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This video is the first in a series of four which will explain
the legal framework of the health care system, and regulation of
drugs and drug pricing, in Canada at the federal and provincial
levels. The series is based on the Global Legal Insights
publication Pricing & Reimbursement 2020-Canada .
The second video in the series will be published next week.
Role of the federal and provincial governments in Canadian
healthcare
Canada s healthcare system, unlike that of the United
States, is mostly publicly funded and is typically free
at the point-of-use for Canadian residents. The Canadian federal
government provides funding to the provinces to finance the
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A patent term extension (PTE) provides a valuable mechanism for an Australian patent holder to extend the term of a pharmaceutical patent beyond the standard 20-year term. The PTE provisions are designed to compensate a patentee for the relatively long time required to develop, test and obtain regulatory approval to commercialise a new drug.
PTE Requirements
An application for a PTE can be made when (i) the patent relates to a pharmaceutical substance or a pharmaceutical substance when produced by recombinant DNA technology, (ii) the substance is included on the Australian Register of Therapeutic Goods (ARTG) before the 20-year term of the patent expires, and (iii) at least five years have elapsed between the effective filing date of the patent application and the first inclusion of the pharmaceutical on the ARTG.
Post-market surveillance for
medical devices: Amendments to the
Medical Devices
Regulations (MDR) are being made to impose additional
post-market reporting requirements for Class II, III and IV medical
devices.
Medical device license holders and
importers will be required to proactively report certain foreign
risk communications and actions to Health Canada.
Medical device license holders will
also be required to create and retain summary reports which address
adverse effects, corrective actions, complaints and incidents.
Health Canada s power to
order assessments, studies and tests: Amendments to the
MDR and
Food and Drug Regulations (FDR) clarify the
conditions under which Health Canada can order license holders to
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In the final days of 2020, the nearly 5,600-page Consolidated
Appropriations Act, 2021 (the CAA) became law. The pandemic relief
and government spending package includes a myriad of provisions
that affect group health plans and insurers. With most health
coverage provisions taking effect for the 2022 plan year or sooner,
and the CAA s promise of regulations, group health plan
sponsors will want to start preparing early. The CAA also included
a number of provisions relevant to retirement plans, which are
summarized in our prior alert, Appropriations Act Includes Several Provisions
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On 2 December 2020 the UN Commission on Narcotic Drugs (CND)
voted to recognize, for the first time in history, the medical
value of cannabis.
The long-awaited decision comes nearly 60 years after cannabis
was first included in the strictest category of the 1961 United
Nations Single Convention on Narcotic Drugs (hereinafter also
referred to as
“Convention”).
Through this historical vote the drugs in Schedule IV of the
Convention concerning dangerous substances with high potential
toxicity and low, or even no therapeutic power – a subset of
those already in Schedule I – no longer include cannabis.