December 2017

Update on Biosimilars

We provide an update on biosimilars in Canada regarding:

• Health Canada’s guidance on biosimilars,
• approvals and reviews of bioismilars to date,
• the effect of CETA amendments to biologics,
• pending patent litigation involving biosimilars, and
• pricing and reimbursement of biosimilars.

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PMPRB News

PMPRB releases scoping paper relating to proposed amended Regulations

As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented Medicines Regulations for comment. On December 11, 2017, the Patented Medicine Prices Review Board (PMPRB) released the PMPRB Guidelines Scoping Paper – High Level Overview of Potential New Framework (Canada Gazette, Part I). According to the paper, the purpose is to provide a non-binding outline of preliminary thoughts on how to best operationalize the proposed changes, and is to be read in conjunction with the proposed amendments and Regulatory Impact Analysis Statement.

The scoping paper describes the framework as a risk-based approach to pricing review that is broken down into five main parts:

1. Interim international price reference test;
2. Screening;
3. High priority drugs;
4. Medium and low priority drugs; and
5. Re-benching.

The paper concludes that the proposed amendments would allow the PMPRB to move to a risk-based framework that scrutinizes drugs with the greatest potential for excessive pricing to take into account their value and financial impact on consumers when setting prices. Finally, the paper encourages specific questions to be considered in consultations with the new proposed Guidelines, and states that it is expected that a first draft of new PMPRB Guidelines will be made public in the spring of 2018, with technical roundtables to follow, with a view to having new Guidelines in place by early 2019.

Federal Court of Appeal upholds decision striking Alexion’s pleading challenging constitutionality of the PMPRB regime

On December 7, 2017, the Federal Court of Appeal upheld Justice Simpson’s decision (previously reported) to strike Alexion’s pleadings challenging the constitutionality of the PMPRB regime: Alexion Pharmaceuticals v Canada (Attorney General), 2017 FCA 241. The Federal Court of Appeal upheld the decision on the basis that (1) Alexion was not entitled to bring the constitutional issue before the Federal Court, as it did not raise the issue before the Board; and (2) the Federal Court of Appeal’s decision in Canada (Attorney General) v Sandoz Canada Inc (as previously reported, leave to SCC discontinued) is binding authority.

Supreme Court of Canada dismisses Apotex's leave application re: trazodone drug submission dispute with Health Canada

As previously reported, the Federal Court of Appeal (FCA) overturned the Federal Court’s conclusion that Apotex failed to mitigate the loss it incurred as a result of Health Canada’s tortious conduct in considering Apotex’s Apo-Trazodone drug submission. The FCA otherwise dismissed the parties’ appeals relating to Apotex’s claims in negligence, misfeasance in a public office, and contract: Apotex v Canada, 2017 FCA 73. On December 14, 2017, the Supreme Court dismissed Apotex's leave application (SCC case no. 37593).

Health Canada News

Guidance Document - Use of a Foreign-sourced Reference Product as CRP

On November 27, 2017, Health Canada announced the release of Guidance Document: Use of a Foreign-sourced Reference Product as a Canadian Reference Product. The Guidance, which replaces Health Canada’s 1995 Canadian Reference Product (“CRP”) policy and is effective as of November 24, 2017, is directed to sponsors of all Abbreviated New Drug Submissions or Abbreviated Extraordinary Use New Drug Submissions that seek to obtain approval based on a demonstration of pharmaceutical equivalence and bioequivalence to a reference drug product marketed in a country other than Canada (i.e., under the CRP definition provided in paragraph (c) of section C.08.001.1 of the Food and Drug Regulations).

Cannabis Act under Senate review

The Government of Canada has proposed An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (“Cannabis Act”), which has passed first reading in the Senate (here). The Cannabis Act would provide a framework for restricted access to cannabis, and is intended to come into force no later than July 2018. 

Health Canada has recently issued a Notice of Intent to develop regulations under the proposed Cannabis Act. “Among other things, the proposed regulatory framework aims to protect the health and safety of young persons and others by restricting promotions or enticements that could appeal to them, to provide Canadians with access to quality-controlled legal cannabis, and to reduce illegal cannabis-related activities.” Health Canada launched a public consultation on November 21, 2017. Comments may be provided online until January 20, 2018.

Proposed amendments to Food and Drug Regulations and the Medical Devices Regulations to publicly release clinical data after completion of regulatory review process

Following release of a white paper in March, on December 9, 2017, Health Canada released proposed amendments to the Food and Drug Regulations under which “clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission” would cease to be treated as confidential and released to the public following a final regulatory decision. Analogous amendments are proposed to the Medical Devices Regulations for Class III or IV medical device applications. Release would not require notice to the affected party. 

Exception would be made for: 

1. information that the manufacturer did not use in the drug submission or medical device application to support the proposed conditions of use or purpose for the drug or medical device; or
2. information that describes tests, methods or assays that are used exclusively by the manufacturer.
   
   

For these exceptions only, the manufacturer would have the opportunity to propose redactions before publication, to be considered by Health Canada. The proposed amendments would apply to clinical information in drug submissions and medical device applications filed both before and after they come into force. Comments will be received until February 22, 2018.

Ontario Bill 160 requiring disclosure of financial relationships between pharmaceutical companies and health care professionals receives Royal Assent

On December 12, 2017, Ontario Bill 160, the Strengthening Quality and Accountability for Patients Act, 2017, received Royal Assent. As previously reported, Bill 160 enacts or amends ten statutes (see News Release for highlights), including enacting the Health Sector Payment Transparency Act, 2017 (Transparency Act). When in force, the Transparency Act will require payors, including manufacturers of pharmaceutical or medical devices, to report financial relationships with health care professionals and organizations, as well as other prescribed recipients. The reported information will be made publicly available. Regulations, not yet released, will prescribe many of the details, including the definition of a ‘recipient’, the manner and frequency of reporting, and which transfers of value will be exempted from reporting. The Health Sector Payment Transparency Act, 2017 will come into force on a day to be named by proclamation of the Lieutenant Governor.

Federal Court grants summary dismissal motion under PMNOC Regulations

On November 22, 2017 the Federal Court issued a judgment granting Apotex's motion under s. 6(5)(b) of the PMNOC Regulations: Bristol-Myers Squibb et al v Apotex Inc et al, 2017 FC 1061. As a result, the Court granted an order dismissing the underlying application in respect of Apotex's proposed generic aripiprazole product (Bristol-Myers Squibb and Otsuka's ABILIFY). The decision is under appeal.

New Court Proceedings

For complete details about these pharmaceutical proceedings, click here.

bortezomib (VELCADE): Millennium, Janssen and Cilag GmbH v Innomar and Dr. Reddy’s 

trastuzumab (HERCEPTIN): Genentech and Hoffmann-La Roche v Amgen Canada

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