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Plus d'informations. This paper aims to provide a better understanding of the law circumscribing the social role of Health Technology Assessment HTA and gain insight into the reasons challenging the inclusion of ethics into HTA. Data collection was based on a literature review and a case study analysis.
The former was founded on previous work. Three HTA agencies were selected for the latter using categories ranging from a greater to a lesser level of legal obligatory intensity. The main trend revealed by the literature review and the case study, is the presence of a pact between science and regulatory law.
The social demand for integrating ELSI, and more precisely, ethical evaluation into HTA, is not the main preoccupation of the traditional legal frameworks governing HTA and remains to be considered primarily by alternative, soft law initiatives. Traditionally, the regulatory system of law has been exclusively concerned with health and safety issues in technological assessment but, over time, environmental issues came to be included in any conventional technology evaluation in what is now referred to as Environmental, Health and Safety Issues EHSI.
It is a multidisciplinary process that summarises information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. Since the publication of this report in , the pros and cons of integrating ethics into HTA have been at the centre of many initiatives and debates in the literature.
Recent studies, under the leadership of Assasi, have also charted what they term barriers and facilitators for the integration of ethics into HTA 6,7. As noted by some authors 8—10 , the different ways in which HTA agencies interpret and fulfill their mandates contributes to limit and restrain a coherent integration of ethics into HTA.
More precisely, demands for scientific assessments by decision makers seem often to preclude a more extensive and complete technology appraisal within the process. What has been referred to as Parliamentary Technology Assessment PTA , whereby ethical inquiry is left to political forces and enshrined in regulatory or political priorities, is a way to frame what should be the scope and focus of HTA.
Since this distinction rests on the scope of the legal constitutive statutes of HTA agencies and their official mandates, analysis of these constitutive laws should show how well ELS issues are considered. However, even if ELS issues are not clearly mentioned in the official mandates of agencies, the integration of ethical considerations in HTA practices have emerged in the field but have not been subjected to clear analysis to this date.
An analysis of the HTA literature can then identify what specific issues in the general debate on legal governance are raised part 2. Many countries have created agencies to protect their citizens from harm coming from different foods, drugs and dangerous products, as well as protecting the environment from damaging pollutants and biohazards.
These agencies have the power to regulate the production and distribution of substances in different ways. Their decisions are supported by laws and regulations and they can impose sanctions upon noncompliant individuals or companies. How can science accomplish this role if not through its access to truth, thus providing truth to power? If we adopt this view, risk assessment is exclusively science-based 14 and completely independent of risk management.
Many social factors can explain why this conception of regulatory science has been criticized. In our view 1 , the governance crisis relating to genetically modified organisms GMO that has risen within the European Community, in some nations of the Americas the United States, Canada, Mexico, Brazil and Argentina as well as in other countries such as Australia, India and New Zealand, clearly shows the limitation encountered by scientific investigation when it comes to risk management.
The difference in perspectives lies in the answer given to two basic questions emerging from the regulatory agencies: the degree of harm that can justify public constraints and the degree of proof that warrants a decision.
Risk analysis rests essentially on the framing of what is considered as health, safety or environmental risks. But they cannot be defined by science alone because risk perception rests on other key contextual, psycho-social and cultural dimensions. Furthermore, one may wonder, should only short-term risk or both short-term and long-term risk be considered? Does one examine the toxicity of the agent by itself or should other synergetic aspects also be taken into consideration? Moreover, the debate over the level of evidence needed to warrant a decision depends on: i how many risk factors an agency is willing to expose its population to, ii how much scientific evidence is needed for decision-making, and iii how scientific evidence can draw the line between ignorance not knowing what will occur , uncertainty knowing what will occur without knowledge of the probabilities and some degree of certainty knowing what will occur and the probability of its occurrence Debates in the fields of biotechnology and nanotechnology have highlighted other limitations of the regulatory process, namely that there exist other effects of these technologies which are not accounted for in regulatory law.
