| SAPI CODE OF MARKETING PRACTICES Whereas the Singapore Medicines Act 1975 provides the main framework for the legal control of the importation, manufacture, distribution and advertising of medicinal products, thereby setting the basic statutory requirements necessary for the protection of the public health, there are areas of activities which, although they may not constitute breaches of the law, they may, by virtue of their unethical nature and, if unrestrained, bring about undue harm to the public health and loss of credibility and respectability for the pharmaceutical industry. This Code of Marketing Practices (hereafter refers to as Code), established by the Singapore Association of Pharmaceutical Industries (SAPI) with the approval of its members, is to provide guidance for the proper conduct in the marketing and promotion of medicinal products and is to serve as basis for self-discipline within the industry. This would include any activity undertaken by the company or by distributors that promote the prescription, supply, sale, or distribution of pharmaceutical products, including vaccines. The Code, which is in keeping with the spirit of the revised Code of Marketing Practices of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) 2006, is administered by the Marketing Practices Committee appointed by the Board of Directors. Acceptance and active observance of this Code are mandatory for membership with SAPI. As it is not possible to draw up a comprehensive set of ethical standards governing all aspects of marketing and trade of medicinal products, this Code shall be given the widest interpretation within the spirit of fair play to all concerned. 2. COMMITMENTS OF THE PHARMACEUTICAL INDUSTRY The Pharmaceutical Industry, conscious of its special position in the healthcare services in Singapore, and being desirous to fulfill its obligations in a free and fully responsible manner, undertakes:
3. GENERAL PRINCIPLES 3.1 Scope of the Code The term 'pharmaceutical product' in the context of the Code means any pharmaceutical or biological product which is primarily 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 under the Medicines Act 1975. Such activities would include, among others:
3.1.1 However, direct-to-consumer advertising of pharmaceutical products, within the definition given, is covered in section 3.9 of the Code, and members should refer to "A guide on Advertisements and Sales Promotion of Medicinal Products" from HSA. 3.1.2. In all matters of application, interpretation and enforcement of any section of the Code, it is to be understood that compliance with Singapore laws, regulations and regulatory decisions and requirements will take precedence. 3.1.3 Products for infant nutrition, in vitro diagnostic tests, and surgical and medical devices are outside the scope of the Code. 3.1.4.With regard to product information on labelling, packaging, leaflets, data sheets and in advertisements, it is understood the Medicines Act 1975 dictates the format and content of the information communicated. Companies should, however, attempt to provide uniform information on indications, contraindications, warnings, precautions, side effects and dosage wherever possible within the context of legal requirements. 3.1.5. The Marketing Practices Committee will not give advice on specific issues or advertising and promotional materials. However, the committee will give advice on the interpretation of the Code. 3.2 Standards of Promotion 3.2.1. In general, the standards of promotion should subscribe to the good practice of ensuring that;
3.2.2. Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the enquiry. 3.2.3. Products, activities or representatives of other pharmaceutical companies must not be disparaged. 3.2.4. The medical and scientific opinions of opinion leaders and health professionals must not be disparaged 3.2.5 Pre-printed prescriptions pads that carry product-specific advertisements are prohibited. 3.2.6. Doctors' names or photographs must not be used in any way that is contrary to medical ethics. 3.3. Duration of approval of promotional items. 3.3.1. Date of first use of all promotional materials circulated to the market shall not be more than two years from the date of approval. Any materials used beyond this point must be re-approved. Henceforth, all published promotional material shall be dated and updated regularly. Thus date of print must be defined on document. 3.3.2. It is the responsibility of the company to ensure that out of date materials are no longer distributed and destroyed. 3.3.3. A register, the approval folder and a sample of each approved item must be maintained locally for a minimum of 2 years. 3.3.4. If new product data is generated that significantly changes the safety and/or efficacy information for a product, then all promotional materials currently in use must be reviewed and either updated or its circulation be discontinued. 