On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use (“Policy 0070”) and revisions to the guidance to industry. Among the new elements introduced by the update is a possibility for the EMA to disclose clinical data which, although submitted to the EMA before 1 January 2015, was relied on in marketing authorisations submitted after that date.
Policy 0070 provides that third parties may access clinical reports and individual patient data that were submitted after 1 January 2015 as part of an application for marketing authorisation or of a post-authorisation procedure for a centrally authorised medicinal product.
The EMA proactively published clinical data submitted by pharmaceutical companies to support their marketing authorisation applications, in accordance with the EMA Policy 0070 for the first time on 20 October 2016.
On 3 March 2016, the EMA published an “External guidance on the implementation of the EMA Policy 0070” (“the external guidance”) in order to, i.e., provide guidance to companies on how to redact and anonymise clinical reports.
The aim of the EMA webinar held on 9 December 2016 was to review the practical experience gained to date on publication of clinical data. The EMA webinar also served to discuss an update of the external guidance to facilitate the process for the companies preparing for future publication.
Key changes to the external guidance
For the purpose of the webinar, the EMA has published a “Summary of changes” which lists the key changes that EMA has included in the external guidance.
A key change to the external guidance is the extension by the EMA of the scope of Policy 0070. The EMA’s view is that all clinical reports that are submitted as part of, or cross-referred to within a regulatory application in the context of Policy 0070 will be subject to publication. This includes clinical study reports submitted in the context of earlier regulatory procedures and to which reference is made in applications for extension or modification of existing marketing authorisations to include additional indications and applications for line extensions.
Publication of such information will occur following redaction of commercially confidential information (“CCI”) and protected personal data (“PPD”). The document clarifies that to distinguish between CCI and PPD redactions, applicants/MAHs are required to colour code the redactions when preparing the Final Redacted document package.
The EMA has also updated the related external guidance to include practical guidance regarding sections concerning out of scope individual patient data (“IPD”), such as per patient per visit line listings. Per patient per visit line listings are listings that include values of measured parameters (e.g. lab values) listed for all patients recruited for a clinical study and covering all clinical study visits. These are considered to fall outside the scope of Policy 0070.
Where a section identifies per patient per visit IPD and the EMA agrees that the IPD are out of scope of Policy 0070, the section can be removed from the documents to be published. The EMA’s position is that this information must not be redacted. The sections that identify per patient per visit IPD must be removed and replaced with blank pages.
The Summary of changes further specifies that all incomplete Redaction Proposal document package or incomplete Final redacted document package submission will lead to the rejection of the package by EMA.
Updates to the implementation of Policy 0070
As of 23 November 2016, the EMA had published clinical data for four medicinal products. These are: Armisarte (pemetrexed diacid monohydrate), Caspofungin Accord (caspofungin acetate), Kyprolis (carfilzomib), Zurampic (lesinurad). Three hundred and eighty-two (382) documents were published in total for these four drugs. Overall, eight (8) of the two hundred and sixty thousand (260 000) pages released were redacted because they consisted of commercially confidential information.
Since the launch of the clinical data website by the EMA on 20 October 2016, two hundred and thirty-four (234) academic and research users and more than a thousand (1,000) general users have registered to use the website. In total, EMA has recorded that those users have viewed nearly four thousand five hundred (4,500) documents and downloaded more than sixteen thousand (16,000) documents.