Sustainability Report 2013 Lek d.d.

43 Environment 2.9.1 Fire safety In the last three years, fire safety arrangements for buildings were carried out at all our sites, on the basis of Novartis and Slovenian legislation. The arrangements included the instal- lation of fireproof doors, sealing of installation through-pe- netrations with fire-resistant materials, covering grey zones with an automated fire alarm system, emergency and safety lighting, installation of fire dampers, organizing intervention accesses, construction of the hydrant network and stable fire fighting systems. The conclusion of all arrangements with regard to fire protection is scheduled for within the next two years. In the Fire Prevention Month (October), tactical fire drills with intervention units that provide emergency assistance, were carried out at our sites. The number of voluntary fire fighters has increased at all sites. A basic fire fighting course was organized as a part of the operation of Lek’s volunteer in- dustrial firefighting team. At the Menge‰ site, we replaced a 20-year old fire engine with a new fire engine and a trailer for transportation of firefighting equipment. Last year we had two events (Ljubljana, Menge‰) resulting in production of smoke on the premises. In the first case, the smoke was due to overheating of insulation on the equipment and in the second case due a fault in a fork-lift’s electrical system. There were no injuries to personnel or objects, only damage to equipment occurred. On 17 September, a container deflagration occurred at the Prevalje site. There were no injuries to personnel, only ma- terial damage occurred. After the event, an investigation was carried out showing that chemical reaction was the most likely cause of the event. There was an increased volume of waste, but no major negative impacts on the environment. Potassium clavulanate, which was in the container, is easily biodegradable and the resulting emissions into the air were in the form of CO 2 , CO and NO x . Technical measures and revised operating procedures were implemented to prevent a recurrence of the event. 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: • Risk Group 1: Biological agents /genetically modified organisms with minimum risk of causing disease in humans, and negligible risk of spreading into the environment ; • Risk Group 2: Biological agents /genetically modified organisms with a potential to cause disease in humans, and potentially hazardous to workers; the risk of spread- ing into the environment is minimal; in most cases, effective prevention or treatment is available. Lek's manufacture involves exclusively biological agents of Risk Group 1 for which risk assessments were made. The risk assessment includes the risk that biological material poses to a worker and containment measures to reduce the risks and potential exposure of workers. We provide them additional preventative measures and biological moni- toring for early detection of potential problems. 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 com- pliance with Slovenian law and Novartis' guidelines. Appoint- ed are also persons responsible for ensuring safety of work with GMOs. Lek, a Sandoz company, also has a 12-member Biological Safety Committee. Its tasks include checking the accuracy of biological agents’ classification into risk groups and, con- sequently, the adequacy of proposed containment meas- ures, and approving individual projects in accordance with the risk assessment. In 2013, an expansion of the closed microbiological control system in Ljubljana was implemented. The Ljubljana site also successfully passed an inspection. 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 biologicals, making them accessible to the public by offering quality, safety and efficacy compa- rable to reference products, yet at a more affordable price. All Sandoz biosimilar drugs are also available to patients in Slovenia. 2.9 Safety With an extensive tactical fire drill at the Menge‰ site we checked our overall emergency preparedness.