Designing the Microbial Research Commons Session 5 Overview of the Governance Considerations A Framework for Discussion Tom Dedeurwaerdere Centre for the Philosophy of Law Université catholique.
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Designing the Microbial Research Commons Session 5 Overview of the Governance Considerations A Framework for Discussion Tom Dedeurwaerdere Centre for the Philosophy of Law Université catholique de Louvain, Belgium Washington DC, 9th October 2009 Examples of the benefits of microbial commons for the public and private sector II. Emerging microbial commons in sequence data, literature and materials III. Survey on current patterns of collaboration in the microbial commons IV. Implications for the general design principles V. Applications to some core components: I. I. II. III. Ongoing Oversight and Administration High Level Institutional Coordination Managing Community Resources at the International Level VI. Concluding Comments I.Examples of the benefits of the microbial commons for public and private sector Ug99 Pathway Update 2008 Known movements are following winds Yemen – most likely source for Iran Highly likely that Ug99 went undetected in southern Iran or southern Iraq? High potential for multidirectional dispersal from Iran New variants likely to follow a similar route Similar issues with fusarium graminearum in US and Canada (Cletus Source : Amri Ahmed, 2nd microbial commons expert Kurzman) workshop, Brussels, 25th of March 2009 Wine grape contamination by certain aspergillus niger species Species of the Aspergillus section Nigri have been extensively used for various biotechnological purposes (e.g. fermentation industry to produce hydrolytic enzymes and organic acids) and are among the fungi best studied causing biodeterioration of commodities and food spoilage. Source: Nelson Lima, 1st microbial commons expert workshop, Brussels, 18th of February New species identified through collaborative research: Aspergillus carbonarius Frequency of new species in the Grapes Source: Nelson Lima, 1st microbial commons expert workshop, Brussels, 18th of February Genetic Biodiversity of the Culture of Matsoni Yoghurt in Georgia W-3202 Senaki S-3203 Mckalchoka W-3207 Kutaisi E-3210 Gori W-3206 Kutais W-3213 Kutaisi W-3217 Kvitiri W-3221Godogani W-3222Godogani W-3225 Opurchketi S-3232 Kobuleti S-3233 Kobuleti W-3235 Senaki S-3238 Gantiadi S-3240 Gantiadi W-3236 Senaki S-3242 Gantiadi S-3245Ortabatumi S-3252 Batumi E-3276 Teleti E-3263 Tabakhmela E-3265 Tabakhmela E-3266 Tabakhmela E-3270 Shindisi E-3273 Teleti E-3275 Teleti E-3271 Shigeligi E-3279 Teleti W-11A Zestaphoni W-12A Zestphoni W-1D Khashuri E-3B Tkneti C-4ABakuriani * E-5B Tsxvarichamia* E-10B Metekhi E-10C Metekhi C-4B Bakuriani * E-6A Gombori * E-13B Tbilisi E-1720 Mtsketa DSM20617T W-1B Khashuri E-3248 Pirveli Maisi E-3261 Tkneti E-3278 Teleti C-3211 Surami C-3212 Surami W-3219 Kvitiri A B1 B2 C Genetic grouping of S. thermophilus strains isolated in different geographycal regions in Georgia based on F-Rep-PCR analysis UPGMA dendrogram Source : Nino Chanisvili, 2nd microbial commons expert workshop, Brussels, 25th of March 2009 UNU/IAS database on bioprospecting in Antarctica www.bioprospector.org/bioprospector/Antarctica/home.action Pharmaceuticals/medical technologies Food/beverage industries 5% 2% 24% Cosmetics/personal care 15% 0% Molecular biology/biotech Chemical processing 17% Environmental remediation Industrial applications 17% 15% 5% Aquaculture/agriculture Nutraceuticals Users of Antarctic genetic ressources Source: United Nations University & Belgian Federal Public service Health, Food chain safety and Environment, as contribution to the discussions on bioprospecting within the Antarctic Treaty Consultative Meeting (presented by Annick Wilmotte, 2nd microbial commons expert workshop, Brussels, 25th of March 2009 2. Emerging microbial commons for biological research materials and digital research infrastructures A brief terminology question: microbial commons “resource shared by a group of people. In a commons, the resource can be small and serve a tiny group, it can be community-level, or it can extend to international and global levels” (ref. Understanding Knowledge as a Commons, Charlotte Hess and Elinor Ostrom (editors), MIT Press, 2007) So includes both semi-commons (partially restricted) fully open commons (totally open) Emerging commons in microbial genetic materials • Commercializing pressures: some collections adopt private sector models and move towards restrictive licence conditions: •Use in host laboratory only •No redistribution without permission •Limits on derivatives • On the other hand emerging commons models : • Contractually reconstructed public domain • • • • • • Culture collections : legitimate exchange in the European Culture Collection Organization, BIOTEC Thailand, etc. Related