3.4 Scientific Evidence 3.4.1. Prescribing information in promotional materials should be based on an up-to-date evaluation of evidence that is scientifically valid and should not give an incorrect or misleading impression. Scientific data to support the claims and recommendations for use should be made available, on request, to healthcare providers. Prescribing information in packaging insert should be approved by the Health Sciences Authority (HSA), Singapore. . 3.4.2. Companies should produce data to support claims whether or not the data are in the public domain but are not required to substantiate indications for use which are already approved by Health Sciences Authority, Singapore. Normal considerations relating to confidentiality of information apply. 3.4.3. Data from in vitro and animal tests should be clearly marked as such and not be cited in such a way that it could give an incorrect or misleading impression. 3.5. Safety Data 3.5.1. Particular care should be taken that essential information as to pharmaceutical products' safety, for example, contraindications, precautions and side effects, is appropriately and consistently communicated, subject to the legal, regulatory and medical practices of Singapore. The word "safe" should not be used without qualification and only if substantiated by published clinical data. 3.6. Disguised and Misleading Promotion 3.6.1. Promotional material, such as mailings and medical journal advertisements, must not be such as to disguise its real nature. Examples of disguised promotion include advertisements in journals which appear to be part of the editorial content. 3.6.2. Post-marketing and surveillance studies should be conducted on a scientific or educational basis. These studies should not be conducted simply as a means to promote a product and influence physicians, with little or no scientific or educational basis. 3.7. Marketing Research 3.7.1. Methods employed for marketing research must never be such as to bring discredit upon, or to reduce confidence in the pharmaceutical industry. This provision applies whether the research is carried out directly by the company concerned, or by an organisation acting on the company's behalf. 3.7.2. Questions intended to solicit disparaging references to competing products or companies must be avoided. 3.7.3. Any incentives offered to the informants should be kept to a minimum, and be commensurate with the work involved. 3.7.4. Marketing research must not in any circumstances be used as a disguised form of sales promotion. 3.7.5. Marketing research must not have the direct objective of influencing opinions of the informant. 3.7.6. The identity of an informant must be treated as confidential, unless he has specifically agreed otherwise. 3.7.8. In the absence of this agreement, it follows that the information provided - as distinct from the overall results of the research - must not be used as the basis upon which a subsequent approach is made to that informant for the purpose of sales promotion. 3.8. Pre-Registration Communications 3.8.1. No pharmaceutical product shall be promoted for use in Singapore until the requisite approval for marketing for such use has been given by Health Sciences Authority, Singapore. However, this provision is not intended to abridge the right of the scientific community and the public to be fully informed concerning scientific and medical progress. It is not intended to restrict a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate dissemination of investigation findings in scientific or lay communications media and at scientific conferences. Nor should it restrict public disclosure to stakeholders and others concerning any pharmaceutical product as may be required or desirable under law, rule or regulation. 3.8.2. At international meetings, where a significant proportion of attendees is from outside the venue country, advertising of locally unapproved products may occur, provided it is legally acceptable in the venue country and in the participant's local code of practice. When such advertising is undertaken, material should clearly indicate that the product is not locally approved. 3.9. Communications to the Public 3.9.1. Where it is permitted by law to communicate directly with patients regarding their prescription medicines, all such information should be accurate, fair and not misleading. 3.9.2. Communications to the public may include the provision of patient package inserts and other leaflets and booklets, etc., made available to inform patients about products prescribed by health professionals. 3.9.3. Where companies assist in the conduct of public/patient disease awareness programs providing information on, signs and symptoms of medical conditions, illnesses, and available treatments, such activities should comply with the Disease Awareness Guidelines of the H SA. 3.9.4. Request from individual members of the public for information or advice on personal medical matters, including about the product which has been prescribed, should be redirected his or her own doctor. 3.10. Company Procedures 3.10.1. Promotional communications should have medical clearance by the responsible person before their release. The responsible person must have appropriate scientific or healthcare qualifications. 