Following the release of new regulations issued last week, user fees for pharmaceutical companies are set to rise in Europe. These fees are “intended to fund regulatory activities by offsetting their expense” as well as streamline the collection and evaluation of adverse drug reaction (ADR) information, according to new regulation released this week. The expanded fees will pay for updated monitoring activities for medicines after their initial approval, as required under the original legislation.
The original law, known as the pharmacovigilance legislation, was passed in 2010 and amended in 2012. The law was adopted to help prevent ADRs, which cause an estimated 197 thousand deaths per year in the EU.
The European Medicines Agency (EMA) said the importance of drug safety justified the collection of additional resources and would help them provide further "service to the industry.”
Impact on the pharmaceutical industry
The EMA maintains that pharma companies authorized to market drugs will benefit from the new law because it provides more clear roles and responsibilities, decreased duplicated efforts, more resources for ADR reporting, and a clear legal framework for post-authorization monitoring.
Under the new law, sponsors will be charged for:
Post-authorization safety studies (€43,000)
Evaluations conducted under safety referrals (€179,000 standard)
Periodic safety update reports (€19,500 each)
Literature monitoring (€67)
The legislation was also established to provide several benefits to EU patients and to inform them about the benefit-risk aspects of taking medicine. Through the creation of new websites with information on medicine, patients are able to report perceived problems with a medicine online, as well as grow more accustomed to relevant safety issues. The legislation also aimed to increase public confidence in the safety-monitoring system and the positive-risk benefit of medicines.
The EMA also plans to collect annual fees beginning in 2015 for nationally authorized medicines. Centrally authorized medicines are already subject to an annual fee. Generic pharmaceutical companies will have to pay reduced user fees. "However, in cases where those medicinal products are part of any of the pharmacovigilance procedures carried out at Union level, the full fee should be charged in view of the work involved," the regulation states.
This move follows shortly after the US FDA published a new guideline establishing user fees in for pharmaceutical compounders.