Why does a drug or other product that is available in the United States take so long to be approved in Canada?
Why is a product that appears to be effective and popular no longer available?
Pharmaceutical companies that develop a new product must
submit an application to a federal government agency along with all the testing and trial work. This agency reviews the documentation and asks the pharmaceutical company to supply additional information if required. That is where the problem lies.
In Canada, the average time for a new product from first submission to response from the regulator is 1,200 days, which is more than three years and three months. Other countries are much quicker.
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The U.S. averages 180 days and the European Union averages 210 days.
In Australia, a country comparable to Canada in resources, population and dependence on agriculture, the period is 240 days.
Canada is doing something wrong.
Pharmaceutical companies pay for their submissions, which may cost more than $100,000. They are required to deal with additional data requests that come at different times from different sections of the agency:
human safety; animal safety; clinical efficacy and manufacturing.
This results in chaos and ineffective use of time.
I favour careful testing of new products, but in most cases the wheel does not need to be reinvented.
Australia works in collaboration with New Zealand. The two countries pool resources and work co-operatively. They also work smarter because they take note when studying a product that has already been approved by the EU or the U.S.
Why should Canada, which is a small market, ask for the same raw data when the same testing has been done elsewhere? Harmonizing our review process with the U.S. would seem to make sense and reduce the burden on taxpayers.
In agriculture, products move back and forth all the time. With the own use clause, producers can acquire products for their own livestock on products technically not approved in Canada. They should be approved but because of the long submission review, approval times are five to seven years longer than in the U.S.
Companies cannot properly launch new products because they have no idea when approval will come. Often, when approval is granted, the optimal season for use has passed, which delays introduction almost another year.
As an example, new longer-acting antibiotics were anticipated to be out last fall. They were not and may be released this spring. The optimal time for use has passed and will not return until fall.
These delays hurt Canadian
producers’ competitiveness and
discourage pharmaceutical companies from investing in Canada. I have heard that a number of
companies are avoiding working in Canada or submitting new registrations here.
Something must change or companies will avoid Canada altogether. Ten years ago 25 people administered drug submissions. Today 101
people do so and due process has continually slowed.
It would be nice if Canada would automatically follow suit if three or four members of the G7 nations approved a product. Often the same requirements are sought in all the countries in areas such as safety, withdrawals and efficacy.
The George Morris Centre in Guelph, Ont., conducted an economic study looking at what these long delays cost to the Canadian economy. From jobs to the benefits to the livestock population, the
costs were staggering.
All this cost comes from a small government department that is
bureaucratically embroiled in itself. It is no wonder some estimate that the total red tape costs of all government departments has reached
$33 billion.
This is a staggering amount and causes Canada to lose competitiveness.
To add insult to injury, companies may be required to submit new data on old products. A recent example is the requirement that new data be
submitted on growth promotants since 1995.
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 and threaten the product’s availability. This is why old products will on occasion be removed from the marketplace.
Any changes such as manufac-turing site or the source of the raw products must be reported.
Although manufacturers would like approvals for these minor changes to take no longer than three months, they can take considerably longer than that. We need clarifi-cation on minor and major changes so streamlining can occur.
Other-wise this can be economically devastating to the Canadian livestock population and the companies that supply it.
Canada is about 22nd on the list of countries in which pharma-ceutical companies want to market. In light of this, I am surprised that any companies are trying to launch new products here. Our market share is small and the process is arduous. Things must improve soon or all investment in Canada will spiral down.
Voice your concerns with your member of Parliament, because most are probably unaware of this.
Maybe the timelines can be brought into reason.
Roy Lewis is a veterinarian practising in Westlock, Alta.
