PMRA undermining government competitiveness agenda

SASKATOON, SK, June 21, 2013 /CNW/ - The Protection of Proprietary Interests in Pesticide Data in Canada (PPIP) regulation administered by the Pest Management Regulatory Agency (PMRA) has been a "headache" for companies that are trying to give farmers access to lower cost products.

The federal government is trying to create an environment within which the primary agriculture industry can be more cost competitive, but it seems the PMRA has not bought into that agenda.

"There's something wrong when farmers in southeast Saskatchewan have found Folicur available in North Dakota for less than $1.50 per acre, while their local price is over $8 per acre," said Darren Palendat, Product Manager with AgraCity Crop and Nutrition (AgraCity), who is one of several suppliers of generic products for Farmers of North America (FNA) Members.  He continued to say that "Banvel is 300% higher in Canada, and we can't convince our regulatory agency to manage the expedient registration of generics, even after the original registrant's exclusive marketing period has ended. It's critical that Canadian farmers are cost-competitive around the world, particularly with their U.S. counterparts."

Bob Friesen, VP Government Affairs with FNA, said many companies can't afford to engage in the process of registering new generic products because of how the regulations were implemented and are being administered. This includes a problem created by embedded contradictions between the ministerial agreement and the regulations. Generic companies and FNA Members have suggested two very concise changes—without compromising basic registrants' exclusive period or their right to data compensation—but the PMRA has taken no action.

"Canadian farmers have been frustrated long enough," said Friesen. "In fact, I am told by some generic companies that Canada is one of the toughest countries in which to register a generic chemical. We are asking the federal health and agriculture ministers to step in and resolve the PMRA's intransigence."

PPIP was implemented in 2010 to achieve balanced objectives, as was intended by the federal health minister. These objectives are not being met.

"PPIP gives original registrants patent protection and an exclusive use period, and we believe they should get a fair price for compensable data," said Friesen. "However, the regulation has ended up giving the original registrants far more than that, including the ability to delay the registration of generics—in some cases indefinitely."

The poor and unbalanced implementation of PPIP has put Canada far behind—compared to other countries—in providing Canadian farmers with lower cost generic alternatives and is occurring in spite of the fact that agriculture minister Ritz and his provincial colleagues included cost competitiveness as an important component in Growing Forward 2. Improving cost competitiveness is also a proactive move to reduce reliance on tax funded government programs in the future.

According to Canadian regulation, farmers and generic companies are entitled to register generics after a certain period, and original registrants are obligated to cooperate in return for an initial period of protection. This is something the PMRA appears to be resisting.

While there have been a few end use products registered since the implementation of PPIP, it does not justify the PMRA stumbling so badly on additional registrations that could save farmers millions.

FNA applauds the Harper government's agenda to increase industry competitiveness and to change or eliminate regulation that prevents competitiveness, as well as their desire to harmonize regulations with our competitor countries. They are on the right track.

"We thank Minister Aglukkaq and Minister Ritz for their work and for being an integral part of the government achieving its objectives, and we are now asking for their intervention on this issue. The message has obviously not resonated within the PMRA since it is clearly not helping the federal government achieve its goals and objectives. That is costing Canadian farmers millions of dollars and undermining their ability to be cost competitive."

Farmers of North America is a farmers' business alliance with the mission of "Improving Farm Profitability."

SOURCE: Farmers of North America

Bob Friesen, VP Government Affairs, FNA
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