- Major Russian legislation changes for 2018

Some significant changes in the legislation of the Russian Federation have been undertaken and coming into force in January and February 2018, in particular in such domains and spheres of regulation as: banking law; tax law; public procurement; intellectual property rights; Internet messengers and mass media; circulation of medicines; medical services; industrial production and technical regulation; inspections of legal entities and individual entrepreneurs. Below among the most relevant for our business.

MEDICINE AND PHARMACEUTICALS

Law on Telemedicine

From 1 January 2018 the Federal Law 'On the Introduction of Amendments to Certain Legislative Acts of the Russian Federation on the Application of Information Technologies in the Area of Health Protection' No. 242-FZ dated 29 July 2017 comes into force (except for certain provisions).

Telemedicine technologies are defined as information technologies that provide for remote interaction of medical officers between each other and with patients, for identification and authentication of them, for documenting their actions during consultations, and for remote medical supervision of
a patient's health.

Medical assistance with the use of telemedicine technologies shall be organised and provided according to the procedure established by the
competent federal executive authority, the procedures for the provision of medical care and based on medical care standards.

Consultations to a patient or his/her legal representative can be provided by a healthcare professional with the use of telemedicine technologies for the following purposes:

- prevention, collection, analysis of patient complaints and history data, evaluation of the effectiveness of medical and diagnostic measures, medical supervision of the patient's health;
- making a decision on the need in a face-to-face attendance (examination, consultation).

When providing consultations with the use of telemedicine technologies, the doctor can correct the previously prescribed treatment, if the diagnosis is established by him/her and the treatment is prescribed at the face-to-face attendance (examination, consultation).

Documenting of the information on the medical assistance to a patient using telemedicine technologies, including making entries into the patient's medical documents, shall be performed using a strengthened qualified electronic signature of a healthcare professional.

A patient or his/her legal representative may receive medical documents (copies thereof) and extracts therefrom, including in e-form, on request sent, inter alia, in e-form.

The Uniform State Information System in the area of public health will be created.

List of Vital and Essential Medicines for Medical Use

On 1 January 2018, the following lists approved by the Order of the Government of the Russian Federation No. 2323-r, dated 23 October 2017:

- list of vital and essential medicines for medical use;
- list of medicines for medical use, including those prescribed by the decision of medical commissions of medical institutions;
- list of medicines for people with hemophilia, cystic fibrosis, pituitary dwarfism, Gaucher disease, malignancy of lymphoid, hematopoietic and related tissue, multiple sclerosis, persons after the transplantation of organs and(or) tissues;
- minimum range of medicines needed for medical care.

The new lists are supplemented with a number of medicines and dosage forms for medicines already included in the lists.

Information on the Interconvertibility of Medicines for Medical Use

From 1 January 2018, information on the interchangeability of medicines for medical use will be included in the state register of medicines (i.e. for the purposes of state and municipal procurements).

It is also allowed to use the results of determining the interconvertibility of medicines for medical use.

(Federal Law No. 429-FZ, dated 22 December 2014; the Order of the Ministry of Healthcare of the Russian Federation No. 80n, dated 09 February 2016)

 

Full text available on 'Important developments in the Russian legislation effective from January-February 2018' by GRATA International.



Source: GRATA International Law Firm (Moscow) - www.gratanet.com

GRATA International is a global team representing different countries and nationalities that has legal advising experience in all areas of law. GRATA International provides legal services across all cities in Kazakhstan. The firm has offices in Baku (Azerbaijan), Bishkek (Kyrgyzstan), Dushanbe (Tajikistan), Moscow (Russia) and Tashkent (Uzbekistan), as well a country desk in Ashgabat (Turkmenistan), and associated offices in Istanbul (Turkey), Kyiv (Ukraine), Minsk (Belarus), Kazan, Novosibirsk, Rostov-on-Don, Saint-Petersburg and Samara (Russia), Prague (Czech Republic), Riga (Latvia), Tbilisi (Georgia), Ulaanbaatar (Mongolia), Warsaw (Poland), and Zurich (Switzerland).
In addition to its offices, our firm has representatives in Beijing (China) and London (United Kingdom). We offer our clients an access to the entire network of our diverse team that has extensive legal experience and knowledge of local business environment in any country of our presence. GRATA International has been recognised by leading international ratings: The Legal 500, Chambers Global, Chambers Asia-Pacific, IFLR1000, Who’s Who Legal, Asialaw Profiles.

MORE INFORMATION

Ms Yana Dianova

Director of the Corporate & Commercial Law Dept.

GRATA International (Moscow)

T.: +7 (495) 660 11 84

E.: ydianova@gratanet.com

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