Genetic Material and Sequence Data to Protect Global Health in the Light of Pandemic Outbreaks: Mapping the Legal Landscape under European and International Law

2020 ◽  
Vol 27 (3) ◽  
pp. 232-241
Author(s):  
Claudia Seitz

Abstract The current pandemic outbreak of corona virus SARS-CoV-2 shows the need for comprehensive European cooperation in drug development and the importance of genetic material and sequence data in research concerning this unknown disease. As corona virus SARS-CoV-2 is spreading across Europe and worldwide, national authorities and the European Union (EU) institutions do their utmost to address the pandemic and accelerate innovation to protect global health. In order to be prepared and to be able to respond immediately to serious epidemic and pandemic diseases, the EU has already adopted the Decision No (EU) 1082/2013 on serious cross-border threats to health. The World Health Organization (WHO) has established a global system to collect genetic material and information to protect a global influenza pandemic outbreak. The article describes the current legal landscape under EU and international law.

2019 ◽  
Vol 60 (3) ◽  
pp. 406-415 ◽  
Author(s):  
Raúl López-López ◽  
Mariano Sánchez

Abstract Background and Objectives The paradigm of active aging has been slowly gaining ground in Europe as the ideal framework for public policy and for responding to the population’s aging. Taking the work by Rune Ervik as its point of departure, this article updates his conclusions on conceptualizations and policies of active aging by performing a study of the institutional discourses in the matter produced by the World Health Organization (WHO), the Organization for Economic Cooperation and Development (OECD), and the European Union (EU). Methods A corpus of 15 WHO, OECD, and EU documents published in the period 2002–2015 and tackling active aging were analyzed qualitatively through a combination of content and thematic analysis, based on a scheme integrated by deductive and inductive iterative manual and computerized codification. Results The institutional discourses on active aging analyzed have not changed dramatically in the period considered. However, a divergent path has emerged regarding the accent placed on participation and contribution in the construction of the paradigm: the more socially productive and health-oriented WHO discourse is slowly separating from the more economically productive and labor-oriented discourses of the EU and OECD. Discussion and Implications The institutional paradigm on active aging is evolving into a reductive treatment of a phenomenon that is multidimensional. International institutions and researchers should pay closer attention and forge a path toward an honest and critical examination of the real conditions and expectations of older people concerning the discursive and practical proposals of active aging, in all its different forms.


Author(s):  
ISHITA KATHURIA ◽  
VIKAS KUMAR SRIVASTAVA

Biologic drugs have revolutionized the treatment of many life-threatening and rare illnesses such as cancer and autoimmune diseases. Biologics are broadly referred as substances that are produced by living cells and are used in the treatment, prevention, or diagnosis of diseases. They include a wide range of substances, such as genetic material, antibodies, vaccines, or processes which act by influencing cellular processes that block disease or affect diseased cells. Biologics have become striking treatment options and the size of the market has grown hastily. It is expected that by 2023, most of the patents will expire in the European Union opening a large potential market. Keeping this in mind, the ability to launch substitutes to original biologics, also known as biosimilars, presents many opportunities to generic companies. The field of biosimilars seems to be “breaking” the traditional division between the creations of innovative NCE-based medicines by research-based companies, on the one hand, and, on the other hand, mapping of these medicines by the generic companies. The field of biosimilars so far presents some considerable challenges, namely, regulatory, safety, economic, and legal which are still being debated and discussed in different forums. In this article, we have tried to summarize the general principles and regulations governing the development of biosimilars by regulatory authorities such as the World Health Organization, European Medicines Agency, US Food and Drug Administration, and Health Canada. Furthermore, we have tried to throw some light on the opportunities, challenges, and current scenarios pertaining to biosimilars.


