Everyone agrees that pharmacovigilance is a good thing. However, it seems that opinions differ on how much it should cost. Last week, the EU agreed a draft plan to charge fees to cover its pharmacovigilance activities but it has come under fire from industry groups. It also announced an initiative for greater global drug safety co-operation.
Under the EU’s pharmacovigilance funding plan there is a different charge for different procedures – PSURs (Periodic Safety Update Reports) would cost the marketing authorisation holder €19,500, post-authorisation studies would cost €43,000 and assessments triggered by routine monitoring , €17,900. This is intended to cover the full cost of EU-level drug safety assessments. There is also a charge of €67 per dosage form that is intended to cover the cost of EMA data management, including its EudraVigilance database.
Several pharma industry groups have issued a joint statement to express concern about level of these fees, citing “the increasing financial burden of regulatory costs incurred since the adoption of the pharmacovigilance package in 2010.″
The EFPIA, EGA, EuropaBio, AESGP and EUCOPE argue that fees for EU pharmacovigilance services have significantly increased in the last five years without open and transparent calculations being given to support the hike. They go on to state that, as these activities are “part of the general mission of the EMA and of the National Competent Authorities to ensure public health,” the cost should be partly covered by community funding.
In the same week, the EMA announced it will be working more closely with the FDA – including a monthly teleconference to share information on medicine safety. “Clusters” like this are set up whenever the EMA identifies a topic that requires more intense exchange of information and collaboration.
Clusters already exist for the EMA and FDA (plus some other national agencies) to discuss issues including biosimilars, cancer treatments, orphan drugs, paediatric medicines, and blood-based products.
“In an increasingly globalised pharmaceutical market, collaboration between medicines’ regulators is essential,” according to EMA Executive Director, Guido Rasi. “Any action taken in one territory has repercussions on the rest of the world.”
Of course an integrated approach to drug safety is essential to avoid the worse mistakes of the past and this doesn’t come cheap. But given the already heavy burden shouldered by industry are these proposed EU fees fair?
I’d love to know what you think.
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