As the House of Commons Standing Committee on Health begins its study on Canada’s pharmaceutical sovereignty this week, much of the discussion will centre on innovative therapies, vaccine development and investments in biomedical research.

Those conversations are important. But if Canada is serious about strengthening the security of its medicine supply and its national health security interests, policy-makers must start with something more fundamental: generic and biosimilar medicines.

These medicines fill 80 percent of prescriptions for Canadian patients. They generate billions of dollars in savings every year for public and private drug plans, creating the financial room governments need to fund new innovative treatments.

Yet generics and biosimilars are too often treated simply as a line item to minimize in health budgets.

That approach overlooks a basic fact: Canada’s generic and biosimilar sector is a strategic asset.

The COVID-19 pandemic exposed how fragile global pharmaceutical supply chains can be. Border disruptions, export restrictions, shortages of key ingredients and geopolitical tensions all threatened the steady supply of medicines around the world.

When supply chains fracture, countries with domestic manufacturing capacity and reliable partnerships are better positioned to protect their populations.

Pharmaceutical sovereignty does not mean producing every medicine domestically. In a highly globalized industry, this is not realistic. But it does mean ensuring Canada has strong domestic manufacturing capacity, combined with resilient international supply chains, so Canadians are not left at the back of the line when disruptions occur.

Canada already has a strong foundation.

Companies in the generic and biosimilar sector operate most of Canada’s pharmaceutical manufacturing capacity. These facilities are supported by a highly skilled workforce and decades of manufacturing expertise.

But this capacity cannot be taken for granted.

Over the past two decades, relentless pricing pressure and procurement policies focused almost exclusively on the lowest possible price have steadily eroded incentives to invest in domestic manufacturing, research and new product development.

At the same time, companies face growing uncertainty when trying to bring new cost-saving medicines to Canada.

Health Canada currently has more than 500 new generic drug submissions under review, with over 100 in backlog , some have missed regulatory targets by years. When companies cannot predict when medicines will be approved, it becomes extremely difficult to justify the investments needed to develop and launch them.

Even when generics are approved, their adoption is often too slow, particularly for more complex generic medicines, which represent the next generation of competition and savings.

Meanwhile, brand-name pharmaceutical companies increasingly rely on patent evergreening, product hopping, relabelled biologics and other strategies to delay and impede competition. In some cases, patents for new uses of older medicines are being used to block generic entry for uses that are no longer under patent protection.

That was not how Parliament had intended the pharmaceutical IP and regulatory system to work.
 

If Canada wants to strengthen its pharmaceutical sovereignty, governments must address these barriers.

That begins with sustainable pricing levels, restoring predictability to the regulatory environment, ensuring timely review of generic drug submissions, and putting in place policies that encourage the use of cost-saving medicines once they are approved.

Governments should also create competitive conditions for investment in domestic pharmaceutical manufacturing through targeted incentives, modernized regulatory pathways and clear, long-term policy signals.

At the same time, Canada should strengthen pharmaceutical supply chain partnerships with trusted trading partners so essential medicines can continue to move reliably during global disruptions.

Canada already has the essential ingredients: skilled workers, established manufacturing capacity and companies that supply medicines to patients around the world.

 Jim Keon is president of the Canadian Generic Pharmaceutical Association and Biosimilars Canada.

 

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