These effects are all gathered under the heading of ELSI. In regulatory law, they are not considered as a basis for constraints but are relevant to the social dynamics between producers and consumers. Therefore, these effects should be taken into consideration by technology producers in order to guarantee trust and acceptance of novel technological developments. ELSI are thus left in the hands of stakeholders.
Here, different Social Sciences and Humanities studies are mobilized to understand risk perception, risk communication, social engagement practises, etc. In other words, regulatory law is concerned exclusively with environmental, health and safety risks, while stakeholders remain responsible for the other ELSI impacts of technological developments. This debate has highlighted several limitations with respect to truth delivery by science.
Its first limitation relates to the means for obtaining truths: epistemology. It gives rise to the following questions: Can science really capture truths in the laws of nature?
Are empirical sciences only based on quantifiable data? Can qualitative research also provide valid information for decision-making? The second limitation relates to the fact that the scientific methodologies applied in risk analysis are value-laden.
At the governance level, the exclusion of ELSI in regulatory law can be criticized on two grounds. This is why an approach integrating all impacts of scientific innovations whether positive or negative on Environmental, Ethical, Economical, Legal and Social issues E 3 LS was introduced in the contexts of genomic research funding 21 , governance in nanotechnologies 22 and regulation of nanomedicine 23 in Canada.
Those supporting this distinction claim that: i the scope of regulatory law is to protect against important harms; ii the role of scientific proofs is the fundamental guide to regulatory decisions; and iii appraisal of scientific proofs and other outcomes should rest in political decision making. In contrast, opponents to this distinction claim that: i the scope of regulatory law should not only focus on limiting harm; ii relying on scientific proofs alone is not enough given scientific uncertainly on numerous issues; iii scientific methods used in decision making processes remain value-laden; and iv priority given to the scientific community in regulation impairs democracy.
Data collection was based on two methodological approaches: a literature review and a case study analysis. The literature review was based on results of our systematic review on the integration of ethics into HTA In this systematic review, an analytical qualitative approach known as the general inductive method 26 was used to select relevant quotes from eligible articles.
Since the strategies and procedures of HTA agencies can vary because of their national settings and, more precisely, the legal conventions defining their mandates, we decided to undertake a case study originally focussing on four different HTA agencies in order to help highlight different approaches of the integration of ELSI into HTA.
To this end, a conducive selection of agencies based on our geographical and cultural specificities was performed. Legal governance was then divided into three categories, each of them ranging from a greater to a lesser level of legal obligatory intensity:.
Traditional hard law : fully obligatory and constraining i. Soft law integrated in hard law : included normative instruments that can either be employed as auxiliary means to complement regulations used by legislators or be used to interpret hard law normative documents used by judges e.
Soft law : without being explicitly recognized by traditional hard law, soft law includes non-obligatory and non-constraining normative instruments aiming to orient the human conduct and behaviours e. Even if the difference of national settings is recognized as a cultural factor defining the mandate of HTA agencies, the debate is focussed on the nature of HTA reports. For some agencies, the reports should only be centred on knowledge synthesis, stating that the evidence be based on its findings Other agencies 34 suggest a two phase report: the first being an assessment followed by another consisting in an appraisal.
In HTA reports, the assessment basically covers clinical effectiveness and safety. This clinical review of scientific literature on the health technology or intervention assesses the scientific proof related to the clinical effects on health and security.
Implementing a health technology or intervention has other impacts on the hospital organisation or healthcare services for the population, on the quality of life of patients, and also triggers ethical and legal issues. Analysis of these is conducted in the appraisal phase, where contextual studies are undertaken and explicit recommendations are made in the reports.
Since traditional HTA has been linked to the capability of science to demonstrate according to levels of evidence, ethical considerations could only be integrated in its reports if the results produced were testable or verifiable The value-ladenness of HTA Table 1, theme d raises questions about the role of science in regulatory law, especially the link between risk assessment and risk management.
The main question being: is risk assessment value free? When risk assessment is not considered related to the decision-making process, it seems value free.
