Cámara Argentina de Especialidades Medicinales. (CAEMe)

Transcription

1 Cámara Argentina de Especialidades Medicinales (CAEMe) CODE OF GOOD PHARMACEUTICAL MARKETING PRACTICES AND INTERACTIONS WITH HEALTHCARE PROFESSIONALS REVISION, JUNE 2013

2 TABLE OF CONTENTS Page I. ETHICAL, LEGAL AND REGULATORY FRAMEWORK 3 II. PREAMBLE 3 III. DEFINITIONS 4 IV. PURPOSE OF THE CODE 5 V. SCOPE OF JURISDICTION OF THE CODE 5 VI. RANGE OF ACTIVITIES 5 VII. CODE PROVISIONS 6 1. MARKETING AUTHORIZATION 6 2. PROMOTIONAL MATERIAL TO BE DELIVERED 7 TO HEALTHCARE PROFESSIONALS 3. PROMOTIONAL INFORMATION STANDARDS 8 4. TRANSPARENCY OF PROMOTION 9 5. USE OF REFERENCE QUOTATIONS DISTRIBUTION OF PROMOTIONAL MATERIAL REVIEW OF PROMOTIONAL MATERIAL GIFTS AND PROMOTIONAL ITEMS HOSPITALITY AND MEETINGS VISITS TO PHYSICIANS AND PHARMACIES SAMPLES STUDIES DONATIONS AND GRANTS SERVICES PROVIDED BY ENTITIES COMPOSED OF 18 HEALTHCARE PROFESSIONALS 15. SERVICES PROVIDED BY HEALTHCARE PROFESSIONALS INTERACTIONS WITH PATIENT ORGANIZATIONS RULES OF APPLICATION QUERIES CONTROL OF CODE COMPLIANCE INFRINGEMENTS AND PENALTIES IMPLEMENTATION GUIDES AND COLLABORATION AGREEMENTS DISCLOSURE AND COMPILATION OF RULINGS ENTRY INTO FORCE 24 2

3 I. ETHICAL, LEGAL AND REGULATORY FRAMEWORK 1. The relevant role of codes of ethics developed by the World Medical Association, the International Council of Nurses and the International Federation of Pharmacists. 2. The Ethical Criteria for Medicinal Drug Promotion provided by the World Health Organization in The Ethics Code for the Health Team of Asociación Médica Argentina (Argentine Medical Association) (2001), the Ethics Code of Confederación Médica de Argentina (Argentine Medical Confederation), and the 2002 PhRMA Ethics Code. 4. The IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) Code of Practice, 2006 and 2012 revisions. 5. The Código Español de Buenas Prácticas de Promoción de Medicamentos y de Interrelación de la Industria Farmacéutica con los Profesionales Sanitarios - FARMAINDUSTRIA, 2008 revision (Spanish Code of Good Practices for the Promotion of Medicines and Interaction with Healthcare Professionals). 6. Applicable Argentine laws in force. II. PREAMBLE (i) The ethical promotion of prescription medicines is vital to the pharmaceutical industry s mission of helping patients by discovering, developing and marketing new medicines. Ethical promotion helps to ensure that healthcare professionals and patients have access to information they need and that medicines are prescribed and used so as to provide patients with the maximum healthcare benefits. (ii) CAEMe and its members are committed to educational and promotional efforts that benefit patients and promotional programs and collaborations that enhance the practice of medicine. CAEMe also seeks to preserve the independence of the decisions taken by healthcare professionals in prescribing medicines to patients. The pharmaceutical industry has an obligation and responsibility to provide accurate information and training about its products to healthcare professionals in order to establish a clear understanding of the appropriate use of the medicines prescribed. Industry relationships with healthcare professionals must support, and be consistent with, the professional responsibilities healthcare professionals have towards their patients. Member companies must maintain high ethical standards when conducting promotional activities and comply with applicable legal, regulatory and professional 3

