More than 120 years of corporate responsibility
As early as 1895, the founders of the Professional Community of German Pharmacists (STADA) set a goal to care for the wellbeing of its patients by preparing certain medicines in accordance with standardized guidelines. The safekeeping of society’s greatest asset, its health, has always been the focus of STADA’s business activities. More than 120 years after the founding of the Company, STADA contributes to efficient and affordable health care and preventative health care and, at the same time, helps to ease the burden on health-care systems.
Responsible Corporate Governance and Compliance
As an internationally active Group, STADA is subject to a wide range of legal framework conditions. Adherence to these conditions forms the foundation of responsible, sustainable and successful corporate governance – because unlawful behavior or even the appearance of a breach of law can damage the reputation and market position of the Company in a lasting manner and cause significant financial loss. For this reason, the principles of transparent, responsible and value-oriented corporate governance
determine the actions of STADA’s Executive and Supervisory Boards. Furthermore, in addition to legal requirements and further regulations such as the German Corporate Governance Code, for instance, the regulatory framework in which the Company operates encompasses the provisions of its Internal Control and Risk Management System, the STADA Code of Conduct and corporate policies on specific topics derived from it.
Product Safety and Quality
Pharmaceutical drugs are products that have a direct impact on peoples’ health. For this reason, STADA, as a pharmaceutical and health-care company, is responsible for ensuring the Group-wide safety of its products and thus also the safety of patients.
Good clinical practice
To ensure product safety and quality, STADA adheres to legal requirements and guidelines in the course of its development activities as well as national regulations in the case of local in-house developments and in the planning and execution of clinical trials also follows so-called Good Clinical Practice (GCP). GCP is an international ethical and scientific standard for the planning, execution, documenting and reporting of clinical trials on human subjects. Compliance with this standard ensures the rights, safety and health of individuals in clinical trials in accordance with the Declaration of Helsinki, as well as the credibility of the data gathered from the clinical trial. Contract research organizations for the execution of clinical trials in Germany and internationally
are qualified by STADA and regularly audited in order to ensure GCP compliance during the conduct of a study. In
addition, all clinical trials are monitored at trial sites so that any deviations from the GCP standard can be recognized at an early stage and corrected if necessary.
Good manufacturing practices
In addition to the Good Clinical Practice, STADA also follows the so-called Good Manufacturing Practice (GMP) for its quality assurance and control. They represent the guidelines for quality assurance in terms of both the processes and the environment in the production of pharmaceuticals and active ingredients as well as cosmetics . STADA is also certified in accordance with external, international quality management systems and, at its numerous production sites, not only focuses on GMP standards, but also on all relevant ISO standards. Group-wide quality management is carried out centrally through STADA Arzneimittel AG, whereby individual, national companies are supported by regional quality assurance officers.
In the context of GMP audits, Quality Management regularly reviews both compliance with quality standards set by the Group for its production sites as well as the facilities of suppliers and contract manufacturers. In addition, inspections are conducted at regular intervals by the responsible national regulatory authorities – within the EU these take place every two to three years. STADA requests additional EU GMP compliance inspections for production sites outside of the EU.
Good pharmacovigilance practices
As part of a Group-wide global pharmaceutical safety system – the so-called STADA Global Pharmacovigilance System – the safety of all STADA pharmaceuticals worldwide is monitored and ensured through the collection and evaluation of all reported pharmaceutical risks. Here, STADA’s subsidiaries work in accordance with standard operating procedures (SOPs) issued by the central department of Corporate Pharmacovigilance. In accordance with Good Pharmacovigilance Practices (GVP) and as part of the Global Pharmacovigilance Quality System, adherence with legal requirements and STADA standard operating procedures is monitored globally by means of a pharmacovigilance auditing system. Pharmacovigilance audits required in accordance with GVP are conducted by auditors from the Medical Affairs/Corporate Pharmacovigilance department. Additionally, STADA’s GVP conformity is regularly inspected by authorities such as the German Federal Institute for Drugs and Medical
Devices (BfArM). In this regard, key persons responsible for pharmacovigilance are present on-site for pharmacovigilance inspections worldwide.
In 2013, STADA was the first pharmaceutical company in Germany to introduce 2D bar code labeling for its products on a large scale, thus simplifying product management and increasing customer safety – in the case of a product recall, for example. With this step, STADA has already established an initial measure on the market which, according to the EU Directive on Falsified Medicinal Products, are first set to be legally implemented throughout the EU by February 9, 2019.
In addition to the assurance of product safety, quality and effectiveness, STADA is also equally responsible for the safe use of its products by patients. In this context, the readability and comprehensibility of a drug’s package insert take on a special meaning. During a pharmaceutical approval procedure, readability tests for package inserts – so-called “readability user tests” – are conducted early on with representative test subjects. Through the optimization of the layout, explanations for technical terms and the use of simple sentence structures it is possible to ensure that patients can easily read and understand the package insert. As a result, compliance is not only increased, but misuse also avoided.
Environmental Protection and Ecological Sustainability
STADA’s operational environmental protection generally covers the areas of energy, gas, water and waste, focusing in this regard on statutory requirements which are fully complied with. The Company, for example, maintains location-related energy balances and in 2015 conducted energy audits at all locations in Germany in accordance with the Energy Services Act (Energiedienstleistungsgesetz). In this regard, STADA’s energy balance was above average in an industry comparison. Subsequent audits are planned at regular intervals and the potentials for improvement that are identified through the energy audits and energy inspections flow successively into the planning of renovation and modernization measures.
Contributions to Society
As a pharmaceutical and health-care company, STADA not only has an obligation to ensure the safety and quality of its products but, with its generics portfolio, it has also assumed a responsibility for providing society with access to affordable medical care and prevention. The Company thus makes a critical contribution to society: it allows people to protect their most important asset, their health.
At the same time, the Company helps to alleviate the cost pressures that burden health-care systems: Due to the relatively low research and development costs attributable to generics and biosimilars, they generally represent a low-cost alternative to the significantly more expensive original products and STADA passes this cost benefit on to its consumers and the health-care systems.
According to a study from the association Pro Generika e.V., in 2016 the use of generics was able to cover 77% of the pharmaceutical demand in public health insurance in Germany, for example, while their share of the actual costs for pharmaceuticals made up less than 10%. According to the latest figures, the association estimates that savings in the amount of around € 18 billion were realized through the substitution of generics in 2017.
Observance of Human Rights
For STADA, good corporate governance means that the focus is not only on the achievement of goals, but also on the way in which these goals are achieved. The Company goal, to achieve economic success in line with ethical responsibility, is also mirrored in STADA’s Code of Conduct, which provides guidance to employees particularly for correct behavior when facing legal or ethical challenges. It includes, for example, behavioral guidelines for dealing with each other and with third parties as well as rules regarding tolerance, respect and discrimination.
Since financial year 2016, STADA has begun to increasingly obligate itself and its suppliers in their contracts to adhere to the ten principles of the UN Global Compact. This is associated with an obligation to, among other things, respect and support the protection of international human rights and ensure that neither party is complicit in any violations of human rights and commits to the removal of all forms of compulsory labor and to the elimination of child labor. At the same time, in the context of a social compliance questionnaire, STADA also increasingly queries its suppliers regarding their handling of the universal rights of each individual.
Further, a person’s right to integrity is taken into account using the application of GCP in STADA’s development and manufacturing practices or using EHS evaluations for example.