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The effects of mental diseases on the employment and working situation can be substantial. They are one of the main reasons for inability to work and reduced earning capacity. Against this background the question arises about suitable occupational reintegration measures for people with severe mental illnesses. In recent years, the principle of supported employment has been internationally shown to be increasingly more successful. In this context mentally ill people are primarily placed at a position of the first employment market and supported on-site by a job coach. This concept is inclusive, individual and evidence based. Despite proven effectiveness, it has so far been insufficiently implemented in German-speaking regions. In the future it will be a matter of considering the individual needs for assistance of mentally ill people more intensively than previously and to respond with functional and in a best-case scenario, multiprofessional and flexible offers.Die Auswirkungen psychischer Erkrankungen auf die Arbeits- und Erwerbssituation können erheblich sein. Sie sind eine der Hauptursachen für Arbeitsunfähigkeit sowie Erwerbsminderung. Vor diesem Hintergrund stellt sich die Frage nach geeigneten beruflichen Wiedereingliederungsmaßnahmen für Menschen mit schweren psychischen Erkrankungen, wobei sich in den letzten Jahren international das Prinzip des Supported Employment als zunehmend erfolgreich erwiesen hat. Hierbei werden psychisch erkrankte Menschen mit beruflichem Rehabilitationsbedarf primär auf einem Arbeitsplatz des ersten Arbeitsmarktes platziert und vor Ort durch einen Jobcoach unterstützt. Dieses Konzept ist inklusiv, individuell, nachhaltig und evidenzbasiert. Trotz erwiesener Wirksamkeit ist es im deutschsprachigen Raum bislang noch wenig umgesetzt. Es wird zukünftig darauf ankommen, stärker als bislang den individuellen Hilfebedarf psychisch erkrankter Menschen aufzunehmen und mit funktional, im besten Fall multiprofessionell und mobil aufgestellten Angeboten zu begegnen.

Patient involvement in health research is an integral part of health care in many countries. It promotes the relevance and quality of research and increases the meaningfulness of research results. Meanwhile, the value of patient involvement has also been recognised in Germany. The lack of a common understanding of patient involvement and appropriate methods make implementation difficult. In Germany, patients are still rarely involved in the planning and conduct of health research. Vulnerable patient groups such as the elderly and the very old are considered particularly challenging for researchers in active patient involvement due to their special needs, which is why they are often neglected. Especially nursing home residents suffer from a variety of health impairments which are accompanied by a high number of prescription drugs and adverse events and can therefore make patient involvement more difficult. The present project aims to test the method of patient advisory boards for the involvement of nursing home residents. Using the design of a clinical trial to optimise medication for nursing home residents as a case study, we will assess the feasibility of the method for this target group. We will also install a patient advocate as moderator of the advisory board. The study plan is described in the present study protocol.Two patient advisory boards with nursing home residents will be established. With a patient advocate acting as moderator, the essential elements of a clinical trial to optimise medication will be discussed and passed on to the study planning team via the patient advocate. The overall topic of the clinical trial is the optimisation of medication in cardiovascular disease. The nursing home residents are informed about the contents and ideas of the study to be planned and the interests of the researchers, respectively, and will discuss the proposals of the study planning team. Nursing home residents', the patient advocate's and the researchers' expectations and experiences will be examined in individual interviews.The study will provide a potentially suitable method to involve nursing home residents in the research process. The jointly developed study design will be incorporated into a new project proposal. The results will be used to inform the development of a German handbook on active public and patient involvement.

