Canada falls behind in new drug submissions compared with the United States and Europe

Canada falls behind in new drug submissions compared with the United States and Europe

Nigel S B Rawson, PhD, Canadian Health Policy Institute

ABSTRACT

Canada has experienced much uncertainty about the federal government’s intention to regulate lower ceiling prices for patented medicines during the past seven years. This study’s objective was to examine how many medicines submitted to the US Food and Drug Administration (FDA) and/or the European Medicines Agency (EMA) between 2006 and 2020 were also submitted to Health Canada by the end of October 2022 and to compare trends before and during the proposed federal regulation changes. New medicine submissions to the FDA and/or the EMA between 2006 and 2020 were identified from publicly available data sources. The number submitted to Health Canada by October 31st, 2022 as a percentage of the number submitted to the FDA or the EMA, whichever came first, was calculated for each year of submission to the first agency (FDA or EMA). Over 80% of new medicines submitted to the first agency in each year between 2006 and 2014 were, on average, also submitted to Health Canada, but the percentage decreased to 44% for medicines submitted to the first agency in 2020. Similar trends occurred in oncology therapies and orphan status medicines. Canada’s federal government continues with its intention to regulate reduced medicine prices. Adding any tougher price regulations to barriers that must already be overcome to bring medicines to Canadians will further delay or deny patient access. Canada’s policy towards new medicines needs to change from obsessive cost-containment to reviving biopharmaceutical research and manufacturing and ensuring patient access.

ACKNOWLEDGMENTS: N/A

CITATION: Rawson, Nigel S B (2023). Canada falls behind in new drug submissions compared with the United States and Europe. Canadian Health Policy, JAN 2023. Toronto: Canadian Health Policy Institute. ISSN 2562-9492, https://doi.org/10.54194/HKBH7107, www.canadianhealthpolicy.com.

CORRESPONDENCE: Nigel Rawson, [email protected]

DISCLAIMER: N/A

DISCLOSURE: No conflicts were declared.

OPEN ACCESS: N/A Not sponsored.

REVIEW: This article was subject to peer review.

SUBMITTED: 7 DEC 2022 | PUBLISHED: 17 JAN 2023

INTRODUCTION

When first elected in 2015, Canada’s current federal government announced plans to regulate lower prices for prescription medicines for federal, provincial and territorial government drug plans.¹ Since then, Canada has experienced an extraordinary degree of uncertainty about federal intentions regarding drug prices, especially following the 2017 announcement of proposed changes to the Patented Medicine Prices Review Board (PMPRB),² the quasi-judicial agency tasked to prevent time-limited drug patents from being abused.³

The PMPRB has performed its role over the past 35 years using a reference pricing test in which a company’s intended list price for a new patented medicine in Canada is compared with list prices in seven countries: France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States. In the proposed changes, Switzerland and the United States, two countries with generally higher drug prices, would be replaced with six countries (Australia, Belgium, Japan, Netherlands, Norway and Spain) that, on average, have lower list prices.

The PMPRB would also have used new economic factors to regulate prices; these were health technology assessments (HTAs) and tests based on Canada’s per capita gross domestic product and the value of the drug’s sales in Canada. Additionally, manufacturers would be compelled to report confidential information about rebates negotiated with insurers to the PMPRB. The PMPRB would have been converted from a patent abuse watchdog into a price setter, and prices of new medicines in Canada drastically reduced to a level unsustainable for drug developers.⁴

The planned changes caused much uncertainty and opposition among drug developers and profound concern among patients.^5,6 Manufacturers’ concerns about the government’s intention were anticipated to lead to them deciding to delay submitting marketing applications for new medicines in Canada or not to submit them at all.^4,7

The objective of this work is to examine the number of medicines submitted to Health Canada as a percentage of those submitted to the US Food and Drug Administration (FDA) and/or the European Medicines Agency (EMA) in the 15-year period between 2006 and 2020 and to compare trends before and during the proposed federal regulation changes.

