Glossary

The 3R principle applies internationally as the guiding principle for all animal testing. By using methods to replace animal experiments (replacement), reducing the required number of animals (reduction), and improving the test methods (refinement), the number of laboratory animals used as well the stress placed on them before, during and after testing are to be kept to an absolute minimum.

The Association for Assessment and Accreditation of Laboratory Animal Care International is a private, nonprofit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs.

Access to Medicine

The index is a ranking of world´s 20 largest pharmaceutical companies on their efforts to increase access to medicine for societies in need. It is published every two years by the Access to Medicine Foundation.

Active pharmaceutical ingredient.

An audit is a process performed by a trained auditor to monitor a management system.

Schistosomiasis is a parasitic disease that is spread in warm lakes and ponds by snails that serve as intermediate hosts.

The term is used to describe the diversity of ecosystems, habitats and landscapes on earth, the diversity of the species and the genetic diversity within a biological species or population.

Corrective action and preventive action

The Carbon Disclosure Project (CDP) is an independent not-for-profit organization that works on behalf of investors to motivate companies to transparently report their greenhouse gas emissions and water consumption.

The European CLP regulation (Classification, Labelling and Packaging of Substances and Mixtures) is based on the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals.

CO₂-equivalent: Indicates how much a specified quantity of a specific greenhouse gas contributed to the greenhouse effect. Carbon dioxide serves as the comparable value.

This term covers compliance with laws and regulations; the application of recognized standards and recommendations; the development of and adherence to internal guidelines; as well as the creation and implementation of guideline and control structures.

Contract research organization

The term describes the development of a population, such as the change in the age structure. In Germany, several other EU countries and the United States, the average age of the population is on the rise.

Dual-use products are goods that are normally used for civilian purposes, but that may also have military applications.

Earnings before interest and taxes on income. Equals the operating result.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is a European umbrella organization representing individual pharmaceutical companies as well national associations of research-based pharmaceutical companies.

Environment, Health and Safety: This abbreviation describes environmental management, health protection and occupational safety throughout the company.

European Medicines Agency: an official body of the European Union, headquartered in London. It is responsible for evaluating and monitoring medicines and plays a key role in the marketing authorization of medicinal products.

Environment Health Safety Security Quality: A Merck KGaA, Darmstadt, Germany function

Eutrophicating substances cause an overabundance of nutrients in the ecosystem.

The EU Falsified Medicine Directive, adopted in June 2011, aims to help prevent counterfeit medicines from entering the supply chain.

Food and Drug Administration: U.S. government agency responsible for protecting and advancing public health, especially as concerns food and drugs.

Sum of sales as well as royalty, license and commission income. Royalties are earned primarily through patents held by the prescription medicines division.

The Greenhouse Gas (GHG) Protocol is the most widely used accounting and reporting system for greenhouse gas emissions.

Globally Harmonized System of Classification and Labelling of Chemicals: An international standard system for classifying chemicals, including packaging labels and safety data sheets.

The Global Compact is an initiative launched by the United Nations in 2003. Its signatories commit themselves to ten principles on human rights, labor standards, environmental protection, and anti-corruption, which are based on key UN conventions.

The Global Product Strategy is an initiative of the International Council of Chemical Associations (ICCA) through which participating companies of the chemical industry make a commitment to comprehensive product responsibility.

Good Manufacturing Practices are rules and procedures that help ensure that pharmaceuticals are of the required quality. GMPs pertain to the methods, facilities and control processes utilized for manufacturing, processing, packaging, and/or storing pharmaceuticals.

Global Pharma Health Fund e.V. is a charitable organization funded by Merck KGaA, Darmstadt, Germany. The organization’s goal is to promote health care within the scope of development assistance, especially with respect to the fight against counterfeit medicines through the use of the GPHF-Minilab®.

The GRI is a global network of stakeholders and experts that has created guidelines for producing sustainability reports with the aim of achieving comparability among these reports. The GRI G3 is the third generation of the guidelines. Apart from information on planning, contents and quality of reporting, it contains a list of the required data on management approach and indicators that are to be communicated as part of sustainability reporting.

Good Clinical Practices (GCP) are rules and procedures for conducting clinical drug trials involving human subjects.

International Council of Chemical Associations.

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) is the global umbrella organization for research-based pharmaceutical companies as well as pharmaceutical associations.

The aim of the “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use” (ICH) is to promote uniform assessment criteria for product registration in Europe, the United States and Japan. The ICH makes recommendations toward achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration. This includes, for instance, Good Clinical Practice (GCP) guidelines for clinical trials of pharmaceuticals and Good Manufacturing Practice (GMP) guidelines for flawless manufacturing.

Interventional studies are “investigations conducted on humans with the purpose of researching or proving the clinical or pharmacological effects of medicines, or of determining their side effects, or of investigating their absorption, distribution, metabolism, or excretion, in order to discern the safety and/or efficacy of the drug”. (German Federal Drug Law (AGM), section 4, para. 23).

