REKS 2nd QUARTER 2020 NEWSLETTER
The transition period in Estonia ends on September 1st, 2020. Regarding this, a test period takes place between 22.06 – 12.07, in which both work processes and communication between parties related to the medicines verification and alerts are tested. The State Agency of Medicines has also changed the guidelines on how to behave in a case of suspected counterfeit medicinal product.
All end users can participate in testing. More information is available on REKS’ website (Testperioodi juhis 2020).
Based on the first week results, there have been 457 alerts (based on EtMVS statistics), out of which, 93 alerts have been notified by end-users by email or via the REKS web form.
REKS has developed alert management software REK-IS, which allows the parties connected to it or in case of alerts transmitted via the web form to receive an immediate feedback to the end users 24/7, whether it is a known exemption that can be issued or a specific case that has been take into manual procedure.
In June training, primarily aimed at end users, was held in the form of a webinar which dealt with the issues related to the completion of the transition period, incl. test period, REKS alert management software and the changes in the guidelines of the State Agency of Medicines. The webinar can also be viewed on the REKS website (REKS veebipõhine infotund 16. juuni 2020).
At the end of August, a second training will take place, where a summer of the test period will be given, and the changes caused by the end of transition period in September will be talked over again. The training is also in the form of a webinar.
In June, Board of REKS approved a new financial model, according to which the annual fees for MAH’s will decrease from 2021. The new annual fee rates will be published on REKS webpage no later than in January. As an important change, the payment will no longer be made in the form of advances for the following year, as was necessary when the system was launched, but for the current year. Thus, REKS will issue invoices for 2021 in the second quarter of 2021. In 2020, no invoices will be issued to MAH’s.
In connection with this change, it is also necessary to renew all contracts with MAH’s in order to reduce the level of some annual fees below the minimum currently set in the contract (for exemptions). REKS will contact all MAH’s during the second half of the year.
In the second quarter, activities related to pharmacy reform were completed. A total of 65 new contracts were concluded.
In June, Arvato completed a new version 1.04.009 of software related to reports, which is currently installed in a test environment.
The ratio of alerts to scans have been mostly stable and the absolute number has been stable in the second quarter. In the period from May 25th to June 21st, the total number of alerts was 2903, which, mathematically evenly distributed means 725 alerts per week.
Figure 1. Alerts during the period of May 25th to June 21st 2020
REKS 2019 Yearbook has been completed, which is available HERE.
REKS thanks all its partners for successful and pleasant cooperation and wishes a beautiful summer! See you at the August training!