions set out in section 131-33 of the same code;
    « 4° The prohibition to manufacture, condition, import and market medical devices, for a maximum of five years.
    "Art. L. 5461-8.-Judicial persons declared criminally liable under the conditions provided for in theArticle 121-2 of the Criminal Code, offences defined in this chapter shall, in addition to the fine in accordance with the terms set out in section 131-38 of the same code:
    « 1° The display of the decision or the dissemination of the decision either by the written press or by any means of communication to the public electronically, in accordance with the terms set out in the 9th of Article 131-39 of the said Code;
    « 2° The final closure or for a period of not more than five years of establishments or one or more of the establishments of the company that have been used to commit the facts incriminated, in accordance with the terms set out in 4° of the same Article 131-39. »
    III. The first paragraph of Article L. 165-8 of the Social Security Code is as follows:
    "The mention, in advertising to the public for products or benefits listed in the list provided for in section L. 165-1 other than medical devices referred to in section L. 5213-3 of the Public Health Code, that these products are reimbursed, even in part, by compulsory health insurance plans or by a supplementary plan is prohibited. »
    IV. ― In the third paragraph of section L. 5212-1 and section L. 5222-2 of the Public Health Code, the word "resale" is replaced by the words "expenditure on a costly or free basis".
    V. ― Title II of Book II of Part 5 of the Code is supplemented by a chapter III, as follows:


    “Chapter III



    « Advertising


    "Art. L. 5223-1.-I. ― An advertisement for in vitro diagnostic medical devices within the meaning of Article L. 5221-1 means any form of information, including demarcation, prospecting or incentive that aims to promote the prescription, issuance, sale or use of these devices, with the exception of information provided in the context of their functions by pharmacists managing a pharmacy for internal use.
    “II. ― are not included in the scope of this definition:
    « 1° Labelling and instructional instructions for medical diagnostic devices in vitro;
    « 2° Correspondence, if any, with any non-advertising document, necessary to answer a specific question about a particular in vitro medical device;
    « 3° Information on warnings, precautions and adverse effects identified in the context of reactovigilance as well as sales catalogues and price lists if there is no information on the in vitro medical device;
    « 4° Information on human health or human diseases, provided that there is no even indirect reference to an in vitro diagnostic medical device.
    "Art. L. 5223-2.-The advertisement defined in section L. 5223-1 covers in vitro diagnostic medical devices that comply with the obligations set out in section L. 5221-2.
    "The advertisement objectively defines the product, if any, its performance and compliance with the essential safety and health requirements, as attested by the certificate referred to in the same article L. 5221-2, and promotes its good use.
    "Advertising may not be misleading or pose a risk to public health.
    "Art. L. 5223-3.- Advertising of certain in vitro diagnostic medical devices whose failure is likely to cause a serious health risk and whose list is fixed by order of the Minister for Health is subject to prior authorization issued by the National Agency for the Safety of Medicine and Health Products.
    "This authorization is issued for a period of five years renewable.
    "This authorization may be suspended or withdrawn by reason of the agency's decision.
    "Art. L. 5223-4.-The National Agency for the Safety of Medicine and Health Products may, under the conditions set out in section L. 5312-4-1, retain the person concerned to withdraw the advertisement, to present his observations and to regularize the situation, if necessary by matching this stipulation of a condition. It may impose a ban on advertising after the company concerned has been put in place.
    "Art. L. 5223-5.-The modalities for the application of this chapter are set by decree in the Council of State. »

    Rule 35 Learn more about this article...


