A FAS Expert Council discussed possibilities to localize production of medical devices

On 23rd January 2013, the Expert Council of the Federal Antimonopoly Service (FAS Russia) for Developing Competition in the Field of Medical Devices Circulation discussed one of the most important issues in production of medical devices – “Possibilities of Localizing Production of Medical Devices: Russian and International Experience”.

The meeting was attended by representatives of federal bodies: the Temporary Acting Head of Roszdravnadzor [the Federal Service on Surveillance in Health Care], Elena Telnova; the Director of the Department for Chemical-and-Technological Complex and Bioengineering Technologies of the Ministry of Industry and Commerce, Sergey Tsyb; and experts of the Ministry of Health Care.

The theme of the discussion caused considerable interest of the expert community. Over 100 experts, representatives of Russian and foreign manufacturers of medical devices took part in the Council work. After the introductory address of the Head of the FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev, a report was made by the Executive Director of the International Medical Devices Association (IMEDA), Alexandra Tretyakova. She discussed international experience and problems of localizing medical devices and transfer of technologies to the local markets. In particular, she talked about global trends in developing medical devices markets, the necessary conditions for localizing production and technologies transfer, the risks and possibilities for localizing medical devices in Russia.

Then a representative of an international company Johnson&Johnson, Natalia Totakhevage, shared experience of localizing production of some types of mass company products.

The Temporary Acting Head of Roszdravnadzor, Elena Telnova, discussed the main changes in regulations of medical devices circulation and answered questions from the audience regarding enforcement practice of the new normative acts.

The main discussion concerned the draft Decree of the Government of the Russian Federation “On Establishing Restrictions in Supplying Medical Devices for State and Municipal Needs”, devised by the Ministry of Industry and Trade.

In general Russian companies supported the draft Decree. However, foreign market participants expressed their concern that the draft Decree prohibits participation of foreign manufacturers of medical devices in competitive bidding. Possibility of their concern was also caused by a possibility to form a list of the types of medical devices, for which the new listing rules will be applied in the interests of particular companies, especially because the draft Decree does not contain the criteria for including medical devices in the list. According to Alexandra Tretyakova, “without analyzing the complete package of documents, mentioned in the Government draft Decree, it is impossible to evaluate its impact on the market”.

IMEDA proposed to replace the concept of prohibitions and restrictions in the draft Decree with developing a package of motivating measures for a state-by-stage localization of manufacturing medical devices in the Russian Federation, including a system of preferences.

The Director of a Department of the Ministry of Industry and Commerce, Sergey Tsybm assured participants that no prohibitions would be introduced. The Decree will be of strategic nature and will serve as a guide-mark for drafting documents, which will determine the national industrial policy in production of medical devices. He said: “We have already made changes to the first Clause of the Decree, which now does not have any prohibitions.”

Summing up the discussion, the Expert Council proposed to change the title of the draft Decree, which now shows that the meaning of the Decree is to introduce restrictions. The Council proposed possible titles designed to support development of domestic manufacturing of medical devices and stimulate localization of medical devices manufacturing.

“It was important for FAS to hear opinions of market participants about variants of localizing manufacturing of medical devices that are being discussed. There is nothing dangerous in the fact that Russian and international companies adhere to different approaches. Our point of view will also reflect the importance of government measures towards supporting localization programmes and the need to maintain competition on the relevant markets. Discussing the concept of localizing medical devices manufacturing is pressing because similar schemes will be applied for other markets”, pointed out of the Head of the FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev.