Orphan Drugs in Canada: A “One Size Fits All” Regulatory Regime

This article was originally published in FDLI's Update magazine here.

Introduction

Medicines targeting rare diseases, also known as orphan drugs,¹ once faced an uphill battle for research funding and market approval. The need for robust commercial incentives to create rare disease treatments spurred the establishment of international orphan drug regulations—first in the United States with the passage of the 1983 Orphan Drug Act, and later in the European Union (EU), Japan, Singapore, and elsewhere.² Today, there are over 400 designated orphan drugs in the global marketplace and dozens of orphan-specific regulatory initiatives to drive investment and ensure public access to orphan medicines.³

These specialized orphan drug frameworks stand in contrast to Canada’s regulatory regime. While Canada has considered implementing an orphan drug framework, such a step has never been taken. Instead, Canada relies on generally applicable mechanisms in its domestic drug approval regime to drive market-entry of orphan drug therapeutics. For example, “innovative drugs” are eligible for data protection in Canada. Additional patent term protection in the form of Certificates of Supplementary Protection (CSPs) and measures such as patent listing under the Patented Medicines (Notice of Compliance) framework (analogous to patent listing in the Orange Book) also offer certain rights to innovators.

Based on recent policy announcements, a specialized orphan drug regulatory regime is not likely coming to Canada in the near future. Instead of crafting a specialized regulatory regime, in the first quarter of 2021, the Canadian federal government formally announced its proposal to develop a National Strategy for High-Cost Drugs for Rare Diseases.⁴ While consultations are ongoing, the government’s strategy is targeted at creating a framework that provides consistent and cohesive drug cost funding for patients with rare diseases, rather than driving market availability of such orphan drugs through regulatory incentives.

Orphan drug regulation in the United States and Europe

On most life sciences regulatory matters, Canada aims to align itself with the United States and the EU. Although Canada does offer certain incentives to orphan drug manufacturers (e.g., accelerated review of drug submissions, fee waivers, tax credits),⁵ which are similar to the pre-market economic incentives available in the US and EU, when it comes to the protection for the orphan drug products themselves, Canada has fallen substantially out of alignment with the international community.

In the United States, drugs targeting rare diseases are eligible for several specifically targeted economic incentives, including market exclusivity, fee waivers, direct funding for research and development, and tax credits. There is no government oversight for pricing of orphan drugs or other medicines.⁶ Similarly, in the EU, orphan drugs are eligible for a range of economic incentives, comparable to those available in the United States, including market exclusivity, administrative assistance, and fee waivers. The price of orphan drugs, and all other medicines, is subject to national laws and policy instruments in each member state.⁷

Canada’s efforts to regulate orphan drugs

The absence of a Canadian orphan drug framework has been a conscious decision on the part of the Canadian government, as such a framework has been considered over the years.

Over the past several decades, as other jurisdictions implemented orphan drug frameworks, Health Canada (Canada’s version of the FDA and EMA) considered whether such a framework might be beneficial but ultimately concluded that an orphan drug framework was not needed because Canadians already had access to the majority of orphan drugs approved in the United States,⁸ either because the drugs had been approved for sale⁹ or were available through the Canadian Emergency Drug Release Program (now known as the Special Access Programme or “SAP”).¹⁰ Others dispute Health Canada’s position on accessibility of orphan drugs.¹¹

In 2012, Health Canada revisited the decision to forego an orphan drug policy and proposed a draft regulatory framework.¹² The draft framework may have been motivated by a desire to harmonize Canada’s regulatory regime with its international trading partners.¹³ Canadians were also lagging behind their United States counterparts in temporal access to orphan drugs.¹⁴ However, Health Canada’s plan was abandoned in 2017, when Health Canada indicated it would continue to pursue the interests of rare disease patients through other means.¹⁵

The current status of orphan drugs in Canada

Given that Canada lacks a regime that protects orphan drugs specifically, the current regulatory scheme presents several key considerations for orphan drug manufacturers.

1. Data protection

Data protection in Canada is available only if the manufacturer’s new drug is considered an “innovative drug.”¹⁶  The statutory definition of “innovative drug” is restricted to new medicinal ingredients not previously approved by Health Canada and that are not variations of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. This means that a previously approved drug with a new, promising rare disease application will not be eligible for data protection in Canada. In contrast, in the US and EU, orphan drug designation (and the corresponding exclusivity) can be received for a new drug or an already marketed drug with a new use.¹⁷ Unlike the US, in Canada, a manufacturer will not be eligible for data protection where it has conducted trials¹⁸ to support the safety and efficacy of a new use, new formulation, new dosage form or new dosing regimen of an orphan drug (or indeed any drug) previously approved by Health Canada.

