chapters of your choice per month, Email updates on the practice areas most interest to you. 4.10 May pharmaceutical companies sponsor continuing medical education? In addition, the “Charter for the information by canvassing or prospection aimed at promoting medicinal products” also contains requirements for companies to provide to their employees (in particular, sales representatives) continuous educational training. The Lancet, 389 (10077) (2017), pp. notably the General Data Protection Regulation). advertisements for medicinal products which have not obtained the relevant product marketing authorisation for commercialisation; advertisements, whether made for the general public or for HCPs, which have not obtained the “visa” (i.e. participating in advisory boards), under certain conditions. studies referred to in the marketing authorisation dossier and which comply with the terms of the marketing authorisation; and. The decisions of the ANSM can be appealed before the French Administrative Courts. Since then, the following thresholds apply to hospitality offered to HCPs: It should be noted that the amounts are to be understood as including all taxes. a medicinal product subject to an ATU (Article L. 5422-3 of the FPHC); a prescription-only medicinal product (Article L. 5422-5 of the FPHC); a medicine which is reimbursed by the French social security schemes (Article L. 5422-5 of the FPHC); or. Competitors may also take direct action through the Civil Courts in relation to advertising infringements, on the grounds of unfair competition, and seek indemnification. In any case, the mere confirmation by the user that he/she is an HCP is not sufficient. However, there may be internal company rules providing for restrictions on social medial activity by company employees using their personal accounts. do these requirements apply to companies that have not yet been granted a marketing authorisation and/or to foreign companies), what information should be disclosed, from what date and how? Article 2313 Du Code Civil / Code Civil Article 5 Il Est Defendu Aux Juges De Prononcer Par Voie De Disposition Generale Et Reglementaire Code Civil Article 4 Le Juge Qui Refusera Ppt Telecharger. The Civil Code of Québec, in harmony with the Charter of human rights and freedoms ( chapter C-12) and the general principles of law, governs persons, relations between persons, and property. 1.4 Are there any legal or code requirements for companies to have specific standard operating procedures (SOPs) governing advertising activities or to employ personnel with a specific role? Will the company be held responsible for the content of the independent site in either case? Yes, volume-related discounts to public or private organisations purchasing medicinal products are permitted by applicable rules in France. hÞbbd``b`¡@é,`±ÄADø"úÇn Áè $D @BIHp¸âïw5HIÊ22ìÌÀH%â?ãî h49 du paragraphe 9o de l'article 1339 du Code civil du Que´bec, D. 1683-93, (1993) 125 G.O. The number of free samples that can be provided is limited to four samples per year and per recipient. HCPs, associations of HCPs, patient organisations, healthcare institutions) (Articles L. 1453-1 and D. 1453-1 of the FPHC). 10. In principle, the contractual arrangements should be set up by the company offering the hospitality, and not the company affiliate where the hospitality takes place. Il modello del nuovo Code Napoléon, Los Principios Latinoamericanos de Derecho de los Contratos y la ley aplicable al contrato, in Opinio Juris in Comparatione, Special Issue, Principles of Latin American Contract Law, 2019. Among those principles, the LEEM indicates that: 5.5 Is it possible to pay healthcare professionals to take part in post-marketing surveillance studies? Trouvé à l'intérieur – Page 258C'est le mari qui administre seul la com . donnés , pour ainsi dire , à eux - mêmes . munauté ( Art . 1421 , C. civ . ) ... il les renvoie à se pourcar l'article 1453 du Code civil lui donne le voir , sans citation préalable , au buchoix ... studies that are not specifically referred to in the marketing authorisation dossier nor in the opinion of the Transparency Commission) may also be used for promotion provided they are in line with the indications validated by the marketing authorisation and the opinion of the Transparency Commission; in such case, they must have been published in a peer-reviewed journal. Yes, it is possible to pay HCPs to provide expert services (e.g. In France, the self-regulatory body is the CODEEM (“Comité de Déontovigilance des Entreprises du Médicament”), which is the committee, created by the LEEM in 2011, responsible for ensuring that members of the LEEM comply with the self-regulatory ethical rules established by the LEEM. including airworthiness code and acceptable means of compliance, for large aeroplanes (« CS-25 »). Free samples of medicinal products cannot be provided for a promotional purpose to the general public (Article L. 5122-10 of the FPHC). If a pharmaceutical company provides financial support to a patient organisation, a written agreement is required, which shall mention notably the amount provided and the purposes of the support. If so, what restrictions apply? Pursuant to Articles L. 5122-8 and L. 5122-9 of the FPHC, the advertising to both the general public and healthcare professionals (“HCPs”) shall be approved in advance by the ANSM, which is in charge of delivering the corresponding “visa” (i.e. Article L. 5122-1 of the FPHC provides that information contained in sales catalogues and price lists are not considered promotional, provided they do not contain any information on the medicinal product. Trouvé à l'intérieur – Page 103des biens communs , les valeurs qu'on y a apportées en qualité d'associé ( V. art . 