POLICY MANUAL on the MARKETING OF BREASTMILK SUBSTITUTES
WYETH PHILIPPINES, INC. POLICY MANUAL on the MARKETING OF BREASTMILK SUBSTITUTES _____________ _________ Policy Author/ Issuing Department Medical Department Mandatory Jan 2014 __________ Po Target Audience All WPI employees, interested members of the public ________ Related Group Principles/ Policies, Standards or Guidelines WHO International Code of Marketing of Breastmilk Substitutes, 1981 EO 51, National Code of Marketing of Breastmilk Substitutes, Breastmilk Supplements and Related Products AO No. 2006-0023, Revised Implementing Rules and Regulations of EO 51 Nestlé Global Charter of Do’s and Don’ts Nestlé Global Policy and Instructions, July 2010 Nestlé Philippines, Inc. Policy Manual, March 2011 Approvers WPI WHO Code Compliance Manager WPI President and General Manager Date of Publication January 2014 Copyright and confidentiality The content of this document may not be reproduced without proper authorization. All rights belong to Wyeth Philippines, Inc. Page 1 of 38 Table of Contents ACRONYMS AND DEFINITION OF TERMS .................................................................. 3 AIM OF THE POLICY MANUAL ................................................................................... 4 MARKET HEAD STATEMENT ...................................................................................... 5 DEFINITION OF TERMS AND PRODUCTS WITHIN THE SCOPE OF THE CODE.............. 6 STATEMENT OF OVER-ALL PRINCIPLES ................................................................... 10 RELATIONSHIP WITH THE GENERAL PUBLIC AND MOTHERS .................................. 12 RELATIONSHIP WITH HEALTHCARE WORKERS AND FACILITIES ............................... 19 PROVISION OF FREE SUPPLIES AND MEDICAL CHANNEL PRICING .......................... 24 PRODUCT QUALITY AND LABELING ......................................................................... 27 MONITORING AND REPORTING .............................................................................. 31 Page 2 of 38 I. ACRONYMS AND DEFINITION OF TERMS ACRONYM AO BFAD DOH EO FDA HCP IAC IFS IRB IIR LT NMA RIRR WHO WHA WPI WPI PGM Page 3 of 38 DEFINITION Administrative Order Bureau of Food and Drugs Department of Health Executive Order Philippine Food and Drug Administration (formerly known as BFAD) Healthcare Professional Inter-Agency Committee Infant Feeding Scheme Institutional Review Board Investigator-Initiated Research Leadership Team Nestlé Market Audit Revised Implementing Rules and Regulations World Health Organization World Health Assembly Wyeth Philippines, Inc. WPI President and General Manager AIM OF THE POLICY MANUAL II. AIM OF THE POLICY The primary aim of this Manual is to lay down the policies that Wyeth Philippines, Inc. has implemented in the marketing of breastmilk substitutes in a responsible and ethical manner, as defined in the: WHO International Code of Marketing of Breastmilk Substitutes – WHO 1981 (WHO Milk Code), WHA Recommendation on Infant and Young Child Nutrition – May 2001 (WHA Recommendation 54.2), National Code of Marketing of Breastmilk Substitutes - October 1986 (EO 51) and its Revised Implementing Rules and Regulations – AO 2006-0012 – May 2006 (RIRR), as well as Global Nestlé Policy and Instructions, and The Philippine Supreme Court Ruling on the RIRRs of EO51, G.R. No. 156041, February 21, 2007, PHAP vs. DOH. It provides strict guidelines to the management of personnel concerned at all levels in the marketing of breastmilk substitutes to ensure that the Company’s marketing practices are in line with all the provisions of these Codes. We seek to ensure also that all personnel employed by WPI, as well as all agents, distributors and merchandisers involved in the marketing and sales of breastmilk substitute products have a full understanding and comply strictly with all the provisions of the above-mentioned Codes. This manual also serves as the driving document of our management system for full compliance which includes procedures and monitoring systems. IMPLEMENTATION It is the responsibility of the management of WPI to ensure that the policies embodied in this document are implemented throughout all relevant departments and followed in both letter and spirit. In line with our leadership principles, they must take the lead in demonstrating WPI’s commitment to this policy and enlisting the interest, participation and support of employees in promoting compliance with the WHO Milk Code, EO 51 and its RIRR in the marketing of breastmilk substitutes. Page 4 of 38 MARKET HEAD STATEMENT III. As a result of the global acquisition of Wyeth Nutrition by Nestle S.A. (“Nestle”), WPI is now a Nestle-affiliate company. Nestlé is committed to the World Health Organization’s International Code of Marketing of Breastmilk Substitutes – WHO 1981 (WHO Code), which aims to protect and promote breastfeeding while recognizing that there is a legitimate market for infant formula when breastfeeding is not possible, and Resolution 54.2 adopted by the World Health Assembly May 2001 (the WHA Recommendation on Infant and Young Child Nutrition). In the Philippines, the WHO Code has been implemented through the provisions of Executive Order 51 - October 1986 (Philippine Code of Marketing of Breastmilk Substitutes) and its Revised Implementing Rules and Regulations (AO 2006-0012 - May 2006) herein after called EO 51 and its RIRR, to which WPI is fully committed to comply as well as the WHO Code, WHA Recommendation 54.2 and Nestle Policy and Instructions, whichever is stricter. Like all other Nestle subsidiaries in the developing world, internal and external auditors regularly audit our marketing practices of breastmilk substitutes. Additionally, WPI has implemented an Internal Ombudsman system for employees to report alleged violations of the WHO Code, WHA Recommendation 54.2, Executive Order 51 and its Revised Implementing Rules and Regulations as well as WPI Policy and Instructions independent of normal management reporting lines. In addition to these control mechanisms, a Management System is also in place and implemented to ensure consistent and complete adherence to the combined purpose of all of these Codes. The Management System comprises: 1. A Policy Manual 2. A Procedures Manual which details the procedures that must be followed to ensure compliance with our policies; and 3. A set of instructions for the personnel which comprise forms for approval, monitoring and reporting. The system is reinforced through regular training of all our personnel and internal audits. Page 5 of 38 IV. DEFINITION OF TERMS AND PRODUCTS WITHIN THE SCOPE OF THE CODE DEFINITION OF TERMS For the purpose of this Policy Manual, the following definition of terms from the WHO Milk Code, EO 51 and its RIRR shall govern. Advertising Any representation by any means whatsoever for the purpose of promoting the sale and distribution of breast milk substitutes/supplements and other related products under the scope of the WHO Milk Code. [RIRR Section 5 (a)] Breastmilk substitute Any food being marketed or otherwise represented as partial or total replacement for breast milk, whether or not suitable for that purpose. [WHO Code Article 3, EO Section 4 (a), RIRR Section 5 (c)] Complementary Food Means any food, except milk substitutes, whether manufactured or locally prepared, suitable as a complement to breast milk to satisfy the nutritional requirements of the infant. Such food is also called “weaning food” or “breastmilk supplement.” [WHO Code Article€ 3, EO 51 Section 4 (b)] Means any food, except milk substitutes, whether manufactured or locally prepared, suitable as a complement to breastmilk to satisfy the nutritional requirements of the infant. [RIRR Section 5 (e)] Container Any form of packaging of products for sale as a normal retail unit, including wrappers. [WHO Code Article€ 3, EO 51 Section 4 (c), RIRR Section 5 (f)] Distributor A person, corporation or any other entity in the public or private sector engaged in the business (whether directly or indirectly) for marketing at the wholesale or retail level a product within the scope of the Code. A primary distributor is a manufacturer’s sales agent, or representative, national distributor. [WHO Code Article€ 3, EO 51 Section 4 (d), RIRR Section 5 (g)] Gifts of any sort Any form of financial, personal or commercial reward, inducement, incentives and other favors provided directly or indirectly by manufacturers, distributors, and their representatives, of products within the scope of the Code. [RIRR Section 5 (l)] Health care system Governmental, non-governmental or private institutions or organizations engaged, directly or indirectly, in health care for mothers, infants and pregnant women; and nurseries or child-care institutions. It also includes health workers in private practice. For the