The ILO is a United Nations agency dealing with labor issues, in particular the formulation and implementation of international labor and social standards, especially the core ILO labor standards. The agency's work focuses on an inclusive, democratically governed globalization process and the creation of decent employment opportunities as a fundamental prerequisite for prosperity.

A federation of research-based pharmaceutical companies in Switzerland

“In vitro” refers to procedures involving components of an organism that have been isolated from their usual biological surroundings (e.g. test tube experiments)

ISAE 3000 (the International Standard for Assurance Engagements other than Audits or Reviews of Historical Financial Information), published by the International Auditing and Assurance Standards Board (IAASB), is currently the far most internationally applied corporate responsibility standard.

This international environmental management standard sets globally recognized requirements for environmental management systems.

This international standard defines globally recognized requirements for energy management systems.

Least Developed Countries (LDC) are countries that, according to the United Nations, exhibit the lowest indicators of socioeconomic development.

The abbreviation for “light-emitting diode”, an electrical semiconductor. When an electrical current passes through the light-emitting diode in the diode's forward direction, the diode emits visible light, infrared light (for infrared diodes), or ultraviolet light in a wavelength determined by the semiconductor material and the doping.

A life cycle assessment (also known as ecobalance) is a systematic analysis of the environmental impact of products throughout their entire life cycle.

These specialty chemicals are used in LC displays (LCD), for example, in flat-panel televisions, notebooks, mobile telephones, etc.

Lost time injury rate: indicator for workplace safety. The number of workplace accidents with one or more days of lost time per million hours worked.

A substance that changes the DNA of an organism.

Neglected tropical diseases (NTD) are conditions that occur primarily in developing countries. NTDs include schistosomiasis, intestinal worms, trachoma, lymphatic filariasis, and onchocerciasis. This group of diseases is called “neglected” because despite the large number of people affected, they have historically received less attention and research funding than other diseases.

Non-governmental organization

Organization for Economic Co-operation and Development, with headquarters in Paris, is a forum of 34 countries committed to the principles of democracy and market economy.

Ecotoxicology focuses on the effects of substances on the ecosystem.

Organic light-emitting diodes. New technology for displays and lighting used, for example, in mobile telephones, MP3 players, and since recently also in televisions and lamps.

Pharmacovigilance is the continual, systematic monitoring of a drug's safety.

A product carbon footprint quantifies the total amount of greenhouse gas emissions that a product causes throughout its entire life cycle, making transparent to what extent a product adversely affects the climate.

Polymer-stabilized vertical alignment: A polymer layer pre-aligns the molecules inside the display in a certain direction. In the black state, the liquid crystals are not exactly vertical, but slightly tilted, which allows the liquid crystals to switch more quickly. The light transmittance of the display is significantly higher, thus reducing the backlighting, one of the most costly components to produce.

A public-private partnership is a collaboration between public sector (government) organizations, private companies and/or non-profit organizations.

Registration, Evaluation, Authorization and Restriction of Chemicals: This is an EU regulation that was adopted in mid-2007 in order to further improve chemical safety.

(Restriction of Hazardous Substances) This EU directive, which was adopted in 2002, serves to limit the use of certain hazardous materials, such as lead and cadmium, in the manufacture of various types of electrical and electronic equipment in the European Union.

The term stands for technical, organizational and personnel measures to avoid dangers that occur knowingly and willingly. This serves to protect employees and the environment as well as company knowledge.

Stakeholders are people or organizations that have a legitimate interest in a company, entitling them to make justified demands. Stakeholders include people such as employees, business partners, neighbors to sites, and shareholders.

Stem cells are undifferentiated cells with the potential to develop into many different cell types that carry out different functions.

The Sunshine Provisions of the Patient Protection and Affordable Care Act aim to create more transparent relationships between manufacturers of drugs, medical devices and medical aids on the one hand and doctors and teaching hospitals on the other.

Greenhouse gases are gases in the atmosphere that contribute to global warming. Greenhouse gases can be either naturally occurring or caused by humans (such as CO₂ emissions caused by burning fossil fuels).

The UK Bribery Act is an anti-corruption law in the United Kingdom. It applies not only to UK companies, but also to all companies that do business in the United Kingdom in any way.

Essential medicines as defined by the World Health Organization are “those drugs that satisfy the health care needs of the majority of the population.”

UNIA is a Swiss trade union that spans multiple sectors of industry.

The Verband der Chemischen Industrie (German Chemical Industry Association) represents the economic-political interests of 1,600 German chemical companies.

The German Association of Research-Based Pharmaceutical Companies represents the interests of 44 international research-based companies and over 100 subsidiaries in health care, research and economic policy.

(Volatile Organic Compounds) A collective term for organic chemical compounds that evaporate readily and are gaseous even at low temperatures.

The World Health Organization is a specialized agency of the United Nations. WHO is the directing and coordinating authority for public health within the United Nations system.