GREAT AT SMALL THINGS

BCCM collections work out the Nagoya Protocol

Access and use of microbial diversity is subject to new regulation

The Nagoya Protocol[1] (NP) under the Convention on Biological Diversity has entered into force on 12 October 2014. It set new rules on access and utilization of biological diversity, including micro-organisms.

In the European Union, there are two kinds of rules related to the Nagoya Protocol.
On the one hand, the rules set by the European Regulation 511/2014 which defines the "compliance measures for users" and its corollary the Commission Implementing Regulation 2015/1866. These define what users must do to abide by the Nagoya Protocol when performing research and development on biological material falling under the CBD.
On the other hand, the rules of access set by national law at the level of each member country of the European Union. That means rules defining what a user must do when getting access to material falling under the CBD.

The BCCM consortium has always acted proactively to facilitate R&D in microbiology, for academic as well as for industrial purposes, starting with the MOSAICC Code of Conduct, until the TRUST initiative. Our goal is to avoid disruption of the delivery of services and microbial material before and after all laws are effectively applicable, with clear administrative requirements, also during the transition period where not all countries parties of the NP have relevant legislation in place. 
BCCM has anticipated these legal developments and have designed solutions in coordination with the World Federation for Culture Collections (WFCC).

 

Access

The Access and Benefit Sharing concept (ABS) has been drawn out of the blueprint of Article 15[2] of the Convention on Biological Diversity (CBD)[3] entered into force in 1993[4]. Article 15 focuses on the sovereign rights of nations to administer their natural resources and rule the access to these natural resources under specific circumstances.
This approach considering that benefit sharing is the reward for facilitated access has been further developed in the Bonn Guidelines issued in 2002[5]. Negotiations went on for eight more years and ended with an agreement signed in October 2010 during the 10th CBD Conference of the Parties in Nagoya, Japan. 

 

Use and benefit-sharing

The Nagoya protocol covers the use of biological diversity in Research and Development activities, not as commodities.

Development of biotech services and products in agro-, food, medical, environmental industries can generate profits subordinated to the Nagoya Protocol Benefit Sharing model. On the other hand, other benefit-sharing mechanisms need also to be taken into consideration, including agreements ruling Intellectual Property Rights, under which the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS)[6] stating that microbiological inventions can be patented, and the Budapest Treaty[7]  administrating the patenting procedure for inventions incorporating or using micro-organisms. 

 

Updated policy of accession and distribution of microorganisms

The Nagoya Protocol, like many others conventions, rules the socio-economic uses of microbiological diversity. BCCM collections adjust their policy to guarantee safe and legally fit-for-use microbiological material and data. These acquisition and distribution policies are translated respectively into contracts called Material Accession Agreements (MAA) and Material Transfer Agreements (MTA) you can read and download from the BCCM website. In addition to these contracts, other technical and administrative measures have been adapted.

 

Initiatives of BCCM

BCCM initiated and coordinated project MOSAICC[8] that was the first effort made by a consortium of collections members of WFCC to face the challenge posed by the Convention on Biological Diversity. MOSAICC is a precursor code still relevant to this day. It has inspired the Bonn Guidelines.

The MOSAICC code of conduct pleaded already in 1999 for simple, efficient rules.

For instance, it proposes a facilitated access to pathogens in case of emergencies[9]. Rapid access to genetic material of pathogens was heavily debated in the World Health Organization (WHO) in 2008. Access to virus samples was denied for several months during the avian influenza epidemic in 2007 although it is vital to allow the international community to respond to emerging threats. Therefore WHO decided to organize the access and exchanges of human pathogenic material by setting up the PIP-framework[10], designed for exchange of influenza strains after the crisis of 2007-2008[11].
These kinds of events have now been taken into consideration in article 8 of the Nagoya Protocol which specifies that such emergencies require special considerations.

MOSAICC and its complementary coordinated action MOSAICS[12], both funded by Directorate General of Research of the European Commission, are the basis for the new initiative called TRUST launched by several collections.

