Why should Canada, a small market, ask for the same raw data when the same testing has been done elsewhere?
Acommon question from livestock producers is, “Why is it taking so long for product X to come on the market? They are using it in the States. Why can’t we get it here?”
Or, “Product Y worked so well. Why is it no longer available in Canada?”
This article will I hope clarify some of these questions and direct producers to where to express their complaints, and help our whole industry advance.
Pharmaceutical companies trying to get a new product approved must submit an application along with all the testing and trial work to a federal government body. It reviews the documentation and if anything else is required, requests it from the company. Herein lies the problem.
In Canada currently the average time for a new product from first submission to response from the regulator is 1,200 days. That’s right, 1,200 days or 3.29 years if my calculations are correct.
The U. S. averages 180 days and the European Union 210 days. Australia, which is comparable to Canada in resources, populat ion and dependence on agriculture, is 240 days. It is obvious in Canada something is seriously wrong. This by the way is a service the pharmaceutical companies pay for. Submissions may cost upwards of $100,000.
With this kind of snail’s pace service why aren’t the companies demanding better? In Canada the current process is the only game in town – a type of monopoly on service and individual personalities get in the way.
On an ongoing basis companies are required to deal with additional data requests (ADLs) coming from different sections (human safety, animal safety, clinical efficacy and manufacturing) at different times. This brings chaos and inefficiency.
OTHERS SHARE DATA
I am all for careful testing of new products regarding withdrawals, precautions safety, etc., but in most cases why reinvent the wheel? In Australia they work collectively in collaboration with New Zealand. They pool their resources and work in cooperation for the betterment of everybody. They also work smarter than us because they put weight on the fact that a product has already been approved by the EU or the U. S. Why should Canada, a small market, ask for the same raw data when the same testing has been done elsewhere? Harmonizing our review process with the United States would seem to make sense and not burden our taxpayers so heavily.
Agriculture products are moving back and forth all the time. With the own-use clause, producers can acquire products technically not approved in Canada. They should be approved but because of the long review times are five to seven years behind the U. S. Companies cannot do proper launches of new products since they have no idea when approval will come. Often when it does the optimal season for usage has passed, delaying implementat ion almost another year.
Canada is a relatively small livestock producer and this huge delay is putting Canadian producers in a very non-competitive position. Why then in the future will pharmaceutical companies want to invest in Canada? I already hear that some companies are avoiding doing work in Canada and in submitting new registrations here. This is a reality. Something must change or companies will avoid Canada altogether. Ten years ago there were 25 people administering drug submissions. Today there are 101 people and the due process has gotten slower and slower and slower.
It would be nice if for example three or four members of the G7 nations approved a product that Canada would automatically follow suit. Often the same requirements are done in all the countries for safety, withdrawals, efficacy etc.
REDUCES CANADIAN COMPETITIVENESS
A George Morris Centre study of these long delays cites high costs from jobs lost to the benefits to the livestock population. All this cost from a small government department which is bureaucratically embroiled in itself. It is no wonder a figure of the cost of total red tape of all government departments to the Canadian economy has been quoted at $33 billion. This is a staggering amount and causes Canada to further lose competitiveness in the world marketplace.
To add insult to injury companies may be required, often out of the blue, to submit new data on old products. An example of the latest one is new data must be submitted on growth promotants post-1995. Needless to say growth promotants have stood the test of time. They continue to be purchased so I presume they work and this type of testing will drive up the cost or companies will feel it is no longer worth pursuing. This is why old products will on occasion be removed from the marketplace.
Any changes such as manufacturing site or the source of the raw products must be repor ted and al though manufacturers would like a no longer than three-month approval on these seemingly insignificant changes, they can take considerably longer.
Currently Canada is about 22nd on the list for livestock pharmaceutical sales. I am actually surprised in light of this that any companies are trying to launch new products here. Our market share is small and in the current situation the process is extremely arduous at best. Things must improve soon or all investment in Canada will spiral down. Voice your concerns with your local members of Parliament. Most are probably unaware of this and maybe the timelines can be brought into reason.
Roy Lewis is a large animal veterinarian practising at the
Westlock Veterinary Centre. His main interests are bovine
reproduction and herd health.