Transcription

1 øçñîä úåëùì ãåâéà ìàøùé ìù íé ñòä ïåâøà çåúéôå ø çîá úå ñåòä úåôåøúä úåøáç ïåâøà The Joint Ethical Convention Of The Israel Medical Association And Pharmaceutical Companies Operating in Israel October 2004

2 Table of Contents The Joint Ethical Convention...3 Code of Ethics Of the Israel Medical Association...6 General...8 Conventions and In-Service Training...9 Gifts and Benefits...12 Research...14 Transparency in Advertising...19 Appendix A...20 Appendix B...22 Code of Ethics of the Pharmaceutical Companies Operating in Israel...26 Introduction...27 Implementation of the Code...29 Commitment of Industry...30 Rules of Ethics (Code) of Marketing Pharmaceutical Products...31 Translated and Edited by Pharma Israel

3 The Joint Ethical Convention The Joint Ethical Convention Of the Israel Medical Association And The Representative Organizations of Pharmaceutical Companies Operating in Israel In recent years, the traditional and long-standing relations between physicians and pharmaceutical companies have undergone dramatic changes, creating a complex reality and presenting all those involved with new questions that demand clear answers. While it is understood that these relations are important for promoting public health, individual well-being and extending life expectancy, they also raise complex ethical and moral issues. The traditional role of the physician is gradually expanding. Apart from being, first and foremost, a faithful and devoted carer for his patients, he is often becoming partner in medical research. The financial means required today in order to develop a new drug, innovative technology or advanced medical instrument are so substantial that the chances of raising them without recourse to commercial companies are negligible. Given this economic reality, physicians, hospitals and prestigious research institutions are cooperating with the pharmaceutical industry and with start-up companies in order to advance the level of medicine and clinical research in Israel. Given the sensitive nature of these relations, we must protect the health of patients and their confidence in a working environment in which commercial considerations might conceivably blur medical truth and impair medical decisions due to foreign interests. With the intention of preserving and cultivating the relations between physicians and pharmaceutical companies, the Israel Medical Association published rules insuring a balance between the various relevant interests, while maintaining maximum transparency and integrity of all those involved in these relations. For their part, and as a reflection of their commitment to public health, the pharmaceutical companies undertook a commitment and responsibility to provide accurate information to all suppliers of medical services, and to promote their sales while adhering to high ethical 3

4 standards. These companies operate within the framework of the international and Israeli ethical rules as published in recent years. In order to maintain public confidence in the relations between physicians and pharmaceutical companies, the Israel Medical Association and the representative organizations of the pharmaceutical companies operating in Israel initiated the publication of this joint convention. For the first time, this convention brings together the ethical rules of the Israel Medical Association regarding the relations between physicians and pharmaceutical companies and the joint ethical marketing code of the pharmaceutical companies. The basic principles underlying this convention are founded above all on concern for patients and on protecting their health and their right to reliable information concerning their treatment. The covenant also maintains the professional independence of physicians, insisting on clear ethical rules in the relations with pharmaceutical companies while maintaining proper rules of marketing and publishing by the companies themselves. The convention also recognizes and reflects the contribution of the pharmaceutical companies to the level of medicine and medical research in Israel. We are confident that The Joint Code of Ethics, which has also been signed by the HMOs, will help promote health policy in Israel and improve public health through transparency and constant review. Witnessed by our signatures: Dr. Yoram Blachar President, Israel Medical Association Prof. Avinoam Reches Chairman, IMA Ethics Committee Mr. Tomer Feffer Secretary General, Pharma-Israel Mr. Yossi Arie Director, The Chemical, Pharmaceutical & Environmental Society of the Manufacturers Association of Israel 4

5 Ms. Roni Reiber Director Health Sectors,, The Federation of Israeli Chambers of Commerce Dr. Nicky Liebermann Head of the Community Medicine Division. Clalit Health Services Prof. Menachem Fainaro Head of Health Division, Maccabi Healthcare Services Dr. Zeev Aharonson Director, Medical Division, Meuchedet HMO Dr. Avraham Meidan Deputy Director-General, Medicine, Leumit HMO 5

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7 Code of Ethics Of The Israel Medical Association Regarding Relations between Physicians and Commercial Companies Medical Policy Division Legal Department Bureau of Ethics

