key: cord-0864925-4b8psykw authors: Edmonds, Sterling; MacGregor, Andrea; Doll, Agnieszka; Vural, Ipek Eren; Graham, Janice; Fierlbeck, Katherine; Lexchin, Joel; Doshi, Peter; Herder, Matthew title: Transparency too little, too late? Why and how Health Canada should make clinical data and regulatory decision-making open to scrutiny in the face of COVID-19 date: 2020-11-19 journal: J Law Biosci DOI: 10.1093/jlb/lsaa083 sha: 68d25ef85326d8ab67d57325b3c6aa02471e6d6b doc_id: 864925 cord_uid: 4b8psykw nan In this article we explain why transparency must be radically expanded in several ways. We argue that meaningful transparency in the context of COVID-19 requires that the clinical data behind SARS-CoV-2 interventions and the regulatory decisions made on the basis of that data must be open to scrutiny. We also argue that transparency should be expanded to occur upstream during therapeutic product development and continue in an expanded manner throughout its lifecycle, beyond the point of regulatory approval, as knowledge about the product's safety and effectiveness continues to evolve. And, while the argument we develop applies in principle across jurisdictions, we zero in on Canada in particular where recently enacted transparency laws provide ample authority to implement our recommendations. Specifically, we detail how Canada's existing transparency laws can be deployed to ensure that data which only the sponsoring company may hold during the research process are made available 9 and facilitate independent scrutiny of information held by sponsors and the regulator alike in order to improve judgments about the safety and effectiveness of SARS-CoV-2 interventions. We begin by setting out the mechanisms by which COVID-19 therapeutic products are being authorized for clinical study and use, then develop arguments about why greater transparency is warranted before 8 Regulatory agencies publicly disclose a great deal of information. The vast majority of data pertaining to the safety and efficacy of a drug or vaccine is disclosed after the intervention has been approved. The US Food and Drug Administration (USFDA), for instance, is legally obliged to publicly disclose the "approval package", which contains all of the scientific reviews completed by various disciplines within the agency. These approval packages often contain a number of details pertaining to the clinical trials carried out by the sponsor in the course of developing the drug, although the actual Clinical Study Reports (CSRs) prepared in respect of those trials are not disclosed by the USFDA. For further details about USFDA's approval packages and their value to public health, see Matthew Herder, Christopher J. Morten & Peter Doshi, Integrated Drug Reviews at the US Food and Drug Administration-Legal Concerns and Knowledge Lost, 180 JAMA Intern Med 629-630 (2020). Like the USFDA, Health Canada and the European Medicines Agency (EMA) disclose the bulk of safety and efficacy data pertaining to therapeutic products after a regulatory decision has been rendered. In those two jurisdictions, however, CSRs are the principal information that is disclosed. The reviews conducted by each agency are not published apart from high-level summaries of the decisions taken. It is also notable that the Canadian and European regulators also disclose such data in the event the intervention is denied market entry. The USFDA, in contrast, treats such rejections as proprietary unless and until a drug is subsequently approved. For an in-depth, comparative review of these three transparency mechanisms, see Alexander C Egilman et al., Transparency of regulatory data across the European Medicines Agency, Health Canada, and US Food and Drug Administration [under review]. 9 For example, Health Canada authorized a SARS-CoV-2 targeting drug (remdesivir) solely on the basis of "study protocols and preliminary and/or topline results." The CSRs that normally accompany an New Drug Submission to the regulator were apparently not provided. We discuss this and other examples of data that only the sponsor may have at the time in question and Health Canada's legal authority to compel the production of that information. See infra. finally presenting how to do so precisely under current Canadian law. We close by considering how added transparency might better assure public trust in regulatory agencies, such as Health Canada. Regulators worldwide have mobilized existing and new temporary mechanisms to expedite clinical trial approval and facilitate access to therapeutic products with uncertain benefits and harms in order to combat COVID-19. 10 In Canada, this involves three mechanisms ( To begin, the Interim Order specifies three new pathways to authorization by Health Canada. One is an expedited authorization procedure that allows for a "rolling application" in which the sponsor submits information to the regulator based upon an agreed upon schedule. 