3.10.2. Companies should establish and maintain appropriate procedures to ensure full compliance with this Code. 4. MEDICAL RERESENTATIVES 4.1. Training and Responsibilities 4.1.1. Medical representatives must be adequately trained and possess sufficient medical and technical knowledge to present information on their company's products in an accurate, responsible and ethical manner. They must also feed back to their company, from contacts in the medical and allied professions, information which they receive on the use of products and particularly reports of side effects. 4.1.2. The training given to medical representative should be an on-going process and should include familiarity with SAPI and IFPMA Codes of practices. The Certified Medical Representative (CMR) awarded by SAPI is one of the qualifications for Medical Representatives in Singapore. 4.1.3. It is the onus of the company to familiarise all employees of the sales, marketing, regulatory, medical or such areas related to the principles of the code of conduct and practices of SAPI and of local legislation. 4.1.4. Medical representatives should ensure that the frequency, timing and duration of calls, together with the manner in which they are made, are such as not to cause inconvenience to the health care professional. The wishes of an individual health care professional, or the arrangements in force at any particular establishment, must be observed by medical representatives. 4.2. Company Responsibility A company will assume the responsibility, under the SAPI Code, for correcting breaches of the Code resulting from misconduct or misrepresentation of facts by any representative. 4.3. Remuneration The system of remuneration of representatives should not be such as to adversely influence the proper prescribing of pharmaceutical products by the physician. The provision relating to remuneration is intended to ensure that no incentives are provided that would lead to unethical behaviour of representatives, and not whether a fixed salary or bonus system is used for compensation. 5. MEETINGS (SYMPOSIA, CONGRESSES AND OTHER MEANS OF VERBAL COMMUNICATION) AND HOSPITALITY 5.1. Objectives Symposia, congresses and the likes are indispensable for the dissemination of knowledge and experience. Scientific objectives should be the principal focus in arranging such meetings and entertainment and other hospitality shall not be inconsistent with such objectives. 5.2. Meetings Sponsorship When a pharmaceutical company or association sponsors a symposium, congress or other medical/health care or educational programme for both local and overseas meetings; 5.2.1. The fact of sponsorship by the company or association should be clearly stated in advance, at the meeting and in any proceedings. Printed, audio-visual or computer-based material arising from such meetings should accurately reflect the presentations and discussions; 5.2.2 Sponsorship to healthcare professionals should be limited to travel, meals, accommodation and registration fees, with travel and accommodation apply to overseas meeting only; 5.2.3. No payments should be made to compensate healthcare professionals for time spent in attending the event; 5.2.4. Any support to individual health practitioners to participate should not be conditional upon any obligation to promote any medicinal product; 5.2.5. If the programme is accredited for postgraduate medical education by a medical or other professional organization, responsibility for the programme content remains with the organization responsible for obtaining accreditation for the meeting, and industry support should be disclosed; 5.2.6. Payments of reasonable honoraria and reimbursement of out-of-pocket expenses, including travel and accommodation, may be provided to healthcare professionals who are providing genuine services as speakers or presenters on the basis of a written contract with the company at the Event. 5.2.7. The sponsorship must be able to withstand public and professional scrutiny and conform to the professional standards of ethics and good trust; 5.2.8. Invitations to such meetings should not be extended to spouses unless they themselves are practising members of the medical or allied profession. 5.2.9. SAPI affiliates and members should only provide Economy Class tickets for air travel of less than 6 hours. This should apply to all faculty members e.g. speakers, member of Advisory Boards, as well as attendees. 5.2.10. Companies should not pay travel costs of persons accompanying invited members of the medical and allied professions. 5.2.11. When a Congress/Symposia sponsored by a pharmaceutical company based in Singapore is to be held in an overseas location, majority of the attendees should be from the country in which Congress/Symposia is held. 5.2.12. When a Congress/Symposia is organised, a minimum of 75 per cent of time should be spent on core activities of the Congress/Symposia and a maximum of 25 per cent of time may be devoted to recreational activities e.g. cultural dance, sight-seeing tour of modest or nominal fees; 5.2.13. Lotteries / lucky draws should not be part of symposia / exhibitions. 