The Federal Court has dismissed the judicial review of a decision by Health Canada denying data protection to the applicant for hexaminolevulinate hydrochloride. The Court found the Minister's decision to be reasonable, finding that the issue relates to the interpretation of the regulations and what is a "variation". This was found to be very closely linked with and dependant on the science involved and with issues that fall within the role and expertise of the OPML.
This drug is stated by the Minister to be an ester variation of a previously approved medicinal ingredient, aminolevulinic acid hydrochloride. The applicant disagreed, arguing it is both a salt and an ester and it should have been considered as an "arguable variation" of a previously approved medicinal ingredient. As such, the Minister should have considered the clinical data submitted in the NDS and should have granted data protection.
New affidavit evidence that was tendered by the applicant for the first time on appeal was not found to be admissible because it included opinion evidence on the very question the Minister is responsible for deciding and did decide. The Minister's responding affidavit was also found to be inadmissible.
In the end the Court held that the examples of "variations" do not foreclose a drug that is both a salt and an ester or other combinations of those examples from being found to be variations, and the Minister reasonably found that the medicinal ingredient is an ester of a previously approved medicinal ingredient, even though it is also a salt.