Archive:
A legal assessment of the use of social/health data by the GKV by Prof. Dr. iur. Dr. med. Alexander PF Ehlers and Alexander Philipp Rösner, both: Ehlers, Ehlers & Partner Rechtsanwaltsgesellschaft MBB.
25.05.2020
On the occasion of the 95th working meeting of the supervisory authorities of the social insurance institutions from November 13th to 14th, 2019 in Schwerin, the resolution from the 85th meeting (November 2014) was confirmed that “the federal and state supervisory authorities are of the opinion that the telephone When acquiring participants within the framework of selective contracts, the requirements of Section 7 Paragraph 2 UWG and the competition principles must be observed. What the supervisory authorities mean by “note” was made clear in letters to the health insurance companies: The insurance company is no longer allowed to contact its insured persons by telephone without prior written consent. The financial regulator is of the opinion that the telephone call constitutes unreasonable harassment within the meaning of the UWG - even if it involves potentially life-saving information. People with heart failure are particularly at risk from this legal opinion - they are also high-risk patients for Covid-19 - who could benefit significantly from such offers. It can be assumed that these people have an interest in being protected from a deterioration in their health. Therefore, there is a need for clarification in the law.
25.05.2020
“The time of virologists is over,” says Hamburg forensic doctor Klaus Püschel (1), who, in view of the increasing relaxation of corona protective measures, demands that we now have to listen more to intensive care physicians. Other specialist groups – such as geneticists and archaeologists (2) as well as innovation economists (3) and mobility researchers (4) – are also drawing attention with scientific contributions and interesting models. And of course all sorts of epidemiologists and virologists who were and are present in multimedia, such as Christian Drosten from the Charité, Gérard Krause from the Helmholtz Center, Martin Eichner from the University of Tübingen or the Bonn virologist Hendrik Streeck, whose own initiative is due to this A 20-person team with the “Covid-19 Case Cluster Study” (5), financed by the state of North Rhine-Westphalia, has already presented the first interim results - initially in a rather unscientific form - on the spread of the corona virus in Heinsberg. But: Where is the voice of this multi-professional scientific discipline that combines many important basic sciences, from epidemiology to sociology to public health? Of course, this refers to health services research, which seems to be strangely quiet at the moment in the era of the corona virus. But appearances are deceiving.
25.05.2020
In two detailed thesis papers - incidentally the first from the ranks of German healthcare researchers - a group of authors deals with the diverse effects of the Covid-19 pandemic on our society and on the health system, but also on the protection of civil rights. The multi-professional group of authors sees their work as neither political nor virologist bashing, but rather “as constructive contributions that aim to support the decisions of the coming weeks”. Two of the protagonists (and incidentally also MVF advisory board members) – Prof. Dr. Matthias Schrappe and Prof. Dr. Gerd Glaeske – in the cover interview with “Monitor Healthcare Research” explain not only the motives but also the core theses of the two papers.
25.05.2020
In February 2020, the novel coronavirus (Covid-19) evolved into a pandemic, with the number of Covid-19 cases increasing dramatically in many countries [1,2]. Television and newspapers reported daily on the spread of the pandemic and quickly triggered fears of an impending economic crisis and recession among the population [3]. As early as February 2020, numerous reports appeared on the Internet stating that the spread of Covid-19 was affecting the global supply of medicines as many of the medicines used worldwide are manufactured in China and India, where production has come to a standstill due to disease outbreaks [4]. The German Minister of Health feared that the Covid-19 pandemic could lead to drug shortages in Europe, although there was no concrete evidence of short-term supply shortages [5]. Reports have been published in various countries that shelf-stable foods such as flour, pasta and canned goods were quickly selling out, leading to shortages [3]. At the same time, pharmacies reported bottlenecks in the antipyretic painkiller paracetamol due to the strong demand during the corona pandemic. The demand for over-the-counter vitamin preparations was also significantly higher than usual in March [6]. So far, no studies have been published on pharmacy sales of various medicines used to treat acute and chronic diseases during the pandemic. It can be assumed that patients will buy larger quantities of medication and request more prescriptions if they fear longer quarantines. The aim of this study was to examine the development of drug purchases during the corona crisis.
