Anvisa's Prior Consent as a Contribution to Global Health and the One Health System

2022 ◽  
pp. 185-203
Author(s):  
Jaqueline Mendes Soares ◽  
Marilena Cordeiro Dias Villea Correa
Keyword(s):  
One Health ◽  
Legal Aspects ◽  
Pharmaceutical Products ◽  
Industrial Property ◽  
The Public ◽  
Multiple Flows ◽  
Prior Consent ◽  
Legal Competence ◽  
The One ◽  
Patent Examination

The participation of the National Health Surveillance Agency (ANVISA) in the granting of patents for pharmaceutical products and processes in Brazil took place since 2001, giving this sector of the Ministry of Health unprecedented legal competence, until then exclusive to the entity of the National Institute of Industrial Property (INPI). This chapter proposes to analyze the technical and legal aspects inherent to patenting combined with the ability to make political decisions in favor of implementing flexibilities in the patent examination of medicines that may be favorable to public health. John Kingdon's Multiple Flows Model was the methodology chosen to understand the most relevant factors that influenced the government's agenda for the creation of Anvisa's prior consent. The results allowed to outline the political window that materialized the formulation of the public policy in question, as well as to call attention to the fundamental importance for the protection of the current needs of humanity and of its future generations inserted in the concept of One Health.

From Jerusalem to Rome via Constantinople

2017 ◽  
Author(s):  
Marinos Diamantides ◽  
Anton Schütz
Keyword(s):  
Roman Empire ◽  
Legal Aspects ◽  
The Other ◽  
Giorgio Agamben ◽  
Public Power ◽  
The Public ◽  
The One ◽  
Religious Aspects ◽  
The Church ◽  
Institutional Order

The globalisation of the Western-Christian institutional order in its manifest legal aspects, but not necessarily of its latent religious aspects, puts a supplement of importance onto the need of grasping its genesis. The most decisive note is located — or so we argue — in unfolding the classical division between polis and politics on the one hand, and the household and the art of handling it (management or oikonomia) on the other, in Christian times. These divides delivered the blueprint for the divide that would differentiate, over more than a millennium, the public power of the Roman Empire in its Eastern and Western re-embodiments from that of the Church. We also refer, by way of contrast, to the pre-Christian biblical model of the divide. Further, by contrast to Giorgio Agamben, we specify that while the today thoroughly studied occidental West, availing of a simplified trinitarian creed, instituted legitimate public power as subject to on-going conflictual competition between the so-called ‘two powers’, the still much less studied East struggled to preserve the unity, or as the Byzantines called it, 'symphony', of the Whole in line with its (original) version of Trinitarianism.

ONE HEALTH AND BIOSAFETY -NEED OF HARMONIZATION IN MONGOLIA

2015 ◽  
Vol 13 (2) ◽  
pp. 146-157
Author(s):  
Zayatiin Batsukh ◽  
Gonchigoogiin Battsetseg
Keyword(s):  
One Health ◽  
Negative Impact ◽  
Well Being ◽  
Social Scientists ◽  
Wildlife Health ◽  
The Public ◽  
Health Practitioners ◽  
Health Concept ◽  
The Many ◽  
The One

The One Health concept recognizes that the health of humans is connected to the health of animals and the environment. The major aim of the One Health is to improve health and well-being through the prevention of risks and the mitigation of effects of crises that originate at the interface between humans, animals and their various environments.Regardless of which of the many definitions of One Health is used, the common theme is collaboration across sectors. Collaborating across sectors that have a direct or indirect impact on health involves thinking and working across silos and optimizing resources and efforts while respecting the autonomy of the various sectors. To improve the effectiveness of the One Health approach, there is a need to establish a better sectoral balance among existing groups and networks, especially between veterinarians and physicians, and to increase the participation of environmental and wildlife health practitioners, as well as social scientists and development actors.As this kind of collaboration newly introduced in Mongolia, there are numerous complications and difficulties may arise, that eventually could lead to the results, with higher negative impact to the public and personal health. From the technical perspective, it is undoubtfully important to evaluate the system and reveal the gap and weakness of each stakeholder in this important network and try to introduce common standard operational procedures for the handling and maintaining infective agents to avoid the unpleasant spill over the pathogen into the environment.Mongolian Journal of Agricultural Sciences Vol.13(2) 2014: 146-152

