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LEGAL ALLIANCE, founded in 1995, is today one of the leading Ukrainian law firms specializing in legal support to pharmaceutical companies doing business in Ukraine and CIS countries.

OUR CLIENTS represent the following industries: pharmaceuticals, medical devices, consumer goods, medicine, cosmetics, para-pharmaceuticals, chemistry, biotechnology, agriculture and food products.

LEADING ASSOCIATIONS — AIPM Ukraine, APRaD as well as the EBA Healthcare Committee have chosen Legal Alliance as their legal advisor.

New Concept of Reforming Procurement of Medicines and Medical Devices

On September 26th, 2018, a new version of the Concept of Reforming Procurement of Medicines and Medical Devices, Ancillary Products and Other Medical Products (hereinafter – the Concept) was approved at the session of the Cabinet of Ministers of Ukraine. Implementation of the Concept is planned for 2018-2021.

It should be reminded that in 2017 the Cabinet of Ministers of Ukraine by its Decree No. 582-р approved the Concept of Reforming the Mechanisms of Public Procurement of Medicines and Medical Devices. The new version of the Concept is aimed at synchronizing the reform of procurement of medicines and medical devices and the reform of healthcare system funding.

Pursuant to the Concept, it is planned to set up the centralized procurement organization at the Ministry of Health of Ukraine which will ensure procurement of medicines and medical devices, ancillary products and other medical products.

It is envisaged that the Centralized Procurement Organization will carry centralized procurement of medicines within programs which will be determined as strategic. Besides, delegation of functions to carry procurements of local customers to the centralized procurement organization to aggregate the orders and obtain the best procurement conditions from the supplier is considered appropriate.

According to the Concept, the Centralized Procurement Organization in its activities will apply procurement procedures, mechanisms and experience which are being successfully employed by specialized organizations in Ukraine. However, from the abovementioned it is unclear whether it means that the Law of Ukraine “On Public Procurement” will not apply to procurement carried by the Centralized Procurement Organization.

The Concept provides the possibility of procurement by the Centralized Procurement Organization by analogy with the procurement carried with the involvement of the specialized organizations which carry procurement, namely the possibility of obtaining bank guarantees, procurement of currency and keeping money in foreign currency on accounts of the Centralized Procurement Organization in case it is needed to make pre-payment; simplification of entry control procedure for import of medicines.

Unlike the previous version, the new version of the Concept does not stipulate any clear stages of its implementation. However, it is stated that in 2018 the Centralized Procurement Organization will start procuring medicines and medical devices, ancillary products and other medical products to fulfil the Global Fund programs pursuant to the Law of Ukraine “On Implementation of the Global Fund programs for Combatting AIDS, Tuberculosis and Malaria in Ukraine” to combat AIDS, tuberculosis and malaria, and will require the transition period simultaneously with the procurement with the involvement of the specialized organizations by 2021. Taking into consideration that state registration of the enterprise which will act as the Centralized Procurement Organization has not been carried yet, and, accordingly, no competition for head selection has taken place, completion of the abovementioned seems questionable.

We will expect that the road map being elaborated, according to the public sources, will clarify the situation.

Contact the author: Alexander Bondar, senior associate at Legal Alliance Company, bondar@l-a.com.ua.

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