8 General 1. The medical community is committed to providing optimum care and service at the highest quality as customary in the State of Israel. 2. The physician will provide care in accordance with his/her best professional judgment regarding and relative to a given patient. 3. The relations between physicians and commercial companies engaged in the development and distribution of medical technologies (drugs, medical instruments, etc.) constitute an integral part of the provision of medical care and service, and are vital to the development and advancement of medicine and research. 4. The Israel Medical Association has formulated these rules regarding the overall relations between physicians and commercial companies. 5. For the purpose of providing an ongoing response on these matters, a committee has been appointed by the Forum for the Examination of Relations between Physicians and Commercial Companies in the Israel Medical Association, headed by Dr. Nili Peilan-Remo. The committee is based at the IMA offices and may be contacted through the committee coordinator, Attorney Rachel Nisanholz-Gannot, on telephone: , fax: , and by rachel@ima.org.il. 6. The above-mentioned committee may be contacted on any matter not addressed in these rules and/or on which additional clarifications are required. 8

9 Conventions and In-Service Training 1. A physician participating in the convention of an international scientific body funded entirely or partly by a commercial company will comply with the following rules: A. No direct contact will take place between the physician and the funding company. Payment for the convention will be executed through the employer. B. Those invited to participate in the convention will be the relevant employer or association or scientific society, and not the physician directly or on any personal basis. The IMA recommends that within each association, an inservice training committee be established to insure the implementation of the guidelines of the IMA steering committee regarding the relations between physicians and commercial companies. C. A physician shall not participate in a convention and/or in-service training program that is not devoted in its overwhelming part to the sphere of medicine. In each case, the balance of the scientific aspect of the convention or in-service training program, and its social aspect, will be examined. 2. An association or scientific society organizing a scientific convention and interested in funding from a commercial company will contact several commercial companies/bodies. 3. Notwithstanding the content of para. 2 above, in certain circumstances, and at the discretion of the association or scientific society, it is possible to contact a single company for the purpose of funding the convention, provided that authorization therefore is obtained from the IMA Bureau of Ethics. 9

10 4. A. The right and responsibility to determine the scientific content of a convention organized by an association or scientific society shall rest solely with the association or scientific society. B. In presenting medical technology at a scientific convention, the physician will present a balanced picture and review the range of possible treatments. C. The association will publish in the booklet of abstracts ahead of the convention, or in any other place at its discretion, the list of companies sponsoring the convention. 5. An association or scientific society interested in sending representatives on its behalf or under its auspices to a scientific convention will do so in accordance with predetermined criteria published among the members of the association or the scientific society. 6. Relatives and/or other persons accompanying the physician to the scientific convention shall pay the additional cost in full. 7. A physician who attends a scientific convention on behalf of the association or the scientific society, or on behalf of the employer, will submit a detailed report on the content of the convention to the sending body within one month from his/her return. 8. A product and/or new technology may be presented at a scientific convention of an association, scientific society or any other body at the discretion of the organizers of the convention. When presenting the medical product or instrument (hereinafter the product ), whether physically or through informative material, the regulatory status of the product, such as its registration in the Registry of Products, indications, warnings and restrictions must be presented. 10

11 9. A physician invited to give a lecture at a scientific convention will act in accordance with optimum professional, scientific and ethical considerations and in accordance with the legal prohibitions regarding advertising. 11

12 Gifts and Benefits 1. A. A physician will not accept a gift, even of marginal value, for prescribing a drug or for referral for a test. B. A physician will not condition the use of a given technology on the granting of a benefit. 2. A physician will not accept drugs in commercial quantities, with the exception of a small number of packets of drugs such as it is customary and accepted to give to physicians, and which shall be labeled Physicians Sample Only. 3. A physician will not accept a gift of money or equivalent, such as: vacation tickets, shopping vouchers, etc. 4. It is permitted to accept a gift that is relevant to the physician s work and which is given as a gesture of politeness or for the purpose of giving information, if it has marginal financial value, such as: office equipment, signs, anatomical posters, etc., and which does not constitute remuneration for prescribing a drug, for referral, etc. 5. It is permissible to accept a gift of considerable value, such as a lap-top computer, digital camera, computer, expensive professional literature, etc., solely if this was given to the ward/clinic for the purpose of advancing medical research, and it shall constitute part of the registered stock of the ward/clinic. 6. A. A physician will not maintain a register of clinical or other data for a commercial body for remuneration and/or indemnification and/or on the promise thereof, except within the framework and with the knowledge of the association / scientific society and/or his/her employer. B. Notwithstanding the above, if the research is undertaken in cooperation with an institution or association / scientific society, and within this 12

13 framework there is an undertaking on the part of the body funding the research to indemnify or compensate the institution and/or any person on its behalf in the event of damage or in another case, this shall be permitted. 13

