The Experts below are selected from a list of 140817 Experts worldwide ranked by ideXlab platform
Carolin Floeter - One of the best experts on this subject based on the ideXlab platform.
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the Accessibility of data on environmental risk assessment of pharmaceuticals is the marketing authorisation procedure in conflict with the international Right of Access to environmental information
Environmental Sciences Europe, 2019Co-Authors: Kim Oelkers, Carolin FloeterAbstract:For a large part of the active pharmaceutical ingredients (APIs) available on the market, there is no or no comprehensive environmental risk assessment (ERA) existent/available. Existing ERAs are, moreover, treated as commercially/industrial confidential information (CCI) and the information content on the ERAs contained in the Public Assessment Reports is very limited. Thus, neither the public can inform itself sufficient nor environmental authorities can use the ERAs to compile environmental quality standards. Environmental information law, on the other hand, requires the general Accessibility of environmental information. Against this background, this investigation examines the following questions in conformity with the environmental information law: Which environmental information on pharmaceuticals is generated in the marketing authorisation? Which of the environmental information generated in the marketing authorisation is available to the public? Does the environmental information on pharmaceuticals concern CCI? According to international and European environmental information law, there is in principal a Right of Access to the ERAs of pharmaceuticals (environmental information according to Art. 2(3)(b) Aarhus Convention), which is ineffective due to product-based data and allegedly conflicting CCI. The practised blanket classification of CCI by the marketing authorisation holders is in conflict with the principle of transparency of environmental information law. In any case, the outcomes of the ERA (in particular the ecotoxicity endpoints) may not be classified as CCI. Furthermore, the publicly Accessible information in the format of the Public Assessment Report does not sufficiently reflect the information from ERAs and thus does not fulfil the mandate of active Access to information (Art. 5 Aarhus Convention). The conflict between the actual Accessibility of environmental information on pharmaceuticals and the requirements of environmental information law could be resolved through an API-based publicly Accessible database with the outcomes of the ERAs (including all underlying ecotoxicity endpoints). To fulfil the Right of Access to environmental information effectively, the database also needs to be extended to “old” APIs for which environmental risk assessments have not yet been carried out. This would be the basis for prioritisation of API and establishing a monograph system. The environmental information law requires an improved Accessibility of ERAs that could be achieved through an API-based publicly Accessible database.
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The Accessibility of data on environmental risk assessment of pharmaceuticals: Is the marketing authorisation procedure in conflict with the international Right of Access to environmental information?
Environmental Sciences Europe, 2019Co-Authors: Kim Oelkers, Carolin FloeterAbstract:BackgroundFor a large part of the active pharmaceutical ingredients (APIs) available on the market, there is no or no comprehensive environmental risk assessment (ERA) existent/available. Existing ERAs are, moreover, treated as commercially/industrial confidential information (CCI) and the information content on the ERAs contained in the Public Assessment Reports is very limited. Thus, neither the public can inform itself sufficient nor environmental authorities can use the ERAs to compile environmental quality standards. Environmental information law, on the other hand, requires the general Accessibility of environmental information. Against this background, this investigation examines the following questions in conformity with the environmental information law: Which environmental information on pharmaceuticals is generated in the marketing authorisation? Which of the environmental information generated in the marketing authorisation is available to the public? Does the environmental information on pharmaceuticals concern CCI?ResultsAccording to international and European environmental information law, there is in principal a Right of Access to the ERAs of pharmaceuticals (environmental information according to Art. 2(3)(b) Aarhus Convention), which is ineffective due to product-based data and allegedly conflicting CCI. The practised blanket classification of CCI by the marketing authorisation holders is in conflict with the principle of transparency of environmental information law. In any case, the outcomes of the ERA (in particular the ecotoxicity endpoints) may not be classified as CCI. Furthermore, the publicly Accessible information in the format of the Public Assessment Report does not sufficiently reflect the information from ERAs and thus does not fulfil the mandate of active Access to information (Art. 5 Aarhus Convention). The conflict between the actual Accessibility of environmental information on pharmaceuticals and the requirements of environmental information law could be resolved through an API-based publicly Accessible database with the outcomes of the ERAs (including all underlying ecotoxicity endpoints). To fulfil the Right of Access to environmental information effectively, the database also needs to be extended to “old” APIs for which environmental risk assessments have not yet been carried out. This would be the basis for prioritisation of API and establishing a monograph system.ConclusionThe environmental information law requires an improved Accessibility of ERAs that could be achieved through an API-based publicly Accessible database.
Kim Oelkers - One of the best experts on this subject based on the ideXlab platform.
