LONDON (Reuters) – The European Medicines Agency (EMA), eager to accelerate access to promising new drugs, may be getting too cosy with the pharmaceutical companies it regulates.
That is the concern of the watchdog charged with overseeing administrative irregularities in the European Union, which is launching a strategic inquiry to see if early-stage interactions with firms could influence agency approval decisions.
The probe by the European Ombudsman will focus on meetings and discussions between drugmakers and agency officials before a new medicine is formally submitted for regulatory approval.
Such “pre-submission activities” have grown in importance in recent years as the EMA has sought to fast-track important new treatments through special arrangements designed to streamline the approval process.
There is an inevitable tension between such actions, which help companies prepare submissions, and the need for rigorous and impartial regulatory oversight.
“In so far as these activities help the development and availability of high-quality, effective and acceptably safe medicines, they benefit patients and serve the public interest,” O’Reilly said in a letter to the EMA.
“Nonetheless, such activities may pose some risks, such as that the eventual decisions by EMA on the authorization of medicines may be influenced by what has been discussed during the meetings with medicine developers prior to receiving their marketing authorization application.”
O’Reilly’s letter to EMA Executive Director Guido Rasi, dated July 17, was released to the media on Wednesday.
Her investigation comes at a time when the EMA, which acts as a one-stop-shop for regulating medicines across the EU, is already in the spotlight as a result of Brexit.
The agency and its staff of around 900 will have to relocate from their current home in London to a new city within the EU as a result of Britain’s decision to leave the bloc. A decision on the new location is due in October.
In her letter, O’Reilly asked the EMA to provide details as to how its pre-submission processes were managed. She also wants a statistical overview of such activities between 2012 and 2016, together with a list of the 10 drugmakers the EMA met with most frequently during the period.
At a time when genetic breakthroughs are shedding new light on the nature of many diseases, the EMA has been keen to promote the early use of novel drugs offering more targeted interventions than conventional remedies.
That chimes with demands from pharmaceutical companies, patient advocacy groups and lawmakers around the world for regulators to cut through what some see as red tape and adopt more streamlined drug approval processes.
Some in Europe, however, fear that moves to accelerate marketing authorizations, including by promoting “adaptive pathways” for clinical trials and designating some products as priority medicines, will increase risks. Critics include Germany’s IQWiG, which plays a key role in determining the cost-effectiveness of drugs.
Reporting by Ben Hirschler; editing by Susan Thomas