Canada’s slow and extremely risk-adverse health regulatory system, coupled with unpredictable drug access and pricing, leaves patients without the novel medicines they need and clinical trials going to other countries.

However, Health Canada is incorporating more flexible and agile regulatory processes, including being able to rely on other countries for new drug approvals instead of always requiring domestic approval, experts said at Research Money’s 25^th annual conference, “Acting on Health: Reimagining Canada’s Promise,” in Ottawa.

Some panelists during a session on regulatory flexibility for innovation said Canada needs to move much faster on implementing crucial improvements, including:

• risk-sharing agreements with pharmaceutical companies to attract and incentivize clinical trials.
• ready access for patients to clinical trials and novel drugs, with predictable and standardized drug pricing across Canada.
• a special designation and optimized regulatory approval for Canadian companies with made-in-Canada drugs and other novel health technologies.
• much better coordination and integration of a jurisdictionally fractured public health care system across Canada.

“We’re seeing, internationally, countries and regions taking more national or regionalized approaches to innovation in this space, whether it's Europe or Australia or the U.K. And I think we're seeing more and more that the regulatory discussion is part of that,” said panel moderator Dr. Supriya Sharma (photo at left), chief medical advisor to the deputy minister at Health Canada.

Canada’s health regulatory system has changed a lot from 20 years ago, when regulators talked only with other regulators and saw their role as very narrow, she said. “It’s completely different [now].”

Health Canada and other federal departments and agencies are “constantly talking about a holistic approach to innovation, attracting innovation, and how all parts of the system can work towards that goal,” Sharma said.

But Patrick Bedford (photo at right), vice-president, regulatory affairs and strategic operations at Montreal-based Morphocell Technologies, a preclinical regenerative medicine company, said academics and innovators are “as woefully unprepared to navigate regulatory pathways as [they] were 15 years ago.”

“Our [health regulatory] system does not support you over time with corporate knowledge and memory, and that's a problem,” said Bedford, who worked as a regulator at Health Canada for 10 years. “Nobody understands how you navigate regulations.”

Also, Canada’s health regulatory system moves slowly because “you'll kill somebody if you don't demonstrate that you have good science and the preclinical studies support the safety and efficacy, and you're able to document it in a useful way,” Bedford noted.

But lawyer and health advocate Louise Binder (photo at left),  health policy consultant with the Save Your Skin Foundation, said Canada’s health regulatory system needs to let patients decide on the risks they’re willing to take, including with novel drugs in a clinical trial.

“We'd actually like to be leading the charge on a lot of this stuff, and do we think there's enough flexibility? No, we don't think there's enough flexibility,” she said.

“We’d really like to see a system that didn't have tails wagging dogs, and we really ought to be the ones that you ought to be thinking about when you're thinking about doing your health innovation,” Binder said.

Patients can’t wait for all of the regulation to work its way through the system, “and we're actually very tired of being protected. Please don't protect us anymore,” she said. “It's really our risk. So let us take it, and then you figure out how to deal with that afterwards.”

Regulators also need to co-create regulations, policies and rules for clinical trials with patients, including unrepresented populations, Binder said. “We actually are experts in our own health and we'd like to be included.”

Clinical trials face a bewildering maze of regulations and guidelines

Susan Marlin (photo at right), president and CEO of provincially funded Clinical Trials Ontario, said there are at least six regulations and guidelines that govern the ethical review and conduct of every clinical trial in Canada.

On top of that are 13 provinces and territories that all have health privacy legislation that impacts the ethical review of clinical trials across Canada, she said. “It’s not easy to try to get alignment around a single research ethics review in Canada.”

Along with different government jurisdictions, “we have hundreds of universities and hospitals that have their own nuances or preferences on top of that,” Marlin said.

In addition, there are at least 300 potential clinical trial sponsors just in Ontario and many more across Canada “that have their own preferences, nuances [and] expectations, often from a global perspective,” she said.

“Clinical trial opportunities are not available, I would say probably to most Canadians, to be honest,” Marlin said. “If you live anywhere outside of a major city centre and you're not being seen at a teaching hospital, it can be extraordinarily difficult for you to get a trial.”

Also, Canada’s federal tax benefits aren’t aligned well with pre-tax or pre-revenue biotech companies seeking early-phase clinical trials for their novel health products, she said. “Australia’s done that brilliantly with their tax incentives for companies, and companies are driven there especially to do their early-phase trials.”

Dr. Bettina Hamelin (photo at left), president and CEO of Innovative Medicines Canada, pointed out that in 2023-2024, Canada lost 11 percent of its clinical trial activity compared with the previous year.

Canada has fallen to eighth place from fifth place globally for hosting Phase III clinical trials.

“We're now sort of in the second tier for clinical research. We have dropped down, and countries like Germany, France, Spain, Italy, China, the U.S. are doing better,” she said.

