This paper argues for the importance of a broad sociological engagement with bioethics. It begins by considering why sociologists should be interested in bioethics and then goes on to explore the cognitive critique of bioethics developed by ethnographers. Some of these authors have also suggested that a more robust bioethics might emerge through the incorporation of the tools of ethnographic analysis. In this paper, it is argued that this is an important claim which needs to be analysed further and that Foucault's concept of discursive formations provides a useful framework for doing so. Once bioethics is redescribed as a discursive formation, the paper explores the challenges and obstacles that sociology and ethnography face in their attempt to open up a space for themselves in bioethics. The paper concludes by suggesting that sociologists and ethnographers need to reflect on the ways in which they might democratically secure legitimacy for their own claims in the field of social ethics.

The use of biotechnology-derived medicines has significantly increased in recent decades. Although biosimilars undergo rigorous characterization as well as clinical studies to document their safety and effectiveness, they are highly complex molecules and small changes in the purification and production process of a biosimilar can have major implications in its safety and effectiveness profile. In Latin America, regulatory authorities have begun to establish well-described and standardized pathways that permit a biosimilar to gain commercial licensure. In order to be certain that a biosimilar reaches its potential in ordinary clinical use, an intensive post-licensing monitoring system must be established since it is the only means to ascertain the true similarity between the original biologic and its biosimilar. Pharmacovigilance allows national authorities to determine a drug’s performance in the marketplace. An effective tracking and pharmacovigilance system for biological medicines has many steps and processes. To aid policy makers in Latin American in addressing the many issues surrounding the establishment of an effective pharmacovigilance system, the Americas Health Foundation convened a group of experts to discuss the topic and develop recommendations for implementation. The group discussed current challenges and gaps in pharmacovigilance in Latin America, paying close attention to the major issues associated with traceability and pharmacovigilance of biosimilars following their approval. The recommendations developed should enable countries to accurately document the safety and performance of a biosimilar as experienced by patients under real-life conditions and have a significant impact on the successful implementation of pharmacovigilance of biosimilars throughout the region.

Background The valuation of medicines as health needs vary depending on the stakeholders involved (users, prescribers, managers, etc.) and their expectations. These factors modulate the role of medicines as a health need and influence access to medicines, and could be useful to explain the rising of Judicialization of access to medicines. Aim To conduct a comparative analysis of the causes and consequences of judicialization of access to medicines in Argentina, Brazil, Colombia and Chile from the perspective of medicines as health needs. Methods A qualitative, cross-country study was carried out in these 4 countries. Semi-structured interviews were conducted with 50 representatives of the different stakeholders involved in the judicialization of access to medicines, including Executive branch, Judiciary, health system managers, patient organizations. The interviews were audio-recorded and transcribed verbatim. Thematic analysis used a framework approach based on the theoretical model for medicines as health needs. Findings Representatives from Argentina, Brazil and Colombia considered judicialization of access to medicines as a widespread phenomenon in their respective countries. Meanwhile in Chile, the respondents highlighted that most lawsuits related to the right to health were filed against private insurers because of unjustified increases in the insurance premiums. The comparative analysis showed that judicialization of access to medicines emerged in the four countries regardless of the constitutional protection or the health system population coverage. Among the causes were mentioned difficulties in guaranteeing access to covered medicines and the influence of pharmaceutical marketing on needs assessment and prescription behaviours. The interviewees highlighted the pressure to health system managers to fulfil their responsibilities as a positive impact of litigation. In contrast, the funding of medicines without evidence of efficacy or safety was considered a negative impact. Only in Brazil, judicialization has had impact on R&D policies. In Colombia, litigation also encouraged the recognition of the right to health as a fundamental right and the development of policies for controlling medicines prices. Conclusion The results suggest that applying the adopted theoretical model creates the possibility of identifying critical points to guide policy makers to improve the health systems performances and to control lawsuits for access to medicines. Electronic supplementary material The online version of this article (10.1186/s12939-019-0960-z) contains supplementary material, which is available to authorized users.

This paper argues that narrative elements from the science fiction (SF) literary genre are used in the discourse of Nanoscience and Technology (NST) to bridge the gap between what is technically possible today and its inflated promises for the future. The argument is illustrated through a detailed discussion of two NST texts. The paper concludes by arguing that the use of SF narrative techniques poses serious problems to the development of a critical analysis of the ethical and social implications of NST.

