scholarly journals Dietary supplements as a challenge for contemporary public health: scale of the phenomenon, health risk, legal regulations

2018 ◽  
Vol 128 (1) ◽  
pp. 30-35
Author(s):  
Agnieszka Marzec ◽  
Michał Skrzypek ◽  
Zbigniew Marzec
Keyword(s):  
Public Health ◽  
Dietary Supplements ◽  
Prescription Drugs ◽  
Pharmaceutical Sciences ◽  
Legal Regulations ◽  
The Subject ◽  
The Look ◽  
Pharmaceutical Agents ◽  
The Eu

Abstract The subject of the study is to present the issues of dietary supplements from the perspective of public health, taking into account definitional problems, the scale of the phenomenon in Poland and the look at the problem in question from the sociomedical perspective emphasizing the use of dietary supplements as a form of self-care. The study also discusses selected legal regulations in Poland and the EU on marketing and trading in dietary supplements. The article also presents, from the perspective of pharmaceutical sciences, the proposals for classification of dietary supplements and selected issues concerning safety of their use. The subject of a part of the present analysis is also the recent data showing the wide popularization of the phenomenon of polypragmasia consisting in simultaneous use of dietary supplements and OTC pharmaceutical agents with prescription drugs in Poland.

Standardization in the EU regulatory strategy concerning the development of the scope of UAS application

2019 ◽  
Vol 125 ◽  
pp. 13-26
Author(s):  
Teresa Idzikowska ◽  
Paulina Rutkowska
Keyword(s):  
Unmanned Aerial Vehicles ◽  
Legal Framework ◽  
Regulatory Structure ◽  
Technical Requirements ◽  
Regulatory Strategy ◽  
European Regulatory ◽  
European Regulations ◽  
The Subject ◽  
The Eu

The article discusses the subject of new European regulations regarding unmanned aerial vehicles (UAV), which define the rules for the use of UAV systems in the European airspace. The introduced legal framework defines the technical requirements for the UAVs, UAV categorization and classification of performed operations in terms of risk, UAV certification matters, rules for the introduction on the uniform European market and their supervision, as well as personnel conditions necessary to ensure compliance with the general requirements. These activities are aimed at development of the UAV market and integration with manned aviation in a safe and environmentally friendly way. The article presents the process of establishing the European regulatory structure for civil UAVs.

scholarly journals The comporative study of the state enterprises in the Czech and European law

2012 ◽  
Vol 60 (2) ◽  
pp. 97-102
Author(s):  
Jana Hroch
Keyword(s):  
The State ◽  
State Enterprise ◽  
Legal Regulations ◽  
European Law ◽  
The European Union ◽  
Public Enterprises ◽  
The Czech Republic ◽  
The Subject ◽  
State Enterprises ◽  
The Eu

The subject of this paper concerns the state enterprise in the Czech and European Law. In this paper the attention is paid especially to the primary law arrangement, involved in the Treaty on the Functioning of the European Union. These problems are tightly connected with the area of the Competition Law in the EU single market. There is very important the comparison of public enterprises and the state monopolies in the European Law with the legal arrangement of the state enterprises in the legal order of the Czech Republic. The focus is then on finding similarities or differences in both legal regulations that might cause problems. The point is to suggest a regulation enabling to overcome possible discrepancies. At the end we summarize the results drawing respective conclusions and formulating subjects for discussion.

Off-Label Drug Use and Promotion: Balancing Public Health Goals and Commercial Speech

2011 ◽  
Vol 37 (2-3) ◽  
pp. 225-257 ◽  
Author(s):  
Aaron S. Kesselheim
Keyword(s):  
Public Health ◽  
Prescription Drugs ◽  
Drug Label ◽  
Safety And Efficacy ◽  
Off Label ◽  
Commercial Speech ◽  
The Past ◽  
Health Goals ◽  
The Subject ◽  
The Universe

Off-label promotion of prescription drugs has become a source of substantial controversy in the past decade. Before a new drug reaches the market, its safety and efficacy must be certified by the Food and Drug Administration (FDA). But the FDA does not simply approve a drug for general use. Rather, it approves drugs for the specific uses requested by manufacturers, who choose the universe of possible indications when they undertake pre-marketing clinical trials. The approval is therefore tied to a particular disease that is the subject of the manufacturer's pre-approval testing and the FDA's formal review. The conditions for which the product is approved are spelled out in the official drug label, including the dose evaluated by the FDA, and the details of administration in which the FDA has determined the drug showed efficacy. The label also describes the safety concerns related to the use.

scholarly journals Endowments in European law: Current state and perspectives

2021 ◽  
Vol 93 (3) ◽  
pp. 700-733
Author(s):  
Jelena Veselinov
Keyword(s):  
Legal Status ◽  
Legal Regulations ◽  
The European Union ◽  
Member States ◽  
Non Profit ◽  
Eu Member States ◽  
Starting Point ◽  
The Subject ◽  
Special Rules ◽  
The Eu