ex situ collections : Biobricks, algOS, … (Minna Allarkhaia) Pool (semicommons, typically EU projects, NSF projects) Clearing house model (Science Commons model for the neurocommons) (Thin Nguyen) Public domain (ocean, antartica) Emerging open knowledge environments Service nodes: Webservices: Straininfo Bioportal (Peter Dawyndt) Standardisation/ontologies : Genomic Standards Consortium (Dawn Field) Digitally integrated thematic knowledge environments Science Commons neurocommons project (for Huntington disease) Interdisciplinary and multi-scale bio-imaging at UCSD National Center for Microscopy and Imaging Research (NCMIR) (Mark Ellisman) Genomic Encyclopedia of Bactria and Archaea (GIBA); with type stains from DSMZ (filling in philogenetic gaps) (Nikos Kyrpides) Design principles for governance Problem : need of moving from a disjointed set of bottum-up initiatives towards an integrated distributed infrastructure Research question : how to create the best possible fit between the governance structures of scientific infrastructures and the normative practices and needs of microbial research commons ? Problems of « crowding out » of productive norms and practices by inadequate institutionalisation (cf. for example studies on paying for blood donation) 3. Survey on current patterns of collaboration in the microbial commons Deposit patterns in 11 major culture collections in developing and developed countries cc1 cc2 cc3 cc4 cc5 cc6 cc7 cc8 Total numbers of strains in the collection: N/A N/A N/A Estimation of percentage of total strains deposited before 1993? accessions 05 51 N/A 90 N/A 436 886 55 2812 104 %without restrictions 98 N/A 100 %with res, non-commercial 2 N/A 0 %other-restrictions 0 N/A 0 Depositors * N/A N/A approx.N/A 200020000 % 65 45 98 others % 35 55 2 foreing countries 18 14 1 35 40 86 79 0 540 2500 50 40 50 90 50 32 272 150 736 0 108 100 0 100 98 100 N/A 0 2 0 N/A 0 0 0 14 21 0 0 N/A 0 0 0 * national cc10 cc11 cc9 * * 86 70 100 99 N/A 57 nr 100 0 1 N/A 43 nr 0 8 0 1 N/A 23 nr 0 14 30 3 Country of origin national % 26 10 98 98 60 53 99 N/A N/A nr 41 other countries % 74 90 2 2 40 47 1 N/A N/A nr 59 foreing countries 43 42 1 3 16 8 1 N/A N/A nr 19 uknown 35 1 0 0 0 N/A N/A nr 19 Collaboration patterns between culture collections Total number of new accessions in 2005 in the 119 WFCC culture collections : approximately 10.000 Academic and hospital research collections Own collecting effort From other WFCC culture collections Total number of strains delivered in 2005 by the 119 WFCC culture collections : approximately 120.000 30% 23% 45% Survey amongst 119 WFCC culture collections 20% None of these categories (for example dying industry collections) 58% To academia research collections To private sector 10% To other WFCC culture collections 5% 9% None of these categories (to hospitals and for teaching mainly) Open Access to published literature Principal findings from research on journals in microbiology and related life sciences (Reichman et al. ) About 30% full open access (OA), including hybrid (both purchased immediate OA and subscription); 20% read-only; 50% subscription. 80% of subscription journals allow author self-archiving on personal websites, but almost 90% do not allow archiving on the author’s institutional websites and most are silent on external repository deposits (e.g., on PubMedCentral). 98% of subscription journals require transfer of copyright. About 75% of all journals surveyed are published by for-profit publishers. Source : Paul Uhlir, Microbial Commons Workshop, NAS, 8th of October 4. Implications for the general design principles General principles Science community driven governance framework Most decisions on governance (quality management, prior informed consent, etc.) imply a deep knowledge of the technical specificities of the field Especially in thematic knowledge environments, the conservation decisions for materials and digital knowledge management decisions depend on a scientific appraisal of the scientific relevancy of the materials/digital content Principle of multilevel governance/subsidiarity Heterogeneity of materials and research fields represented in the culture collections (fungi, yeast, bacteria, vectors for genetic engineering, etc.). The governance mechanisms have to be adapted to the specific needs. Some ex-situ collections produce international public goods and some produce national public goods (national general purpose collections). However, the vast majority of collections produce regional/transregional public goods (research materials as inputs for specialized knowledge communities organized in regional/transregional networks) Principle of specialization and cooperation Today 557 WFCC Collections hold over 1,5 million strains (1,526,805 ; WDCM database, accessed 9 october, but data largely outdated) ; even the largest collections such as