1503 , 1525-10 ) . 632. ... Droits qu'une clause du contrat de mariage ( V. art . 1395 ) attribue à l'époux ( art . ... Application de l'article 1453. The Civil Code comprises a body of rules which, in all matters within the letter, spirit or object of its provisions, lays down the jus commune, expressly or by implication.In these matters, the Code is the foundation of all other laws, although other laws may complement the Code or make exceptions to it. However, other clinical studies (i.e. Please wait while we process your request... Grete Hogstad, Vice President Marketing and Sales - PHOTOCURE ASA, Oslo, Norway, GLG Trouvé à l'intérieur – Page 18Il y a même raison de le décider dans un cas que dans , l'autre , et le Code Civil a une disposition formelle à cet égard ( 1 )警 5 SI 1 . ... Elles disparoissent toutes devant les dispositions du Code Civil , ( 1 ) Art . 1453 . 1 ! If differences apply depending on the target audience (e.g. 7.4 What should a company do if an individual healthcare professional who has received transfers of value from that company, refuses to agree to the disclosure of one or more of such transfers? Pursuant to Articles L. 1453-7 et seq. They are calculated on the basis of observed usage data, so as to converge the real cost of treatment towards a conventionally defined target. Art. As a consequence, advertisements intended for HCPs must be displayed on web pages accessible to HCPs only. It defines influencers as “people who, in the media or on social networks, present one or more health products in order to influence the public”. 2. the recommendations issued by the French National Agency for the Safety of Medicinal and Health Products (the “, the “Charter for the information by canvassing or prospection aimed at promoting medicinal products” (“, the “Charter for the communication and the promotion of health products on the Internet and e-media” (“, the code named “Information on the medicinal product and editorial advertising” (“. The arbitrator shall decide the dispute in accordance with the rules of the law chosen by the parties or, in the absence of such choice, in accordance with the rules of the law he considers appropriate. 4.11 What general anti-bribery rules apply to the interactions between pharmaceutical companies and healthcare professionals or healthcare organisations? The above-mentioned Arrêté was published on 14 August 2020, with an entry into force on 1 October 2020, making the new “anti-gift” rules fully effective. Also, information contained in an advertisement shall be accurate, updated, verifiable and exhaustive in order to allow the HCP to make his/her own opinion on the therapeutic value of the medicinal product. Regarding hospitality, similar principles as those governing hospitality to HCPs apply (e.g. If so, what companies are affected (i.e. 1991, c. 64, a. French HCPs, French associations of HCPs, French patient organisations, French healthcare institutions) (Circulaire issued by the French “Direction Générale de la Santé”, see (Hyperlink) ). 151. 6.5 What restrictions apply to describing products and research initiatives as background information in corporate brochures/Annual Reports? Lily, du haut de ses 12 ans, n'aime pas trop les gens. In addition to those principles, the recent “Ethical professional provisions” issued by the LEEM also specify supplementary principles that must be complied with, and notably: 5.6 Is it possible to pay healthcare professionals to take part in market research involving promotional materials? Such disclosure shall be made every year from 20th to 30th June for payments made the year before (e.g., between 20th and 30th June 2021 for payments made in 2020), either on the company’s websites or on a central platform (Section 23.04 of the Code of Practice). Pursuant to Article R. 5122-3 of the FPHC, the advertisement shall contain, at least, the following information: Please note that, pursuant to Article R. 5122-4 of the FPHC, the advertisement cannot contain certain specific allegations, e.g., that the benefit of the medicinal product is guaranteed. R47 of the Code and from art. Articles L. 1453-1 to L. 1454-10 of the FPHC, relating to transparency and anti-gift principles. According to Article L. 5122-1 of the FPHC, the following shall not be considered “advertising”: 1.3 What arrangements are companies required to have in place to ensure compliance with the various laws and codes of practice on advertising, such as “sign off” of promotional copy requirements? Trouvé à l'intérieur – Page 297Article 1453 A près la dissolution de la communauté , la femme ou ses héritiers et ayant - cause ont la faculté de l'accepter ou d'y renoncer : toute convention co raire est nulle . BOURJON , droit commun de la France , liv . SECTION VI — DES POUVOIRS RÉGLEMENTAIRES RELATIFS À LA TENUE ET À LA PUBLICITÉ DU REGISTRE DE L'ÉTAT CIVIL. the information contained in the press release must correspond exactly to the information request – if this is not the case, the press release should not be sent (see also question 2.1 concerning unsolicited