Sustainability Report 2014 Lek d.d.

49 Environment 69 RC KPI 22, GRI Indicator G4-EN30, G4-DMA 2.9.2 Biological safety We define biological material (cell lines, micro-organisms, small mammals) used in our laboratories or production as biological agents or genetically modified organisms (GSO). Lek, a Sandoz company, deals exclusively with biological agents from Risk Groups 1 and 2 with negligible risk of being released into the environment (see also Glossary of key terms). In the production, we handle exclusively the biological agents of Risk Group 1 for which risk assessments have been made. In the risk assessment we take account of the risk that biological material poses to a worker and containment measures to mitigate the risks and potential exposure of workers. To ensure adherence to biological safety, we appointed a Biological Safety Officer at the corporate level, with deputy commissioners also at the Menge‰, Ljubljana and Lendava sites. Deputy commissioners for biological safety mitigate potential risks in handling biological agents and ensure compliance with Slovenian law and Novartis' guidelines. Persons responsible for ensuring safety of work with GMOs are also appointed. At the Menge‰ site, we registered a new closed system for handling GMOs of Risk Group 1 in 2014. The purpose of the closed system is to test biological activity of biologicals for human use on a laboratory scale. Lek, a Sandoz company, also has a 13-member Biological Safety Committee. Its tasks include checking the accura- cy of biological agents’ classification into risk groups and, consequently, the adequacy of proposed containment measures, and approving individual projects in accordance with the risk assessment. Biological drugs have become an indispensable part of modern medical practice. Due to the highly complex and time-consuming research and development, however, they are extremely costly. Sandoz plays a pioneering role in the supply of similar biologics, making them accessible to the public by offering quality, safety and efficacy comparable to reference products, yet at a more affordable price. All Sandoz biosimilar drugs are also available to patients in Slovenia. 2.9.3 Providing storage and distribution safety 2.9.3.1 Storage At Lek, a Sandoz company, handling and storage of haz- ardous chemicals are carried out in accordance with both statutory requirements and Novartis' guidelines. All of our warehouses for hazardous liquids were declared with the Ministry of Health, whereas specific sites have plans for the management of hazardous liquids. In above-ground tank storage of hazardous liquids, we pro- vide appropriate retarding catchment systems preventing liquid spillage into the environment. In addition, the tanks are fitted in a way to enable detection of any spillage at any time. Chemicals for manufacture and storage purposes, and in the field of waste management are classified and labelled according to the GHS (Globally Harmonized System). 2.9.3.2 Distribution 69 From our production sites, 7,164 consignments of finished products and APIs were dispatched to 100 countries in 2014. During the transport of both non-hazardous and haz- ardous goods, no accidents occurred. Compared to the previous year, the volume of distributed goods increased slightly and amounted to 21,218 tonnes (19,421 tonnes in 2013). In September 2013, new EU guidelines on Good Distribu- tion Practice of medicinal products for human use (GDP) entered into force. We implemented these guidelines in our distribution processes. In 2014, we carried out transport validation for all types of transport (road, air, sea) in both critical periods (winter, summer) and on transport routes, selected on the basis of risk analyses. In the organization of international road transport, we con- tinued with the implementation of the "Control Tower" busi- ness model organized by DHL Belgium. In the organization of air transport, we successfully upgraded the cooperation with our partner DHL Global Forwarding. We focused prima- rily on setting up a common procedure for the implemen- tation of activities in the quality of the executed transport service in line with new GDP guidelines. The trend of transition from air to sea transport continued also in 2014 in order to reduce cost and provide better quality service in terms of GDP. In the area of sea transport we carried out a regular annual tender on a local basis. With this type of transportation we replaced air transportation for larger volumes of goods in 2014 and generated savings. 2.9.4 Chemical safety Safe handling of chemicals in laboratories as well as in the API and finished products manufacturing process is ensured by numerous measures. We keep our employees informed of their hazardous properties in accordance with the legal requirements for the handling of chemicals and the Novartis' guidelines. By taking into account the type of technology used in the manufacture, and the procedures for using chemicals in laboratories, we assess the risks and determine technical and organizational measures to ensure safety in their use. We have established a system for col- lecting data on the manipulation of chemicals subject to statutory reporting, a system for the preparation of regis- tration dossiers for the registration of strategic raw mate- rials and intermediates pursuant to the REACH Regulati- ons (Registration, Evaluation, Authorization and Restriction of Chemical Substances), and the Globally Harmonized System (GHS) of labelling to meet the requirements of the manufacturing process and of the buyers of our APIs. In the area of toxicology and pharmacology, we determine exposure limit values for APIs and strategic intermediates. By determining the exposure limit values and performing measurements in the working environment, we determine appropriate technical and organizational measures, al- lowing safe work in production and in laboratories.