ATCC (72000) and NRRL (87000) hold only a small portion of the total strain holdings of the WFCC members Moreover, each of these collections contains an important set of unique strain holdings (on average 40% of unique strains for the major collections) Many more strains are even conserved outside the culture collections that are member of WFCC (cf. example of Canada infra) Consequences for the governance framework The overarching principle will be one of subsidiarity: The main governance issues (such as quality controls, enforcement, administration) should be dealt with at the level of the open knowledge environments and regional networks of culture collections Supported by appropriate incentives: through a combination of private ordering (rules of conditional reciprocity in sharing arrangements) and mandatory public policy (NIH open access mandate, cf. Jerry Sheehan) Some coordination problems might be better solved at a higher institutional level (eScience advisory board (Paul David), repository of governance strategies (Minna Allarkhaia), standards, etc.) At the international level, representation of the microbial science community (discussion on access to knowledge in WIPO, discussion on access to materials in CBD) V. Applications to some core components A. Ongoing Oversight and Administration B. High Level Institutional Coordination C. Managing Community Resources at the International Level A. Ongoing Oversight and Administration in a decentralized framework A.1. Quality Controls for the Material and Digital Research Infrastructure Steps of quality control (authenticity, viability and purity) At the entry : authentication control / certification (Edward Moore, presentation 2009-03-26 Brussels) Based on tests with various methods, mainly : morphological (phenotyping), fatty acid profiling (chemotyping) and 16S rRNA sequence analysis (genotyping) For example, at the Culture Collection University of Gothenburg, approximately 10 % of requests for deposits are not what they are said to be !! Importance of persistant and unique identifiers for the digital infrastructure Key tool : unique strain number = Accession number for the strain, the unique identifier for one isolate at the collection + its synonyms (accession numbers of copies (clones) of the isolate in other collections) Role of unique identifiers The unique strain number stays the same, while the knowledge of taxonomy is evolving and sub-species diversity is evolving TAXONOMIC DEVELOPMENT IN THE “BACILLUS SUBTILIS GROUP” before ‘73 Gordon et al. ‘73 Appr. Lists ‘80 up to 2003 ‘87 ‘89 ‘94 '95 '96 ‘99 ‘01 B. subtilis subsp. subtilis B. subtilis subsp. spizizenii B. vallismortis (B. clausii) B. mojavensis B. atrophaeus B. amyloliquefaciens ~ 30 named species B. subtilis B. subtilis ~ 10 named species B. licheniformis B. licheniformis ~ 20 named species B. pumilus B. pumilus ~ 2 named species B. firmus B. firmus B. firmus B. lentus B. lentus B. licheniformis B. sonorensis B. pumilus B. sporothermodurans Source : Dagmar Fritze, FAO Workshop, Brussels, 25.-26.03.09 Strain number disambiguation through Globally Unique Identifiers original isolate end user GUID: Ford 13 W.W. Ford (13) GUID: Gibson 971 T. Gibson (971) first BRC deposit GUID: NCIMB 9373 NCIMB 9373 GUID: NCTC 2599 NCTC 2599 GUID: NRRL B-3711 NRRL B-3711 Accession form GUID: new isolate GUID: ATCC 14579 isolate entities Accession form ATCC 14579 culture entities Accession form Accession form end user end user Source : adapted from Peter Dawyndt, 15th September 2006 and MOSAICS report Other quality requirements related to building and digital integration of the microbial commons Availability of all documents in full text searchable format (Samuel Kaplan) On line catalogue of the holdings Minimal information set defined by the participating collections Common ontologies, common data formats A.2. Funding Source : authors’ calculations based on Scott Stern, Biological Resource Centres, 2004 Illustration based on the case of the culture collections in Canada • General data – – 140 collections, of which 23 recognized of strategic importance (1986 survey), 19 of these are WFCC members in 2009 (17 in the survey Sigler 2004) In 2009 (WDCM data), total number of strains in the 19 WFCC collections : 69363 Data from the 17 major collections (survey in Sigler 2004) Number of collections Total number of strains Vulnarable at retirement of curator Acquired other threatened collections Government 5 15525 2 1 (acquired 5) Grant to university 9 29440 3 1 (acquired 3) Private non-profit 1 2300 Industry 2 2675 Reference : Lynne Sigler, Canadian Journal of Plant Pathology, 2004 ; and author’s calculations based on information from WDCM database • Government supported (5) – – – Mainly Public Health Agency of Canada, Canadian Forest Service and Agriculture and Agri-food Canada Permanent endowment, but with the