We previously reported on the Ontario government’s efforts to manage the risk of drug shortages in the early days of the pandemic. Those efforts included a recommendation that pharmacies dispense no more than a 30-days’ supply of medication to patients under the Ontario Drug Benefit (ODB) program. Because the policy resulted in additional dispensing fees being charged to patients, the government took further regulatory action to ensure that patients would not be required to pay additional fees as a result of this policy.

On June 15th, 2020, the Drugs and Devices Division ended its recommendation that pharmacies dispense … Continue Reading

Health Canada recently published a notice to industry detailing its collaborations with international partners during the COVID-19 pandemic. These cooperative efforts aim to ensure that Canadians’ health product needs are being met quickly and effectively during the outbreak, and that Canada’s policies and regulatory strategies are consistent with those in force around the world.

Collaboration with International Regulators

International Coalition of Medicines Regulatory Authorities (ICMRA)

Health Canada is a member of the ICMRA, an entity made up of 29 regulatory authorities and with the World Health Organization (WHO) as an observer. ICMRA members work together … Continue Reading

Canada, the United States, and Mexico have each completed the domestic processes necessary to bring the Canada-United States-Mexico Agreement (CUSMA, also known as USMCA or New NAFTA) into effect. CUSMA will come into force on July 1, 2020, the first day of the third month after it was ratified by each member country. The United States was the final member country to complete its domestic ratification process, giving notice to Canada and Mexico on April 24, 2020. Canada and Mexico had provided notice on April 2 and 4, 2020, respectively.

Next step: Uniform Regulations

The CUSMA member countries … Continue Reading

The Ontario Ministry of Health and Long-Term Care (the Ministry) has amended Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act (DIDFA). The new Regulations are substantially similar to those originally proposed (as we reported). The intended effect of the amendments is to reduce technical requirements for listing a product on the Ontario formulary and align policies with industry standards and other provinces.

The amendments

Key changes to the Regulations include:

• Remove the requirement for the Drug Notification Form (DNF) from formulary drug submissions. A

The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT^® (prasugrel hydrochloride). While the Court rejected Apotex’s allegations of overbreadth, insufficiency, and non-patentable subject matter, it held that the claims were obvious.

Background

The claims of Canadian Patent No. 2,432,644 (the 644 Patent) relate to pharmaceutical compositions comprising prasugrel and aspirin. Prasugrel is a member of the thienopyridine family of compounds. The asserted claims of the patent claimed the use of prasugrel for simultaneous or … Continue Reading