In December 2017 Heath Canada released proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations, providing for the public release of clinical information contained in drug submissions and medical device applications. Health Canada recently published a draft guidance document addressing the implementation of the proposed amended regulations.
Health Canada recently issued the first certificates of supplementary protection (CSPs) against three approvals. In addition, on 1 April 2018 the CSP application fee was increased to C$9,192.
In 2011 the Senate rejected the legislative proposal to establish a mandatory electronic patient record. Subsequently, various national professional associations recommenced the initiative in a different (optional) form, using the already developed nationwide infrastructure for the electronic exchange of personal medical data. The Association of General Practitioners petitioned the courts to prohibit the new initiative. However, the Supreme Court recently allowed it on the basis of present legislation.
The Federal Court of Appeal recently dismissed Teva's appeal regarding the quantification of damages for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court of Appeal rejected Teva's arguments, finding that the Federal Court had not erred in constructing the hypothetical world and that its factual findings were supported by evidence. On 26 March 2018 Teva applied to the Supreme Court for leave to appeal.
The Supreme Court recently dismissed The Winning Combination's leave to appeal. The Federal Court of Appeal had previously set aside the order of mandamus compelling the minister of health to grant a licence to The Winning Combination for its natural health product, Resolve.
The Genetically Modified Organisms (GMO) Act provides the requirements to ensure the responsible development, production, use and application of GMOs. Any entity or person planning to perform a regulated activity under the act must prepare an application to the registrar and pay the application fee. Regulated activities include activities involving genetic modification, the experimental or trial release of a GMO, the contained use of a GMO and the general release of or commodity clearance regarding a GMO.
Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.
Bill C-45 – An Act respecting Cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and Other Acts – is currently before the Senate. Rather than pre-publishing draft regulations, the government released regulatory proposals by way of a consultation paper. Health Canada recently announced the release of a report which provides a summary of the comments received on the consultation paper.
The Canadian Agency for Drugs and Technologies in Health (CADTH) recently announced the release and published a brief overview of its strategic plan for 2018 to 2021. According to the plan, the CADTH – a health technology assessment agency – plans to transition to a health technology management agency.
Unlike many Organisation for Economic Cooperation and Development member countries, Canada has no national pharmacare programme (ie, a single system of public insurance coverage for prescription drugs). However, the Standing Committee on Health recently released a report advocating the establishment of such a programme as an insured service under the Health Act. The report also made a number of recommendations, including with respect to drug pricing.
The Department of Justice has stepped in to defend a relator's attempt to use statistical sampling to prove False Claims Act liability, contending that if the government cannot utilise sampling in False Claims Act cases, "then defendants would be incentivized to commit fraud on a large scale". The resolution of this issue will have significant implications on the scope of False Claims Act claims going forward, particularly those based on lack of medical necessity.
The Office of the United States Trade Representative recently issued its Special 301 Report. Section I.A.1 of the report, which concerns pharmaceutical and medical device innovation and market access, calls on Mexico to address pharmaceutical and medical device IP-related challenges, lists the steps that it should take in order to open its markets to IP-intensive pharmaceutical products and medical devices and encourages it to recognise the value of innovation in these fields.
In a recent case, the Federal Court granted the plaintiff's motion to strike a rival pharmaceutical company's statement of claim for infringement of a patent relating to oxycodone salt. The court overturned the prothonotary's dismissal of the motion, finding that the facts alleged nothing beyond the regulatory use exemption and that the imminence branch of the test for a quia timet action had not been met.
The importance of clinical research for developing new treatments and discovering cures for diseases is indisputable. However, the degree to which patients benefit from participating in clinical trials and whether they should have post-trial access to experimental treatments are highly disputed, especially in Brazil, where free universal healthcare is a constitutional right. The House of Representatives is discussing clinical research and post-trial access as part of a new legislative bill.
The discipline committee of the Ontario College of Pharmacists recently found that two directors of Costco pharmacies had committed acts of professional misconduct by soliciting C$1,266,000 in payments relating to advertising which would reasonably be regarded as rebates for the purchase of interchangeable drug products.
The Canadian Agency for Drugs and Technologies in Health has announced that the Common Drug Review Programme will now accept drug submissions up to six months before a drug manufacturer's anticipated receipt of a notice of compliance (NOC) or NOC with conditions from Health Canada.
The Ontario legislature recently passed the Strengthening Quality and Accountability for Patients Act 2017, which enacts or amends 10 statutes, including the Health Sector Payment Transparency Act 2017. When in force, the transparency act will require the disclosure of financial relationships between pharmaceutical or medical device manufacturers (among other payors) and healthcare professionals (among other recipients).
After seven years, the Supreme Court finally ended the first product-related class action promoted in Italy relating to a medical device. The decision is noteworthy, despite the small sum awarded, because very few class actions have been declared admissible to date and even fewer cases have been upheld on the merits due to strict admissibility requirements.
Alexion Pharmaceuticals recently filed an application for leave to appeal a Federal Court of Appeal decision to the Supreme Court. In its decision, the Federal Court of Appeal had dismissed Alexion's challenge of the constitutionality of certain Patented Medicine Prices Review Board provisions provided for in the Patent Act.
The Patented Medicine Prices Review Board (PMPRB) recently released its March 2018 newsletter (the first since July 2017). Highlights include an update on the PMPRB guidelines, the release of the PMPRB's 2016 annual report and notice that several publications will be released in 2018.