What you’ve heard is true: Canada does in fact take longer than the U.S and the European Union to approve new drugs. According to a study published by the Canadian Medical Association Journal (CMAJ), delays in submitting new drugs to Health Canada for review have had a huge impact on this, with certain products being delayed for up to two years.
Of course, proceeding with caution is paramount when the side effects of new drugs are unknown. However, for those living with chronic disease, this means an extended delay in access to what could be life-saving medication.
Where it begins
Before prescription drug products are authorized for sale in Canada, scientists at Health Canada assess them for safety, efficacy, and quality. Firstly, new drugs must undergo a series of preclinical tests, if the results of which prove desirable and non-toxic, the sponsor (individual or company taking responsibility for the application) can apply to the Health Products and Food Branch (HPFB) of Health Canada for a clinical trial.
If the trial results show greater potential therapeutic value than the risks associated with drug use, the sponsor (typically a pharmaceutical company), can then apply for a ‘New Drug Submission’ with HPFB where another round of tests take place. Although the HPFB does have a priority review process in place for drug products used for “life-threatening” or “severely debilitating conditions”, access can be further delayed at a provincial level.
Chronic heart failure patients in Canada now have access to the prescription drug Entresto, yet there are still limitations on Indigenous populations. Meanwhile, the drug Ivabradine which can be used for the treatment of stable heart failure, was only approved by Health Canada in 2017. Here’s the reality: It had been authorized by the European Medicines Agency five years prior to this, in 2012.
Canadians with public health insurance have access to medical and hospital care, but not full prescription coverage. This is, according to the Canadian Alliance for Sustainable Health Care, because access is a mix between public prescription drug plans and private insurance plans.
The tragic result is that one in ten Canadians cannot afford out-of-pocket costs for the prescription drugs they need. At least one million go without food or heat and forego other household spending in order to purchase the drugs.
Survey findings on the consequences of patient charges for prescription drugs in Canada published by CMAJ Open revealed that additional charges for prescription drugs cause individuals to use more health care services than they would have otherwise, “to skip doses or reduce dosages, delay refilling prescriptions, or refrain to fill prescriptions at all.” This is known as “cost-related nonadherence.”
Furthermore, the results found this to be more common among younger Canadian adults (notably females), lower income groups, Indigenous peoples, and those with poorer health status. It stated that the higher rate of “cost-related nonadherence among Indigenous peoples likely results from structural barriers in the health care system.”
Yes, the First Nations and Inuit Health Branch of Health Canada does provide “universal prescription drug coverage to eligible patients through the Non-Insured Health Benefits Program.” The problem? More than half of all Indigenous people in Canada don’t qualify for this coverage.
Public spending on medications
The Government announced an “Advisory Council on the Implementation of National Pharmcare” in the 2018 Federal Budget. The Council will be studying and analyzing domestic and international programs for full prescription drug coverage before recommending options for implementation in Canada. But how long will those suffering from chronic illness have to wait?
According to a report on provincial public expenditures on medications by the Canadian Institute for Health Information (CIHI), in the time between December 2014 and November 2016, BC only launched 31 (15%) of a possible 209 single source products. Over the same period, Alberta launched 55 products, Ontario 52, Manitoba 64, Quebec 40, Nova Scotia 63, and New Brunswick launched 80.
Overall, medication spending represents only 7.4% of the total provincial/territorial government spending nationally, as stated in a pharmaceutical payer analysis by CIHI.
Provincial spending ranges from a high of 9.1% in Ontario to a low of just 4.9% in British Columbia. The BC government spent $942.6 million on medication in 2010-11, but since then strict budgeting has reduced the sum - it was $927.4 million in 2015-16. A news release issued by the Better Pharmacare Coalition in February 2018, noted that BC’s expenditure on prescription medications is the lowest in Canada on a per capita basis (34% below the national average).
This translates to approximately 40 drugs not being listed for coverage on the BC public formulary that are covered in at least one other Canadian province.
Greater need for patient advocacy
It’s estimated that $14.5 billion (42.7%) of prescribed drug spending was financed by the public sector in 2017. By comparison, $12.1 billion (35.5%) was financed by private insurers, and the remaining $7.4 billion (21.8%) was funded by Canadian households, according to CIHI’s 2017 report on prescribed drug spending.
In January 2018, Ontario became the first province to cover the cost of prescription medications for youth under the age of 25. While this is a great start, it may not benefit many heart failure patients. Health Canada have confirmed that approximately 2.4 million individuals living with heart disease in the country are 20 years of age or older.
The disparity between provincial public expenditure on medications and the high cost of prescription drugs once they are approved for distribution in the market mean that the need for patient advocacy is greater than ever before.
At HeartLife, we’re advocating for better care and working with organizations to help give patients access to the latest therapies and often life-saving medications. The road ahead is long, and we’re committed to supporting heart failure patients nationwide, every step of the way.