ÉditeurIrwin Law
DateJanvier 2024
ISBN9781552216651
Nombre de pages362
Formatpapier
Reliurerigide
Code de produit

343.304

The Regulation of Drugs in Canada : The Food and Drugs Act and Related Intellectual Property Regimes


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Description

The Regulation of Drugs in Canada: The Food and Drugs Act and Related Intellectual Property Regimes provides an overview of the laws in Canada that govern the manufacture and sale of drugs that are subject to the Food and Drugs Act, including pharmaceuticals, vaccines, and natural health products. Among the laws that are discussed are the new regulatory pathways that were made in response to the COVID-19 pandemic. 

This book also describes the intellectual property framework that applies to drugs and explains the impact this framework has on the drug approval process, as well as its unique objective: to encourage innovation and incentivize bringing new therapeutic options to market. Authors Simon Carvalho, T. Nessim Abu-Zahra, and David Edwards explain how this framework regulates the competition between “brand-name manufacturers” who are the first to bring a drug to market and obtain patents and other intellectual property, and “generic” or “biosimilar” manufacturers, who manufacture and sell copies of brand-name products. 

Auteurs

T. Nessim Abu-Zahra is a graduate of Queen’s University (BSc, 1996) and the University of Toronto (MSc, 2000 and JD, 2003). He was admitted to the bar of Ontario in 2004. 

Nessim began his career with an intellectual property boutique firm in Ottawa, where his work included pharmaceutical patent litigation and other intellectual property matters. 

Nessim joined the Department of Justice (Health Canada Legal Services) in October 2008, where his practice involves advising Health Canada officials and other government decision-makers on the drug approval processes under the Food and Drugs Act and Food and Drug Regulations, and the associated intellectual property regimes, namely, the Patented Medicines (Notice of Compliance) Regulations, the Certificate of Supplementary Protection regime, the data protection portions of the Food and Drug Regulations, and the Patented Medicine Prices Review Board.

Nessim is also a registered patent agent and from August 2015 to September 2016 was on a secondment as a Member of the Patent Appeal Board (PAB), where his responsibilities included rendering recommendations on rejected patent applications for Commissioner’s Decisions under the Patent Rules, as well as assistance for other areas of the Patent Act for which the PAB has responsibility, such as cases of abuse of patent rights and regulation of patent agents.

Simon Carvalho holds degrees from the University of British Columbia (BA Hons, 1994), the London School of Economics and Political Science (MSc, 1995), Osgoode Hall Law School (LLB, 2000), and Duke University School of Law (LLM, 2003). He was admitted to the bar of British Columbia in 2001.

Simon started his career in the public sector with Health Canada’s Health Products and Food Branch, and then joined the Department of Justice (Health Canada Legal Services) in 2003. He has advised on the Food and Drugs Act and various regulations under that Act, including the Food and Drug Regulations, the Medical Devices Regulations, and the Natural Health Products Regulations. For several years he taught the Medical-Legal course at the University of Ottawa Faculty of Law.

Simon also has experience working with international health regulators. He advised the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on the project that rewrote the UK’s medicines legislation. He also worked in the Legal Sector of the European Medicines Agency (EMA) via the EMA’s National Experts on Secondment program. In September 2023, Simon assumed a position as Senior Lawyer with the United Kingdom’s Government Legal Department, advising the MHRA on the reform of the UK’s Medical Devices Regulations.

David Edwards is a graduate of the University of Western Ontario (BA, 1986) and Queen’s University (LLB, 1989). He was admitted to the bar of Ontario in 1990. David began his public service career as an official in the Department of Consumer and Corporate Affairs and Industry Canada working as a legislative policy analyst supporting amendments to Canada’s intellectual property and business framework laws. In this role, he took part in the Canadian Delegations that negotiated the Trade Related Intellectual Property Annex to the WTO GATT Agreement and in the development of legislation repealing Canada’s drug patent compulsory licensing laws. David later worked at the Patented Medicine Prices Review Board and then in Health Canada as an advisor in matters relating to access to healthcare and drug benefit management.

David joined the Department of Justice (Health Canada Legal Services) in September 2000. His practice has focused on advising officials in Health Canada and the Public Health Agency of Canada and other regulatory bodies on matters relating to the administration, enforcement, and modernization of the Food and Drugs Act and other statutes within the health portfolio. David has been a General Counsel within the Health Canada Legal Services Unit since 2019. 

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