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Perspectives on the Sharing of Research Materials and Data
Reid AdlerFounder and Principal, Practical Innovation StrategyWashington, DC
Presentation to: Global Health Risk Framework WorkshopNational Academy of MedicineAugust 19 -21, 2015Hong Kong
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The “ecosystem” for transfers of infectious materials and related data
Involves many different factors and “control” points:
• National laws on public health, safety, export and import of biologics
• International treaties
• Public health organizations, such as CDC and WHO
• Networked research institution’s own rules and procedures
• Research funders’ rules (for example, NIH and Gates Foundation)
• Original providers may seek to limit further circulation
• Co-authorship rules of journals
• Requirements for sharing (journals and funders) for replication of results
• Biological material depositories
• Interpersonal relationships, friendship and trust between researchers
• Corporate and academic expectations differ
Global Health Risk Framework WorkshopAugust 19-21, 2015 Hong Kong
Reid AdlerPractical Innovation Strategy
3
Impediments to the sharing of biological materials and data
• Governmental and regulatory controls of release of materials
• Expectation of affordable access to diagnostics and therapeutics developed through use of shared materials
• Transactional burden and inexperience with the legal provisions
• Time-consuming and arcane paperwork including MTAs and CDAs
• Cost and logistics, including staff time, of shipping the materials
• Concerns about research and business opportunity costs
• Loss of intellectual property rights or royalties for downstream commercial products like diagnostics and therapeutics
• Competition among research institutions
• Credit for isolating and characterizing viral agents (including co-authorship)
• Participation in downstream research and opportunity for related grant funding
Global Health Risk Framework WorkshopAugust 19-21, 2015 Hong Kong
Reid AdlerPractical Innovation Strategy
4
Impediments to material and data sharing, continued
• Multiple research institutions contribute research materials and data over time
• Some generate samples in the field and others sequence isolates, develop diagnostics and therapeutic candidates, vaccines, etc.
• Misperceptions and frustrations about IP, which often is actually not relevant
• Vast majority of biological materials are simply short-term research tools
• Most materials will not become commercial products
• Expectations about access to training and technology
• Specimens and materials are not well characterized and may not be processed or labeled consistently
• Probably not whether or not the material actually is already patented
• Other specific impediments to sharing that are relevant for various research or medical community members in particular countries, locations, outbreaks?
Global Health Risk Framework WorkshopAugust 19-21, 2015 Hong Kong
Reid AdlerPractical Innovation Strategy
5
Precedents and frameworks for sharing research materials and data
• NIH Grants Policy on research resources and data (1989-93)
• Developed to encourage resource sharing and avoid reach-through provisions imposed by certain providers of biological research tools
• Uniform Biological Material Transfer Agreement (early 1990s. AUTM)
• Developed to streamline exchange of materials among US academic institutions
• WHO Pandemic Influenza Preparedness (PIP) Framework (2011)
• Developed in response to challenges in sharing of H5N1 samples in 2005
• Gates Foundation AIDS research agreement (2006) and publication policies (2015)
• Developed to accelerate research and sharing of data and material
• Other instructive approaches include policies of various repositories, possibly the international convention on biodiversity
Global Health Risk Framework WorkshopAugust 19-21, 2015 Hong Kong
Reid AdlerPractical Innovation Strategy
6
Points to consider about sharing in the global preparedness context
• Ask researchers and institutions what they need to be able and willing to share data and materials – frank and open communication may be helpful
• What can we learn from recent emerging health threats where access to materials and data was not optimal (Ebola, MERS)?
• Does our experience with the PIP make replicating that system appropriate as a default model? Can that system be improved?
• Effective sharing relationships benefit from trust, which is difficult to develop in an emergency
• Trusted "rules" or "trusted agreements" may be a pragmatic alternative (preapproved)
• Include technological training as an inducement (or benefit of sharing)
• We may need a "first responder" kind of agreement agreed to in advance and used to facilitate sharing of materials and data in emergent situations
• Negotiate terms and provisions of material and data agreements in advance like the UBMTA
• Get cooperation and consent in advance from governments, research institutions, key research leaders and community leaders
Global Health Risk Framework WorkshopAugust 19-21, 2015 Hong Kong
Reid AdlerPractical Innovation Strategy
7
Points to consider about sharing, continued
• The leading "sharing" models (on a previous slide) may not map well to the complexities and realities of emergent diseases
• What is the role for “grassroots” sharing initiatives like the Global Virus Network?
• Consider multiple kinds of agreements tailored to the phases of global response to infectious disease threats
• Or to various types of institutions, taking into account their own missions and scientific or medical capabilities
• Don’t leave IP out of the equation when it’s relevant to product development
• Don’t leave IP to the preferences of each institution
• Perhaps treat IP for diagnostics differently than IP for therapeutics and vaccines?
• Training about material sharing and related agreements may be important at the researcher and research institution level
• Perhaps including patents, data sharing, MTAs, use of standard agreements and other topics like informed consent, benefit sharing, and other key topics
• If such training is important to do, who is organizing and funding this?
Global Health Risk Framework WorkshopAugust 19-21, 2015 Hong Kong
Reid AdlerPractical Innovation Strategy
8
Reid Adler
Founder and Principal, Practical Innovation Strategy
+1-703-637-4445
Washington, DC
Blog: www.practicallystrategic.com
www.RAdlerLaw.com (Law Office of Reid Adler)
Global Health Risk Framework WorkshopAugust 19-21, 2015 Hong Kong
Reid AdlerPractical Innovation Strategy