The following piece is from our sister publication, Germination.
As biotech traits reach the end of their intellectual property protection (including patent protection), opportunities for the seed sector present themselves in regard to selling seeds with generic novel traits (SGNTs).
Along with these opportunities comes the need for good stewardship practices to protect the integrity and durability of products to support grower productivity and sustainability, as well as support international trade.
That was the major takeaway from a meeting of the Seeds Canada biotechnology traits committee at the Seeds Canada annual meeting in Winnipeg, Man.
Speaking at the meeting was CropLife Canada plant biotechnology executive director Jennifer Hubert, who presented a draft document designed to provide stewardship considerations and best practices for responsibly introducing seeds containing generic novel traits to the Canadian marketplace.
“We really wanted to focus on awareness and recognizing that there are going to be companies coming forward and selling generic traits that may not have the same experience that some of the innovator companies have had in bringing these traits to the market,” Hubert told Germination prior to the meeting.
“There are many responsibilities that come along with that, be it stewardship around resistance management, or securing market access. Even when you’re just launching something in Canada, you still need to get export market approvals. With generic traits, those will all be in place, but some of the export market approvals expire, which makes it complicated.”
According to Hubert, questions that arise include:
- What if the innovator decides they’re going to exit the market?
- How do we make sure everyone’s aware of when those approvals are going to expire, and who should be responsible for maintaining them?
“So, the document we’ve created is really about awareness, awareness of things everyone needs to be thinking of, because everyone has a role to play in properly stewarding these products” Hubert said.
“Anyone selling the product is going to have some responsibility. This document is really about bringing the awareness of what needs to be done and things that should be considered when launching the product.”
Considerations for the original developer include:
- Continue to secure existing export market time-limited authorizations while marketing the product.
- Engage in dialogue when approached by SGNT marketers or value chain stakeholders interested in becoming involved in the maintenance of existing export market time-limited authorizations.
- Make publicly available relevant product-specific stewardship practices that help to protect the product, integrity, efficacy and durability in the Canadian marketplace (e.g. product use guides).
- Communicate to the value chain known expiry dates for export market authorizations with sufficient advance notice.
Considerations for entities marketing SGNTs (e.g. seed companies other than the original developer selling generic seed) include:
- Follow the CropLife Canada “Best practices for launching plant breeding innovations”, as though it is a new product. It is recommended this take place in advance of any seed sales and involves conducting a market access assessment and consultation with the value chain regarding intentions to market the product.
- As needed, proactively engage in dialogue with the original developer with respect to the developers plans for maintaining existing time-limited approvals in export markets.
- As a result of the value chain and developer consultations, develop a plan with respect to how existing export market time-limited authorizations will be maintained or other considerations for supporting trade as needed. This may include considerations for sharing or taking on responsibility of maintaining existing approvals.
- If an SGNT marketer pursues maintaining regulatory approvals for an SGNT, considerations should be given to communicating relevant information to the value chain.
- Be aware of and promote any product specific stewardship practices that may be needed to protect the product integrity, efficacy and durability in the marketplace. This information should be publicly available by the original developer.
Considerations for the value chain include:
- Communicate general information to seed marketers on the importance of market access considerations associated with distributing products including SGNTs.
- As needed, provide specific input to seed marketers to support the development of market access plans.
- Be aware of, promote and/or adopt (as relevant) good stewardship practices promoted by seed developers.
Hubert says CropLife Canada is looking for value chain input on the document.
“We’ve been hearing from the value chain that they want to know how these products are going to be managed, and who’s going to be responsible for them. It’s important for them to weigh into this to make sure that they think everything is covered here in terms of the considerations we’ve laid out,” she added.
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