4 requirements. Through the promotion of this Code, CAEMe seeks to ensure compliance with good pharmaceutical ethical promotional practices in Argentina. (iii) It is a requirement of CAEMe membership that member companies accept the conditions of CAEMe s Code of Good Pharmaceutical Marketing Practices and Interactions with Healthcare Professionals and, subject to local laws and regulations, adapt their codes so that they meet local requirements but are consistent with, and as comprehensive as, the CAEMe Code. Member companies commit to incorporate this Code to existing codes in each company. (iv) CAEMe member companies are accountable for compliance with this Code. They should also ensure that internal structures and procedures (including adequate training of employees) are created to secure responsible and ethical promotional activities. Companies not in membership with CAEMe may elect to be subject to the CAEMe Code and to its complaint handling procedures. (v) CAEMe is open to receive genuine complaints, regardless of the source, on any aspect of the CAEMe Code, in accordance with its operating procedures. Upon determination of a breach of the CAEMe Code, the objective is to assure the cessation of the infringements immediately. (vi) CAEMe is a non-profit organization representing major research-based innovative companies of the industry, among others, with headquarters or affiliates in Argentina. These companies are committed to the ethical standards set out in this Code. III. DEFINITIONS For the purposes of this Code: Promotion means any activity undertaken, organized or sponsored by a member company, directly or indirectly through a third party, exclusively intended for healthcare professionals, to promote the prescription, recommendation, acquisition, distribution, dispensation and administration or consumption of its medicinal products, through any and all communication media. Member Company means any company that is a member of CAEMe. Medicinal product means any pharmaceutical preparation or product used for the prevention, diagnosis and/or treatment of a disease or condition, or to modify physiological systems for the benefit of the receiving individual, designated by a conventional name, whether it is or not a manufacturing brand or trademark, or through the generic name corresponding to its composition and dispensation, with a defined, declared and verifiable quantitative composition, with stable pharmaceutical form and demonstrable therapeutic action. 4

5 Events means all meetings, conferences, symposia or any other type of similar activity with scientific, promotional and/or educational nature, including but not limited to meetings of experts, researchers, training meetings or any other meetings organized or sponsored by a member company, directly or indirectly through a third party. The purpose of such events should be to inform healthcare professionals about products and/or to provide and/or develop scientific or educational information related to the practice of medicine. Healthcare professional means, notwithstanding provisions contained in the legal rules in force, any member of the medical, dental, pharmacy or nursing professions, or any other person who, in the course of his or her professional activities, may perform or condition the activities of prescribing, recommending, purchasing, distributing, dispensing or administering a medicinal product. Sales Representative comprises Medical Sales Representatives and Pharmaceutical Sales Representatives, and any other individual that conducts promotions to healthcare professionals. IV. PURPOSE OF THE CODE The CAEMe Code sets out standards for (1) the ethical promotion of medicinal products and (2) the interaction between member companies and healthcare professionals, in order to ensure that such interactions are appropriate and perceived as such. V. SCOPE OF JURISDICTION OF THE CODE The Code covers all forms of promotion of medicinal products and interactions between member companies and healthcare professionals, in Argentina and abroad. VI. RANGE OF ACTIVITIES The Code covers all promotional methods, including but not limited to: press, advertising, direct mail advertising, activities of sales representatives, sponsorship of scientific conferences, professional or scientific meetings, Internet, use of audiovisual material such as films, videos, data storage systems and other that may appear in the future, as well as delivery of samples and hospitality. Moreover, the Code covers all forms of interaction between member companies and healthcare professionals, both resulting from research agreements (clinical trials, studies) and from any other type of agreements (collaboration, consulting, etc). The purpose of this Code is neither to restrict the exchange of medical and scientific information during the development stage of a product nor to limit the interactions between member companies and healthcare professionals, but to establish rules of behavior that all member companies commit to comply. 5

6 This Code does not regulate the following activities: a) Promotion of "over-the-counter" (OTC) products directly intended for the general public. Without prejudice thereto, promotion of OTC products intended for healthcare professionals will be comprised within the scope of this Code. b) Prices, discounts and allowances to participants in the commercialization chain, distributors, pharmaceutical wholesalers and authorized pharmacies, that are part of the commercial policy thereof are not comprised by this Code. c) Labels and package inserts of medicinal products. d) Supply of non-promotional information by member companies. e) Institutional advertising of member companies. f) Originals, reprints, literal translations of scientific articles and abstracts published by reputed scientific sources, provided they do not additionally include printed, stamped or electronically linked trademarks or trade names of medicinal products, advertising slogans or other advertising material, whether related or not to such information. g) Texts written and prepared by journalists in the course of their professional work in regular editions, supplements, special issues or editions, etc., of newspapers, magazines, television or radio programs, etc, in which information about drug therapies, specific treatments, medicinal products submitted as novelties, scientific studies or papers or references to a medicinal product, lines of research or product launches, press conferences, publications, etc, is presented as a news item, an interview, a debate, an editorial, or another similar format, provided there is no relation between the member company or owner of the trademark or medicinal product and the company responsible for the edition or the author of the information. VII. CODE PROVISIONS 1. MARKETING AUTHORIZATION 1.1. A medicinal product may not be promoted prior to the obtainment of the corresponding marketing authorization. This prohibition comprises also those medicinal products authorized in another country which have not obtained the marketing authorization in Argentina. This provision, however, does neither imply a limitation to the right of the scientific community and the public to be fully informed concerning medical and scientific progress nor attempts to restrict a complete and proper exchange of scientific information regarding medicinal products or drug substances, including appropriate and objective dissemination of investigational findings in scientific communications media and at scientific conferences. In such circumstances, scientific information must be provided by the Medical Department or by the relevant technical personnel 6

