Greg Bacon and Nick Michelmore
On 16 July 2018, the EMA published a report on the first year (Oct 2016 – Oct 2017) of its clinical data publication policy (Policy 0070).
The purpose of Policy 0070 was to give open access to clinical data submitted by pharmaceutical companies in support of marketing authorisation applications, with the aim of: enhancing public trust and confidence; avoiding duplication of clinical trials; encouraging innovation and development; and enabling public availability of the scientific data leading to potential public-health benefits. The clinical data are available on the Clinical Data Publication (CDP) website.
The EMA’s report summarises the progress made in this first year, and concludes that the policy has so far been productive. Notable findings include:
- 54 procedures were published in the first year, which was a 100% compliance rate.
- While 19 of these procedures had Commercially Confidential Information (CCI) redactions accepted by the EMA, only 1.46% of published documents contained CCI, and only 0.01% of the total pages published were redacted.
- The most common reasons for CCI redactions were regarding the quantitative composition of the finished/investigational product, detailed information on analytics assays or methods, and future development plans.
- Feedback from stakeholders has been generally positive.
- Users representing the pharmaceutical industry tended to use the CDP website for policy compliance, benchmarking, and awareness of competitors’ activities. Members of academia accessed data for research purposes, while patients used access for information and awareness. Healthcare professionals had expressed interest in using the data to assess evidence relevant to their medical practice.
The EMA has implemented a business continuity plan (BCP) for its relocation from London to Amsterdam in advance of the UK leaving the EU. Despite the optimism in the report on the progress of Policy 0070, the EMA warns that as a result of the BCP ‘some areas have been temporarily reprioritised, suspended or postponed to resource Brexit preparedness activities and safeguard core activities’.
The second half of 2018, and 2019 will therefore ‘see further reduction in the operation of EMA’s proactive publication of clinical data in line with a revised prioritisation of its activities to take due account of the consequences of the relocation’. We can therefore expect a potential stalling of proactive publication of clinical data until relocation of the EMA is complete.
This follows on from an announcement from the EMA that it is no longer in a position to process ‘access to documents’ requests issued outside the EU under Article 2 Regulation (EC) No 1049/2001, due to a high volume of requests resulting in an excessive workload. The decision was made to avoid the EMA's core business tasks and performance being jeopardised.