BIOGAIA SUSTAINABILITY REPORT 2021 27 Materiality and risks BioGaia’s distributors have a direct impact on how the products are distributed and marketed to consumers. The distributors are, for example, responsible for ensuring that BioGaia’s products comply with local laws and regulations in their respective markets. If a distribution partner’s operations do not meet with BioGaia’s expectations, there is a risk that BioGaia’s brand and stakeholders trust in the company will be damaged. How work is conducted As part of BioGaia’s distribution agreements, distributors ensure they meet all legal requirements in the local markets. Distributors assume full responsibility but are offered support by BioGaia’s owns experts. Additionally, BioGaia requires that distributors only make claims supported by research, regard- less of whether any other claims are allowed in the local market. In 2018, BioGaia implemented a Code of Conduct for the company’s approximately 60 distribution partners, which further outlines BioGaia’s expectations and requirements. The aim for 2021 is that all partners will sign the Code of Conduct or present their own equivalent version. At the end of 2021, 97% (90) had signed up to the Code of Conduct, or presented their own equivalent version. Responsible partners (GRI 3-3) Progress and priorities going forward BioGaia is currently working on developing the sales process to be able to further assess distributors’ sustainability performance. In 2021, risk assessments were conducted of all new distributors in high-risk countries using an external tool that monitors negative publicity in the media and warns if the company has a relationship with an individual or organisation that is subject to sanctions. No sanctions or elevated risk were detected among distributors examined. In 2022, BioGaia intends to develop this process further to find an appropriate method in relation to the type of distri- butor with which BioGaia normally cooperates. % Distributors that have signed the partner Code of Conduct (BSD 7) 2021 2020 2019 Distributors 97% 90% 85% Materiality and risks BioGaia’s brand and stakeholders trust in the company may be damaged if support is given to doubtful studies where ethical guidelines are not followed. It is important that the research BioGaia is involved in is carried out in a transparent, independent and ethical manner, both for the sake of the participants and for the reliability of the results. For some time, BioGaia has created a network of independent experts to conduct research. BioGaia’s level of control over studies with the company’s strains and products varies, however, from being highly involved to only providing the study product. How work is conducted All research, pre-clinical and clinical, in which BioGaia is involved should comply with the highest possible ethical standards. The researchers should adhere to international and national legislation as well as the Helsinki Declaration’s ethical principles for medical research when applicable. BioGaia’s high level ethical research policies are outlined in the company’s internal Code of and Conduct and the specific requirements are stipulated in the research contracts. All of BioGaia’s research partners are encouraged to work in accordance with the International Council for Harmonisation on Good Clinical Practices (ICH-GCP). Responsible research (ethics and safety in clinical trials) (GRI 3-3) For clinical trials sponsored by BioGaia, local ethical approval must be obtained prior to study start. All participants must be informed of the study and be willing and able to give written informed consent for participation. Participants can discontinue freely at any time, for whatever reason, without affecting their right to an appropriate follow-up investigation or future care. Pre-clinical studies in animals must be justified and the principles of the 3Rs – replacement, reduction and refinement – must be applied. BioGaia encourages transparent results from researchers. The studies must be registered on a public website, such as ClinicalTrials.gov. Progress and priorities going forward In 2021, BioGaia updated the company’s guidelines for sponsorship of clinical studies in order to standardise the circumstances and scope of such sponsorship. The guidelines aim to clarify the relationship between BioGaia and the research partners that conduct the clinical studies. BioGaia’s patent team has a process and strategy where the potential adverse health impacts due to patent enforcements are considered in the patent registration process. The patent held by BioGaia for its probiotic products has been assessed as not entailing any critical adverse effects. Healthy networks CONTENTS
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