20.500.12556/DKUM-57654 Vzporedna trgovina z zdravili v Sloveniji Pharmaceutical Parallel Trade in Slovenia Vzporedna trgovina se pojavi tam, kjer obstaja med različnimi trgi večja razlika v ceni za posamezen izdelek. Če razlika v ceni izdelka med dvema trgoma zadošča za to, da se ustvari dobiček po odštetju transakcijskih stroškov, in če ne obstajajo druge zakonske ali regulatorne ovire, se bo vzporedna trgovina pojavila. Vzporedni uvoz predstavlja blago, ki je zakonito dano na trg v eni državi, kasneje pa pride do uvoza v drugo državo brez dovoljenja imetnika pravice intelektualne lastnine (patenta, avtorske pravice ali blagovne znamke) na drugem trgu. V teoretičnem delu magistrske naloge smo predstavili proces vzporedne trgovine in dva uveljavljena ekonomska modela vzporedne trgovine. Gonilna sila vsake vzporedne trgovine je dejstvo, da lahko ima isti izdelek v različnih državah različne cene, kar velja tudi za zdravila. Glavni vzroki za obstoj različnih cen za ista zdravila znotraj držav Evropske unije so razlike v bogastvu med državami članicami, njihovem BDP, njihovih izdatkih za zdravstvo, različnih zdravstvenih sistemih ter zakonsko urejenostjo področja oblikovanja cen zdravil. Tradicionalno so bile države izvora za vzporedno trgovino z zdravili države z nižjimi cenami zdravil iz juga Evrope (Grčija, Španija, Portugalska), ciljne države pa tiste z visokimi cenami zdravil (Nemčija, Velika Britanija, Danska, Nizozemska, Irska, Švedska). Z vstopom novih držav članic v EU skupino v letu 2004 so tudi te postale potencialni izvor, tako da lahko rečemo, da sta področji izvora sedaj južna in vzhodna Evropa. Obseg vzporednega prometa z zdravili v EU je v letu 2014 znašal 5,8 milijard EUR. V raziskovalnem delu naloge smo skušali ugotoviti, kje se glede vzporedne trgovine z zdravili nahaja Slovenija. Od Javne agencije Republike Slovenije za zdravila in medicinske pripomočke smo pridobili podatke, da vzporedni uvoz zdravil v Slovenijo ne obstaja. Kaže, da so cene zdravil v Sloveniji tako nizke, da se vzporedni uvoz v Slovenijo trgovcem ne izplača. Od podjetja IMS smo pridobili podatke o obsegu vzporednega izvoza zdravil iz Slovenije v druge države članice EU. Čeprav se podatki o obsegu izvoza, ki jih zbirajo po dveh metodah, med seboj razlikujejo, je iz obeh razvidno, da vzporedni izvoz zdravil iz Slovenije poteka. V drugem delu raziskave smo poskušali s primerjavo uradnih cen zdravil med Slovenijo, Nemčijo in Avstrijo potrditi in dodatno podkrepiti ugotovitve iz prvega dela raziskave. Raziskali smo, kakšne so razlike v uradnih cenah zdravil pod patentno zaščito in pri zdravilih s pretečeno patentno zaščito med temi državami in ali so se te razlike med Slovenijo in Nemčijo med leti 2013 in 2015 povečale. Za ta namen smo izbrali reprezentativen nabor najbolje prodajanih (vrednostno) originalnih zdravil v Sloveniji v letu 2014. Uradne cene originatorskih zdravil v Sloveniji so nižje od uradnih cen originatorskih zdravil v Nemčiji in Avstriji. Čeprav so razlike med cenami pri zdravilih s pretečeno patentno zaščito večje kot pri zdravilih pod patentno zaščito, ne moremo trditi, da se bo vzporedna trgovina pogosteje vršila z zdravili s pretečeno patentno zaščito. Ta zdravila so namreč bistveno cenejša od zdravil pod patentno zaščito. Vzporedne trgovce zanimajo absolutne razlike, ki so večje pri dražjih zdravilih, ki so praviloma zaščitena s patentom. Razlike med uradnimi cenami zdravil v raziskovanem obdobju (v letih 2013, 2014 in 2015) se ohranjajo oziroma celo povečujejo. Slovenija je tako primerna država izvora za vzporedno distribuirana zdravila, njena največja pomanjkljivost na tem področju pa je majhnost njenega trga. Največja omejitev naše raziskave je, da smo med seboj primerjali uradne cene zdravil, ki pa ne odražajo nujno tudi dejanskih cen zdravil na trgu. Proizvajalci namreč pogosto dajejo popuste (zavarovalnicam, bolnišnicam), ki v uradnih bazah niso objavljeni. Parallel trade appears where there is a higher price difference between different markets for individual products. If the difference in price between two markets is sufficient to create a profit after deducting transaction costs, and if there are no other legal or regulatory barriers, parallel trade will emerge. Parallel imports represent goods legally