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2022-03-24 10:46

NEWS OF REGULATION IN THE MEDICAL EQUIPMENT MARKET

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In the current conditions, the Government of the Russian Federation is adopting a number of resolutions that create non-standard conditions for regulation in the healthcare and pharmaceutical markets.

In particular, adopted Decree of the Government of the Russian Federation of March 09, 2022 No. 311(http://static.government.ru/media/files/pdf) and adopted Decree of the Government of the Russian Federation No. 302 of March 06, 2022 (http://static.government.ru/media/files/9Coz7VlDgfXnLXGUA888aLJs3BksA0Bc.pdf), which introduces temporary bans on the export of imported medical devices manufactured in unfriendly countries from Russia.

The temporary export ban applies not only to medical devices, but also to medical equipment, including high-tech equipment, devices used in medicine, surgery, and dentistry.

At the same time, almost simultaneously with the above Decrees, a rather important Decree of the Government of the Russian Federation dated March 06, 2022, No. 299 (http://ips.pravo.gov.ru:8080/default.aspx?pn=0001202203070005) was adopted, which gives the right to Russian equipment manufacturers without the consent of the copyright holder to exercise the right to use an invention, utility model or industrial design, if the patent owner is a representative from an "unfriendly country".

This measure is used to accelerate the import substitution of medical equipment on the Russian market for analogues that are not inferior in quality and to maintain the healthcare and pharmaceuticals at the current level. According to Decree of the Government of the Russian Federation of March 06, 2022, No. 299, medical equipment can be copied using an existing patent without obtaining permission from the copyright holder.

At the same time, it is noted that the rights of copyright holders are preserved if, for example, the copyright holder includes a Russian legal entity (owns a share in the authorized capital of the copyright holder) or the individual, which is unlikely in practice.

Against the backdrop of rapidly changing Russian legislation, most of the suppliers from the EU countries and the USA who still want to keep their business in the Russian Federation despite obvious logistical problems and exchange rate instability and supply high-tech medical equipment to the Russian Federation may change their minds given the new risks of violation patent rights, including in relation to medical equipment.