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the Accessibility of data on environmental risk assessment of pharmaceuticals is the marketing authorisation procedure in conflict with the international Right of Access to environmental information
Environmental Sciences Europe, 2019Co-Authors: Kim Oelkers, Carolin FloeterAbstract:For a large part of the active pharmaceutical ingredients (APIs) available on the market, there is no or no comprehensive environmental risk assessment (ERA) existent/available. Existing ERAs are, moreover, treated as commercially/industrial confidential information (CCI) and the information content on the ERAs contained in the Public Assessment Reports is very limited. Thus, neither the public can inform itself sufficient nor environmental authorities can use the ERAs to compile environmental quality standards. Environmental information law, on the other hand, requires the general Accessibility of environmental information. Against this background, this investigation examines the following questions in conformity with the environmental information law: Which environmental information on pharmaceuticals is generated in the marketing authorisation? Which of the environmental information generated in the marketing authorisation is available to the public? Does the environmental information on pharmaceuticals concern CCI? According to international and European environmental information law, there is in principal a Right of Access to the ERAs of pharmaceuticals (environmental information according to Art. 2(3)(b) Aarhus Convention), which is ineffective due to product-based data and allegedly conflicting CCI. The practised blanket classification of CCI by the marketing authorisation holders is in conflict with the principle of transparency of environmental information law. In any case, the outcomes of the ERA (in particular the ecotoxicity endpoints) may not be classified as CCI. Furthermore, the publicly Accessible information in the format of the Public Assessment Report does not sufficiently reflect the information from ERAs and thus does not fulfil the mandate of active Access to information (Art. 5 Aarhus Convention). The conflict between the actual Accessibility of environmental information on pharmaceuticals and the requirements of environmental information law could be resolved through an API-based publicly Accessible database with the outcomes of the ERAs (including all underlying ecotoxicity endpoints). To fulfil the Right of Access to environmental information effectively, the database also needs to be extended to “old” APIs for which environmental risk assessments have not yet been carried out. This would be the basis for prioritisation of API and establishing a monograph system. The environmental information law requires an improved Accessibility of ERAs that could be achieved through an API-based publicly Accessible database.
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The Accessibility of data on environmental risk assessment of pharmaceuticals: Is the marketing authorisation procedure in conflict with the international Right of Access to environmental information?
Environmental Sciences Europe, 2019Co-Authors: Kim Oelkers, Carolin FloeterAbstract:BackgroundFor a large part of the active pharmaceutical ingredients (APIs) available on the market, there is no or no comprehensive environmental risk assessment (ERA) existent/available. Existing ERAs are, moreover, treated as commercially/industrial confidential information (CCI) and the information content on the ERAs contained in the Public Assessment Reports is very limited. Thus, neither the public can inform itself sufficient nor environmental authorities can use the ERAs to compile environmental quality standards. Environmental information law, on the other hand, requires the general Accessibility of environmental information. Against this background, this investigation examines the following questions in conformity with the environmental information law: Which environmental information on pharmaceuticals is generated in the marketing authorisation? Which of the environmental information generated in the marketing authorisation is available to the public? Does the environmental information on pharmaceuticals concern CCI?ResultsAccording to international and European environmental information law, there is in principal a Right of Access to the ERAs of pharmaceuticals (environmental information according to Art. 2(3)(b) Aarhus Convention), which is ineffective due to product-based data and allegedly conflicting CCI. The practised blanket classification of CCI by the marketing authorisation holders is in conflict with the principle of transparency of environmental information law. In any case, the outcomes of the ERA (in particular the ecotoxicity endpoints) may not be classified as CCI. Furthermore, the publicly Accessible information in the format of the Public Assessment Report does not sufficiently reflect the information from ERAs and thus does not fulfil the mandate of active Access to information (Art. 5 Aarhus Convention). The conflict between the actual Accessibility of environmental information on pharmaceuticals and the requirements of environmental information law could be resolved through an API-based publicly Accessible database with the outcomes of the ERAs (including all underlying ecotoxicity endpoints). To fulfil the Right of Access to environmental information effectively, the database also needs to be extended to “old” APIs for which environmental risk assessments have not yet been carried out. This would be the basis for prioritisation of API and establishing a monograph system.ConclusionThe environmental information law requires an improved Accessibility of ERAs that could be achieved through an API-based publicly Accessible database.
Joan Carles March Cerda - One of the best experts on this subject based on the ideXlab platform.
