OBJECTIVES: Consultative Council (CC) is an independent body playing a central role in decision making of Polish Heath Technology Assessment Agency (AHTAPol). We were interested in how much safety issues of the appraised technologies concern members of CC and what is the influence of safety issues on CC`s decisions. METHODS: We analyzed decisions of CC published until the end of 2009 and distinguish those where safety issues were significant arguments for decline. We indentify the type of key documents quotabled in the decisions in order confront them with documents included in manufacturer’s HTA reports. RESULTS: Among 148 CC`s decisions analyzed, 70 were negative and in 22 safety issues were significant arguments against the positive recommendation (31% of all negative decisions). Apart of the manufacturer’s HTA reports, CC based mainly on EMEA or national Summary Of Product Characteristics (91%), FDA reports and Cochrane reviews (23% each), RCT not included in the submission (17%) and non-systematic reviews (13%). Manufacturer’s HTA reports on safety included mainly III phase RCTs (77%), II phase RCTs (36%), observational studies (27%), systematic (non-Cochrane) or non-systematic reviews (9%). Seldom, if ever, submitted reports mentioned FDA or EMEA reports and patient registries (5%). CONCLUSIONS: Safety issues were important argument in negative opinions of CC. Unlike efficacy, safety analysis comprise evidence other than III phase RCTs. Manufacturer’s HTA reports did not cover many documents significant to CC regarding safety. A wider safety analysis according to the ATHAPol`s guidelines 2009 would be required.