14 Research A physician or association will be able to participate in research funded by a commercial company subject to any law and to the following rules: 1. The researching physician will act in accordance with professional discretion and from the perspective of the good of the patient. The physician will be subject to the rules of ethics and to any law in this matter. 2. A medical trial in humans is the use of a drug, radiation or chemical, biological, radiological or pharmacological substance in contradiction to the authorization granted in accordance with an act of legislation, or when the said use is not customary or has not yet been tried in Israel and is liable to affect the health of an individual. A special medical trial also includes a trial whose principal goal is to examine the efficiency of a medical product relative to the indication, to the form of delivery and to the recommended dose. 3. A medical trial in humans requires receipt of final authorization for the implementation of research signed by the director-general of the medical institution at which the trial takes place. The authorization is granted after the chief researcher has met the requirements of the institutional Helsinki Committee and of the Ministry of Health (including an informed consent form). The authorization is granted to the chief researcher and the medical institution specified therein, and may not be transferred. 4. An authorized physician (MD) is entitled to submit an application to his/her institutional Helsinki Committee and is entitled to undertake a medical trial and to serve as its chief researcher. Any correspondence between a commercial company and the Helsinki Committee must take place through the chief researcher responsible for the research. 14

15 5. A physician, association or scientific society is entitled to participate in research initiated and funded by a commercial company. A physician or association that wishes to initiate research will contact several commercial companies for the purpose of securing sponsorship for the research. It is, however, possible, due to considerations of the physician or the association, to contact a single company. 6. A physician, association or scientific society are entitled to accept remuneration in consideration for conducting the research, provided that the remuneration shall be financial and completely independent of the outcomes of the research. 7. Remuneration on account of research will be forwarded to the researcher via the institution in which he/she works or through the scientific association. A physician conducting research privately may receive remuneration on account of his/her investment subject to any law and to the content of these rules. 8. A grant for the purpose of a trial will be given to the research physician in the form of a research grant or the allocation of drugs and/or medical equipment for the purpose of the trial. 9. A. A physician who has an economic interest in a commercial company, or whose relative has such an interest, and regarding whom there is concern of a possible conflict of interests, will refrain from participating in research sponsored by that company, whether he/she is conducting the research, is a partner in the research work or is writing an article relating directly or indirectly to the company, unless he/she has received prior authorization before beginning the research, and that he/she notes his/her economic interest in the company in the publication of the outcomes of the research. B. In this section, close financial interest means the possession, directly or through a spouse or a descendant, of the securities of a company and/or a corporation associated with the company in the rate of five percent or a 15

16 lower significant rate, and/or a person entitled to appoint a director in a company or a corporation associated with the company. In this section, relative means a spouse, brother or sister, parent, grandparent, descendant or descendant of a spouse, or the spouse of any of the above. Independence of the Physician Researcher in Conducting and Publishing Research 1. Physician researchers must be independent in conducting and publishing their research. 2. No agreement is to be signed with a commercial company restricting the independence of the researchers in conducting the research and in publishing the outcomes, including: an agreement preventing the researchers from examining data independently and/or from submitting the article for publication without the consent of the funding company. Any agreement restricting the independence of the researchers is liable to suggest a prima facie conflict of interests. 3. The authors of an article and/or the executors of a research/trial are required to reveal details regarding their functions and the function of the funding company in planning and designing the research and in collecting, processing and publishing data. Many editors require authors to sign a declaration that they (the authors) take full responsibility for the execution of the research, that they enjoyed access to data, and that the decisions regarding the publication of the research was theirs and not that of the funding company. 4. The funding company is to be permitted a limited period of time (30-60 days) to review the article prior to its publication in order to enable it to file a patent application or an application for the extension of a patent, if necessary. 16

17 5. No research information liable to violate the personal privacy or medical confidentiality of patients shall be published. Research information the publication of which involves patent rights shall be published in such manner as to avoid violating such rights. 6. If some of the authors of the article are employed by the funding company, their contribution to the research is to be published, and, in any case, the company shall not refrain from publishing the outcomes of research in full, including data injurious to its goals. 7. The authors of a medical research article will hold the copyright to the article, and not the funding company. 8. The funding company will enable the researchers to express their opinion on all matters relating to the planning of the research, and will allow them access to raw data, responsibility for processing information, etc. 9. Maximum transparency is to be insured in any publication. 10. In publishing the outcomes of the research, the name of the body granting sponsorship and of the initiator of the research shall be published. If the outcomes of the research are connected with the brand name of a particular product, the name of the product will be published in addition to the generic name. 11. The author of any article or letter must reveal to the editor of the journal details relating to his/her economic and/or personal relations with the funding company liable to influence his/her work. If there are no such relations, this is to be noted. The editor must publish such conflicts of interest in any case. 12. Each researcher must reveal to the participants in clinical research any existing relations between himself/herself and the funding source of the research, and must declare in the article whether he/she has done so. 17

