International News    |   Regulatory    |   Vol. 5 Issue 4   

In previous editions of European Seed, seed company experts discussed struggles relating to the Nagoya Protocol on Access and Benefit Sharing (ABS) for plant genetic resources (PGR), entered into force in October 2014. In our second article in this series, we sat down with experts at various global biotech firms. In this third and last part, we present a picture of how academia is faring. Our experts include: Kristiaan Van Laecke, Head of the Plant Sciences Unit at ILVO (Research Institute for Agricultural, Fisheries and Food) in Belgium; Stefanie van der Burght, Research Integrity & Ethics Advisor at Ghent University in Belgium; Anne-Françoise Adam-Blondon, deputy Director at the Plant Biology and Breeding division of INRA in France; Theo van Hintum and Martin Brink from the Centre for Genetic Resources (CGN) of Wageningen University & Research, The Netherlands; Sebastien Carpentier, a bioscience engineer at Bioversity International, a CGIAR Research Centre in Rome, Italy; Alexandrine Rey, legal expert, Intellectual Property and Biotechnologies at CIRAD, France.

Please note that a shorter version of this article appears in the print version.

ES: What are the ways in which the various ABS regulations have affected your organization?

Stefanie van der Burght (SVB): Researchers have to meet a lot of requirements before starting their research. Because Belgium only ratified recently, this also needs to be done retroactively. There is a lot of administration, a hard process of making contact with the COO (country of origin) and getting the necessary documents, and a lot of uncertainty about implementation. At the organizational level, we must implement the regulations, urgently provide support for researchers, develop policy, create infrastructure and do training and communication for an area that is still undergoing change at the national level.

Anne-Françoise Adam-Blondon (AFAB): First, it has created a very long and ongoing period of legal insecurity around PGR exchanges: France has not yet completely stabilized its national implementation of these regulations. Second, the overall PGR ecosystem has many activities related to the conservation of diversity which are based on trust and non-monetary knowledge sharing.

The other point is that the ecosystem made of genebank public institutions, individual researchers, private seed companies, farmers and NGOs has many activities related to the conservation of diversity which are based on trust and non-monetary implicit shares (knowledge, access). Beyond the rules, it is important to save this trust by discussing the implementation of these rules in our practices with all our partners, while making sure that everybody has the same understanding of the context (which is really very complex).

The good side is that this process has emphasized again the necessity to manage a standardized documentation and to renew the charter of the French public-private networks involved in germplasm conservation. A generic frame of this charter was developed in collaboration with the French Union of seed companies. All the discussions that we still have with French stakeholders are also helpful to better understand the context and its evolutions and to design convergent strategies. Finally, overall it generates lots of administrative burden that slows exchanges.

Theo van Hintum and Martin Brink (TVH/MB): We need to better document the origin of the PGR in our collections and better explain that origin to users. Acquiring new PGR for our collections has also become much more complicated or even impossible. Although the ABS might develop into a more workable system, we see that access to PGR has been reduced considerably in many, if not most, countries in the world, which is obstructing conservation. The ABS regulations are obstructing plant genetic resources conservation. We are very worried about this. Proper access is essential in ensuring world food supply and adaptation to climate change.

Dr. M.J.M (René) Smulders, Plant Breeding Group Leader at WUR: As scientists, we also have the experience that the various regulations have been counter effective, so far. Access to PGR has been reduced considerably for our research, for example, the identification of disease resistance genes.

Kristiaan Van Laecke (KVL): Up to now, these regulations have resulted in material transfer agreements (MTA) between our institute and genebanks when we receive seeds from genebank accessions. Seeds from our collection (not the commercially-available cultivars) are sent to users with MTAs.

Sebastien Carpentier (SC): We have a germplasm bank that we are characterizing to identify the gaps so that we can collect new material. Getting this material is challenging, and of course, needs to happen according to the law. The same is true for providing material to external partners and making it available.

Alexandrine Rey (AR): CIRAD has set up a Biological Resources Committee (Corebio) to secure exchanges and initiate discussions on the management of genetic resources. In this sense, the Nagoya Protocol and the adoption of national legislation have strengthened the legitimacy of these initiatives by imposing a binding, but also clearer, framework.

What changes have you made to comply?

