This article concerns the legitimacy of contracts concluded between clinical trial investigators and sponsors (or sponsors’ designees), that seems to be an ongoing concern in Russia.

Federal Law #61-FZ ‘On Circulation of Medicines’ (April 2010) says a clinical trial is conducted based on the agreement executed between medical institution and the entity that holds the permit of the Ministry of Health (Sponsor or designee). One can read it as investigator agreements are not regulated by this law, thus only institution agreements are possible.

Some professionals might also remember the Decree of the Ministry of Health #266 (June 2003) that expressly forbids payments to clinical trial investigators. Though the Decree is currently void.

The uncertainty on the issue has been fueled by the lack of law enforcement practice and official comments to the legislation.

Thanks to Russian Association of Clinical Trial Organizations (ACTO, http://acto-russia.org/en/ ), the market obtained the official comments of the Federal Service on Surveillance in Healthcare. Their letter (ответ РЗН по оплате PI_2015) expressly says that conclusion of investigator contracts and direct payments to clinical trial investigators is absolutely possible and acceptable: “… in accordance with the Civil Code of the Russian Federation the developer of the medicinal product or organization involved by the developer of the medicinal product for the conduct of the clinical trial has the right to execute agreements with the specialists involved into conduct of the trial as well as perform payments to the said specialists”.

Thus, there should be no doubt that agreements with investigators as well as direct payments to the investigators (and other specialists involved) are officially acceptable in Russia.

CTAF Moscow