May 19, 2017

Office of Information Management

Resource Management and Operations Directorate
Health Products and Food Branch
Health Canada
Graham Spry Building
250 Lanark Avenue
Ottawa, Ontario, Canada
K1A 0K9

Thank you for the opportunity to comment on the Health Canada white paper entitled “Public
release of clinical information in drug submissions and medical device applications”. 1 Health
Canada’s proposed policy change could be a major step towards transparency. We support
the public release of clinical information because Canadians and their clinicians require this
information to be publicly accessible in order to make informed decisions. Greater
transparency will also help Health Canada make better decisions by allowing independent
scrutiny of clinical information. This ability to review the evidence will further enhance the
trust that Canadians should have in the safety and efficacy of health care products. We urge
Health Canada to introduce regulations under the Food and Drugs Act in a timely manner
that gives legal force and effect to the policy proposed in the white paper, as modified by the
changes we outline below.

We recommend the following changes, which must be subsequently translated into legally
binding regulations enacted pursuant to the Food and Drugs Act, to ensure that this proposed
policy will achieve its objective of greater transparency. These changes will help avoid
sponsor practices that can severely restrict the release of information and subvert any attempt
at transparency. Our general suggestion is that Health Canada must significantly limit the
exemptions and restrictions in the proposed policy and remove barriers to accessing clinical
information. Finally, there is additional information that was not mentioned in the document
that must be released.

Exemptions and redactions

1. The following exemptions to the release of information must be removed from the policy
because they are open to abuse: “secondary or exploratory end points which may
constitute a component of an on-going development programme”, “interim clinical study
results” and “methodological details (e.g. in-house modifications or procedures to
analytical, immunogenicity, bioassay, or sample size calculations methods not commonly
used by the industry)”. If Health Canada obtained this information in order to make
regulatory decisions then Health Canada has an obligation to release it. These exemptions
invite sponsors who wish to suppress information –as they currently do by
inappropriately labelling it “confidential” – to use these labels to subvert transparency.
All aspects of the scientific methodology are key components of credible science and
should be made public. Specifically, withholding methodological details may mean that

1
Available at: https://www.canada.ca/en/health-canada/programs/public-release-clinical-
information-drug-submissions-medical-device-applications.html

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 information such as assays used to assess the efficacy of vaccines remain undisclosed
thereby preventing independent assessment of their efficacy. Similarly, withholding
information about non-conventional sample size calculations may mean that the ability to
test and replicate analyses of efficacy may not be possible.
2. Health Canada’s policy must clearly state that the burden of proof is on industry sponsors
to justify why certain information falls under the narrowly defined exceptions to public
disclosure. In this regard, any redactions to the material that is released must be kept to a
minimum and there should be written reasons given for the redactions. Experience has
shown that the greater the number of redactions the more difficult it is to interpret the
information and the less use the documents are in helping to understand the benefits and
harms of medicines.
3. Health Canada must produce a list of the types of documents that it will release based on
its transparency policy along with a clear definition of the content of each of these
documents.

Restrictions

4. Health Canada must proactively release clinical information without requiring people to
apply for its release. We do not support Health Canada applying any restrictions on who
can receive clinical information or how that data can be used. Health Canada may
preclude information obtained under other provisions of the Food and Drugs Act, for
example, information that remains “confidential business information” from commercial
use upon disclosure. However, information that is deemed clinical information following
a regulatory decision should be available without restriction upon publication.

Barriers

5. Health Canada must have the legal authority and be obliged to publish clinical
information after a single exchange with companies pertaining to redactions and, in any
event, no later than 60 days after a product receives a Notice of Compliance. Protracted
exchanges between Health Canada and sponsors can be used as a delaying tactic to the
release of information and are a major barrier to transparency. Health Canada should have
the authority to release information after a single exchange with companies except under
exceptional circumstances.
6. Health Canada must be specific about what circumstances would prevent it from aligning
its practices with those of other regulators where those regulators have more liberal
policies about the release of information than those proposed by Health Canada.

Additional information

7. Health Canada must release all its reviewers’ reports once a product has received a Notice
of Compliance. Similar to the release of information that the companies submit, there
must be strict time windows for the release of these reports and strict criteria about what
information can be redacted.
8. If external reviewers are used at any time during the drug approval process, the names of
these reviewers along with their conflicts of interest must be publicly released.

Health Canada’s discussion paper begins with the statement that “Opening access to clinical
information used to support the authorization has widespread health system benefits and can
help Canadians make informed decisions about their health. It can also help Canadians to

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better understand the basis for HPFB’s regulatory decisions.” We believe that to fulfill this
promise, the information used in the drug approval process must be freely available in a
timely manner to anyone who wants to examine it with only minimal restrictions.

We would be pleased to discuss our recommendations with Health Canada. Health Canada
can contact us through Joel Lexchin at either jlexchin@yorku.ca or 416-964-7186.

