Clinical Trials of Medicinal Products: An Insurance Issue

On January 26th of this year, The Ministry of Health published the draft Law of Ukraine "On Amendments to Some Legislative Acts of Ukraine Concerning Clinical Trials of Medicinal Products" ( hereinafter - the law )

The aforementioned draft law provides for amendments in Ukraine's special law " On Medicinal Products'':

• Firstly , in terms of supplementing the conceptual apparatus of the term "subject studies (patient , healthy volunteer ) " , which the legislator defines as a person who participates in a clinical trial or receives experimental medication , or is included in the control group;

• Secondly , with regard to the introduction of mandatory liability of the sponsor in the event of harm to life and health of the study subjects ( patients , healthy volunteers ) . According to the proposed changes , the relevant contract may be concluded not only by the sponsor of the clinical trial , but also by their authorized representative.

Therefore amendments are provided to the Law of Ukraine "On Insurance" , namely by defining sponsor liability insurance a mandatory type of insurance .

In addition , in the case of the adoption of the draft law for the implementation of the sponsor liability insurance ,an obligation shall be bestowed on the Cabinet of Ministers with a document to develop and approve the rules of procedure and sponsor liability insurance within three months from the date of entry into force of the law .

It is to be noted that to date, the current version of the Law of Ukraine " On Medicinal Products" establishes the obligation of the customer who commissioned the clinical trials to conclude an insurance contract precisely concerning the health and life of the patient ( the volunteer ) . If the draft law is adopted the former insurance will be replaced by the latter.