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The federal government has proposed changes to the Food and Drugs Act (FDA) that would allow the Minister of Health (Minister) to classify products as foods, drugs, cosmetics, devices, or “advanced therapeutic products”; require authorizations to conduct clinical trials; and modify Health Canada’s inspection powers. These changes are included in an omnibus budget bill, the Budget Implementation Act, 2019, No 1 (Bill C-97). Bill C-97 was introduced and received its first reading in the House…
On March 30, 2019, the government published proposed amendments to the Food and Drug Regulations (FDR) intended to clarify whether a generic version of a drug can be approved using the abbreviated new drug submission (ANDS) pathway. These amendments affect how the FDR apply to a generic drug product if it contains a different medicinal ingredient than the Canadian reference product (CRP), but the same therapeutically active component. They also include changes to (i) labelling…
As we reported the Advisory Council on the Implementation of National Pharmacare recently released an interim report calling for the creation of a national drug agency.  Yesterday, the federal government announced funding to implement this recommendation. Specifically, the government intends to work with partners to implement the following: Create the Canadian Drug Agency — to provide a coordinated approach on prescription drugs. Budget 2019 proposes to provide Health Canada with $35 million over four years,…
The Advisory Council on the Implementation of National Pharmacare (“Council”) presented an interim report following consultation with Canadians.  The report outlines work done to date by the Council, core principles the Council believes should underpin national pharmacare, and initial foundational recommendations. As we reported, the Council consulted with Canadians on the implementation of a national program to fund prescription drugs.  The Council engaged with patients and caregivers, healthcare providers, representatives of Indigenous organizations, government…
This week the Ontario government announced legislation that will overhaul the administration of healthcare delivery in Ontario. Bill 74 was introduced in the Ontario Legislature on February 26, 2019, and passed first reading.  The bill creates the Connecting Care Act (the “Act”). The province’s 14 existing Local Health Integration Networks (LHINs) and six other agencies such as Cancer Care Ontario and the Trillium Gift of Life Network will be replaced by a single agency known…
Health Canada has decided that all biologic drugs, including biosimilars, will be identified by both their unique brand name and non-proprietary (common) name — without the addition of a product-specific suffix. The ability to distinguish between biologics with the same non-proprietary name is important for pharmacovigilance and to minimize inadvertent substitution of drugs that have not been deemed interchangeable. This policy statement was communicated in a Notice to Stakeholders, which outlines the following steps…
On January 7, 2019, Health Canada opened a consultation on whether to include the names of sponsor companies on the generic submissions under review list (GSUR) for Abbreviated New Drug Submissions (ANDSs). This type of information was recently added to the list of drug and health product submissions under review (SUR) that Health Canada has maintained since 2015. Historically, the SUR list has been restricted to New Drug Submissions (NDSs) and Supplemental New Drugs Submissions…
Advisory Council on the Implementation of National Pharmacare – Consultation with Canadians The Advisory Council on the Implementation of National Pharmacare (“Council”) is consulting with Canadians on the implementation of a national program to fund prescription drugs.  The consultation is open until September 28, 2018. The Council, which reports to the Minister of Health and the Minister of Finance, was created following an announcement in the 2018-2019 federal budget (reported here). Canadians can provide…
On April 18, 2018 the Standing Committee on Health tabled its report on national pharmacare entitled Pharmacare Now: Prescription Medicine Coverage for All Canadians. The Committee believes that the best way to move forward in establishing a universal single payer public prescription drug coverage program is by expanding the Canada Health Act to include prescription drugs dispensed outside of hospitals as an insured service.  The Act establishes criteria and conditions for insured health services that…
Norton Rose Fulbright Canada LLP recently published an article on the “Top 10 Updates on Canadian Market Access, Exclusivity and Pricing Issues” for the Food and Drug Law Institute’s March/April 2018 issue of Update Magazine. The article contains an overview of some of the most pertinent changes in market access, exclusivity and pricing that have occurred over the past year that will impact stakeholders operating in the Canadian pharmaceutical industry. A link to the article…