We are dedicated to the fundamental principle that all babies everywhere should have access to breast milk and that direct breastfeeding by mothers is best for full-term babies.
Donor milk should be sourced in a way that ensures the health and well being of the donor and her infant.
Our products will never be marketed as a substitute to breastfeeding, nor will we partner, co-brand, or distribute our products with third parties that market breast-milk substitutes.
Our Commitment Medolac Laboratories, A Public Benefit Corporation (Medolac) believes that breast milk is the optimal nutrition for full-term newborns and is dedicated to ensuring that premature infants and young children with special medical needs should also have access to safe, high quality, breast-milk based nutrition adapted for clinical settings.
Medolac unequivocally supports the principles of the World Health Organization (WHO) Code of Marketing of Breast-Milk Substitutes that encourages breastfeeding, and seeks to maximize the exclusive use of breast milk, particularly in clinical settings where substitutes are often used. Medolac’s products facilitate the use of breast milk in clinical settings, especially for infants with special medical needs. We support international and local efforts to develop and implement the highest standards for donor milk formulation, preparation and handling in clinical settings, in all countries where we operate or where we conduct business.
Our Core Policies To give effect to our commitment, we set forth policies that guide our conduct:
1.Marketing and promotion of our products: At Medolac, we are committed to ensuring the ethical marketing and promotion of our products and advancing the aim and principles of the WHO Code. Our products are intended for clinical and adapted therapeutic use and will never be marketed as a substitute for a mother’s own milk nor co-branded or promoted by third parties that market breast-milk substitutes. We adhere to national laws and regulations, and also strongly support efforts by governments to fully implement laws and regulations that restrict the marketing of breast milk substitutes and other infant formula products to address the health needs of their infant and young child populations.
2. Interaction with donor milk banks: Medolac strongly supports independent and autonomous milk banks representing the interests of mothers and commits to transparency regarding our relationships with milk banks. We limit our partnerships and engagement to milk banks that empower women and their families. We have established the ‘Medolac Breast Milk Donor Bank Engagement Standards’ as a key tool to identify and retain partners whose charters, structure, donor compensation, representation and activities are consistent with our values and guidelines. Milk banks must meet requirements outlined in our guidelines which are assessed on a regular basis by Medolac. Donor milk testing should be of the highest standard and the health of donors should always be monitored to ensure the quality and safety of donor milk. Donors should have access to their medical data and that data should be kept confidential, consistent with HIPAA or other legislative requirements.
3. Informal Donor Milk Sharing: Medolac does not support the informal trade of donor milk as it often lacks important safety and quality controls for both donors and infants. Informal milk sharing transactions often do not provide (1)reliable donor screening; (2)protection of donor interests and safety; (3)testing of donor milk for contamination and quality, and (4)safeguards relating to the proper handling and storage donor milk. Medolac does not partner with organizations that facilitate or promote the informal trade of donor milk.
4. Education and Information on Infant Feeding: Our policies include a commitment to always encourage the use of a mother’s own milk wherever possible and to accurately depict the consequences of alternative feeding options. All material is designated for professional use only and will always reflect sound scientific and nutritional facts. Our staff will always uphold these policies throughout areas of interaction with health care providers.
5. Sampling and Incentives: Medolac does not provide free samples of its products. Nor do we provide health care professionals, mothers or caregivers with any incentives, such as coupons or gifts, with our products. Where permitted, we provide samples of our products to healthcare providers as appropriate with the agreement that they will be used only for professional evaluation. In addition, we never offer financial incentives or rewards to health care workers to promote or encourage the use of our products, and commit to billing practices consistent with this policy.
6. Health Care Systems: Medolac is committed to science-based education within healthcare systems supportive of exclusive breastfeeding and, where medically required, the proper safe storage, preparation and use of human milk adapted for clinical use. Medolac does not support or fund “milk nurses”, “mothercraft nurses”, or any similar personnel within the health care system.
7. Product Label and Packaging: Our product labels will always state clearly that except in special circumstances, a mother’s own milk is the superior form of infant nutrition; that our products should be used only on the advice of a medical professional; and that it is critical to prepare, use and store our products correctly. To help ensure the proper use and preparation of our products, our labels are written in official national language(s) and include graphic illustrations of this information. Our labels do not include photos of infants or anything else that might idealize the use of our products over a mother’s own milk. Our standard label (or label insert) includes the following language, tailored for each specific product: “This Medolac product is intended for use only when feeding with a mother’s own milk is not possible. Professional advice should be obtained and followed regarding the need for and proper method of use of our products, and on all matters of infant feeding.”
