Cla­ri­fi­ca­ti­on on the so-cal­­led sta­bi­li­sa­ti­on pha­se in Ger­ma­ny and Euro­pe

It is now five years sin­ce the intro­duc­tion of the Euro­pean Medi­ci­nes Veri­fi­ca­ti­on Sys­tem. The sta­bi­li­sa­ti­on pha­se, which ser­ved as a tran­si­tio­nal peri­od to make it easier for mar­ket par­ti­ci­pan­ts to adapt to the new sys­tem, has offi­ci­al­ly ended in many count­ries, inclu­ding Ger­ma­ny. This marks an important step in the deve­lo­p­ment of an effec­ti­ve pro­tec­tion mecha­nism against fal­si­fied medi­ci­nes.

What was the sta­bi­li­sa­ti­on pha­se?

At the begin­ning of the intro­duc­tion of the EMVS, a sta­bi­li­sa­ti­on pha­se was declared in many count­ries. This pha­se was inten­ded to give tho­se invol­ved in the sys­tem time to fami­lia­ri­se them­sel­ves with the new pro­ce­du­re and the cor­re­spon­ding pro­ces­ses. It was cru­cial that the sys­tem was ‘armed’ from the begin­ning. This means that packs with alarms could not sim­ply be dis­pen­sed - an aspect that must be par­ti­cu­lar­ly empha­sis­ed from the Ger­man per­spec­ti­ve.

The ear­ly initia­ti­ve of tho­se invol­ved in secur­Ph­arm, which was foun­ded back in 2012, is a decisi­ve fac­tor in the suc­cess of the sys­tem. In the initi­al pha­se, the­re were num­e­rous chal­lenges, par­ti­cu­lar­ly with regard to exis­ting packs that were alre­a­dy on the mar­ket befo­re the sys­tem was intro­du­ced. In order not to jeo­par­di­se mar­ket sup­p­ly, the sta­bi­li­sa­ti­on pha­se was declared at the time.

The­re were simi­lar agree­ments in other Euro­pean count­ries, which varied depen­ding on the natio­nal con­text. In Ger­ma­ny, howe­ver, the aim was to set the hig­hest stan­dards from the out­set in order to gua­ran­tee pati­ent safe­ty. For this reason, the so-cal­­led sta­bi­li­sa­ti­on pha­se in Ger­ma­ny only appli­ed to exis­ting pro­ducts, i.e. packs that were pla­ced on the mar­ket befo­re 9 Febru­ary 2019, as sti­pu­la­ted by Euro­pean law. The end of the sta­bi­li­sa­ti­on pha­se will not chan­ge any­thing for mar­ket par­ti­ci­pan­ts in Ger­ma­ny.

Posi­ti­ve con­clu­si­ons after five years

The Euro­pean Medi­ci­nes Veri­fi­ca­ti­on Sys­tem, espe­ci­al­ly the Ger­man com­po­nent secur­Ph­arm, can be con­side­red a suc­cess. The ope­ra­tors of the ACS and NGDA sub­sys­tems have con­nec­ted all affec­ted mar­ket par­ti­ci­pan­ts to the sys­tem in good time. The traf­fic figu­res con­firm full uti­li­sa­ti­on and the sys­tem is sta­ble, relia­ble and fast.

Signi­fi­cant pro­gress can be seen in the reduc­tion of fal­se alarms: the pro­por­ti­on of fal­se­ly trig­ge­red alarms is approa­ching the tar­get rate of 0.05% set at Euro­pean level. This suc­cess is the result of con­ti­nuous opti­mi­sa­ti­on, which enables a con­stant impro­ve­ment in sys­tem per­for­mance.

An important con­tri­bu­ti­on to pati­ent safe­ty

Every sys­tem call in Ger­ma­ny and other Euro­pean count­ries pro­vi­des valuable infor­ma­ti­on for the aut­ho­ri­ties to inves­ti­ga­te and fight fal­si­fied medi­ci­nes. This is evi­dent from the case of the semaglut­ide coun­ter­feit in 2023 and was also con­firm­ed in the EU Commission’s eva­lua­ti­on report on the Euro­pean anti-coun­­ter­­fei­t­ing sys­tem. The aut­hors of the stu­dy con­clude that the sys­tem in Euro­pe ful­fils its inten­ded pur­po­se and makes an important con­tri­bu­ti­on to pati­ent pro­tec­tion.

A brief look into the future

In 2025, the last EU mem­ber sta­tes, Ita­ly and Greece, will also join the sys­tem. This will not only fur­ther increase pati­ent safe­ty, but also streng­then the com­mon fight against fal­si­fied medi­ci­nes throug­hout Euro­pe.