Projects

Previous Hinxton Group Meetings:

Transnational Cooperation in Stem Cell Research

This meeting brought together an esteemed, international and interdisciplinary group to explore the ethical and policy challenges of transnational scientific collaboration raised by variations in national regulations governing embryo research and stem cell science.

The specific objectives of the project were to: 1) identify the primary challenges faced by scientists, universities, and journal editors with respect to international collaboration in stem cell research, 2) determine the extent to which it may be possible to develop guidance for conduct that could be useful across national boundaries and national legal regimes, 3) explore the role of oversight and data sharing in international research, 4) explore the question of oocyte donation and related issues, and 5) identify forward-looking strategies to foster the scientific and ethical integrity of research in a global context.

With the generous support of our funders, the international group – including scientists, clinicians, ethics & policy experts, lawyers and scientific journal editors – convened for a three-day meeting, February 22-24, 2006, at the Wellcome Trust Conference Centre, located in Hinxton, Cambridge, UK.  This meeting resulted in the drafting and dissemination of a Consensus Statement outlining a set of principled recommendations for how work in this area ought to proceed in the context of national variations in policy.

Science, Ethics and Policy Challenges of Pluripotent Stem Cell-Derived Gametes

Immediately following the 2006 meeting, Transnational Cooperation in Stem Cell Research, members of the Hinxton Group Steering Committee, in collaboration with members of the Stem Cell Policy and Ethics Program (SCOPE) at the The Johns Hopkins Berman Institute of Bioethics began developing a follow-up project exploring the Science, Ethics and Policy Challenges of Pluripotent Stem Cell-Derived Gametes.

The specific objectives of the project: 1) Create a road map for the benefit of policymakers and the public, providing best estimates of projected time horizons and relevant contextual information for likely scientific and clinical applications related to PSC-derived gametes; 2) Provide thorough, informed, forward-looking analyses of the challenges to societal regulation of the research and applications related to PSC-derived gametes (e.g., in the areas of somatic cell nuclear transfer research, assisted reproductive technology research and practice, and germ line modification); and 3) Provide guidance regarding appropriate oversight and ethically acceptable modes of pursuing this research, thereby reducing the likelihood that diversity in international response will result in obstacles to ethically and scientifically defensible research similar to those raised by existing differences in national policies governing stem cell research and nuclear transfer.

With the generous support of our funders, the international group – including scientists, clinicians, ethics & policy experts, lawyers and scientific journal editors – convened for a three-day meeting, April 9-11, 2008 at the Wellcome Trust Conference Centre, located in Hinxton, Cambridge, UK.  The immediate result of this meeting was a Statement outlining a set of principled recommendations for how work in this area ought to proceed in the context of national variations in policy.

Proprietary Challenges in Stem Cell Research: Scientific Innovation and Global Justice

Tension is increasing between fairly new and strong proprietary structures in science and norms of openness and free exchange. While structures of intellectual property and funding that are designed to spur innovation in scientific research and development (R&D) have been successful by some measures, some features of the current proprietary environment risk slowing innovation in R&D and skewing attention toward large markets, to the disadvantage of small markets, such as those for rare diseases and those in emerging economies. While these issues are pervasive in science, existing property relations within the field of stem cell research may be especially problematic with respect to both research productivity and benefit distribution. This project aims to identify, evaluate and address, through concrete and actionable recommendations, the challenges raised by proprietary practices in stem cell research in a way that promotes both scientific innovation and the public good. While similar issues have been studied before, prior approaches have inadequately recognized both the deep relationship between efforts to spur R&D in science and accounts of science as a public good, and the benefit to exploring pragmatic solutions in parallel with the philosophical questions underlying the entire endeavor. We propose a more comprehensive approach that grapples with the micro- and macro-level issues simultaneously, thus enabling the development of practical recommendations for near-term fixes that leave the door open for future transformational work to more fully align the whole system with the idea of science as a public good, making the path between the two clear, if not simple.

