State performance in pluripotent and adult stem cell research, 2009-2016.

AIM: To examine how the geographic distribution of pluripotent and adult stem cell research publications within the USA differs from other areas of biomedical research. MATERIALS & METHODS: Publication count data for pluripotent stem cell research, adult stem cell research and a comparison group representative of biomedical research more broadly were collected and analyzed for each US state from 2009 to 2016. RESULTS: The distribution of pluripotent stem cell research differed from the other fields with overperformance in pluripotent stem cell research observed in California, as well as Wisconsin, Massachusetts, Maryland and Connecticut. CONCLUSION: Our analysis suggests that permissive state stem cell policy may be one of the several factors contributing to strong state performance in pluripotent stem cell research.

Research on Human Embryos and Reproductive Materials: Revisiting Canadian Law and Policy.

Research involving human embryos and reproductive materials, including certain forms of stem cell and genetic research, is a fast-moving area of science with demonstrated clinical relevance. Canada's current governance framework for this field of research urgently requires review and reconsideration in view of emerging applications. Based on a workshop involving ethics, legal, policy, scientific and clinical experts, we present a series of recommendations with the goal of informing and supporting health policy and decision-making regarding the governance of the field. With a pragmatic and principled governance approach, Canada can continue its global leadership in this field, as well as advance the long-term health and well-being of Canadians.

Lost in translation? Accountability and governance of clinical stem cell research in China.

Despite China's regulatory initiatives to promote its research accountability, it still needs to prove itself as a trusted player in life science research. In addition, in contrast to its huge investment, China is losing the race in delivering quality application of stem cells. The trial implementation of the 2015 ministerial regulations seemed to offer hope in ending this dual 'lost-in-translation'. Yet skepticism remains. By examining China's regulatory trajectory in the last 15 years, this paper illustrates that it is a post hoc pragmatic policy rationale and a soft centralization regulatory approach that have hampered China's governance. To improve China's governance of accountability, policy-makers need to get beyond an 'act-in-response' regulatory ethos and to engage with diverse stakeholders.

Accelerating regenerative medicine: the Japanese experiment in ethics and regulation.

In 2014, the Japanese National Diet introduced new laws aimed at promoting the clinical translation of stem cells and regenerative medicine. The basic action of these laws is to allow the early introduction of regenerative medicine products into the Japanese market through an accelerated approval process, while providing patients with access to certain types of stem cell and cell-based therapies in the context of private clinical practice. While this framework appears to offer enormous opportunities for the translation of stem cell science, it raises ethical challenges that have not yet been fully explored. This paper critically analyzes this framework with respect to the prioritization of safety over clinical benefit, distributive justice and public trust in science and medicine. It is argued that the framework unfairly burdens patients and strained healthcare systems without any clear benefits, and may undermine the credibility of the regenerative medicine field as it emerges.

Stem cells in court: historical trends in US legal cases related to stem cells.

Using two legal research platforms, we identified 193 stem-cell-related legal cases that were decided in US courts. Classifying the cases by category, we examined historical trends in the types of legal cases related to stem cells. Major types of cases involved plaintiffs seeking to overturn denial of health insurance coverage decisions, disputes related to intellectual property, false advertising, breaches of contract, exposure to hazardous agents, regulatory decisions, stem cell procedures and professional standard of care, use of stems cells in research, and public funding of embryonic stem cell research. Analysis of court decisions provides insight into contemporary and historical legal issues related to stem cells and reveals the breadth of stem-cell-related cases now being decided by US courts.

Embryonic Stem Cell Research: A Policy Analysis.

Many health care issues generate minimal passion, promoting benign commentary and support from the various stakeholders involved. Stem cell research does not fall into this category, and on the contrary, embryonic stem cell (ESC) research has continued to foster controversy and emotion. Since 1998, which marked the first successful laboratory isolation of ESCs, this research continues to ignite moral, ethical, and legal debate over its efficacy. The focus of this policy analysis is to introduce the issues, examine and address the various perspectives that surround ESC research, and present policy options and/or solutions that may be used to successfully create a policy consensus regarding this much debated topic.

Stem cell research in Latin America: update, challenges and opportunities in a priority research area.

Stem cell research is attracting wide attention as a promising and fast-growing field in Latin America, as it is worldwide. Many countries in the region have defined Regenerative Medicine as a research priority and a focus of investment. This field generates not only opportunities but also regulatory, technical and operative challenges. In this review, scientists from Uruguay, Mexico, Chile, Brazil and Argentina provide their view on stem cell research in each of their countries. Despite country-specific characteristics, all countries share several issues such as regulatory challenges. Key initiatives of each country to promote stem cell research are also discussed. As a conclusion, it is clear that regional integration should be more emphasized and international collaboration, promoted.

[Cloning and law in Hungary]. / Klónozás és jog Magyarországon.

