Latest updates

Release of information contained in drug submissions and medical device applications
Smart & Biggar/Fetherstonhaugh
  • Canada
  • June 20 2018

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 Health Canada recently published a draft guidance document addressing the implementation of the proposed amended regulations.

First CSPs issued and application fee increased
Smart & Biggar/Fetherstonhaugh
  • Canada
  • June 20 2018

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.

Electronic exchange of patient data: consent in view of Supreme Court decision, GDPR and future regulations
AKD NV
  • Netherlands
  • June 20 2018

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.

Teva seeks leave in levofloxacin damages assessment
Smart & Biggar/Fetherstonhaugh
  • Canada
  • June 13 2018

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.

Supreme Court denies leave regarding natural health product licence
Smart & Biggar/Fetherstonhaugh
  • Canada
  • June 13 2018

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.

Focus on healthcare and life sciences legislation: Genetically Modified Organisms Act
Edward Nathan Sonnenbergs Inc
  • South Africa
  • June 06 2018

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.

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Smart & Biggar/Fetherstonhaugh
  • Canada
  • June 06 2018

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.

Health Canada reports on consultation on proposed approach to cannabis regulation
Smart & Biggar/Fetherstonhaugh
  • Canada
  • June 06 2018

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.

CADTH releases 2018-2021 strategic plan
Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 30 2018

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.

Proposed national pharmacare programme and prescription and generic drug pricing modifications
Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 30 2018

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.

DOJ defends use of statistical sampling to prove False Claims Act liability
Sidley Austin LLP
  • USA
  • May 30 2018

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.

USTR calls on Mexico to improve pharmaceutical and medical device innovation and market access
Sanchez-DeVanny Eseverri SC
  • Mexico
  • May 23 2018

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.

Federal Court grants motion to strike plaintiff's quia timet pleading in oxycodone infringement action
Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 23 2018

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.

Post-trial access: Congress discusses new bill for clinical research
TozziniFreire Advogados
  • Brazil
  • May 23 2018

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.

Costco pharmacy directors fined for professional misconduct
Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 23 2018

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.

CADTH Common Drug Review accepting submissions up to six months before market approval
Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 16 2018

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.

Consultation on proposed regulations under Health Sector Payment Transparency Act 2017
Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 16 2018

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).

Supreme Court upholds first class action relating to medical devices
Hogan Lovells Studio Legale
  • Italy
  • May 16 2018

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 files for leave to appeal to Supreme Court in challenge of PMPRB's remedial powers
Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 09 2018

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.

Patented Medicine Prices Review Board releases March 2018 newsletter
Smart & Biggar/Fetherstonhaugh
  • Canada
  • May 09 2018

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.

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