Generic companies concerned about inaction
SASKATOON, SK, Dec. 6, 2013 /CNW/ - A group of generic crop protection companies are very concerned about the lack of progress in improving the process to register generic pesticides. It's been a full three years since company representatives met with the PMRA to identify the issues, point out inconsistencies, and submit proposals for a solution. However, none of the issues, even though acknowledged by the PMRA, have been dealt with.
The generic companies are frustrated with the progress to date. Some have pulled applications out of the process. The lack of progress deny Canadian farmers' access to an array of generic crop protection products similar to what we find in the US market. Consequently it has become a competitiveness issue for Canadian farmers in US and international markets. We know that the government implemented the Red Tape initiative so that regulatory complications will not inhibit competitiveness. The Federal Government further engaged in the Regulatory Cooperation Council with the US to harmonize policies and regulation for our integrated industries. This is a classic example of where those two initiatives could make a huge difference. In the US the process to register generic pesticide products is much faster and less onerous. There isn't an industry more integrated than the US-Canada grains and oilseed sectors.
Right now Canada ranks as one of the most difficult places in the world to register a generic pesticide. Generic companies simply want the PMRA to do what they state as one of their policy objectives, to create "...favourable conditions for generic pesticide producers to enter the pesticide market and to increase the selection of products available to the user."
Generic companies are not asking to eliminate fair compensation for relevant data that is to be relied upon for a registration. Nor do they want to undermine the ten year exclusive period. The PMRA should remove the barriers to entry and ensure that the process facilitates easy access into the market for generic products.
We urge Health Minister Rona Ambrose to advise the PMRA to make the changes necessary to create "favourable conditions for generic pesticide producers to enter the pesticide market and to increase the selection of products available to the user".
Source: Mana, NewAgCo, Cheminova, UPI, Albaugh. Together, they represent a group of companies that register generic crop protection products used by farmers in Canada.
SOURCE Mana, NewAgco, Cheminova, UPI, AlbaughFor further information:
Barbara Yates, MANA Canada