Sustainability Report 2012 Lek d.d.

Sustainability Report 2012 – Lek d.d. Environment 44 Lek HSE systems 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. The Risk Portfolio development and compilation are carried out in three steps: • Risk assessment and preparation of a Risk Portfolio for individual sites, • Preparation of a Risk Portfolio for Lek d.d. (Slovenia) and Sandoz, • Annual review of the Risk Portfolio for business groups at the corporate level. In 2012, we performed all the risk management activities required in accordance with the Novartis HSE guidelines. Special care was given to identifying HSE risks in our ope- rations and processes. On this basis, we implemented the measures to minimize risks, such as avoiding potential risks, limiting the risk of exposure to hazards, and taking action to mitigate the negative impacts of any hazardous occurrence that actually took place. At the Lendava site, additional measures were taken to mi- tigate process-related risks in the process of final potassi- um clavulanate drying. In 2012, there were no HSE emergency events. HSE aspects and system of achievement monitoring Pursuant to the Novartis guidelines, environmental aspects at Lek were upgraded into so-called HSE aspects. For a specific area of expertise, they are created at the proposal of the authorized person for each site separately. In addition to environmental aspects, we thus also have HSE, chemi- cal safety, fire safety, explosion safety and biological safety aspects. A standard selection of aspects for individual areas of expertise is determined by the head of the respective area at Lek d.d. The site's HSE responsible person makes an as- sessment based on the results of the Gap Analysis, audits (internal, Novartis'), inspections, complaints, and in conside- ration of hazardous occurrences (near-misses). The aspec- ts are evaluated in consideration of the criteria of legal com- pliance, profitability and the company's reputation, using the risk assessment methodology. Based on the findings in the Registry of HSE Aspects, corrective measures as well as business objectives and programs are defined. Revisions of the Registry of HSE Aspects are carried out at least once a year or in case of major change to the internal or external environment. It ser- ves as a basis for the preparation of the Risk Portfolio, busi- ness and activity plans and programs, and for the setting of personal goals for responsible persons. In our operations, our compliance with legal and other requi- rements is reflected in successfully completed internal and external audits, inspections, water, air and noise monitoring, and with the environmental permits in effect. In 2012, audits of an external customer were carried out as well as an internal energy audit and external auditing of the company's compliance with ISO 14001:2004 and BS OHSAS 18001:2007. Internal audits of the HSE service planned on an annual basis were performed according to individual HSE areas. Concurrently, internal audits of the company’s complian- ce with ISO 14001:2004 and OHSAS 18001:2007 requi- rements were carried out. Internal Novartis and Sandoz audits are more extensive, covering all areas of HSE on the part of the site being audited: environmental protec- tion, occupational safety and health, chemical safety, fire safety, biological safety, explosion safety, and BCM and NEM. The frequency of audits depends on the natu- re of production: at API production sites, they take place every two years, whereas at pharmaceuticals producti- on locations they are performed every three to four years. These audits also assess compliance with ISO 14001:2004, OHSAS 18001, and EMAS Directive. The results of in- ternal audits performed in 2012 showe a high level of the company’s compliance with the statutory requirements as well as internal and external standards in all the areas. Corrective action was taken on an ongoing basis. Environmental performance assessment with regard to Lek’s general and individual objectives is an integral part of the Management Review procedure. All Lek sites meet all the basic EMAS requirements, inclu- ding environmental performance improvement. In line with Novartis and Sandoz policy, Lek is committed to conti- nuous improvement of environmental performance in compliance with local and national programs. Following the EMAS registration in 2012, internal audits will be initiated in 2013 pursuant to the Directive’s requirements. Reporting methodology The reporting methodology used at Lek enables monito- ring of absolute indicators and trends for individual critical HSE aspects. HSE data is collected, recorded, verified and confirmed within a uniform Novartis reporting system in the Data Management System (DMS), whereby their transparency and comparability is ensured. Reporting frequency de- pends on the relevance of the reported data (monthly, quarterly or annually). Collected data serves as a basis for statutory reporting to ministries and other interested stakeholders, whereas once a year it is subject to review within the environmental management review performed by the organization's top management according to the EN ISO 14001:2004 system.