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the Right of Access to health care for undocumented migrants a revision of comparative analysis in the european context
European Journal of Public Health, 2014Co-Authors: Amets Suess, Isabel Ruiz Perez, Ainhoa Ruiz Azarola, Joan Carles March CerdaAbstract:Background: The recent introduction of adjustment measures in the Spanish context by means of the Royal Decree-law 16/2012 (RDL 16/2012), which limits Access to health care for undocumented migrants, raises the question about the state of the matter in different European Union member states. Methods: Narrative review of comparative studies published between 2009 and 2012 that analyzes the Right to health care for undocumented migrants in the European context. Results: The review shows a high degree of variability regarding health care entitlements of undocumented migrants in different European countries, a frequent legal restriction of Access to health care, as well as barriers in the effective Access to health care. The studies coincide in recommending Access at all health care levels, regardless of the administrative status of the person seeking treatment. The analysis of the impact of the current economic crisis on Access and quality of the health care directed to undocumented migrants, as well as the knowledge of the migrants’ perspective are identified as future research areas. Conclusions: Compared with other European countries, the introduction of the measures established in the RDL 16/2012 modifies the place of the Spanish Public Health Care System from being situated in the group of countries that permit undocumented migrants Access to all health care levels, towards the category of highest restriction.
Paul De Hert - One of the best experts on this subject based on the ideXlab platform.
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APF - The Right of Access under the Police Directive : Small steps forward
Privacy Technologies and Policy, 2018Co-Authors: Diana Dimitrova, Paul De HertAbstract:The present article sets out to examine the Right of Access under Directive 2016/680, which regulates the processing of personal data by EU Member States’ law enforcement authorities. The article analyses in detail the provisions on the Right of Access. More precisely, it looks at whether the Right provides for sufficient transparency towards the data subject and whether its scope allows for a harmonized data protection across the law enforcement sector in the EU. The article concludes that while the provisions on the Right of Access make a significant step towards more transparency, they also suffer from deficiencies. Also, the limited scope of the Directive takes away from the harmonization attempts.
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the Right of Access under the police directive small steps forward
Privacy Forum, 2018Co-Authors: Diana Dimitrova, Paul De HertAbstract:The present article sets out to examine the Right of Access under Directive 2016/680, which regulates the processing of personal data by EU Member States’ law enforcement authorities. The article analyses in detail the provisions on the Right of Access. More precisely, it looks at whether the Right provides for sufficient transparency towards the data subject and whether its scope allows for a harmonized data protection across the law enforcement sector in the EU. The article concludes that while the provisions on the Right of Access make a significant step towards more transparency, they also suffer from deficiencies. Also, the limited scope of the Directive takes away from the harmonization attempts.
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A European Perspective on Data Protection and the Right of Access
The Unaccountable State of Surveillance, 2017Co-Authors: Antonella Galetta, Paul De HertAbstract:This chapter provides an up to date analysis of the legal and administrative frameworks surrounding informational Rights at a supranational level in the European Union with a focus on the Right of Access to personal data. The first part of the chapter tracks the development of data protection and privacy legislation in the European Union, offering context and background to understand the journey of such regulation with a specific focus on the Right of Access. The second part of the chapter considers how issues of privacy and data protection have been dealt with by European courts, namely the European Court of Justice and the European Court of Human Rights. The chapter concludes by outlining the role played by the European Data Protection Supervisor.
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Mapping the Legal and Administrative Frameworks of Access Rights in Europe - A Cross-European Comparative Analysis 1
2010Co-Authors: Antonella Galetta, Paul De Hert, Clive NorrisAbstract:This report develops a comparative legal analysis of laws and practices on Access Rights that can be found in the selected countries that we analysed in this research (Austria, Belgium, Germany, Hungary, Italy, Luxembourg, Norway, Slovakia, Spain and the United Kingdom). Although the Right of Access to personal data is protected and enforced in all these countries (in compliance with Directive 95/46/EC), many differences can be observed.
Colin T. Reid - One of the best experts on this subject based on the ideXlab platform.
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Back to Square One: Revisiting How We Analyse the Right of Access to Environmental Information
Journal of Environmental Law, 2019Co-Authors: Sean Whittaker, Jonathan Mendel, Colin T. ReidAbstract:Abstract The Right of Access to environmental information has become a key aspect of contemporary efforts to promote environmental governance in the UK. The Right is enshrined in international law through the Aarhus Convention which, alongside other legal developments, has influenced how academics analyse the Right in the UK. How research into the Right has been conducted is significant because it has led to gaps in how we understand the Right and undermines environmental protection efforts. This article identifies and critiques the common analytical trends used to analyse the Right of Access to environmental information in the UK. The article considers two of these trends, examining their negative impact and the role of the Aarhus Convention in creating these trends. The article concludes by discussing the need to critically engage with these knowledge gaps to improve how the Right is guaranteed and, ultimately, the implementation of environmental protection efforts.