7 of member companies upon the express request of the interested healthcare professionals. 1.2 All advertising elements of a medicinal product must be consistent with the information contained in the current package insert and with indications approved by competent local authorities. 1.3 It should not restrict public disclosure of information to shareholders and to other interested parties regarding any medicinal product, as could be required by laws, regulations or registries. 2. PROMOTIONAL MATERIAL TO BE DELIVERED TO HEALTHCARE PROFESSIONALS 2.1 Any printed promotional material must comply with the requirements established by the regulatory authorities, which will prevail in the event of any inconsistency with this Code. 2.2 All printed promotional materials other than those covered in item 2.3 below, must be legible and include: a) Name of the medicinal product; b) Active ingredients, using approved names where applicable; c) Name and address of the member company or its agent responsible for marketing the product; d) Date of production of the advertisement; e) Quantitative and qualitative composition, pharmaceutical form, indications, contraindications, adverse reactions, warnings, precautions and dose. f) Other "abbreviated prescribing information" reflecting in an adequate and balanced way the risk/benefit profile of the medicinal product. 2.3 A "brand reminder" advertisement is defined as a short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product. In "brand reminder" advertisements, "abbreviated prescribing information" referred to in item 2.2 above, may be omitted. 2.4 The same requirements that apply to promotional printed materials shall apply to promotional electronic materials, including audiovisuals, such as videos, films and similar items as well as interactive systems. Specifically, in the case of medicinal product related websites: a) Identity of the pharmaceutical member company and of the intended audience should be readily apparent; b) Content should be appropriate for the intended audience; 7

8 c) Presentation (content, links, etc.) should be appropriate and apparent to the intended audience; and d) Information should comply with local laws and regulations. 2.5 Printed information or documents that member companies deliver to doctors in order to be given to patients, with respect to certain medicinal products, which due to the complexity of dosage, route of administration, etc., require the supply of additional information, and provided such information is intended to improve treatment compliance, shall not have a promotional nature. 3. PROMOTIONAL INFORMATION STANDARDS 3.1 National laws and regulations dictate the format and content of the product information communicated in the current package insert, packages, data sheets and in all promotional material. Promotion should not be inconsistent with approved product information. Healthcare professionals should have access to similar data to those being communicated in the country of origin of the product, and/or in any country in which it is marketed. 3.2 Information on medicinal products should be accurate and not misleading, precise, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. Information should be based on an adequate evaluation of scientific evidence and clearly reflect that evidence; and it should not mislead by distortion, undue emphasis, omission or in any other way. Absolute or all-embracing claims should be used with caution and only with adequate qualification and substantiation. Descriptions such as safe and no side effects should generally be avoided and should always be adequately qualified. 3.3 All artwork, including illustrations, graphs and tables, must be in accordance with the letter and spirit of the Code. Graphs and tables must be presented in such a way as to offer a clear, fair and balanced vision of the topics covered, and should not be included unless relevant to the claims or comparisons being made. Special care should be taken to ensure that all graphic material included in the promotion is not misleading about the nature of the medicinal product (e.g. if it is appropriate for use in children) or because of an argument or comparison (e.g. when incomplete or statistically irrelevant information or unusual scales are used). 3.4 Information and statements on adverse reactions should reflect available evidence or be capable of substantiation in clinical experience. It must not be stated that a product has no adverse reactions, toxicity or addiction risks. 8

9 3.5 When the promotional material refers to published studies, such studies should be faithfully reproduced or a clear reference enabling to learn about or find them should be provided. Faithfull reproduction is the reproduction reflecting in full the meaning and content of the original source, without adding or excluding any information that may lead recipient to mistake or confusion. In this sense, and by way of illustration, when comparing efficacy, safety or other properties of several active ingredients as an advertising instrument, information such as statistical significance of results may not be omitted nor results from different clinical studies or trials in the same graph or chart be compared without including clarifications, except when the source is a meta-analysis or the result of another work conducted with adequate and acknowledged scientific methodology. Statistics, conclusions or any other datum from several studies conducted pursuant to different methodologies may not be mixed or compared, unless they result from systematic reviews or meta-analysis in which homogeneity criteria are specified. Adaptations that may introduce bias or lead to confusion are not acceptable. 3.6 Promotion should encourage the appropriate use of medicinal products by presenting them objectively. Exaggerated or general statements, or statements leading to assumptions that a medicinal product or drug substance has any special merit, quality or property that may not be substantiated, should not be made. 3.7 Trademarks or trade names of medicinal products from other companies may only be quoted when indicating in an unmistaken, clear and visible way, that such products are the property of the company marketing them. 3.8 Comparative advertising must always comply with the regulations on fair competition. It cannot be disparaging, and comparisons must be based on relevant and comparable aspects. In any case, and particularly as regards comparative advertising, care must be taken to ensure that the sources on which statements are based are valid and immediately accessible to the competitor. 3.9 Any information, statement or comparison included in promotional materials should be well-founded. Such foundation (or rationale) should be provided to physicians and all other healthcare professionals on request. Particularly, any comparison conducted between different medicinal products must be scientifically verified. Such rationale need not be provided for statements literally reproducing approved indications in the current package insert. 4. TRANSPARENCY OF PROMOTION 4.1 Promotional material or activities should not conceal their actual purpose or nature. Clinical assessments, controls, post-marketing experience programs and post-authorization studies must not be confused with promotion. Such assessments, 9