But since the aim of HTA is to guide and ground governmental decisions, there is an essential link between risk assessment and risk management, because risk assessment is part of the decision-making process. The HTA process is therefore considered value laden because it aims to guide the choice of the best alternative which in turn implies a value judgment as to which alternative is best.
The value-ladenness of the decision process in HTA, from the initial scoping phase to the final report, has been explicitly addressed Furthermore, methodological decisions in effectiveness, safety and cost analysis have also been found to be value-laden Can the scientific values entrenched in assessments justify the acceptability of risks and benefits for patients and citizens?
In HTA, this concern has been addressed through particular involvement of patients and citizens in the HTA processes referred to, in this field, as participatory approaches Since CADTH does not have a constitutive statutory law, it was ultimately excluded from the case study; so only three agencies were compared.
In our investigation to identify how ethics is being mobilized in different HTA contexts, we performed an analysis of the legal, administrative and procedural documents relating to the existence and assessment processes of these three agencies. The examination of these formulations brought additional light to how those two expressions are used in the literature 5,38,44, Referring to excellence, independence, openness, scientific rigor, transparency, integrity and equity, Section 4 of the INESSS act defines the conduct that should be expected of stakeholders involved in HTA activities.
To this end, the act explicitly refers to an ethical framework that has to be drafted and published and lay out principles guiding the assessment and appraisal of scientific evaluations, and for stakeholders to explain the reasons behind their recommendations and practice guides. As we look closer, we realise that despite clear constraining obligations emerging from regulatory law, INESSS and its stakeholders have, so far, fallen short on delivering and putting into place the prescribed ethical framework.
Indeed, despite Section 6 of the INESSS constitutive act, it appears that no ethical framework has been adopted or published to this date. However, recent work on an ethical framework based on Accountability for Reasonabless A4R , presented at the HTAi annual meeting in , proposes a multicriteria analysis including ethics and patient involvement. It also refers directly to the need for its scientific committee to respect the ethical framework prescribed by hard law Sections 4 and 7, INESSS act.
Moreover, in some of its best-practice documents regarding the consultation of stakeholders and on practice guidelines, the agency recognises, albeit in very general terms, the importance of the inclusion of ELSI for fulfilling its mandate.
For example, referring to ethical issues emerging from HTA practices 64 or by including ethical issues in the scientific and contextual data collected for an HTA The constitutive act of HAS, referred hearin as its Code hard law , requires that when establishing and publicising recommendations and medico-economic positions on efficient prevention, care or prescription strategies, HAS should take into consideration the respect of ethical principles.
This guide is not prescribed by hard law but is offered as a soft law initiative coming from HAS itself in order to help public decision-making through better information on ethical issues arising from health interventions targeted towards decision-makers and stakeholders p.
This guide uses descriptive ethics and principlism in a very specific way and is intended for specific situations where controversial aspects of the technologies are addressed and where value conflicts are anticipated. It proposes an ethical analysis by which the ethical debate in society is compared to an ethical evaluation that would imply using value judgments in its appraisal.
The proposed standardised approach in reference to ethics includes many interesting elements on the social role and mission of HAS aimed at public decision-making. However, in order to help solve value conflicts and facilitate complex decisions, it remains limited to issues that are deemed important with regards to challengeable elements of some given medical technologies.
It does not propose a method that would allow highlighting of every ethical issue that could arise from any given health technology in defined health care settings p. One example of this restrictive use of ethics is that some methodological approaches involved in medical, economic and public health choices are not being subjected to any ethical assessment because they are deemed scientifically sound and efficient p.
Ethics is mobilised separately, on the fringe of an assessment process that remains independent. It is not questioned by ethical analysis. NICE regulations s. In addition, a Guide was produced to address the social value judgments that should be made in the process of developing NICE recommendations in the context of HTA, especially when NICE has to make choices on effectiveness and cost-effectiveness This prerequisite is clearly linked to the requirements of appraisals and recommendations, and for the need to give reasons to support final decisions.