purpose of this Code, the healthcare system does not include pharmacies or other established sales outlets. [WHO Code Article 3, EO51 Section 4 (f)] Page 6 of 38 Governmental, non-governmental or private institutions or organizations engaged, directly or indirectly, in health care for mothers, infants or pregnant women, and nurseries or child-care institutions. [RIRR Section 5 (k)] Healthcare Worker A person working in a component of such health care system, whether professional or non-professional, including voluntary, unpaid workers. [WHO Code Article 3. EO Section 4 (g) A person working in a component of such a healthcare system, whether professional or non-professional, including volunteer workers. It also includes healthcare workers in private practice. Traditional and other birth attendants, their assistants and other community volunteers involved in health and nutrition promotion and education shall likewise be covered. [ RIRR Section 5 (m) ] Infant A person within the age bracket of 0 – 12 months. [ RIRR Section 5 (n) ] Infant Formula A breast-milk substitute formulated industrially in accordance with applicable Codex Alimentarius standards, to satisfy the normal nutritional requirements of infants up to between four and six months of age, and adapted to their physiological characteristics. Infant formula may also be prepared at home, in which case it is described as "home prepared". [ WHO Code Article 3, EO 51 Section 4 (h)] A breast-milk substitute formulated industrially in accordance with applicable Codex Alimentarius standards. [RIRR Section 5 (o) ] Label Any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed or impressed on, or attached to, a container of any product within the scope of this Code. [WHO Code Article 3, EO 4 (i) RIRR Section 5 (p)] Manufacturer A corporation or other entity in the public or private sector engaged in the business function (whether directly or through an agent or an entity controlled by or under contract with it) of manufacturing a product within the scope of this Code. [WHO Code Article 3, EO 4 Section (i)1 RIRR Section 5 (r)] Marketing Product promotion, distribution, selling, advertising, product public relations, and information services. [WHO Code Article 3, EO Section 4 (k)] Page 7 of 38 Marketing materials and/or services The promotion, distribution, selling, advertising, public relations, information services, internet promotion and communication and information dissemination, in whatever form, including but not necessarily limited to, email, text messages, telephone calls, website advertising, television, motion pictures, stage plays and radio programs, whether live or taped. [RIRR Section 5 (t)] Marketing personnel Any person whose functions involve the marketing of a product or products coming within the scope of this Code. [WHO Code Article 3, EO 51 Section 4 (l), RIRR Section 5 (u)] Milk company Refers to the owner, manufacturer, and distributor of infant formula, followup formula, milk formula, milk supplement, breast milk substitute or replacement, or by any other description of such nature, including their representatives who promote or otherwise advance their commercial interests in marketing those products. [RIRR Section 5 (w)] Promotions Employing any method, scheme, or design, of directly or indirectly, encouraging or enticing people, or group of persons, in whatever for, whether by chance or skill, to purchase or acquire products within the scope of this Code. [RIRR Section 5 (bb)] Samples Single or small quantities of a product provided for without cost. [WHO Code Article 3, EO 51 Section 4 (m)] Single or small quantities of a product provided for free. [RIRR Section 5 (cc)] Supplies Quantities of a product provided for use over an extended period, free or at a low price, for social purposes, including those provided to families in need. [WHO Code Article 3, EO 51 Section 4 (n), RIRR Section 5 (ee)] Young Child A person from the age of more than twelve (12) months up to the age of three (3) years (36 months). [RIRR Section 5 (ff)] Page 8 of 38 PRODUCTS COVERED BY THIS POLICY MANUAL This Manual applies to the marketing, promotion, advertising, selling and distribution of the following WPI products under the scope of the WHO Milk Code, EO 51 and its RIRR, as well as Global Nestlé Policy and Instructions: 1. Infant Formulas (0-6 months) - Bonna - S-26 - S-26 Gold 2. Infant Formulas (0-12 months) - S-26 HA Gold 3. Follow-On Formulas (6-12 months) - Bonamil - Promil - Promil Gold 4. Milk Supplements (12-36 months) - Bonakid - Promil Kid - Progress Gold 5. Formulas for Special Medical Purpose - S-26 LF Gold - S-26 Soy Gold - Promil LF Gold This WPI Policy Manual on the Marketing of Breastmilk Substitutes shall only apply to products included and/or listed in this policy manual. The list shall be updated accordingly as new products falling under the above categories are introduced to the market. Page 9 of 38 V. STATEMENT OF OVER-ALL PRINCIPLES STATEMENT OF OVER-ALL PRINCIPLES WPI’s policy on the marketing of breastmilk substitutes is aligned with the Nestlé policy, which is based on its founder Henri Nestlé’s insistence that every mother who is able to do so should breastfeed her own baby. This principle is still the cornerstone of Nestlé policy today. Our Corporate Business Principles (Nestlé S.A. 2010) state that Nestlé encourages and supports breastfeeding as the best start in life. When breastfeeding is not possible, there is a pressing need for an appropriate breastmilk substitute. This principle is enshrined in the WHO Milk Code, which recognizes a legitimate market for breastmilk substitutes and states one of its aims as being to ‘ensure the proper use of breastmilk substitutes, when these are necessary, on the basis of adequate information and through appropriate marketing and distribution’. WPI is committed to follow the WHO Milk Code. As the WHO Milk Code was adapted as a recommendation to governments, to which it gives the responsibility to implement its aim and principles according to their legislative and social framework. WPI’s policy is to ensure that its marketing practices of Code-covered products conform strictly to national legislation, regulations, or other measures taken by governments to give effect to the aim and principles of the WHO Milk Code. Additionally, in all higher risk countries, Wyeth has decided to unilaterally and voluntarily implement the recommendations of the WHO Milk Code and relevant resolutions subsequently passed by the WHA, when those recommendations are clear enough to be followed and when those recommendations do not conflict with corresponding national regulations or measures. Whenever national regulations or measures are introduced, our policy is to comply with those regulations or measures. However, if the WHO Milk Code is more stringent in any of its recommendations than national regulations or measures, we follow the relevant recommendations of the WHO Milk Code. OUR ROLE IN SOCIETY As a nutrition company, our vision is to be a leading diversified food company known in every village through both its products’ quality, and its people’s reliability, caring, honesty and exemplary service. Our ambition is to be the Nutrition, Health and Wellness Company in the Philippines. • For our people, this means being the preferred employer; we should be a creative, exciting, enjoyable and rewarding place to work and grow in. • For our government, we strive to be a socially and environmentally responsible corporate citizen. • For our consumers, we aim to maintain and build trust whilst constantly innovating, and for our customers, we seek to be a pragmatic, business- focused partner of preference. Page 10 of 38 COMMITMENT TO MATERNAL AND CHILD NUTRITION Good food and nutrition are essential to life, health and well-being. WPI is first and foremost a nutrition company, and as such we are committed to playing an important role in providing safe, nutritious and appropriate foods to infants and young children. Working in partnership with government, health care providers and others, we seek to contribute to the development of national policies that promote safe and appropriate feeding practices for infants and young children. We believe our role is to improve standards in the industry as a whole, as well as within our own company. Page 11 of 38 VI. RELATIONSHIP WITH THE GENERAL PUBLIC AND MOTHERS THE RELEVANT CODE ARTICLES WHO MILK CODE EO 51 and its RIRR Article 4.2 EO 51 Section 5 (b) Informational and educational materials, whether written, audio, or visual dealing with the feeding of infants and intended to reach pregnant women and mothers of infants , shall include clear information on all the following points: 1) the benefits and superiority of breastfeeding; 2) maternal nutrition and the preparation for and maintenance of breastfeeding; 