Knowledge gaps in the epidemiology of Toxocara: the enigma remains

Parasitology ◽  
2015 ◽  
Vol 144 (1) ◽  
pp. 81-94 ◽  
Author(s):  
C. V. HOLLAND
Keyword(s):  
One Health ◽  
Research Effort ◽  
The Public ◽  
Wide Range ◽  
Multiple Routes ◽  
Health Significance ◽  
The One ◽  
Paratenic Hosts ◽  
Key Aspects ◽  
And Control

SUMMARYToxocara species infect a wide range of companion, domestic and wild animals as definitive and paratenic hosts, via multiple routes of transmission, producing long-lived tissue-inhabiting larvae and resistant eggs that can survive in the external environment. Therefore Toxocara and the disease it causes in humans, toxocariasis, represents an ideal aetiological agent for the development of the one health approach. However, despite increasing awareness of the public health significance of toxocariasis, gaps in our understanding of certain key aspects of the parasite's biology and epidemiology remain. These gaps hinder our ability to integrate research effort within the veterinary, medical and environmental disciplines. This review will highlight key deficits in our understanding of nine dimensions of Toxocara epidemiology and discuss a potential scenario to develop a more integrated, one health approach to improve our understanding of the prevention and control of this complex and cryptic zoonosis.

scholarly journals Algoritmos y algunos retos jurídico-institucionales para su aplicación en la Administración Pública.

2020 ◽  
pp. 54-63
Author(s):  
Óscar CORTÉS
Keyword(s):  
Public Sphere ◽  
Public Administration ◽  
Legal Aspects ◽  
The Other ◽  
Technological Changes ◽  
The Public ◽  
Administrative Procedure ◽  
The Public Sphere ◽  
The One ◽  
Secure Implementation

Laburpena: Adimen artifiziala da gaur egungo teknologien artean bultzadarik handiena duenetako bat. Azterlan honen xedea da horren erronka batzuen hausnarketa bat eskaintzea Administrazio Publikoan aplikatzeko. Alde batetik, abiadura-palanka gisa duen gaitasunaren ikuspuntutik, sektore publikoa den bezalako ekosistema juridikoan; beste alde batetik, administrazio-sistemetan bere garapena bideragarri egiteko suertatzen diren galderei erantzuteko beharretik. Horretarako, aztertuko da nola aldaketa teknologiko berriek lege-moldaketekin batera etorri diren maila publikoan bideragarritasuna emateko; aurkeztuko dira algoritmoen aukera eta ziurgabetasun batzuk Administrazioaren teknologia eraldatzaile bezala; azkenik, deskribatuko dira aspektu juridiko batzuk beharrezkoak direnak Administrazioan bere ezapen ziurra eta etikoa lortzeko eta aztertuko dira administrazio-prozedura automatizatu posible baten elementurik aipagarrienak. Resumen: La inteligencia artificial es ya hoy una de las tecnologías con mayor potencial. El presente estudio tiene por objeto ofrecer una reflexión sobre algunos de los retos para su aplicación en la Administración pública. Por un lado, desde el punto de vista de su capacidad como palanca de cambio en un ecosistema jurídico como el sector público; por otro, desde la necesidad de abordar algunos de los interrogantes que surgen para hacer viable su desarrollo en los sistemas administrativos. Para ello, se analizará cómo los recientes cambios tecnológicos han venido acompañados de modificaciones legales para dotarles de viabilidad en el ámbito público, se mostrarán algunas de las oportunidades e incertidumbres de los algoritmos como tecnologías transformadoras en la Administración, se describirán algunos de los aspectos jurídicos que es necesario abordar para su segura implantación ética y jurídica en la Administración y se analizarán algunos de los elementos más destacados de un posible procedimiento administrativo automatizado. Abstract: Artificial intelligence is already today one of the technologies with greatest potential. The purpose of this study is to offer a reflection on some of the challenges for its implementation in public administration. On the one hand, from the standpoint of its capacity as a lever of change and transformation in a legal ecosystem such as the public sector; on the other, from the need to address some of the questions that arise to make viable its development in administrative systems. For that purpose, it will be analyzed how recent technological changes have been accompanied by legal modifications to make them viable in the public sphere, some of the opportunities and uncertainties of algorithms as transformative technologies in administration will be shown, some of the legal aspects that need to be addressed for its legal and ethical secure implementation in the Administration will be described, and some of the most outstanding elements of a possible automated administrative procedure will be analyzed.

scholarly journals Operationalization of the One Health approach in two rural municipalities of Niger

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
L Ben Abdelahfidh ◽  
F Rojas Lopez ◽  
B Djibo Mazou ◽  
M Miller ◽  
L Meissner ◽  
...  
Keyword(s):  
Health Risks ◽  
Health Professionals ◽  
One Health ◽  
Local Level ◽  
Animal Health ◽  
Pharmaceutical Products ◽  
Emerging Diseases ◽  
Epidemiological Surveillance ◽  
Success Factor ◽  
The One

