Dataset Information

Spatiotemporal Controllability and Environmental Risk Assessment of Genetically Engineered Gene Drive Organisms from the Perspective of European Union Genetically Modified Organism Regulation.

ABSTRACT: Gene drive organisms are a recent development created by using methods of genetic engineering; they inherit genetic constructs that are passed on to future generations with a higher probability than with Mendelian inheritance. There are some specific challenges inherent to the environmental risk assessment (ERA) of genetically engineered (GE) gene drive organisms because subsequent generations of these GE organisms might show effects that were not observed or intended in the former generations. Unintended effects can emerge from interaction of the gene drive construct with the heterogeneous genetic background of natural populations and/or be triggered by changing environmental conditions. This is especially relevant in the case of gene drives with invasive characteristics and typically takes dozens of generations to render the desired effect. Under these circumstances, "next generation effects" can substantially increase the spatial and temporal complexity associated with a high level of uncertainty in ERA. To deal with these problems, we suggest the introduction of a new additional step in the ERA of GE gene drive organisms that takes 3 criteria into account: the biology of the target organisms, their naturally occurring interactions with the environment (biotic and abiotic), and their intended biological characteristics introduced by genetic engineering. These 3 criteria are merged to form an additional step in ERA, combining specific "knowns" and integrating areas of "known unknowns" and uncertainties, with the aim of assessing the spatiotemporal controllability of GE gene drive organisms. The establishment of assessing spatiotemporal controllability can be used to define so-called "cut-off criteria" in the risk analysis of GE gene drive organisms: If it is likely that GE gene drive organisms escape spatiotemporal controllability, the risk assessment cannot be sufficiently reliable because it is not conclusive. Under such circumstances, the environmental release of the GE gene drive organisms would not be compatible with the precautionary principle (PP). Integr Environ Assess Manag 2020;00:1-14. © 2020 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

SUBMITTER: Then C

PROVIDER: S-EPMC7496464 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Spatiotemporal Controllability and Environmental Risk Assessment of Genetically Engineered Gene Drive Organisms from the Perspective of European Union Genetically Modified Organism Regulation.

Then Christoph C Kawall Katharina K Valenzuela Nina N

Integrated environmental assessment and management 20200527 5

Gene drive organisms are a recent development created by using methods of genetic engineering; they inherit genetic constructs that are passed on to future generations with a higher probability than with Mendelian inheritance. There are some specific challenges inherent to the environmental risk assessment (ERA) of genetically engineered (GE) gene drive organisms because subsequent generations of these GE organisms might show effects that were not observed or intended in the former generations. ...[more]

PMID: 32250054

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Project description:In European regulations for the deliberate release into the environment of genetically modified organisms (GMO), the objective of General Surveillance in Post-Market Environmental Monitoring is defined as the identification of the occurrence of adverse effects of the GMO or its use which were not anticipated in the environmental risk assessment (ERA). Accompanying the commercial cultivation in the EU of maize event MON 810, General Surveillance was implemented by Monsanto, the authorization holder, on a voluntary basis. We carried out a statistical analysis on the pooled results of ten years of farmer questionnaires, which were a part of this General Surveillance, amounting to 2,627 farmer fields in eight European countries in the period 2006-2015. This analysis did not reveal any unexpected adverse effects associated with the cultivation of MON 810. Results from farmer questionnaires confirmed that the cultivation of MON 810 resulted in a significant reduction in the use of pesticides, efficient protection against the target pests, and healthier, higher yielding crops compared to conventional maize. MON 810 also had reduced susceptibility to disease and pests when compared to conventional maize. Monitoring characteristics related to environment and wildlife revealed no significant differences between MON 810 and conventional maize. Literature searches, that were also conducted as part of General Surveillance, identified a comprehensive set of publications addressing environmental safety as well as food and feed safety aspects of MON 810. None of the publications indicated any adverse effect of MON 810 that was not anticipated in the initial ERA, nor did they lead to a change in the conclusions of the initial risk assessment that demonstrated the safety of MON 810. The development of resistance by the target pests (Ostrinia nubilalis, ECB and Sesamia nonagrioides, MCB) was the only potential adverse effect identified in the ERA of MON 810 cultivation in the EU. The extensive safety data package for MON 810, the robust weight of evidence demonstrating both its safety and benefits, and the history of safe use of MON 810 for 15 years in the EU, indicates that focussing the General Surveillance of MON 810 on literature searches and farmer complaint systems would be appropriately protective. This will allow the identification of potential adverse effect not anticipated in the initial ERA without the intensive effort and organizational challenges of farmer questionnaires.

