The US Department of Justice (DOJ) recently filed a complaint in intervention against a compounding pharmacy, alleging that it had violated the False Claims Act by paying illegal kickbacks to induce prescriptions for drugs reimbursed by TRICARE, the federal healthcare programme for active duty military personnel, retirees and their families. Notably, the DOJ was also pursuing claims against a private equity firm that had a substantial ownership stake in the pharmacy.
The Federal Court of Appeal recently issued public reasons for its decision dismissing Teva's appeal relating to the damages and costs that the Federal Court had awarded against it for its infringement of Janssen's patent for levofloxacin (Levaquin). The Federal Court had awarded close to C$19 million in damages and pre-judgment interest to the plaintiffs and subsequently granted C$1 million in costs.
Health Canada and the Institute for Safe Medication Practices Canada recently opened their consultation on different approaches to the naming of biologic drugs, including biosimilars. The consultation aims to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication use process, including prescribing, dispensing and adverse drug reaction reporting.
Health Canada previously announced January 1 2018 as the proposed date for mandatory filing of specified regulatory activity. As such, all new drug submission, supplementary new drug submission, abbreviated new drug submission and supplemental abbreviated new drug submission regulatory activities for human drugs – as well as additional information and subsequent regulatory activities and transactions – must be filed in Electronic Common Technical Document format as of this date.
The Federal Commission for the Protection against Sanitary Risk recently published new guidelines for the authorisation of ad applications regarding prescription and over-the-counter drugs, herbal remedies and homeopathic medicines. As the guidelines include several provisions that appear to be against the General Health Law and the Health Law Regulations on Advertisements, they may give rise to a number of interesting scenarios.
Health Canada recently published a notice soliciting comments and recommendations from stakeholders regarding potential changes to its guidance document on the use of a foreign-sourced reference product as a Canadian reference product. Stakeholder feedback should be submitted to Health Canada by March 18 2018, preferably in electronic form.
Health Canada recently announced a guidance document clarifying the requirements for drug submissions and applications to be processed under the administrative pathway. The administrative pathway will be available, with some restrictions, for manufacturer and product name change applications, additional product name applications and licensing agreements between two manufacturers. The guidance will be effective from March 1 2018.
The Federal Court recently dismissed a Patented Medicines (Notice of Compliance) Regulations application concerning Apotex's generic aripiprazole product on a summary basis under Section 6(5)(b) of the regulations. An appeal was subsequently filed. On December 15 2017 the Federal Court of Appeal granted a motion by the appellants to stay the dismissal order until the appeal could be heard. The appeal was recently allowed on the parties' consent.
The government aims to make Turkey one of the world's top 10 economies in the field of health services by 2023. As a result, Turkey's pharma industry is expected to reach $23 billion turnover by 2023 and imported products will continue to account for approximately half of the market share. The import of pharmaceuticals is expected to maintain its significant market share in the coming years.
The Ontario Superior Court of Justice recently held that Apotex was entitled to damages for losses resulting from delays in the US Food and Drug Administration's approval of two of its products, which had been caused by contractual breaches and negligence on the part of MDS Pharma Services. Due to MDS's failure to comply with the US regulatory framework for conducting bioequivalence studies, Apotex had been unable to rely on the MDS studies and was forced to repeat them, thus delaying US market entry.
In general, a healthcare professional may testify on observations made in respect of a patient only if he or she has been released from the obligation of confidentiality by the patient personally. However, there are a few limited exceptions to this general rule. The Supreme Court carefully applied these exemptions in a recent decision on the hypothetical release by a deceased person.
In addition to setting out the legal scope for the safety of medical treatments and patients, Law 24/2017 provides the scope for imposing an effective risk management policy on healthcare personnel and prescribes risk allocation standards in the case of damages arising from medical treatments. It also provides for situations of impunity when these events occur despite the guidelines being followed.
Ontario Bill 160, the Strengthening Quality and Accountability for Patients Act 2017, enacts or amends 10 statutes, including the Health Sector Payment Transparency Act 2017. The act will require payors – including manufacturers of pharmaceutical or medical devices – to report financial relationships with healthcare professionals and organisations, as well as other prescribed recipients.
The South African minister of health has called for public comment on the recently published Draft General Regulations Relating to Bonusing. The draft regulations aim to flesh out Section 18A of the Medicines Act, which prohibits the supply of any medicine, medical device or in vitro diagnostic medical device that is subject to a bonus system, rebate system or any other incentive scheme.
The Federal Court recently issued its judgment in Bristol-Myers Squibb v Apotex Inc, in which it granted Apotex's motion under Section 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations. As a result, the court granted an order dismissing the underlying application in respect of Apotex's proposed generic aripiprazole product.
Among other changes, Health Canada recently released proposed amendments to the Food and Drug Regulations. Under the amendments, "clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission" would cease to be treated as confidential and would be released to the public following a final regulatory decision, with no requirement to notify the affected party of the release.
With major developments regarding patent linkage, patent term and other substantive patent issues, 2017 was one of the most significant years in history for Canadian life sciences IP and regulatory law. Highlights included the Supreme Court's striking down of the promise doctrine, the Canada-EU Comprehensive Economic and Trade Agreement amendments and the laying of the foundations to overhaul the Patented Medicine Prices Review Board regulations and guidance.
In its recent decision, the Second Circuit held that the relator's failure to plead sufficiently that the allegedly defrauded agency had changed its reimbursement practices after becoming aware of information supposedly withheld by the defendant doomed the complaint on materiality grounds. The decision underscores the significance of the materiality requirement at the motion to dismiss stage.
The so-called 'Cannabis Act', which provides a framework for restricted access to cannabis and is intended to come into force no later than July 2018, recently passed its first reading in the Senate. Concurrently, Health Canada issued a notice of intent to develop regulations under the proposed act and launched a public consultation, which was open for comments until January 20 2018.
In April 2017 the Federal Court of Appeal overturned the Federal Court's conclusion that Apotex had failed to mitigate the loss that it incurred as a result of Health Canada's tortious conduct in considering Apotex's Apo-Trazodone drug submission. The Federal Court of Appeal otherwise dismissed the parties' appeals relating to Apotex's claims in negligence, misfeasance in a public office and contract. The Supreme Court recently dismissed Apotex's leave application.