Im Rahmen der aktuellen Wissenschaftskultur stellt das Bestreben, die evidenzbasierte Naturheilkunde in die Leitlinien zu integrieren, eine besondere Herausforderung dar. In Deutschland werden medizinische Leitlinien primär von den wissenschaftlichen medizinischen Fachgesellschaften und deren Dachgesellschaft, der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V. (AWMF), entwickelt und verbreitet. Bisher wird das große klinische Potential von Naturheilkunde und Komplementärmedizin an vielen Stellen nur unzureichend berücksichtigt. Mit der Aufnahme der Gesellschaft für Phytotherapie (GPT) in die AWMF wurde im Jahr 2013 ein neues Kapitel in der Leitlinienarbeit der von der Rut- und Klaus-Bahlsen-Stiftung geförderten Arbeitsgruppe «Naturheilkunde und Komplementärmedizin in medizinischen Leitlinien» aufgeschlagen. Die Bestrebung, Naturheilkunde und Komplementärmedizin fester in der konventionellen medizinischen Versorgung in Deutschland zu etablieren, bekommt damit weiter Auftrieb. Durch die Förderung der Rut- und Klaus-Bahlsen-Stiftung wurden die Mitarbeit oder Unterstützung bei bisher mehr als 20 nationalen und internationalen Leitlinien, die Erstellung von 8 Cochrane-Reviews, 4 davon federführend, und von 40 systematischen Reviews und Meta-Analysen in internationalen Peer-Review-Zeitschriften möglich. Erst durch die konsequente Ausweitung und Vollendung der begonnenen Arbeit wird eine Rückentwicklung (und Rückabwicklung) im Feld der Leitlinienarbeit unmöglich gemacht und damit die Anerkennung von Naturheilkunde und Komplementärmedizin im Fächerkanon weiter gestärkt.

On the occasion of the 50th anniversary of the Scientific Working Group for the Therapy of Lung Diseases (WATL) the history is described from its foundation to the present situation. Research topics during this long period are specified and the studies are briefly outlined. In the beginning, WATL was engaged mainly in studies on tuberculosis, later on, the spectrum of WATL was broadened considerably to diseases like sarcoidosis, pulmonary Langerhans' cell histiocytosis, pulmonary emphysema due to α1-antitrypsin deficiency, chronic obstructive bronchitis and bronchial asthma as well as nontuberculous mycobacterioses. Finally, realising that the methodological capabilities of WATL were not sufficient to conduct large trials in classical lung diseases considering current requirements, WATL has begun to acquire competence in rare lung diseases such as lymphangioleiomyomatosis and alveolar proteinosis. In addition, WATL is dedicated to educative aims by organising conferences on topics which are not part of main stream respiratory medicine.

The Federal Joint Committee and the Institute for Quality and Efficiency in Health Care have become important players in the German health care system, not only since the benefit assessment of pharmaceuticals and the Act on the Reform of the Market for Medicinal Products (AMNOG) were established. However, the manifold tasks and duties these institutions have besides the benefit assessment of pharmaceuticals is less known, just as the role the patient's representatives play. The function and structure of the Federal Joint Committee and the Institute for Quality and Efficiency in Health Care as well as their collaboration in consideration of patient involvement will be explained in this article.

Hand injuries are a frequent occurrence and account for 41% of all occupational injuries. In general such accidents are the result of stress, inattention, tiredness, use of defective or poorly maintained machinery. However, artention must equally be directed at the large number of accidents occurring in leisure time activities since the inability to work due to a leisure time accident is similarly cost-intensive. Throughout Europe attempts have been made in the past 10 years to improve prevention. At the initiative of the Hand Trauma Committee (HTC) of FESSH prevention conferences were stated in 2009. These have in part reduced the number of hand injuries in -Europe. In Austria a special controlling committee was founded by the Austrian Workers' Compensation Board (AUVA) with the specific objective of reducing the number of hand injuries. Similarly the "Circle for Leisure Time Hand Injury Prevention" was created to specifically deal with hand injuries occurring during leisure time activities. Through the cooperation of these 2 committees and implementation of the thus decided measures, a reduction in the number of accidents involving the hand is to be expected with a concomitant reduction in the associated costs.

In Germany, medical error reporting systems are well established. They collect information reported principally by physicians. Systematic data collection concerning medical errors is also performed by expert arbitration and advisory boards of the German State Medical Associations.Data base MERS (Medical Error Reporting System); cases from the Expert Arbitration and Advisory Board of the State Baden-Württemberg from the years 2004-2011 (8,042 cases) were evaluated as follows: extraction of the cases from general practitioners (n=307, 4%); categorisation of the type of error and degree of severity; classification according to ICD-10 (International Classification of Diseases); overview of confirmed cases including commentaries of the above board; logistic regression analysis of factors potentially associated with confirmed cases.In 26% (n=80) the board confirmed medical errors. 55% of the errors were assigned to the category "diagnosis" (n=44), 21% to "general therapy" (n=17), 8% to "operative therapy" ("minor surgical operations") (n=6) and 10% to "injections" (n=8). 29% of cases (n=23) were associated with permanent damage or death. The majority of cases could be assigned to ICD-10 categories "I" (cardiovascular system, n=20) and "S-T" or "V-Y" (consequences of external causes or external causes of morbidity and mortality, n=34). No significant associations were found by logistic regression analysis.The rate of confirmed cases corresponds with the rate of all medical disciplines. The presented overview is illustrative and may be of help to avoid errors by using it for continuing medical education.

The Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute developed evidence-based recommendations for the prevention and control of nosocomial infections in Germany. Considering the growing impact of multiresistant pathogens (MRE) on morbidity and mortality related to nosocomial infections, the prevention and control of MRE is one of the most important topics on the current agenda. Currently, the German recommendations on methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE) are being re-evaluated and a recommendation discussing options for the prevention and control of MR Gram-negative pathogens is awaited and will be published in the next months.

With regard to changes in the German law of preventive detention--a sentence handed down to offenders who committed a grave offence and are considered a danger to public safety, similar to the preventive detention law in New Zealand--an online survey amongst forensic psychiatrists has been conducted between July and October 2011. Questions have been raised regarding the necessity of preventive detention, subsequent preventive detention (the possibility of imposing "preventive detention" after sentencing, which was ruled a violation of the European Convention of Human Rights by the European Court of Human Rights), and the Therapy Placement Act from January 1st, 2011.Participants have been contacted via email and participation was anonymous. An online-platform has been established, and has been open for about four months.Most participants have been familiar with either court reports regarding preventive detention or the content of the Therapy Placement Act. Less than one third had already answered issues considering this new law. All participants have considered preventive detention as necessary, but subsequent preventive detention as well as the Therapy Placement Act as not required.The Therapy Placement Act was considered to be modified by involving an interdisciplinary advisory board. Terms of "psychiatric disorder" should be defined or replaced, and frequency of psychiatric assessment should be reduced.

The committee draft for the new patient rights act was approved by the Federal Cabinet on 23 May 2012. Both the demands of the patient representative of the Federal government and some of the demands from the cornerstone paper of the State commission were taken into consideration.The draft of the new act contains comprehensive amendments to the Civil Code with the subtitle"Treatment contract in accordance with §630" and encompasses §§630a-h. The valid legal situation is therefore to all intents and purposes now codified.

Suicide Prevention Austria (SUPRA) is a package of measures which should help the Austrian ministry of health to realize an evidence based suicide prevention program. That such a program is indispensible can be seen on the fact that suicide is on the second position as cause of death in male Austrians up to the age of forty. The concept itself summarizes successful national programs which fit to the Austrian situation. In the meantime the Austrian ministry of health established an office for coordination of the SUPRA program and a commission of experts which is responsible for the first activities of the national Austrian suicide prevention program.

Universal newborn screening for a range of mostly inherited metabolic and endocrine disorders, started in mid-1960ies, is a success story of preventive medicine. New technological advances particularly in the last 10-15 years have led to an expansion of newborn screening in many countries. This has allowed introduction of sometimes life-saving preventive measures in more children, but it has also become more obvious that screening may not be prudent for all conditions in which it is technically feasible. The present article provides criteria that have been used or discussed for the inclusion of "new" disorders in newborn screening programs, and highlights exemplary metabolic disorders that illustrate imminent challenges. In order to secure long-term acceptance of universal newborn screening within the society, its aims and contents should be determined through a transparent decision finding process. This may best be achieved through the establishment of a representative newborn screening advisory board.

Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.

Advanced therapy medicinal products (ATMP) are highly innovative and complex medicines. They comprise gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products (TEP). With the European Regulation on ATMP that came into force in 2008, a consolidated regulatory framework was created, where the Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMA) plays a central role. This article discusses pitfalls and challenges that the CAT has experienced in its discussions of various procedures. Often ATMPs are developed by small and medium-sized enterprises (SME) which also face nonscientific challenges. The CAT wishes to meet these challenges on a scientific and regulatory level during its 2010-2015 work program.

