Werberecht und Absatzförderung/Preisrecht

2019 ◽  

The first lecture given at the 21st Marburg debates on pharmaceutical law addressed the criminal consequences of advertising law going hand in hand with sales promotion. It focused on clarifying which forms of cooperation are still desirable, necessary and allowed. In addition to dealing with the regulatory requirements involved in the contractual organisation of digital communication channels and the legal options offered by the information conveyed, among others, by health insurance companies about the economic feasibility of regu-lations on medication, the conference also highlighted the opportunities offered by fiscally optimised sales models for medical products. This main subject of discussion also encompassed upholding the EU directive on the protection of know-how on the publication of registration documentation by the European Medicines Agency. Pricing laws constituted a further main point of discussion at the conference, with issues re-lating to mixed pricing, the possibility of being exempt from factory discounts, the effects of the German law on increasing the provision of pharmaceutical products on forms of treatment with cytostatic agents, and the provision of discounts being addressed. With contributions by Dr. Manja Epping, Dr. Jan-Tobias Häser, Prof. Josef Hecken, Christian Hübner, Dr. Elmar Mand, Dr. Constanze Püschel, Dr. Christoph Ritzer, Dr. Stefan Todt, Peter von Czettritz, Wolfgang Voit

2020 ◽  
Vol 158 (04) ◽  
pp. 345-350
Author(s):  
Christian Juhra ◽  
Jörg Ansorg ◽  
David Alexander Back ◽  
Dominik John ◽  
Andrea Kuckuck-Winkelmann ◽  
...  

AbstractNew communication technologies allow patients to communicate with their physicians from anywhere using computer or smartphone. Adding video to the mere phone call optimizes the personal contact between patient and physicians regardless of distance. Legal and reimbursements requirements must be taken into account, especially only certified software products must be used. In addition, patient consent is needed and confidentiality must be assured. The video patient consultation can be reimbursed by the health insurance companies. As with all new technologies, the introduction of these video consultations faced some challenges. Although patients and physicians have expressed great interest in this technology, it has been rarely used so far. The current COVID crisis increased the need for video consultations resulting in an increasing use of video patient consultation. It can be expected that this demand will still exists after the COVID crisis.


Author(s):  
Silke Piedmont ◽  
Anna Katharina Reinhold ◽  
Jens-Oliver Bock ◽  
Enno Swart ◽  
Bernt-Peter Robra

Abstract Objectives/Background In many countries, the use of emergency medical services (EMS) increases steadily each year. At the same time, the percentage of life-threatening complaints decreases. To redesign the system, an assessment and consideration of the patients’ perspectives is helpful. Methods We conducted a paper-based survey of German EMS patients who had at least one case of prehospital emergency care in 2016. Four health insurance companies sent out the questionnaire to 1312 insured persons. We linked the self-reported data of 254 respondents to corresponding claims data provided by their health insurance companies. The analysis focuses a.) how strongly patients tend to call EMS for themselves and others given different health-related scenarios, b.) self-perceived health complaints in their own index case of prehospital emergency care and c.) subjective emergency status in combination with so-called “objective” characteristics of subsequent EMS and inpatient care. We report principal diagnoses of (1) respondents, (2) 57,240 EMS users who are not part of the survey and (3) all 20,063,689 inpatients in German hospitals. Diagnoses for group 1 and 2 only cover the inpatient stay that started on the day of the last EMS use in 2016. Results According to the survey, the threshold to call an ambulance is lower for someone else than for oneself. In 89% of all cases during their own EMS use, a third party called the ambulance. The most common, self-reported complaints were pain (38%), problems with heart and circulation (32%), and loss of consciousness (17%). The majority of respondents indicated that their EMS use was due to an emergency (89%). We could detect no or only weak associations between patients’ subjective urgency and different items for objective care. Conclusion Dispatchers can possibly optimize or reduce the disposition of EMS staff and vehicles if they spoke directly to the patients more often. Nonetheless, there is need for further research on how strongly the patients’ perceived urgency may affect the disposition, rapidness of the service and transport targets.


2020 ◽  
Vol 36 (S1) ◽  
pp. 37-37
Author(s):  
Americo Cicchetti ◽  
Rossella Di Bidino ◽  
Entela Xoxi ◽  
Irene Luccarini ◽  
Alessia Brigido

IntroductionDifferent value frameworks (VFs) have been proposed in order to translate available evidence on risk-benefit profiles of new treatments into Pricing & Reimbursement (P&R) decisions. However limited evidence is available on the impact of their implementation. It's relevant to distinguish among VFs proposed by scientific societies and providers, which usually are applicable to all treatments, and VFs elaborated by regulatory agencies and health technology assessment (HTA), which focused on specific therapeutic areas. Such heterogeneity in VFs has significant implications in terms of value dimension considered and criteria adopted to define or support a price decision.MethodsA literature research was conducted to identify already proposed or adopted VF for onco-hematology treatments. Both scientific and grey literature were investigated. Then, an ad hoc data collection was conducted for multiple myeloma; breast, prostate and urothelial cancer; and Non Small Cell Lung Cancer (NSCLC) therapies. Pharmaceutical products authorized by European Medicines Agency from January 2014 till December 2019 were identified. Primary sources of data were European Public Assessment Reports and P&R decision taken by the Italian Medicines Agency (AIFA) till September 2019.ResultsThe analysis allowed to define a taxonomy to distinguish categories of VF relevant to onco-hematological treatments. We identified the “real-world” VF that emerged given past P&R decisions taken at the Italian level. Data was collected both for clinical and economical outcomes/indicators, as well as decisions taken on innovativeness of therapies. Relevant differences emerge between the real world value framework and the one that should be applied given the normative framework of the Italian Health System.ConclusionsThe value framework that emerged from the analysis addressed issues of specific aspects of onco-hematological treatments which emerged during an ad hoc analysis conducted on treatment authorized in the last 5 years. The perspective adopted to elaborate the VF was the one of an HTA agency responsible for P&R decisions at a national level. Furthermore, comparing a real-world value framework with the one based on the general criteria defined by the national legislation, our analysis allowed identification of the most critical point of the current national P&R process in terms ofsustainability of current and future therapies as advance therapies and agnostic-tumor therapies.