23 This mirrors rolling application processes elsewhere and, by reducing the amount of information required initially upon submission, is intended to trigger faster decision-making about whether the benefits of the therapeutic product outweigh its risks. 24 Another pathway allows for authorization where the product has been previously approved by one or more trusted foreign regulators, opening up the list of such regulators from the three eligible regulators under ADEC to at least seven foreign regulatory authorities. 25 Finally, the Interim Order also describes how Health Canada can, without waiting for an application from the sponsor, seek to expand the indication of a previously approved drug to encompass treatment for Secondly, the drug-focused Interim Order aims to prioritize the review of applications by a sponsor for a new or modified "establishment license" in order to lawfully produce a COVID-19 drug. 27 Granting the regulator the discretion to alter the requirements typically applied to establishment license applications, the Interim Order's stated aim is to equip Health Canada with the "agility to facilitate rapid access to COVID-19 drugs while mitigating risks." 28 The third notable change introduced by the Interim Order is the creation of a "pre-positioning" option to allow a drug to be imported into Canada by an establishment license holder and be prepared for 23 September Interim Order, s 3(2). 24 One vaccine has already started this process. protocols, which specify inclusion/exclusion criteria for participants, primary and secondary outcomes that will be used to assess the product's safety and efficacy, randomization and blinding procedures to ensure the integrity of the findings, and a variety of other information. A published summary of Health Canada's decision to approve remdesivir, moreover, raises more questions than it answers given that the sponsor (Gilead Sciences) has yet to provide clinical study reports (CSRs)-the key document that regulators rely upon to assess safety and efficacy-for any of the COVID-19 remdesivir clinical trials. 33 And, while several publicly available lists (identifying, for example, any applications the regulator has 29 September Interim Order, ss 27-28. 30 Prime Minister Announces Funding to Advance the Development of Canadian COVID-19 Vaccine Technologies, Government of Canada (Oct. 23, 2020), https://pm.gc.ca/en/news/news-releases/2020/10/23/prime-minister-announcesfunding-advance-development-canadian-covid. 31 We describe what and when information is currently made transparent in Canada in detail below. 32 Health Canada provides a list of clinical trials involving SARS-CoV-2 interventions that have been authorized on its website. As of October 2020, 68 trials had been authorized. Health Canada, Drugs and vaccines for COVID-19: Authorized clinical trials, aem (2020), https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugsvaccines-treatments/list-authorized-trials.html#wb-auto-4 (last visited Oct 27, 2020). Little to no information about the design of these trials is provided on the website, however, where the trials have been registered on ClinicalTrials.gov additional information is publicly available. As discussed below, however, ClinicalTrials.gov does not include trial protocols or consent forms. received for marketing authorization against Covid-19 34 ) were launched in conjunction with the September 2020 Interim Order, no meaningful changes were made to the regulator's approach to transparency. On the contrary, Health Canada will only release data pertaining to a therapeutic product's safety and effectiveness at the point of authorization. 35 Given that the regulator has, in one case, reduced the level of information required for authorization (e.g., granting Gilead approval for remdesivir even in the absence of CSRs) and relaxed when information is due pursuant to the Interim Order (by creating a rolling application process for all sponsors), there is reason to worry that Health Canada may not possess much data to share. Before outlining how the regulator can take a more proactive and dynamic approach to transparency under Canadian law, we explain in depth why the absence of transparency during the research and development process and beyond approval may precipitate a range of harms in the context of COVID-19. Poor data transparency, in any circumstance, poses risks to trial participants and patients, jeopardizes clinical trial quality, 36 and has the potential to undermine trust in health professionals, pharmaceutical manufacturers, and regulatory decision-making. 37 There is also some evidence that a perceived lack of transparency is one of the drivers of "vaccine hesitancy. 