scholarly journals Healthcare risk management during the SARS-CoV-2 virus pandemic in the European Union: The guaranteed access to medicines

Author(s):  
Silvia Enríquez-Fernández ◽  
Carlos del Castillo-Rodríguez

BACKGROUND: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.

2020 ◽  
Vol 11 (3) ◽  
pp. 481-497
Author(s):  
Sophia PAULINI

This contribution analyses whether the Court of Justice of the European Union (CJEU) provides clarifications on the normative implications that the precautionary principle entails in the context of Regulation 1107/2009, laying out the EU authorisation procedure for pesticides, in its recent judgement in Case C-616/17. In this judgement, which is a response to a request for a preliminary ruling by a French criminal court on the compatibility of certain aspects of Regulation 1107/2009 with the precautionary principle, the CJEU concludes that the questions of the referring court reveal nothing capable of affecting the validity of the regulation. According to the CJEU, to ensure conformity with the precautionary principle, the EU legislature must establish a normative framework that makes available to competent authorities sufficient information to adequately assess the risks to health resulting from the pesticide in question. However, the CJEU’s substantive analysis of the compatibility of the different aspects of Regulation 1107/2009 with the precautionary principle is not conducted concretely in light of this legal standard, but constitutes a mere testing of the general adequacy of Regulation 1107/2009. Furthermore, the CJEU’s judgement examines Regulation 1107/2009 in a vacuum without considering problems that have occurred in its implementation or application.


2018 ◽  
Vol 29 (5) ◽  
pp. 197-200 ◽  
Author(s):  
Robin Blake

In May 2018, the European Union (EU) banned all outdoor uses of three neonicotinoid insecticides due to concerns about adverse effects on pollinators following their use. Neonicotinoids continue to be used in other areas of the world such as North America. However, increasing scrutiny following the European Union decision threatens their availability as a control tool for farmers in these regions too. This article aims to provide an update on the current status of neonicotinoids, including a brief overview of the reasons behind the European regulatory decision, alternative control strategies that are available to farmers, how the situation in Europe might influence what will happen in other regions of the world, and what this means for future regulatory decision-making. The author concludes that the recent neonicotinoid ban in the EU represents an overly conservative approach to pesticide regulation, and in using the Draft Bee Guidance Document, one where the majority of pesticides currently on the market will fail. There is no definitive scientific evidence that neonicotinoids are the primary cause of declines in bees, and although banning these insecticides is the factor that humans have the greatest control over, it represents an overly simplistic solution to a very complex problem, and one that alone may not improve bee health. Whilst extreme pressure from environmental NGOs and politicians have undoubtedly helped shape these decisions, it is imperative that the regulatory process allows scientific innovation to help achieve food security and protect the environment. Ruling against recent lawsuits brought by Syngenta and Bayer CropScience to contest the bans on their respective neonicotinoids, the General Court of the European Union, said that the EU's"precautionary principle" meant that the EU could take measures if there was scientific uncertainty about risks to human health or the environment. The precautionary principle lies at the heart of EU regulation and effectively puts the burden of proof to demonstrate that a pesticide poses no unacceptable risk onto the manufacturers. Given that neonicotinoids are insecticides, and insecticides kill insects, it is not difficult to connect how the use of the precautionary principle led to the neonicotinoid ban. However, this principle is at odds with the desire to innovate – the so-called "Innovation principle" – "whenever policy or regulatory decisions are under consideration the impact on innovation as a driver for jobs and growth should be assessed and addressed". The innovation principle and precautionary principle should be complementary, recognising the need to protect society and the environment while also protecting the EU's ability to innovate. Neonicotinoids represent one such innovation where their highly targeted nature, especially as seed treatments, makes them effective within Integrated Pest Management (IPM) strategies, in comparison to alternatives such as pyrethroids, organophosphates and carbamates, that are known to be highly toxic to bees (and other non-target invertebrates) through spray drift. Replacing neonicotinoids with these products will also result in higher overall environmental risks, including risks to taxonomic groups that are not adversely affected by neonicotinoids such as birds, mammals and fish, together with higher risks to humans, particularly applicators. The HFFA report recommends that potential environmental concerns must be balanced against the need to boost agricultural productivity, and if such an assessment results in societal benefits outweighing the costs, then the technology should be applied. The hope is that regulators in other regions of the world will judiciously balance innovation and precaution, and base decisions on science rather than opinion or fear, and thus allow the continued use of neonicotinoids as vital tools in the global fight against crop pests.


2020 ◽  
Vol 10 (4) ◽  
pp. 574-597 ◽  
Author(s):  
Niels Joachim Gormsen ◽  
Ralph S J Koijen

Abstract We use data from aggregate stock and dividend futures markets to quantify how investors’ expectations about economic growth evolved across horizons following the outbreak of the novel coronavirus (COVID-19) and subsequent policy responses until July 2020. Dividend futures, which are claims to dividends on the aggregate stock market in a particular year, can be used to directly compute a lower bound on growth expectations across maturities or to estimate expected growth using a forecasting model. We show how the actual forecast and the bound evolve over time. As of July 20th, our forecast of annual growth in dividends points to a decline of 8% in both the United States and Japan and a 14% decline in the European Union compared to January 1. Our forecast of GDP growth points to a decline of 2% in the United States and Japan and 3% in the European Union. The lower bound on the change in expected dividends is -17% in the United States and Japan and -28% in the European Union at the 2-year horizon. News about U.S. monetary policy and the fiscal stimulus bill around March 24 boosted the stock market and long-term growth but did little to increase short-term growth expectations. Expected dividend growth has improved since April 1 in all geographies.


