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Regulatory Focus™ > News Articles > Public Health Advocates Worry EMA and Industry are Too Cozy

Public Health Advocates Worry EMA and Industry are Too Cozy

Posted 02 July 2015 | By Michael Mezher 

Public Health Advocates Worry EMA and Industry are Too Cozy

A coalition of health advocacy groups are worried that too much of the European Medicines Agency's (EMA) funding comes from private industry.


Much like the US Food and Drug Administration (FDA), EMA receives much of its funding from fees it collects from industry for various services, such as application fees, scientific advice and pharmacovigilance fees.

Generally, industry has been supportive of regulators charging fees for these services (although sometimes the specifics are contentious) as a means of ensuring timeliness on the part of regulators in conducting reviews.

EMA Independence

However, some see EMA's reliance on fees paid by industry as a threat to the regulator's independence and impartiality.

In response to these concerns, three health advocacy groups, Health Action International (HAI), Medicines in Europe Forum (MiEF) and the International Society of Drug Bulletins (ISDB), have sent in comments to the EU Medicines Agencies Network suggesting changes to be made at EMA.

The group estimates that in 2015, fees paid by industry will account for more than 83% of EMA's budget for the year. This proportion is significantly higher, the group claims, than at FDA, where marketing authorization fees account for roughly 60% of the agency's budget.

Speaking for HAI, Ancel·la Santos claimed that "Reliance on fee-for-service sets up a customer/provider relationship between the regulator and the regulated," and called on the agency to phase out the fees in favor of full EU funding. By sourcing the majority of its funding from the EU, the group claims EMA would be shielded from fluctuations in funding due to fewer marketing authorization applications being submitted.

Additionally, the group requests EMA reconsider offering scientific advice in exchange for fees, as it sees a potential for conflict of interest when a regulator gives the companies it regulates individual advice. Instead, the group proposes that EMA draft "ad hoc guidelines to help drug manufacturers make development decisions."


Press Release, Public Comment

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