Should an orphan drug qualify as an “innovative drug” in Canada, it will be eligible for an eight-year period of data protection. Generic and biosimilar manufacturers are barred from filing for a marketing authorization (a Notice of Compliance or “NOC”) on the basis of a direct or indirect comparison to the qualifying innovative drug for the first six years and Health Canada cannot issue a NOC for eight years. If the innovative drug manufacturer files clinical trial data “conducted for the purpose of increasing knowledge about the use of the pediatric populations” within the first five years of the data protection period, the innovative drug may also be eligible for a six-month data protection extension.¹⁹ 

2. Price regulation issues

Canada’s unique pricing regime for patented medicines, overseen by the Patented Medicines Price Review Board (PMPRB), is also an area which frequently impacts orphan drug manufacturers. The PMPRB can exercise price control over drugs sold in Canada, including orphan drugs, where there is at least one Canadian patent which “pertains to” the medicine.²⁰ If the PMPRB determines that the price of a patented medicine is excessive, the PMPRB can order a price reduction based on factors specified in the Patented Medicines Regulations. To date, the PMPRB’s price regulation framework has not approached orphan drugs any differently than other therapeutic products.

However, amendments to the Patented Medicines Regulations are expected to come into force on July 1, 2021, after several delays due to COVID and a series of court challenges.²¹ The amendments add new factors to the PMPRB’s excessive pricing analysis which may impact orphan drugs, including the medicine’s pharmacoeconomic value in Canada and the size of the market for the medicine in Canada.²²

Updated PMPRB Guidelines,²³ which provide details of the complex tests the PMPRB uses when assessing whether a drug is excessively priced, will also come into effect to support the amended Regulations.²⁴ Early drafts of the updated Guidelines did not specifically address orphan drugs. Following significant stakeholder feedback, the updated Guidelines were further revised and the PMPRB has included a specific carveout for high-cost medicines that are expected to realize below a certain minimum amount in annual revenue. Medicines which realize less than $12 million in annual revenue will not be subject to the most stringent price test, even if they exceed the cost threshold which would normally trigger such review.²⁵ Specifically, such high cost medicines will not be subject to a “maximum rebated price” ceiling even where the annual treatment cost would otherwise require such a price ceiling.²⁶ As a result, a high cost medicine with annual revenues under $12M may be subject to a higher price ceiling than another similarly priced medicine, with greater annual sales.

The Canadian government has acknowledged that this concession was specifically included in the further revised, updated Guidelines to ensure that manufacturers of orphan drugs are “not discouraged from coming to Canada out of concern that their net price will be substantially reduced by regulation.”²⁷ Prior to the release of the further revised, updated Guidelines, the PMPRB had maintained that the current regulatory regime, and the absence of an orphan-drug-specific framework, had not impacted Canadians’ access to orphan medicines.²⁸ The dispensation for drugs with a smaller market cap,  reflected in the final updated Guidelines, is one of the first acknowledgements from the PMPRB that Canadian price regulation may be having a dampening effect on the availability of orphan drugs in Canada. Until these updated pricing Guidelines are applied in practice, it is unclear whether these concessions will provide sufficient comfort to orphan drug manufacturers to launch their orphan drugs in Canada.

3. Standard patent-derived protections

Like all other therapeutic products in Canada, orphan drug manufacturers may seek protections derived from patents. In Canada, the standard term of a patent is 20 years from the Canadian filing date of the application. Drugs with patents pertaining to a medicinal ingredient, or a combination of medicinal ingredients, may be eligible for a two-year extension to the patent term through a Certificate for Supplementary Protection (CSP), provided the medicinal ingredient or combination of medicinal ingredients has not been previously authorized for sale in Canada.

Patent protected drugs may also benefit from additional rights under the Patented Medicines (Notice of Compliance) (PM(NOC)) Regulations. If there is a patent that claims what is approved in a New Drug Submission (NDS) or in a supplemental NDS—such as a claim to the medicinal ingredient, its use, formulation, or dosage form—and subject to certain timing requirements, the patent may be listed on Health Canada’s Patent Register (Canada’s version of the Orange Book). The rights of a manufacturer who has listed a patent on Canada’s Patent Register kick in if another manufacturer directly or indirectly compares its drug with, or makes reference to, the drug in respect of which the patent list was submitted. Subsequent entry is permissible if the patent expires, with the permission of the original manufacturer or sponsor, or once proceedings under the PM(NOC) Regulations have run their course.