8. Provision of Product in Humanitarian Situations: In emergencies, Medolac will provide product at a humanitarian price (or donated when procurement arrangements are not possible) only at the written request of the government or lead relief agency responsible for coordinating nutrition activities. Requests for products from any other organization will be referred to the lead nutrition agency to ensure coordination. Medolac seeks to reinforce the basic principle that a mother’s own milk represents the best source of nutrition for infants in emergency settings and relies on its partners to ensure that all donor milk is utilized in accordance with the Operational Guidelines on Infant and Young Child Feeding in Emergencies issued by the Infant and Young Feeding in Emergencies (IFE) Core Group. Medolac may also provide product in select non-emergency humanitarian settings under the following conditions, so long as it does not displace the use of a mother’s own milk: At the written request of a national government or locally accredited non-governmental organization (NGO), for infants who are in vulnerable social situations (e.g infants in orphanages with no access to their mother’s own milk) or infants with special medical needs requiring adapted breast milk when access to a mother’s own milk is impossible. Where humanitarian (either low-cost or donated) supplies are provided by Medolac, we will work with our partners to ensure that supplies are adequate for as long as the concerned infants require them and where AFASS criteria are met[1].
9. Public policy and contact with governments: Medolac staff follows strict performance policies that guide its interaction with regulators and governments. Our corporate practices are consistent with all legal requirements. In its interaction, Medolac encourages full implementation of guidelines and policies relating to the safe and proper use of donor milk. We always seek to ensure that the WHO Code is fully enacted and that our products support those efforts.
10. Monitoring of Performance and Complaints: Medolac holds itself responsible for monitoring our marketing practices in all countries where we conduct business independent of government measures. To ensure that all sectors of Medolac employees comply with our internal guidelines and with all applicable local laws or regulations, we have enacted the following performance assurance procedures:
11. Training for Staff: Medolac staff, at all levels of the company and in all markets, receive training material and ongoing practical training on our policies and practices concerning the use and promotion of our products. We continually upgrade our training programs to ensure that those involved in the marketing process have a complete and clear understanding of our standards, how to implement them, and the most up-to-date information about national legislation. We utilize an internal compliance hotline through which Medolac employees can report – anonymously and confidentially – any potential non-compliance with our policies or issues with respect to our practices.
12. External Performance Assurance Procedures: We have established a global online system that enables the public to submit questions or complaints about our marketing practices. Any and all complaints are promptly and fully investigated. Hospital staff and other stakeholders are invited to report any possible compliance issues concerning Medolac marketing practices to our dedicated compliance email address (compliance@medolac.com). If a complaint is substantiated, Medolac takes corrective action within 30 days.
13. Suppliers, Distributors and Vendors: Medolac undertakes to make suppliers, distributors and customers aware of the importance of abiding by Medolac's responsible conduct policies and all requirements of national legislation. Where violations are substantiated, Medolac will require corrective action. Absent such action, Medolac will cease relationships with such parties.
14. Executive Responsibility: At a headquarters level, responsibility for implementing and monitoring our policies rests with the CEO of Medolac, members of her leadership team, and with designated managers and staff both at corporate headquarters and in country.
15. Review and Approval of Professional Marketing Material: All professional marketing and promotional material is reviewed and approved by our headquarters based central review committee, which ensures, among other things, that submitted material complies with our internal standards, is only made available for professional use, and is consistent with the aim and principles of the WHO Code and national legislation.
16. Third-party Monitoring: Medolac is committed to transparency in the way we market and promote products and believes its practices should be third-party auditable. Medolac will work with credible third-parties to validate our practices.
17. Achieving Total Adherence: Our primary goal is to ensure that our products are promoted ethically and measures are designed so that inappropriate activity is stopped before it occurs, through staff training, internal accountability, and independent external performance reviews. Should we identify an issue and determine that there is an issue of non-compliance, we commit to taking corrective action, including removing inappropriate material from public view as quickly as possible; determining where the gap in the system occurred; and rectifying it as quickly as possible. All violations and corrective actions are reported to our leadership team on a regular basis.
Medolac will publish a publicly available annual report, detailing the status of our marketing activities, in support of the WHO Code, national country legislation and regulation, and our internal responsible marketing guidelines. These reports will be compared to our benchmark measurements to assess progress and ensure that we are moving forward in achieving a credible and robust marketing adherence program.
[1] AFASS is defined as an Acceptable, Feasible, Affordable, Sustainable, and Safe option.
