Doctor-patient confidentiality - right and duty of a doctor in law regulations

Physician’s professional secrecy is one of the most important duties of a doctor and should be provided with confidentiality regarding his or her health. Generally speaking, there is no legal definition of "physician’s professional secrecy" in Poland, although this concept already appears in the oath of Hippocrates: ‘I will keep secret anything I see or hear professionally which ought not to be told’. The issue of medical confidentiality (physician’s professional secrecy) has been regulated in several legal acts such as: The Patient Rights and Patients Ombudsman Act, The Constitution of the Republic of Poland, The Medical Profession Act, The Civil Code Act, The Criminal Code Act and Code of Medical Ethics which is not considered as a legal act. The patient has the right to require confidentiality of the information concerning him and the obligation to keep medical confidentiality will apply to every representative of the medical profession, who obtained certain information by various professional activities

Definition of medical error and physicians’ interest in changes in the law

The main purpose of the paper is to discuss the definition of medical error. Moreover, the statistical analysis was aimed at demonstrating at what level is the legal knowledge of the professional group of doctors, in relation to the performed profession. The research group consisted of doctors of different specializations, of different ages, with diverse work experiences, performing their profession in the Lubelskie voivodeship. These were people working on the basis of contract of employment, civil law contracts or individual medical practice, employed in provincial hospitals, clinics, district hospitals, outpatient’s clinics, ambulances or medical centers. The author's questionnaire survey consisted of questions and answers for 298 doctors. Damage resulting from a widely understood medical error can be caused not only by the physician but by all medical staff or due to the organizational failure of the medical establishment. It must be stated with all conviction that the formulation of the concept of medical error is still ongoing and will evolve with the development of medicine as well as the law, which will strive to delineate the framework of its occurrence. The majority of doubts, which results from the obtained research, raises the issue of provision of medical help without the consent of the patient and the right to refuse treatment, but above all, what is quite surprising is the question of accepting gifts from pharmaceutical companies. The most frequently cited reasons influencing the lack of updating legal knowledge in the field of the performed profession were lack of time and a large number of duties, whereas the research group, in order to deepen their knowledge on that matter, most frequently used the Internet resources, industry articles, and on the third place was the training related to the subject matter of the medical law

The role of HTA agencies in Poland and in the world

Health Technology Assessment (HTA) is a foundation of submitting applications for reimbursement of a particular health technology. It involves conducting comparative analyzes in which the existing health care standard is compared with the new technology in order to test the benefits of introducing financing of the new technology. There are several dozen authorities responsible for HTA in various countries around the world. The structures, functions, competences and approaches of individual HTA agencies differ due to differences in healthcare systems, as well as due to the heterogeneous political structures in which they operate. In some countries, HTA agencies are responsible only for the HTA assessment process, consisting of reviewing scientific evidence and data synthesis, while in others also for verifying and making a reimbursement decision, based on, among others budget restrictions. However, regardless of the structures and competences of the HTA agencies in individual countries, the introduction of HTA as a tool for rational reimbursement decisions in various healthcare systems has significantly reduced the uncertainty associated with their making. Poland is an example of a country where no medicine is reimbursed without formal procedures. It is not possible for a drug to be reimbursed in a new medical indication, without an assessment of health technologies. Following the example of other developed countries, Poland in 2005 introduced a health technology assessment system to the drug reimbursement process by establishing an advisory body for the Minister of Health - the Agency for Health Technology Assessment, which tasks include in particular, developing recommendations regarding the financing of health technologies. In accordance with the guidelines of the president of AOTMiT, the drug manufacturer, in addition to analyzing the decision problem, have to prepare three types of analysis: the clinical effectiveness analysis, the economic analysis and the analysis of the impact on the healthcare system.Ocena technologii medycznych (HTA) stanowi podstawę wnioskowania nad zasadnością refundacji określonej technologii medycznej. Polega ona na przeprowadzeniu analiz porównawczych, w których zestawia się istniejący standard opieki zdrowotnej z nową technologią, w celu sprawdzenia jakie korzyści wiążą się z wprowadzeniem finansowania nowej technologii. Na świecie istnieje kilkadziesiąt organów odpowiedzialnych za HTA w różnych krajach. Struktury, funkcje, kompetencje i podejścia poszczególnych agencji HTA różnią się ze względu na różnice w systemach opieki zdrowotnej, a także ze względu na niejednolite struktury polityczne, w których agencje te działają. W niektórych krajach agencje HTA są odpowiedzialne jedynie za proces oceny HTA polegający na przeglądzie dowodów naukowych i syntezie danych, natomiast w innych także za weryfikację i podjęcie decyzji refundacyjnej, w oparciu także m.in. o ograniczenia budżetowe. Niezależnie jednak od struktur i kompetencji agencji HTA w poszczególnych krajach, wprowadzenie HTA jako narzędzia do racjonalnego podejmowania decyzji refundacyjnych w różnych systemach opieki zdrowotnej spowodowało znaczne zmniejszenie obszaru niepewności związanej z ich podejmowaniem. Polska jest przykładem kraju, w którym żaden lek nie jest refundowany bez formalnych procedur. Refundacja leku w nowym wskazaniu medycznym nie jest możliwa bez oceny technologii medycznych. Wzorem innych krajów rozwiniętych Polska w 2005 roku wprowadziła system oceny technologii medycznych (ang. health technology assessment, HTA) do procesu refundacji leków poprzez powołanie Agencji Oceny Technologii Medycznych. Zgodnie z wytycznymi prezesa Agencji Oceny Technologii Medycznych i Taryfikacji (AOTMiT) producent leku oprócz analizy problemu decyzyjnego musi przygotować trzy typy analiz: analizę efektywności klinicznej, analizę ekonomiczną oraz analizę wpływu na system ochrony zdrowia