questions from HCPs)). Terms of Service, Articles L. 5122-1 to L. 5122-16 and R. 5122-1 to R. 5122-17 of the French Public Health Code (the “. They are more complex to set up; “proper use” clauses: they may be based on an annual threshold of expenses beyond which the company reimburses all the additional units sold or be based on the collection of specific information on the patient treated; the so-called “capping” clauses: they result in the payment of discounts/rebates equal to 100% of the turnover, beyond a conventionally defined threshold, in exchange for a price consistent with international prices; and. A press release about unauthorised medicinal products and/or off-label information is permitted if such press release is not intended to promote the medicinal product itself, but to present a development achievement of the company from a scientific perspective. Article 1453 Article 1454 Article 1455 Article 1456 Article 1457 Article 1458 Article 1459 Title II - The Arbitral Procedure Article 1460 Article 1461 . 2 R egulat ion (EC) No 1 592/ 20 o f the Europea n Parla mnt and o e Cou cil of 1 July 2002 on com rules in the field of civil aviation and establishing a European Aviation Safety Agency (OJ L 240, 7.9.2002, p.1.) French Contract Law after the 2016 Reforms, ed. correspondence, together with, as the case may be, non-advertising documentation, necessary to answer a precise question relating to a specific medicinal product; concrete information and reference documents related, for example, to packaging modification, warnings concerning adverse effects identified in the context of pharmacovigilance, and sales catalogues and price lists, provided they do not contain any information on the medicinal product; and. 2.4 May such information be sent to healthcare professionals by the company? Ar ticle 1443. the so-called “first-box” discounts/rebates: these are discounts/rebates in proportion to sales volumes; the “price-volume” agreements: they result in the payment of degressive discounts/rebates in proportion to the excess of a conventionally defined turnover threshold; daily treatment, dosage or treatment duration clauses: unlike the first two types of discounts/rebates, they are not volume-related. If so, what rules apply? L'article 1353 du Code civil dispose que : "Celui qui réclame l'exécution d'une obligation doit la prouver. Trouvé à l'intérieur – Page 444Art . 1453. La donation ne peut avoir pour objet des biens à venir . S unique . On entend par biens à venir , ceux qui ne sont pas en la possession du donateur , ou sur lesquels celui - ci n'a point de droit au moment de la donation . Art. 2. 7. However, in such case, a derogation exists (see question 4.2), which provides that donations to HCP associations is permitted, provided the purpose of the association is related to the professional activities of the HCPs concerned, with the exception of national professional councils mentioned in Article L. 4021-3 of the FPHC. 2019-774 dated 24 July 2019 added “influencers” to the list of the beneficiaries targeted by the above transparency requirements (Article L. 1453-1 7 bis of the FPHC). In this respect, the Charter also provides for specific recommendations relating to peer-reviewed journals’ or congresses’ websites. In practice, this person will have to demonstrate a fault (e.g., breach of applicable laws and regulations), damage (e.g., loss of profits due to the unlawful promotional activities of a competitor) and a causal link. If so, what limitations apply? In case of emergency, the ANSM can suspend the “visa”, with immediate effect, for a maximum period of three months (Articles L. 5122-8 and 9 and Articles R. 5122-7 and R. 5122-15 of the FPHC). In practice, such information is likely to be considered promotional if it is communicated (even indirectly) to HCPs, except where such information is communicated in response to a specific request from an HCP. Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances? 4.7 Is it possible to offer a refund scheme if the product does not work? 4) Types of studies that can be used for comparative advertisements: the studies (whether published or not) referred to in the marketing authorisation dossier and studies selected and used by the Transparency Commission to issue its opinion, provided they comply with the therapeutic indications validated by the marketing authorisation and, if any, with the opinion of the Transparency Commission opinions. However, the holder of the marketing authorisation for Product B shall first vary the SmPC before requesting the “visa” in order to be compliant with the marketing authorisation. The position is the same with regard to the provision of off-label information. The therapeutic classes (from the ATC classification system) can be mentioned provided they contain more than one medicinal product. 251, 176 U.S. 1 , 44 L.Ed. 3.6 What rules govern the distribution of scientific papers and/or proceedings of congresses to healthcare professionals? Articles 1442-1527 regulate, respectively, domestic and international arbitration. 