    After Article L. 165-1-1 of the Social Security Code, an article L. 165-1-2 is inserted as follows:
    "Art. L. 165-1-2. - I. For products listed in the list provided for in Article L. 165-1 and within its scope of jurisdiction, the National Drug and Health Products Safety Agency may conduct or require competent bodies to carry out a compliance check with the technical specifications to which the listing is subject. Manufacturers or their agents or distributors are required to compensate for the financial loss suffered by the buyer of the products that are seized by the agency as part of its controls.
    “II. ― Where the Agency finds that a technical specification required for the registration of the product referred to in I of this section on the list referred to in section L. 165-1 is not complied with and after it has put the company concerned in a position to submit its observations, the agency shall send a letter to the manufacturer or its agent or distributor notifying it of the breaches against it and the penalties incurred.
    "A copy of this letter is addressed to Ministers responsible for health and social security, the Economic Committee for Health Products and the Director General of the National Union of Health Insurance Funds.
    "The committee may determine, after the manufacturer or agent or distributor concerned has been put in a position to submit its observations, a financial penalty to the manufacturer or agent or distributor.
    "The amount of this penalty may not exceed 10% of the non-tax sales made in France by the manufacturer or distributor for the last fiscal year ended for the product(s) considered. The amount of the penalty is determined based on the severity of the breach.
    "The penalty is recovered by the organizations referred to in section L. 213-1 designated by the Director of the Central Agency for Social Security Agencies. Its product is assigned to the basic health insurance plans as defined in Article L. 162-37. The appeal against the decision making this penalty is an appeal of full jurisdiction.
    "III. ― Where a failure by the agency under the II resulted in an undue reimbursement by health insurance, the national health insurance organizations shall, by subrogation to the local health insurance organizations concerned, commit the procedure for the recovery of the industed under section L. 133-4 against the manufacturer or agent or distributor of the product concerned. The directors of national bodies shall exercise, under the same conditions, the powers of directors of local bodies derived from the provisions of the penultimate paragraph of article L. 133-4.
    "IV. ― If the Agency's failure to comply with II has made it necessary to dispense health care, benefits or products to an insured person, the professional or health care institution who is aware of this failure and has completed this exemption informs, in accordance with medical confidentiality, the local health insurance organization to which the insured person is affiliated.
    "V. ― The conditions for the application of this article, including the procedures for the implementation of the controls provided for in I, the rules and time limits of procedure and the methods for calculating the financial penalty mentioned in II, are determined by decree in the Council of State. »

    Rule 36 Learn more about this article...


    I. ― Chapter II of Title VI of Book I of the same Code is supplemented by an article L. 162-1-20 as follows:
    "Art. L. 162-1-20.-The sworn and authorized agents of the local health insurance organizations referred to in Article L. 114-10 may carry out their checks and administrative investigations on exhibits and on-site for the purpose of obtaining communication of the documents and information referred to in Article L. 114-19. For this purpose, they must be received in health facilities or by any other natural or legal person authorized to issue the related products or services and accommodations listed in the lists set out in Articles L. 165-1 and L. 162-17 to the beneficiaries mentioned in 1° of Article L. 162-1-14, provided that they have notified the person concerned within a time and in forms defined by decree in the Council of State and, in particular,
    "When the audits or administrative investigation are subject to the facts under section VII L. 162-1-14, this advance information is not required. »
    II. ― In the second sentence of the first paragraph of Article L. 114-10 of the same code, after the words "advice practitioners" are inserted the words "and accountants".
    III. ― At 5° of II of Article L. 162-1-14 of the same code, after the reference: "L. 162-1-17", the reference is inserted: "L. 162-1-20".

    Rule 37 Learn more about this article...


