36 I EUROPEAN SEED I EUROPEAN-SEED.COM E arlier this year in European Seed, we sat down with five experts in their fields about the struggles that a seed company goes through, and if there is any benefit at all to the Nagoya Protocol on Access and Benefit Sharing (ABS). Both were adopted in 2010 and entered into force on 12 October 2014. In our second article in this series, we sat down with Dominic Muyldermans, Senior Legal Consultant IGO Affairs for Croplife International; Paul D. Olson, Head of Germplasm Intellectual Property and Plant Variety Protection (PVP) - R&D Legal Affairs and Intellectual Property for KWS SAAT SE; and Frank Michiels, Plant Variety Protection & Clearance Manager for Bayer. EUROPEAN SEED (ES): HOW HAVE THE VARIOUS ABS REGULATIONS (IT & NAGOYA) AFFECTED YOUR ORGANIZATION? DOMINIC MUYLDERMANS (DM): Various ABS regulations have imposed an additional burden on all activities of compa- nies active in natural product research. First of all, the transac- tion cost of sourcing and using genetic resources has increased. Because of the inherently bilateral nature of the Nagoya Protocol every (prospective) use of a genetic resource potentially requires obtaining a permit and entering into an agreement (to agree upon the benefit sharing arrangements). Since natural prod- uct research often requires access to a wide variety of genetic resources from different countries of origin, this adds a burden- some complexity to the research and development process. In addition, the timelines for developing products resulting from the use of genetic resources have prolonged substantially, since it often takes years to get all necessary permits and secure all necessary contractual arrangements. Last, but not least, legal certainty has decreased since often material has been devel- oped by previously using several genetic resources (often by a multitude of users, including pubic institutions or academia) of which the source or origin cannot be exactly defined or for which related information and documents cannot be obtained. PAUL D. OLSON (PO): The regulations have affected decisions about which genetic resources we use in research. Genetic resources with readily documented prior informed consent and mutually agreed terms are preferred over those where documen- tation takes significant time and effort to acquire. Secondly, the various ABS regulations have increased inter- nal bureaucratic burden to support research. FRANK MICHIELS (FM): As the Crop Science Division of Bayer is actively involved in plant biotechnology and plant breeding as well as development and sale of biological plant protection prod- ucts we are greatly affected by the international and national legal ABS frameworks that developed over the years. ES: WHAT CHANGES DID YOU HAVE TO MAKE TO BE IN COMPLIANCE? EXPERTS EXAMINE THE DIFFERENT ANGLES OF ACCESS AND BENEFIT SHARING, AND ITS IMPACT ON BIOTECHNOLOGY. BY: MARCEL BRUINS No Access, No Benefits – Part 2 DM: Since countries can require prior informed consent (PIC) for the use of their genetic resources, companies will need to establish a material management system to ensure compliance with this required consent when sourcing material. In addition, companies will need to train researchers and setup standard operating procedures on how to handle, with sourcing, the use and transfer of material in a manner that is compliant with all relevant ABS requirements. In addition, mutually agreed terms (MAT) defining the benefit sharing arrangements will need to be entered into, which requires the involvement of the legal and IP departments at an early stage. In addition to the requirements for access (and benefit sharing), which are defined by national laws, countries of use will also (need to) setup compliance systems. The EU has har- monized compliance for use within the EU and has enacted Regulation 511/2014 which establishes a due diligence system. This due diligence system obliges everybody who utilises genetic resources (as defined) to seek, analyse, declare, transfer and keep all relevant information about all genetic resources which are utilised in its research and development process. In order to do so, a company will need to setup a track and trace system for the genetic material and all information related thereto. Such a performing material and information management system requires a lot of time and resources from many departments. PO: In 2014, in response to the growing complexity of ABS leg- islation, KWS conducted an inventory of genetic resources that our researchers were already using. Then KWS designated an in-house expert and identified relevant colleagues globally on the topic to: 1)  Thoroughly understand the legal requirements where we do research and business, 2)  Establish a systematic approach to document the exchange and use of genetic resources, and 3)  Familiarize breeders and lab researchers with the new requirements.   FM: We continuously work to understand, analyze and comply with the requirements in the regulations on genetic resource use in multiple countries relevant to our global life sciences business. Our internal policies, procedures and databases also help ensure compliance, and we have provided training and awareness build- ing of ABS with employees. In the case of ABS, implementation is complex because some of the laws and regulations are still evolving. Laws are also generally not harmonized between coun- tries, whereas genetic resources are often used across several countries. ES: ARE THERE SPECIFIC ASPECTS FOR THE BIOTECH OR CROP PROTECTION SIDE THAT ARE DIFFERENT FROM THE SEED SIDE? DM: Two issues, which are of specific relevance for the biotech sector, are derivatives and digital sequence information.