8.2 What, if any, level of website security is required to ensure that members of the general public do not have access to sites intended for healthcare professionals? The Civil Code of Québec, in harmony with the Charter of human rights and freedoms ( chapter C-12) and the general principles of law, governs persons, relations between persons, and property. Conversely, the self-regulatory body may presumably take up a matter based on adverse findings of French competent authorities. Register with us FREE. In the exercise of civil rights, derogations may be made from those rules of this Code which supplement intention, but not from those of public order. In any event, the transition from one website to the other shall be obvious for the user (either by a message of information, or by opening a new tab). If so, what restrictions apply? Terms of Service and to be contacted regarding GLG’s Trouvé à l'intérieur – Page 59Non - seulement le Code laisse à la femme notoriété , du 27 juillet 1709 , rapporté dans le et fend même qu'on la leur ote par des conyen Ces principes ont été admis par le Code civil , tions antérieures . L'art . 1453 dit : « Après la ... Does it make a difference if the hospitality offered to those healthcare professionals will take place in another country and, in those circumstances, should the arrangements be approved by the company affiliate in the country where the healthcare professionals reside or the affiliate where the hospitality takes place? supra note 6, at 31. Naviguer dans le sommaire du code Article 1453 (abrogé) Version en vigueur du 17 mars 1804 au 01 février 1966. 2.1 To what extent is it possible to make information available to healthcare professionals about a medicine before that product is authorised? Art 671 (alinéa 1er) code civil ou art 1159 et 1160 du code civil sur l'interprétation des contrats, art 7 de la loi organique du 19 mars 1999 relative a la nouvelle Calédonie, ce texte est original a plusieurs titres, sur l'application territoriale de Laws shall take effect after fifteen days following the completion of their publication in the Official Gazette, unless it is . The number of such financial sanctions is rather low (for example, there was only one case for 2018). However, press releases must be made with extreme caution to ensure that they cannot be considered promotional. Trouvé à l'intérieur – Page 360... qu'elle a dilapidé quelque chose depuis la dispa( 1 ) Art . 1453 et suiv . , Code Civil . 1 1 1 11 que ' rition de son conjoint , ils agiront comme ( 560 ) 170. As the case may be, the ANSM can order the concerned company to regularise its situation, and enable it to present its observations, with a possibility of being assisted by an advisor. Avantages matrimoniaux - Protection de tous les enfants non communs contre les avantages octroyés au beau-parent If so, what companies are affected (i.e. As a matter of fact, it had been expressly stated in the decree forming the Compagnie de l'Occident that members This Act shall be known as the "Civil Code of the Philippines." (n) Art. AN ACT TO ORDAIN AND INSTITUTE THE CIVIL CODE OF THE PHILIPPINES. Feel free to add more, and create missing pages. If the HCP actively participates in the scientific meeting, for example as a speaker, it is possible to pay him/her for this. 1991, c. 64, a. In this respect, companies can also provide to an HCP scientific information (on-label and off-label), to respond to a specific unsolicited question from said HCP about a particular product. Employers have the responsibility of checking that this knowledge is genuine and up to date. As a general principle, the website must particularly identify the processor of the website, the intended recipients and the type of information provided. Trouvé à l'intérieur – Page 349avec la solution, sous chaque article, des difficultés... ; suivi d'un formulaire Joseph Adrien Rogron P. A. F. Gérard ... une l'article 1282 et suivants du Code civil , la remise de disposition , celle de l'article 1453 , qui est ainsi ... Also, a contract must be executed in this respect and either (i) declared, or (ii) submitted for prior authorisation (depending on the amount at stake) to the competent board of professionals. information relating to indications and/or other product variants not authorised)? As long as company employees use their personal accounts, there are no specific restrictions on their social medial activity. In such case, the competitor can be sentenced to pay damages, calculated based on the estimated loss of profits of the claimant due to the unfair practices, or based on the estimated gains of the competitor due to such unfair practices. You can download the paper by clicking the button above. This principle was already included in the FPHC before the decision in the Ludwigs case. The ANSM also has a general power to pronounce injunctions. Can and, in practice, do the anti-bribery competent authorities investigate matters that may constitute both a breach of the advertising rules and the anti-bribery legislation, in circumstances where these are already being assessed by the pharmaceutical competent authorities or the self-regulatory bodies? Trouvé à l'intérieur – Page 965La cour de cassation a consacré l'affirmative : « Altendu que l'article 1463 du Code civil , en disant que la femme qui n'a ... attendu que l'article 1453 du Code civil , entendu sainement , n'a pas non plus pour objet de prévoir et de ... The provision of free samples of medicinal products to HCPs is subject to specific conditions set forth by Articles L. 5122-10 and R. 5122-17 of the FPHC. Naviguer dans le sommaire du code Article 311-25 Version en vigueur depuis le 01 juillet 2006. France. 