Reproductive human cloning is prohibited in Hungary, as in many other countries. Therapeutic human cloning is not prohibited, just like in many other countries. Stem cell therapy is also allowed. Article III, paragraph (3) of the Hungarian basic law (constitution) strictly forbids total human cloning. Article 1 of the Additional Protocol to the Oviedo Convention, on the Prohibition of Cloning Human Beings (1998) stipulates that any intervention seeking to create a human being genetically identical to another human being, whether living or dead, is prohibited. In Hungary, according to Article 174 of the Criminal Code, total human cloning constitutes a crime. Article 180, paragraph (3) of the Hungarian Act on Health declares that embryos shall not be brought about for research purposes; research shall be conducted only on embryos brought about for reproductive purposes when this is authorized by the persons entitled to decide upon its disposal, or when the embryo is damaged. Article 180, paragraph (5) of the Hungarian Act on Health stipulates that multiple individuals who genetically conform to one another shall not be brought about. According to Article 181, paragraph (1) of the Hungarian Act on Health, an embryo used for research shall be kept alive for not longer than 14 days, not counting the time it was frozen for storage and the time period of research.

Assessing state stem cell programs in the United States: how has state funding affected publication trends?

Several states responded to federal funding limitations placed on human embryonic stem cell research and the potential of the field by creating state stem cell funding programs, yet little is known about the impact of these programs. Here we examine how state programs have affected publication trends in four states.

Better safe than sorry: ethics review in European Union-funded health research.

Public scrutiny and the increasing number of projects addressing later stages of the research and innovation process announced the need for an enhanced attention to be paid to identify and address ethics concerns. Ex-ante ethics review as implemented in EU-funded health research and a proactive ethics management are a genuinely useful exercise and ensures top-quality research, from the lab to the patient.

International regulatory landscape and integration of corrective genome editing into in vitro fertilization.

Genome editing technology, including zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs), and clustered regularly interspaced short palindromic repeat (CRISPR)/Cas, has enabled far more efficient genetic engineering even in non-human primates. This biotechnology is more likely to develop into medicine for preventing a genetic disease if corrective genome editing is integrated into assisted reproductive technology, represented by in vitro fertilization. Although rapid advances in genome editing are expected to make germline gene correction feasible in a clinical setting, there are many issues that still need to be addressed before this could occur. We herein examine current status of genome editing in mammalian embryonic stem cells and zygotes and discuss potential issues in the international regulatory landscape regarding human germline gene modification. Moreover, we address some ethical and social issues that would be raised when each country considers whether genome editing-mediated germline gene correction for preventive medicine should be permitted.

Políticas internacionais em ciência e saúde: a pesquisa celular e a medicina regenerativa / International policies in science and health: cellular research and regenerative medicine

O desenvolvimento de medicamentos e terapias baseados nos princípios científicos das biociências e das biotecnologias da saúde - com base em células vivas e difíceis de serem estandardizadas - tem sido um tema de amplos debates públicos em nível global. A área tem sido recentemente demarcada como medicina regenerativa, que inclui as pesquisas e terapias com células-tronco (PCT e TC), foco deste estudo. No presente artigo, apresentam-se os principais eventos históricos na área de pesquisa celular, descreve-se o estágio atual na evolução da medicina regenerativa e as características das principais políticas desenvolvidas, em especial pelos países de liderança global, e em relação à regulamentação dos direitos de propriedade intelectual. Desenvolve-se análise quantitativa e qualitativa com dados secundários coletados em nível internacional, revisão bibliográfica e de informações em arquivos das instituições de regulamentação globais, resenhas jornalísticas atualizadas, assim como de artigos especializados publicados em revistas internacionais. A revisão da informação é guiada pelas seguintes perguntas: quais são as trajetórias principais de inovação em ciência e saúde nessa área? Quais fatores incidem principalmente na sua evolução? Conclui-se com reflexões específicas sobre os impactos dos desenvolvimentos associados na Saúde Coletiva...

Medicine and therapy developments based upon scientific principles of biosciences and health biotechnologies - with the use of live cells which are difficult to standardize - have been subject of wide public debates at the global level. The area has been recently defined as one of regenerative medicine that includes stem cell research and therapy, the focus of our study. This paper presents the main historical research events in cellular research, describes regenerative medicine's present stage of evolution and the characteristics of the main public policies developed, most especially in the leading countries and in relation to the regulation of intellectual property rights. A quantitative and qualitative analysis is developed, drawing upon different sets of secondary data collected internationally, bibliographic and archival information from global regulatory institutions, updated journal reviews as well as of specialized articles published in international journals. This information is reviewed guided by the following questions: which are the main trajectories in health innovation in this area? Which factors have most highly influenced its evolution? The paper concludes with reflections on the specific impacts of associated developments on collective health...