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FOREWORD The Pharmaceutical Industry is obligated to contribute to the improvement of human health by manufacturing all pharmaceutical products in compliance with internationally accepted good manufacturing standards with reliable quality as well as marketing said products. Within the framework of this obligation, the pharmaceutical industry shall provide accurate information and training to healthcare professionals regarding its products and is obliged and responsible to ensure that these individuals clearly understand the thorough utilization of these drugs. Promotional activities (marketing implementations) must be in compliance with high ethical standards and the information that is provided to healthcare professionals must be devised so as to assist them in serving their patients better. This information must be objective, accurate, easily intelligible and in compliance with all laws and regulations in effect. Opinions put forth with respect to treatment indications and conditions must take as their basis current scientific findings and must provide sufficient detail regarding side effects, contra-indications and necessary precautions that must be taken. Based on this fundamental principle, in addition to the regulation issued by the Ministry of Health on promotion and related matters, the Pharmaceutical Manufacturers Association of Turkey (IEIS), in order to fulfill its obligations more effectively, has drafted and put into effect the IEIS Code for Promotion of Medicinal Products in 1990. This code, which contains provisions parallel to those specified in the Promotion Regulation of the Ministry of Health, functions as a self-auditory mechanism among IEIS members. The functionality of this mechanism is ensured by the IEIS Supervisory Committee, which has the power to impose legal sanctions. The IEIS Code for Promotion of Medicinal Products, with which all IEIS member companies are obliged to comply, shall provide the necessary assistance to our industry in protecting ethical standards in the promotion of pharmaceuticals. INTRODUCTION AND OBJECTIVE The IEIS Code for Promotion of Medicinal Products has been drafted by the Pharmaceutical Manufacturers Association of Turkey under the authority of the pertaining divisions of member companies in order to ensure the attainment and maintenance of the industry’s high ethical standards in the marketing of pharmaceutical products for human use. With regard to the rational use of pharmaceuticals, IEIS views that informing phsyicians, dentists and pharmacists on products in an accurate and impartial manner is a fundamental right. This information and promotion must be in accordance with ethical criteria and values of public benefit within the framework of legal implementations as set forth by the Ministry of Health. In keeping with the abovementioned specifications, the IEIS Code for Promotion of Medicinal Products functions thoroughly as a self-supervisory mechanism. The compliance of companies with the principles of this self-supervisory mechanism carries great importance with regard to the prestige of the industry in the eyes of all pertinent professionals, organizations and the public in general. Explanations pertaining to the implementation of this code are provided below. These implementations are examined by the Supervisory Committee for IEIS Code for Promotion of Medicinal Products. As a result, when a violation of promotional principles is determined, one or several of the sanctions set forth in Section 9 shall be implemented together, in accordance with the evaluation of the Supervisory Committee. With respect to matters not specified in this code, articles of the Promotion Regulation of the Ministry of Health shall be taken into account. Matters that are not specified in either document and are determined to be in violation of general rules, shall be evaluated by the Supervisory Committee for IEIS Code of Promotion. The Supervisory Committee for IEIS Code of Promotion is constituted by a minimum of 11 members, including: General Secretary, Assistant General Secretary and a Rapporteur At least two academicians from Schools of Medicine, Pharmacology and other related fields Six authorized individuals from the Pharmaceutical Industry involved in the promotion of pharmaceuticals. The General Secretary is the natural chairman of the Committee; during the first meeting, a vice-chairman is elected among the Committee members to serve as chairman in the absence of the General Secretary. Company representatives to the Supervisory Committee shall be selected by the Board of Directors upon the suggestion of companies. The following criteria will be used in determining company representatives: Must be a Medical or Marketing division executive at an IEIS-member company, Must preferably have professional experience of at least five years, Must have received no disciplinary actions throughout the course of his/her professional career and must be well-respected within the sector. Members serve a term of two years in office. In addition, alternate members are selected among academic, syndicate and industry representatives. If needed, experts in fields not specified above may serve in the Supervisory Committee as consultants. The membership of a member who fails to attend three consecutive meetings without providing a written pretext beforehand shall be revoked and an alternate member is appointed to replace him/her. 1. SCOPE AND DEFINITIONS 1.1. Scope The “drug product” (preparation) subsumed under the IEIS Code for Promotion of Medicinal Products, is a pharmaceutical or biological product to be used upon the suggestion of a physician, under the supervision of members of the healthcare profession, in the diagnosis, treatment or prevention of human diseases or in the modification of any function of the human body. The Code refers to pharmaceuticals and pharmaceutical products interchangeably. This Code subsumes promotional activities in Turkey involving medicinal products for human use to members of the healthcare profession. In addition, the principles subsume the transmission of medical and pharmaceutical information to pertaining auxiliary and administrative healthcare personnel for informative purposes. The public promotion of non-prescription pharmaceutical products, including borderline products, shall be effected in accordance with the fundamental principles concerning the public promotion of these types of products as set forth in the “Regulation Regarding