Sustainability Report 2014 Lek d.d.

Sustainability Report 2013 – Lek d.d. 66 Glossary of key terms EMAS (ECO – Management and Audit Scheme) The EMAS Scheme was designed for enterprises to impro- ve their environmental performance and to inform the public of the environmental impacts of their operations. It is based on the ISO 14001 standard, upgraded with additional requ- irements for a more open communication, credibility and periodic publishing of verified environmental information. The environmental statement is the core method of publicly communicating the results of continuous improvement of the organization's environmental performance, and an oppor- tunity to enhance the company’s reputation with customers, suppliers, contractors, community and employees. GRI (Global Reporting Initiative) GRI Guidelines represent one of the world’s most prevalent standards for corporate responsibility and sustainable develop- ment reporting. They require planning and reporting accord- ing to the measurable indicators of the economic, social and environmental impact of an organization. Depending on the scope of disclosures and measurable indicators, reports are classified into two application levels, core and apprehensive. GRI Guidelines provide a high degree of comparability, trans- parency and consistency of non-financial corporate reports, increasing stakeholder trust in corporate responsibility and sustainable development reports. RCI (Responsible Care Initiative). Launched in 1981 in Canada, the initiative was adopted globally by the chemical industry represented by the ICCA (International Council of Chemical Associations). The initiative promotes responsible treatment of employees and the environment in its broadest sense: the implementation of Good Practices, usually through management systems, particularly in the fields of occupatio- nal health and safety, environmental protection, and cautious and safe handling of chemical industry products. The initiati- ve aims to provide constant and measurable improvement of operations in the aforementioned fields, which is measured by means of 16 indicators. Three indicators reflect occupa- tional safety and health achievements, while the remaining indicators are concerned with environmental management, including energy efficiency. Generics are successors to pharmaceutical products whose patent protection has expired. A generic drug is a drug pro- duct that is comparable to a reference listed drug product in quality and quantity composition, active ingredient and dosage form, its bioequivalence being proven by means of respective bioavailability studies. 95 Active ingredient is a carrier substance exerting the pharma- cological action. Antibiotics are either natural products of microorganisms or semi-synthetic derivatives of natural products, destroying other microorganisms or inhibiting their growth. They are used in the treatment of bacterial infections. 96 Modern science knows several thousand substances producing an antibiotic effect. In practice, there are several dozen molecules which have been fully established in standard medical practice. Certain bacteria produce beta-lactamase and are therefore resistant to specific forms of antibiotics. Clavulanic acid is a beta-lactamase inhibitor. In combination with potassium cla- vulanate which prevents bacterial resistance to amoxicillin action, the antibiotic is effective in the treatment of bacterial infection. Biological medicinal product is a medicine, the active in- gredient of which is a biological substance or a substance- obtained by a process which includes biological systems. A biological substance is a substance that is produced by or extracted from a biological source and that requires for its characterisation and the determination of its quality a com- bination of physico-chemical-biological testing, together with the production process and its control. For example, these are medicines produced by a biological or biotechnological procedure, including cell cultures and similar. In the human organism, they try to repair the processes causing the dis- ease. They are used for treatment of hitherto incurable dis- eases, and improve the quality of patients’ lives. They provide a more efficient therapeutic approach to cancer, AIDS, anaemia, rheumatic, cardiovascular and some other types of diseases. Over the past years, biologics have saved lives, prolonged survival and improved the quality of life for patients with severe and often chronic diseases. Biosimilars are officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following expiry of patent and exclusivity on the inno- vator product. They demonstrate quality, safety and efficacy identical to those of originator drugs, yet their lower price ma- kes them more affordable for a wider patient population. Che- mically, biosimilars are protein drugs or glycoproteins. The concept of biological similarity as defined by the European Medicinal Products Act requires a higher level of expertise in science, technology and logistics. Biotechnology combines all the technological applications using biological systems, living organisms or their derivatives with the purpose of creating or adjusting products and pro- cesses for a specific use. In the technological use of biologi- cal cultures, it combines microbiology, biochemistry and engi- neering. Recombinant DNA technology is frequently referred to as gene cloning or genetic engineering. The information needed for the synthesis of a specific protein in the human organism (the desired protein-encoding sequence, or the gene) is trans- ferred from the human organism into another organism, most frequently into a bacteria, isolated mammalian cells or yeasts. Based on the information received, these new cells produce larger quantities of proteins or glycoproteins. Biological agents are microorganisms, cell culture and human endoparasites which may cause infection, allergy or intoxication. • Class 1 biological agent/genetically modified organism poses minimum risk to human health and the risk of being spread into the environment is negligible; • Class 2 biological agent/genetically modified organism of this class may cause human disease and may be hazardous for workers; the risk of being spread into the environment is minimal, in the majority of cases and effective prevention or treatment is available. GMO (genetically modified organism) is an organism whose genetic material has been altered using methods of modern biotechnology. In such an organism a defined gene of an exactly defined characteristic from another organism has been inserted. GSOs include microorganisms (bacteria, fungi, viruses), plants and animals. Biopharmaceutics is the latest and the fastest growing branch of pharmaceutical science. The biologics market is growing twice as fast as the entire drug market. Due to highly complex research and development, biological drugs are extremely costly. Biosimilars are however, more cost effective and therefore accessible for a larger group of patients. Lek started its own genetic technology development as early as the 1980’s, creating a solid foundation for the manufac- 95 Source: Medicinal Products Act – ZZdr-1 (Official Gazette of the RS, No. 31/06 of 24.3.2006) and the Act Amending the Medicinal Products Act – ZZdr-1A (Official Gazette of the RS, No. 45/08 of 9. 5. 2008) 96 Source: Humar M., ·mid-Korbar J., Obreza A. Dictionary of Pharmaceutical Terminology. Ljubljana 2011.