10 programs and studies must be conducted with a primary scientific or educational purpose. 4.2 Whenever a member company finances, ensures, or directly or indirectly organizes the publication of promotional material in newspapers or magazines, it should be expressly stated that such material is not included as an independent editorial topic, and the sponsoring company should be included in a visible place. 4.3 Any material relating to medicinal products and their uses, whether promotional or not, that is sponsored by a company should clearly indicate that it has been sponsored by such company. 5. USE OF REFERENCE QUOTATIONS 5.1 Quotations from medical and scientific literature or from personal communications should accurately reflect the opinion of the author and, if applicable, should mention the product on which the author based its work. 5.2 Quotations regarding medicinal products taken from public broadcasts, such as radio or television, and from private events, should not be used without the formal authorization of the lecturer or speaker being the author thereof. 6. DISTRIBUTION OF PROMOTIONAL MATERIAL 6.1 Promotional material should be sent or distributed to those healthcare professionals for whom the particular information may be relevant. 6.2 All promotional activities will be conducted in accordance with applicable regulations regarding personal data protection. 7. REVIEW OF PROMOTIONAL MATERIAL 7.1 Member companies must have a scientific service (medical department or department performing such task) to compile and collect all information, whether received from sales representatives or from any other source, with the purpose of informing on the medicinal products they market. 7.2 Promotional material should not be issued unless its final form, to which no further amendments will be made, has been reviewed and checked by the scientific service of member companies. The scientific service should guarantee that it has examined the final version of the material and that, in its opinion, it is in agreement with applicable rules regulating advertising and with this Code, that it is in line with the marketing authorization, and 10

11 particularly with the information included in the current package insert, and that it is a fair and faithful presentation of the data about the medicinal products. 8. GIFTS AND PROMOTIONAL ITEMS 8.1 General Principle: No gifts, bonuses, benefits in cash or in kind, or incentives may be granted, offered or promised to healthcare professionals to induce prescription, recommendation, dispensation, supply, sale, administration or consumption of medicinal products, unless gifts are of minimal value and related to the practice of medicine or pharmacy and/or scientific education activities of such healthcare professionals pursuant to the Code. Gifts must not be delivered on a frequent basis to the same recipient. Gifts must have a modest value. Do not use gifts or benefits that may provide an inadequate image, giving the impression of a "preferential" treatment in the use of the products. 8.2 Delivery of the following is not allowed: Cash: Cash or cash equivalents (such as gift certificates or purchase vouchers or other) should not be offered to healthcare professionals or administrative personnel in any circumstance Personal Gifts: Gifts for the personal benefit of healthcare professionals (including, but not limited to, entertainment CDs and/or DVDs, sports or entertainment tickets, electronic items, etc) should not be offered. 8.3 Provision of the following items is allowed: Promotional Aids: Promotional aids (also called merchandising or gimmicks) are those elements serving as product and/or institutional brand reminder. There follows the requirements promotional aids must comply with when provided in the course of medical visits and when offered at events attended by healthcare professionals: Promotional items provided in the course of medical visits: they must be related to the practice of medicine or pharmacy and/or provide a benefit for patients (several office supplies such as stationery and similar items) Promotional items offered at events: they must be related to scientific and/or educational activities attended by healthcare professionals such as items serving as containers of scientific information and/or that may be used by the healthcare professional at the event. 11