ARWe have greater vigilance, ensuring the traceability of the use of genetic resources, especially within collections. In concrete terms, we verify that the exchange of material concerns material whose legal situation is clear. In addition, model contracts have been released and we are working to continually adapt them. We are also working on decision support tools to determine the status of a resource and to designate the appropriate material transfer agreement. To support this process, we launched the ABS4BRCS project which will propose legal solutions for the compliance of biological resource centers.

In addition, we organize in-house trainings so that the people responsible for recovery and researchers can understand the benefit-sharing process at the time of the project and respect the checkpoints set up by the EU Regulation. In order to harmonize the practices of the local scientific community, we also participate in inter-institutional trainings and information days. Finally, the CIRAD legal experts were particularly involved in the drafting of the FRB guide, the “APA PAS A PAS.”

 SVB: A core working group was established to plan an administrative system, support, training and communication. There is a policy advisor that partially (20 per cent) works on ABS and some legal support. We made some tools to guide researchers; a web page with basic info, a decision tree where researchers can find out if their research has to comply ABS regulation (EU and national) and what specific steps they have to take to comply, as well as a manual with tips and tricks and examples to contact the country of origin and follow correct procedure. We have also had to adjust our information system to archive documents.

AFAB: We are updating and signing charters of collaboration for the public-private network for the conservation of PGR, improving the documentation of our collection under the MCPD standard, defining with our partners the subset of our collections that can be exchanged under the Treaty, and having our researchers consult with genebank managers before any exchange to evaluate the type of document or process to be developed.

We are also participating in working groups set up by the Ministries of Agriculture or projects funded by the consortium of national research institute in biology to develop operational tools for genebank managers to be compliant.

TVH/MB: The paperwork involved in distributing material has increased. We need to document the origin of the PGR in our collections much better and supply better information regarding that origin to users. Acquiring new PGR for our collections has also become much more complicated (and sometimes impossible).

What is most difficult?

KVL: Achieving clarity and uniformity on a global scale, with clear translation to each group of users (breeders, researchers).

AFAB: There are uncertainties on the precise rules to be followed, which is totally dependant on each accession, its history, its usage and the projects in which it is used. The use of large diversity panels, necessary to do statistically-sound association genetics studies, is becoming a nightmare under the NP but could be simplified under the treaty. Now this uncertainty is being spread on digital knowledge, which is not very good news for open science goals if the solutions proposed to address benefit sharing on data are as difficult to implement as for the biological materials. Personally, I have pushed very hard towards the generalization of the treaty. However, it seems still impossible to use it for all crops and I understand that its funding mechanism is still under threat. I think it is a pity because this is the right direction: uniform rules, pre-negotiated by all parties under the auspices of the FAO. We are trying also to have an approach where we try to balance the legal risks with the administrative burden, which is quite challenging within networks where the risks are not the same between the partners.

SC: Convincing governments that they need to invest in sharing. There is indeed still confusion. This can be solved be legal advice.

ARFirst of all, we are often faced with the difficulty of explaining to partners/focal points and researchers that sharing in terms of fees is often inappropriate and irrelevant. The objective is rather to allow the strengthening of local research capacities. However, it may be difficult to imagine benefit sharing of this type since the appropriate infrastructures are lacking in the countries providing genetic resources. We are therefore very attentive to the ongoing discussions at the international level on the treatment of digitized genetic information.

In the same vein, we try to reconcile the open data movement with the interest of genetic resource providers by proposing a dissemination of sequencing information under certain conditions (and, in particular, the maintenance of the sovereignty of the country of origin) in order to avoid any misuse of the principles of the CBD. However, here we are confronted with editorial policies and research strategies that does not take into account these issues.

To these new difficulties related to the evolution of activities, there are recurrent difficulties of interpretation concerning the field of application in time and space of the various laws. Indeed, the use of the notion of utilization rather than access as a trigger for ABS does not clearly delineate the obligations of users, especially since this interpretation may vary from country to country and access to the doctrine is often tricky.

In this context, some issues are not solved. For example, the question of when improved material will become independent of the supplier country(s) of origin. Moreover, where there are many crosses over a long period for plant breeding, this imposes that the bilateral negotiation required by the NP involves a multitude of suppliers, which can be very laborious. We believe it is important for the research community to mobilize in order to propose good practices validated by the European Commission which would provide essential details in order to enhance the legal security of users.

 SVB: There is still a lot of uncertainty on terminology in the regulation (e.g. on derivatives, digital sequencing) and on national regulation and infrastructure. We need detailed guidance documents that deal with specific topics and present a best practice approach from looking at specific exemplary cases. Better communication channels and training from EU to the universities and stakeholders is needed. It is very important to know whom to contact for information, approval and negotiation authority and this is not always the case.

