Proposed EMA pharmacovigilance fees are too high and place a disproportionate burden on generics firms according to the European Generic Medicines Association (EGA).
The EGA made the comments in response to the European Commission’s (EC) suggestion that it may make drug manufacturers pay a fee for adverse event monitoring carried out by the European Medicines Agency (EMA), which was detailed in a concept paper published in June .
The EC argument is that EMA pharmacovigilance activities - which are publically funded at present - will increase significantly under new legislation introduced in July and that the drug industry should foot the bill for the additional work.
Under the plan drug firms would pay up to €80,300 for the assessment of periodic safety reports (PSUR) and post-authorisation safety studies (PASS), between €80,300 and €267,400 for the assessment of pharmacovigilance referrals and a service fee of €1,000 per product, per year.
The EGA has a number of concerns according to medical affairs manager Maarten Van Baelen who told in-Pharmatechnologist.com the plans could mean generics firms have to pay huge fees each year.
“It is important to notice that the generic medicines industry is different from the originator industry as the companies have much bigger portfolios. For a big generic company, this can go up to 2000 active substances.”
One of the major worries voiced by the EGA relates to the idea of grouping marketing authorisation holders (MAH) for PSUR assessments.
Under the proposals, assessment requests submitted by several firms authorised to sell the same drug in different European Union (EU) member states would be combined into a single report for which a single fee would be split between group members, plus an additional €500 per request.
In its official response the EGA argues that: “Grouping between companies from a different entity is too idealistic. In reality it is not feasible to apply this to MAHs from different groups of companies, since individual PSURs should be submitted for other regions at the same time and companies will also need their own PSUR to submit in other regions.
“In addition commercially sensitive information, such as sales data, approval and marketing status at country level will not be easily exchanged.”
The level of annual fees that generic companies could face under the proposals is also concern according to van Baelen, who estimates that if MAHs belonging to the same firm are considered as separate, an average-sized generic medicines company may have to pay €20m a year.
“I considered an average generic company with 1000 active substances, which can be divided in an average of 20 MAH per active substance multiplying by a maximum fee of €1000. This is of course only for the annual fee calculation; additional costs are coming from PSURs, PASSes and referrals.”
He added that: “If the EC do not take this into account, the generic industry will be paying the biggest part because of the large portfolios of active substances with a well-known safety profile. Therefore we request proportionality and transparency.”