Advance information contract amendments - 2019 budget planning
The implementation of the EU Falsified Medicines Directive as of February 9, 2019 is getting closer.
We would like to provide you with advance information that amendments to the Contract for IT Services will be required prior to this effective date and that the fee model of ACS PharmaProtect GmbH (ACS) must also be adjusted for 2019.
The fee model for the pilot phase, which has been applied since 2014, was developed in 2013 at a time when the legal principles of Delegated Regulation (EU) 2016/161 of October 2015 for the Falsified Medicines Directive were not yet known and it was not yet possible to assess the integration of the national verification system into a European infrastructure as well as many requirements resulting from the Delegated Regulation. The organisational and contractual foundation also had to be created first. In this respect, it was not yet possible to represent relevant cost items in this fee model.
From January 1, 2019 onwards, the ACS fee model will be converted analogously to the pro-rata models in other European countries to the basic calculation based on package numbers and net ex-factory sales of prescription drugs based on the data of a market data provider. Rebates, discounts or other reductions remain unconsidered.
The annual figures of the previous calendar year will be relevant for calculating advance payments. Based on the real data of the current year, a recalculation is done during the following year.
A binding fee scale can only be presented once binding figures from the EMVO become available, which is expected in October 2018.
The complete letter with the complete argumentation and the changes in costs to come, you may find here.