5.3. Hospitality & Entertainment 5.3.1. Entertainment or other hospitality and any gifts offered to members of the medical and allied professions should be secondary to the main purpose of the meeting and should be kept to a modest level and able to withstand professional and public scrutiny; 5.3.2. The level of hospitality should be appropriate and not out of proportion to the occasion. Its cost should not exceed that level which the majority of recipients might normally adopt when paying for themselves. 5.3.3. Hospitality should be limited to refreshments and/or meals incidental to the main purpose of the meeting and should only be provided to participants of the meeting, and should not extend beyond members of the healthcare professions; 5.3.4. Providing hospitality in relation to food and drinks as per social/cultural norm in a local setting to members of the medical and allied professions should be limited to ?S$100 per person, however this should be accompanied with dissemination of scientific or educational information; 5.3.5. No stand-alone entertainment or other leisure or social activities should be provided or paid for by member companies. However, entertainment of modest nature which is secondary to refreshments and /or meals is allowed during meetings. Activities strictly prohibited include golf, giving doctors tickets to sporting events, opera, theatre and concerts; 6. GIFTS, DONATIONS & GRANTS 6.1. Gifts & Promotional Items 6.1.1. Inappropriate financial or material benefits, including inappropriate hospitality, should not be offered to healthcare professionals to influence them in the prescribing of pharmaceutical products. 6.1.2. Subject to Section 6.1.1. no gifts or financial inducement shall be offered or given to members of the medical and allied professions for purpose of sales promotion. 6.1.3. Payments in cash or cash equivalents (such as gift certificate) must not be offered to healthcare professionals either directly or indirectly; 6.1.4. 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. Gifts should not be contingent on increased prescribing; 6.1.5. Gifts in the form of articles designed as promotional aids, whether related to a particular product or of general utility, may be distributed provided the value of the gifts are of no more than S$20/- and relevant to the practice of medicine or pharmacy. 6.1.6. Inexpensive food items & drinks as per social/cultural norm may be distributed to medical professionals during the course of day to day promotional activities only and should be limited to ≤S$20 per medical professional; 6.1.7. Congratulatory flowers for special occasions such as Promotions, Conferment of Awards or Clinical Opening should be limited to ≤S$150 per occasion; congratulatory messages in any form of media on behalf of a medical profession or a centre are strictly prohibited; 6.1.8. Exceptional gifts during various festive seasons should be symbolic and modest, with a value of up to $50, such as cakes, cookies and mandarin oranges. Each HCP should only be offered a maximum of two such gifts per year; 6.2 Educational Material & Items of Medical Utility 6.2.1. Text or reference-books/information, subscription to on-line journals and other educational material may be given to healthcare providers if they serve a genuine educational function as follows:
6.2.2. Items of medical utility may be offered or provided free of charge provided such items are of modest value and are beneficial to the provision of medical services and for patient care; value of such items should be limited to ≤S$100; 6.3 Donations & Grants Companies may provide donations to requests, strictly for charitable purposes and charitable organizations. In addition companies can provide grants towards financial support strictly for educational programs, (including but not limited to request to fund accredited CME programs, non-accredited educational programs, fellowships, advocacy organizations, societies, medical conferences, congresses or independent meetings) if they are:
7. PRINTED PROMOTIONAL MATERIAL 7.1. General Printed promotional material shall be presented in a legible manner. The scientific basis and presentation of the product information must be in conformity with the general principles set out in Section 3 of the Code and where applicable, with the authorised product information. 7.1.1. Promotional material such as mailings and journal advertisements and loose inserts must not be designed to disguise its real nature. 7.1.2. Advertisements in journals should not be designed so as to resemble editorial material. 7.1.3. Promotional material should conform, both in text and illustration, to canons of good taste and should recognise the professional standing of the recipient. 