Sincerely

Joel Lexchin MD
Professor Emeritus, Faculty of Health
York University
Emergency Physician, University Health Network
Toronto

Peter Doshi PhD

Assistant Professor, School of Pharmacy
University of Maryland

Janice E. Graham PhD

Professor, Faculty of Medicine
Dalhousie University

Matthew Herder JSM, LLM

Director, Health Law Institute
Associate Professor, Faculties of Medicine and Law
Dalhousie University

Tom Jefferson MD
Senior Associate Tutor
University of Oxford

Trudo Lemmens LicJur, LLM bioethics, DCL

Professor and Scholl Chair in Health Law and Policy
Faculty of Law
University of Toronto

Barbara Mintzes PhD

Senior Lecturer
Charles Perkins Centre and Faculty of Pharmacy
The University of Sydney

Navindra Persaud MD
Assistant Professor, Faculty of Medicine
University of Toronto

Elia Abi-Jaoude MD
Department of Psychiatry
The Hospital for Sick Children
University of Toronto

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Professor Arthur Schafer
Founding Director
Centre for Professional and Applied Ethics
University of Manitoba

Brian Hutchison
Professor Emeritus
Departments of Family Medicine and Health Research Methods, Evidence and Impact and
the Centre for Health Economics and Policy Analysis
McMaster University

John H Noble Jr PhD

Emeritus Professor
State University of New York at Buffalo

David Healy
Professor of Psychiatry
Hergest Unit
Bangor Wales
United Kingdom

Michael McDonald
Professor Emeritus of Applied Ethics
Founding Director and Inaugural Chair
W. Maurice Young Centre for Applied Ethics
School of Population and Public Health
University of British Columbia

R. Anne Springer PhD(NURS), MN(APN,)BScN, RN (CNS)

Assistant Professor, College of Nursing
University of Saskatchewan

Rob Wipond
Freelance Health Researcher and Journalist

Yan Xu MD
Royal College of Physicians and Surgeons of Canada Internal Medicine Resident
Department of Medicine
University of Toronto

Adrienne Shnier PhD

JD Candidate, Osgoode Hall Law School
York University

Alice Fabbri MD
Centre for Research in Medical Pharmacology
University of Insubria
Varese, Italy

4
John Abramson MD MSc
Lecturer, Department of Health Care Policy
Harvard Medical School

Lars Jørgensen, MD
Nordic Cochrane Centre
Rigshospitalet, 7811
Blegdamsvej 9
2100 København Ø
Denmark

Danielle Martin MD
Assistant Professor, Family and Community Medicine and Institute for Health Policy,
Management and Evaluation
University of Toronto

Danyaal Raza, MD MPH

Assistant Professor, Faculty of Medicine
University of Toronto

Ron Law
Risk & Policy Adviser
Juderon Associates

Quinn Grundy PhD, RN

Postdoctoral Research Associate
Charles Perkins Centre and Faculty of Pharmacy
The University of Sydney

Hasan Sheikh BSc, MD, CCFP (EM)

Lecturer, Department of Family and Community Medicine
University of Toronto

Ritika Goel MD, MPH

Lecturer, Faculty of Medicine
University of Toronto

Scott A. Halperin MD
Professor of Pediatrics and Microbiology & Immunology
Director, Canadian Center for Vaccinology
Dalhousie University, IWK Health Centre

Karen S. Palmer MS, MPH

Adjunct Professor, Simon Fraser University

Rokuro Hama MD
Director, Japan Institute of Pharmacovigilance (MedCheck),
Part time lecturer, Public Health, Graduate School of Medicine, Osaka University

Alain Braillon MD, PhD

5
Alcohol Treatment Unit
University Hospital
Amiens, France

Ian Bushfield MSc

Executive Director
BC Humanist Association

Nancy F. Olivieri MD, MA, FRCP(C)

Professor, Pediatrics, Medicine and Public Health Sciences,
University of Toronto, Canada

David Carmichael
Executive Director
Canadians for Vanessa's Law

Tim Reed PhD

Executive Director
Health Action International
Amsterdam, The Netherlands

Michael Kruse
Executive Director
Bad Science Watch
Toronto

Lynette Reid PhD,

Associate Professor
Department of Bioethics
Faculty of Medicine, Dalhousie University

Meredith MacKenzie MD, BSc, CCFP, FCFP

Street Health Centre
Kingston

Florian Naudet MD, PhD,

Stanford University
METRICS (Meta-research Innovation Center at Stanford)
Palo Alto, CA

Fiona A. Miller PhD

Associate Professor of Health Policy
Institute of Health Policy, Management & Evaluation
University of Toronto

