November 2021: Transparency Scenario in Europe, United States and Canada

An article, Comparing regulatory transparency in Europe, United States and Canada, was published on TranspariMed on November 02, 2021.

This article, provides a comprehensive overview of the key laws and policies governing disclosure of data by major medicine regulators namely European Medicines Agency, the US Food and Drug Administration, and Health Canada. It also compares the data access provided to certain transparency documents by the regulators. This article was originally published by Cambridge university – Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration

According to the article, the three major medicines regulators are providing more access to key data than ever before. The study focuses on Clinical Study Reports, highly detailed documents that contain important information on the conduct and outcomes of clinical trials that cannot be found elsewhere, but also covers Individual Patient Data plus other types of data and documentation.

The key findings of the article are:

CLINICAL STUDY REPORTS

  • Redactions – The three regulators make only “minimal” redactions to Clinical Study Reports (CSRs) to remove commercially confidential information and data that may endanger patients’ anonymity. Those redactions “generally did not hamper the interpretation of evidence”.
  • Proactive disclosure – Only Health Canada and the European Medicines Agency proactively disclose new CSRs. While the Canadian regulator makes CSRs fully public, the European regulator places restrictions on who can access them, and how. The US Food and Drug Administration has yet to start proactively disclosing CSRs.
  • Reactive disclosure – All three agencies have mechanisms that allow researchers to gain access to older CSRs and other regulatory data upon request. Health Canada provides CSRs far faster and in a more accessible format than the other two regulators do.

INDIVIDUAL PATIENT DATA

Access to Individual Patient Data – Access to IPD via regulators is still impossible in practice. Only the US Food and Drug Administration releases IPD on request, but it when does so, it redacts the data so heavily that they are useless. The European Medicines Agency has formally committed to making IPD accessible in future, but this is not likely to happen any time soon. Health Canada does not have an IPD sharing policy.

ACCESS TO OTHER TYPES OF DATA

The three regulators differ widely in which other types of data they would release.

The article concluded that regulatory data pertinent to public health and clinical medicine, that were used to support the approval of medicines and medical devices are now available proactively or in response to information requests. Over the next decade, regulatory agencies should make Individual patient data available, and additional resources might be needed to ensure the long-term viability of regulatory data sharing programs and to encourage researchers to take advantage of the data that is — for now — more available than ever before.

More information can be found here.