18 13. The editors of medical journals must refrain from selecting external reviewers who have a conflict of interest regarding the subject of the review. 14. Reviewers must reveal to the editors any conflict of interest and, in appropriate cases, must even disqualify themselves from reviewing a particular article. The editors must reveal an existing conflict of interest liable to influence the acceptance of a particular article. 18

19 Transparency in Advertising The advertising of commercial products (that are not medical technologies) is prohibited in accordance with the rules of ethics (see the IMA position on publicity and advertising). In the case of medical technologies, the manufacturer has a commercial interest in securing the support of the association or scientific society for its products, since this bestows the product professional credibility. An association or scientific society may participate in publicizing a medical product on these conditions: 1. The publicity relates to a product that has been authorized for marketing in the State of Israel. 2. The publicity was prepared in order to increase health awareness, and shall not include publicity relating to a specific drug, technology or method. 3. The association or scientific society believes that there is scientific proof of the efficacy of the drug and technology, and the matter has been discussed at a meeting of the association s board. 4. The association or scientific society believes that the publicity for the drug or technology will benefit public health. 5. The publicity will state, in as clear a manner as possible, that the funding was given by a commercial company, noting the name of the commercial company. 6. An association may participate in a general advertisement promoting a field of specialization and/or awareness of a particular disease. This publicity may also be funded by a pharmaceutical company, provided that this fact is brought to the attention of the public in the publicity. 19

20 Appendix A The Work of the Forum to Examine the Relations between Physicians and Commercial Companies In 2001, in response to a growing number of questions regarding the relations between physicians and commercial companies in general, and pharmaceutical companies in particular, and following a worldwide increase in interest in this issue, the IMA decided to establish the Forum to Examine the Relations between Physicians and Commercial Companies. Dozens of physicians participated in the Forum, and were divided into working groups to discuss different issues and the questions these issues raise. The issues discussed were: Conventions and in-service training; Gifts and benefits; Research; Advertisements and transparency. Each working group held discussions and reached conclusions on the issues it addressed. These conclusions were forwarded to the Legal Department of the IMA for processing and for the preparation of clear and understandable rules. After each forum had made its comments on the specific rules, a small group of physicians was elected to serve as a standing committee. The function of the committee is to answer specific questions from physicians, commercial companies and others on the question of the relations between physicians and commercial companies, taking into account the legal, ethical and humanitarian aspects of each case. The committee, headed by Dr. Nili Peilan-Remo, has met on several occasions to discuss the rules and examine questions it has received. A legal consultant attends the committee meetings and coordinates its work. 20

21 The revision of the rules, the establishment of the Forum and the appointment of the committee were intended to constitute a key element on this issue, and to enable physicians or associations considering questions in this field to request and receive as comprehensive and clear answer as possible in legal, ethical and humanitarian terms. At present, there is no single body that coordinates all the material and knowledge on this issue. As a result, we learn from the media of physicians who have been prosecuted and politicians who seek to sever the relations with commercial companies (a step that would deal a death blow to research, and severely impair the standard of medicine and medical knowledge). Individual physicians also often face uncertainty when addressing a given situation. We hope that we will be a significant source of assistance for physicians and scientific associations, and will encourage a proper standard of behavior among physicians. We are convinced that these rules will strengthen the relations with commercial companies, and that transparency on this matter will not only be done, but will be seen to be done. 21

22 Appendix B Declaration of the World Medical Association Regarding Relations between Physicians and Commercial Companies The World Medical Association (WMA) is the parent organization of medical associations around the world. The WMA represents some eight million physicians in 78 countries. The WMA was founded on September 18, 1947, following the Second World War. In light of the crimes committed during WWII in the name of medicine, one of the association s goals was to regulate the ethical code of physicians. The World Medical Association addresses issues of health economics, medical ethics and health-related social issues. The WMA s most famous decisions include the Helsinki Declaration, which regulates medical trials on humans; the Tokyo Declaration against human torture; and the Geneva Declaration, which regulates the ethical rules of physicians. The organization meets twice a year: the general convention is held in September, while in May the council meets, comprised of representatives from the WMA s six regions (Africa, Asia, Europe, Latin America, North America and the Pacific region). At the last convention of the WMA in May 2003, the Chairperson of the IMA, Dr. Yoram Blachar, was elected chairperson of the council the most important executive position in the organization. The Israel Medical Association has been an active member of the WMA for many years. Prior to Dr. Blachar's election as chairperson of the council, he served as chairperson of various committees in the WMA. The IMA also initiated various declarations, such as the child s right to medical treatment, which it also helped draft. 22