Throughout history, endowment, although with the same content, has developed differently in European countries in terms of law. The national legal regulations of the countries in this area define the basic elements, legal status and functioning of legal entities established in the spirit of endowment differently. The idea of the European Union as a market characterized by the free flow of people and capital inevitably led to the emergence of a very complex set of rules that apply to the member states of this union. The inclusion of endowments in the single market and the growing number of those characterized by internationally useful goals often lead to insurmountable problems in the operations of endowments outside national borders due to national legislations of EU countries not being synchronized, regardless of the general aim to create a single space without any barriers to the flow of people, services and capital. This is the starting point used to examine the subject of this paper - the need to regulate and resolve situations in the functioning of endowments and foundations in Europe: by creating special rules at the EU level and equalizing or harmonizing rules relating to these non-profit organizations. The subject of the research was chosen because of the importance of the topic in the process of developing private EU law in the non-profit sector. The aim of this paper is to analyze the legal regulations related to endowments and foundations in the national legislations of the EU member states comparatively in terms of law, but also to analyze the proposals for creating uniform legal rules.

A comparative analysis of the lay-friendliness of Danish EU patient information leaflets from 2000 to 2012

2014 ◽  
Vol 11 (3) ◽  
Author(s):  
Inger Askehave ◽  
Karen Korning Zethsen
Keyword(s):  
Comparative Analysis ◽  
Patient Information ◽  
Patient Information Leaflet ◽  
General Interest ◽  
Information Leaflet ◽  
Empirical Results ◽  
Patient Information Leaflets ◽  
Information Leaflets ◽  
The Subject ◽  
The Eu

Since becoming mandatory in the EU in 1992, the patient information leaflet (PIL) has been the subject of an on-going discussion regarding its ability to provide easily understandable information. This study examines whether the lay-friendliness of Danish PILs has improved from 2000 to 2012 according to the Danish consumers. A reproduction of a questionnaire study from 2000 was carried out. The responses of the 2012 survey were compared to those of the 2000 survey and the analysis showed that Danes are less inclined to read the PIL in 2012 compared to 2000 and that the general interest in PILs has decreased. The number of respondents who deem the PIL easy to read has gone down. According to Danish consumers, the lay-friendliness of PILs has not improved from 2000 to 2012 and a very likely explanation could be that the PIL as a genre has become far too regulated and complex to live up to its original intentions. On the basis of the empirical results the article furthermore offers suggestions for practice changes.

Obywatele Unii Europejskiej – wyborcy Parlamentu Europejskiego – parlamentu ponadnarodowego

2016 ◽  
Vol 14 (3) ◽  
pp. 147-162
Author(s):  
Stefan Marek Grochalski
Keyword(s):  
European Union ◽  
Subject Matter ◽  
European Parliament ◽  
Legal Regulations ◽  
The European Union ◽  
Democratic State ◽  
The Subject ◽  
Direct Elections

Parliament – an institution of a democratic state – a member of the Union – is not only an authority but also, as in the case of the European Union, the only directly and universally elected representative body of the European Union. The article presents questions related to the essence of parliament and that of a supranational parliament which are vital while dealing with the subject matter. It proves that the growth of the European Parliament’s powers was the direct reason for departing from the system of delegating representatives to the Parliament for the benefit of direct elections. It presents direct and universal elections to the European Parliament in the context of presenting legal regulations applicable in this respect. It describes a new legal category – citizenship of the European Union – primarily in terms of active and passive suffrage to the European Parliament, as a political entitlement of a citizen of the European Union.

СОЦИАЛЬНАЯ КОНФЛИКТОЛОГИЯ: ТЕОРЕТИКО-ИСТОРИЧЕСКИЙ АСПЕКТ

2020 ◽  
Vol 15 (2) ◽  
pp. 68
Author(s):  
А. Н. Сухов
Keyword(s):  
Theory And Practice ◽  
Important Task ◽  
Social Conflicts ◽  
Psychological Approach ◽  
Structure Dynamics ◽  
History Of ◽  
The Subject ◽  
First Time

This given article reveals the topicality not only of destructive, but also of constructive, as well as hybrid conflicts. Practically it has been done for the first time. It also describes the history of the formation of both foreign and domestic social conflictology. At the same time, the chronology of the development of the latter is restored and presented objectively, in full, taking into account the contribution of those researchers who actually stood at its origins. The article deals with the essence of the socio-psychological approach to understanding conflicts. The subject of social conflictology includes the regularities of their occurrence and manifestation at various levels, spheres and conditions, including normal, complicated and extreme ones. Social conflictology includes the theory and practice of diagnosing, resolving, and resolving social conflicts. It analyzes the difficulties that occur in defining the concept, structure, dynamics, and classification of social conflicts. Therefore, it is no accident that the most important task is to create a full-fledged theory of social conflicts. Without this, it is impossible to talk about effective settlement and resolution of social conflicts. Social conflictology is an integral part of conflictology. There is still a lot of work to be done, both in theory and in application, for its complete design. At present, there is an urgent need to develop conflict-related competence not only of professionals, but also for various groups of the population.