3) the negative effect on breastfeeding of introducing partial bottle feeding; 4) the difficulty of reversing the decision not to breastfeed; and 5) where needed the proper use of infant formula, whether manufactured industrially or home- prepared. When such materials contain information about the use of infant formula, they shall include the social and financial implications of its use; the health hazards of inappropriate foods or feeding method; and in particular, the health hazards of unnecessary or improper use of infant formula and other breast milk substitutes. Such materials shall not use any picture or text which may idealize the use of breast milk substitutes. Informational and educational materials, whether written, audio, or visual dealing with the feeding of infants and intended to reach pregnant women and mothers of infants, shall include clear information on all the following points: 1) the benefits and superiority of breastfeeding; 2) maternal nutrition and the preparation for and maintenance of breastfeeding; 3) the negative effect on breastfeeding of introducing partial bottle feeding; 4) the difficulty of reversing the decision not to breastfeed; and 5) where needed the proper use of infant formula, whether manufactured industrially or homeprepared. When such materials contain information about the use of infant formula, they shall include the social and financial implications of its use; the health hazards of inappropriate foods or feeding method; and in particular, the health hazards of unnecessary or improper use of infant formula and other breast milk substitutes. Such materials shall not use any picture or text which may idealize the use of breast milk substitutes. RIRR Section 8 (b) Informational and educational materials intended to reach pregnant women and mothers of infants, including women of reproductive age, which materials shall include clear information on all of the ensuing: 1) the benefits and superiority of breastfeeding; 2) maternal nutrition and the preparation for and maintenance of breastfeeding; 3) the negative effect on breastfeeding of introducing partial bottle feeding; 4) the difficulty of reversing the decision not to breastfeed; and 5) where needed the proper use of infant formula, whether manufactured industrially or home-prepared. When such materials contain information about the use of infant formula, they shall include the social and financial implications of its use; the health hazards of unnecessary or improper use of infant formula and other related products including information that powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately. Page 12 of 38 Article 5.1 There should be no advertising or other form of promotion to the general public of products within the scope of this code. EO 51 Section 6 (a) No advertising, promotion or other marketing materials, whether written, audio or visual, for products within the scope of this Code shall be printed, published, distributed, exhibited and broadcasted unless such materials are duly authorized and approved by an inter-agency committee created herein pursuant to the applicable standards provided for in this Code. RIRR Section 12, 13 & 14 Section 12: Authority of the Inter-Agency Committee (IAC) The Inter Agency Committee (IAC) shall review all advertising, promotion or other marketing materials, whether written, audio, visual, cinema, theater, audio-visual and electronics, including but not limited to mail, email, text messages, telephone calls and website advertising, and for communication and information disssemination in any form, for products within the scope of this Code. The Committee shall develop/update substantive and procedural guidelines for reviewing advertising, promotional and marketing materials, including its screening when deemed appropriate. All such materials must have been approved and consented to in writing by the Committee before the Company's first public or commercial exhibition. All approved advertisement and/or promotional materials to milk supplements, complementary food, feeding bottles and teats and related products must bear the messages both in English and in Filipino. The DOH, based on the latest scientific information and products, may modify the messages, provided that wide dissemination of the message to all concerned is ensured. Section 13: “Total Effect” Promotion of products within the scope of this Code must be objective and should not equate or make the product appear to be as good or equal to breastmilk or breastfeeding in the advertising concept. It must not in any case undermine breastmilk or breastfeeding. The “total effect’ should not directly or indirectly suggest that buying their product would produce better individuals, or resulting in greater love, intelligence, ability, harmony or in any manner bring better health to the baby or other such exaggerated and unsubstantiated claim. Page 13 of 38 Section 14: Prior Written Consent and Approval of Committee No advertising, promotion or other marketing materials whether written, audio, visual, audio-visual and electronic for products within the scope of this Code, which are marketed as partial or total replacement of breastmilk, including bottle-fed complementary foods shall be printed, published, distributed, exhibited and broadcasted or in any manner released to the public without the prior written consent and approval of the Committee. No blanket or general approval shall be allowed. Such written approval must be specific in product and time bound. Article 5.2 EO 51 Section 6 (b) Manufacturers and distributors should not provide, directly or indirectly, to pregnant women, mothers or members of their families, samples of products within the scope of this Code. Manufacturers and distributors shall not be permitted to give, directly or indirectly, samples of products within the scope of this Code or gifts of any sort to any member of the general public, including members of their families, to hospitals and other health institutions, as well as to personnel within the healthcare system, save as otherwise provided in this Code. RIRR Section 19 Manufacturers, distributors and marketing firms or their representatives of products within the scope of this Code are prohibited from donating or giving directly or indirectly samples and supplies to any member of the general public, to hospitals and other health facilities, including their personnel and members of their families. Article 5.3 EO 51 Section 6 (c) In conformity with paragraphs 1 and 2 of this article, there should be no point-of-sale advertising, giving of samples, or any other promotion device to induce sales directly to the consumer at the retails level such as special sales, loss-leaders and tie-in-sales, for products within the scope of this Code. This provision should not restrict the establishment of pricing policies and practices intended to provide products at a lower price on a long- term basis. There shall be no point-of-sale advertising, giving of samples or any other promotion devices to induce sales directly to the consumers at the retail level, such special displays, discount coupons, premiums, special sales, bonus and tie-in sales for the products within the scope of this Code. This provision shall not restrict the establishment of pricing policies and practices intended to provide products at lower prices on a long- term basis. RIRR Section 23 There shall be no point of sale advertising, giving of samples or any promotion devices to induce sales directly to the consumers at the retail level, such as special displays, discount coupons, premiums, rebates, special sales, bonus and tie-in sales, loss-leaders, prices or gifts for the products within the scope to this Code. Page 14 of 38 Article 5.4 Manufacturers and distributors should not distribute to pregnant women or mothers of infants and young children any gifts of articles or utensils, which may promote the use of breastmilk substitutes or bottlefeeding. EO 51 Section 6 (d) Manufacturers and distributors shall not distribute to pregnant women or mothers of infants any gifts or articles or utensils which may promote the use of breastmilk substitutes or bottlefeeding, nor shall any other groups, institutions, or any individuals distribute such gifts, utensils or products to the general public and mothers. RIRR Section 21 Section 21. Gifts of any sort from milk companies/ manufacturers, distributors, and representatives of products within the scope of this Code, with or without company name or logo or product or brand name shall not be given to any member of the general public, to hospitals and other health facilities, including their personnel and members of their families. Article 5.5 EO 51 Section 6 (e) Marketing personnel, in their business capacity, should not seek direct or indirect contact of any