The development of guidelines almost always requires considerable time and financial resources. An important task is therefore to identify and evaluate online methods that facilitate guideline work. ONLINE CONSENSUS CONFERENCE: During the development of the S2k guideline for the management of staphylococcus aureus infections an online consensus conference was held using an online tool provided by the Deutsche Forschungsnetz in combination with a telephone conference. During the 2-hour meeting, no technical difficulties occurred. A survey among the participants showed that this format had a high rate of acceptance. ONLINE REVIEW: During the development of the update of the German S3-Guidelines for the therapy of psoriasis an external open review was performed. An online platform allowing direct visible commenting was chosen. During the five week period of commenting, 26 users added 160 comments. After the review process, the comments were assessed by the editors and the original authors. The selected instrument provides a suitable means for online commenting of guidelines and facilitates the revision of the text.

The German interdisciplinary task force for clinical hemotherapy (IAKH) is an independent association of clinicians. It aims for the improvement of blood transfusion application processes, procedures and safety in the absence of a German hemovigilance system. Whereas the producers of blood products concentrate on product safety, the IAKH focuses on administrative needs such as forms and regulations associated with the administration of blood products. It provides information about coagulation disorders, autologous blood donation and cell saving as well as techniques that reduce the amount of allogeneic transfusion needs. Benefits of a membership in IAKH are electronic and individual recommendations to clinical hemotherapy issues, an exchange forum, as well as low cost participation at conventions and meetings. Just recently, a critical incident reporting system for errors in blood transfusion and hemotherapy was launched (www.iakh.de/ BeinaheFehlerErfassung/). The entries reported are analyzed, feedback and recommendations are given. Everybody in contact with the administration of blood products is asked to report errors and critical incidents.

With the move towards globalized international commerce and trade, a call for harmonization of medical device regulatory requirements and practices has evolved. The purpose of the Global Harmonization Task Force (GHTF) is to encourage convergence of regulatory requirements and practices at a global level through consensus to achieve four principle goals: promote safety, quality and performance/effectiveness of medical devices; encourage technological innovation; foster international trade; and serve as a forum of information exchange - all in the interests of protecting and promoting public health. The GHTF is governed by a Steering Committee, and the principle development of the GHTF regulatory model has been, and continues to be, done through five working groups known as Study Groups and supplemented recently by the creation of several Ad Hoc Working Groups. Since its creation in 1992, the members of the GHTF have worked collaboratively to develop what is now ready to be called a global model for the regulation of medical devices.

On the basis of Section 140h of Social Code Book V (German abbreviation: SGB V), which had been newly included in 2004, the Federal Government Commissioner for Patients' Affairs speaks out in favor of a meticulous implementation of patients' right to education, information and joint decision-making in all spheres of the health care system, whenever the commissioner attends the respective panels or events, and also in public. Currently, the commissioner is member of a parliamentary working group which is charged with the elaboration of the contents of a law relating to patients' rights, and experts and patients' organizations are involved in this procedure as well. For this purpose, but also with regard to other key panels of the health care system, self-help organizations are important partners for collaboration, due to their commitment, their experiences and the inspirations they provide. Therefore, they have been strengthened in essential aspects by the policy of the Federal Government over the past few years.

The first step of user participation which was established by the reform of the German health care system in 2004 currently presents one of the most essential innovations in health policy. The participation of patients' and consumers' representatives in the corporate bodies of the federal joint committee ("Gemeinsamer Bundesausschuss") is, in addition to other activities, an essential contribution to more transparency in the decision process. Due to the participation and the consenting or even critical votes of the patients' representatives, the partially controversial resolutions receive more credibility and are better accepted. On the other hand, the consumers' and patients' organizations have proved to be a competent and reliable partner in order to argue for or against controversial decisions. Patients' participation reduces the legitimation deficits of the self-administrational bodies and thus helps to maintain the German health corporatism. The German health care system also benefits from patients' participation because it corresponds to the internal logic of its crucial principles of solidarity and reimbursement.

The Health Advisory Board of the German Federal Association for Rehabilitation (BAR) describes future trends and challenges in rehabilitation as deriving from the socio-demographic development in Germany and the structural characteristics of its Social and Health Care Insurance System. The focus is on elder employees to sustain and regenerate their capacity for employment, on people which are no longer employed to activate their autonomy and ability for self-support, and on rehabilitation as a holistic and integrative process extending through the social security and health insurances. There is an urgent need and a real chance to benefit from already existing scientific findings more frequently and to integrate them effectively into adequate further education and training programmes for professionals. Finally the conclusion summarises 8 theses to facilitate rehabilitation as an integral and essential part of the German social security and health sector. This paper was fully accredited by the members of the BAR Managing Board.