the Promotional Activities Involving Medicinal Products For Human Use” issued by the Ministry of Health and the provisions set forth in sections 2 and 3.2 of this Code. Based upon the experiences gained during the implementation of Regulation provisions pertaining to public promotion and concrete observations, the Code shall be amended in the future to include specifications regarding these details or a separate code shall be constituted. During the implementation of the IEIS Code for Promotion of Medicinal Products, its interpretation, adaptation to situations not specified therein and to newly emerging needs as well as the promotion of compliance among pertaining individuals, particular attention shall be paid to national regulations and any pertaining Ministry of Health resolutions. In addition, where needed, transactions may be processed in compliance with resolutions of the Supervisory Committee of the IEIS Code for Promotion of Medicinal Products on its principles. The Code also subsumes certain areas not directly related to promotion. 1.2. Definitions: 1.2.1. Promotion or Marketing: All informative and reminder activities executed in order to increase the procurement, sale, prescription and use of the medicinal product for human use by the registration or permit holder (pharmaceutical company) or upon obtaining the approval of this company. The principles regulate the following activities: a) The use of promotional materials and other printed materials and activities of medical sales representatives, including verbal promotion; b) Advertisements in medical and professional journals; c) Advertisements via direct mail; d) Activities involving reminder promotion; e) Distribution of free samples; f) Convention of scientific, educational and promotional meetings aimed at healthcare professionals; g) Participation in fairs and expositions, use of voice cassettes, films, records, tapes and video recordings; use of all promotional materials and materials such as radio, television, internet, electronic media, interactive data systems, audio or visual CDs, DVDs and so forth. Activities effected within the scope of the principles set forth in section 2.7 of the Code aimed at informing the public do not constitute promotion. However, diligent care must be taken to ensure that the data used in informing the public as well as the nature and character of the activities undertaken must thoroughly conform to the provisions of the Code, including those pertaining to record keeping. 1.2.2. These principles do not apply to the following matters, which remain outside the scope of promotion: a) Public promotion of medicinal products for human use sold without a prescription in compliance with rules and legislations; b) Public promotion of traditional drugs; c) Promotion of infant formula and baby food; d) Promotion of enteral food for adults; e) Promotion of in vitro diagnostic tests and kits, medical apparatus, devices and consumables sold directly to the consumer; f) Promotion of contact lenses and lens solutions; g) Fact-based, accurate and informative announcements and reference materials pertaining to licensed products, such as packaging changes, adverse reaction warnings, commercial catalogues and price lists, under the condition that they do not contain any claims about the product; h) Written correspondence and responses provided to questions forwarded by healthcare professionals or pertaining administrative staff or to scientific announcements forwarded by such persons in the form of questions or opinions; (these include accurate, non-misleading, non-promotional letters in professional publications pertaining to the matter or question at hand); i) Commercial practices regularly adopted by a portion of the pharmaceutical industry involving conditions of pricing, discounting or sale; j) Summary of Product Characteristics (SPC); k) Drug labels and product leaflets; l) Organizational promotions. 1.2.3. Medicinal Product / Product / Drug: Any combination of material or materials, registered / permitted by the Ministry, with or without a commercial brandmark, that is administered to humans in order to treat or prevent an illness, make a medical diagnosis or treat, adjust or modify physiological functions; 1.2.4. Marketing Registration: Registration Certificate for drugs sold with or without prescription and Permit Certificate for Non-Prescription Borderline Products; 1.2.5. Free Sale Permit: Certificate of adequate quality, required prior to the sales launch of the product, after obtaining the Registration Certificate or Permit Certificate and submitting a sale sample of the product to the Ministry; 1.2.6. Promotional Materials: Any material including the following, but not limited to, items used in direct promotions or advertisements or those actualized through sales representatives; a) Printed materials providing information on the product, such as booklets, books, brochures, advertisements; b) Audio-visual materials such as films, slides, electronic media; c) Free samples of products for human use; d) Materials of modest material value used by healthcare professionals during professional activities, such as notepads, pens, pen holders, calendars and the like; e) Reminder call materials; f) National and international publications that might be sources of data / information for concerning milieus; 1.2.7 Healthcare Professionals: Physicians, dentists and pharmacists; 1.2.8. Medical Sales Representative / Medical Representative: Individual directly promoting the medicinal product for human use to physicians, dentists and pharmacists by visiting them; 1.2.9. Auxiliary Members of the Healthcare Profession: Nurses, midwives, laboratory technicians, healthcare technicians, healthcare administrators and similar individuals who support members of the healthcare profession in their professional activities or who implement the prescribed treatments and methods on patients; 1.2.10. Healthcare Reporter: A journalist or media reporter from an accredited media agency, newspaper, broadcast series or audio-visual broadcast specializing exclusively or particularly on health-related news; 1.2.11. Summary of Product Characteristics : A comprehensive document, which, as a segment of the Registration File, specifies the indications and use of the registered / permitted product; 1.2.12. Law: Law No.1262 on Pharmaceutical and Medicinal Preparations; 1.2.13. Regulation: Regulation Regarding the Promotion of Medicinal Products for Human Use, published on October 23, 2003 in the Official