Drafting a Canadian health policy for rare diseases

U of T researchers say Canada needs to create new framework to broaden access

Drafting a Canadian health policy for rare diseases

In the last federal budget, the Canadian government committed one billion dollars over two years, starting in 2022, to cover the costs of health care related to rare diseases. Canada’s relative lack of a rare disease policy opens conversations on what should be included in an effective strategy to provide Canadians better access to drugs for these ‘orphan diseases.’

Dr. Joel Lexchin, an associate professor at U of T’s Department of Family and Community Medicine, and Nicholas Moroz, a recent Master of Public Health graduate at U of T, published a paper on the subject. It analyzed whether a rare disease policy similar to Australia’s could be effectively implemented in Canada to broaden the availability of treatment options for patients with rare diseases in the country.

The state of orphan diseases in Canada

Orphan diseases are rare diseases that affect approximately five people in 10,000. These diseases have been the subject of policy discourse in Canada for more than two decades, yet no policy has been set, according to the authors. 

Now, as legislators have a go-ahead from the government for investing in orphan drug treatments, they must also consider the best policy for regulating them.

Health Canada currently has two regulatory pathways in place that facilitate the speedy delivery of orphan drugs to the market. These provide patients access to orphan drugs in the interim of passing a formal policy, according to the authors. 

The first is the priority review, which takes 180 days, instead of the standard 300-day review. The second is a 200-day conditional approval of drugs based on limited clinical data. 

Would an orphan drug policy be beneficial?

To determine if a drug policy such as Australia’s would be beneficial to improving access to drugs, Lexchin and Moroz looked at the frequency and speed drugs assigned an ‘orphan’ status by the US Food and Drug Administration (FDA) were approved by Australia and Canada. 

The paper does not suggest that an orphan drug policy like Australia’s would help improve access to medicine in terms of speed or variety. 

The conclusions showed that both Health Canada and the Australian Therapeutic Goods Administration (TGA) approved 74 of the 119 drugs designated for orphan diseases by the FDA. Health Canada shows more propensity for approving drugs, as it approved an additional 11 drugs, while the TGA only approved four other drugs. 

There was no significant difference between the approval rate by Canada and Australia. 

Why do we even need an orphan drug policy?

Australia’s orphan drug policy is focused on getting drugs to the market rapidly. However, the authors noted that Canadian lawmakers could help patients by considering other objectives, including incentives for drug development and economic accessibility. 

While Australia implemented fee waivers for applications for orphan drug status and annual registration, its policy does not guarantee market exclusivity, grants, or tax credits targeted at orphan drug research. Lexchin and Moroz think that such a framework would help provide developmental incentives for new drugs, which is one of the objectives that they argue Canada should include in orphan drug framework. 

When it comes to economic accessibility of orphan drugs, the study recommends that the government include public subsidies and reduce the price charged by companies.  

There is no evidence that having an orphan drug framework similar to Australia’s would make Canada a more attractive market for orphan drugs, wrote the authors. They concluded that in order for Canada to provide quicker access to orphan drugs, it is essential for the policy framework to be much different than the one in place in Australia.

Federal government announces $2.4 million investment in women’s organizations

Endowment to be distributed to five organizations to advance gender equality

Federal government announces $2.4 million investment in women’s organizations

The federal government will be donating a $2.4 million endowment to support five women’s organizations in the Davenport neighbourhood, as a part of the Department for Women and Gender Equality’s Capacity-building Fund.

Davenport MP Julie Dzerowicz, who presented the investment on May 3 on behalf of the Minister for Women and Gender Equality, said that its aims are to “help [women’s] organizations attract and retain talented leaders, to digitize critical data, to improve fundraising, and to ultimately support long-term planning through the availability of sustainable and predictable financial support.”

The press conference was hosted at Sistering, a drop-in centre for homeless or precariously housed women, which is set to receive $203,270 over five years as a part of the endowment.

Other organizations that will receive funding include the Dandelion Initiative, a project run by survivors of sexual assault and violence to tackle gender-based violence; South Asian Women’s Centre (SAWC), which aims to assist South Asian women in increasing their economic, social, and political status; Working Women Community Centre (WWCC), which provides recently immigrated women with employment counselling; and COSTI Immigrant Services, an agency which assists immigrant communities with employment, settlement, educational, and social services. They will respectively receive $740,960, $230,457, $247,598, and $980,000.

Creating “a level playing field”

Speaking on the reasoning for the investment, Dzerowicz said that it aimed to create “long-term, systemic change to ensure progress continues and women advance.”

The particular organizations were chosen for their commitment to assisting women with diverse challenges and for furthering a “strong, viable, and inclusive women’s movement.” Ultimately, Dzerowicz says that the government hopes to help create a “level playing field for everyone.”

The Dandelion Initiative will use the funds it receives to develop its “Safer Spaces Ontario: Strengthening Survivor Centric Work” project. Viktoria Belle, the Executive Director and Founder of the initiative, said at the press conference that the investment “comes at a time when we have a great need to expand and strengthen our network of support for survivors.”

Sistering’s project is expected to help address the unique challenges that homeless and transient women in Toronto face by supporting the hiring of new staff and expanding its support network and services.

The SAWC’s project aims to strengthen its long-term structure and sustainability through strategic planning and communication strategies. Kripa Sekhar, the Executive Director of the centre, said that the funding will “definitely improve the lives of women because more people will know about what we do, and enhance our ability to envision what the future’s going to look like.” This is the first time the centre has received federal funding.

