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REGUCB Report Summary

Project ID: 657361
Funded under: H2020-EU.1.3.2.

Periodic Reporting for period 1 - REGUCB (Regulating Umbilical Cord Blood Biobanking in Europe)

Reporting period: 2015-10-01 to 2017-09-30

Summary of the context and overall objectives of the project

REGUCB is a research on how international, European and national regulations on Umbilical Cord Blood (UCB) banking influence the bioeconomy of this field of biomedicine, that is the collection, banking, research and clinical application of UCB derived stem cells. The aim of REGUCB is to understand how this bioeconomy is structured, how value is produced and what are the main societal issues related.

REGUCB aims at offering a novel approach to Science and Technology Studies (STS) of current biomedicine and its economic and societal implications. It has developed a new analytical model for analyzing the production of value in UCB economy and for considering the embeddedness of UCB banking in social relations.

REGUCB points to contribute to the general debate and policy interests into the emerging bioeconomy. Both the European Union, National States and international organizations such as the Organization for Economic Co-operation and Development (OECD) have invested in this emerging field of knowledge-based economy that aims to produce value from biological products and processes for creating new growth and welfare benefits. REGUCB, by focusing on a particular field of biomedicine aims to offer a better understanding not only of the process of value production but also of societal implications. REGUCB analyses UCB banking addressing the entanglement of value production and social relationships that links individuals, families and the general society with the related obligations, social bonds and forms of solidarity. It therefore aims to offer useful policy suggestions to improve the sector at the European level in a socially responsible way.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

From 1/10/2015 to 31/01/2016.
Analysis of biomedical literature on UCB banking, analysis of bioethical and policy documents. Literature review of STS on bioeconomy and biomedicine. Elaboration of an analytical model that analyses value production in UCB banking surpassing the dominant model employed by bioethics and biomedical literature. Our model shows that the whole UCB bioeconomy cannot be enclosed in rigid distinctions (public-private, redistributive-market economy), but it works through complex economic configurations that overlap, crisscross and hybridize economic forms and institutional arrangements.

A paper entitled A Critical Assessment of the Notion of Hybrid Practices in Tissue Baking has been presented at the International Conference “Living in a Technoscientific World” (Vienna 3-5 December 2015).

An article has been published by one of the most important journal in STS studies of biomedicine:

C. Hauskeller, L. Beltrame 2016. The hybrid bioeconomy of umbilical cord blood banking: Re-examining the narrative of opposition between public and private services. BioSocieties 11(4): 415-434
The article is gold open-access and the financial support by Marie-Curie (Horizon 2020, 657361) is acknowledged in the manuscript.

From1/2/2017 to 1/7/2016.

Analysis of national regulations in UCB banking and the role of national authorities. Analysis of the role of international organizations and of their standards in UCB banking, processing and release. Analysis of private banking materials. Theoretical work on political economy, economic sociology and on sociology of social relations.

A paper entitled Rethinking the Embeddedness of Cord Blood Economy has been presented at the conference “Global Societies: Fragmenting and Connecting, British Sociological Association Annual Conference” (Birmingham 6-8 April 2016).

An article has been published by one of the major journal in STS studies of biomedicine:

C. Hauskeller and L. Beltrame 2016. Hybrid Practices in Cord Blood Banking. Rethinking the Commodification of Human Tissues in the Bioeconomy. New Genetics and Society 35(3), pp. 228-245.
Financial support by Marie-Curie (Horizon 2020, 657361) is acknowledged in the manuscript.

From 1/8/2016 to 1/1/2017.
Starting of the fieldwork with interviews with UCB bank practitioners in Italy and the UK.

We have also organized a panel track entitled Biobanks. The interdependence between forms of biovalue creation and donor participation at the main international conference in STS “Science and Technology by other Means, 4S/EASST Joint conference” (Barcelona, August 31-September 3 2016).

A paper entitled Rethinking the Social Embeddedness of Cord Blood Banking has been presented at the conference “Science and Technology by other Means, 4S/EASST Joint conference” (Barcelona, August 31-September 3, 2016).

A book chapter entitled The Bioeconomies of Stem Cell Research has been written for being published in an edited book entitled The Matrix of Stem Cell Research Revisited that will be published by Rutledge in 2018.

We have also submitted a proposal for a Special Issue entitled Biobanks. The entanglement of forms of participation, identities and biovalues in emerging biobanking configurations to Tecnoscienza. The Italian Journal of Science and Technology Studies. The proposal has been accepted and we will edit the Special Issue that will be published in 2018.

From 1/1/2017 to 28/2/2017.
REGUCB has been prematurely closed since the researcher has obtained a position with a tenure track option in an Italian university. In this period the fieldwork will continue and the researcher will finalise three papers prepared during the project that will be submitted to international journals.

A paper entitled Opportunities and Problems in Hybrid UCB Banking Organisation, summarizing the results of REGUCB project will be presented at the international conference Cord Blood World Europe 2017 (London May 17-18 2017).

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

REGUCB has developed an analytical model of UCB bioeconomy that challenge the dominant model with which the UCB bioeconomy is interpreted by bioethics and biomedical literature. Instead of conceiving a rigid opposition between the public sector and the private one, coupled with the distinction between redistributive and market economy, this model analyses the complex economic configurations that overlap, crisscross and hybridise economic forms and institutional arrangements. This model, moreover, challenges also a diffused view in STS studies on the bioeconomy which seen in the commodification of biological materials the main form of value production. It considers, instead, different processes of value production that are in place at the same time both in the public sector and in the private one.

REGUCB has also analyzed the issue of embeddedness in social relations of UCB banking, and has applied this analytical model to issue of donor recruitment and participation in UCB banking. It thus will provide a novel way of studying the constitution of social relationships in the participation of citizens in the bioeconomy. By confronting the main ways of organizing UCB collection in Italy and the UK, REGUCB could also offer useful insights for optimizing the collection of UCB units for transplantations.

Finally, the analysis of the complex relationships between the public sector and the private one, suggests that an important vector for the development of the bioeconomy of regenerative medicine lies in stronger cooperation between the two sectors not in UCB banking but in the research on UCB derived stem cells.

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