Sustainability Report 2014 Lek d.d.

51 Environment Workshop on improvements in the field of health, safety and environment HSE Workshop Openly about HSE improvements At a workshop that was held in February in Ljubljana, the HSE representatives from all sites of Lek, Sandoz com- pany, presented their work and current issues in individual areas as well as the results of a global survey among the associates. Progress is only possible with a sound knowledge of the situation, obstacles and opportunities on the journey to improvements. Preparing a strategy for achieving Novartis’, Sandoz’ and Lek’s goals in the field of health, safety and environment opened a discussion on how to improve results. They looked deeper into issues and good practices of individual sites and the results on individual incident research. A great deal of attention was devoted to the analysis of incidents that occurred last year, root causes of occurrence of occupational accidents and incidents in the current year. The participants were also updated on the 'Make the Safe Choice' campaign pro- moting safe practices in all Sandoz units and carefully listened to how to effectively create balance between pro- fessional and private goals. Lek HSE systems Environmental impact and risk assessment In accordance with legal requirements, Lek, a Sandoz com- pany, has acquired environmental permits for operation for all of its sites (see Compliance with laws and standards). When planning an intervention and its potential impact on the environment, an impact and stress admissibility asses- sment is made. The assessment is carried out in accord- ance with legal environmental guidelines, data from public sources, monitoring and studies carried out by authorized institutions, the current environment status and pollution, anticipated emissions resulting from the planned activities, and applicable environmental regulations. Impacts of the anticipated intervention are evaluated according to indi- vidual elements of the environment, and separately for the construction time and the operation time. If any environ- mental impact has been identified, mitigation measures are proposed. Pursuant to the Decree on the Prevention of Major Acci- dents and Mitigation of their Consequences (OG of RS, Nos. 71/08 and 105/10) Lek, with the exception of the Menge‰ production plant, is characterized as a negligible source of risk. At the Menge‰ production plant, classified as a source of minor environmental risk mainly due to the presence of flammable substances at the site, hazardous substances were detected as anticipated. By applying the measures planned for emergency cases which may result in large-scale emissions, fire or explosion, and by means of response measures, the necessary action was taken to prevent major incidents. At the beginning of 2015 we ob- tained an environmental permit for a minor environmental risk plant. Safety policy Lek’s safety policy is an integral part of our business policy with an established system for managing major accidents involving hazardous substances in order to prevent any unforeseen events, and timely and effective emergency response. The Safety policy of the Menge‰ facility that is classified as a minor environmental risk plant with regard to the type and quantity of hazardous substances, obliges us to do everything necessary to avoid major accidents involving hazardous substances. http://www.lek.si/media/storage/cms/attachments/2015 /01/27/16/26/01/Varnostna-politika.pdf Measures for risk prevention and mitigation Risk assessment is carried out using various methods. The choice of an appropriate method depends on its suit- ability for the area subject to assessment and on the qualification level of the associates involved. Risk assessment is made for the following: • Risk Portfolio, • Workplace Health Risk Assessment – WHRA, • Capital expenditure projects: with priority use of the Zurich Hazard Analysis (ZHA) or the Hazard and Operability Study (HAZOP Study) in the project qualification phase, • Facilities and production lines: the Zurich Hazard Analysis (ZHA) or the Process Risk Assessment (PRORA), • Introduction of new products and production proc- esses: Process Risk Assessment (PRORA), • Assessment of product quality risks: priority use of the FMEA method. The Risk Portfolio provides the management team with an overview of major HSE risks and levels of risk mana- gement by individual site, country, business group, and in the corporation as a whole.

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