European Medicines Agency Publishes First Report on Implementation of Clinical Data Publication Policy
- 20/07/2018
- Articles
The European Medicines Agency (“EMA”) published on 16 July 2018 its first report on the implementation of its policy on the publication of clinical data (see attached). The report covers one year following the launch of EMA’s clinical data website on 20 October 2016 and lists the 50 medicines for which clinical data were published, including orphan, paediatric, biosimilar and generic medicines, as well as the corresponding 54 regulatory dossiers.
The report sheds light on the total number of documents published, the amount of commercially confidential information (“CCI”) redacted and the anonymisation techniques used to protect personal data.
To implement the policy successfully, EMA issued guidance on a regular basis and also provided one-on-one assistance to individual companies to prepare them for the publication of clinical data. As a result, EMA published an average of six dossiers a month in the period from October 2017 to May 2018. It reached the 100th published dossier on 29 May 2018.
EMA claims to be the first health authority worldwide to provide open access to clinical data submitted by pharmaceutical companies in support of their marketing authorisation applications. EMA considers this to be a cornerstone of its commitment to openness and transparency. It confirms being encouraged by the recent endorsement of its policy by the EU General Court which in three cases decided in February 2018 followed the EMA’s approach to CCI under the EU’s Transparency Regulation (Regulation No. 1049/2001) and the EMA’s own general policy regarding access to data. EMA does not hesitate to congratulate itself on being a global trendsetter in that it has caused fellow regulators such as the US Food and Drug Administration and Health Canada to adopt or consider adopting similar measures.
Lastly, EMA sends a warning about Brexit in that its relocation to the Netherlands will have an impact on the rate of publication of new clinical data in the latter half of 2018 and in 2019. However, EMA promises to do its utmost to resume this activity to the originally intended level once the relocation is complete.
