The European Medicines Agency (EMA) has published the first report on the implementation of its flagship policy on the publication of clinical data (Policy 0070). Under this policy citizens, including researchers and academics, can directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing authorisation applications for new medicines as of 1 January 2015. Clinical reports give information on the methods used and results of clinical trials conducted to demonstrate the safety and efficacy of medicines.
The report covers one year from 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. These data have attracted a total of 3,641 users, resulting in 22,164 document ‘views’ and 80,537 ‘downloads’ for non-commercial research purposes.
The report sheds light on the total number of documents published, the amount of commercially confidential information (CCI) redacted and the anonymisation techniques used. EMA accepted 24% of CCI redactions proposed by pharmaceutical companies, with the result that only 0.01% of 1.3 million pages published contained CCI redactions. The report also details the various anonymisation techniques used to protect personal data. It also suggests conducting a proper assessment of the impact of the anonymisation technique on data utility and improving the quality of the anonymisation reports.
The results of a user survey of the clinical data website are also included in the report. Of the total respondents, 62% were affiliated to the pharmaceutical industry, 14% to academia, 8% were patients and 8% healthcare professionals. The report summarises the reasons of the different user groups for accessing the data and their views on its usability. Importantly, it shows that very few respondents disagree with EMA’s rationale for developing the policy. In addition, most respondents strongly agree that publishing clinical data increases public trust in EMA’s decision-making and that it allows the reassessment of clinical data.
To implement the policy successfully, EMA made sure that the pharmaceutical industry received regularly updated guidance. The Agency 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, reaching the 100th published dossier milestone on 29 May 2018.
EMA is the first regulatory authority worldwide to provide open access to clinical data submitted by companies in support of their marketing authorisation applications. This is a cornerstone of EMA’s commitment to openness and transparency, which was recently endorsed by the EU’s General Court rulings on the limited scope of commercial confidentiality with regard to authorised medicines. Moreover, EMA’s proactive publication of clinical data has shaped the global debate towards more transparency, as other regulators, such as the US Food and Drug Administration (FDA) and Health Canada, have subsequently implemented- or are considering implementing – similar transparency measures.
EMA is currently preparing for its relocation to the Netherlands, its new host Member State, and is implementing the next phase of its business continuity plan (BCP) to facilitate the relocation. This will also impact the publication of clinical data as of the second half of 2018 and in 2019. EMA will liaise with pharmaceutical companies currently preparing their submissions. The Agency will do its utmost to resume this activity to the level outlined at the start of the policy once the relocation is complete.