METHODS

The FDA produces annual reports on new drugs and biologics authorized for use in the United States,^8,9 but only the biologics report includes submission data. Submission information was obtained from the FDA’s website of approved drugs.¹⁰

New medicines authorized through the EMA’s centralized system are detailed in its annual reports.¹¹ Submission through this system is compulsory for new active substances to treat human immunodeficiency virus, cancers, diabetes, neurodegenerative diseases, autoimmune and other immune dysfunctions, viral diseases, medicines derived from biotechnology processes such as genetic engineering, advanced therapy medicines such as gene therapies, somatic cell therapies or tissue-engineered medicines, and orphan status medicines. The centralized system is optional for all other medicines, but the “great majority of new, innovative medicines” pass through it because it allows them to be marketed throughout the European Union.¹² Each medicine authorized has a public information report that includes submission details.¹³ Neither the FDA’s nor the EMA’s website allows searches by submission date. Brief information about medicines under evaluation by the EMA is available in monthly reports.¹⁴

Health Canada produces annual performance reports based on the fiscal year (April to March) for the two directorates that review and authorize drugs and biologics, including submission information; these are available by email request.¹⁵ Health Canada also has two websites that were used for this analysis: one where searches for approved medicines can be performed,¹⁶ although submission information is not included, and another providing information on medicines under review, including the month and year the drug was accepted for review.¹⁷ Both websites are updated regularly.

These sources and data from a previous analysis¹⁸ were used to identify new medicines submitted to the FDA and/or the EMA between 2006 and 2020 (earlier data from the previous analysis were not included because Health Canada review times were much longer prior to 2006 which may have deterred drug developers from submitting their products in Canada). Since the FDA does not report medicines under review, authorizations in 2021 and year-to-date in 2022 were examined to ensure as many submissions as possible were identified.

New medicines were defined as new active chemical or biologic substances designed to provide therapeutic benefit, which excluded diagnostic and surgical products, vaccines and revised versions of existing medicines. COVID-19 medicines were also excluded because they have been authorized for use via interim or exceptional processes unrepresentative of regular review procedures and, in Canada, they are not subjected to PMPRB scrutiny.

Although the process of obtaining authorization to market a new medicine in Canada is similar to that in other industrialized countries,¹⁹ evaluations of the Canadian regulatory drug review process performed since the 1990s^18,20-26 have demonstrated that Canada is normally a “second rank” country behind the United States and European countries on drug developers’ prioritization lists for submitting marketing applications. The median delay between submissions to the FDA and those to Health Canada was 166 days in a recent analysis.¹⁸ Therefore, although the end of the observation period for submissions in the United States and the European Union was the end of 2020, submissions to Health Canada to the end of October 2022 were included to allow for the delay.

For each medicine submitted to the FDA or the EMA, the earliest submission that occurred between 2006 and 2020 was regarded as the first submission. The number of these medicines submitted to Health Canada as a percentage of the number submitted to the first agency was calculated and categorized by the year of submission to the first agency. Sub-analyses of oncology medicines and orphan status medicines were also performed.

Interrupted time series analysis is a useful tool to evaluate a policy change²⁷ such as that proposed for the PMPRB in 2015, but there were insufficient data points in the data for this methodology. As an alternative, separate linear regression analyses were performed on the percentages of submissions for the years between 2006 and 2014 and on the corresponding percentages for submissions for years between 2015 and 2020.

RESULTS

A total of 558 new therapeutic medicines were first submitted to the FDA and/or the EMA between 2006 and 2020; 536 were submitted to the FDA and 442 to the EMA. The number submitted to both agencies was 420 of which 74.0% were submitted to the FDA before or at the same time as submission to the EMA. Of the 558 new medicines, 399 (71.5%) were submitted to Health Canada on or before October 31st, 2022.

More than a quarter of the 558 medicines (147; 26.3%) were for the treatment of cancer. The next largest groups were medicines for infections (65; 11.6%), central nervous system diseases and mental health issues (50; 9.0%), electrolyte and metabolic disorders (44; 7.9%), and cardiovascular disease (38; 6.8%). The remaining medicines were indicated for a wide variety of disorders (214; 38.4%). Orphan status was received from the FDA and/or the EMA for 247 medicines (44.2%); Canada does not have an orphan status program.