Author(s):  
Kaie Kerem ◽  
Tiia Puss ◽  
Mare Viies ◽  
Reet Maldre

The objective of the paper is to review and analyze the health of population and health care expenditure and to examine the trends of convergence of health care expenditure in EU countries. One of the most often used indicators characterizing a populations health is life expectancy at birth. Comparative analyses show that the life expectancy at birth in EU-12 countries is much lower than in EU-15 countries. Although in 1992-2004 the life expectancy increased both in EU-15 countries and in EU-12 countries, the differences in the life expectancy have still remained more or less the same. Besides the low life expectancy in EU-12 countries, also the resources used in health care are below the EU-15 average level. In our paper we test the ?-, ?- and ?-convergence of the health care expenditure. For testing ?-, ?- and ?-convergence the authors have used cross-sectional data over the period 1992-2004 for health care expenditure as share of GDP and per capita health care expenditure. Data of the World Health Organization (WHO) were used for the research. The study demonstrates that although usually the increase of economic integration facilitates economic growth, the mere fact of the European Union enlargement does not bring along an automatic homogenization of health care expenditure and health policy in the EU-12 countries.


2013 ◽  
Vol 18 (37) ◽  
Author(s):  
M J van der Werf ◽  
C Erkens ◽  
A Gebhard ◽  
F Voitzwinkler ◽  
M Dara

On 29 May 2013 three European tuberculosis (TB) networks met for the first time to discuss TB prevention, control and care in the World Health Organization (WHO) European Region including the European Union (EU). This meeting, which took place in The Hague, the Netherlands, provided a unique opportunity to discuss progress with the implementation of the Berlin Declaration on TB [1], the European Centre for Disease Prevention and Control (ECDC) Framework Action Plan to fight tuberculosis in the EU [2,3], and the Consolidated Action Plan to prevent and combat multidrug- and extensively drug-resistant tuberculosis (M/XDR-TB) in the WHO European Region [4]. Surveillance focal points, laboratory experts, and National TB Programme Managers (NTPs) exchanged lessons learned and discussed next steps to reach the targets defined in the plans.


Author(s):  
Ligi Milesh ◽  
Twinkle Mathew ◽  
Ramesh Kumar Kushwaha ◽  
Shoumi Halder ◽  
Rushikesh Jadhav ◽  
...  

The severe acute respiratory syndrome corona virus 2 (SARS-CoV-2), is spreading worldwide rapidly from its original city of China. Corona virus has the presence of positive sense Ribonucleic acid (RNA) genetic material. The infection causes mild respiratory disease especially in humans across all age groups. The widespread distribution of corona virus in other organisms such as birds, livestock and mammals such as bats, pangolins etc. makes it an important pathogen of concern. It has also been reported the number of people that act as healthy carriers of the virus are approximately 2%, where they do not show any symptoms of the infection but act as a prime source of transmission. Transmission of the virus is usually through large droplets generated during sneezing and coughing and thus can remain viable for several days in favorable atmospheric conditions but can be controlled by the usage of disinfectants. World Health Organization recommends isolation as most efficacious method for the containment of patients that are affected by this virus. At present, there are no particular anti-viral medications or vaccines are correctly present to suppress this infection from spreading. However, Polymerase chain reaction (PCR) methods have proved to be effective for assessing viral RNA but may prove to be very time-consuming assay. Thus, as per the present scenario, more research should be carried out to develop a rapid, user-friendly, diagnostic assay which has high specificity and sensitivity at mass level screening thus enabling the further process of drug designing.


