On April 27th, a letter signed by 41 Canadian experts was sent to the Prime Minister of Canada, the Minister of Innovation, Science & Industry, and the Minister of Health. The letter requests the amendment of Schedule 1 of the Patent Act to include ‘COVID-19 vaccine’ to the list of eligible products for export pursuant to the Canadian Access to Medicines Regime.
Schedule 1 can be amended through an order by the Governor-in-Council, based upon the recommendation of the Minister of Health and the Minister of Innovation, Science & Industry. As KEI noted in the Briefing Note on the Canadian Experience with Compulsory Licensing, prior attempts to amend Schedule took large time investments. Amending Schedule 1 is a necessary step in the compulsory license application process. The addition of ‘COVID-19 vaccine’ to Schedule 1 would increase the ability to produce and export much needed COVID-19 vaccines to middle- and lower-income countries.
The full text of the letter follows and a PDF of the letter is also available here.
27 April 2021
The Right Honourable Justin Trudeau, P.C., M.P.
Prime Minister of Canada
Office of the Prime Minister
80 Wellington Street
Ottawa, ON K1A 0A2
The Honourable François-Philippe Champagne, P.C., M.P.
Minister of Innovation, Science and Industry
C.D. Howe Building
235 Queen Street
Ottawa, Ontario K1A 0H5
The Honourable Patty Hajdu, P.C., M.P.
Minister of Health
House of Commons
Ottawa, Ontario K1A 0A6
RE: Request to Amend Schedule 1 of the Patent Act
Dear Prime Minister and Ministers,
We would like to call to your attention the ongoing attempts to amend Schedule 1 of the Patent Act, a part of the Canadian Access to Medicines Regime. We are writing to formally request for the expeditious recommendation by the Minister of Health and the Minister of Innovation, Science and Industry to add COVID-19 vaccines to the list of eligible products pursuant to Schedule 1 of the Patent Act.
Schedule 1 is a list of pre-approved patented pharmaceutical products that are eligible for export under the Canadian Access to Medicines Regime. A product is eligible to be added to Schedule 1 if it is a “patented product that may be used to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics” (s. 21.03 Patent Act). It is without question that COVID-19 vaccines constitute an eligible product that should be added to Schedule 1.
Schedule 1, and by extension the Canadian Access to Medicines Regime, needs to remain current with public and global health needs. The inclusion, in general language, of the diphtheria vaccine and hepatitis B vaccine lends support to adding the broad term ‘COVID-19 vaccine’ to Schedule 1. The addition of COVID-19 vaccines to Schedule 1 would ensure that the Schedule aligns with immediate demand for COVID-19 vaccines to combat the ongoing global pandemic, instead of acting as an inhibitor. Additionally, the amendment would ensure that generic or biosimilar manufacturers in Canada could come forward with an application for a compulsory license under the Canadian Access to Medicines Regime without delay.
Besides the aforementioned reasons to amend Schedule 1, the amendment would also align with Canada’s December 10, 2020 statement at the World Trade Organization (WTO) that Canada “can thus observe, on the basis of concrete experience, that the system worked as intended”. By expeditiously amending Schedule 1, it would corroborate that the mechanism, in its current form, is a successful system to export medicines to countries facing a public health crisis.
We therefore request the urgent response regarding the following actions:
- The Minister of Health and Minister of Innovation, Science and Industry to offer their recommendation for the addition of COVID-19 vaccines to Schedule 1; and
- The Governor in Council make an order to amend Schedule 1 within the next 30 days.
The world has an interest in ensuring that idle Canadian biomanufacturing capacity is used to combat the global pandemic and its ever evolving variants. We respectfully request that the Government of Canada take leadership by acknowledging the urgency needed and take action to help respond to the global COVID-19 pandemic by updating Schedule 1 of the Patent Act. We look forward to your response and welcome the opportunity to speak with you directly on these matters if helpful.
Yours sincerely,
Individuals (with affiliations) and Organizations, listed alphabetically
Adrienne Shnier, PhD, JD, Adjunct Professor, School of Health Policy & Management, York University
Anne-Emanuelle Birn, Professor, University of Toronto
Aidan Hollis, Professor of Economics, University of Calgary
Arianna Schouten, Researcher, Knowledge Ecology International
Ariel Katz, Associate Professor, University of Toronto Faculty of Law
Arne Ruckert, Senior Research Associate, University of Ottawa
Brian Hutchison, Professor Emeritus, Departments of Family Medicine and Health Research Methods, Evidence and Impact, McMaster University
Colleen Fuller, President, REACH Community Health Centre
Corinne Packer, Assistant Director, Globalization and Health Equity Unit, School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa
Danyaal Raza, MD MPH, Assistant Professor, University of Toronto
Dr Dzintars Gotham, Public Health Researcher
Dr. Hasan Sheikh MD MPA, University of Toronto
James Elliott, T1International
Janice Graham, Professor, Dalhousie University
Jeremy de Beer, Full Professor, University of Ottawa
Jillian Kohler, Professor, Leslie Dan Faculty of Pharmacy, Dalla Lana School of Public Health & Munk School of Global Affairs & Public Policy, University of Toronto
Joel Lexchin, Professor Emeritus, School of Health Policy and Management, York University
Dr. John Calvert, Faculty of Health Sciences, Simon Fraser University
Jordan Jarvis, DrPH Researcher, London School of Hygiene & Tropical Medicine (currently based in Toronto, ON)
Lisa Forman, Associate Professor and Canada Research Chair in Human Rights and Global Health
Equity, Dalla Lana School of Public Health, University of Toronto
Marc-André Gagnon, Associate Professor, Carleton University
Mary Wiktorowicz, Professor, York University
Matthew Herder, Director, Health Law Institute, Schulich School of Law, Dalhousie University
Melanie Bechard, MD, University of Ottawa
Michael Geist, University of Ottawa
Muriel Mac-Seing, PhD Candidate, School of Public Health, Université de Montréal
Myra Tawfik, Professor of Law, University of Windsor
Nancy Olivieri, MD, FRCP(C)
Nav Persaud, Canada Research Chair in Health Justice, University of Toronto
People’s Health Movement – Canada
Rachel Kiddell-Monroe LL.B Bioethics, Executive Director SeeChange Initiative and Professor of Practice at McGill University, Board member MSF and UAEM
Régis Blais, Professor, School of Public Health, Université de Montréal
Richard Gold, Professor, McGill University
Ronald Labonté, Professor and Distinguished Research Chair, University of Ottawa
Roojin Habibi, Doctoral Student, Osgoode Hall Law School
Sharon Batt, PhD, Adjunct Professor and Author, Department of Bioethics, Dalhousie University
Smita Pakhale, MD, FRCPC, MSc (Epi & Biostat), Ottawa Hospital Research Institute, University of Ottawa
Srinivas Murthy, MD CM, MHSc, University of British Columbia, Research Chair in Pandemic Preparedness
Dr. Steven G. Morgan, Professor, University of British Columbia
Trudo Lemmens, Professor and Scholl Chair in Health Law and Policy, University of Toronto
Udo Schuklenk, PhD, Professor, Queen’s University