30 November 2016 g. The Government of the Russian Federation adopted Decree No. 1268, which expanded the list of imported medical devices, including technical means of rehabilitation for the disabled, which were prohibited from purchases for state and municipal needs. Among other technical means of rehabilitation, non-implantable hearing aids are also mentioned in this list.. Since the above decision caused a wide resonance among our readers, we read it necessary to comment on its main points. To this end, we turned to our permanent author - lawyer Dmitry Balykin.
- Dmitry, first of all, I would like to clarify, does the above ruling mean a complete ban on the purchase of foreign-made hearing aids and other TSRs, as some media wrote about it?
- Not, foreign-made hearing aids in Russia no one forbids selling, but with their public procurement, serious restrictions are set in the interests of domestic producers. Decree of the Government of the Russian Federation No. 1268 is called “On Amendments to the List of Certain Types of Medical Devices, originating from foreign countries, in relation to which restrictions on admission are established for the purposes of making purchases to meet state and municipal needs”. In the following, I will try to briefly explain the essence of this decision..
All TCP, provided to persons with disabilities by the Federal Social Insurance Fund of the Russian Federation or in some regions by the social protection authorities are acquired under state contracts, which are concluded in strict accordance with the legislation on public procurement. They are purchased through tenders.. These situations are subject to restrictions.. According to the established rules, all applications, containing proposals for the supply of imported medical products, deviate, if no less than 2 applications, that meet the requirements of the procurement documentation and contain proposals for the supply of one or more types of medical devices, which are included in the list and whose country of origin is Russia, Armenia, Belarus or Kazakhstan. At the same time, such applications should not contain proposals for the supply of the same type of medical device from one manufacturer.. Simply put, specified in the list of TSR, though not completely banned., but domestic manufacturers of similar TSR received an advantage in their purchase. With regard to hearing aids, these restrictions have not appeared now, but much earlier, in February 2015 g., when the Decree of the Government of the Russian Federation No. 102 from 05.02.2015 the first edition of this list was approved. Decree of the Government of the Russian Federation No. 1268 this list has been significantly expanded. Will suffer from such expansion, in my opinion, first of all, disabled people with impaired function of the musculoskeletal system, because earlier strollers, walkers and some other TMR they needed were not on this list. 1268 in the group about the problems of the deaf-blind showed, that most consumers do not trust domestic hearing aids and are afraid to switch to them.
– Is it now possible for deaf-blind people to receive well-proven hearing aids from leading foreign manufacturers for a long time??
I do not presume to say anything about domestic hearing aids, because I never used them.. I think, that before mass switching to them, it is necessary to conduct large-scale testing by interested users. This should be important for manufacturers of domestic SA, in dire need of consumer confidence. The possibility of obtaining foreign-made hearing aids for disabled people remains. Here it is necessary to recall, that the provision of disabled people with TSW is carried out in accordance with individual programs for the rehabilitation or habilitation of a disabled person (disabled child) (more IPRA).
It is on the basis of IPRA that the terms of reference are formed. If the recommendations of the IPRA of a disabled person are typical, eg, "providing a powerful multi-channel digital hearing aid" and these characteristics will be consistent with both domestic, and imported device, probably, for a disabled person, a domestic SA model will be purchased. If the IPR of a disabled person indicates certain specific characteristics of the hearing aid, related to his hearing, and there is no domestic hearing aid with such characteristics, in this case, an imported hearing aid will be purchased. Preparing to write this article, I analyzed information on the purchase of hearing aids in some regions of the Russian Federation. According to information taken from the websites of the FSS, imported hearing aids are still purchased in some cases. for example, this happens when providing TMR for children with disabilities. Hence, much here depends on the quality of the recommendations of the audiologist and their reflection in the IPR of the disabled person. Besides, with a disabled person, as before, it remains possible to buy the hearing aid he needs at his own expense and apply for compensation of expenses incurred to the bodies of the Federal Insurance Fund of the Russian Federation or in some regions, for example in Moscow, to the social protection authorities. At the same time, it is important to remember, that compensation cannot exceed the cost of similar technical means, purchased by the authorized body based on the results of the latest purchase of TMR (last completed procurement procedure). She may be less, than the amount spent by the disabled. The amount of compensation must be specified in the bodies of the FSS of the Russian Federation or social protection in your region.
