Life Sciences: product regulation and liability in Romania, Lexology Navigator, May 2018

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

One recent legal development in the pharmaceutical field is the change of methodology for establishing prices for medicinal products which are totally or partially paid for by the social security system. However, already representatives from associations of medicine producers are pushing for this methodology to be revised, claiming that its overall impact on the market is negative and that lowering the prices of medicines to unsustainable levels will end up reducing the variety of medicines available.

Another foreseeable development is the adoption of a bill amending the Pharmacy Law (266/2008), introducing regulations on the online sales of medicinal products (266/2008). This bill would make possible the online sale of medicinal products in Romania, while also aligning the Romanian legislative framework with European regulations in this area.