Amar Jesani MBBS

Editor, Indian Journal of Medical Ethics
Mumbai, India

Colleen Fuller

6
President, PharmaWatch Canada
Vancouver

Jonathan Kimmelman
STREAM Research Group
Associate Professor
Biomedical Ethics Unit / Experimental Medicine / Social Studies of Medicine
McGill University

Alastair Matheson PhD

Independent consultant on pharmaceutical policy issues
Toronto

Brenda A. LeFrançois PhD

Professor
Memorial University of Newfoundland

Jillian Clare Kohler PhD

Professor
Leslie Dan Faculty of Pharmacy,
Munk School of Global Affairs &
Dalla Lana School of Public Health,
University of Toronto

Geneviève Rail PhD

Professor of Feminist Cultural Studies of Health
Simone de Beauvoir Institute
Concordia University

Sergio Sismondo PhD

Professor
Queen’s University

Dr. Ken Harvey

Associate Professor
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Melbourne, Australia

Wendy A Rogers
Professor of Clinical Ethics
Macquarie University

Maya J. Goldenberg PhD

Associate Professor
Department of Philosophy
University of Guelph

Nick Ross

7
Journalist, author and broadcaster
President of HealthWatch UK

David Colquhoun FRS

Professor of Pharmacology, NPP
University College London

Mandy Payne
Editor
HealthWatch UK Newsletter

Lejla Halilovic BSc

Research Contractor
Toronto, Canada

Prof. Edzard Ernst MD, PhD, FMEdSci, FSB, FRCP, FRCP(Edin.)

Emeritus Professor
University of Exeter

Dr. Rosemary Stanton OAM

Visiting Fellow, School of Medical Sciences,
University of New South Wales, Australia

Caroline Richmond
62a Woodside Park Rd
London UK

Dr. James May

Chairman of the UK charity HealthWatch
General Practitioner
London UK

David A Bender
Emeritus Professor of Nutritional Biochemistry
University College London

Warren Bell BA MD CM CCFP FCFP (LM)

Rural mentor, University of British Columbia
Past Founding President, Canadian Association of Physicians for the
Environment

Janet C. Currie
PhD student, University of British Columbia School of Population and Public Health
Founder and Coordinator: Psychiatric Medication Awareness Group
Co-Chair, Canadian Women's Health Network

Courtney Davis PhD

Department of Global Health and Social Medicine
Kings College
London, UK

8
Jo Ann Cook MSW
Ottawa

Rupa Patel MD, CCFP, FCFP

Kingston Community Health Centre
Assistant Professor Queens Department of Family Medicine
Kingston

Brian Goldman MD, MCFP(EM), FACEP

Emergency Physician
Schwartz Reisman Emergency Centre, Sinai Health System, Toronto
Assistant Professor
Department of Family and Community Medicine, University of Toronto

Malcolm Steinberg MBBCh, MSc

Director, Public Health Practice
Chair MPH Program
Faculty Health Sciences
Simon Fraser University

Ellen M J Reynolds MPA

Independent Research Coordinator
Victoria, BC

Dr. John R. Calvert,

Associate Professor,
Faculty of Health Sciences,
Simon Fraser University,
Burnaby, BC

Dr. Alana Westwood

Dalhousie University
Halifax, Canada

Robert F Woollard MD, CCFP, FCFP, LM

Professor, Dept of Family Practice
Faculty of Medicine
University of British Columbia

Health Action International

Amsterdam
The Netherlands

Prof. Silvio Garattini

Director
Istituto di Ricerche Farmacologiche Mario Negri
Milan, Italy

Katie Gibbs PhD

9
Co-founder and Executive Director
Evidence for Democracy

Gordon Guyatt MD FRCP OC

Distinguished University Professor
McMaster University

Luca De Fiore
Associazione Alessandro Liberati Network italiano Cochrane
Rome, Italy

Dr. Alex Hodkinson

Research Fellow in Evidence Synthesis
Centre for Reviews and Dissemination
University of York
York, UK

Marc-Andre Gagnon PhD

Associate Professor
School of Public Policy and Administration
Carleton University
Ottawa

Steve Morgan PhD

Professor
Faculty of Medicine & School of Population and Public Health
The University of British Columbia
Vancouver

James (Jay) Brophy MEng, MD, FRCP(c), FACC, FCCS, PhD

Professor of Medicine & Epidemiology (McGill)
Royal Victoria Hospital
Montreal

Jeff Scott MB.ChB. FRCPC

Paediatrician and Public Health Physician
Canadian Center for Vaccinology
IWK Health Centre
Halifax

Carl Heneghan MRCGP, DPhil

Professor of Evidence-Based Medicine & Director of Centre for Evidence-Based Medicine
Nuffield Dept of Primary Care Health Sciences
University of Oxford
Oxford UK

David Egilman MD, MPH

Clinical Professor of Family Medicine
Alpert School of Medicine Brown University
Attleboro Massachusetts