Gazette, No.25268; 1.2.14. Ministry: Ministry of Health and its pertaining units; 1.2.15. Pharmaceutical Company / Company / Industry: Registration- or permit-holder for the medicinal product for human use. GENERAL PRINCIPLES Ethical Criterion in the Promotion of Medicinal Pharmaceuticals The ethical criterion in the promotion of medicinal pharmaceuticals involves making the necessary effort in order to stay within the boundaries of ACCURACY AND SCIENTIFIC OBJECTIVITY AND PROFESSIONAL HONOR throughout all promotional activities and to avoid any behavior that might damage the respectability of the pharmaceutical industry as well as the principle of mutual respect and professional support among members. Promotional Standards The information utilized in the material for the promotion of pharmaceuticals should adhere to high ethical standards and should be easily understandable by the person who hears the promotion. The views and claims that are made should not transgress the boundaries of scientific evidence and should not be vague. 2.3. The Nature of Information and Scientific Evidence The promotion of pharmaceuticals should be sufficiently informative, truthful, realistic, complete, demonstrable, reliable and understandable to allow a physician to form an opinion regarding the drug’s value in therapeutic, diagnostic and other medical applications, and to permit a pharmacist to assess its uses. The information in promotional materials should be based on updated evaluations of scientifically valid evidence and should be in agreement with the pertinent leaflet and brief product information approved by the healthcare authorities. Scientific evidence used to support the views and claims should be provided if required by the healthcare professional. Promotional materials may include comparisons so long as: a) The comparison is not misleading, b) Drugs and services intended for the same requirements and objectives are compared, c) Meaningful, pertinent and proven properties are compared, d) There is a direct comparison of the same scientific or technical work, e) Comparisons are not mainly utilized to create confusion, f) The comparison does not contain any derogatory remarks regarding the competitive product, g) No unfair benefits are gained at the expense of a competitor’s credibility. Comments that denigrate healthcare professionals or their clinical and scientific views should be avoided. 2.4.1 Safety-Related Data Basic data regarding the issue of drug safety, for instance, contra-indications, conditions to safeguard against, warnings, necessary precautions and side effects, must be provided consistently and in compliance with the product leaflet, brief product information, and legal and medical practices. The terms ‘safe’ and ‘reliable’ must only be used if sufficient characteristics are met. 2.5 Pre-Registration Communication A promotion aiming at utilizing any drug for any condition or mode of administration may not be undertaken prior to its registration for that condition or administration, or before an appendix is made to the existing registration. However, this rule does not prevent the scientific community from being informed about advances made in science and medicine. Therefore, the provision of this article does not constitute an obstacle to fully disseminate information on a drug for the sole purpose of informing and not promotion, nor does it hinder communicating research data through scientific conferences and science oriented medical journals and books not limited to this drug, or as stated in Article 6.3. 2.6. Public Promotion The public promotion of pharmaceutical products not subject to prescription is carried out according to principles defined in the Regulation issued by the Ministry of Health. Companies are responsible for information on their products disseminated by public relation agencies. For products the public promotion of which has been prohibited, the holders of registration take the necessary actions to correct the promotional information published in the printed media and inform the Ministry. 2.7. Informing the Public Printed informative material may be prepared in order to facilitate public understanding of disease symptoms and indications, modes of treatment and especially prevention, and to meet the public’s need for information, pharmaceutical companies may support such programs. In such cases activities should comply with scientific standards, no direct or indirect product promotion should be made and health care professionals should be supported on this subject. In these activities no mention should be made of the drug name, collective group descriptions (such as beta-blockers, statins, fluorochinolones) and/or general names (INN) should be used instead. On live or taped telephone hotlines, which are supported by the company, only medically authorized personnel should be employed and no product promotion should be made in any way. 2.8. Company Procedures In order to ensure full adherence to national and IEIS Code of Promotion as well as legal regulations, pharmaceutical companies assign an employee with sufficient training and experience to be responsible for promotions and forward his/her name and a brief curriculum vitae to the Association. Companies structure the organization of promotional activities via a special unit or service designated specifically for this purpose. This employee, unit or service must develop and maintain the needed procedures, investigate and monitor all promotional materials and activities and prepare the companies’ standard working methods relating to promotional principles. In order to ensure that promotional materials can be easily identified in any circumstance and/or to prevent any misunderstandings, all materials must carry a code and date. Printed promotional materials must adhere to the following conditions: g) They must contain clear medical language and be easily intelligible, h) Their record must be kept, i) Prior to their introduction into the marketplace, the company employee responsible for promotions must submit his/her dated approval, j) A copy of each material must be filed for a period of five years to be submitted to the Ministry upon request, k) Promotional materials taken off the marketplace must be specified with the date of their recall and samples of each material must be filed for a period of five years pursuant to the date of recall. 3. PROMOTION 3.1. The Scope of Promotion 3.1.1 Promotion subsumes the activities cited in the definition provided in Article 1.2.1. 