Controversy over conducting clinical trials in poland

AbstrAct The number of clinical trials per year carried out in Poland is relatively high, however, the Polish regulations related to performing and funding of clinical trials are not very extensive. The NIK in its audit report conlcuded "a lack of a comprehensive system of regulations concerning conducting, financing and financial control of clinical research". The National Health Fund is an authority responsible for, among others, planning and purchasing publicly financed health services. The sponsor is obliged to manage and finance clinical trials, however many procedures performed during the research can be classified as standard medical care guaranteed by the Act on health care services financed from public funds. There is still a need of solving the problem of financing standard health care services being a part of a clinical trial by a proper legal act

Zasady finansowania partii politycznych we Włoszech

The Italian political stage is composed of numerous political parties, and it is deeply divided. The issue of the financing of political parties in Italy is very complex, owing to the fact that the principles of political parties’ financing are governed by frequently changing regulations. On account of a series of scandals involving the illegal financing of Italian parties, the 1974 Law, called ‘the Piccolo Act,’ established a system of public financing of political parties. Further laws, enacted in 1981 and 1982, changed its regulations. A principle was established that political parties have the right to obtain financial means from the state to reimburse the expenses borne by the regional council during election campaigns. The next law to regulate this issue was the 1993 Act, which determined the criteria for dividing the election funds to cover the expenses borne by individual political parties, and defined how the election campaigns for the Chamber of Deputies and the Senate of the Republic should be conducted. Another regulation was the 1997 Act on the financing of political parties that solved the matter of voluntary contributions made to political parties or movements

Lex coronavirus. Włoskie prawo w walce z pandemią

An epidemic caused by the coronavirus SARS-CoV-2 has been existed in Europe and worldwide for several weeks now. On 11 March 2020, the WHO declared it a global pandemic. At the time of writing, Europe, in particular Italy, is the largest outbreak of coronavirus. Italy is attempting to tackle the virus with increasingly drastic legal measures. On 31 January 2020, its Council of Ministers declared a state of emergency related to the sanitary risk of coronavirus infection. Italy has started the fight against the virus using two legal instruments: the first is the Council of Ministers’ declaration of a six-month state of emergency on 31 January 2020, and the second is a decree-law (decreto legge) issued by the Prime Minister temporarily restricting the freedom of movement throughout the state. In exceptional cases, the Italian Government has the right to issue normative legal acts. Recent legislative acts issued in Italy have undoubtedly limited the fundamental rights granted by the Constitution of 1947. These limited rights include the right of movement, but also freedom of assembly, the right to work, freedom of economic activity and freedom of conscience and religion. As a result of the legal solutions introduced, fundamental human rights are subject to justifiable restrictions in order to protect the constitutionally guaranteed right of the community to health care. In situations of epidemiological threats, protecting the lives and health of citizens is essential. Any restrictions on rights and freedoms are intended to protect these goods. However extensive these restrictions may be, in a democratic state this must be introduced under strict control and for a specified period of time linked to the duration of an epidemic

Prawo do sądu we Włoszech

The access to justice is expressed directly in the part one of the Constitution of the Italian Republic of 1947, entitled “The rights and duties of citizens”. In accordance with Article 24 paragraph. 1 of the Constitution, “everyone can take judicial action to protect individual rights and legitimate interests”. It should be noted that it is a wide range of subjective and objective constitutional regulation, in particular, on the right of access to court, the right to defense and right to a fair and due process (Article 111 of the Constitution). The biggest disadvantages that arises from the functioning of the Italian justice system are multiple violations of the right to a trial within a reasonable time and the usage of the cassation, as a court of third instance. Many attempts to correct the Italian judiciary have been made, for example by the introduction of Pinto Law of 2001, which gives litigants the right to the compensation in case of excessively lengthy judicial proceedings. However, it did not have the expected effect of speeding up the court proceedings because of the lack of necessary judiciary reforms (complicated structures and a large number of courts, traditionally low court fees etc.). The impact of the Law was The result of the Law is further increase in the number of cases and budgetary costs. The inefficiency of Italian justice system is needed to be reformed