kind with pregnant women or with mothers of infants or young children. Marketing personnel shall be prohibited from advertising or promoting in any other manner the products covered by this Code, either directly or indirectly, to pregnant women or with mother of infants, except as otherwise provided by this Code. Article 8.2 EO 51 Section 9. Persons Employed by Manufacturers and Distributors Personnel employed in marketing products within the scope of this Code should not, as part of their job responsibilities, perform educational functions in relation to pregnant women or mothers of infants and young children. This should not be understood as preventing such personnel from being used for other functions by the healthcare system at the request and with the written approval of the appropriate authority of the government concerned. Personnel employed in marketing products within the scope of this Code shall not as part of their job responsibilities perform educational functions in relation to pregnant women or mothers of infants. RIRR Section 22 No manufacturer, distributor or representatives of products covered by the Code shall be allowed to conduct or be involved in any activity on breastfeeding promotion, education and production of Information, Education and Communication (IEC) materials on breastfeeding, holding of or participating as speakers in classes or seminars for women and children activities and to avoid the use of these venues to market their brands or company names. Page 15 of 38 Article 8.2 Personnel employed in marketing products within the scope of this Code should not, as part of their job responsibilities, perform educational functions in relation to pregnant women or mothers of infants and young children. This should not be understood as preventing such personnel from being used for other functions by the healthcare system at the request and with the written approval of the appropriate authority of the government concerned. EO 51 Section 9. Persons Employed by Manufacturers and Distributors Personnel employed in marketing products within the scope of this Code shall not, as part of their job responsibilities, perform educational functions in relation to pregnant women or mothers of infants. RIRR Section 22 No manufacturer, distributor or representatives of products covered by the Code shall be allowed to conduct or be involved in any activity on breastfeeding promotion, education and production of Information, Education and Communication (IEC) materials on breastfeeding, holding of or participating as speakers in classes or seminars for women and children activities and to avoid the use of these venues to market their brands or company names. Page 16 of 38 THE POLICY WPI does not advertise nor promote products within the scope of the WHO Milk Code, EO 51 and its RIRR to the general public, unless approval of the IAC is obtained. In keeping with the spirit of the Codes, we will ensure that all information and educational materials intended to reach pregnant women, mothers of infants and young children, and the general public affirm the principle that breast milk is the superior choice for feeding babies, do not promote the use of breastmilk substitutes, and have been approved by the IAC or the FDA. Internal communication materials/publications including those featured in the company's intranet are subject to the restrictions and principles that reiterate the superiority of breastfeeding until two (2) years of age and beyond. We will avoid undertaking marketing and promotional activities that are contrary to the principle that breastfeeding is best for babies. We will not offer samples nor any other inducement for mothers of infants and young children to use infant formula, nor will we undertake any sales-related or volume-related promotional activity at the retail level for products covered by the WHO Milk Code, EO 51 and its RIRR. We will use our influence and resources to ensure that our distributors and partners also comply with this policy. ____________________________________________________________________________________________ WE WILL: Carefully scrutinize general information and educational materials dealing with infant feeding or baby care that are intended for use by pregnant women or mothers to ensure that these comply with the provision of the WHO Milk Code (Article 4.2), EO 51 and its RIRR. Materials to which this policy applies may include educational materials dealing with baby care such as posters, educational charts, mother books, weight/growth charts and slide presentations, video cassette, DVD-ROM and the internet. Ensure that such information and educational materials: Do not mention brand names of products covered by WHO Milk Code, EO 51 and its RIRR Do not contain illustrations of infant formula or babies Have been approved by the IAC Ensure that such informational and educational materials are only distributed by healthcare workers. Provide written instructions to our advertising agents concerning what they can and cannot do to comply with this policy, and monitor them for compliance. Ensure, through our contractual relationships and communication with distributors and trade partners that they understand and comply fully with the provisions of the WHO Milk Code, EO 51 and its RIRR, as well as the Nestlé Global Policy and Instructions in the marketing of breastmilk substitutes and to train their personnel accordingly. Actively discourage distributors, wholesalers and retailers from using promotional devices and monitor them for compliance. This policy applies to the placing of infant formulas at store locations associated with promotions such as gondola ends. Support the Baby Friendly Hospital Initiative. Apply the Company’s Infant Feeding Scheme to our employees only upon presentation of the required doctor’s prescription. Page 17 of 38 WE WILL NOT: Advertise breastmilk substitutes indicated for infants from 0 to 12 months. However, unbranded scientific and factual advertorials in medical journals which are distributed strictly and only for healthcare professionals are allowed. Advertorials in medical journals which carry any branding of any Code-covered products should be cleared and approved by the IAC. Permit personnel whose responsibilities include the marketing of Code-covered products to make direct contact with mothers, except in response to consumer complaints. Distribute samples of products covered by WHO Milk Code, EO 51 and its RIRR to pregnant women, mothers of infants and young children; and the general public including those employed by WPI. Provide gifts of any sort to pregnant women, mothers and the general public. Produce or provide to our distributors, agents or retailers any point of sale materials that advertise or promote products covered by WHO Milk Code, EO 51 and its RIRR. Allow our infant formula marketing and sales personnel to perform educational functions, conduct door-to-door selling, or seek direct or indirect contact with pregnant women, or mothers of infants and young children in their business capacity. Demonstrate feeding with infant formula to pregnant women mothers and the general public or sponsor Mommy events that promote the use of products under the scope of WHO Milk Code, EO 51 and its RIRR. Use price for promotional purposes nor offer discounts, coupons redemption schemes, raffles or lotteries and rebates in the sale of products covered by the scope of WHO Code, EO 51 and its RIRR as well as in the Nestle Global Policy and Instructions. Engage in point-of-sale promotion. Give deals, gifts, special displays or exhibitions, including merchandising display contests. Commission promotional attendants or brand ambassadors to push sales of breast milk substitutes at the retail level. Page 18 of 38 VII. RELATIONSHIP WITH HEALTHCARE WORKERS AND FACILITIES RELEVANT CODE ARTICLES WHO MILK CODE EO 51 and its RIRR Article 7.2 EO 51 Section 8 (b) Information provided by manufacturers and distributors to health professionals regarding products within the scope of this Code should be restricted to scientific and factual matters, and such information should not imply or create a belief that bottlefeeding is equivalent or superior to breastfeeding. It should also include information specified in Article 4.2. Information provided by manufacturers and distributors to health professionals regarding products within the scope of this Code shall be restricted to scientific and factual matters and such information shall not imply or create a belief that bottlefeeding is equivalent or superior to breastfeeding. It shall also include information specified in Section 5. Article 7.2 EO 51 Section 8 (c) & Section 8 (e) No financial or material inducements to promote products within the scope of this code should be offered by manufacturers or distributors to health workers