Property, Privacy, Intellectual Property, and the Role of Technology

 

INTERNATIONAL CONFERENCE

 

TRENTO

 

FACULTY OF LAW

 

7/8 MAY 2010

 

Official site of the conference (click here)

 

 Download Brochure

 

 

Comparative Issues in the

 

Governance of Research Biobanks:

 

 Property, Privacy, Intellectual Property, and the Role of Technology

 

 

INTERNATIONAL CONFERENCE

 

 

TRENTO

 

FACULTY OF LAW

 

7/8 MAY 2010

 

 

Research biobanks today are proliferating in big research centers and secondary hospitals serving peripheral areas. Alongside this development, huge population biobanks ‐ where biological materials of entire communities are gathered, catalogued and studied ‐ are being established in a growing number of countries all over the world. Private companies offering biobanking services are emerging as flourishing new businesses.

 

Just recently, the Report on a “National Cancer Plan 2010/2012” issued by the Italian Ministry of Health in January 2010, stresses the role that a network of Italian biobanks will play in developing a national strategy for cancer research.

 

The biobanking boom of recent years has prompted a lively debate on a host of interrelated legal issues: 1) the Gordian knot of the ownership of biological materials; 2) the privacy concerns raised by the difficulty of accepting that biological samples must be completely anonymous without incurring the practical impossibility of exploiting their information potential, since biological and genetic data retain such potential only if they can be traced to the evolving clinical history of the original donor; 3) the delicate role and the changing content of the donor’s "informed consent", as the main legal tool which may serve to link the privacy and property interests of the donor with the research interests and the set of principles that should inform the functioning of the biobank; 4) the IP issues and the patentability of biological samples and the protection of databases storing genetic information obtained from the samples. Responding to these problems will be crucial for identifying the distribution of the benefits that can be obtained by exploiting the scientific research carried out on the biological samples stored in biobanks.

 

The conference “Comparative Issues in the Governance of Research Biobanks: Property, Privacy, Intellectual Property and the Role of Technology” is aimed at exploring, from a comparative viewpoint, the extent to which digital technology may assist in tackling the many regulatory issues raised by the practice of biobanking for research purposes, issues which may be considered and analyzed under the traditional paradigms of Property, Privacy, Informed Consent and Intellectual Property (Patents).

 

These different theoretical legal facets of biobanking activity are strictly interconnected and must be analyzed taking such interconnection into consideration. A holistic consideration of the issues involved in research biobanking appears to be the only way in which an optimal regulatory governance of biobanking activity can be successfully pursued. This perspective highlights the importance of digital technology as the element capable of providing the infrastructure that may help to coordinate the different interests involved in biobanking activity, at the same time (1) enabling the infrastructure in itself to implement the regulatory standards and (2) providing an environment where the self determination of the donors can find its real expression without incurring transaction costs which may be impossible to sustain.

 

 

 

PROGRAM

 

 

Friday ‐ May 7, 2010

 

 

8.30 Registration

 

8.50 Welcome greetings

 

Davide Bassi ‐ Rector of the University of Trento

 

Gianni Santucci ‐ Director of the Department of Juridical Sciences

 

Giuseppe Bernardi – President “Fondazione prof. Alessio Pezcoller ‐ Trento

 

 

 

9.15‐10.00

Opening Session: Introducing the Issues

 

 

Giovanni Pascuzzi, University of Trento, "A Law & Technology Approach to the Law of Biobanking"

 

Umberto Izzo, University of Trento, “The Role of Technology in Answering to the Regulatory Needs of Research Biobanking: General Remarks and Interests at Stake”

 

Mattia Barbareschi, Trentino Biobank – APSS Trento, “The Reality of Biobanking Regulation from a Biobanker’s Perspective: Scientific and Managerial Premises and Unresolved Issues”

 

 

 

First Session: Property, Privacy & Informed Consent

Chairman: Roberto Pardolesi, Luiss University, Rome

 

 

First sub session (10.00‐11.15)

 

Gideon Parchomovsky, Bar Ilan University Tel Aviv, University of Pennsylvania, “Properties of Biobanks”

 

Stephen Munzer, UCLA School of Law, “Privacy and Ownership: Research Biobanks Meet Synthetic Biology”

 

Roger Brownsword, King’s College – London, “Regulating Biobanks: Another Triple Bottom Line”

 

 

 

11.15 – 11.30 Coffee Break

 

 

 

Second sub session (11.30‐12.45)

 

Jane Kaye, University of Oxford, “Protecting Privacy in the World of Global Biobanking”

 

Eric Feldman, University of Pennsylvania, “The Genetic Information Nondiscrimination Act: A Solution in Search of a Problem?”

