[co-author: Eftychia Sideri]

The European Medicines Agency (“EMA”) has replied to a letter from the European Ombudsman opening a strategic inquiry into EMA’s pre-submission activities.

Background information

On 17 July 2017, Emily O’Reilly, the European Ombudsman, decided to conduct a strategic inquiry concerning EMA’s arrangements with individual medicinal products developers prior to the submission by these developers of an application for marketing authorisation. The European Ombudsman concluded that, in the eyes of the public, interactions between the EMA and medicinal product developers could create, at least, some perception of bias.

On 31 August 2017, EMA’s Executive Director Guido Rasi replied by letter to the Ombudsman’s strategic inquiry.

EMA’s Opinion

EMA’s Executive Director welcomed the opportunity to further clarify and foster public trust in pre-submission activities which have contributed positively to public health by helping introducing to the market new, safe and effective medicines. The Director stressed that the risk of bias can be managed by having the necessary safeguards in place. EMA manages this risk by adopting strong policies in relation to conflicts of interest, an independent process for evaluation of medicinal products, and a high level of transparency for EMA’s operations.

EMA’s Executive Director also mentioned in his letter that pre-submission interactions with medicinal product developers could provide the following benefits:

• Access to new, safe and effective medicinal products;
• Helping EMA to identify the risks and benefits of the new medicinal products sooner;
• Helping developers understand regulatory requirements;
• Providing a platform to include other parties involved in the approval process.

EMA’s Legal Obligation

EMA’s Executive Director highlighted that pre-submission activities are required and conducted in accordance with EMA’s Founding Regulation No 726/2004. Consequently, interaction with medicinal product developers before an application for marketing authorisation is submitted is a legal obligation that EMA must fulfil.

Pre-submission interactions are intended to optimise the related development plan, provide methodological direction and discourage the production of irrelevant or substandard data. In addition, the parties that will be involved later in the evaluation process can develop an overview of the product and thus, assess it more efficiently by minimising unnecessary administrative burdens.

EMA’s Executive Director pointed to the fact that EMA has robust and rigorous assessment processes in place separating the advice procedure from the final decision concerning an application for marketing authorisation. Scientific recommendations are issued by EMA Committees on the basis of extensive peer-review and discussions amongst approximately 30 members supported also by independent experts.

EMA’s Executive Director further observed that the strategic inquiry is extremely broad-ranging. This is because pre-submission activities touch upon all major EMA operational processes. The preparation of detailed statistical overviews will be a challenging exercise, in particular, while EMA is preparing its relocation to another EU Member State after the exit of UK from the EU.

EMA’s Executive Director agreed to meet at the end of September 2017 with the European Ombudsman to further discuss and define a reasonable timeline for the submission of the information required from the strategic inquiry.