12 being rapidly trialed and/or entering clinical use through various expedited regulatory pathways. Delaying disclosure of the data underlying these regulatory decisions until the point of approval may be too late to guide rational decision-making given the misinformation available online about remedies that are not the subject of a clinical trial and, at the same time, intense political pressure to demonstrate progress towards a cure even if the intervention's scientific merits are uncertain. 45 In this particular context, transparency needs to happen upstream, prior to therapeutic product authorization or approval, and across the product lifecycle, in order to mitigate or avoid several significant harms. Further, the prospect of running "challenge trials" in which a healthy volunteer is intentionally exposed to SARS-CoV-2 in an effort to more efficiently assess the effective of the experimental But without consistent transparency of study documents such as trial protocols or correspondence between sponsors and regulators, the opportunity is missed for timely evaluation when inadequacies can in theory still be corrected. 62 Trial design modification may be unlikely even though regulators have the authority to compel changes to study design. But at a minimum the public can be more informed about the potential weaknesses of a given study. Notably, some trial protocols have-at the sponsor's discretion-been publicly disclosed during the course of the pandemic, including both Moderna and Pfizer's mRNA vaccine trials, which include approximately 30,000 and 44,000 participants, respectively, as well as AstraZeneca's US-trial of its adenovirus-based vaccine. 63 The details of these protocols raise some critically important questions, in particular, about whether the integration of "interim analyses" in the design of the trials (the Pfizer, Moderna, and AstraZeneca trials include 4, 2, and 1, interim analyses, respectively) may lead to the trials being halted or modified prematurely (e.g., administering the experimental vaccine to the control group) if the efficacy of the vaccine in question is trending in a positive direction. 64 Precisely how those decisions will be made is not delineated in the protocols that have been made publicly available; rather, those decision will fall to "data monitory committees" (also known as "data safety monitoring boards" or "DSMBs"), which typically operate under conditions of strict secrecy in order to both prevent false hope based on preliminary data, 65 and to shield their members from outside influence. 66 (2020), https://khn.org/news/these-secret-safety-panels-will-pick-the-covid-vaccine-winners/ (last visited Oct 6, 2020). 16 see fit to disclose them) as well as other key materials such as the "charters" used by DSMBs to guide their decisions about stopping or modifying an ongoing trial (either because a safety issue has arisen or the intervention is showing significant therapeutic promise), it is not possible to fully interrogate the quality of COVID-19 trial designs and the reliability of trial outcomes. And, in the absence of trial protocol and DSMB charter transparency, before full data from the trial is released, there is a significant risk that downstream decisions by physicians about whether to administer the intervention in question to patients will be made without the benefit of strong evidence. Third, the rush to promote partial, preliminary findings, has the potential to propagate misinformation. That is the main reason why data that are considered by DSMBs during the course of a trial are normally kept confidential. 67 Over the course of the pandemic, however, sharing preliminary data has become the norm, not the exception. And while preprints have become an important vehicle for rapidly sharing scientific findings, they also have the potential to be misinterpreted or accepted as accurate before they have been subjected to rigorous peer review. 68 Without the benefit of a peerreviewed publication, let alone access to the underlying data which provide a more comprehensive record of a trial's results, 69 there is a significant chance that the risk-benefit profile of a given product will be misunderstood by both clinicians and the public. Consider, for example, remdesivir's path to market. No trial designs were publicly available before participant enrolment began. Weeks before "preliminary findings" were published in high-profile journals, 70 details of the drug's purported benefits began to appear in the media, which Gilead promoted by press release. 71 US government officials, specifically Dr. Anthony Fauci, suggested remdesivir would become the "standard of care" treatment for COVID-19. 72 Trial details emerged, only after these press releases and announcements, raising significant concerns including the "serious methodologic error" of prematurely censoring data of deceased patients, as well as design weaknesses such as lack of blinding and control, and limited sample size which may have produced unreliable results. 