b'SGNT is a new term for many people. Why is CropLifeWe need to inform generic seed developers Canada working to bring awareness to Seeds withand the seed industry of various considerations Generic Novels Traits? they may not have thought about with regards to Its new, but its something that weve been talk- stewardship and market access. There are intrica-ing about for over 10 years. The first commercialcies that have to do with the global approvals for Jennifer Hubert biotechnology events in the United States wentbiotech traits as well as product specific steward-Plantoff patent and became generic in back in 2014.ship, where if theyre not understood by people BiotechnologyThe American Seed Trade Association workedselling these traits, it could create issues with Executivewith the value chain to create what they call thetrait performance as well as international trade. Director AgAccord. This entails a contractual legal frame- Its important to know how the regulatory CropLife Canada work to support business opportunities for thoseenvironment works for biotech traits and how its seeking to use off patent events in the Uniteddifferent from pesticides. For pesticides, every States while ensuring important global regula- manufacturer of a pesticide, including a generic tory commitments are maintained for off-patentmanufacturer, needs to get their own regulatory events with the goal of protecting Americanapproval. exports from disruption. The accord was estab- For example, once products are authorized, lished in 2012 and information on this frameworkfor the most part, anyone can use it and addi-was presented at multiple Canadian seed indus- tional authorizations arent needed, although try meetings around that time and our membersthere are some exceptions. Seed derived from felt there was an absolute need to educate peopleapproved seed is exempt from regulations, but here in Canada on this.it wasnt clear how this exemption applied to authorizations where there were conditions. Bt How did the AgAccord discussions in the Unitedcorn has specific insect resistance management States lead to this discussion in Canada? activities that need to be implemented that are CropLife Canada and the former Canadian Seedpart of the condition of authorization. When Trade Association created a joint working groupunder patent protection, the developer can on this. We needed to determine if we requiredenforce these through contractual agreements something similar. These discussions led to thewith licensees and growers, but after patent development of a white paper in 2016 that reallyexpiration the developer cant do this with enti-framed up the issue and the roles and responsi- ties who may be selling the seed without any bilities of various value chain members, and thiscontracts in place.included establishing the scope and coining the term SGNT.What can we expect in terms of guidance?We recently finalized a document that provides Why are SGNTs such a serious issue for the market- considerations and best practices for responsi-place? bly introducing SGNTs. Were waiting to seek Prior to launching products for the first time ininput from the value chain before we release it Canada, given the global trade of grain, its beenpublicly. Well be looking to publish it on the a best practice to secure approvals in key trad- CropLife Canada and Seeds Canada websites, ing markets (we just published along with Seedsand well be doing some outreach with the seed Canada a guidance document in regard to that).sector to ensure awareness of it, hopefully in the Another complicating factor is these approvalsnext few months. have time limits and they require renewals. With new entities entering into the markets, there is concern over there being sufficient awareness around market access and stewardship best prac-tices and who will maintain these global authori- Watch our recent webinar on this topic! germination.ca/SGNTszations. SUPPORTED BY: ENDORSED BY:42GERMINATION.CAJANUARY 2023'