Summary:A Spanish National PBPC Donor Registry has recently been established for short-and long-term safety data collection in normal donors receiving rhG-CSF. To date, 466 donors have been included in the Registry. Median (range) dose and duration of rhG-CSF administration was 10 g/kg/day (4-20) and 5 days (4-8), respectively. Donors underwent a median of two aphereses (range, 1-5). Adverse effects consisted mainly of bone pain (90.2%), headache (16.9%) and fever (6.1%), but no donor discontinued rhG-CSF prematurely due to toxicity. Side-effects were more frequent in donors receiving Ͼ10 g/kg/day than in those with lower doses (82.8% vs 61.8%; P = 0.004). A significant decrease between baseline and post-apheresis platelet counts was the most important analytical finding (229 ؋ 10 9 /l vs 140 ؋ 10 9 /l; P Ͻ 0.0001), with a progressive reduction in platelet count with each apheresis procedure. One donor developed pneumothorax that required hospitalization due to central venous line placement. The mean CD34 ؉ cell dose collected was 6.9 ؋ 10 6 /kg (range, 1.3-36), with only 14 donors (2.9%) not achieving a minimum target of CD34 ؉ cells of 2 ؋ 10 6 /kg. No definitive information about potential long-term side effects is yet available. However, we hope this National Registry will serve as a useful basis for better monitoring of the efficiency and side-effects of cytokine administration in healthy people. Keywords: granulocyte colony-stimulating factor; normal donors; stem cell mobilization; side-effects Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is being widely used to treat neutropenia secondary to chemotherapy and to collect peripheral blood progenitor cells (PBPC) for use in autologous transplantation. [1][2][3] More recently, rhG-CSF has been given to healthy people for granulocyte collection, 4,5 and to mobilize and collect PBPC for allogeneic transplants. [6][7][8][9][10] In the allogeneic setting, the routine use of mobilized PBPC must be based not only on clinical results, but also on the safety of donors. remain important issues. Regarding this, the optimal dose and schedule of rhG-CSF for mobilization of PBPC have not been definitively established, and specific information about short-and long-term biological and clinical effects of rhG-CSF in normal donors is still limited. Thus, a prolonged follow-up of donors is clearly needed in order to rule out the development of toxicity and to ensure that administration of this cytokine to healthy individuals is completely devoid of long-term side-effects. This task will be more easily approached by the development of PBPC national or international donor registries that allow the inclusion of higher number of donors. 11,12 In Spain, a National PBPC Donor Registry has recently been developed to address potential adverse effects of the administration of rhG-CSF to normal donors for PBPC mobilization and collection. The objectives of this registry include a standardized data collection for the different centers administering rhG-CSF to normal d...

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ELSI (Ethical, Legal and Social Implications) initiatives are frequently attached to major science programmes. The expectation is that ELSI research will produce a practical advanced assessment of the impacts of technological development. Williams' overview of the field demonstrates that this encourages a mechanistic understanding of technological development leading to compressed foresight, i.e. the notion that the future is imminent in the present. The development of the ELSI domain in Canada has been characterised by an affinity between the types of knowledge valorised by the field and modes of legal reasoning, suggesting a legal variant of compressed foresight. The concept of juridification and an analysis of two related modes of legal reasoning (analogy and reflective equilibrium) shed light on the connection between legal reasoning and the ELSI field in Canada. The deployment of the aforementioned modes of legal reasoning enables law to define and operationalise difficult questions by drawing on currently existing principles and precedents. Thus, when legal modes of reasoning are brought to bear on ELSI questions, the future is made a calculable and manageable extension of the present, dovetailing with the ELSI field's requirement of pragmatic, advanced assessment.

It is argued that the legitimacy of an emergent technology, such as nanotechnology, depends on its ability to develop a narrative that mobilises and integrates a number of pre‐existing narrative scripts. In the case of nanotechnology, especially in its NBIC variant (i.e. the convergence of Nano, Bio, Information technology and the Cognitive sciences), the narrative types include science as transcendence, risk, hype, social accountability, ELSI (Ethical Legal and Social Implications) and Science Fiction. This article draws on a number science studies fields to show how components from each of these narrative types make their appearance in the discourse of nanotechnology, but also how they are ordered and stabilised around a key metaphor: practitioners of nanotechnology as master builders. This metaphor links nanotechnology to Science Fiction as a key site for the construction of alternative worlds, and also to the above‐mentioned narrative scripts. In the conclusion, some troubling implications of how nanotechnology is currently legitimated are highlighted.