An Update on Vanessa's Law 

This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act (“FDA”) and granting new powers to the Minister of Health directed at post-marketing oversight over therapeutic products (drugs, medical devices and drug-device combinations).

There have been many developments since 2014, including passage of certain associated regulations (see our articles in this issue on New regulations governing powers to require assessments, tests and studies and notification of foreign incidents and New regulations governing post-market oversight over opioids) and release of Health Canada Guidance.

We have prepared a summary chart of the current status of the coming into force of key provisions under the Act, associated Regulations, and related Health Canada Guidance. That chart includes links to previously published articles, and our current articles on the new regulations. We will continue to report updates as further regulations and guidance arise.

View Chart >>

Health Canada News

New regulations governing powers to require assessments, tests and studies and notification of foreign incidents

On April 20, 2018, the sections of Vanessa’s Law that grant powers to the Minister to require assessments, tests and studies, and to create appropriate regulations came into force.  The accompanying Regulations Amending the Food and Drug Regulations and the Regulations Amending the Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) came into force on April 23, 2018 other than the provision relating to foreign risk reporting requirements which will come into force on October 23, 2018.

The amendments to the Regulations, among other matters:

 

New regulations governing post-market oversight over opioids

Part of a federal initiative to address the opioid crisis, the Regulations Amending the Food and Drug Regulations (Opioids), which add post-market oversight over prescription opioids, came into force on April 23, 2018. We previously reported on the proposed regulations.

The Minister of Health can now impose terms and conditions on the market authorization for listed opioids (“Class B” opioids, set out in Part B of a List of Opioids). As explained in the Regulatory Impact Analysis Statement, the regulatory change contemplates that Health Canada will require a risk management plan (RMP) to be developed by the opioid drug sponsor or authorization holder and updated throughout the product’s life cycle. An RMP would include risk-monitoring activities and risk-minimization measures relating to the product. 

The amendments also introduce a mandatory warning sticker and patient information handout (for “Class A” opioids, set out in Part A of the List of Opioids, presently identical to the Part B list).  Aimed at better informing patients about the safe use and risks of opioids, the amendments require pharmacists or practitioners to provide the warning sticker on the drug’s packaging and to provide the handout to the patient at the time the drug is dispensed.  These provisions will not come into force until October 23, 2018.      

Health Canada has published information on the new regulations, including Guidancefor industry on the RMPs and Questions and Answers for pharmacists and practitioners on the sticker and handout requirements.

PMPRB to strike Working Group on Guideline reform in June, anticipates concurrent release of guidance on operationalization of anticipated regulatory changes 

In its May 2018 NEWSletter, the Patented Medicine Prices Review Board (PMPRB) announced that the next step in its Guideline reform would be the inception of a multi-stakeholder Working Group intended to gather stakeholder input on key technical aspects of the new regime (see our prior articles on the proposed amended Patented Medicines Regulationsand scoping paper here and here). The PMPRB anticipates concurrently releasing more specific guidance on how it foresees operationalizing the anticipated regulatory changes. The report of the Working Group will be presented to the PMPRB for consideration prior to the publication of draft Guidelines in the fall, followed by a further period of consultation.

Separately, in its 2018 Special 301 Report, the Office of the United States Trade Representative placed Canada on its Priority Watch List, based in part on the proposed changes to the PMPRB regime, concluding that they “fail to appropriately recognize the value of innovative medicines in both the private and public markets, and would make Canada’s pricing policies an outlier among similarly situated countries.” 

Supreme Court of Canada leave applications

SCC denies Idenix leave to appeal in SOVALDI dispute.  On April 26, 2018, the Supreme Court of Canada dismissed Idenix’s application for leave to appeal (docket no. 37781) the Federal Court of Appeal (FCA)’s decision (reported here) which affirmed the trial decision relating to two competing patents over Gilead’s SOVALDI (sofosbuvir). The FCA upheld the validity of Gilead’s Patent No. 2,527,657, and declared Idenix’s Patent No. 2,490,191 invalid on the basis of insufficiency of disclosure and inutility.

Eli Lilly seeks leave in olanzapine section 8 damages action.  As previously reported, the Federal Court of Appeal (FCA) dismissed Eli Lilly Canada (Lilly)’s appeal of a trial decision awarding more than $70 million to Teva Canada (Teva) under section 8 of the Patented Medicines (Notice of Compliance) Regulations in respect of olanzapine (Lilly’s ZYPREXA). The FCA granted Teva’s cross-appeal seeking to add to its recovery lost pipefill sales and an adjustment to account for an under-reporting of sales in the data relied on by both parties’ experts: Eli Lilly Canada Inc v Teva Canada Limited2018 FCA 53. On April 23, 2018, Lilly applied to the Supreme Court of Canada for leave to appeal (docket no. 38077).

Quebec Court declines to dismiss claim under Ontario Statute of Monopolies for lack of jurisdiction

In an action relating to amlodipine besylate (Pfizer’s NORVASC), Apotex is seeking relief in the Quebec Superior Court pursuant to the Ontario Statute of Monopolies, U.K. Statute of Monopolies, the Trade-marks Act, and unjust enrichment. Pfizer brought a motion to dismiss Apotex’s claim. On April 25, 2018, the Quebec Superior Court dismissed an application by Pfizer (part of the motion to dismiss) to dismiss the action, finding that the Quebec Superior Court has jurisdiction to adjudicate Apotex’s claim under the Ontario Statute of Monopolies: Apotex Inc c Pfizer Limited2018 QCCS 1765. The balance of Pfizer’s motion to dismiss has been deferred to the trial in the liability phase of the proceeding. 

Agreement reached between Competition Bureau and Metro on Quebec pharmacy competition issues 

The Competition Bureau previously found that Metro’s proposed acquisition of The Jean Coutu Group would “likely have led to substantially higher prices or decreases in services for consumers related to the purchase of medications and other pharmacy products in eight regions in Quebec.” On April 23, 2018, the Competition Bureau announced an agreement whereby Metro will sell properties/leases and take steps to terminate agreements relating to pharmacies in certain Quebec markets.

 

New Court Proceedings

For complete details about these proceedings, click here.

 
 

PM(NOC) Proceedings

rituximab (RITUXAN, RIXATHON): Hoffmann-La Roche; Biogen; Genentech v Sandoz

nanoparticle, albumin-bound paclitaxel (ABRAXANE): Abraxis Bioscience; Celgene v Panacea