3.1.2 Promotional activities may only be undertaken for drugs that have received registration/permit as per the provisions of the legal regulations currently in effect and the indications of the drugs specified within the registration. However, with respect to drugs that have not yet received registration or permit, informative activities as specified in Article 2.5 and Article 6.3 may be undertaken at scientific conferences, symposia and seminars, within the framework of scientific presentations and discussions and scientific-based medical journals and books. 3.1.3 Pharmaceutical products for human use may be promoted to healthcare professionals specified in Article 1.1 on Scope. 3.1.4 In instances where the promotion of the drug is prepared and/or handled by third parties (advertising agency, advertising consultant, contracted research organization, etc.), the responsibility still lies with the registration/permit holder. If the drug has not yet received registration, the responsibility lies with the individual or organization that has applied for registration/permit. In this case, as in others, the promotional text must be approved by the company employee in charge of promotions. 3.2. General Rules 3.2.1. Promotion methods that may hurt the respectability of the pharmaceutical industry or jeopardize public trust may not be utilized. Unsubstantiated, baseless claims regarding rival companies, targeting a particular product and specifying its active ingredient may not be made; unnecessary and ill-intended complaints may not be suggested. Negative statements using a commercial name may not be made either directly or indirectly. 3.2.2. Distribution of samples, all activities involving medical representatives, hospitality provided at scientific meetings and other promotion-related activities must aim to communicate promotional information and not deviate from this fundamental principle. 3.2.3. Promotions may not involve chance-based methods such as raffles, lotteries, etc. or activities that provide recreational services such as vacation trips. (Without prejudice to the provision set forth in Article 4.5). 3.2.4. Promotions may not suggest the use of a medicinal product in a manner that does not conform to the indication(s) and administration methods specified in the product leaflet as permitted by the Ministry, with the exception of the circumstances as set forth in Article 2.5 and Section 6.3. 3.2.5. With prior permission from the Ministry of Health, pharmaceutical manufacturers, pharmaceutical importers and registration holders may engage in or support health education activities aimed at informing the public of positive approaches to health. 3.2.6. In the post-marketing phase, surveillance and other activities aimed at product monitoring may not overstep the objective of data gathering about the company’s product and may not be used as promotion or a means to influence physicians under the guise of research. 3.2.7. The preparation and administration of market research, post-marketing surveillance studies and similar activities may not be conducted with an objective to promote. Research findings resulting from marketing-related studies may not be used in promotion. 3.2.8. While conducting a market research, it is not necessary to divulge the name of the company; however, it is absolutely required to indicate that the research is being conducted at the request or with the support of a pharmaceutical company. 3.2.9. The name of the pharmaceutical company and/or the commercial drug name as well as reminder information pertaining to the pharmaceutical preparation may not be included in the documents used by official and private healthcare organizations. 3.2.10. Nutritional ingredients or preparations may not be used as direct or indirect materials in promoting the drug. 3.2.11. In accordance with the provisions of Article 22 of Law No.3984 Regarding Radio and Television Organizations and Broadcasts, pharmaceutical products for human use, sold under prescription, may not be promoted via radio or television. 3.2.12. Excess in the forms and costs of promotional materials must be diligently avoided. 3.2.13. Postcards, other public mailings, envelopes or packaging materials may not carry information that might be construed as public advertising. 3.2.14. With the exception of cases where a request has been received or prior permission from an individual has been granted, telephones, mobile phone messages, e-mails, faxes and so forth may not be used as promotional materials. 3.2.15. If a pharmaceutical company provides support to activities and materials, regardless of whether they are intended for promotion or not, pertaining to drugs and their use, the support provided must be clearly specified. 3.2.16. Companies may not engage in covert product promotion (such as broadcasting via announcements, news or reports, concealing sponsorships, etc.). 3.2.17. Unless specified in the joint promotion contract, all responsibility for activities lies with the registration holder. 3.3 Standards Pertaining To Information Used In Promotions 3.3.1 All information that is used in the promotion of a product to healthcare professionals must be accurate, verifiable and sufficient so that healthcare professionals are able to form their own opinions upon the therapeutic value of the product in question. One must always bear in mind that the primary obligation of the pharmaceutical industry, with regard to promotion, is to enable physicians and, with regard to products sold without prescription, to enable pharmacists, in particular, to choose the most appropriate drug by providing them with thorough and pertinent information in a meticulously accurate, objective and detailed manner. 3.3.2 The statistical significance of utilized data must be clearly indicated. The design and interpretation of certain studies may be flawed. Care must be taken to avoid using such data. 3.3.3 Misleading or unverifiable, invalid data may not be utilized in promotions. The following instances fall within the scope of misleading promotion: a) Insinuating that the drugs possess therapeutic and other biological properties which have not been substantiated, b) Giving the impression that treatment with the drug will provide definitive results or that its normal or long term use will not cause any harmful effects, c) Providing information on the drug’s composition and its other pharmaceutical properties that may be misinterpreted, d) Providing false and/or misleading information on the manufacturer of the drug and the its employees, e) Issuing data from in vitro tests and in vivo animal experiments without explicitly stating this, giving rise to misunderstandings and erroneous interpretations that these have been obtained from experiments on humans, f) Using the gravimetric activity of drugs as an indication of potency and efficacy, thereby making misleading comparisons, g) Making price comparisons of different drugs including pharmaceutical equivalents of the same drug, based on a single pharmaceutical form or price per box without taking into account the price of the daily dose or of the total dose used during the treatment, h) Making absolute and definitive statements citing a scientifically inadequate study that is based on an insufficient sampling size and lacking in investigative detail. 