PMRA inaction on generic pesticides costs farmers

Farmers are paying inflated pesticide prices because the federal Pesticide Management Regulatory Agency takes far too long to approve generic versions of brand name weed and bug killers, Farmers of North America says.

Saskatoon-based FNA says in a statement that a massive price differential exists between pesticide products in Canada and the U.S. because of PMRA inaction. It takes at least two years to bring a generic version to market in Canada after the patent of a brand name product expires, compared to six months in the U.S.

“It makes no sense,” says Darren Palendat, crop protection manager with AgraCity Crop & Nutrition, one of the companies that supplies products for FNA members. “PMRA actually conceded that the problems existed, yet nothing has been done to remove them.”

In some cases, because of regulatory contradictions and PMRA management, companies are simply throwing up their hands in frustration and walking away from the process, he added.

FNA said another of its suppliers has had an application in the process for four years that is still not completed. “PMRA cites policy issues as the reason for the delay,” its release says.

The farmers’ buying group and its suppliers have pointed out the problems at PMRA for three years, yet the agency “appears to be no closer to finding solutions” correcting the issues surrounding its Protection of Proprietary Interests in Pesticides regulation, Palendat said.

The generic companies don’t object to the 10 years of patent protection the brand name companies have to recoup their development costs. They are also entitled “to be fairly paid for relevant and legitimate data” the generics use.

The stumbling block for the generic companies is PMRA handed the brand name companies “the tools to control the process,” he added. “These are the very companies that will do almost anything to keep a generic product out of the market.”

In a separate statement, the generic companies said PMRA’s inaction denies “Canadian farmers’ access to an array of generic crop protection products similar to what we find in the U.S. market. Consequently it has become a competitiveness issue for Canadian farmers in U.S. and international markets.” The companies are Mana, NewAgCo, Cheminova, UPI and Albaugh.

The PMRA inaction has survived both the Harper government’s Red Tape initiative and participation in the Regulatory Cooperation Council with the U.S. to keep regulations from inhibiting competitiveness.

When asked to comment on the FNA and companies’ statements, PMRA issued a statement that didn’t deal with their complaints.

Since the data protection regulations came into force in 2010, Health Canada’s Pest Management Regulatory Agency (PMRA) has registered 77 generic pesticides. The PMRA continues to work with stakeholders to refine the data protection system to meet the needs of data owners and generic manufacturers and best serve Canadian growers.

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