Sustainability Report 2012 Lek d.d.

57 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 require- ments for a more open communication, credibility and periodic publishing of verified environmental information. Environmen- tal statement is the basic method of publicly communicating the results of continuous improvement of the organization's environmental performance, and an opportunity to enhance the company’s reputation with customers, suppliers, contrac- tors, community and employees. GRI (Global Reporting Initiative) GRI Guidelines represent one of the world’s most prevalent standards for corporate responsibility and sustainable deve- lopment reporting. They require planning and reporting ac- cording to measurable indicators of economical, social and environmental impact of an organization. Depending on the scope of disclosures and measurable indicators, reports are classified into three application levels (C, B and A). A “plus” (e.g. C+) signifies that the report was reviewed by an indepen- dent third party. GRI Guidelines provide a high degree of comparability, tran- sparency and consistency of non-financial corporate reports, increasing stakeholder trust in corporate responsibility and sus- tainable development reports. RCI (Responsible Care Initiative) - Launched in 1981 in Cana- da, 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 manage- ment systems, particularly in the fields of occupational health and safety, environmental protection, and cautious and safe handling of chemical industry products. The initiative aims to provide constant and measurable improvement of operations in the aforementioned fields, which is measured by means of 16 indicators. Three indicators reflect occupational safety and health achievements, while the remaining ones are concerned with environmental management, including energy efficiency. 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. 80 Modern science knows several thousand substances producing an antibiotic effect. In practice, there are several dozen molecules whi- ch 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 infections. 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. Similar biological drugs, however, are more cost effective and affordable to a larger group of people. Lek started its own genetic technology development as early as in the 80’s of the 20th century, creating a solid foundation for the manufacture of recombinant proteins and/or biophar- maceuticals for human use. Biological drugs (active ingredients) are large, complex mo- lecules generated by recombinant molecular biology or hybri- doma techniques and are produced from cultured genetically modified cells. In the human organism, they try to repair the processes causing the disease. They are used for treatment of hitherto incurable diseases, and improve the quality of pati- ent lives. They provide a more efficient therapeutic approach to cancer, AIDS, anemia, 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. Biotechnology combines all the technological applications using biological systems, living organisms or their derivatives with a purpose of creating or adjusting products and proces- ses for a specific use. In the technological use of biological cultures, it combines microbiology, biochemistry and engine- ering. 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 dosa- ge form, its bioequivalence being proven by means of respec- tive bioavailability studies. 81 GMO (genetically modified organism) is an organism (with the exception of humans) or microorganism whose genetic material has been altered using techniques which change the genetic material in ways different from crossbreeding or natu- ral recombination under natural conditions. Similar biological drugs are officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following expiry of patent and exclusivity on the innovator product. They demonstrate quality, safety and efficacy identical to those of originator drugs, yet their lower price makes them more affordable for a wider patient populati- on. Chemically, biosimilars are protein drugs or glycoproteins. The concept of biological similarity as defined by the Europe- an Medicinal Products Act requires a higher level of expertise in science, technology and logistics. 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. 80 Source: Humar M., ·mid-Korbar J., Obreza A. Dictionary of Pharmaceutical Terminology. Ljubljana 2011. 81 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).