 

Claudio Filippi, Vice Secretary of the Italian Data Protection Authority, “Personal Health Data and Research Biobanking: The Italian Data Protection Authority View”

 

 

 

12.45 ‐14.15 Lunch

 

 

 

Third sub session (14.15‐16.30)

 

Mariachiara Tallacchini, Cattolica University of Piacenza, “Human Tissues in the ‘Public Space’: Beyond the Property/Privacy Dichotomy”

 

Amedeo Santosuosso, University of Pavia, “Should Privacy Be Abolished in Biobanking?”

 

Andrea Rossato, University of Trento, “Digital Architectures and the Regulation of Research Biobanks”

 

Paolo Guarda, University of Trento, "Biobanks as Electronic Gatekeepers of Personal Health Data: Open Issues"

 

Matteo Macilotti, University of Trento, "Reshaping Informed Consent in the Biobank Context”

 

Question time for all the subsessions and preliminary conclusions

 

 

 

16.30‐16.45 Tea break

 

 

 

Second Session: Medical and Technological Perspectives

 

 

First sub session (16.45‐18.15)

 

Chairman: Giorgio Stanta, University of Trieste

 

Giuliano D’Agnolo, Vice‐President National Committee for Biosafety – Rome / with the collaboration of Elena Bravo, Istituto Superiore di Sanità, “The Italian Prototype Networks of Research Biobanks”

 

Georges Dagher, Director for clinical research infrastructures at the French national health and medical research institute (INSERM ‐ Paris), “The Biobanking and Biomolecular Resources Research Infrastructure (BBMRI): Coordination of European Tissues Banks”

 

Manfred Dietel, Charité ‐ Universitätsmedizin Berlin, “Surgical Pathology Archives: Invaluable Historical Collections for Cancer Research”

 

Giorgio Inghirami, University of Turin, “Biospecimen Collection, Storage and Quality Assurance. Do We Need an European Standard?”

 

 

 

Dinner 20.00

 

 

 

Saturday May 8, 2010

 

 

 

Second sub session (8.00‐9.45) 

Special Panel organized with the scientific collaboration of SIAPEC (Italian Society of Anatomical Pathology and Diagnostic Cytopathology) & Istituto Superiore di Oncologia

 

Chairman: Gianluigi Taddei (University of Firenze), Paolo della Palma (APSS ‐ Trento)

 

Oscar Nappi, Cardarelli Hospital ‐ Napoli, “Biobanks and the Italian Society of Surgical Pathology”

 

Mattia Barbareschi, Trentino Biobank –APSS Trento, “Surgical Pathology: A Powerful Source of Well Annotated Human Tissues for Cancer Research”

 

Giorgio Stanta, University of Trieste, “An Italian Network of Archival Tissues Biobanks”

 

Barbara Parodi, National Institute for Cancer Research ‐ Genova, “Governance of Biobanks for Cancer Research: Proposal for a Material Transfer Agreement”

 

Discussants:

 

Enzo Galligioni, APSS ‐ Trento

 

Guido Grandi, Novartis ‐ Milano

 

Marco Pierotti, Cancer Institute ‐ Milano

 

Alessandro Quattrone, University of Trento

 

 

 

9.45‐10‐00 Coffee Break

 

 

 

10.00‐12.50

Third Session: Biobanks, Intellectual Property, and Digital Technology

Chairman: Gideon ParchomovskyGiovanni Pascuzzi

 

Roberto Caso, University of Trento, "Control over Biobanks’ Information: A Law and Technology Approach"

 

Donna Gitter, Baruch College ‐ New York City, “The Challenges of Achieving Open Source Sharing of Biobank Data”

 

Richard Gold, McGill University ‐ Montreal, “Beyond Open Source: Patents, Biobanks and Sharing”

 

Thomas Margoni, University of Western Ontario / Matteo Macilotti, University of Trento, “The Role of Material Transfer Agreements in Biobanking”

 

Mark Perry, University of Western Ontario, “Accessing Biobanks and Benefit‐Sharing”

 

 

12.15 Plenary discussion

 

 

12.40 Conclusions

 

 

12.50 End of the conference