23 Another declaration proposed by the IMA is now on the agenda of the WMA. Titled WMA Declaration regarding Relations between Physicians and Commercial Companies, the declaration was drafted by the IMA s legal department, based on the IMA s existing rules on this matter, the disc ussions and conclusions of the Forum to Examine the Relations between Physicians and Commercial Companies, and guidelines from various countries and from organizations around the world. The declaration relates to rules concerning conventions, gifts and research funded by commercial companies. We believe that the World Medical Associ ation is the most appropriate body to establish guidelines and standards regarding the WMA Declaration regarding Relations between Physicians and Commercial Companies even more so than domestic legislation. The reason for this is that the WMA sets ethical standards for physicians throughout the world, and organizes international conventions providing an opportunity for encounters between physicians from different countries. The declaration was sent to the secretariat of the WMA, which discussed it in the Medical Ethics committee meetings during the council s convention in May After preliminary discussions in the council, the declaration was sent to all the members of the WMA for comments, which were then discussed at the WMA s general convention in October Some of the comments requested minor changes in wording, but others reflected differences of principles relating to certain sections. For example, some countries felt that physicians should not accept any gifts from pharmaceutical companies, while others believed that they should be permitted to receive gifts of marginal value. Discussion also focused on the structure of the declaration: given cultural and other differences, some countries felt that it would be preferable to establish general guidelines, while the details would be determined by each individual country. However, there was universal agreement that the declaration was important and was acceptable to everyone with the required changes, and that it could be adopted after amendment. 23

24 Following the discussion, the IMA amended the declaration and re-submitted it to the secretariat of the WMA, which distributed it among its members for further comments. The declaration was raised for another discussion at the convention of the council in May 2003, which discussed the controversial sections. It was decided to establish a work group comprising of IMA and the medical associations of Canada, Japan and Finland. This committee recently completed its work, and the WMA council subsequently adopted the declaration in a form agreeable to all. The plenum is expected to ratify the declaration in October 2004, thus establishing official guidelines binding on physicians throughout the world. 24

25 øçñîä úåëùì ãåâéà ìàøùé ìù íé ñòä ïåâøà çåúéôå ø çîá úå ñåòä úåôåøúä úåøáç ïåâøà The Marketing Code of Ethics of The Pharmaceutical Companies Operating in Israel

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27 INTRODUCTION The pharmaceutical industry develops, manufactures and promotes the sale of pharmaceuticals intended for the prevention and treatment of illness. As a result of its commitment to improve healthcare, the industry devotes considerable resources to research and development, to make new and more effective medicine available to all persons. In light of this mission, the industry believes that high ethical standards should be defined and respected in all its activities. As an integral part of this responsibility, the pharmaceutical industry and its medical representatives should disseminate complete and truthful medical information to all who practice medicine. So far as marketing activities are concerned, self-discipline will best serve the public interest. Pharmaceutical companies from more than 60 countries around the world are members of the IFPMA (International Federation of Pharmaceutical Manufacturers Association) which is based in Geneva. The Federation has published a binding Code of Ethics, detailing the principles and basic standards required by its members in their marketing procedures. This Code is also consonant with the ethical criteria as defined by the World Health Organization. This code was adapted to meet Israeli conditions and circumstances. Among other changes, the section on medical representatives in clinics and hospitals has been considerably elaborated. In addition, this Code contains a complaint and enforcement mechanism which is open to all the companies and bodies that have signed the joint ethical convention of the Israel Medical Association and the pharmaceutical companies operating in Israel. The Chemical, Pharmaceutical & Environmental Society of the Manufacturers Association of Israel, the Pharmaceutical Branch of the Trade Association and 27

28 Pharma Israel the association of R&D based pharmaceutical companies, have decided, through the adoption of this Code, to establish a mechanism that will ensure the compliance with its rules as a basic duty of each company in its marketing activities. Each company that adopts this Code will give written notification to that effect to the Joint Review Board (see below) and will commit to assimilating the rules of ethics among its employees. The company will be entitled to use the symbol of ethics (see below) on its various documents and publications. 28