73 Numerous news sources, including Presidential tweets, referred to hydroxychloroquine's emergency authorization as an "approval" which sowed confusion and inflated perceptions of safety and efficacy. 78 Subsequent randomized trials of hydroxychloroquine in hospitalized COVID-19 patients reported no evidence of benefit, and the EUA was subsequently revoked by the USFDA in mid-June, citing a lack of efficacy and concerns over side-effects. 79 Lack of transparency around the EUA prevented independent scrutiny of the USFDA's initial determination that "the totality of scientific evidence" made it "reasonable to believe that [the drugs] may be effective in treating COVID-19." 80 Under constant pressure from the Trump administration, the USFDA is holding firm to its stated standard of not authorizing a vaccine-even on an emergency basis-until at least two months have elapsed since trial participants have received the vaccine in question, and its observed efficacy meets or 19 surpasses a pre-defined threshold. 81 If and when an EUA is granted, it will be critical to ensure that the knowledge which continues to accumulate during the remainder of the trial is proactively and publicly shared post-authorization. The worry that underpins this call for continuous data transparency is twofold: if a vaccine appears sufficiently effective, the DSMB may elect to allow it to be administered to participants in the control arm of the trial, nullifying the trial's randomized design; or, even if no changes to the trial design are made, many participants will withdraw from the study once the decision has been made to grant an EUA. 82 In either eventuality the integrity of the trial's results will be jeopardized. Canada's regulator has a long history of secrecy, electing to keep data confidential as a matter of practice. 85 The introduction of "Vanessa's Law" in 2014, 86 however, promised fundamental change. Adding a variety of patient safety measures to Canada's Food and Drugs Act, including the power to unilaterally recall drugs from the market and compel acute care hospitals to share adverse event data with the federal regulator, 87 one of the express purposes of Vanessa's Law was to "promote greater confidence in the oversight of therapeutic products by increasing transparency." 88 To achieve that goal, several new legal authorities were added to the legislation, which, taken together, positioned Canada to become a global leader in transparency. 89 Implementation of these transparency provisions has been gradual, 90 Secondly, even when disclosure is permitted, Health Canada may not possess the data to make it available. In ordinary circumstances, Health Canada does not, for example, require sponsors to submit CRFs unless a serious adverse event has occurred in the course of a study. 98 Unless the regulator compels companies to submit and/or disclose such patient-level data, it is not possible for independent researchers to carry out a re-analysis of a trial-a labor-intensive act of independent scrutiny that continues to be undervalued but has, at times, revealed deep inconsistencies between published studies and what the trial actually found. 99 In the context of the current pandemic, however, Health Canada has shown a willingness to accept data on a piecemeal basis and even approved one drug (remdesivir) without the benefit of Clinical Study Reports (CSR). Until those CSRs are submitted to Health Canada little to no information about remdesivir's safety and efficacy is likely to be published via the Portal. With the Interim Order's introduction of a new expedited "rolling application" process it is unclear how much data Health Canada will have to release at the time of market authorization. 100 Finally, the Portal does not incorporate product safety and efficacy data that accumulates postapproval. 101 23 anticipated that many of the trials investigating COVID-19 drugs and vaccines will continue following authorization, especially if authorization occurs after an interim analysis; however, unless that postauthorization evidence is incorporated into the Portal the evidence that will be open to independent scrutiny may represent only a fraction of what is known. [ INSERT TABLE 2 HERE] Fortunately, Canada's Food and Drugs Act provides several options to address the foregoing gaps, in turn, improving the overall transparency of the data and decision-making process surrounding SARS-CoV-2 interventions. Depending on who possesses the information at a particular interval, different legal mechanisms can be invoked (or modified by way of an Interim Order) to ensure that data disclosure occurs through one of several existing information-sharing platforms. Further, transparency need not always mean disclosure to the public writ large; instead, the approach to disclosure should be specific to the type of information involved, purpose-driven, and complemented by the necessary resources (Table 3) . 