Guidelines
Marine scientific research activities need to be organized in full respect of international and national legal commitments related to ABS and the law of the Sea Convention (LOSC).
This section illustrates the steps to be followed by users/scientists in order to guarantee that legal compliance and certainty is achieved: this is beneficial for the research community, the provider countries and also the possible private investors. Scientists will need to take the following steps in order to comply with ABS requirements set out in the CBD, the Nagoya Protocol and the EU ABS Regulation, and other requirements according to the UNCLOS. Please note that additional national or regional laws might exist that require a scientist to get additional permits, for instance to sample in national parks.
Step by step guidelines
First of all, when a scientist is planning to undertake a research project on GRs (notwithstanding if the source of the GR is the country of registration of the research institution where he/she works) the first necessary step is to refer the matter and raise awareness of the legal issue to the legal representative of the research institution and to the legal department or the technology transfer office of the institution (if any exists ). The only person who is entitled to sign legal documentation on behalf of a research institution is the legal representative of the institution, or any other member who has been invested of such competence; therefore it is of fundamental importance that employed scientists do not sign the legal documentation described in this section, unless they are entitled to do so. Receiving professional legal advice and support by private consultancies is the best option in case the research institution does not have in-house the competences to deal with ABS.
1. Access to in situ Marine Genetic Resources
As a step 0, scientists need to check in which maritime zone the sampling is planned:
- It can be in waters under national jurisdiction (case A: internal waters – territorial seas – exclusive economic zones);
- In areas beyond national jurisdiction (ABNJ) (case B: the high seas and the deep seabed beyond the continental shelf);
- Or in the Antarctic Treaty area (case C: the Antarctic).
Case A: sampling in internal waters, territorial seas or exclusive economic zones
If sampling is planned to take place in internal waters, territorial seas and/or exclusive economic zones, regardless of whether in a foreign country or the country of the research institution, the following steps need to be undertaken:
Step 1: First of all, users need to verify if the country from where they want to source their GRs is a party to the CBD and the Nagoya Protocol. If this is the case, as soon as possible, notify the primary National Focal Point (NFP) for CBD, and the NFP and Competent National Authorities (CNA) of the Nagoya Protocol of the country where sampling is planned (Provider State) and ask if any additional steps need to be taken. It is often useful, and sometimes even required by ABS national legislation, to undertake such research project with a local partner who might know about the national procedure and might help in negotiating benefit-sharing terms.
In the particular context of marine GRs, the CNA is sometimes different from the one competent for terrestrial GRs.
Step 2: Ask for advice on the specific requirements to be fulfilled prior to sampling activities according to the Provider State’s legislation on ABS. Basic information on national ABS legislations and measures can be found on the website of the ABS Clearing House.
Step 3: If the Provider State has ABS legislation in place requiring Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT), contact the Provider State’s competent authority for ABS and start negotiating an ABS agreement. Legal support will be needed for such negotiation .
Step 4: Access and use the material only in accordance with the requirements set out in the permit and/or the ABS agreement. The permit will need to be inserted in the ABS Clearing House by the provider country, and in this case it will become the internationally recognized certificate of compliance (IRCC).
Step 5: Transfer the sampled material and/or the associated knowledge (which includes data and scientific results) to a third party only in accordance with the requirements set out in the permit/ABS agreement and upon the signature of a Material Transfer Agreement (MTA). The MTA sets out the conditions on use (if any) of the samples material and/or associated knowledge by the third party, in accordance with the original ABS agreement/permit negotiated with the provider country. Together with the MTA, users need to transfer to subsequent users the IRCC and the information on the MAT. In case the IRCC does not exist, the following information has to be passed on:
– date and place of access to GR
– description of the GR
– the source
– the presence or absence of rights and obligations related to ABS
– the access permit and the MAT.
This information needs to be kept for 20 years after the end of the utilization. Finally, if this information is not complete or if there is uncertainty, the user shall obtain an access permit or discontinue utilization.
