Patented medicine regulations in Canada can be complex and the review process is fast-paced. In this Top Ten, in-house counsel will learn the essential points of how to prepare for the "Regulations" review. Editor's note: This article was updated to reflect recent developments; a prior version of this article was published on August 6, 2020.
COVID-19 has shaken up the healthcare industry in many ways. Following a downturn in early 2020, merger and acquisition (M&A) activity is expected to return, to support recovery and stabilize post-pandemic operations. This list summarizes ten key considerations specific to healthcare M&A transactions.
Canada is an attractive market for pharmaceutical manufacturers. Most Canadian consumers have some form of drug coverage through government programs and/or private insurance. Below are ten patent and regulatory topics that in-house counsel need to know before bringing an innovative product to Canada. Editor's note: This article was updated to reflect recent developments; a prior version of this article was published on December 16, 2020.
In September 2017, amendments to the Patented Medicines (Notice of Compliance) Regulations introduced a new scheme for pharmaceutical patent linkage litigation in Canada. That scheme is now much closer to the United States' (US) Hatch-Waxman scheme, but with remaining key differences that are explained in this article.
Amendments to the Canadian Patent Act and enactment of the Certificate of Supplementary Protection Regulations flowing from the Canada-European Union (EU) Comprehensive Economic and Trade Agreement (CETA) in September 2017 introduced a new framework in Canada for the issuance of Certificates of Supplementary Protections (CSPs). Key aspects of the two regimes, Canada's and the EU's, are compared in this chart.
This sample form provides a template for a financial disclosure between the Principal Investigator, each Co-Investigator, and each Sub-Investigator involved in the treatment or evaluation of research subjects in a study. The details of this form should be restructured to your specific situation as a result of legal consultation.
This sample policy provides a brief overlook of all components to consider when drafting a professional services agreement. This sample policy is developed for the perspective of an entity employing or contracting for services of an individual professional or group of professionals. The document is NOT intended as an exhaustive list. The document should be tailored to your unique situation and any specific legal questions through legal consultation.
This checklist provides entities a comprehensive list and tips of components and terms to consider when drafting a vendor contract. This material should be tailored to your specific situation and legal questions through legal consultation.
This sample form provides a template for a voluntary self-disclosure with the Office of Inspector General. Self-disclosure gives providers the opportunity to avoid the costs and disruptions associated with a Government-directed investigation and civil or administrative litigation. This document should be tailored to your specific situation and legal questions through legal consultation.
This sample checklist provides a comprehensive list of components to be considered in an employment contracts audit. The checklist should be adapted to your unique situation and legal questions through legal consultation.
This “Guide” is not meant to be an exhaustive analysis of the return-to-the-office situation post-Covid; rather, it should be used as a starting point for employers to create or update their policies and practices in conjunction with a thorough analysis of all applicable laws, ordinances, and guidance.
This checklist contains requests that can be used as a starting point for conducting due diligence from an information technology standpoint.
This checklist contains requests that can be used as a starting point for conducting due diligence from a privacy and security standpoint.
This checklist can be used as a starting point for assessing legal issues in negotiation for software/technology services from a Buyer's standpoint.
This sample form provides a Research Misconduct Policy that assists research staff members to establish and maintain high standards of ethical practices in research. The form contains policy that describes ongoing obligations of research staff to promote an environment that supports ethical research and process.
This article provides an analysis on laws pertaining to apps that are used for treating, diagnosing, or monitoring a condition. Specifically, these kinds of apps are likely to be subject to stricter pre-market requirements under newly implemented reforms.
This article provides insight into amendments made to the Work Health & Safety Act 2011 (Qld), which was amended previously to provide for the offense of industrial manslaughter. It was later amended in 2020 to cover the resources sector including coal. The piece also provides analysis and key issues for the 2020 amendment of the law.
At a recently panel discussion in which the panelists discussed the prevailing local and global trends in the healthcare sector, with a particular focus on the future of healthcare and the significance of data governance. This article summarizes the key discussion points of the panel discussion.
People around the world continue to grapple with the COVID-19 pandemic, the most extreme public health emergency in a century. This Top Ten discusses the public health law framework in the United States and summarizes some recent developments in the law arising from the COVID-19 pandemic.
This checklist is for the health law industry members to evaluate HIPPA security compliance effectiveness.
In this template/checklist members of the health law industry can track developments in their acquisition project, using the best due diligence practices.
This checklist includes the considerations when responding to a document subpoena.
This is a social media policy for healthcare industry professionals.
The concept of credentialing by proxy is designed to offer hospitals that wish to expand their services through telemedicine (referred to as “originating site hospitals”, or the sites where patients receiving the telemedicine services are located) a streamlined credentialing process for credentialing distant site telemedicine practitioners.
This is a checklist for professional liability coverage for telemedicine providers.
The False Claims Act (FCA) imposes civil liability on entities or persons who make (or cause to be made) false claims or statements to the federal government for payment. This Quick Overview explains specific types of FCA Cases specifically in Healthcare industries.
This article is a fifty state survey of commercial insurance laws.