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.


Continue Reading Latest Developments in the Transparency Activities of the European Medicines Agency

Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12 months of the completion of the trial (not after grant of the marketing authorisation), including a summary of the results and conclusions.

The retrospective cohort study found that despite the Commission guidance, of the 7,274 trials where results were due, only 49.5% reported results, although trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% compared to 11.0%).


Continue Reading Update on Clinical Trials Transparency in the EU

In a report published on 16 July regarding the implementation of its flagship policy on the publication of clinical data (Policy 0070), the EMA has announced that Brexit and the Agency’s relocation will result in some areas of work being “temporarily reprioritised, suspended or postponed to resource Brexit preparedness activities and safeguard

On 27 June 2018, the EMA published a short notification on its website informing readers that “The Agency is no longer in a position to process access to documents requests issued from outside the EU.

Article 2(2) of Regulation (EC) No 1049/2001, setting out the EU legislative framework for freedom of information (the Public Access Regulation), provides EU institutions with the discretion to disclose to individuals from third countries documents they have drawn-up or received, provided the conditions of such access are no less restrictive than that provided to EU citizens under Article 2(1) of the same regulation. This change in policy means that only “Citizens of the EU and natural or legal persons residing or having their registered office in an EU Member State have the right of access to EMA documents.
Continue Reading Update to the EMA’s Position on Access to Documents

The European Ombudsman, who investigates complaints of maladministration in the institutions and bodies of the European Union, recently handed down its decision in a case against the European Medicines Agency (EMA). The complaint concerned the EMA’s refusal to disclose the identity of parties who request access to documents held by the EMA. In the past, the EMA had stated that the “identity and/or the name of the organisation of the requestor will be used for the sole purpose of processing the request and will not be disclosed to third parties”. Instead, third parties, including the owner of the document requested, would only be told the request came from a “pharmaceutical company” or “law firm”. Last week, the Ombudsmen confirmed that the EMA has changed its policy in light of its recommendations.

Continue Reading EMA’s revised approach to disclosure of the parties who request access to documents

Legal clarity on the meaning of ‘commercially confidential information’ within sight

Demand for greater transparency and disclosure of pre-clinical and clinical data by industry continues to attract significant debate. Recent academic studies, published in Current Medical Research and Opinion and the British Medical Journal, have systematically assessed the disclosure policies of trial data arising from studies sponsored by pharmaceutical companies. In the EU, the European Medicines Agency (EMA) has adopted policies and guidance setting out its approach to data disclosure. Certain aspects of the adopted policies are currently being considered by European Courts, to address the nature of the balance to be struck between the public interest in transparency and the interest (both public and private) in protecting innovative research from unfair commercial use. In a broader context, the prevailing legal framework is based on a need for coherence and equilibrium between the general regulation governing public access or freedom of information and the sector-specific legislation regarding authorisation and supervision of medicines. In this blog post, we provide a summary of these cases, as heard in the European Courts to date.


Continue Reading Update on transparency of clinical data