 

Gaining trust, building TRUST

Trust, confidence, is a prerequisite for lasting cooperation in science and for socio-economic development. Trust can be attained partly through a transparent system of transfer of microbial material. Several institutions specialized in microbiology, including BCCM, have decided to coordinate their efforts, to build TRUST, literally and practically. They are aiming at adjusting their tools to each other and at providing a cost-efficient, simple, fast multiple users, and multiple purposes global system.

TRUST stands for TRansparent User-friendly System of Transfer. It aims at managing the incidence of the CBD and Nagoya Protocol on the scientific, technical and administrative activities of CC and, more generally, at incorporating the Nagoya Protocol into the daily life of microbiologists.

TRUST is a modular system having as backbone the Global Catalogue of Microorganisms and making use of the expertise gained by MOSAICC, MOSAICS, and other initiatives. The TRUST system comprises the following elements:

 

I. The TRUST guidelines[13] providing for administrative and technical procedures. It set the principles of facilitated access to microbial genetic resources. TRUST combines updated features of the Code of Conduct MOSAICC and administrative workflows of the MOSAICS Integrated Conveyance System adjusted to the Nagoya Protocol and improved in light of past experience.

Complementary elements of the guidelines are the concept of “bundle of rights”[14] innovatively applied to biological material and the design of “microbial commons”[15] which provides basic common use principles for access to biological material and related information.

II. Material Accession Agreement (MAA) and Material Transfer Agreement (MTA) models with standardized definitions.
The CCs community has developed an efficient information and material handling strategy to deal with the Prior Informed Consent (PIC) that may be required in some countries. The concept of registered collections as future trusted sources for ABS-compliant genetic resources like it is organized in the EU Regulation 511/2014 is imbedded into the CCs community at the outset.  Consequently it is of primary importance that:

  1. Every microbial genetic resource "entering" a collection is covered by a PIC or similar obtained either at the time of its collection from in situ conditions or after corrective administrative action.
  2. Every microbial genetic resource having entered a collection with the appropriate initial PIC or similar document is distributed with this information attached and under standardized contractual conditions.

III. A powerful automatic integrated data management and processing system able to provide for any information related to microbial material: the ground breaking Global Catalogue of Microorganisms (GCM)[16].

GCM is the backbone of the global system linking the microbial genetic resources to all kind of related data. It concatenates the online catalogues of culture collections around the world and organizes the flow of information, preserving the need for confidentiality while being connected to the ABS Clearing House Mechanism[17] for non-confidential data.

GCM is a major program launched by the World Data Centre for Micro-organisms (WDCM)[18] under the aegis of WFCC, which is now chaired by a BCCM staff member.

Collections like BCCM, joining the CGM, enable their customers to retrieve information about the possession, location, transmission and use of uniquely identified microbial strains in catalogue, including country of origin, existence of Prior Informed Consent (PIC), the creation of derived patents and associated scientific publications. This system already includes more than 70 collections from 30 countries.

Although most of the procedures and ICT tools have been developed before the Nagoya Protocol, these tools have been reviewed and refined to be relevant solutions for microbiologists implementing the Access and Benefit Sharing concept. The WFCC and its members work towards the development of a global system incorporating these developments, combining adapted legal concepts and bioinformatics.

 

Conclusion

The best way to achieve ABS efficiently is to build on existing procedures so that ABS is effectively more beneficial to all and does not require coercive measures or penalties.

BCCM has now adapted the deposit procedure, coherently with BCCM general conditions of distribution of material. These processes aim at providing BCCM's customers with legal certainty about what may be done with the material they deposit in the collection or the material they purchase from the Belgian consortium of collections.

On the one hand, as depositor of microbiological material a customer may be confident that when some profit (scientific or commercial) arise from the utilization of a particular material deposited in the collection, this material may be traced back to her/him. On the other hand, the purchaser of a strain from the BCCM catalogue will know exactly what he/she may do, including marketing, in full legality.

Besides adapting the procedures, the BCCM consortium is preparing webpages dedicated to the practical aspects of depositing strain in a collection and purchasing strain from a collection.