10
Carl Elliott MD, PhD
Professor, Center for Bioethics
University of Minnesota
Minneapolis, Minnesota

David Juurlink MD, PhD, FRCPC, FAACT, FACMT

Eaton Scholar and Professor of Medicine, Pediatrics and Health Policy, Evaluation &
Management
University of Toronto
Senior Scientist, Institute for Clinical Evaluative Sciences
Toronto

Stephen Hwang MD
Professor, Faculty of Medicine
University of Toronto

Terence Young
Chair, Drug Safety Canada
Oakville

Francoise Baylis CM, ONS, PhD, FRSC, FCAHS

Professor and Canada Research Chair in Bioethics and Philosophy
Faculty of Medicine
Dalhousie University
Halifax

M.C. Heffernan MD
REACH Community Health Centre
Vancouver

Sharon Batt PhD

Adjunct Professor
Department of Bioethics, Dalhousie University
Halifax

Fernand Turcotte MD, MPH

Professor Emeritus
Preventive Medicine and Public Health
Faculté de médecine of Université
Laval University

Michael Rachlis MD, MSc, FRCPC, LLD (Hon)

Adjunct Professor Dalla Lana School of Public Health
University of Toronto
Toronto

Jacques Thivierge MD
Department of Psychiatry
Laval University

11
Pierre Biron MD
Honorary Professor of Medical Pharmacology
Université de Montréal
Montréal

Adriane Fugh-Berman MD
Professor Department of Pharmacology and Physiology
Georgetown University Medical Center
Washington DC

Mary R. L’Abbe PhD

Earle W. McHenry Professor, and Chair, Department of Nutritional Sciences
Faculty of Medicine
University of Toronto

Pierre La Rochelle MD, MSc

Clinical Professor, Emergency Medicine and Family Medicine
Universite Laval

Braden O'Neill MD, DPhil

Family Medicine Resident
University of Toronto

Wendy Lee A. Koenig

Consumers Association of Alberta
Edmonton

Harriet Rosenberg PhD

Emerita
Health and Society Program
York University

Janusz Kaczorowski PhD

Professor and Research Director
Docteur Sadok Besrour Chair in Family Medicine
GSK Chair in Optimal Management of Chronic Disease
Department of Family and Emergency Medicine
University of Montreal and CRCHUM

André Poirier MD, MSc

Microbiologiste Infectiologue
CIUSSS.MCQ
Trois-Rivières

Soren Gantt MD, PhD, MPH

Associate Professor of Pediatrics
Faculty of Medicine
University of British Columbia

Devon Greyson PhD

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Postdoctoral Fellow, Faculty of Medicine
University of British Columbia

Athena McConnell MD, FRCP(C), MMed

Associate Professor, College of Medicine
University of Saskatchewan

François Boucher MD FRCPC

Chief, Paediatric Infectious Diseases
Centre Mère-Enfant du CHU de Québec
Associate Professor of Paediatrics
Laval University Faculty of Medicine

Amélie Perron, RN, PhD

School of Nursing
University of Ottawa

Katrina Perehudoff
PhD Candidate, Global Health Unit
Department of Health Sciences
University Medical Centre
Groningen

Jane Turner
President, REACH Community Health Centre
Vancouver

Carole Lunny, MPH

PhD Student
Cochrane Australia
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
Melbourne

Sarah Newbery MD, CCFP, FCFP

Assistant Professor, NOSM
Family Physician, Marathon Family Health Team
Marathon ON

Shelly McNeil, MD
Chief, Division of Infectious Diseases, Nova Scotia Health Authority
Deputy Director, Canadian Center for Vaccinology,
Dalhousie University

Karina Top MD, MS, FRCPC

Assistant Professor
Departments of Pediatrics and Community Health & Epidemiology
Dalhousie University

13
Katherine Fierlbeck
McCulloch Professor of Political Science
Dalhousie University

Margaret Russell MD, PhD

Associate Professor, Cumming School of Medicine
The University of Calgary

Alana Cattapan
CIHR Postdoctoral Fellow, Faculty of Medicine
Dalhousie University

Rita Banzi
Laboratory of Drug Regulatory Policies
IRCCS-Istituto di Ricerche Farmacologiche Mario Negri
Milan, Italy

Jacalyn Duffin MD, PhD, FRCPC, FRSC, FCAH

Professor
Hannah Chair of the HIstory of Medicine
Queen's University

Mary Wiktorowicz MSc, PhD

Interim Director, Dahdaleh Global Health Research Institute
Associate Dean, Community and Global
Professor, Health Policy and Management
Faculty of Health
York University

Andrew Fenton, PhD

Assistant Professor
Department of Philosophy
Dalhousie University

Ian Stewart
Assistant Professor
History of Science and Technology Programme
University of King's College
Halifax

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