Ordinance
on Clinical Trials
with the exception of
Clinical Trials of Medical Devices¹
(Clinical Trials Ordinance, ClinO)

¹ Ex­empt from li­ab­il­ity in re­la­tion to clin­ic­al tri­als un­der Art­icle 19 para­graph 1 HRA shall be any per­son who proves that the dam­age is at­trib­ut­able to:

a.

the ad­min­is­tra­tion of an au­thor­ised medi­cin­al product used in ac­cord­ance with the pre­scrib­ing in­form­a­tion;

b.

the ad­min­is­tra­tion of an au­thor­ised medi­cin­al product, if this is re­cog­nised as stand­ard in guidelines pre­pared in ac­cord­ance with in­ter­na­tion­ally ac­cep­ted qual­ity cri­ter­ia;

c.²¹

the use of a product un­der Art­icle 2a para­graph 2 TPA that has been re­por­ted pur­su­ant to Art­icle 6 para­graph 3 MedDO²² in its ver­sion of 1 Janu­ary 2002²³ in ap­plic­a­tion of Art­icle 108 para­graph 1 let­ter b MedDO and used in ac­cord­ance with the in­struc­tions;

d.

the use of some oth­er health-re­lated in­ter­ven­tion which is re­cog­nised as stand­ard in guidelines pre­pared in ac­cord­ance with in­ter­na­tion­ally ac­cep­ted qual­ity cri­ter­ia.

² Also ex­empt from li­ab­il­ity un­der Art­icle 19 para­graph 1 HRA shall be any per­son who proves that the ex­tent of the dam­age is no great­er than would be ex­pec­ted in the cur­rent state of sci­entif­ic know­ledge and:

a.

com­par­able dam­age could also have oc­curred if the in­jured party had un­der­gone stand­ard ther­apy for the dis­ease; or

b.

in the case of acutely life-threat­en­ing dis­eases for which no stand­ard ther­apy ex­ists.