The state of democracy in the European Union in scenarios: federation, empire and Europe à la carte

2016 ◽  
pp. 90-108
Author(s):  
Marta Witkowska
Keyword(s):  
European Union ◽  
Reference Point ◽  
The State ◽  
The European Union ◽  
Scenario Development ◽  
Normative Approach ◽  
Norms And Values ◽  
The Subject ◽  
The Eu ◽  
A La Carte

The aim of the article is to present possible scenarios on maintaining democracy in the EU, while assuming different hypothetical directions in which it could develop as a federation, empire and Europe à la carte. Selected mechanisms, norms and values of the EU system that are crucial for the functioning of democracy in the European Union are the subject of this research. The abovementioned objective of scenario development is achieved through distinguishing the notions of policy, politics and polity in the research. In the analysis of the state of democracy in the European Union both the process (politics) and the normative approach (policy) have been adopted. The characterised norms, structures, values and democratic procedures in force in the EU will become a reference point for the projected scenarios. The projection refers to a situation when the existing polity transforms into a federation, empire or Europe à la carte. The article is to serve as a projection and is a part of a wider discussion on the future of the basis on which the European Union is build.

The Swiss Prison Study (SWIPS): Protocol for Establishing a Public Health Registry of Prisoners in Switzerland (Preprint)

2020 ◽  
Author(s):  
Thomas Gaisl ◽  
Naser Musli ◽  
Patrick Baumgartner ◽  
Marc Meier ◽  
Silvana K Rampini ◽  
...  
Keyword(s):  
Public Health ◽  
Medical History ◽  
Large Scale ◽  
International Classification Of Diseases ◽  
Disease Prevalence ◽  
Vulnerable Population ◽  
International Classification ◽  
Classification Of Diseases ◽  
Health Registry

BACKGROUND The health aspects, disease frequencies, and specific health interests of prisoners and refugees are poorly understood. Importantly, access to the health care system is limited for this vulnerable population. There has been no systematic investigation to understand the health issues of inmates in Switzerland. Furthermore, little is known on how recent migration flows in Europe may have affected the health conditions of inmates. OBJECTIVE The Swiss Prison Study (SWIPS) is a large-scale observational study with the aim of establishing a public health registry in northern-central Switzerland. The primary objective is to establish a central database to assess disease prevalence (ie, International Classification of Diseases-10 codes [German modification]) among prisoners. The secondary objectives include the following: (1) to compare the 2015 versus 2020 disease prevalence among inmates against a representative sample from the local resident population, (2) to assess longitudinal changes in disease prevalence from 2015 to 2020 by using cross-sectional medical records from all inmates at the Police Prison Zurich, Switzerland, and (3) to identify unrecognized health problems to prepare successful public health strategies. METHODS Demographic and health-related data such as age, sex, country of origin, duration of imprisonment, medication (including the drug name, brand, dosage, and release), and medical history (including the International Classification of Diseases-10 codes [German modification] for all diagnoses and external results that are part of the medical history in the prison) have been deposited in a central register over a span of 5 years (January 2015 to August 2020). The final cohort is expected to comprise approximately 50,000 to 60,000 prisoners from the Police Prison Zurich, Switzerland. RESULTS This study was approved on August 5, 2019 by the ethical committee of the Canton of Zurich with the registration code KEK-ZH No. 2019-01055 and funded in August 2020 by the “Walter and Gertrud Siegenthaler” foundation and the “Theodor and Ida Herzog-Egli” foundation. This study is registered with the International Standard Randomized Controlled Trial Number registry. Data collection started in August 2019 and results are expected to be published in 2021. Findings will be disseminated through scientific papers as well as presentations and public events. CONCLUSIONS This study will construct a valuable database of information regarding the health of inmates and refugees in Swiss prisons and will act as groundwork for future interventions in this vulnerable population. CLINICALTRIAL ISRCTN registry ISRCTN11714665; http://www.isrctn.com/ISRCTN11714665 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/23973

EU Health Law & Policy

2019 ◽  
Author(s):  
Anniek de Ruijter
Keyword(s):  
Public Health ◽  
Health Care ◽  
Human Health ◽  
Fundamental Rights ◽  
The European Union ◽  
Health Issues ◽  
Division Of Powers ◽  
Legal Principle ◽  
Legal Competence ◽  
The Eu

This book describes the expansion of EU power in health care and public health and analyses the implications of this expansion on EU health values and rights. The main conclusion of the book is that the EU is de facto balancing fundamental rights and values relating to health, implicitly taking on obligations for safeguarding fundamental rights in the field of health and affecting individuals’ rights sometimes without an explicit legal competence to do so. This brings to light instances where EU health policy has implications for fundamental rights and values without the possibility to challenge the exercise of power of the EU in human health. This begs the question of whether subsidiarity is still the most relevant legal principle for the division of powers and tasks among the Member States, particularly when EU policy and law involves the politically sensitive areas of health care and public health. This question draws out the parameter for continuing the debate on the role of the European Union in promoting its own values and the wellbeing of its peoples, in light of its ever-growing role in human health issues.

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