One of the requirements under the Food and Drug Regulations for an abbreviated new drug submission (ANDS) is that the generic manufacturer’s drug be the “pharmaceutical equivalent” of the innovator’s drug (the Canadian reference product), defined under s. C.08.001.1 as:
“pharmaceutical equivalent” means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients; [Emphasis added.]
As reported previously, in the December 2013 decision Apotex Inc v Canada (Health), 2013 FC 1217, the Court allowed Apotex's judicial review application of Health Canada's decision to refuse to review the ANDS for Apotex's Apo-Telmisartan. Health Canada decided that Apotex's finished product differed from the Canadian reference product (CRP) MICARDIS because in the CRP the medicinal ingredient is telmisartan-sodium, whereas Apo-Telmisartan contains telmisartan-potassium. Health Canada’s view was that under the definition of “pharmaceutical equivalent,” the medicinal ingredient found in the finished product or dosage form must be identical to the CRP. Apotex however argued that the starting ingredient was identical insofar as it was telmisartan. The Court found that the Minister's interpretation of “identical medicinal ingredients” in the definition of “pharmaceutical equivalent” was unreasonable and sent it back for reconsideration. The Court noted that its interpretation was at the screening stage and that the safety and effectiveness would be assessed at the next stages of approval. The Court also noted that Health Canada’s policy, Interpretation of 'Identical Medicinal Ingredient' (2003), does not address the point at which the identicality is to be determined. Apotex’s ANDS was ultimately approved.
On June 16, 2015, Health Canada issued an Interim Policy on its interpretation of “medicinal ingredient” (available here). It indicates:
This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (that is, new drugs and abbreviated new drugs) of changes in Health Canada's interpretation of medicinal ingredient, and therefore to the assessment of pharmaceutical equivalence. The changes below form the basis of an interim policy, which Health Canada has implemented in view of a Federal Court decision (Justice Kane, 2013 FC 1217). The interim policy outlined herein supplements the existing Policy entitled, Interpretation of 'Identical Medicinal Ingredient' (2003). Taken together, the interim policy and the 2003 Policy will remain in effect while the matter is being fully considered and until further notice.
The changes do not apply to biological or radiopharmaceutical products, or to medicinal ingredients which do not possess a unique chemical structure [for example (e.g.), polymers with varying molecular weights].
The Interim Policy addresses s. C.01.004 of the Food and Drug Regulations which provides:
C.01.004. (1) The inner and outer labels of a drug shall show
(c) on any panel
(iv) a quantitative list of the medicinal ingredients of the drug by their proper names or, if they have no proper names, by their common names.
The Interim Policy states:
Following the court's decision and for regulatory consistency, Health Canada has reassessed its interpretation of "medicinal ingredient" as used in section C.01.004(1)(c)(iv) of the Food and Drug Regulations to mean the Active Pharmaceutical Ingredient (API) used as the raw material in the manufacture of the finished dosage form (FDF). As a result, drug labels must refer to the API as the medicinal ingredient. For drug products in which the medicinal ingredient undergoes a change in chemical form during the manufacturing process (e.g., in situ changes), the label should further indicate the chemical form in the FDF in brackets after the API. The source of the counter ion for a salt should not be listed as a non-medicinal ingredient. [Emphasis added.]
Under the Interim Policy, the input ingredients will be considered for “pharmaceutical equivalence” but if those ingredients diverge into different forms, additional safety, effectiveness and quality data may be required. However, “[i]f the medicinal ingredients are different chemical forms at the input stage but nonetheless converge into the same chemical form, the medicinal ingredients will be considered "identical", and additional safety, effectiveness and quality data will not be required.”
Application of PMNOC Regulations
The Interim Policy indicates that the PMNOC Regulations “will continue to apply where a comparison or reference is made to a drug found on the Patent Register, regardless of the question of equivalence. The application is not dependent on the determination of pharmaceutical equivalence. ”
Further, “the established meaning of "claim for the medicinal ingredient" will continue to apply to the listing of patents on the Patent Register” and “there is no impact on the application of the data protection provisions in section C.08.004.1.”
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