Project description:BACKGROUND AND AIMS:The World Health Organization recommends increasing alcohol taxes as a 'best-buy' approach to reducing alcohol consumption and improving population health. Alcohol may be taxed based on sales value, product volume or alcohol content; however, duty structures and rates vary, both among countries and between beverage types. From a public health perspective, the best duty structure links taxation level to alcohol content, keeps pace with inflation and avoids substantial disparities between different beverage types. This data note compares current alcohol duty structures and levels throughout the 28 European Union (EU) Member States and how these vary by alcohol content, and also considers implications for public health. DESIGN AND SETTING:Descriptive analysis using administrative data, European Union, July 2018. MEASUREMENTS:Beverage-specific alcohol duty rates per UK alcohol unit (8 g ethanol) in pounds sterling at a range of different alcoholic strengths. FINDINGS:Only 50% of Member States levy any duty on wine and several levy duty on spirits and beer at or close to the EU minimum level. There is at least a 10-fold difference in the effective duty rate per unit between the highest- and lowest-duty countries for each beverage type. Duty rates for beer and spirits stay constant with strength in the majority of countries, while rates for wine and cider generally fall as strength increases. Duty rates are generally higher for spirits than other beverage types and are generally lowest in eastern Europe and highest in Finland, Sweden, Ireland and the United Kingdom. CONCLUSIONS:Different European Union countries enact very different alcohol taxation policies, despite a partially restrictive legal framework. There is only limited evidence that alcohol duties are designed to minimize public health harms by ensuring that drinks containing more alcohol are taxed at higher rates. Instead, tax rates appear to reflect national alcohol production and consumption patterns.

Project description:BackgroundMedications and their prices are key issues for healthcare. Although access to medicines at affordable prices had been specified as a key objective of the European Health Policy, it seems that these goals have not been achieved. Therefore, we attempted an evaluation of affordability of selected medicines at full prices.MethodsThe analysis concerned 2012 and was conducted between 2013 and 2015 in all the European Union (EU) countries divided into 3 groups depending on the date of their accession to the EU. Finally, we considered 9 originators used in the treatment of schizophrenia and multiple sclerosis. Information on drug prices were collected from pharmacies. Participation in the study was voluntary and anonymous in order to avoid accusations of advertising. To evaluate affordability, several factors were used (e.g. minimum earnings and Gini coefficient). Due to unavailability in some countries, the exact number of analyzed medicines varies.ResultsDrug prices vary significantly between EU Member States. Almost eleven fold difference was observed between Germany (EUR 1451.17) and Croatia (EUR 132.77) in relation to Interferone beta-1a 22 μg. Generally, prices were the highest in Germany. The cheapest drugs were found in various countries but never in the poorest ones like Bulgaria or Romania. Discrepancies in wages were observed too (the smallest minimum wage was EUR 138.00 in Bulgaria and the highest EUR 1801.00 in Luxembourg). Full price of olanzapine 5mg, however, was higher in Bulgaria (EUR 64.53) than, for instance, in Belgium (EUR 37.26).ConclusionsAnalyzed medications are still unaffordable for many citizens of the EU. Besides, access to medicines is also impaired e.g. due to parallel trade. Unaffordability of medications may lead to the patients' non-compliance and therefore to increased direct and indirect costs of treatment. Common European solutions are needed to achieve a real affordability and accessibility of medications.

Dataset Information

Spatiotemporal Controllability and Environmental Risk Assessment of Genetically Engineered Gene Drive Organisms from the Perspective of European Union Genetically Modified Organism Regulation.

Publications

Spatiotemporal Controllability and Environmental Risk Assessment of Genetically Engineered Gene Drive Organisms from the Perspective of European Union Genetically Modified Organism Regulation.

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