Conclusion

Canada’s approach to orphan drugs is likely to face further scrutiny in the coming years. The newly announced National Strategy for High-Cost Drugs for Rare Diseases will not likely be implemented for several years, so changes to the funding patients receive for orphan drugs will be slow to materialize. Further, the true impact of the new PMPRB pricing rules on orphan drugs will not be known until those rules have been applied in practice.

In the interim, orphan drug patient advocacy groups and the PMPRB remain at odds. Orphan drug patient advocacy groups have been critical of the PMPRB’s reluctance to specifically relax price regulation on orphan drugs. From their perspective, the specific price regulation exceptions that have been created for COVID-19 vaccines are an acknowledgement that “the [pricing] rules block speedy access to medicines” in Canada.²⁹ At the same time, the PMPRB remains adamant that their price regulation is not impacting Canadian’s access to new drugs as new drugs have continued to enter Canada at a steady rate over the last five years.³⁰

Add to this dynamic the widespread criticism of the Canadian government and Health Canada in relation to the COVID-19 vaccine rollout³¹, characterized by media as “utterly botched”, “bungled” and “lagging”. As Tracey Lindeman of The Atlantic recently reported, “… Canadians—usually so smug about our universal health care—are looking on (the United States) with jealousy.”³² Per capita vaccination numbers lag behind more than 45 other countries (vaccinations per 100 people).³³ The pandemic has shone a light on Canada’s lack of domestic manufacturing capabilities. As a result, the federal government is focusing its attention on a national biomanufacturing strategy.³⁴

Against this backdrop, it is unlikely that Canada’s approach to regulating orphan drugs and offering market exclusivities to encourage orphan drug manufacturers to launch orphan drugs in Canada will change in the short term. Instead, the federal government’s focus is more likely to continue to be domestic manufacturing and procurement.

If efforts to manage orphan drug access through patient funding and pricing regulation are not successful in the coming years and orphan drug manufacturers become increasingly reluctant to launch orphan drugs in Canada, the Canadian government may re-consider the need for a bespoke orphan drug regulatory regime. However, at this point, the Canadian government has not signaled any intention to re-open that debate.

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¹ The definitions of “rare disease” and “orphan drug” vary across jurisdictions and given the absence of a bespoke orphan drug regulatory regime, Canada does not have a statutory definition. Health Canada refers to the European definition of a condition that afflicts no more than five in 10,000 people and the US definition of a condition that affects no more than 200,000 people in the US. See: Health Canada, About orphan drugs and rare diseases (updated August 14, 2018), https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/regulatory-approach-drugs-rare-diseases/about-drugs-rare-diseases.html.

² Todd Gammie, Christine Y. Lu, & Zaheer Ud-Din Babar, Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries, 10 PLOS One 10 (2015).

³ National Institutes of Health, FAQs About Rare Diseases, Genetic and Rare Disease Information Center (updated January 26, 2021), https://rarediseases.info.nih.gov/diseases/pages/31/faqs-about-rare-diseases.  

⁴ Health Canada, National Strategy for High-Cost Drugs for Rare Diseases Online Engagement (updated January 28, 2021), https://www.canada.ca/en/health-canada/programs/consultation-national-strategy-high-cost-drugs-rare-diseases-online-engagement.html.

⁵ Health Canada, Canada’s regulatory approach to drugs for rare diseases: orphan drugs (updated July 3, 2020), https://www.canada.ca/en/health-canada/services/licences-authorizations-registrations-drug-health-products/regulatory-approach-drugs-rare-diseases.html.

⁶ Panos Kanavos, Alessandra Ferrario, Sotiris Vandoros, & Gerald F. Anderson, Higher US Branded Drug Prices and Spending Compared to Other Countries May Stem Partly From Quick Uptake of New Drugs, 4 Health Affairs 32, 758-759 (2013).

⁷ European Commission, Pricing and reimbursement of medicinal products (retrieved June 8, 2020), https://ec.europa.eu/growth/sectors/healthcare/competitiveness/products-pricing-reimbursement_en.