This Hinxton Group project will use our previously successful methodology, involving the convening of an international, interdisciplinary group of experts to explore and debate over the course of a three-day plenary meeting, augmented with an enhanced data collection and synthesis period conducted by the members of the US/UK steering committee plus a small number of additional experts. This executive committee has been tasked with gathering facts about the current state of proprietary issues in stem cell research, specifying the kinds of problems stakeholders are facing, and systematically examining the extent to which existing models can be adapted to address the challenges in stem cell research. The steering committee includes  Sarah Chan, Peter Donovan, Ruth Faden, John Harris, Robin Lovell Badge, Debra Mathews, Alan Regenberg, Julian Savulescu, and David Winickoff. The executive committee includes Bob Cook-Deegan, John Gearhart, Gregory Graff, Aurora Plomer, Krishanu Saha, Christopher Scott, John Sulston and Patrick Taylor. Following extensive information gathering and critical analysis, we have produced foundational documents that will be used as discussion tools to frame plenary and breakout meeting sessions.

Proprietary Challenges in Stem Cell Research: Data and Materials Sharing and Intellectual Property in Pluripotent Stem Cell Science in China and Japan

The current project follows an international project and final meeting held in Manchester, UK, in November 2010. The Manchester meeting resulted in a set of consensus recommendations, the Hinxton Group’s “Statement on Policies and Practices Governing Data and Materials Sharing and Intellectual Property in Stem Cell Science.” This consensus statement will serve as the springboard for the current project focused on Japan and China. We have invited key stakeholders from Japan and China in a process to evaluate and refine the Hinxton Group’s consensus recommendations for managing the challenges raised by intellectual property (IP) and data/materials sharing practices in stem cell research in a way that promotes both scientific innovation and the public good, and to identify those elements of the refined recommendations that may be actionable at the institutional, regional or national level in these countries.

Tension is increasing between fairly new and strong proprietary structures in science and norms of openness and free exchange. The distribution of knowledge and scientific resources is garnering renewed attention in part over concerns that increased commercialization and patenting in academic science could be affecting the pace of development and distribution of research data, materials and products. While current structures of IP and funding that are designed to spur innovation in scientific research and development (R&D) have been successful by some measures, some features of the current proprietary environment risk slowing innovation in R&D and skewing attention toward large markets, to the disadvantage of small markets, such as those for rare diseases and those in emerging economies. Scientific communities and policymakers alike have noted that increased sharing of data and materials could produce collective gains and create better conditions for solving complex technical hurdles, a view that is in some ways in tension with maintaining strong patent rights.

While these issues are pervasive in science generally, existing property relations within the field of stem cell research may be especially problematic with respect to both research productivity and benefit distribution. First, the tree-like shape of cell differentiation pathways lends itself to blocking positions. Second, data and materials sharing is particularly important, especially with respect to cell lines and affiliated data, including characterization data, culture conditions, and information about the human donors of the materials used to create the cell lines. Third, cell-based interventions have potential both in therapies that can be applied generally and those that are individually tailored. Finally, governments at different scales have explicitly invested in stem cell research for purposes of economic growth, problematizing the notion of science as a global public good, and creating a patchwork of regulations governing this work. This public investment is reflected in the significant percentage (44%) of stem cell-related IP held by government and academic entities, which may have less experience and expertise than their industry counterparts in effectively exploiting such portfolios.

While similar issues have been studied before, prior approaches have inadequately recognized the deep relationship between efforts to spur R&D in science and accounts of science as a public good. Furthermore, there is benefit to exploring pragmatic solutions to the problems of spurring R&D, while at the same time addressing the deeper philosophical questions underlying the entire endeavor. A more comprehensive approach that grapples with both the micro- (e.g., individual lab difficulties procuring needed cell lines) and macro-level (e.g., the philosophical orientation of national patent systems) issues simultaneously enables the development of practical recommendations for near-term fixes that leave the door open for future transformational work to more fully align the system as a whole with the idea of science as a public good, making the path between the two clear, if not simple. Furthermore, such a project is particularly timely given the current rethinking of global financial arrangements, including the advisability of state intervention in the market.

While delegates for the Manchester meeting included experts from Japan and China, the consensus statement reflects the views of the full group of approximately 45 delegates from 9 countries. The current project takes on the critical task of evaluating the applicability of the Manchester consensus statement at the local level, in individual countries.

Asia has a special role to play for a number of reasons. First, there is a huge amount of basic science being done (including the game-changing work by Shinya Yamanaka), but Asia is dramatically underrepresented in terms of IP in stem cell research. Second, the region faces unique challenges due to a less well-developed innovation infrastructure, making it generally more difficult to get new inventions to market. Finally, it is not at all clear that the moral principles governing stem cell research arrived at by a mostly Western group will be entirely transferable to Japan or China.

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