Proposed new regulations governing the registration of generic pesticides could save growers millions of dollars starting as early as spring 2010.
The regulations, drafted by Health Canada and published in the Canada Gazette on Nov. 14, are designed to speed up entry of competitively priced generic pesticides into the Canadian marketplace.
“We’ve cut the length of time for generics to come to market substantially,” said Richard Phillips, executive director of Grain Growers of Canada.
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According to a statement prepared by Health Canada, the rules would allow generics to enter the market about one year sooner than under the previous policy.
The agency predicts that by introducing price competition into the market earlier, growers will save an estimated $11 million to $26 million over 10 years, depending on the number of generic submissions brought forward.
Phillips thinks the agency low-balled that estimate. Not only will generic companies be able to start negotiating with innovator companies a year before the product comes off patent, but there is a process that prevents negotiations from dragging out.
“The new regulations will cut it from a three-year process to less than a year to bring a generic to market. That’s a big step forward,” he said.
The regulations also provide innovators with the opportunity to extend the 10-year patent protection period associated with their products by adding minor uses to the original registration.
Chemical companies have traditionally been reluctant to spend money on gathering the residue and efficacy data required to support registration on minor use crops. But they may be willing to do so under rules that give them an additional year of protection for every three minor uses.
All told, the minor use provisions could provide innovators with up to five years of additional data protection.
In its cost-benefit analysis, Health Canada said it was reasonable to anticipate that benefits to growers of minor crops would outweigh costs to other growers from extended data protection.
The agency said there is a national list of approximately 3,600 minor use needs. The needs of tree fruit and berry growers are particularly acute.
Phillips said it’s difficult to assess whether the minor use clause is a net benefit or net cost. He leans toward it being a good thing for growers.
But, he said, when viewed overall, the proposed regulations have to be seen as a positive.
“When we look at all this, the pluses and minuses, I’d say we’re strongly in favour of this.”
Phillips favours a clause that allows generic companies to get products to market before they receive permission from the innovator company.
Generics can do this by depositing funds in escrow sufficient to meet the innovator’s last offer made at the end of the negotiation period. Phillips said that prevents delays caused by an arbitration process.
Interested parties have 75 days from publication to comment on the proposals. If Health Canada determines no serious amendments need to be made, the regulations could become law by the end of February.
Phillips said that would pave the way for some of the dozens of generic products already in the queue to get to market by spring 2010.
He warned grower groups against proposing major changes to the regulation because that could result in a long delay in implementation.
