Charles Pirraglia and Deborah Brown

We’re in an extraordinary era for medical innovation. The pharmaceutical industry is yielding protection against diseases, focusing more on rare and complex disease treatments, and the world is getting better health outcomes. Global life expectancy is more than 

 as diseases that were once considered terminal are now treatable.

And as more manufacturers and innovators bring new therapies to market, they’ll continue to look at the largest markets to make an impact, including markets like Canada.

Canada, a country with 10 provinces and three territories, has just over 38 million residents, yet most reside in four provinces—Ontario, Quebec, British Columbia, and Alberta, which constitutes nearly 87% of the population. The nation is the world’s 10th largest pharma market, has some of the highest per capita healthcare spending in the globe, and drug pricing ranks 9th when compared to other Organization for Economic Cooperation and Development (OECD) countries.

For manufacturers, Canada makes a lot of sense. But it also offers several unique challenges that companies must be aware of as they work to bring their therapies to the “Great White North.”

The path to product commercialization in Canada can be complex and challenging, given the highly regulated nature of market access and pricing. First, it is important to remember that healthcare in Canada is publicly funded but privately delivered​. This means that while most healthcare services are “free” at the point of use, they are delivered by private providers (i.e., physicians)​.

Second, both administration and service delivery are highly decentralized​. Administration is a mix of public and private institutions delivering and serving the needs of patients.

Third, it is relatively common knowledge that there is a significant delay in Canada for drug approvals compared to other countries like the US or the EU. In fact, a recent study done by The Fraser Institute illustrates that this lag results in an average delay of 469 (median 289) days for a therapy to be approved versus the US, and 468 (median 154) days versus Europe.

By and large, delays are almost entirely due to the manufacturer’s decision to file later in Canada and has little to do with the efficiency of the regulatory processes. These are missed revenues and ultimately, missed patients and lives benefiting from these therapies. This lag to file in Canada equates to an average of a 1.3-year delay in Canadian patient access to these new or improved therapies.

Navigating the complexities of Canadian market approvals

Historically in the industry, there has been an assumption that the Canadian filing process would consume valuable resources from stretched regulatory teams. Yet recent events and increased global harmonization through the work of organizations like the International Council for Harmonization (ICH) have helped make this process more agile.

Today, there is increasing cooperation among the leading regulatory agencies around the world. Take for example 

, which launched in 2019 as a framework for concurrent submission and review of oncology drugs among international partners (which now include the US, Canada, Australia, Singapore, Switzerland, UK, Brazil, and Israel).

This framework and other forums have begun to promote more regulatory convergency, helping to increase speed to market and remove barriers that have historically existed, creating wins for everyone.

Additionally, more companies are turning to in-market experts that know the industry and have trusted relationships with key stakeholders. Local knowledge of requirements in Alberta versus Ontario versus other provinces and territories is critical for companies to understand as they consider bringing products to Canada.

Great progress continues to be made each day, and more solutions are also on the way.

Ultimately, Canada is an ideal market for biotech and pharmaceutical companies to see their products grow in sales and impact more lives. Canadian patients deserve timely access to treatment. And with innovative commercialization models now available, manufacturers can know that their investments can be reliably returned in the Canadian market.

Charles Pirraglia is Managing Director, while Deborah Brown is Lead, Strategic Partnerships, both at EVERSANA.

Articles

Product commercialization in Canada is by no means simple, but the end result presents its advantages