Lygiagrečiai importuojamų vaistinių preparatų kainodaros reguliavimo problemos Lietuvoje
Klaipėdos universiteto leidykla |
| Date Issued |
|---|
2011 |
Straipsnyje, taikant teisės aktų sisteminės analizės metodą, nagri-nėjamas vaistinių preparatų kainodaros reguliavimas Lietuvoje ir siekiama įvertinti, ar esanti kainodara išnaudoja visas galimy-bes lygiagretaus vaistinių prepara-tų importo dėka mažinti kompen-suojamų vaistinių preparatų kainas. Atlikus sisteminę analizę, daroma išvada, kad valstybės pasirink-tos kainodaros dėka lygiagrečiai importuojamo vaisti-nio prepara-to buvimas rinkoje tiesiogiai neįtakoja rinkodaros teisės turėtojo rinkai teikiamo vaistinio preparato kainos, o atskiros kainodarą re-guliuojančios normos sukuria teorines prielaidas konkurencijos rinkoje mažinimui.
The parallel import of medicinal products involves importing the medicinal product into one EU Member State from another one and then distributing it outside the distribution network set up by the manufacturer or market authorization holder. The parallel import as such is driven by price differentials in both the parallel export country (low-priced market) and the parallel import country (high-priced market). On the other hand, the parallel import is a mean creating a price competition for the medici-nal products that are being put on the market by a marketing authorization holder. This sort of competition is significant from the perspective of pub-lic health as it increases economic accessibility of medicinal products. The article uses systematic analysis of national legal documents and aims to evaluate whether the regulation of medicinal products pricing in Lithuania takes an advantage of opportunities to reduce prices of reimbursable medicines when the parallel import of medicinal product is available. The article discusses legitimacy of national regulation of parallel imported medicinal products pricing, the problem of reference pricing system and requirements for parallel imported products pricing. In conclusion the article states, that price of parallel imported medicinal products has no direct effect on the pricing of medicinal products placed on the market by the marketing authorization holder. Some legal norms in national legal system even crate prerequisites for anticompetitive behavior of the marketing authorization holder in the market. Therefore, further legal evaluation is needed.