2021 ◽  
Vol 11 (11) ◽  
pp. 5108
Author(s):  
María Esther Liébana-Durán ◽  
Begoña Serrano-Lanzarote ◽  
Leticia Ortega-Madrigal

In order to achieve the EU emission reduction goals, it is essential to renovate the building stock, by improving energy efficiency and promoting total decarbonisation. According to the 2018/844/EU Directive, 3% of Public Administration buildings should be renovated every year. So as to identify the measures to be applied in those buildings and obtain the greatest reduction in energy consumption at the lowest cost, the Directive 2010/31/EU proposed a cost-optimisation-based methodology. The implementation of this allowed to carry out studies in detail in actual scenarios for the energy renovation of thermal envelopes of public schools in the city of Valencia. First, primary school buildings were analysed and classified into three representative types. For each type, 21 sets of measures for improving building thermal envelopes were proposed, considering the global cost, in order to learn about the savings obtained, the repayment term for the investment made, the percentage reduction in energy consumption and the level of compliance with regulatory requirements. The result and conclusions will help Public Administration in Valencia to draw up an energy renovation plan for public building schools in the city.


2018 ◽  
Vol 53 (2) ◽  
pp. 1802033 ◽  
Author(s):  
Roland Diel ◽  
James D. Chalmers ◽  
Klaus F. Rabe ◽  
Albert Nienhaus ◽  
Robert Loddenkemper ◽  
...  

Estimates of healthcare costs for incident bronchiectasis patients are currently not available for any European country.Out of a sample of 4 859 013 persons covered by German statutory health insurance companies, 231 new bronchiectasis patients were identified in 2012. They were matched with 685 control patients by age, sex and Charlson Comorbidity Index, and followed for 3 years.The total direct expenditure during that period per insured bronchiectasis patient was EUR18 634.57 (95% CI EUR15 891.02–23 871.12), nearly one-third higher (ratio of mean 1.31, 95% CI 1.02–1.68) than for a matched control (p<0.001). Hospitalisation costs contributed to 35% of the total and were >50% higher in the bronchiectasis group (ratio of mean 1.56, 95% CI 1.20–3.01; p<0.001); on average, bronchiectasis patients spent 4.9 (95% CI 2.27–7.43) more days in hospital (p<0.001). Antibiotics expenditures per bronchiectasis outpatient (EUR413.81) were nearly 5 times higher than those for a matched control (ratio of mean 4.85, 95% CI 2.72–8.64). Each bronchiectasis patient had on average 40.5 (95% CI 17.1–43.5) sick-leave days and induced work-loss costs of EUR4230.49 (95% CI EUR2849.58–5611.20). The mortality rate for bronchiectasis and matched non-bronchiectasis patients after 3 years of follow-up was 26.4% and 10.5%, respectively (p<0.001). Mortality in the bronchiectasis group was higher among those who also had chronic obstructive lung disease than in patients with bronchiectasis alone (35.9% and 14.6%, respectively; p<0.001).Although bronchiectasis is considered underdiagnosed, the mortality and associated financial burden in Germany are substantial.


2018 ◽  
Vol 2 (3) ◽  
pp. 43-47
Author(s):  
Rajkumar Gupta

The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products. The main focus of drug regulations is to check that safety, quality and efficacy of the drug products over its lifecycle.


2018 ◽  
Vol 1 (2018/1) ◽  

The health insurance market in Poland reflects global trends – such as the rising awareness of personal health impact on quality of life. As a consequence, the health insurance market has seen substantial growth during the last years, which is forecasted to continue at over 20 percent more than life or P&C insurance globally. However, private health insurance has not yet unlocked its full potential.


2020 ◽  
Vol 31 (2) ◽  
pp. 477
Author(s):  
Beáta Gavurová ◽  
Adela Klepáková ◽  
Ladislava Ivančová

The day surgery is a highly effective tool for providing health care which has been used in Slovakia only for the last decade. The unified system of payment for inpatient or outpatient (day care) surgeries causes the reduction of health insurance companies´ spending. Incorrectly configured and economically demotivating system of refunding is a cause of lagging behind the European average in utilization of day surgery. Without the evaluation of day surgery it is not possible to link the progress in the social sphere, which leads to the restriction of day surgery availability for some social groups and thus the subsequent stagnation of day surgery in Slovakia. This contribution presents a pilot study conducted in Slovakia and its partial findings focused on the development and trends in the implementation of day surgery in order to increase the efficiency healthcare system.


Author(s):  
Igor M. Akulin ◽  
Lubov Yu. Zhiguleva

The RF health care reform is gaining momentum. A thorough consideration should be given to the discussion on the need to exclude health insurance companies from the compulsory health insurance system (CHI). Formation of the National Health Care System of Russia is the main problem of the national health care at this stage of reforms. Additional payment for medical services in the CHI by the general public is not advisable. Changes in the regulatory framework of the CHI system is deemed to be the basis for reforming the system of compulsory and voluntary health insurance in Russia.   


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