ACTION ALERT: Health Canada Consultation
Until May 26th, 2017, Health Canada is accepting submissions for a public consultation on a white paper called “Public Release of Clinical Information in Drug Submissions and Medical Device Applications” that describes the framework for the release of clinical trial reports and other data when a new pharmaceutical or medical device is licensed for sale in Canada.
As a signatory to the AllTrials campaign in the UK, Bad Science Watch has participated in this consultation, and we are urging our supporters and all interested parties to tell Health Canada that we need a permanent registry of clinical trials as well as release of all clinical trial reports.
You can find our comment on the consultation HERE.
Dr. Joel Lexchin, emeritus professor in the faculty of health at York University has produced a public letter that he is seeking support for to submit to Health Canada. Bad Science Watch will be lending its name to this letter and submitting our own analysis and recommendations in the coming week. If you wish to add your name to Dr. Lexchin’s letter, please see the text below and contact Dr. Lexchin at firstname.lastname@example.org with your name and affiliation as you’d like it to appear on the letter.
To make your own submission go to the Health Canada consultation page and click on comments. Let us know you have submitted by tweeting at us @badsciencewatch or emailing us at email@example.com with “alltrials” in the subject line.
Full Text of Dr. Joel Lexchin’s Letter:
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”. 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 information such as assays used to access 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.
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.
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.
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 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.
Joel Lexchin MD
Professor Emeritus, Faculty of Health
Peter Doshi PhD
Assistant Professor, School of Pharmacy
University of Maryland
Janice E. Graham PhD
Professor, Faculty of Medicine
Matthew Herder, JSM LLM
Director, Health Law Institute
Associate Professor, Faculties of Medicine and Law
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
Charles Perkins Centre and Faculty of Pharmacy
The University of Sydney
Navindra Persaud MD
Assistant Professor, Faculty of Medicine
University of Toronto