Brand and influencer collaborations are a key component in marketing products and services, as highlighted in our article on Like & Follow! What to know when #advertising with #influencers. Ad Standards recently updated its...more
Canada is an attractive market for pharmaceutical manufacturers. While universal healthcare does not currently extend to drugs in an outpatient setting, most Canadian consumers have some form of drug coverage through...more
This article highlights key tips, traps and trends for advertisers for the coming year. Though Canadian law is referenced, the concepts have global relevance. The term “dark patterns” was first coined over a decade ago but...more
Pharmaceutical manufacturers in Canada often enter into Product Listing Agreements (PLA), particularly with public payors, to facilitate their drug being reimbursed. It is common for PLAs to take the form of a first dollar...more
In today’s competitive innovation economy, digital technologies and artificial intelligence (AI) tools are increasingly used in business transformation and growth. In-house counsel at companies across industries need to be...more
The world of digital marketing & advertising is fast-paced and always evolving to adopt the latest technology and capitalize on pop culture trends and new media channels. Join us to learn about the legal aspects of these...more
Promoting competition and innovation in Canada’s health sector, including the pharmaceutical industry, is a strategic priority for the Competition Bureau. In 2021, the Bureau announced that it joined its counterparts in the...more
1. PAAB’s Accelerated Review Options -
In July 2022, the Pharmaceutical Advertising Advisory Board (PAAB) will launch four Accelerated Review Options (ARO) to its standard pre-clearance pathway, covering a range of...more
Since 2018, Health Canada has undertaken an initiative to adapt its regulatory approach to better support digital health technologies, specifically medical devices. Key focus areas include artificial intelligence, software as...more
12/1/2021
/ Artificial Intelligence ,
Cybersecurity ,
Digital Health ,
Health Care Providers ,
Health Information Technologies ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Popular ,
Telehealth ,
Telemedicine
As previously reported... on September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order), which...more
4/16/2021
/ Canada ,
Coronavirus/COVID-19 ,
Deadlines ,
Health Canada ,
Intellectual Property Protection ,
Manufacturers ,
Minister of Health ,
Patented Medicines ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PMNOC Regulations ,
Prescription Drugs ,
Vaccinations
On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers...more
The Canadian Agency for Drugs and Technologies in Health (CADTH) published an interesting new report on January 29, 2021 about Health Technology Trends to Watch. The report identifies the following list of emerging trends...more
3/30/2021
/ 3D Printing ,
Artificial Intelligence ,
Augmented Reality ,
CADTH ,
Canada ,
Connected Items ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Health Canada ,
Health Technology ,
Life Sciences ,
Medical Devices ,
Pain Management ,
Pharmaceutical Industry ,
Popular ,
Regenerative Medicine ,
Telehealth ,
Virtual Reality ,
Virus Testing
UPDATE: The Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were published in the Canada Gazette on September 1, 2021. These amendments are intended to provide Health Canada with...more
12/18/2020
/ Advertising ,
Canada ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Food & Drug Regulations ,
Health Canada ,
Imports ,
Infectious Diseases ,
Interim Measures ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Amendments ,
Record Retention ,
Supply Chain ,
Supply Shortages ,
Vaccinations
On September 28, 2020, the Regulations Amending Certain Regulations Made under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) (Regulations) came into force. Health Canada subsequently published a Notice,...more
11/9/2020
/ Canada ,
Controlled Substances ,
Final Guidance ,
Food and Drug Act ,
Health Canada ,
Health Care Providers ,
Hospitals ,
Life Sciences ,
Manufacturers ,
New Regulations ,
Patented Medicine Prices Review Board (PMPRB) ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs
UPDATE: See our article here regarding transitional measures.
On September 16, 2020, Canada’s Minister of Health approved an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to...more
UPDATE: The Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice was made on May 3, 2021 (see Notice here) and repeals the Interim Order respecting clinical trials for...more
Health Canada has instituted numerous measures to help address and combat COVID-19, from facilitating access to COVID-19 products to protecting the public from false or misleading advertisements claiming to prevent, treat or...more
COVID-19 has resulted in the launch of numerous new products, as well as numerous new claims about existing products. Products can be classified as drugs (including natural health products and hard surface disinfectants) or...more
Health Canada has recognized for many years that the current regulatory regime on drug sampling, which significantly restricts the distribution of drug samples to both consumers and health care professionals, is outdated. For...more
6/9/2020
/ Amended Regulation ,
Health Canada ,
Health Care Providers ,
Manufacturers ,
Natural Products ,
New Guidance ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs
The federal government has been proactive in seeking help from industry in tackling the pandemic. For example, Health Canada contacted Health Product Licence Holders to let them know specific areas where they may be able to...more
5/18/2020
/ Canada ,
Clinical Trials ,
Health Canada ,
Medical Devices ,
Medical Research ,
Medical Supplies ,
Personal Protective Equipment ,
Regenerative Medicine ,
Research and Development ,
Supply Chain ,
Supply Shortages ,
Vaccinations
UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more
4/22/2020
/ Canada ,
Clinical Trials ,
Controlled Substances ,
Coronavirus/COVID-19 ,
Expedited Approval Process ,
Food and Drug Act ,
Guidance Documents ,
Health Canada ,
Medical Devices ,
Personal Protective Equipment ,
Pharmacies ,
Prescribing Authority ,
Prescription Drugs ,
Public Health Emergency ,
Relief Measures ,
Temporary Regulations ,
Transparency ,
Vaccinations ,
Virus Testing
UPDATE: The Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 was made on March 1, 2021 (see Notice here) and repeals the Interim Order Respecting the Importation and...more
4/9/2020
/ Canada ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Health Canada ,
Imports ,
Infectious Diseases ,
Interim Rule ,
Manufacturing Facilities ,
Medical Devices ,
Medical Research ,
Medical Supplies ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Public Health Emergency ,
Vaccinations ,
Virus Testing
In November 2019, we highlighted the key proposed amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). The proposed amendments aim to reduce...more
2/10/2020
/ Canada ,
Drug Interchangeability and Dispensing Fee Act (DIDFA) ,
Final Rules ,
Payment Caps ,
Pharmaceutical Benefits Scheme ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Product Labels ,
Proposed Amendments ,
Public Consultations ,
Rebates ,
Regulatory Burden
Innovative Medicines Canada (IMC) has announced changes to its Code of Ethical Practices for the first time since the last significant update in 2014. IMC has indicated that several major changes have been made which include...more
On October 28, 2019, the Ontario Ministry of Health and Long-Term Care (the Ministry) published proposed changes to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee...more