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.
Proprietary Challenges in Stem Cell Research 