Why Special Access Should Be a Bridge, Not a Long-Term Solution for Canadian Patients

Canada has one of the most highly regulated pharmaceutical markets in the world. That regulatory framework plays an important role in protecting patients and ensuring that medications sold in Canada meet appropriate standards for safety, efficacy and quality.

However, there remains an important gap.

There are medications that are routinely used in other countries, sometimes for many years, that are still not commercially available in Canada. When Canadian patients require these therapies, clinicians may need to turn to Health Canada's Special Access Program (SAP).

The SAP is an essential component of Canada's healthcare system. But it was designed to provide exceptional access to non-marketed medications, not to replace having a reliable Canadian supply of medications that patients repeatedly need.

What Is the Special Access Program?

Health Canada's Special Access Program allows healthcare practitioners to request medications that are not marketed in Canada for patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable or are unavailable.

This provides an important pathway for patients who might otherwise have no reasonable treatment option.

But SAP authorization is different from Canadian market authorization. Health Canada specifically notes that an SAP authorization does not represent the same assessment of a product's safety, efficacy and quality that occurs through the normal drug approval process.

In other words, SAP fills a gap. It does not eliminate the gap.

SAP Is Used More Often Than Many Canadians Realize

The scale of the program demonstrates just how important access to non-marketed medications has become.

Health Canada reports receiving approximately 12,000 SAP requests each year. It now publishes a list of the medications most frequently accessed through the program, specifically noting that this information can help potential market authorization holders identify unmet medical needs and consider bringing these drugs to the Canadian market.

Some medications received hundreds of Canadian SAP requests in 2025 alone.

That raises an important question:

When a medication is repeatedly required by Canadian patients year after year, should special access remain the long-term solution?

In some cases, there may be an opportunity to create something more sustainable.

The Challenges of Relying on Special Access

For an individual patient, SAP can be invaluable. From a healthcare-system perspective, however, repeated reliance on special access can introduce additional complexity.

Administrative Burden

Patients cannot apply to SAP themselves. A healthcare practitioner must submit the request and provide the clinical rationale and supporting information. Requests are evaluated individually by Health Canada.

For physicians, pharmacists and hospitals already working in a resource-constrained healthcare system, this represents another administrative process required simply to obtain a medication that may already be routinely available elsewhere.

Access Does Not Guarantee Supply

Health Canada may authorize the sale of a medication through SAP, but the manufacturer is not obligated to provide it. Health Canada explicitly states that it cannot compel a manufacturer to supply an unauthorized medication through the program.

This creates a fundamental difference between permission to access a drug and having an established, reliable Canadian commercial supply.

Continuity Can Be More Complicated

SAP is intended for exceptional circumstances rather than routine commercial distribution. Additional requests may be required as treatment continues or stock needs to be replenished.

For therapies used repeatedly or for chronic diseases, relying indefinitely on an exceptional-access mechanism may not be the most efficient long-term model.

Healthcare Organizations Must Manage Additional Logistics

Non-marketed products can create operational considerations involving procurement, importation, inventory management, product information, storage and clinical processes.

These challenges are manageable, and healthcare organizations across Canada manage them every day. But where there is persistent demand for a medication, establishing an authorized Canadian product can provide a more conventional and sustainable supply pathway.

Why Aren't More of These Medications Marketed in Canada?

The answer is often economics rather than medicine.

Canada represents a relatively small portion of the global pharmaceutical market. For medications serving smaller patient populations, manufacturers must weigh expected Canadian revenues against the cost and complexity involved in regulatory submissions, manufacturing requirements, packaging, distribution, pharmacovigilance and maintaining a Canadian commercial presence.

A medication can therefore be clinically valuable without representing a sufficiently attractive opportunity for a large multinational pharmaceutical company.

The result can be an unusual situation: Canadian physicians know a medication exists, evidence supports its use, patients need it and the drug may be commercially available elsewhere, but no company has taken responsibility for bringing it to the Canadian market.

That is precisely where smaller and more focused pharmaceutical companies may have an important role to play.

Turning Repeated Special Access Into Sustainable Access

Special Access Program utilization can provide an important signal.

If healthcare practitioners repeatedly request the same medication, it may indicate a persistent unmet need rather than an isolated clinical exception.

Health Canada itself recognizes this opportunity. Its publication of frequently requested SAP drugs is intended, in part, to help potential market authorization holders identify medications for which there may be an unmet Canadian need.

And there is evidence that this transition can occur.

Health Canada's 2025 SAP reporting identifies numerous medications that had previously been accessed through SAP and subsequently received Canadian market authorization.

Once an authorized medication is marketed and available in Canada, SAP access generally ends because patients can transition to the Canadian-approved product. Health Canada's guidance describes SAP as providing a limited transition period rather than operating indefinitely alongside an available marketed product.

This is an important distinction.

The goal should not necessarily be to make Special Access easier for medications Canadians repeatedly need. The better long-term solution may be to reduce the need for Special Access altogether.

A Canadian Opportunity

There is an opportunity for Canadian pharmaceutical companies to look differently at smaller and overlooked medications.

Not every pharmaceutical opportunity needs to involve discovering a new molecule.

Sometimes innovation means identifying an established therapy that Canadian patients already need and building the regulatory, manufacturing and commercial infrastructure required to make that medication reliably available here.

This can include working with international manufacturers, securing Canadian commercialization rights, navigating Health Canada's regulatory pathway, establishing compliant supply chains and ultimately creating a Canadian-approved source of a medication that previously required exceptional access.

The commercial market for an individual medication may be relatively small.

Its impact on the patients who need it may be anything but.

Building a More Resilient Canadian Drug Supply

Canada will always need the Special Access Program. There will always be rare conditions, emerging therapies and exceptional clinical circumstances where physicians need access to medications that have not yet reached the Canadian market.

SAP performs that role extremely well.

But when the same medications are requested hundreds of times, year after year, we should also ask whether those requests are telling us something.

They may be identifying opportunities to strengthen Canada's pharmaceutical supply chain.

They may be identifying medications that have been overlooked because their markets are too small for traditional pharmaceutical business models.

Most importantly, they may be identifying Canadian patients who deserve a more predictable way to receive the medications they need.

Special access is an important safety net. Whenever practical, our goal should be to turn repeated special access into sustainable Canadian access.