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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…
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 recently published a notice outlining its phase III pre-market transparency initiatives for prescription drugs. Beginning October 1, 2018, Health Canada will publish a new list of abbreviated new drug submissions (ANDSs) on the Submissions Under Review (SUR) List, as well as publish Regulatory Decision Summaries (RDSs) for ANDSs, supplemental abbreviated new drug submissions (SANDSs) and certain supplemental new drug submissions (SNDSs). These phase III initiatives are being implemented further to five proposals related…
The Federal Court of Appeal (FCA) has dismissed Apotex’s appeal arising from its application to end Health Canada’s requirement for additional information establishing the integrity of data from Indian drug manufacturing facilities. The FCA found that the Federal Court (FC) properly considered the evidence and that it did not err in finding that the decision to implement the requirement for additional information was not improperly motivated. Background This appeal arises from the third in a…
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 June 13, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) released its draft Brand Process Guidelines (Guidelines) for stakeholder feedback. As part of the consultation process, pCPA is planning a webinar for innovative manufacturers on June 22, 2018. The pCPA also released a Frequently Asked Questions (FAQ) document, and a Letter of Intent (LOI) template with the Brand Process Guidelines. Brand Process Guidelines. The Guidelines are intended to promote a common understanding of the pCPA process,…
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…