2020 ◽  
Vol 17 (1) ◽  
pp. 76-98
Author(s):  
Rogier Kegge ◽  
Annemarie Drahmann

This article aims to assess whether a programmatic approach could still be a useful legal instrument for the allocation of scarce environmental rights and a legitimate tool for implementing EU Directives. In response to the recent judgment of the Court of Justice of the European Union (cjeu) in the Dutch Programmatic Approach to Nitrogen case, 1 we will examine under what conditions a programmatic approach could be compatible with the precautionary principle and the freedom to conduct a business as protected by EU law. These principles are inextricably linked, and the Member States and the cjeu must find a balance between a high level of environmental protection and the freedom to conduct a business.


2010 ◽  
Vol 1 (2) ◽  
pp. 123-135 ◽  
Author(s):  
Liana Giorgi ◽  
Annuradha Tandon

This article reviews the policy process of setting maximum levels for aflatoxins by the European Union and the Codex Alimentarius Commission. The differences between the two regulatory organizations and the difficulties entailed in the alignment of the two standards are illustrative of the problems inherent in risk analysis in the food sector. This case is also instructive with respect to the way in which scientific evidence is used when deciding on appropriate food safety standards.


NanoEthics ◽  
2020 ◽  
Vol 14 (3) ◽  
pp. 245-257
Author(s):  
Sven Ove Hansson

AbstractThe precautionary principle has often been described as an extreme principle that neglects science and stifles innovation. However, such an interpretation has no support in the official definitions of the principle that have been adopted by the European Union and by the signatories of international treaties on environmental protection. In these documents, the precautionary principle is a guideline specifying how to deal with certain types of scientific uncertainty. In this contribution, this approach to the precautionary principle is explicated with the help of concepts from the philosophy of science and comparisons with general notions of practical rationality. Three major problems in its application are discussed, and it is concluded that to serve its purpose, the precautionary principle has to (1) be combined with other decision principles in cases with competing top priorities, (2) be based on the current state of science, which requires procedures for scientific updates, and (3) exclude potential dangers whose plausibility is too low to trigger meaningful precautionary action.


2021 ◽  
Vol 13 (10) ◽  
pp. 5395
Author(s):  
Ali Cheshmehzangi ◽  
Maycon Sedrez ◽  
Junhang Ren ◽  
Dezhou Kong ◽  
Yifan Shen ◽  
...  

The COVID-19 pandemic has spread rapidly all over the world, affecting many countries to varying degrees. In this study, an in-depth analysis of the factors influencing the spread of COVID-19 is offered mainly through big data in the European Union (EU) context. In doing so, the data of the first wave of the pandemic are assessed. Afterward, we evaluate the impacts of the COVID-19 spread in specific countries and regions. Based on the existing literature, mobility is recognized as a significant direct factor affecting disease transmission. The same applies to the case of COVID-19. However, compared with the analysis of mobility itself, this paper explores more profound reasons that affect mobility, ranging from policy and economy to geographical and transportation factors. Specifically, this paper studies nine EU countries based on their population density and the degree of impact of the epidemic in the first six months (February to July 2020) of the pandemic. Our study aims to illustrate how policies, economies, and geographical locations (including transportation factors) directly or indirectly affect the spread of the novel coronavirus by applying the SEIR model to analyze all selected countries’ big data. The key findings of this research are: (1) the timeliness of relevant policies and the effectiveness of government implementation indirectly limit the spread of the epidemic by reducing population mobility; (2) a better medical level would contribute to detect, isolate, and treat patients, and help control the epidemic; and (3) the large land borders and developed transportation between countries exacerbate the spread of the COVID-19. The paper contributes to ongoing research on COVID-19 by addressing the above points.


2013 ◽  
Vol 4 (3) ◽  
pp. 335-345 ◽  
Author(s):  
Vasco Gonçalves

In this article a synthesis of formal models for the economic interpretation of the precautionary principle is presented, with their virtualities, limitations and measures to overcome them.The concept of precaution has great relevance in environmental regulation in the European Union. On the one hand, and despite the somewhat vague nature of legislation, the interpretation of the precautionary principle has seen recent progress with the development of some economic models and their application. There is, however, a need for a regulatory framework for the implementation of this principle in environmental decision-making, i.e., to clarify concepts and management procedures that are appropriate to the nature of environmental risks.It is therefore important to know the most relevant economic approaches and models with the aim of identifying their contribution to the debate on precaution in the context of environmental risk management and discuss their practical relevance in public decision-making.


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