June 2018

Update on biosimilars

Further to our update in December 2017, here, we provide a mid-year update on biosimilar approvals, litigation and other news.

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Health Canada News

Health Canada issues updated guidance on PMNOC Regulations

Health Canada has issued updated guidance reflecting the September 21, 2017 amendments: Guidance Document: Patented Medicines (Notice of Compliance) Regulations (see our summary of the amendments here). The guidance, which became effective on May 11, 2018, also reflects current administrative practices, for example, by replacing references to “patent hold” with its currently preferred term, “intellectual property hold”. Further revisions include:

• Directions on how to provide litigation information to Health Canada so that it is aware of barriers to the issuance of a second person’s NOC, given that the Minister is no longer a party to proceedings commenced under the amended PMNOC Regulations;

• Example scenarios outlining when Certificates of Supplementary Protection will and will not be eligible for inclusion on the Patent Register and the process for eligibility assessments; and

• Directions on how to renounce the application of the 24-month stay imposed on second persons when an action is commenced under subsection 6(1) of the amended PMNOC Regulations

Proposed new regulations for hospital reporting of serious adverse drug reactions and medical device incidents

Urszula Wojtyra
uwojtyra@smart-biggar.ca

On June 15, 2018, Health Canada announced the publication of proposed Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting — Hospitals) and the Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals). The regulations specify that for the purposes of section 21.8 of the Food and Drugs Act, as amended by Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law), hospitals are the prescribed health care institutions that shall provide information in their control to the Minister of Health. Pursuant to the proposed amendments, all hospitals must provide the specified information relating to serious adverse drug reactions and medical device incidents (as defined in the proposed amendments) directly to Health Canada within 30 days of first documenting the reaction or incident in the hospital. The reporting requirements apply to pharmaceuticals (prescription and non-prescription), biologic drugs (excluding vaccines that are part of a routine immunization program), radiopharmaceuticals, disinfectants and medical devices, but exclude these products when used in clinical trials or as part of the Special Access Programme. The consultation period ends on August 30. We have updated our previously published chart (An Update on Vanessa’s Law) to include these proposed regulations.

Health Canada publishes guidance documents that address reporting of adverse reactions

Health Canada recently published two guidance documents, effective May 23, 2018, that address the reporting of adverse reactions to marketed health products (excluding blood and blood components and cells, tissues and organs). First, Reporting Adverse Reactions to Marketed Health Products provides assistance on reporting adverse reactions to marketed health products including good case management practices. Second, Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products addresses the format and content of annual summary reports (ASRs) and issue-related summary reports (IRSRs), as well as procedures for submission of these reports to Health Canada. 

Cannabis Act passes in Canada without controversial amendments

After an unpredictable few weeks, Bill C-45, the Cannabis Act, received Royal Assent on June 21, 2018, and adult use cannabis will be legal in Canada as of October 17, 2018. Canada will be only the second country in the world (after Uruguay) to permit adult use cannabis at a federal level. The delay until October 17, 2018 is intended to provide sufficient time for provinces and territories to prepare for this new regime, which will permit consumers to purchase cannabis from both brick-and-mortar stores and online.

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New Court Proceedings

For complete details about these proceedings, click here.

PMNOC Proceedings

doxycycline (APPRILON): Galderma; TCD Royalty Sub v Apotex

fampridine/4-aminopyridine (FAMPYRA): Biogen; Acorda Therapeutics v Taro

Other Proceedings

vadadustat: Akebia Therapeutics v Fibrogen

pneumococcal conjugate vaccine (V114): Merck v GlaxoSmithKline

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