12 Moreover, promotional aids that can be delivered in the course of medical visits may also be offered at events Cultural Courtesy Gifts: Cultural courtesy gifts may be offered, for national, cultural and/or religious holidays, and also for those events aimed at continuing professional education and updating (e.g. promotion, obtainment of a scientific award, and significant literature publication for the practice of medicine, among other). Cultural courtesy gifts may include an institutional reminder. Brand reminders should not be included in any circumstance. Sales representatives may assist in the delivery logistics. 9. HOSPITALITY AND MEETINGS The following rules shall apply to any type of Event. 9.1 Hospitality at professional or scientific events should be reasonable. The concept of hospitality includes payment of actual travel, registration, accommodation and per diem expenses by member companies, which must be reasonable and limited to the days on which the scientific or professional event is planned to be held. Hospitality cannot be extended beyond a reasonable period after the event. All events should be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the event or meeting. Member companies should avoid using luxurious venues. 9.2 Hospitality should always be secondary to the main purpose of the meeting. Scientific goals must be the primary focus in the organization of such meeting. Cultural or social aspects should not prevail over scientific ones. Social activities shall be those related to breakfasts, lunches, tea parties or dinners exclusively, and such activities are allowed. However, it is not allowed to offer or finance any type of entertainment or leisure activity. Hospitality shall not include the sponsorship or organization of entertainment or leisure activities (such as sports events, music events or other). 9.3 Hospitality offered by member companies should not be extended to persons other than healthcare professionals. 9.4 No payments may be made to healthcare professionals or groups of healthcare professionals, either directly or indirectly, for the rental of meeting rooms unless it is duly evidenced that such rooms are intended for scientific or professional meetings. 12

13 9.5 When meetings, conferences, symposia and similar events are sponsored by member companies, this fact must be disclosed in all documents regarding the meeting and also in any published paper, speech or document related to such events. 9.6 Payment of reasonable fees and reimbursement of out-of-pocket expenses, including travel for speakers and moderators at such meetings, conferences, symposia and similar scientific or professional events, is permissible. In the event of hiring foreign healthcare professionals, the market value of the country in which such professional exercises his/her activity will apply. 9.7 Companies cannot organize or sponsor events outside Argentina (international events) unless this makes more sense from a logistics and/or security viewpoint, such as that the majority of invited participants are foreigners and/or multiple countries participate or that a relevant resource or expertise that is the main purpose of the event is located abroad. If international events are organized or sponsored, in addition to this Code, member companies must also observe the specific provisions of the Codes of Good Practices for the Promotion of Medicines of the country in which the event is held. 9.8 Scientific material distributed and/or activity conducted in exhibition stands at scientific events held in Argentina may refer to medicinal products not registered in Argentina or registered under different conditions, provided they do not have a promotional nature. 9.9 In no case can money be offered to merely compensate time used by healthcare professionals in attending the event. Sponsorship provided to individual healthcare professionals should not be conditional upon an obligation to prescribe, recommend, acquire or promote a medicinal product or to obtain an undue advantage for the member company. 10. VISITS TO PHYSICIANS AND PHARMACIES 10.1 Sales representatives should be adequately trained by or on behalf of the company employing them, and shall have sufficient scientific knowledge to present the information on the member company medicinal products in an accurate and responsible manner Sales representatives should perform their work in a responsible way, observing the applicable law and ethical rules as well as the provisions of this Code. 13

14 10.3 Sales representatives should not use any incentive or subterfuge in order to obtain an interview. No payment shall be offered or made for the obtainment of an interview Sales representatives should ensure that the frequency, timing and duration of their visits to healthcare professionals, administrative staff, health authorities and the like, together with the manner in which they are conducted, do not cause inconveniences Both when interviews are arranged and conducted, sales representatives should, from the very outset, take any reasonable steps to ensure they do not generate confusion as to their identity or that of the company they represent Sales representatives shall comply with rules on pharmacovigilance and adverse event reporting as per the scheme established by each company At each visit, sales representatives will provide to the visited person or will have available for him/her if requested, the current package insert of each of the medicinal products they promote, together with information on various pharmaceutical forms and doses, prescription and dispensing terms, price information, terms of reimbursement by the National Health System, if applicable, and whenever possible, estimated treatment cost Companies shall take effective actions to ensure that their sales representatives and their personnel related in any way to the preparation or approval of promotional material or information intended for healthcare professionals, are fully conversant and comply with this Code and the applicable regulations on advertising and promotion of medicinal products. Moreover, they shall adopt effective actions and shall ensure that interactions between sales representatives and other member company personnel with healthcare professionals comply, at all times, with this Code and with applicable rules Sales representatives who call on pharmacies shall comply with the same rules and shall observe, in the course of their activity, applicable law on the promotion of medicines as well as ethical rules and the provisions of this Code. 11. SAMPLES In accordance with local laws and regulations, a reasonable number of free samples may be supplied to healthcare professionals authorized to prescribe medicinal products, in order that they familiarize themselves with such products and/or initiate therapies. 14