⁸ Matthew Herder & Timothy Mark Krahn, Some Numbers Behind Canada's Decision to Adopt an Orphan Drug Policy: US Orphan Drug Approvals in Canada, 1997-2012, 4 Healthcare Policy 11, 72 (2016).

⁹ Id.

¹⁰ Id.

¹¹  Hugh J. McMillan & Craig Campbell, We need a “made in Canada” orphan drug framework, CMAJ October 16, 2017 189 (41) E1274-E1275, https://www.cmaj.ca/content/189/41/E1274. Emma Jones, Canada may fall behind without an ‘orphan’ drug strategy, Healthing, (December 8, 2020), https://www.healthing.ca/policy/canada-needs-a-separate-orphan-drug-strategy-says-rare-disease-group.

¹² Office of Legislative and Regulatory Modernization, Initial draft discussion document for a Canadian orphan drug regulatory framework, (December 13, 2012), www.orpha.net/national/data/CA-EN/www/uploads/Initial-Draft-Discussion-Document-for-A-Canadian-Orphan-Drug--Regulatory-Framework.doc.

¹³ Matthew Herder & Timothy Mark Krahn, Some Numbers Behind Canada's Decision to Adopt an Orphan Drug Policy: US Orphan Drug Approvals in Canada, 1997-2012, 4 Healthcare Policy 11, 70-81 (2016).

¹⁴ Id. at 78.

¹⁵ Maura Forrest, Health Canada gives 'kiss of death' to planned policy for rare-disease drugs, National Post, (October 16, 2017), https://nationalpost.com/news/politics/health-canada-gives-kiss-of-death-to-planned-policy-for-rare-disease-drugs.

¹⁶ “Innovative drug” means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. C.08.004.1 (1), Food and Drug Regulations, C.R.C., c. 870.

¹⁷ 21 C.F.R. § 316.20(a); Regulation (EC) No 141/200.

¹⁸ A manufacturer is required to have generated data to support the approval of the medicinal ingredient under consideration and the generation of that data must have required considerable effort. See Health Canada’s Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations (updated April 8, 2021), https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-document-data-protection-under-08-004-1-food-drug-regulations.html. 

¹⁹ Health Canada, Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations, (updated April 8, 2021), https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-document-data-protection-under-08-004-1-food-drug-regulations.html#a21.

²⁰ Section 79(1) of the Patent Act, in relation to patented medicines, defines “patentee” as follows: “in respect of an invention pertaining to a medicine, means the person for the time being entitled to the benefit of that invention and includes, where any other person is entitled to exercise any rights in relation to that patent other than under a licence continued by subsection 11(1) of the Patent Act Amendment Act, 1992, that other person in respect of those rights.”

²¹ The amendments to the Regulations have been subject to several court challenges, but the majority of the amendments have withstood these challenges (Innovative Medicines Canada v. Canada (Attorney General), 2020 FC 725; Merck et al. v. Canada (Attorney General), Court File No. 500-17-109270-192). See Torys’ Bulletin for further discussion: https://www.torys.com/insights/publications/2021/01/a-decision-and-a-delay.

²² Patented Medicines Regulations, SOR/94-688, https://laws-lois.justice.gc.ca/eng/regulations/sor-94-688/nifnev.html.

²³ Government of Canada, PMPRB Guidelines (updated March 17, 2021), https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/about-guidelines/guidelines.html.

²⁴ The new Guidelines are currently being challenged in Federal Court (Innovative Medicines Canada et al v. Canada (Attorney General), Court File No. T-1419-20).

²⁵ Government of Canada, PMPRB Guidelines, paragraphs 39, 57-59, 61, 64, Appendix D, (updated March 17, 2021), https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/about-guidelines/guidelines.html.

²⁶ Government of Canada, PMPRB Guidelines, section V, Appendix D (updated March 17, 2021), https://www.canada.ca/en/patented-medicine-prices-review/services/legislation/about-guidelines/guidelines.html.

²⁷ Government of Canada, PMPRB Draft Guidelines Consultation (updated January 4, 2021), https://www.canada.ca/en/patented-medicine-prices-review/services/consultations/draft-guidelines.html#bgsec1.

²⁸ PMPRB, Orphan Drug Launch Monitor (updated May 9, 2016), http://www.pmprb-cepmb.gc.ca/view.asp?ccid=1257&lang=en.