or members of their families, nor should these be accepted by health workers or members of their families. No financial or material inducements to promote products within the scope of this Code shall be offered by manufacturers or distributors to health workers or members of their families, nor shall these be accepted by health workers or members of their families except as otherwise provided in Section 8 (e). Article 7.5 EO 51 Section 8 (e) Manufacturers and distributors of products within the scope of this Code should disclose to the institution to which a recipient health worker is affiliated any contribution made to him or on his behalf for fellowships, study tours, research grants, attendance at professional conferences, or the like. Similar disclosures should be made by the recipient. Manufacturers and distributors of products within the scope of this Code may assist in the research, scholarships and continuing education of health professionals in accordance with the rules and regulations promulgated by the Ministry of Health. RIRR Section 9. Research, Ethics Committee, Purpose The DOH shall ensure that research conducted for public policy purposes, relating to infant and young child feeding should, at all times, be free from any commercial influence/bias; accordingly, the health worker or researcher involved in such must disclose any actual or potential conflict of interest with the company/person funding the research. In any event, such research and its findings shall be subjected to independent peer review. Towards accomplishing these ends; a. Assistance for research and clinical trials given by manufacturers and distributors are allowed only upon approval by an ethics committee led by DOH. The same committee shall monitor said researches. The researches shall be conducted in accordance with an approved protocol. Any changes in the protocol after it has been approved will be subject to a new review and approval by the Ethics Committee. Page 19 of 38 b. Assistance for research may be allowed subject to the following conditions: c.1. Researches involving well or ill infants and children as subjects shall be limited to physiological factors and therapeutic studies; c.2. These studies should in no case be harmful to the subject, and c.3. Should be limited to those with potential benefits for the particular subject. c. d. Recipients of research awards shall not allow themselves, their organizations or their subjects, to be used directly or indirectly for any promotional activity related to products within the scope of the Code. These may be by way of display of posters and streamers patronizing the Company, their products, and/or as lectures/speakers or testimonials in the promotion of the products that undermine breastfeeding. Assistance for support of laboratory costs, reagents and other materials shall be allowed only upon approval and review by the Ethics Committee regarding their use based on a submitted protocol. Section 10. Public Disclosure For transparency purposes, a disclosure and/or disclaimer of the sponsoring company should be done by the company itself, health worker, researcher involved through verbal declaration during the public presentation of the research and in print upon publication. Article 7.4 EO 51 Section 8 (d) Samples of infant formula or other products within the scope of this Code, or of equipment or utensils for their preparation or use, should not be provided to health workers except when necessary for the purpose of professional evaluation of research at the institutional level. Health workers should not give samples of infant formula to pregnant women, mothers of infants and young children or members of their families. Samples of infant formula or other products within the scope of this Code, or of equipment or utensils for their preparation or use, shall not be provided to health workers except when necessary for the purpose of professional evaluation or research in accordance with the rules and regulations promulgated by the Ministry of Health. No health worker shall give samples of infant formula to pregnant women and mothers of infant or members of their families. RIRR Section 19 Manufacturers, distributors and marketing firms or their representatives of products within the scope of this Code are prohibited from donating or giving directly or indirectly samples and supplies to any member of the general public, to hospitals and other health facilities, including their personnel and members of their families. Page 20 of 38 Article 6.8 Equipment and materials, in addition to those referred to in Article 4.3, donated to a healthcare system may bear a company's name or logo, but should not refer to any proprietary product within the scope of this code. RIRR Section 52. Other Donations by Milk Companies not covered by this Code. Donations of products, equipment and the like, not otherwise falling within the scope of this Code or these Rules, given by Milk companies and their agents, representatives, whether in kind or in cash, may only be coursed through the Inter Agency Committee (IAC), which shall determine whether such donation be accepted or otherwise. Article 6.2 EO 51 Section 7 (b) No facility of the healthcare system should be used for the purpose of promoting infant formula or other products within the scope of this Code. This code, does not however, preclude the dissemination of information to health professionals as provided in Article 7.2 No facility of the healthcare system shall be used for the purpose of promoting infant formula or other products within the scope of this Code. This Code does not, however, preclude the dissemination of information to health professionals as provided in Section 8(b). Article 6.3 RIRR Section 35. No Promotions. Facilities of health care system should not be used for the display of products within the scope of this Code, for placards, or posters concerning such products, or for the distribution of material provided by manufacturer or distributor other than the specified in Article 4.3 The health workers and the healthcare system shall not be used for dissemination, distribution and promotion of products within the scope of this Code. No healthcare facility should be used for promotion of products within the scope of this Code nor as venues that undermine breastfeeding. Article 6.4 The use by the healthcare system of « professional service representatives », « mothercraft nurses » or similar personnel provided or paid by manufacturers or distributors should not be permitted. Page 21 of 38 THE POLICY In keeping with the letter and spirit of the WHO Milk Code, EO 51 and its RIRR and the Nestle Global Policy and Instructions, we will ensure that the information we provide to healthcare workers emphasizes the importance of safe and adequate nutrition to infants and young children and affirms the superiority of breastfeeding as the best choice of nutrition for babies up to 2 years and beyond. We will ensure that the information we provide is strictly scientific and factual. We will not conduct promotional activities at the healthcare facilities with respect to products covered by these Codes. We support scientific activities such as conventions, congresses, scholarship, study tours and provision of educational materials that aim to help HCPs acquire up-to-date knowledge and further develop their professional capabilities in order to serve patients better. We ensure that there is NO link between WPI's sponsorship of such activities and the HCP's use nor promotion of products covered by the above-mentioned Codes. WE WILL: Restrict materials and activities intended for healthcare workers regarding products within the scope of the Codes to factual and scientific matters. Ensure that all informational materials that are promotional in nature have been approved by the IAC before these are distributed to the healthcare workers and healthcare facilities. Maintain records of all informational materials given to healthcare workers and healthcare facilities, including those materials “for use with medical professionals only” for traceability. Provide clear instructions to our marketing personnel and reinforce through training, what they can and cannot say to healthcare workers when describing the characteristics of products covered by the Codes. These include instructions to emphasize the superiority of breastfeeding over infant formula. Actively participate in activities aimed at raising the level of healthcare workers’ awareness and understanding of the Codes in close collaboration with the DOH and the Medical and Paramedical Associations. Inform healthcare workers and healthcare facilities that purchased products within the scope of the Codes should be limited to the hospital pharmacy and should not be displayed. These should be kept in a closed cabinet for