Bases legales de la realización del derecho a la asistencia sanitaria en Polonia / Legal Foundations for the Development of the Right to Medical Care in Poland

El tradicional enfoque paternalista de las relaciones entre doctor y paciente ha quedado superado con el triunfo del principio de autonomía del paciente. En el ámbito sanitario, la dignidad del paciente debe reflejarse en el respeto por la autonomía. Existen dos instrumentos en los reglamentos sanitarios que protegen la autonomía del paciente: el consentimiento informado y las directivas avanzadas. La Ley 41/2002, del 14 de noviembre, relativa a la autonomía del paciente y a sus derechos y obligaciones respecto de la información y documentación clínica, expone estos dos instrumentos.Palabras clave: derecho sanitario, sistema sanitario, derechos humanos, derechos sociales.        Abstract: The legal basis of the right to health care in Poland. The topic of the article is the analysis of legal basis governing the right to health in the Polish Republic. Polish health care system, which, in practice, implementing the right to health is characterized by far-reaching instability, but its basic foundations remain the same. Statutory regulations of 1989 are subject to constant change, and the solutions implemented constitutionality was challenged by the Constitutional Court. Also, there is currently no comprehensive vision of the health  system, and all the changes were made so far is partial. Lack of comprehensive reforms, as well as the disorder in some areas of the health system by adopting the law uniformly regulating specific issues causing adverse situations for beneficiaries and does not contribute to the stabilization of the legal system in this sector.Keywords: the right to health, the health care system, human rights, social rights </p

Evaluation of Encapsulation Potential of Selected Star-Hyperbranched Polyglycidol Architectures: Predictive Molecular Dynamics Simulations and Experimental Validation

Polymers, including non-linear copolymers, have great potential in the development of drug delivery systems with many advantages, but the design requires optimizing polymer–drug interactions. Molecular dynamics (MD) simulations can provide insights into polymer–drug interactions for designing delivery systems, but mimicking formulation processes such as drying is often not included in in silico studies. This study demonstrates an MD approach to model drying of systems comprising either hydrophilic tinidazole or hydrophobic clotrimazole drugs with amphiphilic hyperbranched copolyethers. The simulated drying protocol was critical for elucidating drug encapsulation and binding mechanisms. Experimentally, two polymers were synthesized and shown to encapsulate clotrimazole with up to 83% efficiency, guided by interactions with the hydrophobic core observed in simulations. In contrast, tinidazole is associated with surface regions, indicating capacity differences between drug types. Overall, this work highlights MD simulation of the drying process as an important tool for predicting drug–polymer complex behaviour. The modelled formulation protocol enabled high encapsulation efficiency and opened possibilities for the design of delivery systems based on computationally derived binding mechanisms. This demonstrates a computational–experimental approach where simulated drying was integral to elucidating interactions and developing optimized complexes, emphasizing the value of molecular modelling for the development of drug delivery formulations

Wybrane aspekty prawne ochrony dziecka poczętego w świetle projektu nowelizacji Kodeksu Karnego

