Placing Canada's healthcare policy during the COVID-19 pandemic in the perspective of the Rare Disease Community
The COVID-19 pandemic has brought enormous strains to the Rare Disease (RD) community. As reported by Rare Disease International in June 2020, 50% of RD patients experienced difficulties in accessing medical care and rehabilitation or critical services, 40% experienced some or great barriers to access medicines, and 75% experienced some or great anxiety, fear, and stress due to COVID-19 related impacts.1
To mitigate the harm brought by disruptions in healthcare services, actions were taken to restructure methods of providing healthcare. These include having access to telehealth, off-site blood labs, in-house healthcare services, and mental health protection programs.2-6 Interestingly, unlike other countries, surveys done by the Canadian Organization of Rare Disease found that most Canadian on-going clinical trials were not interrupted.1
Most importantly during this critical time, the national policies and responses to the COVID-19 crisis would shape the experiences of the Canadian RD community. Figure 1 shows a comparison of the actions taken by the Government of Canada to the European Union (EU), United States (US), and Australia to reflect the timelines and the key focuses of Canadian Healthcare policy.
“From now on, there is a need to improve preparedness, collaboration, information transparency, speed of workflow, and innovation amongst all levels of the healthcare system including front-line clinical care, pharmaceutical industries, research innovations, drug regulatory bodies, and other sectors in Canada.”
The following article focuses on reviewing Canada’s actions on public safety guidelines, drug and medical supply shortages, and post-pandemic plans relevant to the RD community.
In Canada, public responses addressing vulnerable populations were published on October 1st, 2020 by the Public Health Agency of Canada.7 Unfortunately, this response was a two-page guideline with general recommendations that failed to address the special needs of unique vulnerable groups, especially the RD community. In contrast, the FDA held a public hearing session in September 2020, one month earlier than Canada, which thoroughly addressed the profound difficulties unique to the RD community, and provided well-thought out actionable strategies.8
Additionally, Canada faced a shortage of drug supply during the COVID-19 crisis.9 To ensure a stable drug supply chain, Health Canada (HC) expedited the establishment of License Review, Submission Review, Lot release, and Special Access Programs for medications. The Minister of Health granted HC additional flexibility in securing a stable drug supply.10-12 The federal government created drugshortages.ca to communicate relevant updates.12 Although the collaborative effort of all was appreciated, the COVID-19 crisis highlighted the vulnerability of the current drug regulatory process and drug import system that Canadians rely on.14 For example, Globalnews Canada reported, Claire Cortnar, a patient of CL2 Batten Disease, experienced interruptions of usual therapy treatments throughout the course of COVID-19.15 And many RD patients, families with children living with RD experienced similar access and financial barriers to necessary treatments and drugs which are vital to their survival. Looking into the future, domestic drug manufacturing is proposed to avoid being at the mercy of the international market during an unprecedented health crisis.16
Strategies and Planning for a Post-Pandemic world
As COVID-19 vaccine coverage in the global population increases, the post-pandemic world is on the horizon. Canada is establishing actionable strategies supported with funding to better meet the needs of the RD community. In 2019, the Canadian federal budget proposed investing up to $1 billion for 2022-23 to facilitate patient access to expensive RD drugs with an ongoing budget of up to $500 million per year.17-19 From January 27th to March 26th in 2021, HC engaged all Canadians in a discussion to develop a national strategy for high-cost drug (NSHCD) for RDs.16 Further relevant updates await.17
A national strategy on high-cost drugs for the RD community is of necessity. Up-to-date, fewer than 10% of RDs have available treatments while policies continue to encourage research and biomedical breakthroughs.17 Innovation brings financial burden on government and private insurers, researchers, pharmaceutical manufacturers, and other stakeholders, which is transferred to RD communities through drug and treatment costs.17
The NSHCD aims to find solutions to current barriers and build a better system. It prioritizes the ease of financial strain on the healthcare system across the country and the promotion of cooperation among federal, provincial, and territorial governments to further reduce costs and increase patient access.17 The goals of NSHCD involve providing pre-determined principles that facilitate making common healthcare related decisions, simplifying the funding process, providing common processes in evaluating the real-world impacts of the drugs, and stimulating the innovation of research for RD treatments.17 The discussion of NSHCD is well participated, however, it also faces public criticisms. For instance, the Canadian Life and Health Insurance Association (CLHIA) published a submission stating their support for a single framework for decision making and higher transparency in coordinating bodies while pointing out the following flaws:20 Compared against the federal budget, insurers paid out more than $650 million for RD drugs to over 13,000 insured Canadians in 2020, which has far exceeded the annual federal funding of $500 million for 2022-2023.20 This implies a risk of the federal first-payer model not achieving a balance between needs in the RD community and the cost of meeting that need. On the other hand, the Canadian Health Policy Journal criticized that HC prioritized the discussion of drug cost over the patients’ unmet needs, and their lack of a holistic view of RD therapies ranging from the early detection, screening, diagnosis, patient care, to long-term drug impacts.21
In a similar light, the COVID-19 pandemic has stimulated healthcare policy progressions in Europe.22-24 Recently, the EU has established a new European Policy Framework (EPF) and a Strategy for the Rights of Persons with Disabilities 2021-2023 (SRPD).25,26 Importantly, unlike the focus on costs in Canada, the EPF aims to better prepare for the future by constructing an up-to-date strategy combining research, healthcare, and social welfare complementing current legislation.25 It also provided measurable goals for 2030, which included diagnosing patients with medically defined RD within six months of coming to medical attention, making a thousand new therapies available with 3-5 times more affordability, and reducing the level of psychological, social and economic vulnerability of the RD community by a third.25 Similarly, the SRPD puts awareness and patient support first by improving social protection, disability assessments, labor market outcomes, and reducing barriers in the daily lives of persons with disability.26
Though the pandemic has not come to an end, it is not too early to reflect on some of the lessons learned from the COVID-19 crisis. From now on, there is a need to improve preparedness, collaboration, information transparency, speed of workflow, and innovation amongst all levels of the healthcare system including front-line clinical care, pharmaceutical industries, research innovations, drug regulatory bodies, and other sectors in Canada.27 In other words, Canada needs a well-developed plan to provide guidance under a health crisis, a strongly collaborative system tying the flow of all medical specialties and drug distribution/administration/regulation, a feasible national strategy to meet financial strains, and the promotion of medical and technological innovation to support the needs of RD patients.27,28
Zheng Song
Works Cited
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Cite This Article:
Zheng M., Sri A., Dong C., Liang A., V A., Ananthakrishnan O., Chharawala, V., Lombo, L. Placing Canada’s Healthcare Policy During the COVID-19 Pandemic in the Perspective of the Rare Disease Community. Illustrated by E. Jung. Rare Disease Review. January 2021. DOI:10.13140/RG.2.2.35742.46401.