    Sub-section 1 of chapter V, section 1 of Book I, title VI, of the same code is supplemented by articles L. 165-11 to L. 165-13 as follows:
    "Art. L. 165-11.-I. ― The purchase, supply, care and use by health facilities referred to in Article L. 162-22-6 of health products other than the drugs referred to in Article L. 162-17, funded under hospital benefits defined in Article L. 162-22-6 and which fall into homogeneous categories defined by decree of ministers responsible for health and social security, are limited to the products listed on the list of products
    “II. ― The homogeneous categories referred to in I of this section include health products that, in order to justify their funding in the framework of the hospitalization benefits defined in section L. 162-22-6, must meet, in the light of their invasive nature or the risks they may pose to human health, at least one of the following requirements:
    « 1° Validating their clinical effectiveness;
    « 2° The definition of specific technical specifications;
    « 3° Appreciation of their efficiency with regard to available therapeutic alternatives.
    "III. ― In order to register on the list provided for in I of this section, manufacturers or their agents or distributors of health products belonging to homogeneous categories file an application for registration with the commission under section L. 165-1.
    "IV. ― Registration on the list is made for a fixed, renewable term. Registration or renewal of registration may include a limitation and use condition and subject to the completion by the manufacturers or their agents or by the distributors of additional studies requested on health products.
    "V. ― The conditions for the application of this article, including the modalities for determining the homogeneous categories of health products concerned, the modalities for the registration of these products on the list mentioned in I, the methods of assessment and the time limits of procedure, are set by decree in the Council of State.
    "Art. L. 165-12.-Health establishments that purchase or use health products belonging to the homogeneous categories referred to in I of section L. 165-11 without being listed in the same I list are liable to a financial penalty.
    "This penalty is imposed by the Director General of the Regional Health Agency following an on-site inspection by public health inspectors or consulting practitioners and auditors of health insurance organizations and after the establishment has been put in a position to present its observations. The amount of this penalty, determined on the basis of the gravity of the breach, cannot exceed the total cost of purchase by the establishment of the products considered in the year prior to the finding of the breach. The penalty shall be notified to the establishment and shall be recovered by the credit union referred to in sections L. 174-2-1 or L. 174-18, subject to the conditions provided for in the last paragraph of section L. 162-1-14.
    "Art. L. 165-13.-In the event of a lack of timely completion, by the manufacturer or agent or by the distributor of a medical device, of additional studies requested pursuant to the IV of Article L. 165-11, the ministers responsible for health and social security may issue, after they have been put in a position to present their observations, a financial penalty against them.
    "The amount of this penalty may not exceed 10% of the non-tax sales made in France by the manufacturer or agent or by the distributor, for the product(s) considered, during the twelve months preceding the finding of the breach. The amount of the penalty is determined based on the severity of the breach.
    "The penalty is recovered by the organizations referred to in section L. 213-1 designated by the Director of the Central Agency for Social Security Agencies. Its product is assigned to the basic health insurance plans as defined in Article L. 162-37. The appeal against the decision making this penalty is an appeal of full jurisdiction.
    "The rules and time limits of procedure and the methods of calculating the financial penalty are defined by decree in the Council of State. »

  • PART V: OTHER PROVISIONS Rule 38 Learn more about this article...


    I. ― Under the conditions provided for in Article 38 of the Constitution, the Government is authorized to make by order, within twelve months of the promulgation of this Act, the measures in the field of the law which are to transpose the Directive 2011/62/EU of the European Parliament and the Council, of 8 June 2011, amending Directive 2001/83/EC establishing a Community code on medicines for human use, with regard to the prevention of the introduction of medicines to the lawArticle L. 5311-1 of the Public Health Code in order to regulate, with respect to them, electronic information and trade.
    II. ― The measures mentioned in I include the measures necessary for their extension and adaptation to the Wallis and Futuna Islands and, as they fall within the competence of the State, New Caledonia and French Polynesia.
    III. – A bill of ratification is tabled before Parliament within three months of the issuance of the order.

    Rule 39 Learn more about this article...


    Under the conditions provided for in Article 38 of the Constitution, the Government is authorized to make an order within twenty-four months of the promulgation of this Act to take measures within the scope of the law which are:
    1° To harmonize and harmonize the provisions relating to penal sanctions and administrative sanctions in the field of products mentioned in theArticle L. 5311-1 of the Public Health Code with the provisions of this Act establishing such sanctions;
    2° To adapt the prerogatives of the agents and authorities responsible for detecting and implementing the breaches punishable by these sanctions.
    A bill of ratification is tabled before Parliament within three months of the issuance of the order.

    Rule 40 Learn more about this article...


    Under the conditions provided for in Article 38 of the Constitution, the Government is authorized to make by order, within twelve months of the promulgation of this Act, the measures relating to the area of the law necessary for the extension and adaptation of the provisions of this Act to the Wallis and Futuna Islands and, as they fall within the competence of the State, New Caledonia and French Polynesia.
    A bill of ratification is tabled before Parliament within three months of the issuance of the order.

    Rule 41 Learn more about this article...