15 11.2. Companies should have adequate systems of control and accountability for samples provided to healthcare professionals, including surveillance of such samples whilst they are in possession of sales representatives Each sample must bear the statement free sample - sale forbidden, and the coupon of the medicinal product must be suppressed or cancelled Delivery of samples of medicinal products containing psychotropic or narcotic substances, as defined in the international agreements, or of medicines that may cause dependency or give rise to public health problems for improper use, and of any other medicinal product as determined by regulatory authorities, is forbidden Samples distributed through sales representatives will be directly provided to healthcare professionals qualified to prescribe medicinal products or exceptionally to persons authorized to receive them in their name. 12. STUDIES A clinical trial comprises all research conducted on human beings in order to determine or confirm clinical, pharmacological and/or other pharmacodynamic effects, and/or to detect adverse reactions, and/or to study the absorption, distribution, metabolism and excretion of one or various medicines under investigation, aimed at determining their safety and/or efficacy. Pharmaceutical companies shall conduct this type of trials in accordance with applicable laws and regulations, having first obtained the favorable opinion of the Clinical Research Ethics Committee, the approval of each of the Centers where the trial will be conducted and the authorization of the Argentine Drug, Food and Medical Technology Administration (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica - ANMAT) Companies conduct observational post-authorization studies, i.e. studies performed during the marketing of a medicinal product in accordance with the conditions of the current package insert or under normal conditions of use, in which the assignment of a patient to a given therapeutic strategy is not decided beforehand by a trial protocol but by standard medical practice, and the decision to prescribe a given medicinal product is clearly dissociated from the decision to include the patient in the trial. No diagnostic or follow-up intervention is applied to patients other than such as are standard in clinical practice, and epidemiological methods shall be used to analyze the data gathered. This kind of trials must be conducted in accordance with the requirements of applicable laws and regulations - among other, the favorable opinion of an acknowledged Clinical Research Ethics Committee, the submission of documents to the regulatory authority for registration, etc. - and with a fundamentally scientific or educational purpose. These trials should in no case be conducted as a procedure to promote a product or with the purpose of inducing prescription. 15

16 The design and follow-up of observational post-authorization trials shall be in charge of the Medical or Clinical Research Departments of member companies. Sales representatives shall not be involved in these trials other than in logistical issues. Trial results must be analyzed by or in the name and behalf of the pharmaceutical company, which shall put at the disposal of the scientific service of member companies, within a reasonable term, a summary of such trials. Such scientific service shall keep a registry of all trials for a reasonable term. Pharmaceutical companies shall submit a summarized report to all healthcare professionals participating in the trial and shall put such report at the disposal of the Supervisory Committee of this Code, on request. If the trial shows significant results for risk/benefit evaluation or assessment, the summary of such report must be submitted to the relevant authority Companies also conduct other types of studies or programs, not comprised within the previous paragraphs, gathering data or opinions of healthcare professionals on their clinical practice, on a given disease, on the health condition of their patients or on their knowledge or use of certain medicinal products. It is important to adopt a series of precautions to avoid that such studies or programs may imply an inducement to prescription or contain an incentive prohibited by this Code. Thus, apart from complying with applicable regulations as the case may be (particularly as regards personal data protection), any study other than those established in items 12.1 and 12.2 mainly conducted, funded or sponsored by a company, shall: a) Be informed to the Supervisory Committee of this Code within the scope provided for in the respective regulation to be issued. b) Be conducted with a scientific or market research purpose. Objectives, methodology and expected results must be consistent with the scientific or market research questions. c) Ensure the study does not modify the prescribing habits of the physician or the dispensing habits of the pharmacist. d) Have a written protocol clearly establishing objectives, methodology, expected results and use. e) In this respect, written agreements shall be executed between the professionals and/or entities with which the studies will be conducted and the companies sponsoring the studies, specifying the nature of the services to be provided, participation and compensation terms of professionals, etc. f) Payment to participating professionals must be based on market criteria and must be in accordance with the time allocated, the work performed and the responsibilities undertaken, and shall be adequately documented. Payment shall be in cash. 16

17 g) Guarantee that conduct of the study does not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer medicinal products. h) Be approved prior to their conduct by the scientific service of member companies or by the compliance officer established in item 12.1 of this Code. i) Sales representatives shall not be involved in these trials other than in logistical issues Failure to report the studies referred to in item 12.3, when such communication is mandatory, shall constitute an infringement to this Code. 13. DONATIONS AND GRANTS. EDUCATIONAL SUPPORT AND SUPPORT TO RESEARCH INITIATED BY HEALTHCARE PROFESSIONALS Donations, grants or benefits in kind to institutions, organizations, associations or foundations made up by healthcare professionals, and/or that provide social or humanitarian assistance services, or conduct research, education or training services, are only allowed if: a) Entities are legally created and registered for fiscal purposes; b) They are made with the purpose of cooperating with healthcare, research, education/training or social or humanitarian assistance; c) They are made based on written applications of the entities, clearly describing the program or project and its purpose and benefit, and including how patients will benefit and/or how patient healthcare quality will be improved with such applications. They shall indicate how the funds will be used. d) They are documented and kept on record by the providing company; e) They do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer medicinal products. f) The evaluation process and approval of donations or grants shall be outside the scope of the commercial, marketing or sales area. Donations or grants to individual healthcare professionals are not allowed a) Educational support to individual healthcare professionals and support to research initiated by healthcare professionals may be granted provided they comply with the requirements established in item 13.1.d), e) and f), as applicable, and payment is made directly to the educational supplier involved. Moreover, scientific updating and/or medical utility items may be offered to healthcare professionals (including books or material in optical, magnetic, electronic or similar media, on medicine or pharmacy topics) provided they are adequate to the medical activity and/or patients care. 17