7.1.4. Representation of the nude adult human form or partly clothed figures, should not be used in promotional material in such a way as to arouse a visual or emotional response in order to attract attention to the text. Displays of part of the naked body which are necessary to illustrate pictorially the message of the text are permissible, provided that they conform to the dictates of decency and good taste. 7.1.5. Material and articles from the lay press should not be used as promotional material. 7.1.6. Illustrations must not mislead as to the nature of the claims or comparisons being made, nor as to the purpose for which the product is used. 7.1.7. Artwork and graphics must conform to the letter and the spirit of the Code. Graphs and tables should be presented in such a way so as to give a clear, fair, balanced view of the matters with which they deal, and should only be included if they are relevant to the claims or comparisons being made. 7.1.8. Graphs and tables must not be used in any way which might mislead, for example by the incompleteness or by the use of suppressed zeros or unusual scales. 7.2. Reprints, abstracts and quotations in print or other media. 7.2.1. Such material from medical literature or from personal communications received from doctors, must accurately reflect the meaning of the author and the significance of the study (which should not be distorted by the addition of highlighting or underlining to give prominence to selected portions of the material) 7.2.2. Care must be taken to avoid ascribing claims or views relating to the medical products to authors when such claims or views no longer represent or may not represent the current view of the authors concerned. 7.3. All Advertisements 7.3.1 All advertisements appearing in print must include:
7.3.2. The mailing address of the contact from which further information may be obtained must appear, either in the advertisement itself or be readily accessible from the publication in which the advertisement appears. 7.4. Full Advertisements Full advertisements are those which include promotional claims for the use of the products. In addition to the requirements of paragraph 7.3., full advertisements must also include prescribing information in the form of:
7.5. Reminder Advertisements 7.5.1.. An abbreviated or "reminder" advertisement is defined as a short advertisement containing no more than a simple statement of indications to designate the therapeutic category of the product. 7.5.2. For reminder advertisements, the requirements of paragraph 7.3. apply, but the prescribing information required under paragraph 7.4. may be omitted, provided that there is a form of words which clearly indicates that further information is available on request. 7.5.3. The statement that further information is available on request should normally appear in the advertisement but the requirement will be deemed to have been met if a general notice to this effect, referring to all advertisements, is clearly printed on the same page of the publication. Reminder advertisements should not be used for new products. 7.6. Reference 7.6.1. When promotional material relates to published studies, a clear reference to these should be given in the printed material, detail aids and other promotional items including journal advertising. 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. 7.6.2. Where brand names of competitor products are used, extreme care must be taken to ensure that trademarks are not infringed. 7.7. Frequency and Volume 7.7.1. The frequency and volume of mailings of printed material to the healthcare professionals should be reasonable. 7.7.2. Requests by physicians for their names to be removed from mailing lists for promotional material should be respected but full mailing lists should be maintained in order to permit provision of important information concerning adverse reactions, precautions, warnings, etc. 8. AUDIO-VISUAL AND COMPUTER-BASED PROMOTIONAL MATERIALS Promotional information provided using these media must fulfill the relevant requirements for printed material, as set out in Section 7. Prescribing information may be omitted provided that complete product information is made available to the audience. 9. SAMPLES 9.1. Giving away of "samples" as an inducement to purchase is prohibited. Reasonable quantities of samples (including patient starter packs), clearly identified as such, may be supplied to the prescribing professions 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 sold. 9.2. Samples must not be used for clinical studies. 9.3. Where samples of products restricted by law to supply on prescription are distributed by a representative, the sample must be handed directly to the doctor or given to a person authorised to receive the sample on his behalf. 9.4. Control and Accountability : Companies should have adequate systems of control and accountability for samples provided to healthcare professionals including how to look after such samples whilst they are in possession of medical representatives. 10. ADMINISTRATION OF THE CODE. 10.1 Submission of Complaint. Members that are involved in any dispute should treat that any complaint to the Marketing Practices Committee is a last resort action to resolve the issue after they have exhausted all reasonable avenues, including contacts between the CEOs of both companies, to resolve it amicably. All complaints on breach of SAPI Marketing Code of Practice, must be made in writing and submitted by the CEO of the complainant company (in order that the CEO of that company is aware that a complaint has been submitted) together with a processing fee of $1,500.00 to SAPI. It will first be validated to ensure that:
The minimum information required is: Source of the complaint
Company For each case in the complaint, the identity of company which is alleged to be in breach of the Code, and the name of any product(s)/marketing activities which are specifically involved. Reference material For each case, a specific reference to the source of the advertisement/activity which is the subject of the complaint of printed material or other evidence. Date The date of the alleged breach of the Code. Summary For each case, brief description of the complaint with a specific reference to the part of the Code under which the complaint is being made (section & paragraph numbers) 10.1.1 All complaints of breaches of the Code against member companies must be sent directly to SAPI instead of through third parties, e.g. Health Sciences Authority,Ministry of Health. If a complaint against a member company is referred or re-directed to SAPI by any third party, the complaining member company must pay the applicable processing fee to SAPI to review the complaint. 10.1.2 Externally generated complaints from doctors, pharmacists or members of the public against any member company will be dealt with in the same manner as if they came from a member company,except that no processing fee will be levied on the complainant. 10.2. Marketing Practices Committee Members. 10.2.1. The Marketing Practices Review Committee (MPC) for the review of any complaint shall consist of at least 50% of the MPC voting members, subject to a minimum of 5 members and 1 secretariat staff. The MPC members are unique for each case, to prevent any lack of quorum if there is a conflict of interest. 10.2.2. If there is a lack of quorum due to the members being the affected parties in the complaint, the MPC can call upon any member that the MPC deems suitable, to serve under the MPC for a particular case. 10.2.3. The secretariat staff is the Executive Director of SAPI and will not have the voting rights. 10.3. Review Procedures Any complaint against a breach of SAPI Code of Marketing Practice should be addressed to the Marketing Practices Committee c/o SAPI. See Appendix A for the summary of the procedures. 10.3.1. A single complaint may cover more than one 'case', i.e. the complaint may refer to several advertisements from different companies and/or for different products. Each 'case' is handled separately by the Marketing Practices Committee (MPC) under the main complaint reference. Complainant's processing fee of $1,500 (Singapore Dollars One Thousand Five Hundred Only) is deposited payable to SAPI upon submission of complaint. 10.3.2. The MPC shall table the complaint at a meeting within 6 weeks of receipt of the complaint from the Secretariat to decide if there is a case for the subject company to address. Whenever necessary, the member against whom the complaint is lodged shall be requested by the MPC to give rebuttal to the allegations. 10.3.3. If, after due consideration, the MPC concludes that there has been a breach of the Code, the offender shall be asked to give an undertaking in writing to stop the activity which is in breach of the Code with immediate effect and not to commit a similar offence in future. The respective company should respond to the decision of the MPC within 14 working days starting from the receipt of MPC decision. The processing fee of $1,500 will be refunded to the complainant within 14 working days and the offending company will pay to SAPI the $1,500 processing fee instead. If the MPC concludes there has not been a breach of the Code, then the complainant's processing fee will be forfeited. The MPC may impose an administration fee of up to $10,000 over and above the processing fee of $1,500 on member companies found guilty of infringements of the Code. The additional administration fee levied will be pegged to the severity of the infringement and the time and resources required to deliberate on the case. 10.3.4. The offending company can appeal the MPC decision within 14 working days and submit the appeal in writing together with a processing fee of $5,000. The MPC will convene an Appeal Committee (AC) within 6 weeks of the receipt of the letter. Please refer to section 10.4 for the make up of the Appeal Committee. The AC decision will take effect after the approval and endorsement by Board of Directors. The affected parties will comply immediately. If the AC upholds the MPC decision, then the processing fee of $1,500 will be refunded to complainant within 14 working days and the appellant's processing fee of $5,000 will be forfeited. If the AC overturns the MPC decision, then the appellant's processing fee of $5,000 will be refunded within 14 working days and the complainant's processing fee will be forfeited. 