This is a follow up to our previous posts relating to the European Medicines Agency’s (EMA) various policies on access to documents. This continues to be an area of activity for the EMA and there have been a number of developments that have impacted the EMA’s position. Firstly, Brexit has directly affected one of the main pillars of the transparency activities of the EMA, namely the proactive publication of clinical trial data submitted by pharmaceutical companies in support of certain types of regulatory submissions to the Agency (the EMA’s Policy 0070).

Secondly, while the reactive transparency activities of the EMA relating to access to documents in accordance with Regulation (EC) No 1049/2001 (the EMA’s Policy 0043) have been less affected by Brexit, there may be other challenges for the EMA ahead.

Proactive Publication of Clinical Data

Since the launch of the EMA’s initiative on proactive publication of clinical data in October 2016, the Agency has published almost 3,300 documents and more than 1,300,000 pages of documents, according to the EMA Update on Clinical Data Publication activities.

As we noted in an earlier post, the Brexit referendum in the UK and the subsequent relocation of the EMA to Amsterdam led to the Agency adopting a business continuity plan that ensures the operational continuity of the EMA activities in light of these challenges. As part of this plan, the Agency temporarily suspended Policy 0070. Currently, any clinical data submitted to the EMA by pharmaceutical companies after the end of July 2018 is not processed by the Agency for publishing. Moreover, pharmaceutical companies are no longer invited by the EMA to submit clinical data for publication until the suspension is lifted.

This suspension is still in place, and it is unclear when the EMA will resume these activities. We anticipate this will depend on the availability of EMA resources and the outcome of the ongoing internal reorganisation of the EMA. The Agency’s dedicated website provides updates on this topic.

Access to Documents

The first and second phases of the EMA business continuity plan classify the access to documents activities of the Agency as one of its highest priority activities. These activities were not, therefore, suspended as a result of Brexit and the EMA’s relocation to the Netherlands.

However, the handling of requests for access to documents requires substantial Agency resources. As highlighted in the EMA’s Annual Report for 2018, the Agency receives more than 800 requests for access to documents each year and releases well over 400,000 pages of documents per year. One direct consequence of the high number of requests and the related resource burden is the Agency’s decision to no longer process requests from individuals or entities based outside the European Union. As noted in an earlier blog post, this restriction, as reflected in the Section “Who can request access to documents” on the dedicated EMA website, was introduced last year. It could be speculated that this restriction may also be partially and indirectly related to Brexit and the EMA’s relocation. There are no indications from the EMA that this restriction will be removed in the near future.

In addition, we are aware that there are substantial delays in receiving responses from the EMA to request for access to documents. The EMA has stated that as of October 2019, access to documents requests “cannot be processed immediately and will be dealt with in chronological order from the time they are received”, which is said to be due to “operational constraints of the fourth phase of EMA’s business continuity plan to ensure operational continuity during its relocation to Amsterdam”.

The Challenges Beyond Brexit

The access to documents activities of the EMA and the interpretation of the EMA’s Policy 0043 has resulted in a number of legal challenges by pharmaceutical companies against the Agency’s decisions to release documents. The judgments of the General Court in some of these cases, which firmly sided with the EMA, led to appeals by the companies to the Court of Justice.

Last month, Advocate General Hogan delivered his Opinions to the Court of Justice in two of these appeals. In these cases, the General Court had dismissed the actions for annulment of the EMA’s decisions to release the company documents. However, the Opinions of the Advocate General raise substantial questions concerning the General Court’s wholehearted endorsement of the EMA’s position. In particular, the General Court’s rejection of the existence of a presumption of confidentiality of documents held by the EMA, and the EMA’s interpretation of the definition of “commercially confidential information” have been called into question.

The judgments of the Court of Justice in these cases are expected in the first half of 2020. If the Court of Justice follows the Opinions of Advocate General Hogan, this is likely to impact the current approach of the EMA and its policy on access to documents, including the definition of commercially confidential information used by the Agency to determine what information should be protected from disclosure.

In addition, the EMA has confirmed on a number of occasions that the Agency applies the same definition of and approach to commercially confidential information in its reactive access to documents activities as in the proactive publication of clinical data. The judgments of the Court of Justice may, therefore, also have an impact on the EMA’s activities for the proactive publication of clinical data, once these activities are resumed.