In contrast, the legal mandates of HAS and NICE clearly confirm the post-war social contract between science and governance in regulatory law whereby science, by its assessments, speaks the truth to decision-makers. The need for taking ELSI into account in regulatory law is fulfilled differently by the different agencies analysed.
In establishing international norms, such as those in international environmental law, one might turn to ethics for three reasons. First, as an individual or government engaged in the process of moral reasoning, one might be seeking guidance in identifying the morally ideal choice among the available policy alternatives: which option ought to be brought about? Second, one might employ ethics to persuade others to endorse the same choice. The third use of ethics would be to justify imposing a law or policy on others who remain unpersuaded by reason. Environmental ethics comes into play when we wish to evaluate environment-affecting actions on account of their impact on the environment rather than on account of their indirect impact on present or future humans.
Environmental law now regulates most aspects of a company's activities. conduct in line with social expectations, its scope for control is.
To cope with stressors like climate change, economic instability, and socio-political or ideological shifts, environmental governance needs to formally embrace a broader set of environmental actors, organizations, and institutions, and become more flexible, responsive, and innovative Folke et al. Vital natural resources are collapsing throughout the world because of unsustainable environmental practices MEA , FAO driven by outdated conceptions of nature Clark et al. These shortcomings threaten human welfare Dietz et al. Adaptive governance, as a concept Chaffin et al.
Environmental governance is a concept in political ecology and environmental policy that advocates sustainability sustainable development as the supreme consideration for managing all human activities— political , social and economic. To capture this diverse range of elements, environmental governance often employs alternative systems of governance, for example watershed-based management. It views natural resources and the environment as global public goods , belonging to the category of goods that are not diminished when they are shared. Public goods are non-rivalrous—a natural resource enjoyed by one person can still be enjoyed by others—and non-excludable—it is impossible to prevent someone consuming the good breathing. Nevertheless, public goods are recognized as beneficial and therefore have value.
This paper discusses good environmental governance in the framework of environmental protection and management. The evironmental view of governance itself provides a conceptual framework in which public and private behavior is regulated in supporting more ecologically oriented arrangements. The framework forms a reciprocal relationship between the community global, regional, national and local in dealing with the access and use of environmental goods and services and binds them at any level with certain specific environmental ethics. Then as a system, Environmental Governance consists of socio-cultural aspects, political and economic interactions among many actors in civil society.
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Мидж появилась в дверях со свежей распечаткой в руке. - Директор, Стратмору не удается отключить ТРАНСТЕКСТ. - Что?! - хором вскричали Бринкерхофф и Фонтейн. - Он пытался, сэр! - Мидж помахала листком бумаги. - Уже четыре раза.
Сьюзан покачала головой, не зная, что на это возразить. Хейл улыбнулся: - Так заканчивал Танкадо все свои письма ко. Это было его любимое изречение. ГЛАВА 32 Дэвид Беккер остановился в коридоре у номера 301. Он знал, что где-то за этой витиеватой резной дверью находится кольцо. Вопрос национальной безопасности. За дверью послышалось движение, раздались голоса.
Хейл засмеялся: - Можете пристраивать к ней черный ход - я слова не скажу. - Потом в его голосе зазвучали зловещие нотки. - Но как только я узнаю, что вы следите за мной, я немедленно расскажу всю эту историю журналистам. Я расскажу, что Цифровая крепость - это большая липа, и отправлю на дно все ваше мерзкое ведомство. Стратмор мысленно взвешивал это предложение. Оно было простым и ясным.
Они также подошли к Танкадо. - Неудачный выбор места, - прокомментировал Смит. - Халохот думал, что поблизости никого. Халохот какое-то время наблюдал за происходящим, потом скрылся за деревьями, по-видимому, выжидая.
We now possess the knowledge that our actions do have a real impact on the environment.Amaranto J. 04.06.2021 at 10:46
Plus d'informations.Zerbino G. 04.06.2021 at 14:45
E-Book (PDF). Availability: Not Yet Published. ISBN: Publication Date: 01 Jan Cover Environmental Law, Ethics and Governance.LeГіnidas S. 07.06.2021 at 22:08
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