Building Canada’s Pharmaceutical Sovereignty

Medicines should no longer be viewed solely as imported commodities. Recent crises have demonstrated their central role in ensuring collective security. The pandemic, together with persistent geopolitical tensions, has revealed an important reality: disruptions in supply chains can result in shortages of essential treatments.

Today, more than 88% of the drugs sold in Canada are manufactured abroad. This dependence has very real impacts: Canada is among the countries most affected by active drug shortages. Strengthening our pharmaceutical sovereignty is a choice of resilience and responsibility towards protecting Canadians. 

Yet Canada has enviable assets: a strong scientific ecosystem, highly skilled talent, state-of-the-art infrastructure, and a globally trusted regulatory environment. Domestic pharmaceutical developers and manufacturers play a key role in ensuring continuity between research, manufacturing, and distribution.

Generic drugs, which account for nearly 80% of prescriptions in Canada, contribute directly to the sustainability of our healthcare system. They provide access to safe, effective, and affordable treatments, while reducing pressure on public finances.

Recent history shows that a strong local manufacturing base is a strategic asset. Investments made in previous years to modernize manufacturing infrastructure demonstrate that pharmaceutical resilience can, and must, be built here. 

The federal government has sent positive signals along these lines. Whether by strengthening critical supply chains, exploring regulatory and tax modernization, integrating bioproduction into the industrial defence strategy, or through the “Buy Canadian” policy, a clear commitment is emerging: to reduce the country’s dependence and support its industrial capacity. The challenge now is to translate this direction into coherent and sustainable measures.

The Order Allowing Reliance on Decisions of Foreign Regulatory Authorities (Reliance Order): A Tool to be Used Strategically

It is in this context that Health Canada is conducting a consultation on the Reliance Order to expedite the approval of certain drugs.

We support this initiative when it is used for its intended purpose: accelerating access to specialized treatments, particularly in areas such as rare diseases and pediatrics, where domestic supply is limited or non-existent. Used appropriately, the Reliance Order can be a powerful lever to address urgent and unmet medical needs. 

However, its application must be carefully defined. If used too broadly or indiscriminately, it risks deepening Canada’s structural dependence on foreign supply at a time when strengthening domestic capacity should be a national priority. 

Crucially, the Reliance Order must not stand alone. It should be explicitly coupled with policies that promote the development and manufacturing of medicines in Canada. Without this balance, short-term gains in access could come at the expense of long-term resilience.

The challenge is therefore clear: to modernize without compromising on our ability to develop and manufacture products in Canada. This is not only an economic consideration. It is a matter of national resilience, directly tied to our capacity to support Canada’s broader security and defence objectives.  

Priority review mechanisms for players with a national footprint in research, development, and manufacturing must be an integral component of any regulatory change. Integrating such a measure would strengthen domestic development and production while preserving Canada’s scientific rigor.

The goal is not to choose between regulatory efficiency or local development and manufacturing capacity. These two ambitions are not mutually exclusive. They are mutually reinforcing. 

A Shared Responsibility

Canada now has an opportunity to align its defence, procurement, taxation, biomanufacturing, and regulatory policies around a common goal: ensuring stable, sustainable, and secure access to medicines for Canadians.

At Pharmascience, a Canadian pharmaceutical company with over 40 years of experience in research, development, and manufacturing, we believe that pharmaceutical sovereignty cannot be dictated: it must be built through long-term vision, Canadian investments, regulatory alignment and consistency to ensure the Canadian population’s needs are met at all times.