emergency use. Evaluate requests of the healthcare workers who are endorsed by the DOH or officer of health institutions or medical associations to which they belong for sponsorship of continuing medical education activities/educational materials. Ensure that grants given to healthcare workers are not in any way linked to their support or prescription of products covered by the Codes. Maintain records of sponsorships made in support of continuing medical education of healthcare workers up to thirty-six (36) months. Page 22 of 38 WE WILL NOT: Use false or misleading information or claims for products within the scope of the Codes. Display products, placards, or posters featuring products within the scope of the Codes at the healthcare facilities. Allow informational and educational materials relating to the use of products within the scope of the Codes to be displayed publicly in the healthcare facilities. Allow Medical Field Operations personnel to promote products within the scope of the Codes in the hospital. Act in the capacity of professional service representatives, mothercraft nurses or use medical personnel to promote products covered by the Codes to the public. Provide samples and free supplies of products covered by the Codes to any member of the general public, health workers and healthcare facilities, including their personnel and members of their families. Give financial or material incentives to healthcare workers or healthcare facilities, including their personnel and members of their families for the purpose of promoting or using products within the scope of the Codes. Give gifts of any sort to any member of the general public, to hospitals and other healthcare facilities, including their personnel and members of their families Use sponsorships/provision of educational materials to induce recipients to promote products within the scope of the Codes. Use health workers and the healthcare system in the dissemination, distribution, and promotion of products within the scope of the Codes. Be involved in any activity on breastfeeding promotion, education and production of Information, Education and Communication (IEC) materials on breastfeeding. Page 23 of 38 VIII. PROVISION OF FREE SUPPLIES AND MEDICAL CHANNEL PRICING RELEVANT CODE ARTICLES WHO MILK CODE EO 51 and its RIRR Article 5.3 EO 51 Section 6 (c) In conformity with paragraphs 1 and 2 of this article, there should be no point-of-sale advertising, giving of samples or any other promotion device to induce sales directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales, loss-leaders and tie-in sales, for products within the scope of this Code. This provision should not restrict the establishment of pricing policies and practices intended to provide products at lower prices on a long- term basis. There shall be no point-of-sale advertising, giving of samples or any other promotion devices to induce sales directly to the consumers at the retail level, such as special displays, discount coupons, premiums, special sales, bonus and tie-in-sales for the products within the scope of this Code. This provision shall not restrict the establishment of pricing policies and practices intended to provide products at lower prices on a long-term basis. Article 6.6 EO 51 Section 6 (f) Donations or low-price sales to institutions or of supplies of infant formula or other products within the scope of this Code, whether for use in the institutions or for distribution outside them, may be made. Such supplies should only be used or distributed for infants who have to be fed on breast milk substitutes. If these supplies are distributed for use outside the institutions, this should be done only by the institutions or concerned. Such donations or low-price sales should not be used by manufacturers or distributors as a sales inducement. Nothing herein contained shall prevent donations from manufacturers and distributors of products within the scope of this Code upon request by or with the approval of the Ministry of Health. Article 7.4 EO 51 Section 8 (d) Samples of infant formulas or other products within the scope of this Code, or of equipment or utensils for their preparation or use, shall not be provided to health workers except when necessary for the purpose of professional evaluation or research in accordance with the rules and regulations promulgated by the Ministry of Health. No health workers shall give examples of infant formula to pregnant women and mothers of infants or members of their families. RIRR Section 51. Donations within the Scope of this Code Donations of products, materials, defined and covered under the Milk Code and these implementing rules regulations, shall be strictly prohibited. Page 24 of 38 RIRR Section 52. Other Donations by Milk Companies Not Covered by this Code Donations of products, equipment, and the like, not otherwise falling within the scope of this Code or these Rules, given by milk companies and their agents, representatives, whether in kind or in cash, may only be coursed through the Inter Agency Committee (IAC), which shall determine whether such donation be accepted or otherwise. Page 25 of 38 THE POLICY PROVISION OF FREE SUPPLIES We do not donate products covered by the scope of the WHO Milk Code and EO 51 and its RIRR. In case of clinical research, we may provide products covered by the scope of the WHO Milk Code and EO 51 and its RIRR only if approved by the IAC, FDA or the DOH. MEDICAL CHANNEL PRICING Products which are covered by WHO Milk Code and EO 51 and its RIRR can be procured by selected medical channels. The prices for these products are set at commercially sustainable levels on a long term basis (for at least 6 months). WE WILL: Establish clear pricing policies and structures. Implement clear guidelines and agreements to medical channels to ensure that they use the established suggested retail price when selling their stocks in their pharmacies. WE WILL NOT: Donate products covered by the WHO Milk Code and EO 51 and its RIRR. Sell products covered by the WHO Milk Code and EO 51 and its RIRR at a price below what is required for long term commercial viability. Provide samples or free supplies of products covered by WHO Milk Code and EO 51 and its RIRR to health workers or health facilities except for research and clinical trials. In such cases, the following conditions must be met: Page 26 of 38 IAC, FDA or DOH has approved in writing the research or trial. Research protocol is complete, meets the detailed requirements and is approved by the Medical and Clinical Development Team in Vevey. Research and clinical trials are not used, nor be interpreted as sales inducement. IX. PRODUCT QUALITY AND LABELING RELEVANT CODE ARTICLES WHO MILK CODE EO 51 and its RIRR Article 9.1 EO 51 Section 10. Containers/Labels Labels should be designed to provide the necessary information about the appropriate use of the product, and so as not to discourage breastfeeding a) Containers and/or labels shall be designed to provide the necessary information about the appropriate use of the products, and in such a way as not to discourage breastfeeding. RIRR Section 25. Containers/Labels Appropriate Use Containers and labels shall be designed to provide the necessary information about the appropriate use of products within the scope of the Code and in such a way as not to undermine, or equate it to, breastfeeding. RIRR Section 26. Content Each container/label shall contain such message in both Filipino and English languages, and which message cannot be readily separated therefrom, relative to the following points : Page 27 of 38 a) The words or phrase 'Important Notice' or 'Government Warning' or their equivalent b) A statement of the superiority of breastfeeding c) A statement that there is no substitute for breast milk d) A statement that the product shall be used only on the advice of a health worker as to the need for its use and the proper methods of use e) Instructions for appropriate preparation, and a warning against the health hazards of inappropriate preparation and f) The health hazards of (the use) necessary or improper use of infant formula and other related products including information that powdered infant formula may contain pathogenic microorganisms and must be prepared and used appropriately. Article 9.2 EO 51 Section 10 (b) Manufacturers and distributors of infant formula should ensure that each container has a clear, conspicuous, and easily readable and understandable message printed on it, or on a label which cannot readily become separated from it, an appropriate language, which includes the following points: Each container shall have a clear, conspicuous and easily readable and understandable message in Filipino or English printed on it, or on a label, which message cannot readily become separated from it, and which include the following