24 human health and/or public safety, 103 provided they intend to use the CBI for a health or public safety related purpose rather than a commercial one. 104 This legal authority could be used, in the context of COVID-19, to share a number of different data with independent researchers before a decision is made to authorize a COVID-19 intervention for broader clinical use. Upon request from an eligible person (or government body), 105 for example, the Minister could disclose completed COVID-19 pre-clinical studies and trials conducted outside Canada that are submitted to Health Canada as part of an application to conduct a new clinical trial. With several candidate vaccines now under study in large, Phase 3 clinical trials, this same discretionary authority could also be invoked to share the Interim Analyses conducted by DSMBs and shared with the regulator. As described above, it is plausible that such Interim Analyses will be used to justify an expedited authorization of a vaccine. While the trials will likely continue after such an authorization, any decision by a DSMB to alter a trial should be open to scrutiny by independent trialists and other researchers. Finally, at a later point in time, when trials are completed, Health Canada can make the individual patient-level data (IPD) available to eligible researchers in order to validate the safety and efficacy findings that are reported by the sponsor. In the eventuality that Health Canada does not possess the necessary IPD (e.g., Case Report Forms) from completed trials, an additional provision in the Food and Drugs Act can be invoked to compel sponsors to disclose that information-as prescribed by regulations-in respect of products that have been imported into Canada for the purpose of a clinical trial and/or received an authorization or approval from Health Canada. 106 The regulator would need to define how that would occur using a new Interim Order and, in collaboration with other government agencies 25 (e.g., Canadian Institutes of Health Research), marshal the resources to fund the labor-intensive work of re-analysing and validating previous trial results using the IPD. 107 Provided that the recipients of the IPD protect the privacy of trial participants', 108 allocating even 1-2% of the > $850 million already earmarked for the development of SARS-CoV-2 interventions for independent assessment would appear to be a worthwhile investment. Public Disclosure: Consent Forms, Trial Protocols, Clinical Study Reports & Regulatory Other types of data merit disclosure to the wider public. In order for the public to know that participants are being appropriately informed about the risks of participating in rapidly designed and authorized clinical trials, template consent forms that serve to enrol participants should be publicly shared before trials begin and in the event that the forms are updated in response to an adverse event. Challenge trials, if sanctioned, must be accompanied by disclosure not only of the consent forms but also the regulator's underlying ethical justification for authorizing a challenge trial design given the absence of an effective treatment against SARS-CoV-2 in order to assuage public concerns about this type of trial. 109 Where the goal is to improve clinical trial reliability and promote scrutiny of trial results as well as regulatory decision-making, Health Canada should leverage its existing Clinical Information Portal and Drug and Health Product Register (DHPR) 110 to make these and other data publicly available. The Portal can serve to publicly share the pre-clinical and clinical evidence behind all clinical trial authorizations and all expedited authorizations granted pursuant to ADEC or the Interim Order. The DHPR can provide a repository for consent forms used in trials while also serving as a space for the regulator to document its rationale for each decision, including authorizing challenge trials, key correspondences with sponsors about trial designs, trial results, studies required to be carried out postapproval, and any other considerations that factored into the decision to authorize a product. Currently, both the Portal and DHPR encompass information pertaining only to approved drugs and devices. However, Health Canada has broad authority to alter what information is considered CBI, and when to deem it no longer to be CBI in order to release the information. Amendments to the regulations, or an Interim Order, can be used to expand the information to be publicly disclosed to points upstream in the research process as well as after authorization as the evidence base continues to evolve. 