29 Implementation of the Code In order to achieve self-discipline, the Code of Ethics details a mechanism for processing complaints of alleged breaches of the Code. Where it is determined that there has been a breach of the Code, this will be corrected as soon as possible in order to prevent the recurrence of a similar breach. The Chemical, Pharmaceutical & Environmental Society of the Manufacturers Association of Israel, the Pharmaceutical Branch of the Trade Association and Pharma Israel believe that being open to receive bona fide complaints from any source signed on this Code on any aspect of the Code provides for more effective operation of the Code, rather than monitoring what would be a very small proportion of advertisements - themselves only a modest proportion of the industry's promotional activities. An important feature of the Code is its universal applicability. It is a requirement that the terms of the Code should apply to any company, whether or not it is a member of the Chemical, Pharmaceutical & Environmental Society of the Manufacturers Association of Israel, the Pharmaceutical Branch of the Trade Association or Pharma Israel. It hardly needs to be added that any of the provisions of the Code of Ethics will be interpreted in a manner that is consonant with the content of any relevant law, regulations or other act of legislation. 29

30 Commitment of Industry The pharmaceutical industry is committed to improving human health through research and development of new medicines and the production and marketing of pharmaceutical products of reliable quality, in accordance with the defined international standards of good practice. As part of their commitment to public health, those involved in the industry accept an obligation and responsibility to provide accurate information and education about their products to health care providers in order to establish a clear understanding of the appropriate use of medicines. Promotional activities (marketing practices) must be consistent with high ethical standards and information should be designed to help health care providers improve services to patients. Information must be presented in an objective and professional manner, and must conform to all relevant laws and regulations. Instructions and explanations for use of the product must be based on valid scientific evidence and include clear statements with respect to contra-indications, warnings, side-effects and necessary precautions. 30

31 Rules of Ethics (Code) of Marketing Pharmaceutical Products I. GENERAL PRINCIPLES 1. Scope of the Code The term pharmaceutical product in this Code means any pharmaceutical or biotechnological product which is intended to be used on the advice of, or under the supervision of a health care professional, and which is intended for use in the diagnosis, treatment or prevention of disease in humans, or to affect the structure or any function of the human body. The promotional activities within the scope of the Code include direct-to-consumer advertising, where this is permitted in domestic law. In all matters of application, interpretation and enforcement of any section of the Code (or its Annexes), the standards established in law, regulations and regulatory decisions are to be followed. 2. Standards of Promotion Promotional material for pharmaceutical products must be accurate and reflect reality. It should be presented in such a way as to conform not only to legal requirements but also to high ethical standards. It must also be presented in a professional manner. Claims should be based on scientific evidence, and every effort should be made to avoid ambiguity. 3. Scientific Evidence Information in promotional material must be based on professional, up-to-date and accurate material, and must not give an incorrect or misleading impression. Information must be based on the physician s leaflet as approved by the Ministry of Health, and/or on up-to-date medical information in accordance with the provisions of the relevant law and the Ministry of Health guidelines. Scientific data to support the claims and recommendations for use should be made available, on request, to healthcare providers. 31

32 4. Safety Data Particular care should be taken that essential information regarding the safety of pharmaceutical products, such as contra-indications, precautions and side effects, is appropriately and consistently communicated, subject to the legal, regulatory and medical practices of each country. The word "safe" should not be used without professional support. 5. Disguised and Misleading Promotion Promotional material, such as advertisements and professional medical journals, must not be such as to disguise its real nature. Post-marketing studies should be conducted on a scientific or professional basis. These studies should not be conducted without a scientific or professional background, even if partial, as a means to promote a product and influence physicians. 6. Pre-Registration Communications No pharmaceutical product shall be promoted for use until the requisite approval for marketing for such use has been given in that country. However, this provision is not intended to abridge the right of the scientific community and the public to be accurately informed concerning scientific and medical progress. Neither is it intended to restrict a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate analysis of research findings in mass media communications, professional literature and at scientific conferences. Nor should it restrict disclosure to stockholders and others concerning any pharmaceutical product as may be required by any law, rule or regulation. 7. Communications to the Public All information provided to the patient by the company must conform to the approved indication, and must be accurate, fair and not misleading. If companies participate in programs to enhance public awareness of diseases in order to meet growing demand for more information and enhance public understanding of disease prevention, signs and symptoms of medical conditions, illnesses, and 32

33 available treatments, such activities must adhere to the highest standards of accuracy in order to support the role of the health care provider. 8. Internal Company Procedures Promotional communications must have regulatory approval or, when appropriate, approval by the responsible person in the company, who shall have appropriate scientific and professional qualifications. Companies should establish and maintain appropriate procedures to ensure full compliance with domestic and international codes and to monitor all their promotional activities and publications. II. MEDICAL REPRESENTATIVES 1. All marketing and sales personnel, including members of staff involved in any way with the preparation or approval of promotional material or of information to be provided to members of the health professions and to appropriate administrative staff, or of information to be provided to the public, must be fully conversant with the relevant laws, regulations and procedures for marketing pharmaceutical products, and with the Code of Ethics and must comply therewith. 2. Medical representatives must pass an internal or external training course in the company, and must have sufficient scientific knowledge to enable them to provide full and accurate information about the medicines they promote. Pharmaceutical companies will issue Medical Representative certificates to candidates who successfully complete the required training. These certificates shall be signed by the company s Medical/Sale Director or General Manager. It will be a condition for granting such a certificate that the representative is conversant with the requirement of this Code. 3. Representatives will at all times maintain a high standard of ethical conduct in the discharge of their duties and must comply with all relevant requirements of the Law in Israel and the Code of Ethics. 4. Representatives will ensure that their visits to physicians for the purpose of marketing any medical product do not inconvenience the physicians with whom they meet. 33