Abstract Despite multiple efforts made by its government to improve public health, Niger still regularly faces numerous disasters including epidemics. Between 2017 and 2019, a consortium was established between Doctors of the World and Veterinarians Without Borders to implement a “One Health” project. This approach aims to reduce the populations' vulnerabilities to health risks related to environmental disasters and improve the health system's resilience at several levels. By promoting interdisciplinary between human, veterinary and environmental health issues, it aims to tackle emerging diseases with pandemic risk. The project was implemented in 2 municipalities: Sakoira and Ingall. For the first time, a program focused on preventing health and environmental risks rather than responding to a crisis. An external evaluation based on 278 interviews identified 5 project's achievements: (1) the increase in availability and accessibility of human and veterinary pharmaceutical products which improved vaccination coverage and medicalization while lowering treatment and prevention costs; (2) the mobilization and coordination of human and animal health professionals, national authorities and municipalities; (3) the strengthening of joint epidemiological surveillance through professional and community actors in order to reduce the response time to epidemics and disasters; (4) the strengthening of communities' understanding of health risks and how to prevent them; (5) the capacity building of professionals regarding the One Health approach at national, regional and local level. Coordination between human and animal health professionals has made possible the design and implementation of joint actions. These actions have enabled to: build capacity for 43 health providers, 116 community health workers and 41 livestock auxiliaries, vaccinate, de-worm and treat 24311 small and 7590 large ruminants, give primary health care to 4190 people, sensitize 2268 people on human and animal health. Key messages The project is innovative as it focuses on preventing epidemic risks instead of responding to crisis. Collaboration between human and animal health actors is the main success factor of the project.

scholarly journals Economics of zoonoses surveillance in a ‘One Health’ context: an assessment ofCampylobactersurveillance in Switzerland

2017 ◽  
Vol 145 (6) ◽  
pp. 1148-1158 ◽  
Author(s):  
S. BABO MARTINS ◽  
J. RUSHTON ◽  
K. D. C. STÄRK
Keyword(s):  
One Health ◽  
Economic Assessment ◽  
Added Value ◽  
Disability Adjusted Life Years ◽  
Costs And Benefits ◽  
Cost Information ◽  
The Public ◽  
Disability Adjusted Life ◽  
Life Years ◽  
The One

SUMMARYCross-sectorial surveillance and general collaboration between the animal and the public health sectors are increasingly recognized as needed to better manage the impacts of zoonoses. From 2009, the Swiss established aCampylobactermitigation system that includes human and poultry surveillance data-sharing within a multi-sectorial platform, in a ‘One Health’ approach. The objective of this study was to explore the economics of this cross-sectorial approach, including surveillance and triggered interventions. Costs and benefits of the One Health and of the uni-sectorial approach toCampylobactersurveillance were identified using an economic assessment framework developed earlier. Cost information of surveillance activities and interventions was gathered and disability-adjusted life years (DALYs) associated with the disease estimated for 2008 and 2013. In the first 5 years of this One Health approach toCampylobactermitigation, surveillance contributed with information mainly used to perform risk assessments, monitor trends and shape research efforts onCampylobacter. There was an increase in costs associated with the mitigation activities following integration, due mainly to the allocation of additional resources to research and implementation of poultry surveillance. The overall burden of campylobacteriosis increased by 3·4–8·8% to 1751–2852 DALYs in 2013. In the timing of the analysis, added value associated with this cross-sectorial approach to surveillance ofCampylobacterin the country was likely generated through non-measurable benefits such as intellectual capital and social capital.

scholarly journals Should the Increased Awareness of the One Health Approach Brought by the COVID-19 Pandemic Be Used to Further Tackle the Challenge of Antimicrobial Resistance?

