Are Therapeutically Important Drugs No Longer Available in Canada?

Abstract

The pharmaceutical industry and its allies often claim that various aspects of Canadian pharmaceutical policy result in new drugs not being introduced into the Canadian market. These arguments ignore international evidence that shows that only a minority of new drugs offer major therapeutic gains. A corollary to the industry's message is the threat that new drugs will not be made available if governments or regulatory agencies introduce measures that threaten the profits of pharmaceutical companies. The government should not be intimidated by these threats and should continue to take actions that increase accessibility to necessary medications for all residents of Canada.

Introduction

Pharmaceutical companies, Innovative Medicines Canada (IMC), the lobby organization representing the majority of the large drug companies operating in Canada, and their allies often point out that many new drugs are not marketed in Canada. They attribute this situation to the complexity of Canadian drug pricing policies, the lack of incentives to introduce new drugs, lax Canadian intellectual property laws and overall indifferent government support of the industry (IMC 2022; Skinner 2024). This commentary synthesizes the existing evidence about whether new drugs that offer significant therapeutic advances over existing products are being withheld from the Canadian market. In doing so, it makes it clear that although the question has not been definitively settled, the bulk of the evidence supports the position that products that offer major therapeutic gains are still being introduced into Canada.

Examples of New Drugs Not Available in Canada

Nigel Rawson and John Adams, both of whom have extensive ties with the pharmaceutical industry (see the Declaration of Interest in their article), claim that Canadian drug pricing policies are one of the main reasons why orphan drugs (drugs for rare diseases) are not marketed in Canada (Rawson and Adams 2024). They point to five drugs for Duchenne muscular dystrophy that are available in the US but not in Canada.

A second example is a December 2021 report from researchers at McMaster University that named 15 newly developed antibiotics that were not available in Canada (Table 1) (Burrows et al. 2021). Sponsors of the report included IMC, Merck and GlaxoSmithKline. (One of the 15 antibiotics had actually been approved in Canada before the report appeared.) Indirectly, the authors attributed the absence of these antibiotics to the need for new government incentives.

Table 1.

Therapeutic evaluation of antibiotics not available in Canada

Generic name	Evaluation of additional therapeutic value			Highest of the three ratings	Notes
	Prescrire International (France)	Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Germany)	Haute Autorité de Santé (France)
Bezlotoxumab	Not acceptable	Proof of nonquantifiable (at most considerable) added benefit	Minor	Moderate
Cefiderocol	Judgement reserved	No evaluation	Moderate	Moderate
Ceftaroline	Nothing new	No evaluation	Minor	Minor
Ceftazidime/avibactam	Possibly helpful	No evaluation	Moderate	Moderate
Delafloxacin	Nothing new	No evaluation	None	Minor
Eravacycline	No evaluation	No evaluation	None	Minor
Imipenem-cilastatin/relebactam	Nothing new	No evaluation	Moderate	Moderate
Lascufloxacin	No evaluation	No evaluation	No evaluation	No evaluation
Lefamulin	No evaluation	No evaluation	No evaluation	No evaluation	Approved by Health Canada on July 10, 2020; cancelled premarket by manufacturer
Meropenem/vaborbactam	Possibly helpful	No evaluation	Moderate	Moderate	Approved by Health Canada on December 20, 2024
Omadacycline	No evaluation	No evaluation	No evaluation	No evaluation
Oritavancin	No evaluation	No evaluation	None	Minor
Plazomicin	No evaluation	No evaluation	No evaluation	No evaluation
Sarecycline	No evaluation	No evaluation	No evaluation	No evaluation
Tedizolid	Nothing new	No evaluation	No evaluation	Minor	Approved by Health Canada on March 17, 2015; wrongly classified by authors as not approved in Canada; cancelled premarket by manufacturer

A final example is an Ernst & Young LLP report commissioned by IMC and PhRMA, IMC's US equivalent (Ernst & Young LLP 2019). The report examined how Canada ranked in terms of marketing new drugs that had been approved globally. Over the period from January 2011 to June 2018, 243 drugs were launched, 124 of which were not available in Canada, ranking Canada 14th out of 69 jurisdictions in terms of total launch count. The report attributed the relatively low number of launches to Canada's drug pricing policies.

Therapeutic Value of New Drugs

All these comments and many other similar ones fail to consider the fact that only a small minority of new drugs are major therapeutic advances over existing products, and the majority are no better than what we currently have.

Out of 145 new drug indications approved through either the Food and Drug Administration's (FDA) accelerated approval pathway or the European Medicines Agency's (EMA) conditional marketing authorization pathway from 2007 to 2021, 38.9% and 37.5%, respectively, demonstrated high therapeutic value (Vokinger et al. 2022). In Canada, only 55 (10.8%) new drugs out of 509 approved between 1995 and 2016 were rated as innovative (Lexchin 2018). Out of 290 new drugs launched in the UK in roughly the same time period, only 26% were rated highly innovative (Ward et al. 2014). After investigating the added therapeutic benefit of 216 new drugs and new indications for existing drugs introduced into the German market between 2011 and 2017, the German health technology assessment agency Institute for Quality and Efficiency in Health Care (IQWiG) concluded that only 54 (25%) drugs had a considerable or major added benefit (Wieseler et al. 2019). Prescrire International reports that out of 1,027 new drugs and new indications for existing drugs that were introduced in France between 2014 and 2023, only 17 (1.7%) drugs were major therapeutic advances in an area where previously no treatment was available or were important advances but with certain limitations (Prescrire Editorial Staff 2024).