points: a) the words “Important Notice’ or their equivalent; a statement of superiority of breastfeeding; b) a statement that the product should be used only on the advice of a health worker as to the need for its use and the proper method of use; c) instructions for appropriate preparation, and a warning against the health hazards of inappropriate preparation. Neither the container nor the label should have pictures of infants, nor should the label have pictures of infants, nor should they have other pictures or text, which may idealize the use of infant formula. They may, however have graphics for easy identification of the product as a breastmilk substitute and for illustrating the methods of preparation. The terms “humanized,” “maternalized” or similar terms should not be used. Inserts giving additional information about the product and its proper use, subject to the above conditions, may be included in the package or retail unit. When labels give instructions for modifying a product into infant formula, the above should apply. i. the words “Important Notice” or their equivalent; ii. a statement of the superiority of breastfeeding; iii. a statement that the product shall be used only on the advice of a health worker as to the need for its use and the proper methods of use; and iv. instructions for appropriate preparation, and a warning against the health hazards of inappropriate preparation. EO 51 Section 10 (c) Neither the container nor the label shall have pictures or texts which may idealize the use of infant formula. They may, however, have graphics for easy identification of the product and for illustrating methods of preparation. EO 51 Section (d) The term “humanized,” “maternalized” or similar terms shall not be used. Page 28 of 38 THE POLICY Quality is the hallmark of WPI. Any product that carries the Wyeth Nutrition brand embodies the highest quality standards. It meets or exceeds applicable standards recommended by the Codex Alimentarius Commission as well as the Codex Code of Hygienic Practice for Foods for Infants and Children. WPI ensures that the design of labels on its products covered by the WHO Milk Code, EO 51 and its RIRR and other relevant regulations encourages the practice of breastfeeding as the best choice for babies, and that any pictures or words used on the labels do not undermine breastfeeding and idealize the use of infant formula in any way. We also ensure that the labels provide adequate and understandable information on the proper preparation and use of the products, and contain the nutritional information specified by EO 51 and its RIRR. WE WILL: Ensure that our products are of the highest quality and that our manufacturing practices meet the following codes and standards: Government Regulations on Food Labeling and Advertising Codex on Infant Formula and Follow-On Formula Codex Alimentarius Committee on Nutrition and Food for Special Dietary Uses Rules and Regulations promulgated by DOH and/or FDA, as well as by the DTI (Consumer Act of the Philippines) and all other relevant local health and trade regulations. Codex Code of Hygienic Practices for Foods of Infant and Young Children WPI Good Manufacturing Practices WPI Quality Management Systems Implement a strict approval procedure for the design of labels, which involves the approval of Wyeth Nutrition Global, Regulatory, local Marketing, Medical and other stakeholders. Page 29 of 38 Ensure labels are: Properly attached Provide clear, conspicuous and easily readable and understandable words in English and Filipino to convey the message relevant to the WHO Milk Code and EO 51 and its RIRR, as approved by appropriate government authorities. Conform to rules and regulations set by the FDA and the DTI. Produce graphics that help customers identify the product as a bona fide breast milk substitute and that illustrate methods of preparation only. Inserts or leaflets that carry additional product information placed within the package are subject to WPI labeling policy and FDA approval. Ensure that labels of all growing up milks bear a warning that the product is not to be used as a breastmilk substitute and labels clearly indicate that the product should not be used to feed babies below one year of age. Implement strict procedures for exchanging and destroying damaged or expired products. WE WILL NOT: Label our infant formula and follow-up formula with a picture of a baby/babies, pictures of babies with their mothers, fathers, siblings, grandparents, or other relatives or caregivers, or such other pictures or graphics of similar import. Provide statement that indicates the product to be "superior" or "equal" to breast milk. Provide statement or pictures that encourage mothers not to give breast milk. Put pictures of feeding bottles or teats, except for the strict purpose of describing appropriate preparation instructions. Allow distribution outlets to open cans, boxes or sachets and sell or retail products by the cup, bag or any other form. Page 30 of 38 X. MONITORING AND REPORTING RELEVANT CODE ARTICLES WHO MILK CODE EO 51 and its RIRR Article 11.2 EO 51 Section 12 (a) Monitoring the application of this Code lies with governments acting individually and collectively through the World Health Organization as provided in paragraph 6 and 7 of this Article. For purposes of Section 6 [a] of this Code, an inter- agency committee composed of the following member hereby creed: The manufacturers and distributors of products within the scope of this Code, and appropriate nongovernment organizations, professional groups, and consumer organizations should collaborate with governments to this end. Secretary of Health - Chairman Secretary of Trade and Industry – Member Secretary of Justice – Member Article 11.3 Secretary of Social Service and Development - Member Independently of any other measures taken for implementation of this Code, manufacturers and distributors of products within the scope of this Code should regard themselves as responsible for monitoring their marketing practices according to the principles and aim of this Code, and for taking steps to ensure that their conduct at every level conforms to them. The members may designate their duly authorized representative to every meeting of the Committee. The Committee shall have the following powers and functions: 1) To review and examine all advertising, promotion or other marketing materials, whether written, audio or visual, on products within the scope of this Code; 2) To approve or disapprove, delete objectionable portions from an prohibit the printing, publication, distribution, exhibition and broadcast of, all advertising promotion or other marketing materials, whether written, audio or visual on products within the scope of this Code; 3) To prescribe the internal and operational procedure for the exercise of its powers and functions as well as the performance of its duties and responsibilities; and 4) To promulgate such rules and regulations as are necessary or proper for the implementation of section 6 (a) of this Code. Article 11.5 Manufacturers and primary distributors of products within the scope of this Code should apprise each member of their marketing personnel of the Code and of their responsibilities under it. EO 51 Section 12(b) The Ministry of Health shall be responsible for the implementation and enforcement of the provisions of this Code. For this purpose, the Ministry of Health shall have the following powers and function: 1) Page 31 of 38 To promulgate such rules and regulations as are necessary or proper for the implementation of this Code and the accomplishment of its purposes and objectives 2) To call the assistance of government agencies and the private sector to ensure the implementation and enforcement of , and strict compliance with the provisions of this Code and the rules and regulations promulgated in accordance herewith 3) To cause the prosecution of the violators of this Code and other pertinent laws of products covered by this Code. 4) To exercise such other powers and functions as may be necessary for or incidental to the attainment of the purposes and objectives of this Code. RIRR Section 36. Monitoring, Implementation Functions The Department of Health shall be primarily responsible for the monitoring, implementation and enforcement of the Milk Code and these Implementing Rules and Regulations. In coordination with other agencies involved in the implementation of the Code, the Department shall adopt such appropriate monitoring guidelines for the national, regional and provincial levels. It shall likewise provide regular training on monitoring compliance and enforcement on violations of the Milk Code for all persons engaged in or volunteering to help in the monitor and implementation of the Code. The Department may request for the assistance of nongovernmental