Sustainability Report 2013 Lek d.d.

63 Glossary of Key Terms EMAS (ECO – Management and Audit Scheme) The EMAS Scheme was designed for enterprises to improve 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 requirements for a more open communication, credibility and periodic publish- ing of verified environmental information. The environmental state- ment is the core method of publicly communicating the results of continuous improvement of the organization's environmen- tal performance, and an opportunity 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 stan- dards for corporate responsibility and sustainable development reporting. They require planning and reporting according to the measurable indicators of economic, social and environmental impact of an organization. Depending on the scope of disclo- sures and measurable indicators, reports are classified into three application levels from C to A). A "plus" (e.g. A+) signifies that the report was reviewed by an independent third party. GRI Guidelines provide a high degree of comparability, transpa- rency and consistency of non-financial corporate reports, increas- ing stakeholder trust in corporate responsibility and sustainable 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 im- plementation of Good Practices, usually through management systems, particularly in the fields of occupational health and safety, environmental protection, and cautious and safe han- dling of chemical industry products. The initiative aims to provide constant and measurable improvement of operations in the afore- mentioned fields, which is measured by means of 16 indicators. Three indicators reflect occupational safety and health achieve- ments, while the remaining ones are concerned with environ- mental management, including energy efficiency. Generics are successors to pharmaceutical products whose patent protection has expired. A generic drug is a drug product 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 bio- availability studies. 97 Active ingredient is a carrier substance exerting the pharmaco- logical 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. 98 Modern science knows several thousand substances producing an antibiotic effect. In practice, there are several dozen molecules which have been fully estab- lished 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 clavulanate 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 combi- nation of physico-chemical-biological testing, together with the production process and its control. For example, these are medicines produced by a biological or biotechnological procedu- re, including cell cultures and similar. 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 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 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 population. Chemically, biosimilars are protein drugs or glycoproteins. The concept of biological simi- larity 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 proc- esses for a specific use. In the technological use of biological cultures, it combines microbiology, biochemistry and engineering. 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 de- sired protein-encoding sequence, or the gene) is transferred 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. GMO (genetically modified organism) is an organism whose genetic material has been altered using methods of modern bio- technology. 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 rese- arch and development, biological drugs are extremely costly. Bio- similars are however, more cost effective and therefore accessi- ble 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 manufacture of recombinant proteins and/or biopharmaceuticals for human use. The Integrated Pollution Prevention and Control (IPPC) Directive on integrated pollution prevention and control of indu- strial pollution, has been transposed into Slovenian law by the Regulation on activities and installations with major pollution potential. The European Union has brought the IPPC Directive together with six other directives related to industrial emissions in a single Industrial Emissions Directive (IED). 97 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) 98 Source: Humar M., ·mid-Korbar J., Obreza A. Dictionary of Pharmaceutical Terminology. Ljubljana 2011.