Russia's limits on x-ray and other imports set to expand

2015 08 12 08 15 39 716 St Basils 2 200

Russia is preparing to impose new restrictions on the purchase of imported medical equipment and supplies, adding to the limits on foreign-made x-ray machines and other devices that were enacted earlier this year. The country's safety rules also may be updated soon.

Prime Minister Dmitry Medvedev signed a law in February that requires public health institutions to give preference to domestic manufacturers of medical supplies and those produced in a Russian-backed Eurasian trade bloc. The list covers more than 40 items and could be expanded to include some 100 foreign-sourced products in the coming months.

Analysts say the import curbs are unlikely to have any immediate effect on health services at Russian public medical facilities and emphasize the measures do not prohibit the purchase of products from major suppliers in Europe, the U.S., and Japan. The law also does not apply to Russia's small private health sector.

Doctors fear local substitutes may not be of the same quality as imported equipment, Dr. Valentin Sinitsyn said.Doctors fear local substitutes may not be of the same quality as imported equipment, Dr. Valentin Sinitsyn said.

"I believe that if these restrictions are implemented, they will not create a new big problem for Russian medicine," said Dr. Valentin Sinitsyn, PhD, head of the radiology department at the Federal Center of Medicine and Rehabilitation in Moscow. "But some doctors are worried -- will the 'local' substitutes be of the same quality as imported (and banned) drugs and equipment?"

The radiology-related measures are most likely to affect low-end x-ray and ultrasound systems and CT scanners with 4-16 detector rows, according to Sinitsyn, who became the first Russian to preside over the ECR in 2014 and is a member of the editorial advisory board of Access to advanced MRI, angiography, SPECT, and PET/CT systems are unlikely to be affected, he added.

Indeed, foreign firms are likely to remain the dominant suppliers of sophisticated imaging machines because there "is a big deficit of research and development necessary to produce high-technology medical equipment," said Kamil Karibov, a Moscow-based lawyer whose specialties include procurement law.

The current list of restricted devices includes photofluorographic x-ray, CT, and mammography and mobile x-ray machines. In addition, the law targets medical supplies such as syringes, hearing aids, and condoms, stated the Ministry of Industry and Trade.

The import restrictions bring state and local health facilities under compliance with similar measures contained in a 2014 procurement law. The limits are in line with a plan of priority measures to ensure sustainable economic development and social stability in 2015, according to a Russian government synopsis of the law.

Production vs. patients

The February medical purchasing law, known as Act 102, is part of broader government efforts to help shield domestic manufacturers from competition while also pressuring multinational suppliers to set up joint ventures in Russia, said Karibov, who is a partner in Beiten Burkhardt, a law firm with headquarters in Munich.

Foreign vendors are very reserved about transferring their technology, Kamil Karibov said. Image courtesy of Beiten Burkhardt.Foreign vendors are very reserved about transferring their technology, Kamil Karibov said. Image courtesy of Beiten Burkhardt.

"The first aim is to protect the Russian producers, and the second aim is to attract foreign manufacturers to establish production in the Russian Federation. The first aim is very clear," he told "The question is whether the volume of this [domestic] production is sufficient to secure all needs of the Russian medical institutions, and at what point there may be a deficit of medical equipment."

Also uncertain is whether foreign firms are willing to gamble on setting up joint ventures at a time of fraught relations between Russia and the West. GE is one of the few major international healthcare companies to have set up local production, manufacturing imaging equipment with a Russian partner.

Doubts about the strength of Russia's legal system to protect intellectual property are also a constraint. Foreign companies are very reserved to transfer their technology into the Russian Federation, Karibov pointed out.

Russia's broader procurement law aimed at reducing dependence on imports predates the sanctions imposed by the EU and U.S. following Russia's annexation of Crimea in March 2014 and support for separatists in Ukraine's disputed regions of Donetsk and Luhansk.

New safety rules

In addition to import limitations, Russia and its partners in the new Eurasian Economic Union -- Armenia, Belarus, and Kazakhstan -- are preparing laws on the safety of medical devices. There is speculation that these rules could further tighten limits on imports.

"Common requirements will cover, for example, toxicological, clinical and technical requirements, and testing," according to recent analysis by the SGS Group, a Swiss firm that focuses on inspection, verification, testing, and certification of goods for its clients. "The intention is to harmonize requirements within the Customs Union with existing European requirements. How this will be realized is not defined at this stage."

Nina Pihlman, SGS's Helsinki-based operations manager for Russia, believes the new safety standards are likely to take effect at the start of 2016. Click here for more details about her research.

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