5.4 Is it possible to pay healthcare professionals to provide expert services (e.g. 96 A Esmein, 'L'originalité du Code civil' in Livre du centenaire vol 1 (Paris, Rousseau, 1904) 5. To our knowledge, there is no important recent example where a financial sanction has been pronounced by the ANSM in relation to an advertisement for medicinal products. However, from a social security point of view, it would be far more difficult to implement such a refund scheme if the product is reimbursed by the social security schemes (in such case, the refund would have to be offered to the social security). Transpose and integrate the new EFPIA Code approved and ratified on 17 June 2019 by the EFPIA bodies: the three existing codes have been merged into one. 94-665 as of 4 August 1994, requiring that all advertising be drafted in French. Does it make a difference if the meeting is sponsored by the company responsible for the product? 2. LA COUR CONSIUIONNELLE 318 ANEIS Section 8. However, the comparison shall be as exhaustive as possible and, in order to be objective, shall be made on essential, significant, relevant and ascertainable characteristics, which implies that the comparison be based on relevant data. To what extent may competitors take direct action through the courts in relation to advertising infringements? CN 1804. 1.6 If the authorities consider that an advertisement which has been issued is in breach of the law and/or code of practice, do they have powers to stop the further publication of that advertisement? Effectuer une recherche dans : Tous les contenus. 2. What rules govern such studies? Since then, we were waiting for the publication of a decree and two Arrêtés clarifying certain notions and allowing “finally” the full implementation of the new “anti-gift” set of rules. If so, what may be paid for? Le jour où elle apprend que ses filles vont mal, Anna prend une décision folle : elle les embarque pour un périple en camping-car, direction la Scandinavie. A person may only renounce the exercise of his civil rights to the extent consistent with public order. Article 152.1. However, the principles of the said Charter shall apply. Each sample shall not be larger than the smallest presentation on the market and contain the following mention: “free sample”. It should be noted that these advantages are not subject to authorisation or declaration (see below). See notes 19 and 20, infra. A l'egard de la capacite de recevoir, ii suffit qu'elle existe au moment de !'acceptation de la donation entre-vifs, ou au moment de l'ouverture de la succession du testateur. 4.2 Is it possible to give gifts or donations of money to healthcare professionals? Et pour cause, après la conclusion du contrat entre les parties, celles-ci ont l'obligation de respecter chacune de ses clauses. Articles L. 1453-1 to L. 1454-10 of the FPHC, relating to transparency and anti-gift principles. Regarding advertising to the general public, infringers are notably subject to one year of imprisonment and a fine of €150,000 (€450,000 for legal entities) for every advertisement for: In addition to the above criminal sanctions, pharmaceutical companies declared criminally liable may also be subject to additional sanctions listed in the French Criminal Code, such as, among others, the exclusion from the public procurement tenders. For example, would there be any objection to the provision of such goods or services if they could lead either to the expansion of the market for, or an increased market share for, the products of the provider of the goods or services? informational or educational materials, provided they are (i) related to the practice of medicine or pharmacy, and (ii) for the direct benefit of the patient care; or. Article 1496. Some aggravating circumstances may even lead to seven years of imprisonment and a fine of €750,000 (€3,750,000 for legal entities). Objection to irregularities in notice; waiver. 1474. 95 J Vanderlinden, The concept de code en Europe occidentale du XIIIe au XIXe siècle. In practice, a pharmaceutical company can provide funds to other types of legal entities, such as educational institutes or organisations. Gouvernement du Québec O.C. In such case, the information provided to the HCP must not go beyond the scope of his/her question (i.e. No corresponding article. In practice, French competent authorities may investigate matters drawn to their attention that may constitute a breach of both the laws and any relevant self-regulatory code, even though such matters are already being assessed by the competent self-regulatory body. F orêt 'ar Ln 136/2007 du 7 novembre 2007 relatif à l'article 731 du Code civil 270 G. rêt 'ar Ln o 96/2008 du 26 juin 2008 relatif à l'article 124, ancien, de la loi du 25 juin 1992 sur . Since several changes have been implemented in recent years, we do not expect significant developments in the field of pharmaceutical advertising in the short term. Article L. 162-17-4 of the French Social Security Code. The request for authorisation must be submitted in accordance with a specific agenda determined by the ANSM and detailed on the ANSM website. Academia.edu no longer supports Internet Explorer. Pursuant to Article L. 1453-4 of the FPHC, the provision of an advantage to associations grouping HCPs, including those offering continual medical education programmes, is subject to the general prohibition of advantages.
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