Canada finally opens up data on new drugs and devices

More than four years after the Canadian parliament passed legislation to make clinical information about drugs and devices publicly available, the federal regulator Health Canada has finalised regulations1 and begun publishing information on its website.2 The proactive release of information about new therapeutic products, including drugs, biological treatments and medical devices, after they have been either approved or rejected will be phased in over the next four years, starting with new chemical entities. In addition, Health Canada will now release on request similar information about drugs and devices already on the market.

This level of transparency represents a fundamental shift in how Health Canada handles clinical trial information, including detailed clinical study reports. Previously, Health Canada maintained that such information must be kept confidential despite clear flexibilities in the law to allow greater transparency.3 As early as 2000, Health Canada’s own science advisory board called the “current drug review process … unnecessarily opaque,” saying it was “inconsistent with public expectation and contributes to a public cynicism about the integrity of the process.”4

Decades of reports and advocacy sounding the same concern finally motivated fundamental reform in 2014, with the passage of “Vanessa’s law.”5 This federal law is intended to “promote greater confidence in the oversight of therapeutic products by increasing transparency” through several new legal mechanisms, including the regulations that underlie Health Canada’s new public portal for accessing clinical information relating to drugs and devices.

The Canadian regulations and resulting portal mirror policies adopted by the European Medicines Agency in 2010 and 2014 that grant access to clinical study reports on request and authorise the publication of study reports submitted by drug companies.6 For lonoctocog alfa, the first and—so far—only drug posted on Health Canada’s portal, the information released is identical to that available on EMA’s website, with identical redactions and a watermark indicating that the files were submitted to EMA.

Health Canada has gone beyond the European regulator in several important ways, however. Its reforms are grounded not just in policy but in legislation, strengthening its position should its approach be challenged in court, as the EMA has been.6 In addition, unlike EMA, Health Canada and its new regulations cover medical devices, and the clinical data behind one device (a new mammography system) has already been posted. Health Canada also allows anyone to download the data without registration, something EMA’s policy now limits to residents of the European Union.

Whatever their differences, both EMA and Health Canada now stand far ahead of the US Food and Drug Administration when it comes to transparency. More than a year since announcing a voluntary programme to post clinical study reports, the FDA has released only one.7

Health Canada also demonstrated a willingness to change its position while developing the new regulations. Early in the process, it proposed an exemption for material that “contains information on … end points which may constitute a component of an on-going development programme.”8 This wording was open to interpretation and risked misuse by industry. After critical feedback, the exemption was clarified to read “clinical information that was not used by the manufacturer … to support the proposed conditions of use.”1

A second exemption to disclosure gives ongoing cause for concern, however. Health Canada will not release “information that describes tests, methods or assays that are used exclusively by the manufacturer.”1 Independent assessment of drug safety may not be possible if data about the performance of the tests, methods, or assays are not made public. Moreover, the regulator may be poorly equipped to identify exclusive use of a test, method, or assay given that industry usually treats them as proprietary.

If the necessary resources are in place to scrutinise that exemption and support the public portal generally, Health Canada’s approach promises to be transformative. It might also encourage transparency beyond Canada’s borders since information put into the public domain loses its proprietary status.9 As millions of pages of clinical data are made public, the FDA’s approach of treating such data as confidential may become untenable. More immediately, the two clicks required to access data through Health Canada’s portal should eliminate the bureaucratic delays and red tape experienced by researchers who are committed to reanalysing trials through the restoring invisible and abandoned trials initiative (RIAT).1011 Health Canada must now design a robust mechanism for feeding such reanalyses back into its regulatory decision making.

With increasing volumes of clinical trial data becoming available online, the onus is now on the research community to scrutinise and analyse the data, and on research institutions (including funding agencies, universities, and organisations producing systematic reviews12) to encourage and reward researchers who do the essential work of open science in the pharmaceutical sphere.