3.3.4 If studies cited in the promotion of a product were not conducted using that particular product, claims may not be associated with a commercial product brand, but rather, with the name of the molecule. 3.3.5 All data used in the promotion must be accurate and verifiable; evidence must be available to be presented upon request; exaggerated claims exceeding the boundaries of scientific evidence must be avoided at all times. 3.4. Comparative Promotion 3.4.1 Product comparisons must conform to the latest scientific data and publications and must be executed in an honest, verifiable, objective and balanced manner. 3.4.2 In the promotion of pharmaceuticals, one may not issue derogatory statements, either directly or indirectly, regarding the products of other companies by specifying the active ingredient or commercial name; one may not engage in promotion by vilifying another product. Comparisons may not involve commercial names. 3.4.3 One may not engage in exaggerated or all-inclusive assertions and, with the exception of clearly and thoroughly proven characteristics, superlative adjectives (such as best, most reliable, most effective, excellent, etc.) may not be used. If there is any mention of an innovation, the innovative feature, whether it is a new dosage, a new strength, a new preparation of a known drug or whether it is indeed a new drug, must be clearly specified. If a period of 12 months has elapsed, following the approval of the ‘innovative’ feature in Turkey, promotional materials may not use the term ‘new’ in reference to the drug. In the promotion of the drug, the term “reliable” may not be used instead of the term “safe”. The term “reliable” may only be used in necessary instances when it is backed by sufficient and valid medical evidence and the context in which it is “reliable” is specified; otherwise, the use of this term shall be considered as misleading. Statements claiming that a product carries no side effects, toxicity or risk of addiction may not be made. 3.4.4 A product may not be promoted based on the specification that it has received approval from foreign national or international organizations such as FDA, EMEA, etc. 4. PROMOTIONAL MATERIALS Promotional materials comprise (i) Printed promotional materials, (ii) Product samples and (iii) Reminder promotional materials which are not printed. Although bags and educational materials are not considered promotional materials, they have been placed in this subsection for traditional reasons. 4.1 Printed Promotional Materials: Printed promotional materials include (i) printed materials such as brochures or similar full advertisements which make claims regarding the use of the product and which contain comprehensive information, and (ii) printed promotional material or advertisements which are abbreviated. Printed promotional materials should be legible. Information pertaining to products must comply with the general rules specified in Section 2 of this Code and the special provisions set forth in Section 3.2 and not fall in conflict with the summary of product characteristics (SPC) and product leaflet approved by the Ministry of Health. Full or abbreviated advertisements cannot be published in periodicals or newspapers except for those clearly indicating that they are addressing physicians and/or dentists and/or pharmacists and scientific and/or vocational content journals registered in accordance with the legal legislations pertaining to press and publications. The provisions of Section 4.1.3.2 shall remain reserved. In addition to the information explained in detail below, printed promotional materials shall also bear the class of presentation, the date of preparation of the material or its last update as well as the code distinguishing the material. 4.1.1 Printed promotional materials bearing a claim or encompassing integrated information: If printed promotional materials present a claim pertaining to the use of the drug or are in the form of an advertisement (full advertisement) published in a periodical with the abovementioned characteristics, they shall contain the following information: • Commercial name of the drug, • Name of the active substance(s), or its INNs (International Nonproprietary Names) or approved generic names, • Amount per dosage of the active substances in its composition, • Therapeutical (pharmacological) class or, where available, subclass of the drug. • At least one approved indication, (The specification of all indication would be preferred. However, in some cases, only the indication being promoted may be mentioned. In such a case, the following information should be provided with this indication.) • Mode of utilization and dosage, • Major side effects, • Major interactions, • Contra-indications, warnings, cases where precaution is required, • Method of administration, • Registration/permit date and number • Name and address of manufacturing or distributing company, • The statement, “Consult our company for further information”, • Legal category (such as narcotics or other drugs under control, prescription or non-prescription drugs). • Price and date of approval • Code and/or publication date of the printed promotional material (month and year) (Printed promotional material in the form of a loose insert, placed inside a journal, should contain a separate number or date because it may not be regarded as part of that journal.) The information indicated above shall comply with the information in the product leaflet of the drug product being promoted. Quotations, tables and other visual materials taken from medical journals or other scientific studies other than the patient leaflet may be used upon sticking to the original text and specifying exactly the reference on the