34 5. Representatives will ensure that the privacy of patients is safeguarded, and will not be present in the physician s room during treatment. 6. In an interview, or when seeking an appointment, representatives will make every effort to ensure that they do not mislead as to their identity or that of the company they represent. 7. Representatives shall only deliver information, whether personally or in writing, which can be scientifically validated and which can be provided upon request. Such information can take the form of either published material or data on file. 8. Representatives must provide, or have available to provide if requested, a copy of the physicians leaflet, if any, relating to the medicine they are promoting, as approved by the Ministry of Health. In the absence of such approval, they shall provide the physician with information adapted to the approved indications in Israel, or with up-to-date medical information conforming to relevant legal provisions and Ministry of Health guidelines. 9. Companies are responsible for the activities of their representatives in accordance with this Code of Ethics. III. SYMPOSIA, CONGRESSES AND OTHER MEANS OF VERBAL COMMUNICATION 1. Objectives Symposia, congresses and the like are indispensable for the dissemination of knowledge and experience. Scientific objectives should be the principal focus in arranging such meetings. 2. Sponsorship When a pharmaceutical company or association sponsors a symposium, congress or other medical/health care or educational program, it must act in accordance with the following rules: The fact of sponsorship by the company or association should be clearly stated in advance in the invitations, during the meeting and in any conclusions. Printed, audio-visual or computer-based material arising from such meetings must accurately reflect the presentations and discussions; 34

35 Entertainment or other hospitality and any gifts offered to members of the medical professions should be secondary to the main purpose of the meeting and should be kept to a modest level; Sponsorship or support of the convention is not to be conditioned on any obligation to promote any medicinal product or indication; If the program is accredited for postgraduate medical education by a medical or other professional organization, responsibility for the program remains with the organization responsible for the meeting, and sponsorship should be disclosed; Payments of reasonable honoraria and reimbursement of out-of-pocket expenses, including travel, for speakers/presenters are customary; Pharmaceutical companies will not pay travel costs of persons accompanying physicians. 3. Participation in Seminars, Courses and Scientific Conventions and Travel Abroad A pharmaceutical company may make a financial allocation to the research fund of a professional association or a recognized medical institution in order to support or facilitate participation in seminars, courses and scientific conventions, including overseas scientific conventions. The company may also allocate sums to academic or scientific bodies, including professional unions of the IMA, which organize such conventions, subject to the binding circular of the director-general of the Ministry of Health. Under no circumstances will a company propose to healthcare professionals or to members of their families, direct assistance for the participation in a convention otherwise than through the above-mentioned bodies. Relatives or accompanying persons will pay their own costs. 4. Promotional Material at International Congresses and Symposia Promotional material which appears on exhibition stands or is distributed to participants at international congresses or symposia, and which refers to products which are not registered in Israel, or which are registered in various countries under different conditions, will adhere to the following conditions: Promotional material for products not registered in Israel must include a suitable statement indicating the registration status of the product; 35

36 Promotional material which refers to the prescribing information (indications, warnings etc.,) authorized in other countries differently than in Israel must include an explanatory statement indicating that registration conditions differ internationally. Promotional material for products which are not registered anywhere at the time of the Congress or Symposium, may not be displayed or distributed to participants. Scientific papers on such products may, however, be provided, in accordance with Section I.6 of the Code. IV. HOSPITALITY AND PROMOTIONAL ITEMS 1. Hospitality Financial or material benefits should not be offered to healthcare professionals to influence them in the prescription of pharmaceutical products. This shall not prevent a reasonable level of hospitality. 2. Promotional Items Promotional items of insignificant value, provided free of charge, are permissible as long as they are related to the health care provider's work and/or entail a benefit to patients. 3. Professional Information Reference books of educational value will be given to libraries of hospital departments and community clinics and not directly to healthcare professionals. V. PRINTED PROMOTIONAL MATERIAL 1. General Printed promotional material shall be presented in a clear manner. The scientific basis and presentation of the product information must be in conformity with the general principles set out in Section I of this Code Advertisements All advertisements appearing in print must include: The name of the product (normally the brand name); The active ingredient/s, using an approved name where one exists; The name and address of the company or agent responsible for marketing the product.

