EMA Argues Pre-Submission Activities Under Ombudsman's Radar Are A Legal Requirement
Executive Summary
The European Medicines Agency maintains it is fulfilling a legal obligation by organizing early interaction meetings with drug developers. The regulator is meeting with the EU Ombudsman, who is investigating whether such interactions can influence the agency’s decisions on marketing authorization applications.
The European Medicines Agency, which is undergoing an inquiry by the EU Ombudsman into whether it might be influenced during the pre-submission meetings it holds with drug developers, maintains that having these early interactions with companies is a legal obligation that the agency must fulfil to facilitate timely patient access to promising innovative medicines.
In an Aug 29 letter to Ombudsman Emily O'Reilly, EMA executive director Guido Rasi said that pre-submission activities touch upon "all major operational processes" of the agency, and that providing a detailed statistical overview of all these activities over the past five years "would be a challenging exercise" as it would potentially cover thousands of exchanges.
The EMA has offered to meet the Ombudsman on Sept. 28 in London to have an "initial exchange" on the matter. The Ombudsman’s inquiry was launched in July.
Specifically, the EMA is worried that the scope of the inquiry is too broad-ranging. The agency has been asked to prepare and submit to the Ombudsman's office, among other things, a detailed statistical overview of all its pre-submission activities between 2012 and 2016. (Also see "Ombudsman Probes Whether Industry Can Influence EMA In Pre-Submission Meetings" - Pink Sheet, 21 Jul, 2017.)
Rasi is hoping that the "initial exchange" with the Ombudsman will help the EMA to identify the precise scope of the inquiry and result in an agreement on a "reasonable timeline" for the agency to provide further information that would supplement the inquiry.
Regarding the questions the Ombudsman wants the EMA to address, Rasi said that some of these could be initially answered based on information already published on its website, while others would "require a careful analysis as to their scope and purpose."
The EMA is already under pressure as a result of Brexit. Rasi explained that over the next 18-24 months, the agency will be "extremely busy" relocating its offices from London to another EU city. 19 countries have put themselves forward as the ideal candidate for hosting the EMA when it moves out of London. The agency has also suspended some of its activities to free up staff to support the re-location. (Also see "EMA’s Future Home: Assessment Of Bids Nears Completion Amid Growing Staff Concerns" - Pink Sheet, 21 Sep, 2017.) (Also see "EMA Suspends Some Activities & Warns That High Job Losses Could Halt Its Operations" - Pink Sheet, 2 Aug, 2017.)
Rasi told the Ombudsman that the agency obviously needs to limit what it can undertake. He said the EMA had to plan its activities "with extreme care to ensure that the huge disruptions linked to Brexit, affecting both the Agency as a whole and our staff individually, do not have an adverse impact on public health."
Legal Obligation
The EMA is maintaining that its pre-submission-activities are required by law and are organized in accordance with the necessary legal framework. "They exist in strict fulfilment of the Agency’s primary public health priorities, namely to facilitate timely access by patients and healthcare professionals to promising innovative medicines whilst maintaining their quality and safety in use," it said.
Early dialogue can help optimize a medicine’s development plan, provide methodological direction and discourage the production of irrelevant or substandard data. The process is beneficial for both companies and the regulators, the agency said.
It increases the likelihood that a medicine will be developed "in a way that generates the evidence we need to properly evaluate its benefits and risks," Rasi said. It also allows EMA assessors/experts/scientific secretariat (who are to be involved in the evaluation) "to gain an overview of the product and its development so that their assessment can be performed more efficiently and minimise any unnecessary administrative delay."
The EMA's pre-submission activities include various early development advice services. These services relate to such things as providing scientific advice for human medicines. They also involve dealing with pediatric development issues, and applications for orphan designation, the priority medicines (PRIME) scheme and the qualification of novel methodologies. Interactions by the agency’s Innovation Task Force also fall under pre-submission activities, as does the work the EMA does to support micro-, small- and medium-sized enterprises (SMEs), and the work it does under its adaptive pathways approach.
Also, there are opportunities for early interaction with companies developing advanced therapy medicinal products (ATMPs) to support the classification of such products, and to issue ATMP certification to SMEs. In addition, the agency holds pre-submission meetings with companies prior to the submission of a marketing authorization application.
To remove the potential for bias during such interactions, Rasi said the agency has a robust and rigorous assessment processes in place, "which separate the advice function from the final decision." Commenting on the inquiry, the EMA chief said he welcomed any opportunity to further clarify and foster public trust in these important operations.
From the editors of Scrip Regulatory Affairs.