footnote. In the event that the drug product investigated in these references is different than the product which is promoted, or if the generic (INN) name of the drug has been used in the reference, these should be specified and these data should not be presented upon substituting the name of the drug product which is promoted or adding the commercial name after the generic name. If the quotations, tables and graphics mentioned above have not been used exactly in the same manner and have been adapted, this should be clearly specified. When being adapted, the vertical/horizontal axis and columns/line explanations, number of subjects, where available, and the rate of statistical significance should be clearly specified and the figures should not be distorted. The claims used in medical journals or scientific studies upon making references, must comply with the comment of the researcher/author. Furthermore, the use obsolete and invalid claims shall be regarded as the violation of the code. 4.1.2 Abbreviated Printed Promotional Materials and Abbreviated Advertisements: Abbreviated printed promotional materials and abbreviated advertisements are short advertisement containing only the indications to designate the therapeutic category of the product and which do not contain any claim, yet present brief information regarding the product. They shall only contain the following information: a) Commercial name of the drug, b) Generic names of the active substances, c) Name and address of the manufacturers, importer or registration holder, d) The statement “Consult our company for further information” intended to the prescriber. 4.1.3 Other Provisions: 4.1.3.1 No pharmaceutical advertisement shall be published in journals other than medical journals with scientific and/or professional content, intended for physicians, dentists and pharmacists and the journals bearing the statement “To be distributed solely to physicians/dentists or pharmacists”. 4.1.3.2 Advertisements for drugs may be given out upon obtaining a permission from the Ministry of Health, only as specified in the relevant laws and regulations. However, this advertisement shall not include any pictures or visuals. 4.1.3.3 If the printed promotional material is related with published studies, these shall be clearly indicated as reference (author, title, volume, page number and year). Quotations from medical literature of personal statements, shall not modify nor distort the meaning intended by the author, clinical researcher or the study or investigation taken as reference. Congress paper abstracts may be used as reference for a maximum period of 2 years pursuant to their publication date. If any citation is made on data on file in the printed promotional material, these should be forthwith available in case of request by healthcare professionals. 4.1.3.4. The distribution frequency and volume of printed promotional materials to healthcare professionals shall be conducted at a reasonable level. Due respect shall be paid to the requests of physicians for omitting their name from the distribution list for promotional materials; however, the full mailing list should be preserved for the procurement of vital information to all physicians in cases of adverse reactions, warnings and precautions. 4.2 Samples Samples may be provided with due compliance to the restrictions set forth by the Ministry and the abovementioned conditions, only to prescribing physicians and to dentists only for drugs used in dentistry, as well as pharmacists, for the purpose of enabling them to get acquainted to the new products and/or gain experience in their professional activities or upon their request, by condition that it is clearly indicated that they are samples. 4.2.1. The registration holder companies shall establish an adequate registration and control system and designate responsible persons for the manufacture, importation and distribution of free product samples to be transmitted and documented to the authorities of the Ministry upon request. 4.2.2. Each sample shall be smaller than the smallest presentation in the market. However, the condition of reduced presentation shall not apply on the samples of products which cannot be reduced due to their pharmaceutical form (for instance, single vial or flacon pack, infusion solution, small volume drops. 4.2.3. The packages of reduced drug samples to be distributed shall comply with the principles set forth by the Ministry of Health and as they are not intended for resale, they shall bear the statement “free promotional sample, not for sale” in a legible manner. 4.2.4. The promotional samples shall be presented with the relevant SPC. 4.2.5. No sample distribution shall be conducted for drugs comprised by red and green prescription and drugs containing other active substances subject to control. 4.2.6. Samples may be directly delivered to healthcare professionals or persons authorized to receive them. 4.3 Reminder Promotional Materials Other Than Printed Materials The reminder promotional materials, other than printed materials, intended for the promoting the drug, shall comply with the following features: 4.3.1. Such type of materials shall suit the professional level of the receiver and remain within modest limits with an indicated financial value. They shall not be of low quality, disparaging or repugnant or conceal or divert the intention of distribution. These materials and their financial limits have been indicated in Annex III. 4.3.2. Small gifts to be distributed shall be designed in such a manner so as to not be used in public places, and assist in the professional practice of the recipients. Such materials may only bear the commercial name of the drug, the name of the active substance and the name of the manufacturing and/or importing company. 4.3.3. They shall not carry the characteristic of being used in public places, in particular, except for healthcare institutes, institutions or areas where drugs are kept and in private area of the recipient. 4.3.4 In the promotion of medical products to healthcare professionals, these shall not be offered nor promised any pecuniary advantage or benefit in kind to these persons, except for the gifts defined in Article 4.3.1, for the prescription, procurement, enable the use of and recommend a drug. Donations performed in due compliance with laws and regulations, shall not be regarded as gifts. 