An average of 82.6% of medicines submitted to the first agency (FDA or EMA) between 2006 and 2014 were also submitted to Health Canada (Figure 1), but the percentage decreased to 43.8% for medicines submitted to the first agency in 2020. As Table 1 demonstrates, the slope of a linear regression fitted to percentages between 2006 and 2014 is not significantly different from zero (p=0.94) as it is virtually a flat line. The downward slope of the line fitted to percentages between 2015 and 2020 is significantly different from zero (p=0.01).

Figure 1: Percentage of medicines submitted in Canada by year of submission to first agency
(To access figures and tables download PDF)

The 147 oncology medicines had a higher average rate of submission to Health Canada between 2006 and 2014 of 86.2%, which declined to 50.0% in 2020 (Figure 2). Although there may appear to be an increase in the percentage of oncology medicines submitted to Health Canada between 2006 and 2014, the slope of a linear regression fitted to these percentages is not significantly different from zero (p=0.17). The downward slope of the line fitted to percentages between 2015 and 2020 is significantly different from zero (p=0.03). Non-oncology medicines showed a similar pattern (Table 1).

Figure 2: Percentage of oncology and non-oncology medicines submitted in Canada by year of submission to first agency
(To access figures and tables download PDF)

The 247 orphan status medicines had a lower average rate of submission to Health Canada between 2006 and 2014 of 79.2%, which declined to 39.3% in 2020 (Figure 3). Again, the slope of a linear regression fitted to percentages between 2006 and 2014 is virtually zero (p=0.56), whereas the downward slope fitted to percentages between 2015 and 2020 is significantly different from zero (p=0.03).

Table 1: Results of the linear regression analyses

(To access figures and tables download PDF)

Figure 3: Percent of orphan and non-orphan status medicines submitted in Canada by year of submission to first agency
(To access figures and tables download PDF)

One hundred and fifty-nine medicines submitted to the FDA and/or the EMA were not submitted to Health Canada; of these, 21% were oncology medicines, 49% were orphan drugs, and four were innovative gene therapies. One hundred and fifteen (76.7%) of these medicines were developed by smaller companies of which almost two-thirds were based in the United States.

DISCUSSION

Pharmaceutical manufacturers submit applications to regulatory agencies based on their prioritization of markets, such as the United States and Europe, over countries like Canada, based on the country’s population size and wealth and the attractiveness of its biopharmaceutical environment.²⁸ Almost 75% of the new medicines were submitted first in the United States, which is consistent with the Pharmaceutical Research Manufacturers of America’s estimate.²⁹ This is no surprise because pharmaceutical companies generally develop new drugs for the United States’ market and, when they do well there, sales in Europe, Canada and elsewhere are considered to be additional benefits or “gravy.”³⁰

This evaluation showed a marked decrease in the pace of all new submissions and those for oncology and orphan status medicines in Canada compared with the United States and the European Union from 2015 onwards. These results are in accordance with research demonstrating that strict price controls impact how manufacturers negatively view such markets^31,32 and other evidence.^33,34 New Zealand offers an illustration of the negative effect of strict price control of new medicines on patient access.³⁵

Some of the medicines submitted to the FDA or the EMA that so far have not been submitted to Health Canada may eventually come to Canada – 39 medicines submitted to Health Canada between 2006 and October 2022 had been submitted to the FDA and/or the EMA before 2006. At 5.5 years, the median delay for these medicines was substantial. Canadians should be concerned that the decrease in submissions, especially those for oncology therapies and orphan status medicines, will mean even longer delays. Orphan status medicines are predominantly drugs for rare disorders for which a comprehensive strategy is long overdue in Canada.³⁶ In addition, nearly half of the medicines not submitted to Health Canada were orphan drugs and over 20% were oncology medicines.

Innovative advances are commonly undervalued in Canada³⁷ and new medicines are apparently no exception.^38-40 Innovation was not assessed in this study because it is a subjective judgement with no consistent agreement on how it should be evaluated.³⁸ However, technological advances are being made following the sequencing of the human genome. If Canadians are to benefit from these advances, they need their governments to provide incentives for developers to bring innovative medicines to Canada, not deter them with punitive price controls. Deloitte, one of the world’s largest accounting companies, estimates that the average internal rate of return from pharmaceutical innovation is only 3.2% after excluding COVID-19 products.⁴¹ The industry is not the huge profit producer that many believe.