Next to working with ex situ material you may need to sample and collect material from in situ conditions. In the latter case, the ABS Clearing House (https://absch.cbd.int) is where you can find basic information related to the laws of the parties to the Nagoya Protocol. When no legal framework is in place TRUST explain how to proceed. Do not hesitate to ask your collection for advices.

 

[1]    Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. (http://www.cbd.int/abs/ )

[4]    29 December 1993

[5]    COP Decision 6/24 Access and benefit-sharing as related to genetic resources. A. Bonn Guidelines on Access to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization http://www.cbd.int/decision/cop/default.shtml?id=7198

[6]   TRIPS Agreement is Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco on 15 April 1994. Article 27.3.b) states that micro-organisms cannot be excluded from patentability.

[7]   Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. Combined with the Regulations Under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. http://www.wipo.int/treaties/en/registration/budapest/

[8]    MOSAICC - Micro-Organisms Sustainable use and Access regulation International Code of Conduct (http://bccm.belspo.be/projects/mosaicc)

[9]    "A fast-track procedure should be available in cases of emergency such as epidemic,...," MOSAICC Version June 2011 page 5.

[10] Pandemic Influenza Preparedness framework  ( http://www.who.int/influenza/pip/en/ )

[11] Fidler, D.P. (2008). Influenza Virus Samples, International Law and Global Health Diplomacy. Emerg. Infect Dis Jan 2008 14(1): 88-94.

[12] MOSAICS - Micro-Organisms Sustainable use and Access regulation Integrated Conveyance System (http://bccm.belspo.be/projects/mosaics)

[14] The innovative concept of “bundle of rights” is a dynamic model of ownership management moving away from the static concept of ownership towards a flexible allotment of rights. Ownership constitutes a “bundle” of use and decision rights that are attributed to a number of stakeholders / economic agents. It is a set of operational and collective choice rights defining respectively who decides upon the use that one can make of a resource, and who decides upon the future exercise of the rights on the resource. Such scheme allows multi-ownership of a gradual level of use and decision rights. These rights can begin with basic access rights, encompassing research delivering outputs to the public domain, distribution on to third parties, exploitation rights to develop intellectual property and its ownership which may include reach through rights. The application of the “bundle of rights” makes possible the enforcement of the “sovereign rights of States over their natural resources” without prejudice to private rights. Unambiguous allotment of rights in advance will facilitate rightful benefit sharing “at the end of the pipe”.Dedeurwaerdere Tom. Understanding ownership in the knowledge economy: the concept of the bundle of rights. BCCM News Edition 18 - Autumn 2005. 

[15] This development is complementary to national regulations on ABS and to existing IPR laws, as it will constitute a demarcated space where material and information are relatively freely accessible provided that the outputs are injected back into this open space, to be shared again. Inside this space access and benefit-sharing are “commonly shared”. Outside this demarcated space, access and benefit-sharing will be ruled through ordinary national and international laws, including IPR and specific CBD inspired regulations. A practical development similar to this model is the NIEMA system. See http://www.thecommonsjournal.org/index.php/ijc/article/view/215/144

[18] WFCC has developed a pioneering database system by registering its members through a unique acronym and numerical identifier in its official directory. It also helps its members to catalogue their microbiological resources. This system is managed by the World Data Centre for Micro-organisms (WDCM).  Combining the WDCM system and the use of electronic markers called “Globally Unique Identifiers (GUIDs)” set up a robust system to organise transfers of (micro) biological items, tracking the flow of resources and related information. This system also facilitates the application of ABS since it can potentially retrieve all kinds of information about microbiological resources, including information related to the location and movements of the resource. The WDCM portal acts as an information broker between all online catalogue entries of the culture collections. See http://www.wdcm.org  and   http://bccm.belspo.be/documents/files/projects/mosaics/ics_report.pdf

 

Philippe Desmeth
BCCM International Cooperation Manager
President of the World Federation for Culture Collections
http://www.wfcc.info