4.3.5 Creams and similar cosmetic products, which may be utilized during the execution of the profession of a healthcare professional or for hygienic purposes can be used as reminder promotional materials at retail package size. However, the reminder information presented on them shall not be in a form, which may result in the perception of the cream, tissue and similar products as a drug. Furthermore, a clear statement shall be presented on the product, indicating that it does not contain any drug and is a promotional material. 4.3.6. Paper tissues, towels and covers for professional use, to be disposed upon utilization, may also be used as reminder promotional materials. 4.4 Bags Packaging materials used for carrying the drug purchased at pharmacies (bags, wrapping papers, etc.) may only be allowed to carry the company logo. As non-reimbursed non-prescription drugs are allowed to be promoted to the public, the following may be presented with regard to these products, provided that “they are affiliated with only one drug”; • Commercial name of the drug, • Active substance(s), • Name of company. Besides for this information, no other statement or claim or picture or figure specifying the indication of the drugs or used for promotional purposes shall be included. Provided that they are actually educational in nature, textbooks, reference books, similar materials in electronic media and other education materials may be procured or distributed upon drawing where they may not be procured in sufficient amount. 5. MEDICAL SALES REPRESENTATIVES 5.1 Training and Responsibilities Medical sales representatives shall receive adequate training and equipped with sufficient medical and technical information for properly presenting the information pertaining to the products of the company, with the acknowledgement of the responsibility they are carrying, in line with the promotional ethics. Company personnel associated with promotional topics such as the preparation of promotional materials, their approval, transfer of information to healthcare professionals and notification of healthcare authorities, shall be adequately trained with regard to the conditions and requirements of this Code and the relevant Regulation. Education-steering materials shall not induce directly or indirectly any act which may result in the violation of the Code. Furthermore, any information pertaining to product usafe, obtained from medical or relevant professionals they are in contact with and especially about adverse effects shall be communicated to the company. 5.2 Responsibilities of Companies Pharmaceutical companies shall be responsible for the violation of the promotion code to arise from the erroneous transmission or misinterpretation of the information pertaining to the promoted drug, by medical representatives and for their correction. 5.3 Scientific Service and Duties The registration holder shall establish a Scientific Service in his/her company, to work in line with the principles set forth below, to be responsible for the medicinal products introduced into the market. A person responsible for such activities shall be appointed. The Scientific Service shall ensure the compliance of the promotion of medicinal products the registrations of which are held by the company, to the conditions set forth in the Regulation and Code. The Scientific Service shall prove and document that the medical sales representatives employed by the company have received sufficient training, regularly receive updated information and fulfill the responsibilities expected from them. The Scientific Service Responsible shall procure to the Ministry, upon request, any type of information and document required, concerning promotional activities. He/she shall ensure the forthwith and full implementation of the decisions taken by the Ministry on the promotion of medicinal products for human use. Before the implementation of the promotional activities, the application indicating the target group and the first date of announcement of the promotion shall be presented to the Ministry. Samples of all promotional materials, which are planned to be used, shall be retained for at least five years to be presented to the Ministry, upon request. 5.4 Internal Approval Process of Promotional Materials and Activities The Scientific Service Responsible shall not permit the use of promotional materials not approved in line with this article, on behalf of the company. No changes may be performed on the approved final form. Not only promotional materials, but all promotional activities, including meetings, need to be approved. Materials which are continuously used, shall undergo a re-approval process at least once every two years in order to confirm their compliance of their content with the Regulation and Code. 5.5 Ethical Rules to be Abided By Sales Representatives 5.5.1. Sales representatives shall act in conformity and pay due respect to ethical criteria and deontology in each phase of their duties. 5.5.2. Accurate and demonstrable information shall be transmitted during promotional activities, in the presentation of printed promotional materials as well as verbal promotion. 5.5.3. Sales representatives shall not make comparisons, which are unfair or misleading or indicate a therapeutical superiority that has not been proven yet. 5.5.4. Sales representatives shall be liable for complying with the conservation conditions of the medical products they are responsible for and taking the necessary precautions for the purpose of fulfilling these conditions. 5.5.5. Sales representatives shall not propose any financial or other type of inducement to physicians, dentists or healthcare authorities, for the purpose of influencing them in an acceptable manner. 5.5.6 Sales representatives shall avoid direct contact with the patients. 6.CONGRESSES, SYMPOSIA AND OTHER VERBAL COMMUNICATION TOOLS 6.1 Objectives 6.1.1 Scientific and educational activities pertaining to pharmaceutical promotion shall not be used for purposes other than transmitting the current information and presenting new information. 6.1.2. Symposia, congresses and similar events are indispensable media for enabling the dissemination of information and experience. When organizing such meetings, the scientific objectives shall be kept primarily on the forefront and the factors of entertainment and hospitality shall be secondary to the scientific objectives. 6.1.3 Companies shall not provide hospitality to healthcare professionals, except for organizations such as scientific meetings, promotional meetings, scientific congresses and similar meetings. 