Pharmaceutical companies will admit that not all drugs are major advances; however, according to the director general of the European Federation of Pharmaceutical Industries and Manufacturers, they are still valuable. “How can you argue against options? Offering a greater number of choices allows patients and doctors the possibility to determine a treatment that not only works, but works best for that particular patient” (Bergström 2014).

The absence of any consideration of the degree of therapeutic benefit is seen in both the article by Rawson and Adams (2024) and in the antibiotic report. The drugs for Duchenne muscular dystrophy were approved using a surrogate endpoint – a small increase in a muscle protein – and according to one review, “questions remain about the effectiveness and long-term safety of these products” (Bendicksen et al. 2023). Ten of the 15 antibiotics not available in Canada had been evaluated by one or more of three independent international organizations – the French Haute Autorité de santé (2024), the German IQWiG (2024) and the French drug bulletin, Prescrire International (Prescrire International: A Critical Eye on New Drugs Authorised in Europe 2024). Five were considered minor improvements, and an additional five were rated as moderate improvements, but none were major improvements. However, the impression one gets from reading the report is that the introduction of these antibiotics would make an important contribution to controlling serious infectious diseases (Table 1). Page 19 of the report includes the statement, “This chart shows how novel antibiotics approved elsewhere could help treat infections caused by the pathogens Canada has deemed a priority.”

Industry Responses to Government Initiatives

A corollary to the message that Canada is missing out on new drugs is the threat from industry and its allies that new drugs will not be made available if governments or regulatory agencies introduce measures that threaten the profits of pharmaceutical companies. When the Ontario government was in the midst of passing legislation making it mandatory for drug and devices companies to report on “transfers of value” to healthcare professionals, organizations and institutions, in a brief to the Ontario government, IMC warned that the law could “have the effect of delaying or preventing the launch of new medicines in Canada” (Grant 2018). After the Patented Medicine Prices Review Board (PMPRB) proposed new regulations in 2016 (Health Canada 2017) that would have substantially reduced the price of new patented medicines, the response from IMC, once again, was that these changes would act “as a disincentive to the introduction of new innovative medicines to Canada” (IMC 2016) The Montreal Economic Institute, a free-market think tank, echoed IMC, saying that “this complexification of the assessment process for new drugs will in all likelihood affect their availability” (Bédard 2018). The opinion of the Canadian Organization for Rare Disorders, which lists 26 pharmaceutical corporate members on its website (Canadian Organization for Rare Disorders 2025), was that “there will be delayed access or, worse, no access to new medicines as a result of these changes, and this will harm patients” (Hoskyn and Field 2020).

Similar messages about the consequences of a national pharmacare plan came from the Fraser Institute, another free-market think tank, and IMC. The former claimed that “Unfortunately, in Canada, the proposed pharmacare programs are setting us up for failure. Specifically, Canadians may experience more limited access to new drugs, poorer health-care outcomes, excess burdens of taxation, and reduced pharmaceutical innovation” (Acri 2023). The latter warned that pharmacare “has potential to negatively impact Canadians' access to new, innovative treatments” (IMC 2024). In fact, a pharmacare system could improve access to drugs as federal/provincial/territorial governments take advantage of their monopsony buying power to increase access at lower prices, while at the same time giving pharmaceutical companies a guaranteed market for the life of the contract. This deal is how Australia significantly increased the number of people getting access to medicines to treat the hepatitis C virus at a price that was estimated to be 40% lower than it otherwise would have been. The existence of the agreement between the Australian government and the companies making the drugs strongly suggests that the companies found it attractive (Moon and Erickson 2019).

Are Therapeutically Important Drugs Missing From the Canadian Market?

Are Canadians missing out on therapeutically important new drugs, or could that happen in the future if the government introduces measures to lower drug prices? The answer to the first part of the question appears to be no. Gaudette et al. (2023) looked at 230 new active substances approved by the FDA or the EMA or both between 2016 and 2020, of which 75 were not marketed in Canada. Their analysis suggested that most of these drugs would reach few Canadians and would have a limited health impact. Tadrous et al. (2024) concluded that there was similar access to important prescription drug therapies in the US and Canada. (I am one of the co-authors on the Tadrous paper).

However, if drug prices are significantly lowered, there is uncertainty about whether this conclusion applies. An analysis was done of 242 new drugs launched before publication of the proposed PMPRB amendments and 107 drugs during the following period when it was uncertain whether the amendments would be adopted (Zhang et al. 2024). No negative impact on launches was observed when comparing Canada with other countries, except for molecules with major therapeutic benefits. The authors concluded that “reduction in launches of medicines with major therapeutic benefit in Canada requires continuing investigation” (Zhang et al. 2024). On the contrary, Lexchin (2023) found that although the number of therapeutically important medicines not being introduced into Canada following the announcement of proposed changes to the PMPRB regulations increased, that increase was not due to the proposed price reforms.

Conclusion

Not all drugs are marketed in Canada. The reassuring news is that most of them do not offer any therapeutic benefits beyond what are already available in the country, but that group of unavailable drugs may include a few therapeutically important ones. If that is the case, then in the short term we need to work to identify alternatives. In the longer term, we need to identify the reasons why companies are not submitting those drugs for approval and see what changes need to be made in a manner that takes into account the need to ensure accessibility. It is also important that the government is not intimidated by threats from those who are ideologically opposed to actions to improve access and lower drug prices, including drug companies and those individuals and groups who benefit from economic ties to the companies. All levels of government should continue to take measures that increase accessibility to necessary medications for all residents of Canada, including through lowering prices and adopting a national pharmacare plan.