provison that some revenue could be obtained from fees for services On average 1 full-time equivalent curator/collection • Grants to university (9) – – – – University-based collections recognized as being « essential for science and cultural research and for training future generations of researchers » 3 year grants to universities through the Research Council of Canada (NSERC) through a competitive evaluation On average 1 full-time equivalent curator/collection However : existence of the collections partially threatened at each renewal (especially for specialized staff) • Private non-profit (1) – Funded by 3000 forest industry companies (members of the research institute), canada forest service and canadean provinces – Funding insufficient • Industry (2) – Mainly industrial strains for baker’s yeast and brewery’s, but also developping probiotics, environmental, etc. Lessons for sustainable funding of culture collections The vast majority of materials are distributed to public sector recipients (77% according to a survy of 119 collections), for research and training purposes. This is reflected in the fact that more than 80% of the culture colletions that are member of the WFCC belong to public sector entities Funding is often on a competitive basis, especially in the cases of universities. However, because of the very specific expertise required to curate microbials in a particular field of research, this is not appropriate for the funding of the core staff, which should be on a more permanent basis Lessons for sustainable funding of the digital infrastructure Funding for the digital infrastructure in the thematic knowledge environment could be part of the grants structure to the individual culture collections, when succesful can attract new grants The generic webservices provide a service to all culture collections and could be constructed as a national digital infrastructure resource / or through international collaboration A.3. Enforcement of Contracts Use of contracts to foster sharing for non- commercial research European Culture Collections Standard Material Transfer Agreement Legitimate Exchange Clause in some collections : the AllRussian Collection, the Biotec collection in Thailand The FAO Standard Material Transfer Agreement (of the International Treaty) Enforcement through private ordering (cf. Peter Lee) Through peer pressure Through conditional reciprocity Enforcement challenges in the compensatory liability rule Common quality management Tracking of transfer of materials within the research commons (transactions for non-commercial use) Use of formal transfer agreements at each transaction Keeping track of the transaction history in the catalogue Tracking of transfer of materials to commercial clients Currently, under conditions of secrecy Enforcement of the open access license conditions for the digital content in the Open Knowledge Environment No major enforcement problem Mainly a normative and reputational issue (motivating scientists to publish their content in the open access environment, to use theses licenses from the beginning) B. High Level Institutional Coordination B.1. Standard Setting Two examples for the need of higher level institutional coordination Standards for unique strain numbers Currently system based on WDCM accronyms, but potential errors upon multiple handling (and renaming) of copies of the same material The service nodes could play a role in managing the Universal GlobalID system The Science Unions (IUMS) and the Federation (WFCC) could play a role in working out agreements with publishers on the use of the unique numbers in publications Minimal information disclosure requirements Distributed database infrastructure with minimal information disclosure requirements : publication, course country, etc. (cf. CABRI or other standards) Common ontologies : role of GSC Common format (xml) : role of standard software package Could build upon existing initiatives Common Access to Biological Resources and Information (CABRI), minimal data set http://www.cabri.org/guidelines/catalogue/CPds.html Minimal Information about a Genome Sequence Specification (MIGS), published in Nature B.2. Guidelines and norm building An early example for an attempt to lay down common principles are the WFCC voluntary Guidelines (WFCC, 1992). These have been updated in various initiatives (WFCC 1998 ; OECD 2001) More recently, the Demonstration Project for a GBRCN (Global Biological Resource Centres Network), the most recent networking activity of microbial culture collections, has as its major goal the establishment of a legal operational framework for the exchange of materials and information C. Managing Community Resources at the International Level C.1. Representation of the community in policy Formulation on Biodiversity Related Issues (Convention on Biological Diversity) Convention on Biological