²⁹ Canadian Organization of Rare Disorders, New PMPRB guidelines can’t fix flaws in regulations that will stall new treatments for Canadian patients, October 23, 2020, http://www.raredisorders.ca/new-pmprb-guidelines-cant-fix-flaws-in-regulations-that-will-stall-new-treatments-for-canadian-patients/.

³⁰ Patented Medicines Price Review Board, New drugs entering Canada at steady rate over past 5 years, February 20, 2021, https://www.canada.ca/en/patented-medicine-prices-review/news/2021/02/new-drugs-entering-canada-at-steady-rate-over-past-5-years.html. 

³¹ Tristin Hopper, National Post, How Ottawa utterly botched Canada’s COVID vaccine acquisition, February 5, 2021, https://nationalpost.com/news/how-ottawa-utterly-botched-canadas-covid-vaccine-acquisition; Tracey Lindeman, The Atlantic, Canada’s vaccine mess, April 6, 2021, https://www.theatlantic.com/international/archive/2021/04/canada-vaccine-rollout-problems/618516/; BBC News, Why Canada is falling behind in Covid vaccinations, February 19, 2021, https://www.bbc.com/news/world-us-canada-56035306; Jaime Watt, Toronto Star, Lagging vaccine rollout could cost Liberals in a big way, February 7, 2021, https://www.thestar.com/opinion/contributors/2021/02/07/lagging-vaccine-rollout-could-cost-liberals-in-a-big-way.html?rf.

³² Tracey Lindeman, The Atlantic, Canada’s vaccine mess, April 6, 2021, https://www.theatlantic.com/international/archive/2021/04/canada-vaccine-rollout-problems/618516/.

³³ Our world in data, Cumulative COVID-19 vaccinations per 100 people, https://ourworldindata.org/grapher/covid-vaccination-doses-per-capita?tab=table.  

³⁴ Prime Minister of Canada, Justin Trudeau, Prime Minister announces Canada’s plan to mobilize industry to fight COVID-19, March 20, 2020, https://pm.gc.ca/en/news/news-releases/2020/03/20/prime-minister-announces-canadas-plan-mobilize-industry-fight-covid.  

Le mois dernier, le Canada a publié sa première Stratégie industrielle de défense (la Stratégie), qui souligne l’engagement du Canada à développer une base industrielle de défense solide et à stimuler la croissance économique. Ces efforts pourraient aussi comprendre le renforcement de l’état de préparation à la biodéfense et aux contre-mesures médicales, ce qui pourrait constituer des débouchés pour le secteur canadien des sciences de la vie en raison de l’importance accordée aux capacités nationales en ce sens et de la nécessité d’atténuer les risques d’urgences sanitaires.

Développement de contre-mesures médicales au Canada

Comme indiqué dans les bulletins précédents, le quatrième pilier de la Stratégie est axé sur la « sécurisation des chaînes d’approvisionnement pour les intrants et les biens clés » par le renforcement de la production nationale et le stockage de ressources. L’accent est mis tout particulièrement sur les contre-mesures médicales, en précisant que nos « alliés ont établi un lien explicite entre l’état de préparation à la biodéfense et aux contre-mesures médicales et leur sécurité économique et nationale, en élaborant de nouvelles stratégies et de nouveaux mécanismes pour faire progresser ces travaux ». Les contre-mesures médicales désignent divers produits réglementés pouvant être utilisés pour protéger la population lors d’une situation d’urgence de grande ampleur, comme l’éclosion d’une maladie ou une attaque impliquant des armes chimiques, biologiques ou nucléaires. Il peut s’agir de vaccins, de médicaments thérapeutiques et produits biologiques, de dispositifs de tests diagnostiques, des équipements de protection individuelle ou industrielle, et d’autres dispositifs médicaux. Les contre-mesures médicales sont essentielles à la réduction et à l’atténuation des dommages lors d’une urgence de santé publique.

Exploiter les voies réglementaires mises en place lors de la pandémie de COVID-19