Step 6: If a user wants to use the material and/or associated knowledge for other purposes than the ones agreed upon in the ABS agreement/permit obtained (change of intent), then the user needs to go back to the relevant authorities of the Provider State and renegotiate, as should be specified in the MAT.
Case B: sampling in Areas Beyond National Jurisdictions
There is neither notification nor permits required so far. As highlighted in the Background a process is undergoing at the United Nations level to discuss an Implementing Agreement to the UNCLOS addressing marine biodiversity in ABNJ: this will likely have implications for accessing and/or utilizing GRs coming from ABNJ in the future. It is advisable to keep a record of the sampling provenance for a period of 20 years, in order to be able to demonstrate the source, in case this is questioned.
Case C: sampling in the Antarctic Treaty Area
Any activity undertaken in the Antarctic Treaty area (south of 60º latitude) is subject to prior notification. Moreover, the national legislation of the country undertaking the research might require from the researchers to apply for and to obtain a permit.
2. Access to ex situ Marine Genetic Resources
The users have to exercise due diligence according to the EU ABS Regulation, which means that they have to seek either the IRCC related to the materials they want to access in the collection (if it exists), or all the relevant ABS information related to the materials (see step 5 above). When this information is insufficient or uncertainties exist about the legality of access, the users have to obtain an access permit from the provider country or discontinue utilization. Of course, this is only applying to materials deposited in the collections after the entry into force of the EU ABS Regulation. Given the immense efforts collections will have to undertake in order to adjust their management system to the new rules, this is going to be challenging, both for collections and users. However, the EU ABS Regulation prescribes the possibility for collections to apply for being registered (either as a whole or in part) in the Register of Collections established by the European Commission. This will have the advantage for the users to assert that, when accessing materials in a registered collection, they have exercised due diligence.
EU compliance
In case of research undertaken within the EU and implying the utilization of GRs, in the drafting phase of a project, and before applying for grants, scientists already need to foresee what kind of ABS issues they might be facing during the project, and how to handle them in compliance with national and international legislations. As a matter of fact, this is required by the EU ABS Regulation through the due diligence declaration system. The first checkpoint is at the stage of external funding. At this checkpoint, the users have to submit to the Competent National Authorities of their country a declaration of due diligence. Certain funding programs of the EU, such as for example Horizon2020, already include an ethic self-evaluation within the ethical self-assessment part of the proposal.
Therefore, scientists need to undertake a preliminary analysis in order to demonstrate that they will be able to exercise due diligence, which means being sure that the GRs they will use are or will be accessed in accordance with applicable ABS legislation. Once they made sure that all required legal permits are in place prior to sourcing the desired GRs, they will then need to undertake the steps described further below. Two different scenarios can occur and will require taking different steps, depending on whether the GR are sourced in situ directly from sampling the sea, or are sourced ex situ from existing collections.
The second possible due diligence checkpoint is at the point of commercialization, when again a due diligence declaration has to be made to the Competent National Authority of the country where the utilization (i.e., the research) was done, or was coordinated from (in case of a consortium). If a GR leaves the EU before the R&D process has been completed, even if a final product has not yet been developed, a similar due diligence declaration has to be made.
Note that under the EU ABS regulation, relevant information has to be stored for a period of 20 years after the end of the utilization.
Law of the Sea compliance
According to the UNCLOS, a research permit is needed from the coastal state in order to undertake Marine Scientific Research in the territorial seas and exclusive economic zones of that coastal state.
If scientists are planning to sample in:
a) Their own State’s national waters (meaning the research institution’s country), they need to contact the authority which is competent to release such a permit (it is usually the Ministry of Environment or the Ministry of Research or the Ministry of Transports) and provide full details on the research project.
b) In a foreign country’s waters, they need to contact the Embassy of the Provider State at least six months in advance of the expedition, and provide full details on the research project. The Embassy should assist in obtaining the necessary consent and permits from the competent authority.