Since October 2013, EU legislators have been seeking to overhaul the way in which they collect user fees from pharmaceutical manufacturers in support of a newly strengthened pharmaceutical adverse event monitoring system.
Those systems, also known as pharmacovigilance systems, keep track of medications in postmarket settings, allowing regulators to keep track of issues in real-world use settings.
But pharmacovigilance systems aren't free. They're paid for by a mix of taxpayer money, used to fund regulators directly, and user fees paid for by pharmaceutical companies with marketed products.
As Focus wrote in 2013, the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) had proposed to increase the number of activities on which a user fee can be demanded by regulators, including several activities called for under the 2012 pharmacovigilance legislation.
For example, legislators said that the size of a drug unit should not be taken into account, as a pack that contains 20 tablets is no more a burden than one with 10 tablets. Elsewhere, legislators proposed that user fees cover generic medicinal products, which would no longer be eligible for a reduced yearly fee.
Still other parts of the proposed system called for a weighted fee contingent upon the complexity of the pharmacovigilance procedures involved.
Council, Parliament Agree to Reforms
On Wednesday, 19 February 2014, EU legislators confirmed that they had come to an agreement on the funding mechanism for what they called "reinforced pharmacovigilance."
In a statement, the Council of the European Union's Permanent Representatives Committee said it had approved a compromise with the European Parliament on the draft regulation which will adjust the user fees paid to the European Medicines Agency (EMA) and allow EMA to remunerate national competent authorities for their work in support of pharmacovigilance monitoring.
Under the new system, manufacturers can be charged both an annual flat-rate fee of EUR 67 per "pharmaceutical form," such as a tablet, and separate fees dependent on which pharmacovigilance assessment procedure is required.
Explained the Council: "The amount of the fees varies for each procedure: the assessment of periodic safety update reports (fee of EUR 19,500 per procedure, out of which EUR 13,100 for national competent authorities), the assessment of post-authorisation safety studies (EUR 43,000, out of which EUR 18,200 for national competent authorities) and assessments in the context of referrals initiated as a result of pharmacovigilance data (standard fee of EUR 179,000, which can reach up to EUR 295,000 in exceptional cases involving five and more active substances)."
Some fees may be shared between competent authorities and marketing authorization holders in cases where multiple entities are involved.
Small and medium-sized (SME) business entities will be assessed a user fee at a 40% reduced rate.
The draft regulation still needs to be formally approved by the European Parliament at plenary and by the Council, the statement said.
The statement made no word of whether generic pharmaceutical products would be included in the new user fee agreement.
European Council Statement