Pendant et après la pandémie de COVID-19, le Canada a mis en place plusieurs nouvelles voies réglementaires comme mécanismes d’accélération des approbations de produits médicaux, ce qui pourrait offrir au gouvernement des options pour déployer des contre-mesures médicales afin de faire face aux risques pour la santé publique. Au début de la pandémie, Santé Canada a émis diverses ordonnances provisoires pour permettre l’importation et la vente de médicaments et de dispositifs médicaux qui n’avaient pas eu l’approbation des voies réglementaires traditionnelles. Or, Santé Canada a plutôt fait confiance aux voies d’approbation réglementaire et de l’exemption de certaines exigences en homologation de produits des pays impliqués dans la transaction. Beaucoup de ces règles provisoires ont depuis été officiellement intégrées à la réglementation en vertu de la Loi sur les aliments et drogues et ont été appliquées bien après la COVID-19. Conformément au Règlement sur les aliments et drogues, Santé Canada tient à jour la Liste des maladies qui menacent la santé publique et utilisera une procédure d’autorisation modifiée pour les médicaments d’urgence de santé publique pouvant traiter les affections figurant sur la liste. De même, le Règlement sur les instruments médicaux a établi une liste d’instruments médicaux répondant à un besoin urgent de santé publique, ce qui permet à Santé Canada d’autoriser la commercialisation de ces instruments de manière accélérée. Ces outils réglementaires sont utilisés automatiquement quand une situation médicale présente un grand risque pour la santé publique au Canada et nécessite une action immédiate pour contrer ce risque.

Le rôle de la Stratégie dans le renforcement du régime réglementaire de la santé au Canada

La stratégie prévoit que le Canada adoptera une approche proactive en matière de planification en amont des crises sanitaires. Le gouvernement entend s’assurer que les produits médicaux sont déjà disponibles au Canada afin qu’ils puissent être distribués rapidement en cas d’urgence. D’autres modifications récentes au Règlement sur les aliments et drogues permettent de prépositionner au Canada tous les médicaments d’urgence en santé publique, ce qui signifie qu’ils peuvent être importés dans des installations d’entreposage canadiennes avant que leur mise sur le marché n’ait été autorisée. La Stratégie s’appuie sur ces fondements, en faisant référence à l’organisme existant Préparation aux crises sanitaires Canada (PCSC), un organisme opérationnel spécial au sein d’Innovation, Sciences et Développement économique Canada (ISDE), et à un nouveau Fonds des sciences de la vie, lesquels « collaborent avec des partenaires internationaux et de soutenir l’élaboration et la production de contre-mesures médicales ». PCSC supervise la Stratégie en matière de biofabrication et de sciences de la vie du Canada, qui vise à développer un secteur national des sciences de la vie fort et compétitif doté de capacités de biofabrication de pointe, en mettant l’accent sur la capacité à se préparer et à faire face aux futures priorités et crises sanitaires. Dans cette optique, il y aura des occasions pour les fabricants de nouer des collaborations de recherche et des accords commerciaux ou d’approvisionnement liés aux contre-mesures médicales financées par des programmes fédéraux.

Étroitement lié aux capacités nationales, le pilier III de la stratégie implique « Investissement ciblé pour renforcer un secteur canadien de la défense novateur », avec la promesse que le gouvernement fédéral « soutiendr[a] la recherche et le développement, protéger[a] la propriété intellectuelle, soutiendr[a] les petites et moyennes entreprises, investir[a] dans les compétences et la formation, et encourager[a] les exportations afin de créer un secteur de la défense agile et concurrentiel à l’échelle mondiale ». La nécessité de favoriser le développement de la propriété intellectuelle (PI) et la conservation des droits du Canada est mentionnée à plusieurs reprises dans la Stratégie. Par exemple, la Stratégie prévoit l’établissement de partenariats officiels avec l’industrie canadienne qui « [assureront] la propriété et le contrôle nationaux de la propriété intellectuelle (PI) et des capacités essentielles. » La Stratégie reconnaît l’immense talent des établissements canadiens et la précieuse recherche qui y est menée actuellement et qui est déjà financée par des subventions de recherche d’organismes tels que le Conseil de recherches en sciences naturelles et en génie et les Instituts de recherche en santé du Canada, et fait aussi référence à l’engagement de 1,6 milliard de dollars pour de nouveaux fonds de recherche dans le budget de 2025. Cette prise de conscience de la nécessité de promouvoir et de soutenir l’innovation au Canada laisse présager des possibilités de financement, notamment dans les domaines où le Canada accuse un retard en matière de production nationale et où des engagements d’investissement et de fabrication au Canada peuvent être pris.

Prochaines étapes

Dans les prochains mois, nous prévoyons que le gouvernement du Canada publiera d’autres directives et des mesures de suivi. L’équipe de défense des conservateurs poursuivra sa couverture de perspectives sur la défense au Canada en publiant une analyse supplémentaire pour donner des précisions sur l’incidence de la Stratégie sur de multiples secteurs.