1. Perspectives on the Sharing of Research Materials and Data Reid Adler Founder and Principal, Practical Innovation Strategy Washington, DC Presentation to: Global Health Risk Framework Workshop National Academy of Medicine August 19 -21, 2015 Hong Kong

2. 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 Workshop August 19-21, 2015 Hong Kong 2Reid Adler Practical 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 Workshop August 19-21, 2015 Hong Kong 3Reid Adler Practical 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 Workshop August 19-21, 2015 Hong Kong 4Reid Adler Practical 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 Workshop August 19-21, 2015 Hong Kong 5Reid Adler Practical 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 Workshop August 19-21, 2015 Hong Kong 6Reid Adler Practical 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 Workshop August 19-21, 2015 Hong Kong 7Reid Adler Practical Innovation Strategy

8. Reid Adler Founder and Principal, Practical Innovation Strategy reid@practicalinnovationstrategy.comeid@practicalinnovationstrategy.com +1-703-637-4445 Washington, DC Blog: www.practicallystrategic.comwww.practicallystrategic.com www.RAdlerLaw.comwww.RAdlerLaw.com (Law Office of Reid Adler) Global Health Risk Framework Workshop August 19-21, 2015 Hong Kong 8Reid Adler Practical Innovation Strategy