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Edited by Lukasz Gruszczynski

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Edited by Lukasz Gruszczynski

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The Regulation of E-cigarettes

International, European and National Challenges

Edited by Lukasz Gruszczynski

Combining the insights of leading legal scholars and public health experts, this unique book analyses the various legal problems that are emerging at different levels of governance (international, European and national) in the context of the regulation of e-cigarettes. The expert authors assess in depth the possible application of the precautionary and harm reduction principles in this area, examine the legal constraints imposed on states by international and European rules, as well as the regulatory approaches currently in place in selected national jurisdictions.
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Jos Boertjens, Johan van Manen, Misja Mikkers and Wolf Sauter

Because the risk of ill health is part of the human condition, there is a universal interest in providing access to high-quality healthcare while controlling the sacrifices that are necessary to obtain it – after all, the funds used for healthcare cannot be allocated to alternative uses. Affordability is therefore an important consideration that is closely linked to access. Quality determines the health value of the treatment provided. Arriving at a social consensus on how to achieve these goals is difficult, however, which in most countries leads to intense debate on healthcare, as the contributions to this book regarding the US, South Africa, Colombia and the Netherlands all illustrate. Unsurprisingly, there is no one particular healthcare system that meets all three of the needs identified above perfectly. Instead, there is a wide variety of such systems, each with different advantages, disadvantages and trade-offs. Hence it is important that data on the problems encountered are collected and analysed, and that learning occurs between different health systems. This is a practical as well as a scientific challenge, because hitherto most studies on healthcare regulation have not taken a comparative perspective based on comparable data. In fact, in many respects, no such data yet exists. This book charts hospital financing across the three dimensions of access, affordability and quality. It does so based on an international comparison spanning four different continents. For the purpose of our project, we have collected 11 country reports, compiled by national experts according to a standard structure. In addition, six thematic chapters are included that explore specific questions. The invited authors include academics and practitioners (primarily, but not exclusively, policymakers).

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The Law and Policy of Healthcare Financing

An International Comparison of Models and Outcomes

Edited by Wolf Sauter, Jos Boertjens, Johan van Manen and Misja Mikkers

Examining the ways and extent to which systemic factors affect health outcomes with regard to quality, affordability and access to curative healthcare, this explorative book compares tax-funded Beveridge systems and insurance-based Bismarck systems. Containing contributions from national experts, The Law and Policy of Healthcare Financing charts and compares the merits of healthcare systems throughout 11 countries, from the UK to Colombia.
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Jos Boertjens and Mary Guy

In this chapter the authors compare the health care systems of England and the Netherlands with respect to contracting, accountability frameworks and the duty to provide care and access to health care. The objectives of contracting are different in these two countries. While in the Netherlands contracting is envisaged to promote efficiency and quality, contracting in England appears to set a minimum requirement. Under the Dutch system, the insurer must fulfill its duty to provide care. In England it is difficult to hold any party accountable for ensuring that patients receive necessary care. Various types of co-payments and out-of-pocket charges occur in both England and the Netherlands. In both countries personal care budgets exist to put patients in charge of their own budgets.

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Global Genes, Local Concerns

Legal, Ethical, and Scientific Challenges in International Biobanking

Edited by Timo Minssen, Janne R Herrmann and Jens Schovsbo

With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking. Addressing pressing questions such as how do national biobanks best contribute to translational research and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.
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Edited by Timo Minssen, Janne R Herrmann and Jens Schovsbo

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Brian J. Clark and Tina Bossow

In the context of this chapter, “bioscience industries” refers to companies involved in research, development and manufacturing of products that improve diagnosis, treatment, or prevention of human diseases, or the provision of enabling technologies or services in support of the same aims. This diverse grouping includes the pharmaceutical, diagnostics, biotechnology, and research and development services industries. Many companies within the bioscience industries use biological samples derived from humans (“human biosamples”) in their research, development, or manufacturing processes and some finished products may contain human biosample components. While the for-profit business model of commercial companies sometimes leads to mistrust and questions over their legitimacy as users of human biosamples (HBS), such companies are and will remain essential for the discovery, development, and delivery of innovations in healthcare that are of benefit for populations. Therefore, the legitimacy of the bioscience industries as valid users of HBS for purposes intended to deliver public benefit should not be in doubt. Instead, the pivotal question should be whether the bioscience industries can demonstrate that they use HBS in ways that are socially responsible, ethical, compliant with applicable laws or regulations, and safe, such that they merit access to precious HBS. In fact, this same question should equally apply to any user of HBS, whether a for-profit industrial user or a not-for profit or public institutional user. All users should be able to demonstrate that they are legitimate and responsible users of HBS.

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Edited by Israel Doron and Nena Georgantzi