Responsibility to our stakeholders
As a manufacturer and provider of life-sustaining medical products and services, Fresenius Medical Care has a special responsibility towards its stakeholders, especially its patients and business partners. Our conduct towards them as well as our processes in research and development are based on Company and industry standards and regulations. Moreover, we are committed to improving the quality of life of kidney patients – as a service provider in our clinics, as a member of associations, as a neighbor in our surroundings, and as a company in society. In this way, we not only aim to meet our responsibilities, but also to strengthen our good reputation in the dialysis market.
Behavior towards patients and business partners
The code of conduct of Fresenius Medical Care provides the framework for our responsible and correct behavior towards our patients and business partners in accordance with statutes; for more details on the code of conduct. Among other things, it contains specific behavior guidelines for management and employees in clinics and for sales and marketing. These guidelines cover matters such as the correct invoicing of products and services, fair competitive behavior, and treating patients with respect and integrity. Our marketing and sales employees receive specific compliance training tailored to their field of activity. In our work with our health partners in the U.S., we also apply the codes of conduct of the U.S. industry associations PhRMA for pharmaceutical companies and AdvaMed for manufacturers of medical technology products.
Research and development
When Fresenius Medical Care wants to release new medical devices or pharmaceutical products onto the market, we have a legal responsibility to provide evidence for and extensively document their effectiveness and safety based on clinical studies. This means that new developments must be used with a group of patients in a clinical environment over a specific period. For purposes of comparison, one or several additional groups of patients are treated with existing state-of-the-art products and methods.
Extensive guidelines and laws apply to our industry, which ensure that no ethical principles are violated during such studies, that physicians and institutions carrying out such studies for the companies are carefully selected based on their qualification, and that they apply scientifically sound methods. Fresenius Medical Care’s clinical research is founded on these rules and laws. They include, among others, the Helsinki declaration of the World Medical Association, which sets out basic ethical principles for clinical research, and international guidelines such as Good Clinical Practice (GCP), the EU guidelines for pharmaceuticals such as Directive 2001/20/EC, the EU Medical Device Directive (MDD) and ISO standard 14155, which defines the criteria for clinical investigation and reporting. Additionally, we observe national laws and guidelines such as the German Pharmaceuticals Act (AMG) and the Medical Devices Act (MPG) in Germany, as well as U.S. Food and Drug Administration (FDA) guidelines. Our own Fresenius Medical Care Standard Operating Procedures combine these guidelines with internal requirements to ensure that clinical studies commissioned by us are carried out and documented properly. Before a study can even begin, ethics committees in the relevant countries must approve our application. Compliance with such requirements by manufacturers of medical devices and pharmaceutical products is an important condition for publishing the research results in the scientific media.
We use animal testing for new products and treatments to the extent that this is required by law. Such tests are carried out exclusively by third-party research institutes in approved test laboratories, and are always first approved by an ethics committee for animal testing. Fresenius Medical Care does not carry out animal testing itself. It is generally our strategy to avoid animal testing and to use alternative methods.
As a dialysis company, it is our aim to continuously improve the quality of life of kidney patients. We pursue this aim even beyond our core products and services by engaging in numerous initiatives which promote an active, healthy lifestyle of patients despite the disease, help to improve access to high-quality treatment and provide information and education about chronic kidney failure.
Commitment to patients’ quality of life
Fresenius Medical Care cooperates with regional and supraregional associations and institutions around the world that champion the interests of dialysis patients. In addition, we develop our own initiatives to help patients lead a healthier and more active life. In the U.S., for instance, we support the Renal Support Network, a charitable association of and for patients with chronic kidney failure, which aims at providing patients and their families with health information, empowering them and giving them more confidence in their everyday lives. In Brazil, we provide financial and professional support to the Fundação do Rim, a charitable foundation committed to the needs of dialysis patients between 0 and 21 years. This organization works with authorities and the public to ensure access to medication and kidney transplantations for children and adolescents, and promotes the establishment of more pediatric dialysis units in hospitals. At the same time, it organizes special programs for young patients, such as exercise, art and music therapy courses, and trains parents in how to deal with their children’s disease. In Australia, we organize an annual Kidney Kids Camp together with a children’s hospital in Sydney. This is a weekend trip for young peritoneal dialysis patients, offering fun and enjoyment as well as safe dialysis treatment by professional dialysis nurses. This initiative aims at giving kids with kidney disease the chance to enjoy a carefree weekend with others their own age, while at the same time taking pressure off the parents, who normally carry out the treatment.
In Columbia, we set up a foundation to promote the health and well-being of our patients even beyond their actual dialysis treatment. The Fundación Fresenius is financed by donations from business, our employees and private individuals. We prepare regular reports to show how the funds are used. In the year under review, we extended our publicity work for this foundation to raise the number of donations and thus allow us to further extend the range of services for patients. In 2010, for instance, we provided 6,300 patients with regular and healthy hot meals, and each month more than 2,400, or approximately 40%, of our patients were given free travel between their homes and the dialysis center. Moreover, joint events were held, such as day trips, cultural events, handicraft courses and a Halloween party for children with kidney disease. We provided particularly needy patients with groceries. Special tents were set up for poorer peritoneal dialysis patients who have insufficient space at home for safe treatment, and a dialysis nurse trained the patients in the safe use and proper cleaning of these tents.
