Hap­py Bir­th­day, secur­Ph­arm e. V.

secur­Ph­arm e. V. cele­bra­tes its 10th anni­ver­sa­ry today. The Ger­man orga­niza­ti­on for authen­ti­ca­ti­on was foun­ded on 16 March 2012. Sin­ce then, the asso­cia­ti­on has been working with its mem­bers to pro­tect pre­scrip­ti­on medi­ci­nes against coun­ter­feit­ing and thus to pro­tect pati­ents. The association’s mis­si­on was to set up an IT-based anti-coun­ter­feit­ing sys­tem in accordance with the requi­re­ments of the 2011 EU Fal­si­fied Medi­ci­nes Direc­ti­ve. What is now - three years after the sys­tem was intro­du­ced - inte­gra­ted into the busi­ness pro­ces­ses of phar­maceu­ti­cal com­pa­nies and phar­maci­es in the legal sup­p­ly chain as a mat­ter of cour­se, was a novel­ty ten years ago and mark­ed the start of digi­tal anti-coun­ter­feit­ing pro­tec­tion. It was clear from the out­set that one of the lar­gest infra­struc­tu­re pro­jects in the phar­maceu­ti­cal sup­p­ly chain could only suc­ceed with the par­ti­ci­pa­ti­on of all indus­try play­ers. Thus the basic idea of secur­Ph­arm was born, name­ly to invol­ve all sup­p­ly stages in the asso­cia­ti­on and sys­tem deve­lo­p­ment. The sys­tem and the indus­try pro­ces­ses first had to be anti­ci­pa­ted, deve­lo­ped and set up tog­e­ther with all sup­p­ly stages so that the sys­tem could be desi­gned in a prac­ti­cal way and thus func­tion under real con­di­ti­ons. Among other things, pro­duc­tion lines had to be con­ver­ted, soft­ware pro­ducts deve­lo­ped and the ser­vers set up - all wit­hout inter­fe­ring with busi­ness ope­ra­ti­ons and pati­ent care. To this end, repre­sen­ta­ti­ves from all sup­p­ly stages, labe­l­ing spe­cia­lists and prac­ti­tio­ners came tog­e­ther under the umbrel­la of secur­Ph­arm. Their ide­as were tes­ted in a pilot pro­ject in 2013 and the fin­dings were trans­for­med into adjus­t­ments to the sys­tem. From the very begin­ning, the part­ners united in secur­Ph­arm were keen to inform mar­ket play­ers about the chan­ges they would face with seria­liza­ti­on. This included three major events with over 400 natio­nal and inter­na­tio­nal par­ti­ci­pan­ts. On Febru­ary 9, 2019, the time had final­ly come: the sys­tem went live on time. The tho­rough pre­pa­ra­ti­on paid off. Despi­te the need for some adjus­t­ments, the sys­tem was quick­ly trans­fer­red to sta­ble and relia­ble rou­ti­ne ope­ra­ti­on. secur­Ph­arm was the first natio­nal orga­niza­ti­on to coope­ra­te with EMVO, which was also new­ly foun­ded, and con­nec­ted its sys­tem to the EU hub in 2014. This pro­vi­ded both sides with important insights for the imple­men­ta­ti­on of legis­la­ti­on in the mar­ket. Today, 30 coun­try orga­niza­ti­ons are con­nec­ted to the EU-HUB. Greece and Ita­ly will be added in 2025. The pro­tec­tion of medi­ci­nes against coun­ter­feit­ing has gai­ned strength thanks to the inter­na­tio­nal con­nec­tion. In an eco­no­mic area with free move­ment of goods, the inter­na­tio­nal track­ing of data flows is also important for strong pro­tec­tion against coun­ter­feit­ing. On its 10th bir­th­day and 3 years after the sys­tem went live, secur­Ph­arm is a natu­ral part of the phar­maceu­ti­cal sup­p­ly chain and an ele­men­ta­ry com­po­nent of pati­ent pro­tec­tion.