Proposed changes to Canadian regulation affecting generic drug submissions and data protection

The Canadian government has published proposed amendments to the Food and Drug Regulations (Regulations) that will make it easier for a generic drug manufacturer to bring a chemical variant of an existing innovator drug to market.

What you need to know

• The proposed Regulations are not law. Stakeholders may provide comments to Health Canada on the proposed Regulations until June 8.
• Drug manufacturers will be able to submit an Abbreviated New Drug Submission (ANDS) to Health Canada for generic drug products that are a salt, hydrate or solvate of a Canadian reference product (CRP).
• The proposed Regulations are forward looking: they will only apply to drugs where the regulatory submission for the generic drug product has a filing date after the date the regulations come into force.
• In connection with this update, the definition of “innovative drug” in Canada’s data protection regulations will be modified. This proposed change is forward looking and would apply to drug submissions filed after the coming into force date.

Notable changes

Increasing the use of the ANDS pathway

In Canada, a drug manufacturer may receive a Notice of Compliance (NOC) to market a generic version of a drug product previously authorized by Health Canada (i.e., an innovator drug). To obtain regulatory approval, a drug manufacturer must file an ANDS with information demonstrating the generic drug product is the “pharmaceutical equivalent” of the CRP (i.e., the previously approved innovator drug). Under section C.08.001.1 of the current Regulations, a generic drug product is considered to be the pharmaceutical equivalent of a CRP if it contains “identical amounts of identical medicinal ingredients.”

In 2003, Health Canada’s official position was that the medicinal ingredient found in the dosage form of the generic drug product had to be chemically identical, but not necessarily physically identical, to that of the CRP to be considered a “pharmaceutical equivalent.” Generic drug manufacturers criticized this interpretation, as it did not account for changes to the form of the active pharmaceutical ingredient that can occur during the manufacturing process of the dosage form. Apotex challenged Health Canada’s position in a proceeding before the Federal Court, and in 2013, the court held that pharmaceutical equivalence could be assessed by comparing the starting ingredients used in manufacturing the dosage form.¹

In response to the Federal Court decision, Health Canada altered its position, and stated that comparing input medicinal ingredients would be acceptable for determining pharmaceutical equivalence for an ANDS. However, if the medicinal ingredient in the generic drug product diverged into a different form than the CRP in the dosage form, Health Canada could request additional safety, effectiveness and quality data. In a 2017 interim policy, Health Canada also expanded the types of drug products that would be eligible for regulatory approval through the ANDS pathway. Specifically, Health Canada stated that different salt forms of a CRP could be eligible for an ANDS.

The proposed Regulations codify Health Canada’s current position with respect to ANDS eligibility. Under the proposed Regulations, ANDS eligibility will no longer be determined by assessing whether the generic drug product contains an “identical medicinal ingredient.” Instead, ANDS eligibility would be determined by assessing whether there is an “identical therapeutically active component.” A “therapeutically active component” will be defined as “a medicinal ingredient, excluding those appended portions, if any, that cause the medicinal ingredient to be a salt, hydrate or solvate.” In other words, generic drug products that are a salt, hydrate or solvate of a CRP will be eligible to be approved through the ANDS pathway.

These amendments will only apply to chemical (small molecule) drugs, and not to radiopharmaceutical drugs or biologics. Health Canada has indicated that the proposed Regulations are aimed at improving access to generic medicines in Canada.

Limitations on data protection

Drug products that fall within the definition of “innovative drug” are entitled to an eight-year term of data protection, which can be extended for an additional six months for pediatric population submissions. The proposed Regulations would update the definition of “innovative drug” in section C.08.004.1 of the Regulations to make it consistent with the other proposed amendments. The following table compares the current definition of “innovative drug” to the definition in the proposed Regulations:

What’s next

The proposed Regulations are not law. Stakeholders may provide comments to Health Canada on the proposed Regulations until June 8. Health Canada has also opened public consultations on two draft guidance documents relating to the proposed regulatory changes. Stakeholders may provide comments on the draft guidance documents until June 17.

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¹ Apotex Inc. v. Canada (Health), 2013 FC 1217.

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