Canada Prepares To Publish Draft Rules On Release Of Clinical Data
Executive Summary
Following a public consultation earlier this year, Health Canada has asked for expert advice on its plans to allow the release of clinical data that is currently considered confidential. It expects to publish draft regulations this autumn.
The Canadian health authorities are preparing to propose new draft regulations on the publication of clinical data contained in new drug submissions and medical device applications. Under the new rules, the data, which are currently treated as confidential, would be made public once a final regulatory decision had been taken on the submission.
Health Canada says that public access to clinical information on safety and efficacy “will allow independent analysis that increases our understanding of the safety and efficacy of health products,” and enable the secondary analysis of clinical data for other kinds of research.
It would also reduce duplication of clinical research that “unnecessarily exposes participants to harm,” and improve patient care by helping patients and healthcare providers make more informed decisions about using drugs or medical devices.
The process of drawing up the regulations began in earnest in March this year when Health Canada released a consultation document entitled “Public release of clinical information in drug submissions and medical device applications” for a two-month comment period.
“Specified” clinical information will be made available for non-commercial purposes following the completion of the regulatory review process – Health Canada
The regulations, which are expected to be released during the autumn, will cover areas such as processes for data review and redaction, mechanisms for public release, and safeguards against commercial use of the data. Options for the phasing in of the regulations will also be considered, Health Canada said.
In line with current practice in other jurisdictions, for example the EU and the US, Health Canada said that “specified” clinical information would be made available for non-commercial use following the completion of the regulatory review process, although certain categories of commercial information could be exempted from public release.
Clinical study reports, overviews, and summaries of completed drug trials would cease to be commercial business information (CBI), unless the data contained information on secondary or exploratory endpoints that might be a component of an on-going development program.
For drugs specifically, the information for release would comprise data contained in common technical document (CTD) and electronic CTD format in modules 2.5, 2.7 and 5, together with the appendices (other than case report forms in section 5.3.7).
For medical devices the information would comprise the summary of all clinical studies for Class III and Class IV medical devices, and detailed information on all clinical studies for Class IV devices.
Noting that clinical study reports, overviews, and summaries can include methodological details, specifications and validation information, the consultation document says that for drugs and medical devices, only portions of the methodological details should be treated as confidential. For medicines, only clinical data that provide insight into the stereochemistry that is not already known and necessary for ongoing clinical development should be treated as confidential.
The consultation document defines “non-commercial use” as meaning information that “will not be used to support a marketing authorization application anywhere in the world or sold or traded to another person.”
Health Canada says that it will develop guidance to help implement the new rules, which will take the form of amendments to the Food and Drug Regulations. The guidance will lay out the procedures for identifying clinical information in submissions and redacting CBI and personal information before release of the data.
“Drug or medical device manufacturers would be expected to provide specific justification for each proposed redaction based on regulations” and any information that could lead to the identification of trial participants would be redacted in compliance with the Canadian Privacy Act, it says.
Expert Views Wanted
Health Canada said that face-to-face meetings with stakeholder groups and technical experts were to be scheduled between spring and autumn. In the second stage of the process, in June the authority called for expert input in six specific areas:
- Data protection and privacy law.
- Health data science and statistics.
- Open data and end-user experience.
- Clinical trial reporting and medical writing.
- Anonymization and de-identification methods.
- Regulatory affairs and the CTD.
Experts were expected to be available for discussion until December 2017.
Health Canada said the expert advice would complement its own analyses and that the draft regulations, when ready, would be presented for feedback to stakeholders including drug and medical device companies, healthcare providers, academic researchers, and patient groups.
From the editors of Scrip Regulatory Affairs.