European Ombudsman questions the EMA’s plans to reinstate its policy on the proactive publication of clinical data

As reported previously (here), after a part suspension, the European Medicines Agency (EMA) has recently announced that it will fully reinstate Policy 0070 (the Policy) pursuant to which the EMA proactively publishes clinical data contained in marketing authorisation (MA) applications.

When the Policy is reinstated in September 2023, the first phase will involve the publication of clinical reports which are submitted alongside initial MA applications for medicinal products which contain a new active substance (NAS) and for which the Committee for Medicinal Products for Human Use has issued an opinion.

On 23 June 2023, the European Ombudsman launched a strategic initiative to examine the EMA’s plans for the reinstatement of the Policy. In parallel with its inherent power to investigate maladministration in the EU institutions, the European Ombudsman has the power to proactively work on broader strategic issues on her own initiative. Strategic initiatives aim to draw attention to matters of public interest and investigate wider systemic issues affecting EU institutions and their decision-making processes. The Policy represents a paradigm shift in the transparency of clinical data in the EU. Its reinstatement is therefore in the public interest meaning that it falls within the remit of the European Ombudsman.

The Ombudsman’s strategic initiative

As a general matter, strategic initiatives are launched by the European Ombudsman to request clarification from European institutions to ensure that their operational or policy practices (a) comply with the guiding principles for good administration behaviour, including those relating to transparency and accountability and (b) are compatible with the broader EU legislative framework to protect the fundamental rights of an individual or a legal person. Consistent with the normal practices, following completion of an initiative, which takes four months on average to complete, the European Ombudsman will publish a set of recommendations to guide good practices.

In this case, whilst the European Ombudsman is generally supportive of the EMA’s plans, she has requested further information from the Executive Director of the EMA. In particular, she has requested information on:

• The EMA’s action plan to clear the backlog of procedures concerning clinical trial data for medicinal products that were completed when the Policy was part suspended between 2018 and 2023;
• The possible prioritisation plan for proactive publication of clinical data according to therapeutic areas;
• Whether the relevant external stakeholders, e.g. the pharmaceutical industry, were consulted in the development of the current plan; and
• The proposed plan for expanding the scope of the Policy beyond initial MA applications for medicinal products containing NASs.

The information provided by the EMA to the European Ombudsman could inform a view on whether there is a need to improve or optimise the process for the Policy to be relaunched. The European Ombudsman has given the EMA until the end of September 2023 to reply and has indicated that she may invite EMA representatives to a meeting in order to discuss the responses.