10.3.5. The complainant can appeal the MPC decision within 14 working days of the receipt of the decision and submit the appeal in writing together with the additional fee of $3,500 for a total processing fee of $5,000. The MPC will convene an Appeal Committee (AC) within 6 weeks of the receipt of the letter. Please refer to section 10.4 for the make up of the Appeal Committee. The AC decision will take effect after the approval and endorsement by Board of Directors. The affected parties will comply immediately. If the AC upholds the MPC decision, then the appellant's processing fee of $5,000 will be forfeited. If the AC overturns the MPC decision, then the appellant's processing fee of $5,000 will be refunded within 14 working days and the offending company will pay to SAPI the $1,500 processing fee instead. 10.3.6. In the event of the member being unwilling to comply with the decision of MPC and/or AC, and/or that the breach of the Code is perpetuated, the Marketing Practices Committee shall report its finding to the Board of Directors who may then decide whether to refer the matter to the member's parent company or head-office or publish the matter in the MPC's Quarterly Report. 10.4. Appeal Committee 10.4.1. The appeal committee shall consist of a Chairman, 4 committee members and 2 members of the expert group and a secretariat staff. Please see Appendix B for the summary. 10.4.2. The Chairman nominated by the Board of Directors (BOD) of SAPI must be a member of the Board of Directors of SAPI. 10.4.3. The 4 committee members must be made up of the Chairman of MPC, one member nominated by the offending company, one member nominated by the appealing company and one member nominated by the BOD of SAPI. If the Chairman of the MPC is a party in the complaint, then the Chairman of the Appeal Committee will appoint one of the MPC members to replace the Chairman of the MPC. The nominees must be either medical doctors or pharmacists who are working with any member of SAPI, excluding the affected members involved in the dispute. (see Appendix B) 10.4.4. The 2 members of the expert group shall consist of any member from either the Singapore Medical Association or Pharmaceutical Society of Singapore. 10.4.5. The secretariat staff is the Executive Director of SAPI. 10.4.6. All appeal committee members will have voting rights except the secretariat staff. 10.5. Sanctions. 10.5.1. In addition to the sections 10.3.3. to 10.3.6., the BOD may apply the following sanctions; 10.5.1.1. In the case of international companies, the matter will be referred to the Head Office of the Company, informing it of the case and the Board of Director's decision and appealing to the Head Office to persuade their subsidiary to comply, by withdrawing the offending material, or discontinuing the practice not later than 4 weeks from the date of the communication. 10.5.1.2. In the interim, the BOD can invoke SAPI constitution paragraph 16 (b) to suspend subject company up to the date of an Extraordinary General Meeting being convened under SAPI Constitution paragraph 9 (e). 10.5.1.3. If no indication of the withdrawal of the material or discontinuance of the practice is received by the set deadline, then the Board of Directors will inform the IFPMA of the matter and take action under Constitution's paragraph 9 (d) and 16 (b) for the termination of the subject company from the Association. 10.5.1.4. In the case of other companies, the BOD can invoke SAPI Constitution paragraph 16 (b) to suspend the company for a period up to the date of an Extraordinary General Meeting being convened under SAPI Constitution in paragraph 9 (e) and take action under Constitution's paragraph 9 (d) and 16 (b) for the termination of the subject company from the Association. 10.5.2. The decision of the Board of Directors in the matter shall be final and information on above sanctions may be made known to the Health Sciences Authority, as well as Script, Market Letter and any other relevant publication, and included in the regular reports of the Marketing Practices Committee and the Annual Report of the Board of Directors to members. 10.5.3. Any details of complaints on alleged breaches of the Code, the decisions of the Marketing Practices Committee and the Appeal Committee and subsequent actions taken by all parties in the matter may not be used by the complainant or the subject company for any publicity or promotional purposes. 10.5.4. The Marketing Practices Committee, the Appeal Committee, the Board of Directors, SAPI and its staff, including individuals serving in any capacity in these committees, shall not be subject to any legal action by any party on decisions taken relating to the complaint. DATE OF REVISION, MARCH 2006 Appendix A: Summary of Marketing Practices Review Procedures.
APPENDIX A.1
Appendix B: Marketing Practices Committee and Appeal Committee
|
|||||||||||||||||||||||||||