04.04.2020
Since the first publication of the "Thesis paper on the pandemic caused by SARS-CoV-2/Covid-19 - improve the database, further develop prevention in a targeted manner, protect civil rights" on April 5th, 2020, the development has taken a rapid and sometimes surprising course. On April 15, 2020, at the conference of the Federal Chancellor and Prime Minister, measures to relax containment were taken on individual points (e.g. reopening of certain shops, some schools, etc.) (Anonymous 2020). This was preceded by the Leopoldina’s third ad hoc statement (Leopoldina 2020) on April 13, 2020, the European Commission’s recommendation of April 11, 2020 to relax containment measures in the EU area (European Commission 2020) and the statement by the non-university research institutions on April 28, 2020 (Kleiner et al. 2020). The result was partially contradictory recommendations, but overall the official side is sticking to the restriction of public life, access to education, freedom of occupation and some fundamental rights such as freedom of movement and demonstration. The conference of the Federal Chancellor and Prime Minister on April 30, 2020 did not deviate from this line either, but the importance of regional problem-solving skills was emphasized (point 3).
04.04.2020
The present text sets itself the task of scientifically clarifying the epidemiological problem and deriving recommendations for effective preventive measures from the given situation. The suggestions for prevention are placed in a socio-political framework which, for the authors, is inextricably linked to the facts described. The extensive analytical part is preceded by a shorter summary, which is intended to enable quick orientation about the points of view represented. As would be expected for a thesis paper, the most important results are condensed into three theses with corresponding sub-points, which can be found verbatim in the summary and at the end of the respective chapters. The authors strive to clearly identify the facts and problems. This does not mean any criticism of the people involved who in the past few weeks had to make decisions under the conditions of - the increase is permitted - "even more incomplete information" than is the case today. In every respect, the statements in this thesis paper are intended as constructive contributions with the purpose of supporting the decisions of the coming weeks.
04.04.2020
Based on the statements on the GSAV, it can be seen that, among other actors, the medical profession in particular has expressed considerable criticism of the planned regulation on the interchangeability of biosimilars. The National Association of Statutory Health Insurance Physicians (KBV) points out that biosimilars cannot “automatically be substituted by the pharmacist without close monitoring by the doctor” [2]. The Federal Council also expressed clear reservations about the change in the law and stated that there is currently a “lack of valid data to assess the effects of substitution on adherence and therapy results”. At the same time, the Federal Council warns of “a significant risk to the success of a therapy and patient safety” that can be associated with an aut-idem substitution of biosimilars [3]. The National Association of Statutory Health Insurance Funds, on the other hand, expressly welcomes the proposed regulation and regrets the delayed entry into force, which the association finds “also incomprehensible in terms of content” [4]. The present report is intended to contribute to the health policy discussion about the requirements for the underlying evidence for the possible interchangeability of biosimilars.
04.04.2020
The group of people under 60 years of age may already have osteoporotic fractures. The changes in bone density and structure can be ideopathic, postmenopausal, or caused by harmful medication as well as other secondary causes such as hormonal disorders (hyperthyroidism, hyperparathyroidism, hypogonadism, diabetes) (Torner 2015). To date, there have been few separate studies on the frequency of osteoporotic fractures, specifically in middle age (between 50 and 64 years). Against the background of epidemiological information, previous and current work focuses primarily on geriatric clients in the derivation of preventive interventions, for example in secondary prophylaxis (Conley et al. 2019). However, there is little literature on the relevance of health promotion and prevention for working-age patients. In particular, the risk factors known for osteoporosis, drug use, vitamin D and calcium deficiency or psychosocial stress and lack of exercise (DVO; DiPietro et al. 2019; Follis et al. 2019) could play a role in this population. The aim of the present work is to describe the frequency of hospital-diagnosed osteoporotic fractures within the middle age between 50 and 64 years in Germany. Furthermore, the relevance and type of possible preventative measures in this phase of life should be discussed.
04.04.2020
“Rare diseases” are not “rare” at all, but extremely common. After all, around four million people in Germany suffer from a chronic “rare disease” (SE). In Europe, a disease is defined as rare if it affects fewer than 5 in 10,000 people. Of the 30,000 currently known diseases, around 7,000 to 8,000 are classified as “rare”. Despite the small number of patients per disease, the impact of SE can be profound not only for patients and their families but also for society. Rare diseases therefore pose particular challenges for all those involved in the healthcare system. A special case among “rare diseases” are those that are treated with biotherapeutics. These include defects in the immune system, autoimmune disorders or chronic inflammatory diseases of the nervous system. Preparations obtained from plasma are vital for the treatment of these diseases. The uniqueness of the raw material plasma as a starting material for the production of vital medicines must therefore be given special consideration. Immunoglobulins (IG) obtained from human plasma are of particular importance in the treatment of immune defects. IG preparations are highly complex biological medicines that cannot be produced synthetically but are obtained exclusively from voluntary blood/plasma donations. Raising awareness of and improving the diagnosis of immune defects as well as an expansion of immunomodulatory indications are causing the need for plasma to continue to rise. At the same time, however, the number of potential donors is decreasing due to demographic developments and also due to a lack of willingness to donate. This development can lead to bottlenecks in the plasma supply in the long term.