Sustainability Report 2013 Lek d.d.

Sustainability Report 2013 – Lek d.d. Environment 24 2.1 Implementation of active environmental policy 29 The key direct environmental aspects of our operations include the use of energy, water, emissions to the air, emission to water, waste, and, to a lesser extent, odour, noise and the use of soil. Indirect environmental aspects mainly include impacts from suppliers (Items 2.1.6 and 6.1.2). The active environmental policy of Lek, a Sandoz company, is implemented through a number of activities to protect the environment which often goes beyond mere fulfilment of statutory provisions. The most important among them are the upgrading and improvements of existing measures and the introduction of new ones. Business decisions are made in consideration of direct and indirect environmental impacts. In the area of innovation and development of new products, we carefully consider all benefits and risks in a scientific and transparent manner. Resolving HSE related complaints is carried out in accord- ance with internal procedures which require the person respon- sible to start an investigation within 24 hours. With respect to the investigation outcome and justification of the complaint, the head of the HSE site ensures that necessary corrective measures are taken. The entire process is documented and archived. With efficient resolution of HSE related complaints and by taking appropriate corrective actions, we provide a safe and employee-friendly work environment, mitigate busi- ness related environmental risks and contribute to creating the company’s goodwill. In 2013 we were not charged any penalties for non-compliance with environmental laws; however, we received four external complaints, which are described under Item 1.5.3.1, together with action taken. 2.1.1 Specifics of business operations and disparities in data collected When identifying environmental impacts, certain factors have to be taken into account. They primarily refer to the efficiency of the use of materials, energy resources, water, waste, atmos- pheric emissions and wastewater per tonne of product. Con- sequently, there are considerable differences in product and API weight. Compared to some self-medication drugs, similar biological drugs, for example, have low weight, yet their manu- facture requires larger quantities of water and energy resour- ces, and their financial value is higher as well. These dispari- ties become particularly noticeable when seeking a common basis for the preparation of data for Lek, a Sandoz company, and they are also apparent at the Ljubljana and Menge‰ sites, which have an extensive and versatile product portfolio. Our operations are also characterized by interim adjustments of the production program to changes in demand, which could again be observed in 2013. The manufacturing structure therefore varies from year to year. As a result of the above, year-on-year comparability of effi- ciency data and of individual production sites is compromised. 2.1.2 Major environment protection achievements By implementing our environmental policy, we improve the environmental performance of our processes. In 2013: • Continued projects aimed at reducing atmospheric emissions and replaced the existing devices for air emissions treatment (adsorbers) at the Prevalje site with a control device (Regenerative Thermal Oxidizer – RTO) of higher performance and improved energy efficiency, the emissions of which reach lower values than prescribed. Over the last six years, Lek, a Sandoz member, installed four such devices: two in Ljubljana, one in Menge‰ and one in Prevalje; • By removing adsorbers in Prevalje, we reduced hazar- dous waste volumes (wastewater containing ethanol) produced during the process of the adsorber’s operation; • By installing a device for effective removal of pharma- ceutical ingredients in wastewater by means of ozone at the Menge‰ site, we additionally reduced environ- mental impacts; • By more intensive waste separation, we reduced the amount of municipal waste for disposal. To the largest extent the amount of this waste was reduced at the Prevalje site. On account of waste for recycling, there was 58% less waste compared to 2012; and • At the level of Lek, a Sandoz company, we continued the “sustainable packaging” project and reduced the use of raw materials, and with smaller packaging sizes we reduced the impact of transport on the environment (lower fuel consumption, lower CO 2 emissions). 2.1.3 Investments in environmental management 30 Environmental investments are part of our everyday busi- ness operations. In 2013 they amounted to EUR 2.8 million. The major investment projects included the following: • Completion of investment in a new device for thermal oxidation of emissions to reduce VOC emissions to the air at the Prevalje site; • Investment in a device (ozonizer) for effective filtering of pharmaceutical ingredients in wastewater in Menge‰; • Installation of effective filtration systems of air-condition- ing outlets and technological ventilation systems. The installation was carried out in the context of projects to increase production capacities at all sites; • Restoration and improvement of energy efficiency of the roof at the manufacturing plant in Ljubljana; and • Additional reconnections and amendments to the sys- tem of removal of organic solvents from technological exhausts at the Menge‰ site. 2.1.4 Verification of compliance with implemented standards Lek, a Sandoz company, with all of its four sites, became in 2012 the first Slovenian pharmaceutical company to join the EMAS scheme, the EU Eco-Management Audit Sy- stem. The EMAS environmental verifier (the Slovenian Insti- tute of Quality and Metrology – Accreditation Number SI-V- 0001) confirmed that the Sustainability Report of Lek d.d. for the year 2012 reflects a reliable, credible and correct image of all the organisations/sites activities, within the scope mentioned in the environmental statement. To a series of successful audits and inspections, we added new ones in 2013. Other external checks also confirmed the compliance of our operations with the quality standards of conduct in the field of the environment ISO 14001, health and safety at work OHSAS 18001 and the Responsible Care Initiative. 29 GRI G4-DMA, Disclosure G4-14, Indicators G4-EN29, G4-EN34 30 GRI Indicator G4-EN31

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