6.1.4 No payment shall be made for compensating the time spent by healthcare professionals for attending a conference or meeting. Similarly, no fee shall be proposed or paid to healthcare professionals for the call. 6.1.5 National regulations or guidelines shall always be observed. During the preparation of the promotional materials to be used in symposia and congresses, companies shall be responsible for verifying their adequacy to these guidelines and other arrangements. 6.1.6 With regard to products which have not obtained a registration in Turkey or in the country where the meeting is held, it shall be unnecessary to prepare a full list of countries where it is available. In explanatory texts, major industrialized countries where the product is available (USA, European Community, Japan) may be specified and its non-availability in Turkey should be emphasized. 6.2 Sponsorship Registration holders may organize congresses, symposia, scientific, educational meetings, which would be useful for the communication and discussion of information or they may provide scientific/financial contribution to such activities. Such meetings shall be conducted in suitable locations, in an adequate manner and level. Activities such as congresses, symposia, seminars and similar activities to be held or supported throughout the year shall be communicated to the Ministry during the previous year, in the form of an annual program; any changes to be carried on the program shall be communicated to the Ministry before the event. Only healthcare professional may be invited to such meetings. The lists of participants of such meetings as well as copies of the information and documents presented to the participants shall be retained for being submitted to the Ministry upon request. When pharmaceutical companies assume the sponsorship of a symposium, congress or other medical/healthcare or training program. 6.2.1 The sponsorship of the pharmaceutical company shall be priorly and adequately communicated to the Ministry of Health, in accordance with the Promotion Regulation of the Ministry and this shall be clearly specified during the meeting or in the proceedings. The printed, audio-visual or computerized materials should reflect flawlessly the presentations made during the meeting and the discussions. 6.2.2 The entertainment to be provided to the physicians, dentists and pharmacists, hospitality services or the promotional materials other than printed materials which will be distributed, shall be secondary to the purpose of the meeting. 6.2.3 Registration holders shall not provide any financial contribution to any person for participation, except for the registration holders, those presenting a scientific study such as communiqués, publications, posters and persons attending the meeting for training purposes. 6.2.4 The travel and accommodation expenses of these persons may be covered and the speakers may receive an “honorarium”. 6.2.5 Any support to be provided with regard to the participation of healthcare service personnel to these meetings shall never be bound to a prerequisite – for instance, specific prescription of a product by a physician. 6.2.6 If the program, meeting or symposium is being accredited by a medical or other professional organization, its content shall be under the responsibility of the organization conducting the accreditation and the support of the pharmaceutical industry shall absolutely be emphasized. 6.2.7 It is customary and adequate to cover the expenses such as awards and the travel costs of the speakers/presenters. 6.2.8 Companies shall not cover the travel costs of the persons accompanying the speakers/presenters or physicians who have been invited to the meeting (for instance, spouses). 6.3 Use of Promotional Materials in International Congresses and Symposia The promotional materials available on the booths set up in international congresses or symposia or distributed to the participants, may belong to products which have not been registered in Turkey or have been registered under different conditions, provided that the following rules are complied with: • The meeting shall be fully international in nature and comprise scientific events and sessions where speakers and participants from abroad are assuming a major role. • In places where the promotional materials of products not registered in Turkey are being distributed, a written explanation should be available, stating that the product is not registered in Turkey. A booth may be set up for the promotion of the product, based on this condition; however, the samples of the products may not be distributed to the participants. 7. HOSPITALITY Financial or any other type of benefit, including hospitality at an inadequate degree, shall not be provided to the healthcare professionals, for the purpose of influencing their prescription of drug products. No hospitality and financial benefit shall be procured on the basis of the previous performance of the physician. No support shall be provided for the participation of spouses to congresses, symposia and similar promotional meetings. 8. PROMOTION THROUGH AUDIO-VISUAL MEANS AND E-MAILS The promotional information to be provided by use of these media, shall comply with the general rules specified in Section I of the Code and the special provisions indicated in Section II, and should also adhere with the conditions stipulated for printed promotional materials. Abbreviated product information may not be provided, by condition that the full product information is presented to the persons to whom the promotion is addressed. 9. SANCTIONS The complaints to be presented with regard to the companies not complying with the IEIS Code for Promotion of Medicinal Products shall be evaluated by the IEIS Code of Promotion Inspection Committee. This evaluation shall be referred to the Supervisory Committee with the adequate view of the Board of Directors and the following sanctions shall be applied. Furthermore, the relevant company may be asked to send a letter of apology/correction to the target physicians and/or this may be published on the publications of the relevant company and on IEIS web page. Unnecessary and malicious complaints, especially unsubstantiated complaints targeting a specific product, where unrealistic claims are raised and the company presenting the claim is regarded to be unjust, the company presenting the claim may be subjected to the sanctions foreseen in the Code. Table on the Sanctions To Be Applied in Relation With Complaints:
*WITHIN A
PERIOD OF 12 MONTHS
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