111 The challenge concerning the clinical evidence to be posted on the Portal is timing. Unlike pre-clinical studies and other data that the regulator possesses as part of an application to conduct a clinical trial, the main documentation summarizing the safety and efficacy findings for completed trials (i.e., CSRs) can take weeks or months to prepare. The example of remdesivir suggests that Health Canada is prepared to accept and approve a drug submission without CSRs and more complete data in hand, and the recent introduction of a rolling application process appears to codify that same approach for the remainder of the pandemic. Therefore, to improve scrutiny of clinical trial designs and findings, Health Canada should disclose all information it has regarding new trials, especially trial protocols, within 15 days of trial authorization (the same timeframe in which the regulator is reviewing trial applications during the pandemic). The regulator should also invoke its authority-similar to patientlevel data-to expedite the preparation and transfer of CSRs of all completed trials to Health Canada. 112 The regulator can then disclose these data to the public via the Portal within a reasonable timeframe following trial completion (e.g., 60 days) as opposed to the current 120 days. 113 Finally, the DHPR, which presently contains only dates of meetings and limited summaries of than at a single point-in-time. With one intervention already approved in Canada (remdesivir) and one or more vaccines approaching authorization probably within the next 3-6 months, the federal government may need to overcome additional barriers to knowledge sharing in order to scale up production of the most promising products as no one manufacturer likely has the capacity to produce enough doses to meet the world's needs. 117 This may entail issuing a compulsory license in order to allow other manufacturers to produce a patented vaccine 118 as well as encouraging firms to share manufacturing know-how, proprietary adjuvants, and assays, which may be protected as trade secrets. 119 The prior task, however, is to ensure that the evolving knowledge about COVID-19 product candidates is meaningfully and continuously open to scrutiny. In principle, rendering clinical and decision-making data open to scrutiny carries competing considerations but none appear persuasive. The first concerns compliance with international law. Canada, like other signatories to international treaties governing intellectual property rights, is required to protect data against unfair commercial use. That commitment is an effort to balance the interests of first-mover and generic firms within the industry as they compete for market share. 120 In the context of COVID-19, however, this balancing can and has already been addressed in other ways. Specifically, the Interim Order passed in September stipulates that any product (and, by extension, its underlying data) that is authorized under the Order cannot be cited as a reference product by a generic firm in an effort to obtain regulatory approval. 121 As such, sponsors that reach the market first will not face generic 117 and regulators alike, and public vaccine hesitancy seemingly on the rise, 123 providing funds for independent researchers to interrogate the data behind one or more vaccines would seem a sound investment. In the end, there is no necessary relationship between transparency and trust. Sharing less information might, in theory, limit fears of potential adverse events. On the other hand, the current situation echoes government-driven vaccine races from the past, such as the one developed for the forecasted 1976 influenza pandemic, the side effects of which helped to propel anti-vaccination movements to this very day. A COVID-19 intervention that is administered to whole swaths of the world's population-without full transparency about its safety and efficacy-may engender lasting distrust not only against COVID-19 vaccines but a range of other infectious disease interventions with more established safety and efficacy profiles. 124 The best way to prevent that outcome is to ensure high- Clinical Study Reports Any clinical study reports, including methodological details, specifications, and validation information. Studies that evaluate the rate and extent of release of active substance from the medicinal product (PK and BA data) In vitro studies to assess PK using biological systems In vivo PK studies Reports on Human Pharmacodynamic (PD) Studies Receptor binding, receptor sensitivity, post-receptor effects, and chemical interactions Reports of Efficacy and Safety Studies All available completed or on-going safety/efficacy-related studies on the drug in proposed and non-proposed indications. Reports summarizing market experience (e.g. significant safety observations) Published articles, meeting minutes, regulatory advice. Clinical