The WWCC’s grant will help expand its support network for newcomer women from Portugal, Latin America, the Caribbean, and Africa. The funding will help further the WWCC’s work in helping women with language instruction, housing, and job training. Marcie Ponte, the Executive Director, expects the investment to “make a difference in the lives of many women throughout the Greater Toronto Area.”

The largest investment, nearing $1 million, goes to COSTI’s project. With the funding, Executive Director Mario Calla hopes to enhance their ability to identify and fill service gaps for diverse women who are experiencing gender-based violence.

Things to know about the 2019 federal budget

Budget increases student work placements, entrepreneurship support, eases student loan costs

Things to know about the 2019 federal budget

The federal government’s recently announced 2019 budget outlines a number of key provisions to support students and young adults, ranging from increased job creation to easing student loan repayments. What is the significance of some of these major changes, and how will they be implemented? The Varsity spoke to Minister of Innovation, Science and Economic Development Navdeep Bains and Parliamentary Secretary to the Minister of Finance (Youth Economic Opportunity) Jennifer O’Connell to learn more about what the budget has in store for students.

Student work placements

The federal government aims to create 84,000 new student work placements per year by 2023–2024. Expanding this program will cost about $798.2 million over five years. Of this amount, $631.2 million will be used to expand student work placements beyond the STEM fields. This will provide 20,000 new placements per year for students across numerous disciplines by 2021–2022.

Beginning in 2020–2021, $150 million will be allocated to the government’s Employment and Social Development Canada to create partnerships with businesses and support 20,000 additional student work placements.

The final portion of these changes is $17 million, budgeted to support the Business/Higher Education Roundtable, which aims to create 44,000 additional jobs per year by 2021. The initiative is run by the Business Council of Canada and partnered with a number of postsecondary institutions and private companies to “deepen collaboration and improve opportunities for young Canadians.”

“The idea is to complement current co-op programs, to complement internship initiatives, not to replicate and not to undermine existing academic institutions that have programs in place,” Bains said. “The goal is to leverage the most we can of the private sector.”

When asked how the government would ensure that its investments would be apportioned to creating student work placements that would benefit students and universities, Bains said that the vetting system “is still a work in progress” that would be adjusted “in the coming weeks and months as [the government moves] forward with implementing this initiative.”

O’Connell said that ensuring work placements are both incorporated into curricula and are paid is important. “We think that if students are being paid for their work, that [will ensure that there are no] abuses in the system, that you’re not just taking advantage of a student’s work… if a business has to pay that student, then they’re going to make sure that it’s a position that is actually adding that value.”

Entrepreneurship and research

With $38 million in renewed funding to non-profit organization Futurpreneur, the federal government is expecting to support the work of approximately 1,000 young entrepreneurs per year. Futurpreneur has provided financial and mentorship support to over 12,000 entrepreneurs since 1996.

“The exciting part is 40 per cent of them [in 2017] are women and that’s double than what we see in the private sector,” Bains said. “We’re really excited about that trendline because we want an economy that works for everyone.” Of the funding, $3 million will specifically be targeted support for Indigenous entrepreneurs.

Bains added that this funding would complement existing entrepreneurship programs at U of T, including “Vector, [the Creative Destruction Lab], or MaRS, where there’s a lot of commercialization occurring, where businesses have the opportunity, where students have the opportunities to take their ideas to market.”

Bains also mentioned Canada’s Intellectual Property Strategy, an initiative that he launched in 2018, as an example of the supports provided to young entrepreneurs and researchers more broadly.

“One thing that we are very mindful of is that as we’re developing investments in research, as we’re focusing on commercialization, that we also lead on governance,” Bains said. “I’m firmly of the view that in the coming weeks and months you’ll see us take clear positions around how do we build trust with these investments as they’re becoming more and more commercialized.”

When asked to comment on the federal government’s stance on Huawei given security concerns brought up by other countries, Bains said that it is currently analyzing whether the Chinese firm is a cause for concern over privacy and public safety. He added that the Intellectual Property Strategy is a tool that can address incursions into research, including research that U of T conducts through its million-dollar Huawei partnership. “We need to… have robust policies and frameworks to protect the Canadian ideas and Canadian partnerships.”

Student loans

In a move that will cost $1.7 billion, the budget also outlines plans to change the federal portion of student loans by lowering interest rates and making the six-month grace period following graduation interest-free. These changes are expected to save approximately $2,000 over the period of their loan repayment. For students using the Ontario Student Assistance Program, these changes counter the provincial Progressive Conservative government’s introduction of interest accrual during the grace period in January. The provincial government said that its change was to “align Ontario’s repayment terms with that of the federal government… to reduce complexity for students.”

“We think more people should be able to afford a postsecondary education and we think we’re concerned about the increase of that cost and the debt,” O’Connell said. She added that the federal government’s changes to student loans were inspired by comments and concerns it had received from before Ontario’s changes.

O’Connell, who represents the Pickering—Uxbridge riding, said that she has heard a number of concerns with the provincial government’s changes to student loans. “I think that this budget and our focus on youth and making education more affordable should be a signal,” she said. “We’re happy to work with the province if they want to align their policies in this way.”

— With files from Srivindhya Kolluru