According to their registration data, some 35% of our patients in Argentina do not hold a primary school diploma, which children in this country gain after seven years at school. The problems resulting from this in everyday life became particularly evident in art therapy and story-telling workshops with the patients. Their low level of education places additional restrictions on their quality of life. It makes it more difficult for them to find an occupation in an employment market that is already tight, and aggravates the typical problems of living with dialysis, above all the need to comply with the treatment plan and the intake of medication in a disciplined way. In order to open up new opportunities for these patients and to enable them to help themselves, we started a project together with the Ministry of Education of the Buenos Aires province. The Ministry sends out teachers from its adult learning program to four of our dialysis clinics. In 2010, these teachers taught around 80 dialysis patients with the aim of enabling them to complete their school education. The focus was on reading and writing, in which many of the participating patients are not proficient. In the year under review, we held a graduation ceremony for the first successful primary school graduates. In the current business year, we plan to extend this project to other clinics.
Donations and emergency aid
We provide funds, dialysis machines and medical supplies in crisis situations and for institutions that need specific aid immediately. Similar to our help after the severe earthquakes in Italy and China in the past years, we sent dialysis supplies to Haiti at the start of 2010. We donated around twelve tons of dialysis equipment and accessories, which were transported by ship and a chartered cargo plane. Moreover, we took a leading role in organizing aid from the emergency association of the U.S. dialysis industry, KCER see here and magazine. Several Fresenius Medical Care clinical nurses volunteered as medical personnel for various charitable institutions in Haiti on their own initiative. In Brazil, we donated hemodialysis machines to the new pediatric nephrology ward of a hospital in Rio de Janeiro in the year under review. Thanks to this equipment, children with chronic kidney disease who are treated at the hospital for other reasons can continue their dialysis therapy.
Promoting knowledge and further education
Fresenius Medical Care organizes and promotes scientific conferences and further education programs by international nephrology experts worldwide for physicians and dialysis nurses, thereby contributing to quality in dialysis. This is especially the case in regions where modern health care standards are still being developed. One example for this commitment can be found in our magazine. We also participate in projects aimed at getting young doctors interested in nephrology and promoting new talent in this area. In Brazil, for instance, we supported an initiative of the national society for nephrology in the year under review. In this initiative, medical students close to graduation were awarded for research projects in which they developed solutions to improve the prevention of chronic kidney disease in their communities. In Venezuela, we organize nephrological conferences for physicians and medical students. As part of an agreement with the Universidad Central de Venezuela, we also offer clinical internships in dialysis for nursing students.
Projects for better patient care
We also take part in local projects to improve the care of dialysis patients. Between 2008 and 2010, for example, we cooperated with the Indonesian nephrology association Pernefri and a development bank in a public-private partnership project; also see here. The aim of this project was to improve access to dialysis treatment and treatment quality in rural Indonesia. As part of the partnership, we extended the dialysis units of four public hospitals by a total of 40 hemodialysis machines and four water-preparation units. This created capacity for approximately 240 additional patients, who could previously not be treated due to the lack of infrastructure. Additionally, we trained 20 internal specialists and 60 nurses in dialysis in cooperation with Pernefri. We want to continue this commitment in similar projects in future.
The Renal Research Institute, a joint venture between Fresenius Medical Care North America and a hospital in New York, is a partner of the Sustainable Kidney Care Foundation. This foundation promotes projects in Tanzania, Africa, in which patients with acute kidney failure in regions without an existing supply structure are given access to dialysis treatment. Acute kidney failure frequently occurs there in connection with other severe diseases such as HIV or tuberculosis.
Raising public awareness
Last but not least, Fresenius Medical Care is also involved in raising the health awareness of the general public. In Taiwan, for instance, we organize an annual information event together with the national nephrology society and several hospitals with the aim of raising the public’s awareness of a healthier lifestyle and promoting the early recognition of kidney diseases. In the U.S., we again supported Kidney Walks, sporting events and other fundraising events sponsored by the National Kidney Foundation (NKF) in all parts of the country. The Kidney Walks also have the purpose of increasing public awareness of the symptoms of chronic kidney disease. The donations benefit the work of the foundation. Apart from providing information to raise awareness of chronic kidney disease, the NKF also provides research grants in nephrology for physicians, advocates for the interests of dialysis patients and for research in kidney disease and its causes, as well as for organ donation to increase rates of kidney transplantation. In Brazil, we started several awareness initiatives in 2010 for our employees, patients and the public as part of the global World Kidney Day. Among others, we organized talks about the function of the kidney, a healthy diet as well as heart and vascular diseases, and provided free blood pressure measurements and glucose tests to recognize diabetes.