Hamelin noted that it costs about $3.5 billion and takes 10 to 15 years to get a new drug approved in Canada, leaving only about five to eight years on average for a company to sell its drug before its patent expires.

Even after Health Canada approves a drug, it takes another 2 ½ years on average to get the cost of that new medicine reimbursed by the public health care system in Canada, she said.

Canada is exposed on the research and development side because there’s a global shift in where R&D is going, based on countries that have favoured-nation pricing and make innovation a priority, she said.

For example, this year China surpassed the U.S. for the number of cell and gene therapy clinical trials.

Canada has a complex regulatory system coupled with inefficient and unpredictable assessment of health technologies and pricing of new drugs, Hamelin said.

During the last five years, she noted, more than half of the recommendations by Canada’s Drug Agency, which includes the federal, provincial and territorial governments, required a reduction in price of new drugs of more than 73 percent, and more than one-quarter of new drugs to be reduced by 90 percent in price.

“Now put yourself in the shoes of the innovator that is looking at $3.5 billion Canadian dollars to develop this drug, but needs to accept a 90-percent decrease in pricing. That is just not sustainable and we're just extremely exposed if we don't figure out how we work across the ecosystem,” Hamelin said.

Also, even when the price of a new drug is negotiated with pharmaceutical companies by the pan-Canadian Pharmaceutical Alliance, with all the government jurisdictions sitting at the table, then the pharmaceutical company still has to negotiate with every province to have the cost of its drug reimbursed by the public health care system.

As a pharma company, she said, “Why would you do a clinical trial in a country that does not approve and reimburse your medicine after? You don't. And that's where, in this geopolitical rewriting of R&D and innovation, [clinical trials] are not coming to Canada.”

New policy will enable Health Canada to rely on other countries’ approval for new drugs in Canada

David Lee (photo at right), chief regulatory officer at Health Canada, said the public trusts the federal regulator to ensure that novel drugs and other medical products are safe, effective and high quality.

Regulation is “always mapped against that public trust. So it takes a lot of communicating, it takes a lot of adjusting, a lot of thinking, and that's why it takes time. Too much time, sometimes,” he said.

Health Canada works with international regulatory organizations, such as the U.S. Food and Drug Administration, the European Medicines Agency, and Project ORBIS (for new cancer drugs) in reviewing new drugs and other health products, Lee said.

He has drafted a “Ministerial Reliance Order” aimed at creating a new law enabling Health Canada to rely on decisions or documents made by comparable regulators in other countries. The federal government published the order this month.

“It means that if Europe [for example] makes a decision and it's the type of drug we can deal with, then we will use that for approval,” he said.

Health Canada also is part of a group, with other medium-sized international regulatory authorities, called the Access Consortium that’s working together to streamline the assessment of medicines and speed up patient access to them. The consortium works to promote regulatory collaboration, align requirements, and reduce duplication of effort among health regulators.

“The more this happens and we have tools to make it happen, I think it's a good direction. There are parts of the regulatory system where we do that,” Lee said.

Health Canada also sometimes has a priority review pathway, with shorter review timelines, for novel products that show significant improvement.

But Binder said rather than typically doing long, complex and cumbersome regulatory reviews, Canada needs to have risk-sharing agreements with pharmaceutical companies to provide novel drugs while negotiating on price.

“I think the problems really reside with our federated health care system and the fact that we have all these different players in the health care system in terms of deciding whether something is valuable or whether it ought to be put on reimbursement plans,” she said.

That approach leaves patients “skipping and hopping” across the country “just to get our hands on a drug that’s going to keep us alive and give us some decent quality of life,” Binder said.

Also, all the provinces and territories agree on the price for a new drug, then that drug should be available to patients at that price across Canada, she said.

Bedford said multinational biotech and pharma companies go to the top tier countries for clinical trials, like the U.S., the European Union and Japan, to submit their new drugs for approval. Because Canada is now a second-tier country for clinical trials, that leaves Canadian patients waiting 18 to 36 months for Canadian companies to get their new drug submissions in front of those international regulators.

Canadian companies that are built in Canada, based on made-in-Canada technologies, should get “a preferred seat at the table, or have a shorter line” to regulatory approval, he said.

“We need a special designation for Canadian technologies that are desirable in helping with Canadian health care systems, that patients want and need, and meet those requirements that can be cost effective to our health care system, whether they're making profit or saving our health care system money.”  

“We also need a special, optimized pathway for novel technologies,” such as advanced therapeutic products, Bedford said.

Such a pathway could include a framework that uses electronic quality management systems and AI-driven automated manufacturing processes that would enable a hospital to be licensed by Health Canada to safely and efficiently produce advanced therapeutic products “at the bedside,” he said.

“I think there's really low-hanging fruit that just has all the pieces that we just need to put together,” Bedford said.

“There’s a lot of truculence from different groups for very historical reasons that you could say are good. But I think we just have to sweep that out of the way and then start doing it.”

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