Antibiotics ◽  
2021 ◽  
Vol 10 (4) ◽  
pp. 464
Author(s):  
Mohamed Rhouma ◽  
Michelle Tessier ◽  
Cécile Aenishaenslin ◽  
Pascal Sanders ◽  
Hélène Carabin
Keyword(s):  
Antimicrobial Resistance ◽  
One Health ◽  
Global Scale ◽  
The Public ◽  
Sustainable Solutions ◽  
The One ◽  
Human Infections ◽  
Restrictive Measures ◽  
Effective Drugs ◽  
The Impact

Several experts have expressed their concerns regarding the potential increase in antimicrobial resistance (AMR) during the COVID-19 pandemic as a consequence of the increase in antimicrobial and biocide use in humans globally. However, the impact of the pandemic on antimicrobial use (AMU) and AMR in animals has yet to be discussed and evaluated. Indeed, veterinary practices have been hugely impacted by the pandemic and its restrictive measures around the world. In this perspective, we call for more research to estimate the impact of COVID-19 on AMU and AMR in both humans and animals, as well as on the environment, in coherence with the One Health approach. In addition, we argue that the current pandemic is an opportunity to accelerate the implementation of a One Health approach to tackle the AMR crisis at the global scale. Indeed, the momentum created by the increased general awareness of both the public and decision-makers for the development and maintenance of effective drugs to treat human infections, as well as for the importance of a One Health approach to prevent the emergence of infectious diseases, should be used as a lever to implement global collaborative and sustainable solutions to the complex challenges of AMR.

The screen performance as an instrument of propaganda (on the example of Ivan Kavaleridze’s film «Koliivshchyna», 1933)

2019 ◽  
Vol 25242644 ◽  
pp. 63-68
Author(s):  
Alina Lisnevska
Keyword(s):  
Video Content ◽  
The Public ◽  
Screen Media ◽  
Social Settings ◽  
Soviet Ideology ◽  
The One ◽  
Historical Truth ◽  
Screen Performance ◽  
Personalized Video ◽  
Remote Past

The myth-making processes in the communicative space are the «cornerstone» of ideology at all times of mankind’s existence. One of the tools of the effective impact of propaganda is trust in information. Today this come round due to the dissemination of information on personalized video content in social networks, including through converged media. New myths and social settings are creating, fate of the countries is being solved, public opinion is being formed. It became possible to create artificially a model of social installation using the myths (the smallest indivisible element of the myth) based on real facts, but with the addition of «necessary» information. In the 20–30 years of the XX century cinematograph became the most powerful screen media. The article deals with the main ideological messages of the Ukrainian Soviet film «Koliivshchyna» (1933). In the period of mass cinematography spread in the Soviet Ukraine, the tape was aimed at a grand mission – creation of a new mythology through the interpretation of the true events and a con on the public, propaganda of the Soviet ideology. This happened in the tragic period of Ukrainian history (1933, the Holodomor) through the extrapolation of historical truth and its embodiment in the most formative form at that time – the form of the screen performance. The Soviet authorities used the powerful influence of the screen image to propagate dreams, illusions, images, stereotypes that had lost any reference to reality. I. Kavaleridze’s film «Koliivshchyna» demonstrates the interpretation of historical events and national ideas, the interpretation of a relatively remote past through the ideology of the «Soviet-era». The movie is created as a part of the political conjuncture of the early 1930s: the struggle against Ukrainian «bourgeois nationalism» and against the «Union of Liberation Ukraine», the repressive policies against the peasants, the close-out of the «back to the roots» policy. The movie, on the one hand, definitely addresses to the Ukrainian ideas, on the other hand it was made at the period of the repressions against the Ukrainian peasantry. In the movie «Koliivshchyna», despite the censorship, I. Kavaleridze manages to create a national inclusive narrative that depicts Ukrainian space as multi-ethnic and diverse, but at the same time nationally colorful.

Prawne regulacje pobierania i transplantacji narządów oraz tkanek w ujęciu europejskiej konwencji bioetycznej

2016 ◽  
pp. 52-65
Author(s):  
Patryk Kołodyński ◽  
Paulina Drab
Keyword(s):  
Ex Vivo ◽  
Legal Aspects ◽  
European Convention ◽  
The Public ◽  
Additional Protocol ◽  
The Past ◽  
Reliable Source ◽  
International Legal Order ◽  
Definition Of ◽  
Source Of Information

Over the past several years, transplantology has become one of the fastest developing areas of medicine. The reason is, first and foremost, a significant improvement of the results of successful transplants. However, much controversy arouse among the public, on both medical and ethical grounds. The article presents the most important concepts and regulations relating to the collection and transplantation of organs and tissues in the context of the European Convention on Bioethics. It analyses the convention and its additional protocol. The article provides the definition of transplantation and distinguishes its types, taking into account the medical criteria for organ transplants. Moreover, authors explained the issue of organ donation ex vivo and ex mortuo. The European Convention on Human Rights and Biomedicine clearly regulates the legal aspects concerning the transplantation and related basic concepts, and therefore provides a reliable source of information about organ transplantation and tissue. This act is a part of the international legal order, which includes the established codification of bioethical standards.

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