The setting up of an interdisciplinary tumor treatment center together with a "tumor board" has resulted in early specialty-bridging assessment and therapeutic decisions of cancers, some of them complex, in hospitalized patients with visceral tumors. It was the aim of this study to compare the use and value of the decisions of the tumor board ("second opinion") with those of the original assessment made elsewhere after primary surgical treatment.Information on the tumor board's database, recorded explicitly as "external comments" or "second opinion" were accessed. The data were then classified according to organs or organ systems and further divided into those cases in which the primary tumor had not been treated, those with tumor recurrence and those with metastases or recurrence of metastases.8298 cases were evaluated during a five-year period. There were 373 "second opinions" (4.5%), most of the referrals relating to tumors of the upper gastrointestinal tract, corresponding to the focus of our institution. Previously untreated primary tumors amounted to 53.6% of cases, local recurrences in 14.7% and initial evidence of metastases of a visceral tumor in 9.9%. In 21.7% progression of a known metastasizing tumor was the main reason for requesting a second opinion. The second opinion agreed with the external decision for surgery alone in 16.4% of all enquiries. Minor modifications of the external therapeutic decisions were recommended in 5.9% of referred cases, while in 47.2% major changes were recommended. 28,7% of enquiries could not be evaluated because essential data were not available.Requests for a second opinion in the treatment of visceral tumors are still rare in Germany. Good and current findings are requisites for giving a reliable second opinion. In fewer than a fifth of cases was there agreement with regard to a primarily surgical intervention. The concept of multimodal forms of treatment are usually given priority, which underlines the need for establishing interdisciplinary advisory panels.

For the first time, this study investigates to which extent elderly persons write to the federal government commissioner for patient issues in Germany.A 33% sampling (n=850) of the written inquiries (correspondence and emails) addressed to the commissioner in the first six months of the year 2005 (n=2580) was investigated. Socio-demographic data were extracted from the material; furthermore, it was registered which diseases the citizens described.Older persons outweigh the younger (69% over 60 years, mean age 63 years). Within the group of the elderly, approximately as many persons belong to the age group 60-69 years and to the age group 70 years and older. Most frequently, the citizens describe chronic diseases of the musculoskeletal system.The new service of the federal government commissioner for patient issues appeals to the elderly in Germany. The high proportion of people with chronic illness among the inquirers emphasizes the need for information, advice and support for this target group. Further research is needed on the answers to the inquirers, and on the question how helpful the contact to the government commissioner's office is from the viewpoint of the citizens; furthermore, possible barrieres (e.g. social state) should be analyzed.

In accordance with the German Animal Welfare Act, animal experiments in fundamental biomedical research may only be performed after licensing by the responsible authority. This license may only be granted if the experiments are considered indispensable and if the distress of the animals seems ethically acceptable in relation to the purpose of the study. Since 1987 advisory committees have been established to support the authorities in the evaluation of these provisions. Animal welfare organisations had expected case-by-case evaluations of the in-dispensability of research proposals and of the distress of the animals and the scientific benefit of the experiments to take place in these committees, so that such projects that would not meet the criteria of ethical acceptability could be prevented. However, already the lack of parity in the advisory committees alone, in which as a rule four scientists counterpart two representatives from animal welfare organisations, often-times prevents a balanced discussion of these provisions from taking place. Additionally, due to the freedom of science granted in the German Constitution without reservations, until 2002 also the licensing authorities were merely permitted to perform a formal examination of the applications. In the mean time, by including animal welfare as a national objective in the Constitution, the preconditions were made to enable an examination of the contents. From the point of view of animal welfare it therefore is to be requested that now also the advisory committees are ascribed more importance in the course of the licensing procedure and to establish the legal framework for this, if necessary by a revision of the Animal Welfare Act.