Indirect costs of diabetes and its impact on the public finance: the case of Poland

<p><b>Background</b>: Growing public and private expenditure on healthcare results i.a. from the spreading of chronic diseases. Diabetes belongs to the most frequent ones, beyond neoplasms and cardiological diseases, and hence generates a significant burden for the public finance in terms of the direct costs. However, the economy suffers also from the indirect cost of diabetes that manifests itself in the loss in Gross Domestic Product (GDP) and general government revenues.</p> <p><b>Methods</b>: This paper aims to measure this indirect cost, both in terms of GDP drop (social perspective) and public revenue drop (public finance perspective), in the case of Poland in 2012–2014. We use a modified human capital approach and unique dataset provided by the Social Security institution in Poland and the Polish Central Statistical Office.</p> <p><b>Results</b>: Diabetes is a substantial and growing burden for the Polish economy. In the years 2012, 2013 and 2014 the indirect cost (output loss) amounted to 1.85 bn USD, 1.94 bn USD and 2.00 bn USD respectively.</p> <p><b>Conclusions</b>: Estimated indirect cost of diabetes can be a useful input for health technology analyses of drugs or economic impact assessments of public health programmes.</p

DataSheet1_Reimbursement decision-making system in Poland systematically compared to other countries.docx

Introduction: Our objective was to analyze and compare systematically and structurally reimbursement systems in Poland and other countries.Methods: The systems were selected based on recommendations issued by the Polish Agency for Health Technology Assessment and Tariffication (AHTAPol), which explicitly referred to other countries and agencies). Consequently, apart from Poland, the countries included in the analysis were England, Scotland, Wales, Ireland, France, Netherlands, Germany, Norway, Sweden, Canada, Australia and New Zealand. Relevant information and data were collected through a systematic search of PubMed (Medline), Embase and The Cochrane Library as well as competent authority websites and grey literature sources.Results and discussion: In most of the countries, the submission of a reimbursement application is initiated by a pharmaceutical company, and only a few countries allow it before a product is approved for marketing. All of the agencies analyzed are independent and some have regulatory function of reimbursement decision making body. A key criterion differentiating the various agencies in terms of HTA is the cost-effectiveness threshold. Most of the countries have specific mechanisms to improve access to expensive specialty drugs, including cancer drugs and those used for rare diseases. Reimbursement systems often lack consistency in appreciating the same stages, leading to heterogeneous decision-making processes. The analysis of recommendations issued in different countries for the same medicinal product will allow a better understanding of the relations between the reimbursement system, HTA assessment, stakeholders involvement and decision on reimbursement of innovative drugs.</p

OFF-LABEL USE OF MEDICINAL PRODUCTS - LEGAL RULES AND PRACTICES

The off-label use of medicinal products raises many interpretation-related issues, not only among physicians, but also pharmacists and lawyers. The use of drugs in a manner other than that specified in the Summary of Product Characteristics is not regulated by Polish law. The authors’ goal is to discuss the topic mainly from the practical perspective, while also considering its theoretical aspects, and to identify systemic solutions to several problems, that are extremely important for the proper functioning of the entire healthcare system. The paper highlights that there is a fine line between experimental medicinal practices and those that are in keeping with current medical knowledge

Cytostatic and cytotoxic waste – rules of conduct in Poland

Polska jest jednym z krajów europejskich, w których wytwarza się najwięcej niebezpiecznych odpadów medycznych. Mimo że w Europie ilość produkowanych odpadów cytotoksycznych i cytostatycznych (stosowanych w chemioterapii przez chorych onkologicznie) od kilku lat się zmniejsza, w Polsce – rośnie. Odpady te stanowią zagrożenie bezpieczeństwa dla pracowników medycznych oraz chorych otrzymujących leki. Dlatego wymagane są specjalne procedury postępowania, które pozwalają ograniczyć szkodliwość tych leków dla zdrowia ludzi. Celem pracy było przedstawienie zasad postępowania w Polsce z lekami cytotoksycznymi i cytostatycznymi oraz ich odpadami. Med. Pr. 2019;70(3):377–391Poland is one of the European countries with the highest level of production of dangerous medical waste. Although in Europe the volume of produced cytotoxic and cytostatic waste (used in chemotherapy by oncological patients) has been declining for several years, in Poland a reverse trend has been observed. As this waste puts the safety of medical workers and patients at risk, special handling procedures are required to limit the harmful effect of these drugs on human health. In view of the above, the aim of the work was to present the rules of conduct with cytotoxic and cytostatic drugs, and their waste, in Poland. Med Pr. 2019;70(3):377–9