    I. ― Article 1 II takes effect on the date of entry into force of the decree provided for in Article L. 1451-3 of the Public Health Code and no later than 1 August 2012.
    II. ― Section L. 1454-3 of the same code applies from the date of publication of the Order in Council for the purposes of section L. 1453-1 and no later than 1 August 2012 for the conventions applied or concluded and the benefits granted and remuneration paid as of 1 January 2012.
    III. ― Section 5, with the exception of V to VII, and Article 7 come into force on a date provided for by the Order in Council for their application and no later than August 1, 2012. As soon as this comes into force, the National Agency for the Safety of Medicine and Health Products exercises all the rights and supports all the obligations of the French Health Product Safety Agency.
    Until the entry into force referred to in the first paragraph of this III, the powers and powers that this Act attributes to the National Drug Safety Agency and Health Products are exercised by the French Health Product Safety Agency.
    IV. – V to VII of Article 5 come into force as of July 21, 2012.
    V. ― Section L. 162-17 of the Social Security Code applies to applications filed as of January 1, 2012.
    VI. ― Article 19 comes into force under the conditions defined by the decree provided for in Article L. 161-38 of the Social Security Code and not later than January 1, 2015.
    VII. ― Authorities granted on the basis of provisions of Article L. 5121-12 of the Public Health Code in their drafting prior to the promulgation of this Act shall remain governed by these provisions, including for their renewal, for the three years following the promulgation of this Act. These provisions also continue to apply, during the same period, to new applications for authorization referred to in 2° I of the same article L. 5121-12 if similar authorizations have already been granted in the same indication for the drug concerned.
    VIII. ― Advertising that has been the subject of, before the day on which this Act was promulgated, the filing under this ActArticle L. 5122-9 of the Public Health Code in its drafting prior to the promulgation of this Act, for a period of one year from that same date, continue to be governed by Chapter II of Books I and IV of Part 5 of this Code and by Chapter II of Title II of Books I and IV of Part 5.Article L. 162-17-4 of the Social Security Code in their drafting prior to the promulgation of this Act.
    IX. ∙ The Government submits to Parliament, by 1 January 2013, a report providing proposals for compensation for damages when the risk of a drug is realized.
    X. ― Prior to June 30, 2012, the National Drug and Health Products Safety Agency provides Parliament with a report on the safety of medical devices and the measures that could improve it.

    Rule 42 Learn more about this article...


    After article L. 5121-10-2 of the Public Health Code, an article L. 5121-10-3 is inserted as follows:
    "Art. L. 5121-10-3. - The holder of an intellectual property right protecting the appearance and texture of the oral pharmaceutical forms of a reference specialty within the meaning of Article L. 5121-1 may only prohibit oral pharmaceutical forms of a generic specialty that may be substituted for this specialty pursuant to Article L. 5125-23 present an identical or similar appearance and texture. »

    Rule 43 Learn more about this article...


    After article L. 5312-4 of the same code, an article L. 5312-4-2 is inserted as follows:
    "Art. L. 5312-4-2. - No person may be discriminated against, be excluded from a recruitment procedure or from access to an internship or to a period of professional training, or be punished or subject to a discriminatory, direct or indirect measure, including in respect of remuneration, treatment, training, reclassification, assignment, qualification, classification, professional promotion, transfer or renewal of contract,
    "Any provision or act that is contrary shall be void of full right.
    "In the event of a dispute with respect to the application of the first two paragraphs, as long as the person establishes facts that allow the person to assume that he or she has referred to or testified to facts relating to health security, it is the responsibility of the respondent, in the light of the evidence, to prove that his or her decision is justified by objective elements outside the statement or testimony of the person concerned. The judge shall form his conviction after ordering, if necessary, all the measures of instruction that he considers useful. »

    Rule 44 Learn more about this article...


    Article L. 5134-1 of the same code is amended as follows:
    1° The second sentence of the first paragraph is deleted;
    2° The second paragraph is amended to read:
    (a) In the first sentence, the words: " Contraceptive, and especially" are deleted;
    (b) After the first sentence, a sentence is inserted as follows:
    "Nurses in these services may issue and administer these drugs. »

    Rule 45 Learn more about this article...