TVH/MB: Getting access to new PGR and organising collection trips. Another important difficulty is that the procedures and responsibilities within provider countries are often unclear, and that efforts to get more clarity are often unsuccessful because people do not respond or do not dare to make decisions. The regulations should become much simpler: all PGR(FA) in one regulation, no documentation per transaction but BS based on levies or tax. Within the framework of the ITPGRFA, steps into this direction are being discussed, but so far, agreement has not been reached.

What would you advise to other organizations like yours in dealing with the regulations?

KVL: Pay attention to these regulations when developing varieties with a certain percentage from genebank accessions that are under an MTA.

SVB: Exchange information with others. We are all dealing with the same issues and can learn from each other. This is starting to happen in EARMA Ethics Group.

TVH/MB: Follow the rules and be transparent. We also feel it the responsibility of the professionals dealing with PGR to give clear signals to policy makers that the current regulations are not doing their job, and that their effects are even contra-productive. They are meant to promote benefit-sharing, but by limiting access, they are also limiting benefit-sharing.

SC: Organizations such as ours should further invest in legal advice and communication.

ARWork on renewed research practices, organized around the partnership with a local researcher.

What is your overall view of the detractions and benefits of the new framework?

KVL: It causes additional administration and may result in a reduced use of foreign PGR in developing new varieties. A much better alternative would be to unify the breeder’s exemption globally (no restrictions on the use of plant material in the development of new varieties). Of course, in situ and ex situ conservation of genetic resources should be further supported by governmental financial contribution.

AFAB: It puts good questions on the table about fair exchanges and has pushed everyone towards better documentation and overall management practices. Globally it was one of the triggers (research in itself was a stronger one) for improving overall management practices. It has also pushed us to gather all our different research domains networks involved in the conservation of genetic resources into a single infrastructure; we realized we could really help each other. However, it is still an unstable and difficult system in practice, which should be simplified.

TVH/MB: Getting access to new PGR and organising collection trips is now more difficult. The procedures and responsibilities within provider countries are often unclear and efforts to get more clarity are often unsuccessful because people do not respond or do not dare to make decisions. The regulations should become much simpler. Professionals dealing with PGR must to give clear signals to policy makers that the current regulations are not doing their job. They are meant to promote benefit-sharing, but they are also limiting benefit-sharing.

SC: It’s fair that benefits are shared and that this is legally contracted. More benefits need to flow back to the COO if the system is going to continue.

SVB: Improving biodiversity is important and researchers should ensure their work benefits stakeholders, but highly-invasive regulation is not the best way to do this. There should be a pragmatic balance to make sure people don’t spend unnecessary time doing administration.

ARThese regulations have the advantage of proposing a fair redistribution of the products of research and an encouragement to the conservation of biodiversity insofar as this is considered as an exchange value. This allows us to reconsider the process of value creation and to spread the idea that the value is not only embodied by scientific knowledge but also by a raw genetic resource, fruit of a territory and conserved since millennia, or traditional knowledge.

How do you see the future, let’s say in 20 years from now, in terms of what will have changed because of these regulations?

KVL: Awareness of the value of PGR will have increased. As the benefits return to society, benefit sharing will have to be organized by public taxes, ensuring free use and conservation of PGR.

SVB: ABS will be a common part of doing research. It will be easier as infrastructure and regulation will already be in place and operating efficiently. We hope that once national regulations are in place, and available in a common language like English, there will be some stability, and hopefully these regulations aren’t changed frequently.

AFAB: The worldwide documentation on accessions will be greatly improved. There will be a more realistic view on the costs of PGR maintenance and how to fund it; the importance of non-monetary advantages will have been understood and this will help simplify the system. More species will have been added to the treaty. A reasonable agreement will have been created concerning associated digital data.

TVH/MB: Hopefully regulations will not obstruct collection of PGR, preventing genetic erosion due to the changing climate etc. A simpler ABS system may exist.

ARIn the coming years, the mechanism proposed by the ITPGRFA should extend beyond Annex 1 because it simplifies the issue of benefit sharing in the field of plant breeding, and pools the benefits, so that they are used in a concerted manner between all the supplying countries. Moreover, the logic of the ITPGRFA seems to support the dynamics of the commons, particularly legitimate in the field of food and agriculture, provided that the supplier countries are really involved in their management.

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