This analysis has some limitations. First, although FDA authorizations in 2021 and year-to-date in 2022 were reviewed to identify any submissions made between 2006 and 2020, submissions where the FDA required more data and deferred its review could not be identified. Second, the COVID-19 pandemic may have led to companies focusing submissions on the large markets of the United States and the European Union and exacerbated the decline in submissions to Health Canada between 2020 and October 2022. However, the decrease began after the announcement in 2015 by Canada’s federal government of its intention to reduce drug prices which preceded the beginning of the pandemic. Third, the study was limited by the number of data points preventing the use of interrupted times series and necessitating a less sophisticated analysis.

The original proposed changes to the PMPRB regulations led to legal challenges that resulted in courts striking down the use of HTAs and the other economic factors to set prices and the requirement to reveal business secrets. In April 2022, the federal Cabinet cancelled all proposed revisions, except the change in countries used in the price reference test, which was implemented on July 1st, 2022.⁴² New draft guidelines were made available in October 2022 for public consultation and 88 submissions were received.⁴³ More than half came from biopharmaceutical developers and their business associations who all viewed the guidelines negatively. They were not alone; with two exceptions, patient groups, health professionals, academics, and chambers of commerce expressed concerns about the planned changes and, even private insurers were lukewarm. In December, the PMPRB’s guidelines consultation website was updated to state that the “new guidelines will not be implemented on January 1st, 2023.”

The negative reaction to the latest proposed guidelines was unsurprising. They were vague, perhaps deliberately to obfuscate what the Board was doing. Nevertheless, it was apparent that the level of therapeutic innovation would not be recognized (a change from the PMPRB’s previous rules) and decisions on appropriate comparator medicines would be decided primarily by PMPRB staff, not its advisory clinical committee.⁴⁴ The PMPRB’s focus was to be on threatening an investigation if a manufacturer’s list price was not considered to be low enough. In addition, regular reassessments could be imposed with every new indication for a medicine, new sales of medicines in other countries, and fluctuating currency exchange rates. Developers would have had to consider whether a new medicine’s price would be PMPRB-compliant both at launch and over its patent life because prices would be benchmarked annually. It was clear that the PMPRB intended to use its powers to reduce medicine prices as much as it could, despite a court ruling in July 2021 that the PMPRB’s role is to prevent time-limited, patent protection monopolies granted for new medicines from being abused by excessive prices and not to set prices by helping itself to powers it does not lawfully have.⁴⁵

Stronger price regulations will add to existing impediments that already discourage drug developers from bringing their products to Canada.²⁸ These include weaker patent and data protection than in comparable countries, non-accountable and non-transparent HTA processes performed by organizations making recommendations to federal, provincial and territorial governments that manage and fund them, and a similarly non-accountable and non-transparent price negotiation organization responsible to the same governments.^46-48 The obstacles erected by Canada’s governments are indicative of their long-standing antipathy towards the biopharmaceutical industry,^49,50 which results in delayed or denied patient access to new drugs and continued suffering.^51-54 Canadian patients may want more affordable access to innovative medicines, but they certainly do not want their access to new drugs to be restricted by their governments penalizing manufacturers to the point where they decide not to bring their medicines to Canada.⁵

CONCLUSION

The cancellation of most of the original and the latest proposed PMPRB revisions does not mean the federal government and the PMPRB have abandoned their objective of forcing a reduction in medicine prices in Canada. Consequently, much uncertainty remains and more innovative medicines may not be brought to this country as Canada’s priority for drug developers slips from being a second-tier country to a lower ranking.⁵⁵ Adding any tougher price regulations to the barriers that drug developers must already overcome to bring innovative medicines to Canadians will further delay or, worse, deny patients’ access to new beneficial therapies. Medicines can improve patient health reducing the need for ever more expensive and, in Canada, frequently difficult-to-access health care interventions in a system on the brink of collapse.⁵⁶ However, innovation is at risk as long as policy-makers see new medicines in terms of high prices, instead of the benefits they can bring to patients and the health care system.⁵⁷ Canada’s policy towards new patented medicines needs to change from obsessive cost-containment to reviving biopharmaceutical innovation, research and manufacturing and ensuring patient access.⁵⁰

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