After the expenses for development and operation of the database system of the pharmaceutical industry incurred since 2010 were fully borne by the trade associations BAH, BPI and vfa so far, a successive integration of marketing authorization holder in the financing started since the year 2014.
However, apart from their own services, the trade associations will continue in 2016 to shoulder about 75% of the expenses for the further development and provision of the system. No later than 2019, the year in which the verification obligation will probably become effective, the system will have to finance itself from user fees.
The role of the manufacturers’ associations as managing partners of ACS PharmaProtect GmbH ensures that an efficient system in terms of the cost-benefit ratio is provided. In order to protect the interests of all manufacturer categories,the ACS fee model is based on the following three components:
Component A / Initial set-up fee
This fee component is due once when establishing the user in the MAH system. The fee will increase in stepwise fashion by 2018, which means that joining early will provide companies with financial advantages.
Component B / Operating fee
The monthly operating fee is due for system provision and basic support. The operating fee was degressively scaled, which means that the operating flat fee had decreased with an increasing number of users, which were newly contracted and has reached with the 100th participant its final amount.
Component C / Fee per data set (pack volume)
This variable fee is due for each data set (pack volume) that is provided via the MAH system. This component is also degressively scaled, i.e. with an increasing number of packs provided by a pharmaceutical company the costs will decrease. The last uploaded data set in a year determines the price for all data sets entered during that year. The basis are all data sets of the company in question.
Usage costs – Case studies
The case studies below show the costs for four different companies in the year 2016 depending on the number of packs provided into the database system of the pharmaceutical industry by the marketing authorization holder in question.
The above information represents general information about the fee model of ACS PharmaProtect GmbH; it is no substitute for a specific quotation. Only the user agreement in its current version will be binding. Please contact us anytime for additional information or a specific model calculation for your company.