18 13.2 b) Support for Continuing Medical Education Continuing Medical Education (CME) helps insure that healthcare professionals obtain the latest and most accurate information and insights on therapeutic areas and related interventions that are critical to the improvement of patient care and overall enhancement of the healthcare system. The primary purpose of an educational meeting must be the enhancement of medical knowledge, and, therefore financial support from companies is appropriate. When member companies provide content to CME activities and programs, such material must be fair, balanced and objective, and designed to allow the expression of diverse theories and recognized opinions. Content must consist of medical, scientific or other information that can contribute to enhancing patient care. Member companies should observe, when applicable, regulations governing interactions with healthcare professionals herein included. 14. SERVICES PROVIDED BY ENTITIES COMPOSED OF HEALTHCARE PROFESSIONALS Agreements with institutions, foundations, scientific societies, organizations or associations of healthcare professionals, for the provision of any service to a pharmaceutical company (or any other type of agreement from which compensation or funding not covered by this Code arises) are only allowed if such services: (i) are provided with the purpose of supporting health assistance, research, education/training, or the organization of professional or scientific events; (ii) are documented and kept on record by the contracting member company; and (iii) do not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer medicinal products. 15. SERVICES PROVIDED BY HEALTHCARE PROFESSIONALS It is allowed to hire healthcare professionals, individually or in groups, for the provision of advisory or consulting services such as lecturer or moderator at meetings, training activities, expert meetings, etc., where such participation involves the payment of remuneration and/or travel and boarding expenses. Agreements covering the lawful provision of this kind of services must comply with the following conditions: a) Prior written agreement specifying, at least, the nature of the services to be provided and the fees to be paid; b) Clear identification of a legitimate and genuine need for these services in advance of requesting the services and entering into agreements with the prospective consultants; 18

19 c) Criteria for selecting consultants are directly related to the identified need and the people in charge of selecting the consultants and/or responsible for the approval of such hiring has the necessary expertise to assess whether the healthcare professionals meet such criteria; d) The number of healthcare professionals hired does not exceed the number reasonably necessary to attain the anticipated goal; e) The contracting company should keep documentary records of the services provided by consultants, and make appropriate use of such services; f) The hiring of healthcare professionals for the provision of this kind of services is not an inducement to recommend, prescribe, purchase, supply, sell or administer a particular medicine; g) Fees for services provided by participating professionals should be based on market criteria and in line with the time devoted, the work performed and the responsibilities assumed. Each member company should establish a process to assess that agreed fees are in line with the parameters established in this item. Service fees must be paid in cash. h) The Supervisory Committee shall establish, from time to time, and for guidance purposes only, reference values for service fees obtained by healthcare professionals In their agreements with healthcare professionals, pharmaceutical companies are encouraged to include provisions regarding the obligation of the healthcare professional to declare that he/she is a consultant to the member company, whenever he/she writes or speaks in public about an issue that is subject matter of his/her agreement or that is related to the company. Likewise, companies that employ healthcare professionals on a part-time basis, i.e. healthcare professionals that continue practicing their profession, are encouraged to ensure such healthcare professionals are obliged to declare their employment arrangement with the member company, whenever he/she writes or speaks in public regarding an issue subject matter of such employment or that is related to the company. 16. INTERACTIONS WITH PATIENT ORGANIZATIONS 16.1 Scope: The pharmaceutical industry has many common interests with patient organizations. All interactions with patient organizations must be ethical. The independence of patient organizations must be respected Declaration of Involvement: When working with patient organizations, member companies must ensure that the involvement of the company and the nature of that involvement are clear from the outset. No company may require that it be the sole funder of the patient organization or any of its programs. 19

