State health care organizations in Belarus (the procuring entity) carry out procurements of medical equipment and medical supplies (“medical devices“) at public expense in line with the public procurement rules and taking into account the specifics laid down for this category of goods. In addition, Belarusian legislation sets some special conditions for foreign medical devices to participate in the public procurement procedure analyzed in this article.
The main feature for procurement of medical devices in Belarus is centralization, which means:
1) State bodies (regional executive committees, Minsk city executive committees and others) establish lists of medical devices that require centralized procurement. For example, the list for 2018 set by the Minsk executive committee is available under the link.
2) The organizer of procurements is State unitary enterprise “Belmedtechnika” and its subsidiary companies. The organizer purchases listed medical products. At the same time "Belmedtechnika" carries out not only the "traditional" powers of an organizer of public procurements but also concludes a contract with the winning bidder.
3) After that, "Belmedtechnika" distributes medical devices purchased to state health care organizations without further procedures.
Decisions by local executive committees may set exceptions to this rule, enabling purchases to be carried out independently (usually this concerns low-value procurements).
Foreign bidders as well as Belarusian bidders submit their bids in Russian (or Belarusian). Information on the tender, invitation, tender documents, including the draft agreement, are available in Russian on the official public procurement website www.icetrade.by. To submit a bid, the bidder should obtain a public key certificate for an electronic digital signature. Submission of bids is carried out through the official site www.icetrade.by (applies for open tendering procedures) or through the online trading platforms www.zakupki.butb.by or www.goszakupki.by (applies for online auctions). So, in Belarus, the following types of procurement procedures for medical products exist:
(i) online auction - applies when the approximate cost of purchasing goods is more than 300 basic values (more than 300 euros) and the goods are on the list of goods for procurement under this procedure (in practice, this frequently applies to procurements of medical devices);
(ii) RFQ procedure - applies when the estimated cost of purchasing goods is more than 300 euros and not more than 1000 euros: the procuring entity takes into account only the lowest bid price;
(iii) open tender - applies in all other cases. The main difference from other procedures is that the selection criteria are not limited to the best price but include other terms set by the procuring entity in the invitation;
(iv) single source procurement - may apply in exceptional cases, such as when a previous procedure is declared invalid.
The bidder may file a complaint against a procuring entity's actions (inaction) to the procuring entity, the Ministry of Antimonopoly Regulation and Trade of the Republic of Belarus and (or) to the court. Belarusian legislation sets a procedure and deadlines for this. At the same time, a foreign bidder should bear in mind that for them the law sets certain non-challengeable conditions for participation in procurement, in particular:
1) Domestic goods (or goods from Eurasian Economic Union (EAEU) countries) are subject to a preferential adjustment of 15%. This means that, when comparing bids, the price from a Belarusian bidder (a bidder from EAEU countries) reduced by 15% will be taken into account, while the price of a foreign bidder remains unchanged. Accordingly, when comparing bids in an online auction, the price of a foreign bidder will be increased by 15%.
2) The “Odd man out“ rule applies only to a certain group of medical devices: if two or more bids are submitted on certain goods originating in EAEU countries, a bid from another country of origin will not be allowed to participate in the public procurement procedure. This rule applies only to the following list of medical devices:
- medical, surgical, dental or veterinary furniture and parts;
- ozone, oxygen, aerosol therapy, artificial respiration devices;
- ultrasonic lithotripters; other instruments and devices;
- devices for nervous stimulation; other instruments and devices;
- equipment and apparatus for anaesthesiology;
- dental tools and appliances;
- syringes with or without needles, used in medicine, surgery, dentistry or veterinary medicine;
- devices and equipment for measuring blood pressure (including sphygmomanometers, tensiometers and oscillometers).
In terms of supplying foreign medical devices to the Republic of Belarus, the need for such technology for private medical health care organizations should not be overlooked, so in this case the rules of public procurement do not apply. For those who may wish to create their own production setup in Belarus, we note the possibility to conclude an investment agreement with the Republic of Belarus, which grants benefits for investors or projects in areas with a preferential legal regime for doing business such as free economic zones, the Great Stone industrial park and others.
We will be glad to assist you in realizing your projects in the medical devices field and advise you on public procurement rules, commercial contracts, as well as other legal and tax matters.