The European Medicines Agency (EMA) announced on 1 August 2018 that, as part of its Brexit business continuity plan, it is temporarily suspending the publication of clinical data submitted to it as part of marketing authorisation applications. Data packages submitted before the end of July 2018 will be processed and formalised but no new procedures will be begun as of 1 August 2018.
The Agency explained in its press release that some temporary curtailment of its activities is required because the Agency will lose more staff on its relocation to Amsterdam from London than it had initially anticipated. Some activities must be temporarily suspended or cut back in order to safeguard the Agency’s core activities related to the evaluation and supervision of medicines. Clinical data publication pursuant to the Agency’s controversial Policy 0070, therefore, becomes another casualty of Brexit for the time being.
The announcement comes shortly after the EMA published a report on the first year of clinical data publication under Policy 0070 (Oct 2016 – Oct 2017), which indicates that as of 20 October 2017, clinical data corresponding to 54 regulatory procedures for 50 medicines were publicly available on the Clinical Data Publication website, amounting to over 3,000 clinical documents, totalling more than 1.3 million pages. It emerged from the report that the amount of CCI redactions in the documents published was very low, in only 0.01% of total pages published. In the clinical instances, the five most commonly accepted CCI redactions, starting with the most frequently seen, related to: detailed information on analytical assays or methods; future development plans; contractual agreements with suppliers and vendors; the amount of financial compensation given to study volunteers; or post marketing exposure per country.
It may not be co-incidental that the Agency had announced earlier in July that it was also changing its policy of providing access to documents pursuant to Policy 0043 and Regulation (EC) No 1049/2001. Requests from outside the EU (which may include requests by UK applicants post-Brexit) for access to documents held by the Agency will no longer be processed. This is due, the Agency says, because of a high volume of requests resulting in an excessive workload. The EMA Annual Report 2017 indicated that the number of requests for access to documents received by the EMA had increased from 377 in 2014 to 844 in 2017. Citizens of the EU and natural and legal persons residing or having their registered office in an EU member state continue to have a right of access.
The Agency’s hope that its workload in responding to requests for access to documents might be reduced may, however, be misplaced as it has become a common practice for requestors to use an undisclosed agent in the EU to make the request. This practice will not be checked by the change in policy and it is the obvious route to go down for requestors situated outside the EU.