37 2.1 Full Advertisements Full advertisements for medical professionals will describe all the properties and characteristics relating to the use of the product, including indications and principal restrictions as noted in the Registry of Pharmaceutical Products. The advertisement will include a referral to the marketing company for additional information. 2.2 Reminder Advertisements In the absence of local regulations, an abbreviated or "reminder" advertisement is defined as a short advertisement containing no more than a simple statement of the approved indications of the product. For reminder advertisements, the requirements of paragraph 2 apply, but the prescribing information required under paragraph 2.1 may be omitted, provided that it is clearly noted that additional information may be obtained from the company on request, and that review of the physician s leaflet is recommended. 3. References When promotional material relates to published studies, a clear reference to these should be given in the printed material. Quotations from medical literature or from personal communications must not change or distort the intended meaning of the author or clinical investigator or the significance of the underlying work or study. 4. Frequency and Volume The frequency and volume of mailings of printed material to the healthcare professionals should be reasonable. Requests by physicians for their names to be removed from mailing lists for promotional material should be respected. VI. AUDIO-VISUAL AND COMPUTER-BASED PROMOTIONAL MATERIAL Promotional information provided using these media must fulfill the relevant requirements for printed material, as set out in Section V. Prescribing information may be omitted provided that complete product information is made available to the public. 37

38 VII. SAMPLES Samples of medical products may be supplied only to those authorized to issue prescriptions, in order to familiarize them with the products, to enable them to gain experience with the product in their practice, or upon request. Samples should not be distributed in commercial quantities. The procedures of the medical institution where the samples are distributed must always be respected. VIII. INTERNET Subject to legal provisions in Israel, the pharmaceutical industry is committed to the IFPMA Code of Ethics, and supports the right to use the Internet as a means of providing accurate and scientifically-reliable information on medicines. Such use must be in a responsible manner, for the benefit of patients, healthcare professionals and other appropriate parties while recognizing that patient safety is of paramount importance. The goal of the Code is to encourage the appropriate use of the Internet. The content of information appearing on the site should conform to the Ministry of Health guidelines. There should be open access to all information appearing on the Internet, while recognizing that there are national differences in the laws and regulations governing the promotion of medicines. Many pharmaceutical companies have established corporate sites on the Internet which provide information about the company. The Chemical, Pharmaceutical & Environmental Society of the Manufacturers Association of Israel, the Pharmaceutical Branch of the Trade Association and Pharma Israel recognize that certain uses of the Internet may fall within the scope of the Code of Pharmaceutical Marketing Practices. The following points concern product-related information: The identity of the pharmaceutical company and of the intended audience should be readily apparent. The content should be appropriate for the intended audience. 38

39 Links should be appropriate and apparent to the intended audience. Country-specific information must comply with local requirements. IX. Symbol of Ethics The Review Board will choose a Symbol of Ethics which will symbolize the company s commitment to uphold the rules of this Code. As stated in the Introduction, a company which endorses the rules of ethics will be entitled to use the symbol of ethics on its various documents and publications as well as distribute it on pins for its employees. 39

40 X. Code of Ethics Review Board Structure and Procedure 1. Composition and responsibilities 1.1 The Code of Ethics Review Board is comprised of five members. 1.2 A retired supreme or district court judge, agreed upon by all members signed on this code, will be the Chairperson of the Code of Ethics Review Board. 1.3 Four additional members agreeable to all three organizations signed on this code will be appointed to the Board. 1.4 The Review Board will be responsible for the application and enforcement of the Code of Ethics, and will be entitled to offer its opinion, at the request of a company signed on this code, on questions relating to the implementation of the ethical code and on the question whether a given action is permitted in light of the provisions of the code. 1.5 The members of the Review Board will be asked to sign a commitment to maintain confidentiality and avoid any conflict of interests. 2. Pre-Ruling The representatives of companies signed on this code shall be entitled to apply to the Review Board to receive an opinion on issues relevant to the Code of Ethics. The request for an opinion shall relate solely to actions not yet executed by the applying company. The Review Board will give its opinion within 30 days. The cost of convening the Review Board will be born by the appellate company or companies, where there are several standing issues. A copy of the decision will be distributed among the organizations 60 days after it is forwarded to the appellate company. If there is disagreement among the members of the Board regarding a requested opinion, both positions of the majority and minority of the Board shall be forwarded. 40