Ease compliance obligations regading the Nagoya Protocol (in the EU)

[bressco]

Problem

The Convention on biological diversity (CBD) and the Nagoya Protocol specifying certain aspects of it establish, amongst other, access- and benefit sharing obligations. The EU implemented related compliance obligations in Regulation (EU) No 511/2014 (ABS Regulation).

Those compliance obligations apply to all users of genetic ressources or traditional knowledge associated with such ressources inside the EU. These obligations are documentation and due diligence. These obligations can create additional work and could easily be missed, as they are potentially seen as a burden. This could lead to liability of the users or their institution, as laid down in Art. 11 ABS Regulation and the relevant national law.[^2]

Genetic material is "any material of plant, animal, microbial or other origin containing functional units of heredity", Art. 2 CBD.

Digital Sequence Information (DSI) and similiar informations are not adressed by the ABS Regulation (yet), at least in the view of the Commission.[^1] However, discussion regarding DSI is ongoing between the parties of the CBD.

Proposed solution

Including certain information would simplify fulfilling due diligence and information obligations for users of the resources and could improve compliance. Below possibly relevant types and profiles are listed, currently without a concrete proposal for naming etc. Maybe the information could already be included without creating new properties.

Also, the information could used to automate certain aspects of the obligations, e.g. checking whether a IRCC is valid.

Possibly relevant Types

SDO

• Gene

Possibly relevant Profiles

Bioschemas

• Gene, but possibly just sequence information to which the ABS Regulation does not apply
• Sample

Information in the metadata relevant for the ABS Regulation that should be at least ...

• recommended:
  • location of origin. Needed to determine whether the nagayo protocol potentially applies. Allows to check the ABSCH for further information.
  • date of access to the ressource
  • description of the ressource
  • source of the ressource, from which it was obtained
  • presense or abscence of rights and obligations to access and benefit-sharing
  • access permits, where applicable
  • mutually agreed terms, where applicable
• optional:
  • Internationally recognized certificate of compliance (IRCC): Used to demonstrate due diligence regarding the resource. Should be complemented by information on the content of potential mutually agreed terms relevant for subsequent users. Either the document could be referenced (via the ABSCH) or those terms could be represented in e.g. ODRL. If an IRCC is given, it replaces most of the recommended information regarding the obligation to due diligence. However, the information should still be documented.
  • Registered collection the resource was obtained from. The ABS Regulation considers due diligence having been applied when a resource is obtained from certain collections. The information named before needs still to be documented and shared, however.

---

[^1]: OJ C 313, 27.8.2016, p. 10.

[^2]: E.g. G zur Umsetzung der Verpflichtungen nach dem [...] und zur Durchführung der Verordnung (EU) Nr. 511/2014 v. 25.11.2015 (BGBl. I 2092; FNA 188-108), ÄndVO v. 19.6.2020 (BGBl. I 1328, 1332).

[bressco]

The ABS Regulation has some potential edge cases, mostly relating to other international treaties such as the plant treaty. For more information see https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52021XC0112(02), Sections 2.3 and 5.2. Those could require the inclusion of more relevant metadata.

[ljgarcia]

Hi @gtsueng @nsjuty could you please add this topic to your discussions on BioSample? @bressco is there a suggestion in terms of properties to cover this topic? Any approach that you have seen structuring this kind of data?

[ljgarcia]

@bressco Going through the initial thread with some questions, using a gene as an example, sorry if I am misunderstanding something:

recommended:

• location of origin. Needed to determine whether the nagayo protocol potentially applies. Allows to check the ABSCH for further information. --would this location be for the actual specimen? If I am not mistaken, Gene in Bioschemas is a gene in a database, a composite, not an actual gene. Could work for the actual sample
• date of access to the ressource --would this be the date when someone (person or machine) access, for instance, a gene databank? If yes, then it would not go at the gene level but at the level of an action representing the access by someone in particular to that resource
• description of the ressource --the resource would be, for instance gene databank, that goes at the resource level, and we have it, for instance description of a database
• source of the ressource, from which it was obtained --maybe provenance for sample submission (but for composite genes)

If my comments, make no sense, maybe we are misunderstanding, please Slack

[gtsueng]

I don't think it makes sense to apply it to the Gene schema based on the definition provided: "any material of plant, animal, microbial or other origin containing functional units of heredity", since the Gene IS the functional unit of heredity. Based on the definition it sounds like it should apply to anything containing genes, but it's not clear to me that it applies to genes themselves.

It might make sense to apply it to Sample, but I don't see why the requisite information for compliance needs its own fields and couldn't just be included via the locationOfOrigin, conditionsOfAccess, and ethics properties already defined for the Sample type.