Trump's Drug Pricing Push Exposes Flaws in Canada's Health Technology Assessment System
核心洞察
Canada's health technology assessment (HTA) process relies on inadequate premarketing clinical trial data that fails to reflect real-world effectiveness, distorting drug coverage decisions.
The QALY-based cost-effectiveness threshold of $50,000 used in Canada has not been adjusted since the 1990s and undervalues both healthy life and scientific innovation.
The Trump administration's executive order linking U.S. drug prices to foreign reference prices may incentivize manufacturers to delay or skip launches in low-price markets like Canada.
Donald Trump's latest executive order to slash prescription drug prices in the United States is sending shockwaves through Canada's pharmaceutical pricing system, exposing fundamental weaknesses in how the country evaluates and covers new medicines. The order, signed last May, instructs the U.S. Trade Representative to ensure foreign countries are not "forcing American patients to pay for a disproportionate amount of global pharmaceutical research and development, including by suppressing the price of pharmaceutical products below fair market value."
As a result, Washington now requires pharmaceutical manufacturers to sell new prescription drugs at the lowest price for which they sell in a select group of reference countries. Since the American market accounts for roughly half of all patented drug purchases, this policy shift will dramatically reduce global industry revenues and reshape international pricing dynamics.
For Canada, the implications are stark. The country's health technology assessment (HTA) system — one of five layers of drug gatekeeping that manufacturers, clinicians, and patients must navigate — relies on methods that systematically undervalue both the worth of a healthy life and scientific innovation.
Four Critical Flaws in Canada's HTA System
According to analysis by John Adams, senior fellow at the Macdonald-Laurier Institute (搜索), and Nigel Rawson, Canada's drug evaluation framework suffers from at least four distinct deficiencies.
First, current HTAs are based on inadequate data drawn from premarketing clinical trials. These randomized controlled studies enroll standardized patients with precisely defined diagnoses who are vigilantly monitored to ensure perfect medication adherence. "The sample of patients in clinical trials are rarely representative of the spectrum of the population when they typically exclude people with more than one sickness," Adams and Rawson note. What is needed, they argue, is effectiveness data — the extent to which a drug used in routine clinical practice does what it is intended to do.
Second, HTAs typically use a drug's list price rather than the price eventually negotiated by large purchasers such as government drug plans. Despite their apparent sophistication, these assessments rely on pricing data that can distort coverage decisions.
Third, HTAs employ quality-adjusted life-years (QALYs), which compress quality and quantity of life into a single, simplistic metric on a linear scale from 0 (death) to 1 (perfect health). "In reality, disease burden is a complex, non-linear physical, psychological, and social condition," the authors state. "The use of QALYs in this way is not fit for the purpose of determining the genuine value of a new drug."
Fourth, the assumed value of a QALY — the willingness-to-pay threshold — remains set at $50,000 in Canada, a figure dating to the 1990s that has never been adjusted for inflation, economic growth, disease severity or rarity, or rising innovation costs. This threshold is low by international standards and has enabled Canada's Drug Agency (搜索) to recommend price cuts of up to 93 percent. "The Trump take could be the Canadian government system wants drugs for 7 per cent of what Americans are called on to pay," Adams and Rawson observe.
The UK Model and Potential Consequences
The United Kingdom has already responded to U.S. pressure by agreeing to pay up to 25 percent more for new medicines through a raised QALY threshold as part of a zero-tariff trade deal. UK spending on innovative medicines will increase from 0.3 percent of GDP to 0.35 percent by 2028 and double to 0.6 percent by 2035.
In contrast, Canada's continued reliance on negotiated price cuts and strict eligibility criteria may lead to greater delays and restricted access. The new U.S. rules give pharmaceutical companies an incentive not to launch new drugs in markets where governments keep prices low — no launch means no sales and no lower reference price. "Each delay or denial imposes a real cost in poorer health outcomes," Adams and Rawson warn.
A Call for Reform
In the United States, 29 patient advocacy groups have formed Value Our Health (搜索) to push for changes in value assessments. Their key principles include addressing costs and benefits that matter to patients — such as lost time at work, risk of disability, and caregiving needs — while acknowledging diversity among patients rather than using one-size-fits-all summary measures like cost per QALY.
Adams and Rawson argue that Canadian governments should adopt these principles and replace what they describe as "contentious and flawed value assessments for new medicines." They advocate for initial and rapid drug listings followed by real-world studies and price adjustments based on actual benefits in regular clinical practice, with cost-effectiveness thresholds appropriate to disease severity. "For example, diseases rapidly leading to death or crippling disability should be assessed against a much higher QALY threshold than minor or moderate conditions," they conclude.