International Developments:A Context for the Creation of a

Microbiology CommonsDesigning the Microbial Research Commons:

An International SymposiumNational Academy of Science

October 9, 2009

Anita EisenstadtOffice of Science and Technology Cooperation

U.S. State Department

• Two Key Principles for Engagement in International Science and Technology Cooperation

• Challenges Associated with Biological Data• Former and Current Work at the OECD

Pertinent to Establishment of a Microbial Commons

• CBD

International Science and Technology Cooperation

• Science , technology and innovation are accelerated by international cooperation

• Harness science and technology to address the grand challenges of the 21st century - Obama Innovation Strategy

• Global challenges (energy, global climate change, water, health, food security) require international science and technology cooperation

Access to Publicly Funded Research

Data• Obama Administration supports openness and

transparency in Government, including access to scientific data and information

• U.S. longstanding tradition of promoting access to data and results of publicly funded research • OMB Circular A-130• Paperwork Reduction Act

Harnessing the Power of Digital Data

• Published by NSTC Interagency Working Group on Digital Data in January 2009

• “Digital Scientific Data are National and Global Assets – The ability to achieve innovation in a competitive global information society hinges on the capability to swiftly and reliably find, understand, share, and apply complex information from widely distributed sources for discovery, progress, and productivity. Limits on information access translate into limits on all other aspects of competitiveness. Thus, digital information preservation and access capability are critical to the progress of individuals, nations, science and society.”

Biological Data Challenges

• We have unprecedented amounts of biological data • Biological materials are essential to advancements in

biotechnology, health, agriculture, environmental remediation, and sustainable biofuels

• How do we facilitate the transformation of biological data into scientific understanding and knowledge?

• How do we assure that physical data collected can be interpreted by other investigators and compared with data from different laboratories?

Biological Data Challenges (continued)

• Need a framework to compare and combine experimental data collected in different laboratories by different disciplines to gain fuller understanding of identity, structure and biological function

• Shared vocabulary, enhanced analysis methods for large databases, interoperability and compatibility issues

• Legal Implications (intellectual property, privacy, dual use issues) – more complex for sharing of human data

OECD • International organization headquartered in Paris,

founded in 1961• OECD has 30 members - US is a founding member• Brings members together to support sustainable

economic growth and maintain financial stability• Governments can compare policy experiences, identify

good practices. and coordinate national and international policies

• Committee on Science and Technology Cooperation and Working Party on Biotechnology

OECD Recommendations

• OECD Recommendation of the Council on Principles and Guidelines for Access to Research Data from Public Funding, December, 2006

• OECD Recommendation of the Council for Enhanced Access and More Effective Use of Public Sector Information – OECD Ministerial Meeting on the Future of the Internet Economy, Seoul Korea, June 17-18, 2008

Rationale for Developing Research Guidelines

• Exchange of data, knowledge and ideas is fundamental to progress.

• Internet has opened up new applications for research data. Databases are rapidly becoming an essential part of the infrastructure for the global science system. Effective access to research data is needed to take full advantage of opportunities afforded by ICTs.

• Access to research data increases the return from public investment and reinforces open scientific inquiry.

• Data is increasingly used in areas beyond the original project.

Purpose of Guidelines• Promote a culture of openness and sharing of

data among the public research communities.• Raise awareness of cost and benefits of

restricting and enhancing access to data.• Encourage governments to address access to data

issues in national policies.• Provide a commonly agreed upon framework of

operational principles.• Offer recommendations for improving

international data sharing.

Best Practice Guidelines for Biological Research Centers

• Biological resources – living organisms, cells genes and related information – are the essential raw materials for the advancement of biotechnology, human health and research, and development in the life sciences.

• OECD developed best practice guidelines for BRCs in 2007

• Definition of BRCs – Repositories and providers of high quality biological materials – essential part of the infrastructure underpinning technology

BRCs (continued)• Four sets of best practices – (1) generic quality aspects

(2) biosecurity (3) BRCs holding and supplying micro-organisms; and (4) BRCs holding and supplying human-derived materials

• State of art methodologies for preservation, replication and quality control of biological materials

• Best practices designed to provide internationally unified quality control and management, authenticity of biological materials, accuracy of data, minimum data sets, training, and facilitate exchanges, protect IP

BRCs (continued)

• Facilitate international cooperation among BRCs through informatics systems that link biological data to biological materials across BRCS and upon common technological frameworks –GBRCN

• Certification of BRCs

Knowledge Markets

• Knowledge Markets Workshop, October 2008• KMs are mechanisms in biomedical sector that

facilitate sharing of intellectual assets (e.g. data, materials, expertise, services). KMs make knowledge available, accessible, usable and sometimes tradable.

• KMs encourage knowledge sharing and creation; they may also increase the speed and efficiency with which health-related research is translated into innovative goods and services.

Knowledge Markets

• Increased communication amongst distributed, virtual and diverse knowledge resources

• ICTs enables users to flexibly interconnect these resources and to deliver research efficiencies

• OECD is developing a typology of KMs and forming a steering group to develop ideas for future work

• Part of OECD Innovation Strategy

CSTP Multilateral Scientific Cooperation Project

• New Approaches and Governance Mechanisms for Multilateral Cooperation in Science Technology and Innovation to Address Global Challenges

• Steering Group Meeting on October 21, 2009• Are existing policies and frameworks for international science

cooperation adequate to meet today’s needs and working together on global challenges?

• Two year project – analytical work on approaches and governance mechanisms, including agenda setting, legal and regulatory frameworks that affect international scientific cooperation, and channels for the transmission of research results into practical solutions for global challenges

CBD

• CBD entered into force in 1993 – 191 countries are members; US signed but had not ratified

• Three primary objectives: conservation of biological diversity; sustainable use of its components; and fair and equitable sharing of benefits from genetic resources

• 2010 is pivotal year - Agreed at WSSD in 2002 to develop international regime on access and benefits arising out of use of genetic resources, which includes animal, plant and microbial with potential impact on scientific research in biotechnology, agriculture, and other fields in October 2010,Nagoya, Japan

• Bonn Guidelines