News

Amendments to the Federal Law on protection of public health permitted medical care under clinical testing

03.04.2015

Vladimir Putin has signed the Federal Law "Amendments to the Federal Law "On fundamental of protection of public healthcare in the Russian Federation"" which regulates the organization of health care provided under clinical testing of prevention, diagnosis, treatment and rehabilitation methods

The Federal Law was passed by the State Duma on February 27 and approved by the Federation Council on March 4, 2015.
Explanatory memorandum of the State Legal Department
The Federal Law "On fundamental of protection of public healthcare in the Russian Federation" is being amended to establishing a new kind of health care, namely, care provided under clinical testing of new methods for prevention, diagnosis, treatment and rehabilitation.
According to the Federal Law, clinical testing is a practical application in the provision of health care of newly developed and not previously applied methods for prevention, diagnosis, treatment and rehabilitation in order to confirm the evidences on their effectiveness.
The Federal Law states that medical care within the clinical testing shall be provided after obtaining of conclusion from the Ethics Committee and the Expert Council to be established by the authorized federal agency. The same federal agency will approve the order of making such conclusions. The Law has provisions that the Expert Council will elect medical institutions to provide health care under clinical testing; the selection criteria shall be approved by the Government of the Russian Federation. The procedure for organizing clinical testing and provision of health care under clinical testing, including the procedure for referral of patient for such care, shall be approved by the authorized federal executive body.
According to the Federal Law, medical care under clinical testing is to be provided at the expense of federal budget.