    I. ― second paragraph of Article L. 245-6 of the Social Security Code is supplemented by the words and a phrase so written: "and sales or resales to foreign countries. Resellers shall notify the operator of the marketing authorization of the quantities claimed or intended to be sold outside the national territory for a list of products fixed by order and under conditions defined by a tripartite convention between the State, one or more trade unions or organizations representing the companies manufacturing or operating drugs and one or more trade unions or organizations representing the wholesalers-repartitors. »
    II. ― After the first sentence of the third paragraph of article L. 5121-17 of the Public Health Code, a sentence is inserted as follows:
    "Resellers shall notify the licensee of the marketing authorization of the quantities claimed or intended to be sold outside the national territory for a list of products fixed by order and under conditions defined by a tripartite convention between the State, one or more trade unions or organizations representing the companies manufacturing or operating drugs and one or more trade unions or organizations representing the wholesalers-repartitors. »
    III. ― After the second paragraph of Article L. 5123-1 of the same code, it is inserted a paragraph as follows:
    "The first two paragraphs do not apply to drugs and products not consumed in France and intended for export. »

    Rule 46 Learn more about this article...


    The first paragraph of section L. 5124-6 of the Public Health Code is amended as follows:
    1° In the first sentence, the words "six months" are replaced by the words "one year";
    2° The third sentence is deleted;
    3° In the sixth sentence, after the word "inform", the words are inserted: "in a motivated manner" and, after the word "stock" are inserted, twice, the words "or any rupture".

    Rule 47 Learn more about this article...


    After article L. 5124-17 of the same code, articles L. 5124-17-1 and L. 5124-17-2 are inserted as follows:
    "Art. L. 5124-17-1.-An astreinte system is organized to meet the urgent needs of drugs outside the opening days generally practiced by wholesalers-retributors in their distribution territory.
    "All wholesalers-retributors mentioned in the first paragraph are required to participate in this system.
    "The organization of the system of interference is regulated by the representative organizations of the profession. If there is no agreement or if the organization is unable to meet public health needs, a decision of the Director General of the regional competent health agency regulates the organization of the said system.
    "The organisation of the system of interference is determined by decree in the Council of State.
    "Art. L. 5124-17-2.-The wholesalers-retributors are required to comply with the public service obligations determined by decree in the Council of State.
    "They ensure the continued supply of the national market to cover the needs of patients in their distribution territory. »

    Rule 48 Learn more about this article...


    In the first sentence of the first paragraph of article L. 6325-1 of the same code, after the word "physician", the words ", a surgeon-dentist".
    This law will be enforced as a law of the State.


Done in Paris, December 29, 2011.


Nicolas Sarkozy


By the President of the Republic:


The Prime Minister,

François Fillon

The guard of the seals,

Minister of Justice and Freedoms,

Michel Mercier

Minister of Economy,

finance and industry,

François Baroin

The Minister of Labour,

employment and health,

Xavier Bertrand

Minister of Higher Education

and research,

Laurent Wauquiez

(1) Preparatory work: Act No. 2011-2012. National Assembly: Bill No. 3714; Report of Mr. Arnaud Robinet, on behalf of the Social Affairs Committee, No. 3725; Discussion on 27 and 28 September 2011 and adoption, after an accelerated procedure, on 4 October 2011 (TA No. 741). Senate: Bill, passed by the National Assembly after the Accelerated Procedure, No. 5 (2011-2012); Report of Mr. Bernard Cazeau, on behalf of the Social Affairs Committee, No. 44 (2011-2012); Text of Commission No. 45 (2011-2012) Discussion on October 26 and 27, 2011 and adoption on October 27, 2011 (TA No. 8, 2011-2012). National Assembly: Bill, amended by the Senate, No. 3881; Report of Mr. Arnaud Robinet, on behalf of the joint parity commission, No. 3941. Senate: Report of Mr. Bernard Cazeau, on behalf of the Joint Parity Commission, No. 100 (2011-2012). National Assembly: Bill, amended by the Senate, No. 3881; Report of Mr. Arnaud Robinet, on behalf of the Social Affairs Committee, No. 3964; Discussion on 22 and 23 November 2011 and adoption on 23 November 2011 (TA No. 766). Senate: Bill, passed by the National Assembly on new reading, No. 130 (2011-2012); Report of Mr. Bernard Cazeau, on behalf of the Social Affairs Committee, No. 162 (2011-2012); Discussion and rejection on December 13, 2011 (TA No. 26, 2011-2012). National Assembly: Bill, rejected by the Senate again, No. 4072; Report of Mr. Arnaud Robinet, on behalf of the Social Affairs Committee, No. 4075; Discussion and final adoption on 19 December 2011 (TA No. 805).
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