Scientific advice for potential applicants for marketing authorization for medicinal products has been part of the tasks of the European Medicines Agency (EMEA) ever since its establishment in 1995, and has been of increasing significance. Based on Article 56(3) of Regulation (EC) No. 726/2004, this task is now the responsibility of an independent working group of the EMEA, the Scientific Advice Working Party (SAWP). National scientific and regulatory advice has also been part of the work of two national authorities in Germany, the Federal Agency for Medicinal Products and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI) for several years, but has gained in significance especially over the past 3 years. The basis for advice at a national level is Article 71c of the Law on Administrative Procedures (Verwaltungs-Verfahrensgesetz), the Drug Law, the Guidelines for the Evaluation of Medicinal Products (Arzneimittelprufrichtlinien), and relevant guidelines defining the scientific state of the art. A company developing medicinal products may consult the EMEA or the national authority at any time in order to obtain opinions on the investigations and studies on the pharmaceutical, preclinical and clinical development required for a particular stage of development. In this context, the focus is exclusively on the data required for the planned authorization and the assessment of the evaluation strategy suggested by the company itself. The agreement between the company and the regulatory authority prior to marketing approval is designed to achieve a more effective development of the product and to obtain a more rapid decision on a future authorization procedure. An important component of the scientific advice procedure is the discussion between the company and the agencies. The results of this oral exchange is always summarised in writing. Advice is available for all medicinal products, including "orphan drugs". At the European level, the authorization procedure is prepared with the EMEA which provides administrative and legal support, whereas the scientific opinion itself is elaborated by the members of SAWP, and is adopted by CHMP after a maximum of 3 months following the application. In addition to the written opinions elaborated by two members of SAWP, acting as coordinators, and the internal discussion, the exchange of positions within a "discussion meeting" is also an important part of the European procedure. Scientific advice is a fee-paying procedure, with certain exceptions. Experience from previous advice from the EMEA and the BfArM has shown a certain acceleration in subsequent procedures. This experience, however, also shows very clearly that it is the data actually established in the investigation, especially on efficacy and safety, which are important for a successful and fast approval procedure.

Harmonization of European GCP-V-related decrees crushed German urogenital cancer study activities and has led to complete discontinuation of investigator-initiated studies since August 2004. For renal cell carcinoma, the two major branches of the German cancer society (Deutsche Krebsgesellschaft e.V.), the Association for Urogenital Oncology (AUO) and the Association for (Internal) Medical Oncology (AIO), founded a Renal Cancer Task Force Group composed of the active members of the former "Intergroup Competence Network Renal Carcinoma" (IKN-N) in the spring of 2004. The resulting intergroup consortium represents an overall community of more than 100 German clinical departments that are highly experienced in oncological studies and ready to go for future trials. The basic ideas of the concept were transparency, multilateral consultations within the Task Force, and early involvement of national and international representatives of pharmaceutical companies and medical care insurance providers in the process of future study developments. Therefore, two pharmaceutical hearings took place at the University of Frankfurt.

The Senate Commission on Food Safety (SKLM) of the German Research Foundation (DFG) advises authorities and the government on food safety. The risk assessment of foodstuffs, including novel and functional foods, covers the evaluation of food ingredients and additives as well as the evaluation of novel processing methods. In carrying out this task the Commission expresses its opinion primarily on those aspects which are concerned with the safety assessment. In addition, questions relating to the technological need and to nutritional or physiological benefits are also considered. The topics considered may originate from enquiries of the Ministry for Consumer Protection, Nutrition and Agriculture (BMVEL). Other topics may be selected by the Commission on its own initiative, if they are considered to be of particular importance for consumer protection. Within the context of this activity the SKLM also organises symposia and expert discussions, their outcome subsequently being published as resolutions, conclusions or opinions.

In 2002, the European Commission and the European Parliament established the European Food Safety Authority (EFSA). The provisional seat of the new Authority is Brussels and the final seat of the authority will be Parma, Italy. EFSA's main task is to carry out risk assessment and to provide independent scientific advice on all matters linked to food and feed safety. This includes animal health and welfare and plant health-as well as nutrition. Therefore, EFSA's risk assessments provide risk managers with a sound scientific basis for regulatory measures in order to ensure a high level of consumer protection. EFSA is confessed to openness and transparence. The authority keeps good links to all European institutions, particularly to the European Commission and the European Parliament, to national authorities, which have similar tasks to EFSA, and to stakeholders such as consumer and food industry organisations.