Couple of weeks ago we discussed how non-negotiability can be tackled during site budget negotiation. This time we would like to talk about CTA wording, namely covering insurance in Eastern Europe, in particular Russia and Ukraine.

In both countries there is a legal requirement to arrange for insurance of the subjects’ life and health. If Sponsor doesn’t provide this kind of insurance, the study cannot even be submitted to the regulatory authorities for approval.

In addition to subjects’ life and health insurance many Sponsors want to ensure that site’s professional liability is also covered. This requirement is logic and understandable, however in reality sites refuse to arrange for this kind of insurance simply because it is not required by the legislation.

Sites professional liability insurance often becomes a burden for successful negotiation in Russia and Ukraine. Sponsors insist that it is a must-have for the sites, sites object saying they will not provide it since it is not required by the law.

What would be our advice in this situation? Practice shows that Sponsors will have to accept sites’ position. Very limited number of sites (if we speak about Russia) will agree for professional liability insurance, but only if this is provided and paid by the Sponsor.

Site’s logic is always quite simple, and their approach is firm: before 2010 liability insurance for clinical trials was required by the law in Russia, now this requirement is excluded from the legislation, i.e. the state ‘simplified’ the legal environment with regards to insurance focusing it only at subject’s life and health. Vast majority of sites support this state’s intention, especially public ones, and consider any additional insurance as not their responsibility.

Thus, Sponsors have two obvious options: 1. To limit insurance requirement to one required by the local legislation, 2. To provide site with the liability insurance at own account.

Please feel free to share your experience or ask questions in comments!

CTA Focus team