Requirements have been approved for healthcare organisations which conduct clinical trials of medical products

For the attention of: heads of healthcare organisations which conduct clinical trials of medical products as well as R&D and registration units of producers/distributors of medical products.

Pepeliaev Group advises that on 14 February 2014, Rossiyskaya Gazeta, the official edition of the Russian Government, published Order No. 300n of the Russian Ministry of Healthcare dated 16 May 2013 "On approving the requirements for healthcare organisations which conduct clinical trials of medical products, and the procedure for establishing whether the healthcare organisations comply with these requirements" (the "Order"). This order entered into effect on the 25th of February.

Summary of the main changes

The Order sets out several requirements for healthcare organisations which conduct clinical trials of medical products and clinical trials for in vitro diagnostics. In addition, the instrument also determines the procedure for establishing whether a healthcare organisation complies with these requirements for the purposes of being officially declared competent and authorised to conduct clinical trials of medical products within the class of medical aid offered.

The Order actually introduces an additional licensing procedure, along with the existing procedures for licensing healthcare activities. Now, a healthcare organisation which conducts clinical trials of medical products must possess, in addition to a licence, a permit for clinical trials.

To confirm that a healthcare organisation which plans to conduct clinical trials (i.e. before any trials are conducted) complies with the above requirements, it should submit to the Federal Service for Surveillance in Healthcare an application to conduct trials, in a form approved by the Order, as well as documents provided for by the Order.

Within 20 business days after the documents are submitted, the Federal Service for Surveillance in Healthcare considers them and decides whether the applicant complies or does not comply with the requirements for healthcare organisations. The Service then posts the information about the applicant healthcare organisation on its official website and includes it in its list of organisations conducting clinical trials.

Since no regulation in the form of licensing is exercised in relation to confirming that the Order's requirements are complied with, the only regulation is in the form of supervising the circulation of medical products. Thus, in accordance with the Order, if the Federal Service for Surveillance in Healthcare, further to state regulatory measures to oversee the circulation of medical products, identifies any violations committed when a healthcare organisation conducts clinical trials, the Service strikes such healthcare organisation off its list of companies which may conduct clinical trials.

At the same time, we draw attention to the fact that on 1 January 2014 a new article 6.28 was enacted in the Russian Code of Administrative Offences which sets liability for violating existing rules relating to the circulation of medical products in the form of a fine of RUB 30,000 up to RUB 50,000. Since there is as yet no law enforcement practice relating to the above article, it cannot be ruled out that if an organisation does not comply with the requirements for conducting clinical trials, this may result in it being held liable under that article.

To think about, to do

1.        Healthcare organisations which intend to conduct clinical trials in 2014 and subsequently, should:

• determine the exact class of medical aid within which the organisation plans to conduct clinical trials of medical products;

• make sure that the organisation has a licence for providing medical services within the relevant class of medical aid;

• undergo the procedure of being entered in the relevant list before starting clinical trials.

2.   Companies developing or producing medical products, or authorised representatives of such producers, who involve healthcare organisations in conducting clinical trials of their medical products should:

• when executing agreements for clinical trials to be conducted, request a permit to conduct such trials from the healthcare organisation and, with a view to checking the counterparty, verify whether this organisation is in the applicable list on the website of the Federal Service for Surveillance in Healthcare.   

Help from your adviser

Pepeliaev Group's lawyers are ready to provide legal assistance in regulating the activities of healthcare organisations which conduct clinical trials, and to provide legal support services in relation to clinical trials of medical products being conducted in Russia. Our experts will readily advise on how the Ministry of Healthcare’s new order should be applied, provide recommendations in relation to producers of medical products cooperating with the organisation which conducts the clinical trials and the Federal Service for Surveillance in Healthcare.

Vladimir Sokov, Senior Partner, Head of Corporate Division of Pepeliaev Group, tel. +7 (495) 967-00-07, or email: v.sokov@pgplaw.ru;

Oksana Migitko, Head of Commercial Practice of Pepeliaev Group, tel. +7 (495) 967-00-07, or email: o.migitko@pgplaw.ru;

Sergey Klimenko, Senior Associate of Pepeliaev Group, tel. +7 (495) 967-00-07, or email: s.klimenko@pgplaw.ru.