Diversity Contribution to ex situ conservation (article 9) Contribution to in situ conservation (article 8), through financial support from down stream commercial applications Example of Yellowstone Park in US (special agreement with ATCC to retain residual rights on the microbial resources), of Merck-In Bio in Costa Rica (preferential access to samples of the national park system in exchange for research funding) However, danger of proliferation of ad hoc arrangements (science friendly arrangements), or of emergence of restrictive access conditions (out of fear of commercial applications, example of access to soil samples of Rothamsted, UK) Third objective of the Convention: fair and equitable sharing of benefits arising out of utilization of genetic resources (concerns of international equity) Limits of a voluntary scheme such as the microbial research commons for an international access and benefit sharing regime: Even if the microbial research commons might contribute to access and benefit sharing, for example through a standard compensatory liability clause, there is not obligation for the parties to put material in the research commons Moreover the research commons are designed for resources with unknown and unlikely commercial value (where the scientific payoffs of putting it in the open outweighs the expectations of direct commercial pay-offs), while the major equity concerns are raised for strains with known commercial value However, in the absence of an agreement, some countries might (and do) restrict access to all biological resources (including those intended for non-profit research purposes) Therefore for addressing the ABS concerns, there is a need of an approach that deals with all ex-situ resources, beyond the sub-set of resources deposited in the scientific research commons C.2. Representation in policy formulation on Food and Agriculture, and Climate Change Issues The FAO Commission on Genetic Resources for Food and Agriculture (CGRFA) was asked to contribute to further work on ABS, in a direction supportive of the special needs of the agriculture sector, in regard to all components of biological diversity (10th session, 2005) major contributions for addressing these problems can be expected from measures which: provide for a standardized solution to the benefit-sharing with the original providers of the strains to culture collections support further standardization of the license conditions used in the various MTAs both for deposit and distribution of strains Concluding Comments There is no evidence that formalization of the commons as such is leading to more restrictive license conditions or an overly high administrative burden These, and other points, lead to think about the possibility of developing common normative approaches and a repository of practical solutions to depositing and use of microbial materials and sharing of digital data and information which in turn can support the further development of a fully integrated distributed infrastructure based on the emerging initiatives in the microbial commons Thanks for your attention www.microbialcommons.org www.straininfo.org Some References Designing the Microbial Research Commons, Jerome Reichman, Tom Dedeurwaerdere, Paul Uhlir, manuscript on file with the authors Tom Dedeurwaerdere, Maria Iglesias, Sabine Weiland, Michael Halewood, Use and Exchange of Microbial Genetic Resources Relevant for Food and Agriculture, Report (under review at the Commission on Genetic Ressources) Per Stromberg, Tom Dedeurwaerdere, Unai Pascual, The Contribution of Public Networks to Knowledge Accumulation (under review at Research Policy) www.microbialcommons.org ; june 2008 conference proceedings (special issue forthcoming in the International Journal of the commons, January 2010) Robert Cook-Deegan and Tom Dedeurwaerdere, “The Science Commons in Life Science Research: Structure, Function and Value of Access to Genetic Diversity”, in International Social Science Journal, vol.188, 2006, pp.299-318. Peter Dawyndt, Tom Dedeurwaerdere, and J. Swings, “Explorating and exploiting microbiological commons: contributions of bioinformatics and intellectual property rights in sharing biological information. Introduction to the special issue on the microbiological commons”, in International Social Science Journal, vol.188, 2006, pp.249-258. Tom Dedeurwaerdere, “The institutional Economics of sharing Biological Information”, in International Social Science Journal, vol.188, automne 2006, pp.351-368. Acknowledgements Participants to the FAO expert workshops, Brussels, 18-19 Feb 2009 and Brussels, 25-26 March 2009 Researchers of IAUP V/23, IAUP VI-06, REFGOV : Per Stromberg, Maria-Jose Iglesias, Sabine Weiland Co-authors of the FAO report : Maria-Jose Iglesias, Michael Halewood and Sabine Weiland Co-authors on the microbial commons project : Jerry Reichman, Paul Uhlir