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

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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

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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

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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

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Reid Adler

Founder and Principal, Practical Innovation Strategy

reid@practicalinnovationstrategy.com

+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