2021 ◽  
Vol 9 (6) ◽  
pp. 34-39
Author(s):  
Magdalena Molendowska

Purpose of the study: The object of the analysis is to evaluate the effectiveness of the measures taken by international organizations in the fight against the COVID-19 pandemic and thus to assess the effectiveness in ensuring public security. Two very important organizations were chosen for the analysis – the European Union, whose competences resulting from treaty provisions do not directly concern health, and in contrast – the World Health Organization (WHO), which was established to promote, ensure, and protect health. Methodology: The paper was prepared based on critical analysis of literature and the uncontrolled observation method. Main findings: The methods, forms of action and measures adopted to combat the pandemic, both by the EU and the WHO, cannot be described as fully effective. This was due to many reasons, different for both organizations, including lack of experience, adequate preparation, response time, information flow, access to vaccines, etc. Nevertheless, both organizations played a very important role. The EU has played and continues to play an integrating role, providing a sense of solidarity in the fight against the pandemic. The WHO, in turn, acts as an authority in the medical field, its guidelines and recommendations are credible to most of the international community. Application of the study: The presented article refers to the issue of security in a crisis situation, which is the COVID-19 pandemic. It implies reflections in such scientific fields as, among others security, healty and psychology. In addition, the study may be relevant to the discussion on strengthening the competences of the EU and WHO. Original/Novelty of the study: The subject matter addressed is very timely, in fact we are all caught up in the problem identified. The fight against the pandemic is still on and the current assessment is probably only a fraction of the research that can be fully presented once the pandemic is over. Therefore, the article may serve as an inspiration to continue deliberations about this topic. Perhaps only the invention of an effective drug, rather than a vaccine for COVID-19, can be declared a battle won.


2020 ◽  
Vol 14 (3) ◽  
pp. 479-505
Author(s):  
Lyle Fearnley

Abstract On several occasions, the People’s Republic of China refused to share influenza viruses isolated on their territory with the World Health Organization pandemic flu surveillance system. Scholars in STS and allied disciplines have described these disputes as examples of growing conflict between global health norms of free exchange and Asian state claims of viral sovereignty. However, the discussion has largely overlooked the fact that laboratories in China freely shared genetic sequence data from isolated viruses, even when they refused to ship physical samples, a fact that complicates the opposition of open data and viral sovereignty with the different material forms of the physical sample and the nucleotide sequence. This article provides a comprehensive comparison of the heterogeneous circulations of influenza virus samples and virus gene sequences in global health influenza surveillance and argues this difference is rooted in the different knowledge-control regimes designed for exchanging samples and sequences. Engaging with debates on the position of Asian science within global scientific circulations, the article suggests that Asian scientists confront a multiplicity of global scientific infrastructures and do not necessarily rely on the authority of nation-state sovereignty to reshape global exchanges.


2009 ◽  
Vol 14 (20) ◽  
Author(s):  
A Melidou ◽  
G Gioula ◽  
M Exindari ◽  
D Chatzidimitriou ◽  
E Diza-Mataftsi

Influenza viruses continue to threaten the world with a new pandemic. While currently attention is focused on the newly emerged A(H1N1) virus, the avian influenza A(H5N1) virus is still a cause of concern. Extended research is focused on the genetic evolution of the viruses, as well as their susceptibility to available antiviral drugs. One of the major priorities of the World Health Organization is to develop candidate vaccines, four of which are already licensed for use in the European Union. Since the last influenza pandemic in 1968, our knowledge of the influenza virus and its biology has greatly increased, revealing new avenues in the research for antiviral strategies and the development of effective vaccines.


2016 ◽  
Vol 21 (12) ◽  
Author(s):  
Csaba Ködmön ◽  
Phillip Zucs ◽  
Marieke J. van der Werf

Migrants arriving from high tuberculosis (TB)-incidence countries may pose a significant challenge to TB control programmes in the host country. TB surveillance data for 2007–2013 submitted to the European Surveillance System were analysed. Notified TB cases were stratified by origin and reporting country. The contribution of migrant TB cases to the TB epidemiology in EU/EEA countries was analysed. Migrant TB cases accounted for 17.4% (n = 92,039) of all TB cases reported in the EU/EEA in 2007–2013, continuously increasing from 13.6% in 2007 to 21.8% in 2013. Of 91,925 migrant cases with known country of origin, 29.3% were from the Eastern Mediterranean, 23.0% from south-east Asia, 21.4% from Africa, 13.4% from the World Health Organization European Region (excluding EU/EEA), and 12.9% from other regions. Of 46,499 migrant cases with known drug-susceptibility test results, 2.9% had multidrug-resistant TB, mainly (51.7%) originating from the European Region. The increasing contribution of TB in migrants from outside the EU/EEA to the TB burden in the EU/EEA is mainly due to a decrease in native TB cases. Especially in countries with a high proportion of TB cases in non-EU/EEA migrants, targeted prevention and control initiatives may be needed to progress towards TB elimination.


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