Sustainability Report 2012 Lek d.d.

41 Environment 56 GRI Indicator EN14 2.9.1 Fire safety Within our routine fire-safety activities, we performed four tactical fire drills in 2012. At the Menge‰ site, the drill was carried out on a larger scale, involving 8 fire intervention te- ams, a cave rescue team, a mountain rescue unit, emergen- cy medical service, a police unit, the Slovenian rescue dog handlers' association, and the Ljubljana Regional Notificati- on Center. The drill covered the following aspects: training of fire intervention teams, employee evacuation, verification of active fire safety system functionality, and verification of the compliance of emergency management procedures and guidance. We checked the level of protection and rescue teams’ response, equipment availability, and their conduct in case of emergency. For all the employees, we organized theoretical training programs and evacuation drills with real- -life fire-extinguishing tests. Within the Fire-Safety Month campaign, workshops on the local fire-safety awareness raising were held for the emplo- yees at all of the Lek sites. Investments were made to upgra- de the active and passive firefighting systems. In 2012, there were no major fire-safety interventions. 2.9.2 Biological safety Lek deals exclusively with biological agents from Risk Groups 1 and 2: • Group 1: Biological agents with minimum risk of cau- sing disease in humans, and negligible risk of sprea- ding into the environment; • Group 2: Biological agents with a potential to cau- se disease in humans, and potentially hazardous to workers; the risk of spreading into the environment is minimal; in most of the cases, effective prevention or treatment is available. Lek's manufacture involves exclusively biological agents of Risk Group 1. All the genetically modified organisms (GMO) belong to this group as well. For the biological agents, risk assessments were made. Responsibilities for biological safety assurance have been clearly defined. Each of the Menge‰, Ljubljana and Lendava sites employs a Biological Safety Officer, which is also the case at the Lek corporate level. Furthermore, certain emplo- yees are responsible for GMO management safety. The ba- sic task of Biological Safety Officers is to reduce potential risk of biological factors management and to ensure compli- ance with the Slovenian laws and Novartis' guidelines. At Lek, a nine-member Biological Safety Committee ope- rates. Its tasks include checking the accuracy 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. The programs for risk management in working processes featuring biological factors in contained areas, prepared in 2012, were implemented in the new laboratory of cellular and molecular biology established in the Biopharmaceuticals Development Center at the Menge‰ site in 2012. Biological drugs have become an indispensable part of modern medical practice. Due to highly complex and time- -consuming research and development, however, they are extremely costly. Sandoz plays a pioneering role in the su- pply of similar biologicals, making them accessible to the public by offering quality, safety and efficacy comparable to reference products, yet at a more affordable price. All the three Sandoz biosimilar drugs are also available to patients in Slovenia. 2.9 Safety 2.8.3 Noise In order to control any excessive environmental noise pol- lution, we perform regular monitoring and analyses, while implementing appropriate preventive measures as early as in the production technology design stage. None of the me- asurement results indicates any noise overload at any of the four Lek sites, which applies to both day and night shifts. The main identified source of noise is manufacturing activity, par- ticularly the operation of fermentors, compressor stations, as well as ventilation and cooling devices. The noise-emission levels are largely due to the immediate vicinity of busy roads, especially at the Ljubljana site. A project designed for the Prevalje site in 2012 is aimed at mitigating noise emissions through installation of the fan of the RTO inside the energy facility. The standard RTO design with an external fan could be environmentally problematic due to proximity of residential buildings. In 2012, Lek received two noise-related complaints. 2.8.4 Biodiversity 56 Lek’s awareness of the significance of environmental pro- tection is reflected in its consistent adherence to statutory waste and industrial water management requirements and proactive measures taken. We thereby strive to mitigate any impact on the quality of the environment and consequently on the biodiversity of the areas surrounding our production sites. Lek facilities are located within industrial zones where there are no major environmentally critical habitat types or protected vegetation. With an extensive tactical fire drill performed at the Menge‰ site we checked our overall emergency preparedness.