Criminal Law Codification Commission, acting at the Ministry of Justice prepared proposals for amendments in the Polish Penal Code, related to offenses against life and health that were presented to the public in 2013. The draft provides for the protection of the child in the prenatal stage, introducing a new category of the entity, to be protected, which is “unborn child” and “unborn child able to live outside the mother’s body”. These regulations provide for mother’s criminal liability and responsibility of the medical staff (a doctor), as well as the child’s father to the extent in which he is obliged to take steps aimed at rescuing the fetus. It is doctor’s responsibility to show particular care for human health and life since a doctor has special medical knowledge and that is regulated by art. 30 of the act on professions of doctor and dentist. The proposed rule changes were not brought before the legislature in the current term of the Sejm (2011-2015), but due to the development of medicine, including obstetrical ultrasound, which enables visualization of a child that moves in the womb and is treated as a separate entity with distinct personal features the grounds are given for the opinion that the issue of the legal status of the unborn child, particularly in the context of causing death of a child in the last phase before birth as a result of medical malpractice or other external factors will be back in the public discussion.Komisja Kodyfikacyjna Prawa Karnego, działająca przy Ministrze Sprawiedliwości, przygotowała propozycje zmian w Kodeksie Karnym, dotyczącego przestępstw przeciwko zdrowiu i życiu, które zostały przedstawione opinii publicznej w 2013 r. W projekcie przewidziano ochronę dziecka w fazie prenatalnej, wprowadzając nową kategorię podmiotu, podlegającego ochronie, jakim jest „dziecko poczęte”, „dziecko poczęte zdolne do życia poza organizmem matki”. Przepisy te przewidywały odpowiedzialność karną matki oraz odpowiedzialność personelu medycznego (lekarza), a także ojca dziecka poczętego w takim zakresie, w jakim ciążył na nim obowiązek podejmowania czynności zmierzających do ratowania dziecka poczętego. Na lekarzu spoczywa bowiem obowiązek szczególnej troski o zdrowie ludzkie i życie jako osobie, która dysponuje szczególną wiedzą medyczną wynika przede wszystkim z art. 30 ustawy o zawodach lekarza i lekarza dentysty. Zaproponowane zmiany przepisów nie zostały w obecnej kadencji Sejmu (2011-2015) skierowane na drogę postępowania ustawodawczego, jednak ze względu na rozwój medycyny, w tym diagnostyki ultrasonograficznej, która daje możliwość wizualizacji dziecka, które porusza się w łonie matki i traktowane jest jako odrębny byt z wyodrębnionymi cechami osobniczymi, daje podstawy do twierdzenia, że problematyka statusu prawnego dziecka poczętego, w szczególności w kontekście spowodowania śmierci dziecka w ostatniej fazie przed urodzeniem na skutek błędu lekarskiego lub innych oddziaływań zewnętrznych powróci w dyskusji publicznej

Aspekty prawne sprzedaży produktów leczniczych przez lekarza ginekologa

Sales and distribution of medical products and drugs in Poland remains under strict regulations, especially legal regulation contained in the Medical and Dental Practitioners Act, that banned sales of medical products by doctors. It needs to be emphasized that currently doctors are allowed to sell drugs and medical products only in rigorously specified situations. Knowledge of current legal regulations concerning sales of medical products by gynecologists allows to conform with the law and to distribute drugs and medical products under special and predefined conditions.Obrót i sprzedaż produktów leczniczych i leków w Polsce podlega szczególnemu reżimowi prawnemu. Podstawowe znaczenie w tym zakresie mają przepisy ustawy o zawodach lekarza i lekarza dentysty, które wprowadzają zakaz handlu artykułami medycznymi przez lekarza. Zaznaczyć należy, że przepisy powszechnie obowiązującego prawa w ściśle określonych przypadkach dopuszczają jednak możliwość sprzedaży leków i produktów leczniczych przez lekarzy. Znajomość obowiązujących przepisów prawnych w zakresie możliwości sprzedaży przez lekarza ginekologa produktów leczniczych pozwoli na właściwy obrót produktami leczniczymi i lekami

Evidence for West Nile Virus and Usutu Virus Infections in Wild and Resident Birds in Germany, 2017 and 2018

Wild birds play an important role as reservoir hosts and vectors for zoonotic arboviruses and foster their spread. Usutu virus (USUV) has been circulating endemically in Germany since 2011, while West Nile virus (WNV) was first diagnosed in several bird species and horses in 2018. In 2017 and 2018, we screened 1709 live wild and zoo birds with real-time polymerase chain reaction and serological assays. Moreover, organ samples from bird carcasses submitted in 2017 were investigated. Overall, 57 blood samples of the live birds (2017 and 2018), and 100 organ samples of dead birds (2017) were positive for USUV-RNA, while no WNV-RNA-positive sample was found. Phylogenetic analysis revealed the first detection of USUV lineage Europe 2 in Germany and the spread of USUV lineages Europe 3 and Africa 3 towards Northern Germany. USUV antibody prevalence rates were high in Eastern Germany in both years. On the contrary, in Northern Germany, high seroprevalence rates were first detected in 2018, with the first emergence of USUV in this region. Interestingly, high WNV-specific neutralizing antibody titers were observed in resident and short-distance migratory birds in Eastern Germany in 2018, indicating the first signs of a local WNV circulation