20 16.3 Written Documentation: Member companies that provide financial support or inkind contribution to patient organizations must have in place written documentation setting out the nature of support, including the activities and funding thereof Events: Member companies may provide financial support for patient organization meetings provided that the primary purpose of the meeting is professional, educational, and scientific in nature, or otherwise supports the mission of the patient organization. When member companies hold meetings for patient organizations, companies must ensure that the venue and location are appropriate and conducive to informational communication. In addition, any meals or refreshments provided by a company must be modest. 17. RULES OF APPLICATION Member companies or companies adhered to the Code commit and undertake to observe the principles contained in this Code in their promotional activities as well as in their interactions with healthcare professionals or with any other person who, in the practice of his/her profession, may perform or determine the activities of prescribing, purchasing, distributing, dispensing or administering a medicine Each company should appoint at least one adequately qualified employee or manager, who will be in charge of the internal supervision of Code compliance. An implementation guide shall explain the basic principles and mechanisms of internal control to be observed by all member companies. Nevertheless, the existence of persons in charge of the internal supervision does not release the highest company representatives from their liability Moreover, member companies or companies adhered to the Code on an individual basis, shall be held responsible for possible infringements to the Code committed by third parties acting in their name and behalf, or under their control, or pursuant to a written agreement (e.g.: external sales networks, marketing research firms, travel agencies, advertising agencies, etc.). 18. QUERIES Member companies subject to this Code may submit queries on the conformity to the Code of a given promotional activity or of interaction with healthcare professionals or request clarifications of a more general nature related to the Code. Queries on the content of specific promotional materials are excluded Queries should be addressed to the Compliance Commission Neither the particular queries submitted nor their outcome can be mentioned in promotional activities or in interactions with healthcare professionals. 20

21 18.4. Queries of general interest for the whole industry may be published in the form of question-answers, maintaining the anonymity of the company that submitted the query, at the discretion of the Steering Committee. 19. CONTROL OF CODE COMPLIANCE Control of compliance with the rules established in this Code corresponds to the Supervisory Committee and to the Steering Committee. The composition, appointment and issue of the Regulations of the Supervisory Committee shall be defined by the Compliance Commission. Any reference to the Steering Committee corresponds to the Steering Committee of CAEMe as per its By-Laws. The Supervisory Committee, the Compliance Commission and the Steering Committee shall have the following powers and duties: Supervisory Committee: the Supervisory Committee shall be composed of 3 persons of the Compliance Commission by drawing of lots. As a body in charge of the active surveillance of compliance with this Code, the Supervisory Committee shall have the following powers and duties: a) Cooperate with the Steering Committee in furtherance of the effective application of the rules contained in this Code, whether on its own initiative or on request of any person with legitimate interest. b) Suggest possible corrective processes and/or penalties to the Steering Committee, whenever the existence of an alleged Code violation results from its supervisory functions. c) Investigate complaints filed pursuant to this Code. d) Any other function it may have pursuant to the Code and its Regulations Members of the Supervisory Committee shall abstain from participating in cases where conflict of interest exists. It should be assured that the Supervisory Committee always protects the confidential nature of the information it has access to or it generates in the course of its activity Compliance Commission: It shall have the following powers: a) Prepare the Regulations of the Supervisory Committee and submission thereof to the Steering Committee b) Perform advisory, guidance and training tasks with respect to the Code. c) Take the necessary actions aimed at investigating if a given promotional activity of one or several member companies complies with the Code. d) Make preventive warnings to member companies whenever, in the promotional activities to be performed and pursuant to the data in its possession, there is a risk of infringement. 21

22 e) Issue technical opinions / circular notes on the various topics related to this Code requested by the Ethics Committee, the Steering Committee and/or member companies. f) Any other function it may have pursuant to the Code and its Regulations Steering Committee: CAEMe's Steering Committee as defined in its By-Laws, as ultimate body in charge of the implementation, updating and compliance with this Code, shall have the following powers and duties: a) Approve the Regulations of the Supervisory Committee. b) Request periodic reports to the Compliance Commission on the implementation progress of this Code. c) Act as last instance jury in cases of investigations of alleged violations to this Code by member companies, ratifying or rectifying the penalties proposed by the Supervisory Committee. d) Approve amendments to and/or updatings of this Code, based on the powers vested upon it by the General Assembly of CAEMe. Members of the Steering Committee shall abstain from participating in the cases where conflict of interest exists In this regard and notwithstanding the request to cease the infringing behavior that may be sent to the pharmaceutical company that committed the alleged infringement, member companies subject to this Code pursuant to article 18 hereby undertake to file their possible complaints against promotional practices or interactions with healthcare professionals of other member companies subject to the provisions of this Code, to the Compliance Commission in first instance and prior to resorting to the Courts of Justice or to the Health Authorities. They also agree to immediately obey and observe the mediation agreements reached and the content of the decisions of the Steering Committee Both the complainant and the respondent member companies commit to preserve the confidential nature of the handling of the claim and its decision, refraining from disclosing any information about it. The Steering Committee shall be entitled to disclose the final and non-appealable resolution, pursuant to the regulations to be issued in this respect For the effective application of this Code and for the handling and decision of possible complaints to be filed against promotional activities or interactions with healthcare professionals of member companies subject to this Code, the Supervisory Committee and the Steering Committee shall abide by the provisions of their respective Regulations Failure to cooperate with any of the bodies in charge of supervising compliance with this Code by a member company subject to its provisions shall constitute an infringement as established in Article