study overviews, including methodological details, specifications, and validation information. Clinical Summary Summaries of all completed clinical studies and information submitted in support of the drug/medical device application for primary, secondary, or exploratory endpoints. Food & Drugs Act, s 21.1(3)(c) Authorizing the disclosure of confidential business information without notice or consent from the person to whose business the information relates, for the purpose of protection or promotion of human health or the safety of the public. Food & Drugs Act, s 21.1(3)(a) Authorizing the disclosure of confidential business information without notice or consent from the person to whose business the information relates, to a government body. services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization/list-drugs.html; Health Canada, List of Foreign Drugs in Relation to The COVID-19 Pandemic, Government of Canada Public Release of Clinical Information: Guidance Document, Government of Canada By 'quality' we mean the trial's ability to answer the most important public health or scientific questions. We use this term in contrast to clinical trial 'reliability', i.e., the trial's ability to accurately answer the questions it has selected however important to public health they may be The Montreal Tuberculosis Outbreak Revisited Pandemic publishing poses a new COVID-19 challenge, 4 NAT. HUM. BEHAV Several studies have shown that published versions of trials present a very different picture than the evidence (from the same trials) that are submitted to regulators Remdesivir in Adults With Severe COVID-19: A Randomised, Double-blind Hailed as Potential COVID-19 Treatment Standard of Care' for COVID-19, Fauci Says, MEDSCAPE See Stefanos Bonovas & Daniele Piovani Letter to the Editor Trump Administration Secures New Supplies of Remdesivir for the United States Global Shortage of Key Covid Drug Leads to NHS Rationing, THE GUARDIAN Treatments don't work if we can't afford them: the global need for open and equitable access to remdesivir Despite this, Canada has also made a procurement agreement for Remdesivir. Public Services and Procurement Canada, Government of Canada Signs New Agreements to Secure Additional Vaccine Candidate and Treatment for COVID-19 Re: Request for Emergency Use Authorization for Use of Chloroquine Phosphate or Hydroxychloroquine Sulfate Supplied from the Strategic National Stockpile for Treatment FDA Says Hydroxychloroquine and Chloroquine Can Be Used to Treat Coronavirus Emergency Use of Hydroxychloroquine and Chloroquine to Treat COVID-19, REASON Trump Wrongly Claims FDA 'Approved' Drug Chloroquine to Treat the Coronavirus, CNN Food and Drug Administration, Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorizations for Chloroquine and Hydroxychloroquine Re: Request for Emergency Use Authorization for Use of Chloroquine Phosphate or Hydroxychloroquine Sulfate Supplied from the Strategic National Stockpile for Treatment of 2019 Coronavirus Disease Unlocking Health Canada's cache of trade secrets: mandatory disclosure of clinical trial results Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Vanessa's Law, ss 3, 5 It is worth noting that the legislation did not originally include any measures to improve transparency. During the legislative process, though, the bill was amended to address the issue of transparency. Matthew Herder, The Opacity of Bill C-17's Transparency Amendments Search for Clinical Information on Drugs and Medical Devices Guidance Document on Public Release of Clinical Information: Profile Page, (Appendix A) Disclosure of Confidential Business Information Further Health Canada has already utilized this mechanism during COVID-19 See Canadian Institutes of Health Research, DSEN Abstract )(c) of the Food and Drugs Act Here it is important to note that although one treatment (remdesivir) has been approved by Health Canada to date, the evolving evidence casts significant doubt on its efficacy. Interim results published on October 15 found that remdesivir (as well as 3 other interventions) had "had little or no effect on overall mortality, initiation of ventilation and duration of hospital stay in hospitalized patients ); and, WHO Solidarity Trial Consortium et al., Repurposed antiviral drugs for COVID-19; interim WHO SOLIDARITY trial results Search for Clinical Information on Drugs and Medical Devices The Drug and Health Product Register It appears that there is growing hesitancy in Canada and the US about COVID-19 vaccines. See Jung, Hauser et al., supra note 90. For reason related to vaccine hesitancy in general, see Eve Dubé et al., Understanding Vaccine Hesitancy in Canada: Results of a Consultation Study by the Canadian Immunization Research Network Adverse Consequences of Rushing a SARS-CoV-2 Vaccine: Implications for Public Trust, 323(24)