New Fraser Institute report suggesting reduced regulation will accelerate access to new ‘life-saving drugs’ in Canada builds on data that shows drug companies are responsible for the delay, not the regulations. health.
The report, titled “Timely Access to New Pharmaceuticals in Canada, the United States and the European Union,” compares the time it takes for new drugs to be approved in Canada, the United States and the United States. in the EU.
Unsurprisingly, the right-wing think tank says it has found evidence showing why health regulations need to be removed so that big pharmaceutical companies can sell their products as quickly as possible.
Why? There are a number of reasons – read more here: https://t.co/Hu0ZwdApDG pic.twitter.com/B4WcMBelYT
– The Fraser Institute (@FraserInstitute) May 13, 2021
First, the Fraser Institute says drugs were approved on average 469 days earlier in the United States than Canada between 2012/2013 and 2018/2019, and on average 468 days earlier in Europe.
It has made headlines in right-wing media like the Toronto Sun and The Epoch Times suggesting that long waits for “government to approve drugs” result in long delays for “life-saving drugs”.
My Sun Media Thursday Column: Long waits for life-saving drugs harming Canadians: We wait 15 months longer on average for new potentially life-saving drugs compared to Americans and Europeans: study https://t.co/0A8H1xkZwD #cdnpoli
– Lorrie Goldstein (@sunlorrie) May 13, 2021
Except these headlines are misleading.
In the Fraser Institute’s own report, it is admitted that the 15-month deadline has little to do with Canadian regulators.
In fact, the Fraser Institute admits that the “most important factor” in explaining the delay is that the drug companies themselves waited hundreds of days before submitting drug approval applications to Health Canada:
“The most important factor in explaining these delays in approving new drugs in Canada is the difference in the dates on which manufacturers have submitted new drugs to agencies for regulatory approval.
In other words, the main reason for the delay is that the drug companies never bothered to file their documents.
Although an infographic accompanying the report claims that the average “wait” for “new drugs” in Canada is 469 days compared to the United States, but the fine print buried in the Fraser Institute report indicates that ‘there is an’ average difference of 464 days between submission dates’. between when pharmaceutical companies file documents in either country.
So the average gap between regulators approving new drugs once they have received applications is actually closer to four days, not 469 days.
Likewise, the average difference between approval dates in Canada and the EU consists of an average gap of 395 days between submission dates and an average of only nine days between regulatory bodies approving new drugs.
While the deadline is tied entirely to when companies choose to file their own documents, the Fraser Institute argues that Canada should remove mandatory approvals for new drugs anyway.
The report recommends that Canada completely abandon mandatory requirements for drug approval and instead accept approvals from the U.S. Food and Drug Administration or the EU’s European Medicines Agency as sufficient to grant the access to the sale of new drugs in Canada.
“The obvious benefits of this approach would be a reduction in the costs of entering the Canadian market and a significant reduction in the time it takes for Canadians to access new drugs,” concludes the Fraser Institute report.
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However, Dr Joel Lexchin, professor emeritus of health policy at York University, said the Fraser Institute recommendations pose several problems.
Dr Lexchin noted that several studies have shown that the FDA and EMA don’t always come to the same conclusions about approved drugs, and the same is likely between Health Canada and other regulatory bodies. Dr Lexchin explained that this raises questions about whether or not Canada would decide whether or not to approve a new drug if the FDA and EMA come to different conclusions about its safety and effectiveness.
“In the United States, the job of the FDA commissioner is a presidential nomination, which means that a Republican president will nominate someone with right-wing views and the same for a Democratic president,” Dr. Lexchin said. PressProgress.
“EMA relies heavily on external consultants and these people often have conflicts of interest and these can affect regulatory decisions,” added Dr Lexchin.
“There is a culture of regulation that has developed, which means that the evidence will be interpreted differently – there is always a subjective element in the interpretation of the evidence.”
The Fraser Institute speculates “several reasons” as to why pharmaceutical companies take longer to file applications for the sale of new drugs in Canada, including the attractiveness of the market in each jurisdiction and “the additional financial burden involved. by the user fees and costs associated with creating a quote for a particular agency. “
However, Dr Lexchin said the lax US approach to drug pricing was the most important factor.
“Pharmaceutical companies typically seek approval first in the United States because the FDA process is faster than other regulators, but more importantly the United States does not control the prices and there is therefore has more money to earn faster than anywhere else, ”said Dr. Lexchin explained.
“If Health Canada didn’t give its own approval, that probably wouldn’t change when drugs are submitted to Canada, because there would always be no more money to be made here. As rational economic actors, pharmaceutical companies go where they can maximize their revenues. “
The United States has some of the highest drug prices in the world, which means many American patients cannot afford life-saving prescription drugs.
Ultimately, Dr Lexchin said, the Fraser Institute report makes the false assumption that all new drugs have benefits and distorts the data through a right-wing ideological framework.
“This report makes the same assumption as almost every right-wing think tank (and Innovative Medicines Canada) that every drug is an important therapeutic innovation and that patients will reap major benefits from every new drug.” . This is simply not the case, ”explained Dr Lexchin.
“I reviewed all of the new drugs approved in Canada from 2010 to 2018 that were independently assessed for their therapeutic value compared to drugs already on the market (287 drugs approved and 224 with therapeutic reviews).”
“Only about 10% provide a significant new therapeutic benefit.”
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