EUROPEAN-SEED.COM I EUROPEAN SEED I 35 European Seed sat down with Tonny van den Boom, Global Genetic Resource Coordinator Vegetables for Bayer; Xavier Bouard, Regulatory Affairs Officer at Limagrain; Mariann Börner, Gene Bank Manager for Enza Zaden, and Lisanne Boon, company lawyer at Rijk Zwaan, who spoke about the struggles that a seed company goes through, and if there is any benefit at all to these regulations. Anke van den Hurk, Deputy Director of Plantum, provided additional input. EUROPEAN SEED (ES): HOW HAVE THE VARIOUS ACCESS AND BENEFIT SHARING (ABS) REGULATIONS (IT & NAGOYA) AFFECTED YOUR COMPANY? TONNY VAN DEN BOOM (TVDB): We used to have an open global network of breeding programs with an active exchange of breeding material between the programs. Some of these pro- grams have now been isolated by domestic ABS regulations, because governments claim sovereign rights over material in our collections which considerably hampers a free exchange of these genetic resources between different countries. In some cases, domestic ABS regulations even paralyze the exchange of genetic resources that originated from non-domestic material. MARIANN BÖRNER (MB): The current ABS regulations hamper the free flow of genetic resources as source for innovation and breeding/research activities. For the constant need to develop varieties that are better adapted to environmental changes and customer wishes, the free flow of genetic resources is key. Companies face big administrative burdens and unrealistic requests to point out ownership to genetic resources that have been distributed all over the world since decades. XAVIER BOUARD (XB): We keep watching at the developments of those regulations for years to anticipate as much as possible their practical consequences, to be and remain in line. Internal proce- dures of access and management of genetic resources (GR) are constantly being adapted to the new conditions resulting from the ABS legislations. Legal certainty and traceability are the main issues. Notwithstanding the Clearing House information web site, the accessibility to clear information concerning ABS national regulations is not easy and creates legal uncertainty. It can be in a language that we don’t understand, or difficult to understand due to local legal specificities or to their complexity, or unpublished. Without clarity, access cannot be possible. And, the never-ending ABS obligations makes burdensome the track- ing and tracing of the accessed materials forever. TVDB: We have to deal with legal uncertainty because many of the national ABS regulations are difficult to find and often difficult to interpret. Moreover, it is quite difficult to establish communication with the different National Focal Points because of a lack of response, language barriers and a lack of understand- ing of the way of working within the plant-breeding sector at the side of the National Focal Point. So, in order to ensure com- pliance with the ABS Regulations, we have had to implement a rigid system for access to genetic resources and administration of such access, and we have had to teach all of our breeders and scientist how to comply with it. ES: WHAT CHANGES DID YOU HAVE TO MAKE TO BE IN COMPLIANCE? TVDB: We have implemented procedures concerning the access to, and use of, genetic resources. We have modified certain busi- ness software applications used in R&D to be able to ensure com- pliance with the various ABS regulations. In addition we have appointed a specialized team to exercise due diligence (two full time employees), and last but not least, we have also established a company network of legal experts on ABS regulations. MB: To ensure that our company is in compliance with all these regulations, we had to: • get legal advice • build an advanced track and tracing system; • set up a new internal procedure; • create new responsibilities. XB: Some of the practical consequences of these regulations are: • adaptation of track and tracing tools; • staff training to new legal constraints; • development of internal procedures to secure access and use regarding ABS. ES: I UNDERSTAND THERE IS STILL A LOT OF UNCLARITY ON THE REGULATIONS. HOW CAN THIS BE SOLVED, IN OTHER WORDS, WHAT DO YOU NEED TO ARRIVE AT LEGAL CERTAINTY? LISANNE BOON (LB): The website of the ABS Clearing House is an important source for information. But unfortunately, also on this website, the information remains very general. Some countries did already include the applicable legislation in their country on the website. But this is often a large document, most of the times only in the national language, which makes it dif- ficult to find a quick answer to the question if Prior Informed Consent (PIC) and Mutually Agreed Terms (MAT) are required. To help the users comply with all these rules, it would be very helpful if the country profile on the ABS Clearing House website would contain some concrete information in English. For exam- ple, whether PIC is required. And if so, how it can be acquired. XB: One of the issues comes from the endless obligations oblig- ing to track and trace PGRFA forever. The seed sector needs to access GR under workable and bearable conditions. The multiple legislations must be clear and the practical pathway to access and use GR in each NP member must be clear and rapid. This means that: • Legislations must be all published on the ABS Clearing House web site; • They must be translated in English; • As they can remain unclear, a summary of the steps and obligations to follow should also be published; • The national authorities in charge of ABS should always give answers within reasonable delays; • The ABS status of commercial varieties used as GR should respect the breeder’s exemption philosophy and therefore be freely usable for further breeding. LB: Commercial varieties are very important sources for breed- ers. To develop new varieties that meet the demands of growers and consumers, it is important that breeders can continue to access commercial varieties freely, without unnecessary bur- dens. And, as they say, ‘No access, no benefits’. TVDB: The National Focal Points of the countries which are a party to the CBD, should be obliged to publish their ABS regula- tions and ensuing measures on the ABS Clearing House website, and all regulations and measures should be summarized in a uniform way, where especially the scope of the measure should be transparent. Currently, it is too much of a burden on the users of genetic resources to contact the National Focal Points to find out the scope and jurisdiction of the applicable ABS regulations and measures. What we urgently need is more clarity; for exam- ple, by finalizing the draft sectorial guidance documents of the EU Commission. ES: WHAT WOULD YOU ADVISE TO OTHER SEED COMPANIES? MB: My advice would be that seed companies need to get pre- pared for more administrative tasks, and they would need to