CONGRESS REPORT Who should own biomedical innovations? Report on the international workshop “Biomedical Innovations and Intellectual Property” Marco Annoni*, Giuseppe Schiavone, Luca Chiapperino§
The recent international workshop held in Lucca, 28 September 2011, “Biomedical Innovations and Intellectual Property” questioned the actual role of the concept of ownership with respect to biomedical and biotechnological innovations. The event, under the patronage of BIOM (Italian Society for History, Philosophy and Social Studies), took place within the context of the Viareggio Health Festival (4th edition). The conference brought together political and institutional authorities and people from diverse disciplines such as bioethics, sociology and experimental medicine. Prof. Giovanni Boniolo, Faculty of Medicine of the University of Milan, and coordinator of the PhD program in Foundations and Ethics of the Life Sciences at the IFOMIEO Campus and SEMM, gave the opening address. Maura Cavallaro, councilor for the Environment in the Province of Lucca and Michela Maielli, head of the local hospital centers, underlined the political relevance of the topic with respect to current public health concerns. Chaired by Prof. Federico Neresini, Sociology Department of the University of Padua and president of Observa, the first part of the workshop hosted the contributions of Prof. John Harris, co-director of the Centre for Innovation, Science and Society at the School of Law of Manchester, Giovanni Boniolo, Catherine Rhodes from the School of Law of the University of Manchester and Giuseppe Testa, principal investigator of a research group in “Epigenetics and Stem Cells”
at the Department of Experimental Oncology, IEO, Milan. On the one hand, Harris’ and Boniolo’s contributions highlighted the importance of economic incentives in fostering research and the development of new biomedical technologies. On the other hand, Catherine Rhodes and Giuseppe Testa pointed to the shortcomings of the traditional categories of intellectual property when confronted with recent biomedical advances. Harris presented a paper, co-authored by Nobel laureate John Sulston, in which he claimed that the acritical endorsement of a precautionary principle is hardly compatible with the promotion of scientific curiosity, as a value. According to Harris, concerns for risks linked to research and development do not provide a reasonable ground to sustain the progressive momentum of science. In fact, limiting economic and non-economic incentives for biomedical research would be a self-defeating strategy with regard to scientific innovation, in that barriers to biotechnological progress would mean giving up the societal benefits that the progress itself would bring. Harris also underlined how those innovations that prima facie might seem to cause social inequalities could turn out in fact to progressively improve the distribution of therapeutic applications. From a different point of view, Prof. Giovanni Boniolo, put forward a pragmatic argument in defense of scientific innovation. Boniolo showed that any definition of the common good grounded on metaphysical assumptions is inconsistent. He then pointed to the inescapable role of a financially affluent environment for the growth of scientific innovation and basic research. Prof. Catherine Rhodes focused her talk on the limits of intellectual property in fostering academic research. Given the essential role played by academic institutions, Rhodes argued, the best model would be one built around three essential coordinates, namely ‘education’, ‘knowledge gaining’ and ‘global access to the results of research’.
*Corresponding author § All authors contributed equally and are presented in alphabetical order. Email addresses: MA:
[email protected] GS:
[email protected] LC:
[email protected] PhD students in ‘Foundations and Ethics of the Life Sciences’, SEMM (European School of Molecular Medicine), Faculty of Medicine and Surgery, University of Milan, IFOM-IEO Campus (FIRC Institute of Molecular Oncology and European Institute of Oncology), Milan, Italy
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Congress report
According to the empirical data presented by the speaker, the revenues and incentives deriving from patenting and intellectual property play just a minor role in promoting basic research, both at the public and the academic level. Combining the perspective of a scientist with expertise in the field of Science & Technology Studies, Dr. Giuseppe Testa emphasized how a sociological analysis of recent scientific advances provides a way to rethink the traditional paradigm of intellectual property. Today’s technologies forge new biomedical platforms, such as those of Navigenics and 23andWe, which are increasingly dependent on a direct participation of society in the scientific endeavor. This phenomenon, in turn, is reshaping the way in which the profits and burdens are and will be distributed in society. Furthermore, Testa underscored how the conflation between commercial interests in personalized genomics and the need to fuel scientific research is replacing the old and monolithic ideal of intellectual property. This process is already leading to the emergence of new forms of socially distributed and “diluted” ownership. The second part of the workshop continued with the presentations of Daniela Bellomo, General Director of TTFactor, Giulio Draetta, Vice-director of Dana-Farber’s Belfer Institute for Applied Cancer Science in Boston, Prof. Federico Neresini, and Prof. Nils Hoppe of the Centre for Ethics and Law in the Life Sciences, Leibniz University of Hannover. Using oncology as a case in point, Giulio Draetta underlined how difficult it is for scientific knowledge to acquire the status of a viable clinical resource. In particular, drugs’ high attrition rate, the long period of experimentation required for market approval, and the costly investments entailed by the whole business of drug-development all point to the shortcomings of financial schemes that do not rely heavily on patenting. In his speech, Neresini contrasted two different notions of innovation. On the one hand, the one that conceptualizes innovation in terms of a linear process in which science produces knowledge and then the industry transforms it into new technological applications. According to this
notion, society can play only a passive and receptive role in the adoption of new scientific innovations. On the other hand, technological innovations must be understood as the result of a collective process of experimentation in which different stakeholders play a part. According to this latter model, the benefits and responsibilities ought to be redistributed fairly among a larger share of society. Daniela Bellomo’s contribution highlighted the importance of ‘technology transfer’ (TT) in maintaining a balance between universities’ need for economic support and the opportunity to promote investors’ trust in research. Thus, TT is a fundamental kernel for the translation of knowledge into societal benefits. Furthermore, Bellomo drew the audience’s attention to the Manchester Manifesto guidelines according to which biomedical knowledge, and the innovations that it generates, ought to be thought of as ‘common goods’. Elaborating on concrete legal cases, Nils Hoppe argued for a thorough rethinking of the conceptual frame in which issues of private property are currently being dealt with. The concept of property, as it is embodied in current legal systems, has proven deficient in solving controversies that arise concerning the commerciability of the body and of parts of it. Given what Hoppe named the ‘ungetriddable-ness’ of private property for the construction of consistent legal systems, the speaker urged a reconceptualization of the categories that are currently deployed in laws. The opening of biomedical research to a widespread community must entail a reasonable extension of property rights concerning bodily materials, which will in turn result in more inclusive processes of scientific innovation. In conclusion, this workshop made explicit the need for a redefinition of the conceptual framework that regulates property rights in biomedical innovations. Highlighting the necessity of a multidisciplinary approach capable of integrating the need for scientific development with societal participation, this event represents a first step towards the construction of a renewed understanding of the impact of biomedical innovations on our society.
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