placed in the market in one country, but subsequently imports into another country will take place without the permission of the holder of intellectual property rights (patents, copyrights or trademarks) in another market. The theoretical part of the thesis presents the process of parallel trade and the two established economic models of parallel trade. The driving force behind each instance of parallel trade is the fact that the same product has different prices in different countries, which applies also to drugs. The main reasons for the existence of different prices for the same drugs within European Union countries derive from the differences in wealth between Member States, their GDPs, their healthcare budgets, different healthcare systems and the legal regulation of their pricing of drugs. Traditionally, countries of origin for parallel trade in drugs have been countries with lower-priced drugs from southern Europe (Greece, Spain, Portugal), while target countries have been those with higher-priced drugs (Germany, Great Britain, Denmark, Netherlands, Ireland, Sweden). With the accession of new Member States in the EU in 2004, these new countries have also become a potential source. In 2014 the volume of parallel trade in drugs in the EU amounted to EUR 5.8 billion. The research part of the thesis includes an investigation into where Slovenia's place is in the parallel trade in drugs. The information obtained from the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices shows that in Slovenia there are no parallel imports of drugs. It appears that the prices of drugs in Slovenia are so low that parallel imports into Slovenia are not worth introducing. The company IMS provided us with data on the volume of parallel exports of drugs from Slovenia to other EU Member States. Although the sets of data on volume of exports, collected using two different methods, differ from each other, it is clear from both sets of data that parallel exports of drugs from Slovenia exist. The second part of the research focuses on confirming and additionally validating the findings of the first part by comparing the official prices of drugs among Slovenia, Germany and Austria. It includes an investigation into the differences in prices of on-patent drugs and off-patent drugs among those countries, and whether these differences are increasing between 2013 and 2015. For this purpose we provided a representative set of best-selling (in terms of value) original drugs in Slovenia in 2014. The official prices of branded drugs in Slovenia are lower than the official prices of branded drugs in Germany and in Austria. Although the differences between the prices of off-patent drugs are higher than the differences in prices of off-patent drugs, it is not possible to claim that parallel trade in off-patent drugs occurs more frequently. This is because off-patent drugs are significantly cheaper than on-patent drugs. Parallel traders are interested in the absolute differences, which are higher in more expensive drugs, which as a rule are patent-protected. The differences in prices of drugs between Slovenia and Germany during the reference period (2013, 2014 and 2015) were maintained or were even increasing. Slovenia is therefore an appropriate country of origin for parallelly distributed drugs, its biggest flaw being the smallness of its market. The most important limitation of the research is the fact that the comparisons covered the official prices of drugs, which do not necessarily reflect the actual prices of drugs on the market. vzporedna trgovina oblikovanje cen zdravil vzporedna trgovina z zdravili primerjava cen zdravil parallel trade pricing of drugs pharmaceutical parallel trade comparison of drug prices true true false [N. Bjelan] Slovenski jezik Angleški jezik Magistrsko delo 2016-03-06 23:53:24 2016-05-26 14:25:23 2022-06-14 03:07:02 2021-05-16 03:26:41 2016 0 Maribor 0 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 339.138 12290844 URN:SI:UM:DK:C0M9IIGP MAG_Bjelan_Nenad_2016.pdf MAG_Bjelan_Nenad_2016.pdf 1 E9C35D886DA1D25CA6CF9BFA535523C0 c0a001d5c8f22254825deae670d6974f91f91babe2c27eb17b6b160f4347c89b f3e88dca-7c0b-11eb-bb7a-00155d0001ca https://dk.um.si/Dokument.php?lang=slv&id=86926 Ekonomsko-poslovna fakulteta 0 0 0