Counterfeit medications threaten the life and health of their users. Thus, their importance far exceeds the damage they, as pirated copies, cause the original producers. This comparative law project studies the various methods by which affected countries seek to protect the pharmaceutical sector from counterfeit products and how they counter offenses committed by increasingly internationally-operating offenders.

Phar­ma­ceut­ic­al safety is a vi­tal health policy con­cern. It is pro­moted by com­pre­hens­ive leg­al reg­u­la­tions that cov­er the pro­duc­tion and mar­ket­ing of med­ic­a­tion, but in the in­ter­na­tion­al sphere it is in­creas­ingly en­dangered by the pro­duc­tion and cir­cu­la­tion of coun­ter­feit products. The con­sequences of miss­ing, in­cor­rectly dosed, or tox­ic in­gredi­ents range from the fail­ure of so-called "life­style" drugs to pro­duce the de­sired ef­fect all the way to the death of un­sus­pect­ing pa­tients. The mar­ket­ing of coun­ter­feit products on the in­ter­net ex­acer­bates the prob­lem.

With­in the scope of this com­par­at­ive law pro­ject, the con­tri­bu­tion crim­in­al law can make to­wards coun­ter­ing phar­ma­ceut­ic­al coun­ter­feit­ing and the dif­fi­culties it is con­fron­ted with in this pro­cess was in­vest­ig­ated. The crim­in­al law in­stru­ments must be viewed as part of an over­arch­ing leg­al strategy that in­cludes di­verse ad­min­is­trat­ive reg­u­la­tions and meas­ures de­signed to pre­vent the pro­duc­tion and mar­ket­ing of coun­ter­feit med­ic­a­tions, de­tect the pres­ence of such med­ic­a­tions, and trace them back to their place of ori­gin. The fo­cus of this pro­ject, however, was on the func­tion of crim­in­al law.

The goal of the pro­ject was to ana­lyze the ex­ist­ing crim­in­al law in­stru­ments in se­lec­ted coun­tries that are af­fected in vari­ous ways by the phe­nomen­on of "phar­ma­ceut­ic­al coun­ter­feit­ing" with a view to­wards eval­u­at­ing their ef­fic­acy and, where ap­plic­able, to de­vel­op re­com­mend­a­tions for fur­ther de­vel­op­ment. The spec­trum of coun­tries in­cluded ranges from in­dus­tri­al na­tions, which are home to pro­du­cers of coun­ter­feit­ing-rel­ev­ant products, to those coun­tries whose dis­tri­bu­tion sys­tems are es­pe­cially sus­cept­ible to in­filt­ra­tion by coun­ter­feit products. Brazil, China, Egypt, France, Ger­many, Greece, In­dia, Ni­ger­ia, Paraguay, Rus­sia, Switzer­land, and the USA (with a fo­cus on Cali­for­nia and Flor­ida) were se­lec­ted. A primary aim was to de­term­ine wheth­er "weak spots" are loc­ated (more) in the area of le­gis­la­tion or (more) in the area of pro­sec­u­tion. Where avail­able, stat­ist­ics were also stud­ied. Cur­rent leg­al policy ef­forts on the in­ter­na­tion­al level (World Health Or­gan­iz­a­tion, G8 coun­tries) were mon­itored and re­ceived act­ive aca­dem­ic sup­port.

In a first step, re­ports based on a uni­form pro­ject design and con­tain­ing ana­lyses of the rel­ev­ant le­gis­la­tion, lit­er­at­ure, and case law (and – in some coun­tries – res­ults of sup­ple­ment­ary ex­pert sur­veys) were pre­pared by leg­al schol­ars from the re­spect­ive coun­tries. In a second step, these re­ports were the sub­ject of a com­par­at­ive leg­al eval­u­ation by the pro­ject lead­er.

The res­ults il­lus­trate the di­versity of modi op­erandi and mani­fest­a­tions and the vari­ous levels of crime sever­ity; they also show a con­sid­er­able vari­ance with re­spect to the con­trol mech­an­isms em­ployed in the rel­ev­ant crim­in­al of­fenses. Loop­holes in the sub­stant­ive crim­in­al law emerge be­cause of proof prob­lems that arise when coun­ter­feit­ing of­fenses re­quire caus­a­tion of (at least) palp­able dangers to life and/or health. Dis­tinc­tions made in crim­in­al of­fense defin­i­tions between coun­ter­feited med­ic­a­tions and poor-qual­ity genu­ine med­ic­a­tions as the "ob­ject of the act" have little if any im­pact on the leg­al con­sequences, at least in cases of in­ten­tion­al crime. Sanc­tions range from fines and in­car­cer­a­tion (with or without pro­ba­tion) to – at the ex­treme end of the scale – the death pen­alty. In some coun­tries, dam­age claims of a pen­al nature or fines with a com­pens­at­ory func­tion are pos­sible. The profits and ob­jects used in the com­mis­sion of the crime can be seized or con­fis­cated in al­most all coun­tries stud­ied. As far as its func­tion­al lim­its are con­cerned, crim­in­al law in this con­text is, as usu­al, de­pend­ent on gen­er­al cir­cum­stances, such as suf­fi­cient per­son­nel, tech­nic­al, and pro­ced­ur­al re­sources. Oth­er “in­ter­fer­ing factors,” however, such as cor­rup­tion, can also play a con­sid­er­able role.