organizations, civil society and concerned international agencies in order to better monitor of the implementation of these rules. Accordingly, a monitoring team, composed of the ensuing, is hereby created and established: National Level: Page 32 of 38 National Center for Disease Prevention and Control (NCDPC) National Center for Health Facilities and Development (NCHFD) Gov’t / Non-Gov’t Organizations / Civil Societies without any conflict of interest with the breastfeeding culture, and/or direct or indirect connection, financial or otherwise or with commercial interest within the scope of the Code. Ad Hoc International Agencies such as the United Nations Children’s Emergency Fund (UNICEF) and/or the World Health Organization (WHO) Regional/Provincial/City/Municipal/Barangay Levels (in collaboration with their respective Local Government Units): Center for Health Development Offices Provincial Health Offices City Health Offices Municipal Health Offices/ Rural Health Units Barangay Health Office GOs/ NGOs/ Civil Societies The Monitoring Team shall have the following functions: Monitors compliance as well as problems encountered in the implementation of the Milk Code. Reviews/acts on reports of violations of the provisions of the Code. Verifies reports of violations of the Milk Code. Monitors labels of products within the scope of the Code and marketing practices in various distribution centers. Recommends sanctions or punitive actions for violations of the Milk Code to the Bureau of Food and Drugs. Submits regular reports on the status of the Milk Code implementation to the Bureau of Food and Drugs. RIRR Section 37. Reports to the Secretary of Health Monitoring teams comprised of duly accredited teams from non-governmental organizations, and/or civil society may report their findings to the Office of the Secretary of Health who shall appropriately respond thereto with sufficient dispatch. RIRR Section 38. Role of DOH/BFAD in IAC The Department of Health shall convene and chair the Interagency Committee (IAC) with BFAD acting as its member/secretariat. Page 33 of 38 RIRR Section 39. Role of Bureau of Food and Drugs The Bureau of Food and Drugs (BFAD) shall investigate and verify reports of violations, when appropriate, apply administrative sanctions against the violators; and/or file criminal complaints against persons and entities found to have violated, singly or repeatedly, the provisions of the Code or these implementing rules and regulations. RIRR Section 40. National Level Violations Reports of violations of the Milk Code committed at the national level shall be filed and investigated at the Bureau of Food and Drugs. RIRR Section 41. Regional/ Provincial Level Violations Problems/violations arising at the regional/ provincial levels shall be filed, investigated and resolved at these levels. The regional/provincial levels shall notify BFAD of any action taken relative to the aforesaid problems/violations. Violations that require prosecution or imposition of administrative functions stated in these rules shall be elevated to the BFAD for appropriate action. RIRR Section 42. Meaning of National/ Regional/ Provincial Level Violations When the violation consists of commercial exhibition or advertisement for those products within the scope of this Code and found in areas beyond regions, then the violation is deemed to be national. When found or existing in a specific region only, then regional and so on down to the other geographical areas. RIRR Section 43. Issuance of Cease and Desist Orders (CDOs) Immediately upon receipts of the report of the violation, the investigating officer shall conduct an ex-parte examination of the evidence presented. If a prima facie case is established, a Cease and Desist Order (CDO) shall be issued by the BFAD Director or the DOH Regional Director as the case may be. Non-compliance with the CDO shall be ground for the imposition of administrative sanctions as stated in Section 47 (f) hereof. The issuance of the CDO shall be without prejudice to the imposition of the appropriate administrative sanction, if so warranted, after due notice and hearing. Page 34 of 38 RIRR Section 44. Authority of the IAC to Issue CDO The IAC Secretariat shall have the authority to determine if any advertising, marketing, or promotional material violates these Rules and Regulations. In such case, the IAC Secretariat shall issue a CDO, signed by the IAC Chairperson stopping the further release, printing, broadcast or dissemination of the violative advertising, marketing or promotional material. In instances where the CDO is not complied with, the rules, stated in the second paragraph of the preceding section shall apply. RIRR Section 45. Role of the Department of Justice The Department of Justice (DOJ) shall cause the criminal prosecution of the violators of this Code. RIRR Section 49. Liability of Manufacturers/Distributors Manufacturers and Distributors of the products covered by the Code shall be directly liable for any violation of the provision of the Code and its RIRR. Should the offense be committed by a juridical person, the Chairman of the Board of Directors, the president, general manager or the partners and/or directly responsible therefore, shall be made accountable. RIRR Section 50. Penalties Any person who violates the provisions of this Code or these rules and regulations shall, upon conviction, be punished by a penalty of two (2) months to one (1 year) imprisonment or a fine not less than One thousand pesos (P 1,000) nor more than Thirty Thousand (P30,000) or both. Should the offense be committed by a juridical person, the Chairman of the Board, the president, general manager, or partners and/or persons directly responsible therefore, shall be penalized. Page 35 of 38 THE POLICY MONITORING AND REPORTING WPI collaborates with Philippine government agencies (DOH, DTI, FDA, etc.,) non-governmental organizations, industry associations, and all other stake holders in all efforts aimed at improving compliance with the WHO Code and EO 51 and its RIRR. We closely monitor the activities of all our personnel associated with the manufacture, marketing and sale of Code-covered products at all levels as well as those of our business partners to ensure that they comply with the WPI policies on the marketing of breastmilk substitutes. We will take corrective action where any deviation from the policy is committed. WE WILL: Conduct regular internal audit of compliance with our policies. The audits will cover all relevant departments including, but not limited to, marketing, sales, manufacturing units and depots. Document audit results; draw them to the attention of WPI President and General Manager, WPI Milk Code Ombudsman and management personnel in the area being audited and take corrective action to remedy any deficiencies highlighted by the audit. Require our wholesalers, agents, merchandisers, distributors, retailers and third party detailing team to comply with our policies and specify such requirement in our contracts. Monitor the manner by which our distributors and retailers display our Code-covered products to check their compliance with the WHO Milk Code, EO 51 and its RIRR, as well as Nestlé Global Policy and Instructions and report any infringements of our policy to the WPI President and General Manager for corrective action. Maintain records that document our compliance with and the effective implementation of the WPI policy for adhering to the WHO Code and EO 51 and its RIRR and make them readily available for internal or external inspection. Appoint an Ombudsman to which WPI personnel may report any violations of the WHO Milk Code. The Ombudsman will carry the delegated authority of the Market Head to investigate and, where necessary, propose corrective action to prevent breaches of the Code. Support efforts at raising awareness and understanding of the purpose and requirements of the WHO Milk Code and EO 51 and its RIRR within the industry, government, and healthcare system as well as consumer groups, non-governmental organizations and other advocacy groups. Page 36 of 38 Make public by appropriate means, including our website, our membership to industry or trade associations related to infant nutrition, if any. Conduct quarterly Milk Code Committee meeting reviews led by the WPI President and General Manager on current internal and external factors/circumstances related to compliance with the WHO Milk Code, EO 51 and its RIRR and Nestle Global Policy and Instructions. Ensure that the WPI Ombudsman submits an Annual Report on or before January 15th of the succeeding year to the WHO Code Global Ombudsman on any violations or allegations of noncompliance to the Milk Code and its IRRs the past year and how these were handled and/or resolved. Page 37 of 38
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