Logistics. In August, the state enterprise Medzakupili Ukrainy received 9 deliveries of medicines and medical devices purchased last year in the amount of UAH 230 million. In total, since the beginning of the year, our specialists have received 390 deliveries under the centralized programs of the Ministry of Health for 2020. The total value of the received deliveries is UAH 4.46 billion. Thus, we received 96% of the goods purchased last year.

In total, the Ministry of Health delivered medicines and medical products worth UAH 4.26 billion to regional health departments and health care facilities. 92% of medicines and medical devices purchased at the expense of 2020 were delivered to final recipients.

MZU continues to receive goods purchased centrally in 2021. As of the end of August, deliveries in the amount of 22.8 million were received. Also in August, the delivery of medicines and medical devices, which were centrally purchased at the expense of 2021, began. Regional departments and health facilities received 7.76 million worth of goods, including pediatric, adult oncology and idiopathic familial dystonia.

Anti-corruption activities and compliance. 11 unique suppliers in 28 purchases were tested and qualified. Qualified 73 new suppliers for the medical part of the e-catalog Prozorro Market. 64 winners of procurement procedures for concluding contracts were qualified, 3 winning suppliers were disqualified because they did not submit documents within the specified period. 18 winners in negotiation procedures are qualified. 3 job candidates were checked.

Procurement procedures 2021. As of the end of August, contracts for the purchase of 233 INNs worth UAH 1.65 billion have been concluded for the centralized procurement of drugs and medical devices for 2021. In the process of concluding agreements – 25 positions, procedures for another 283 positions are underway.

Procedures for the purchase of ambulances and stationary angiographic X-ray systems have begun. In 2021, the State Enterprise MZU plans to purchase 325 ASHD type B (standard ambulance) all-wheel drive and 297 ASHMD type C (resuscitation vehicle) all-wheel drive and 24 angiographs.

Supervisory Board. In August, the period of submission of documents for competitive selection of members of the Supervisory Board of the State Enterprise MZU ended. As a result, by September 13, an international recruitment company will form a shortlist of candidates. The final composition of the Supervisory Board (5 independent members) is approved by the Nomination Committee of the Cabinet of Ministers of Ukraine.

Development of Prozorro Market. Within the administration of the medical part of the electronic catalog Prozorro Market, 170 agreements worth UAH 1.3 million were concluded. 91 public customers in August used a medical e-catalog for procurement.

On August 13, the first meeting of the advisory group of the State Enterprise “Medical Procurement of Ukraine” in the field of “Medicines and medical devices for health care facilities to provide treatment for patients with cardiovascular and cerebrovascular diseases” was held. 20 doctors will work in this direction on a volunteer basis. Similar groups will be formed in all areas, which were brought to the purchase of the State Enterprise MZU in 2021.

State Enterprise “Medical Procurement of Ukraine” continues to open data for convenient analysis of our purchases. IT team of MZU has created a new dashboard “Suppliers” in the existing analytical system – https://bi.medzakupivli.com/

The dashboard contains information on all suppliers with which MZU cooperated within the framework of centralized procurement, in particular:

-Company name;
-Resident status (resident / non-resident);
-Budget year when the supplier cooperated with the State Enterprise MZU (2020 and/or 2021);
– Direction of purchase (nosology);
-Number of concluded contracts and names of purchased INNs from a specific supplier, summarized amounts of concluded agreements.

Using filters, in the upper left corner you can find a supplier from the drop-down list or enter a company name. You can filter by budget year of purchase, the direction of purchase, specific INN, resident status.

The new dashboard will be useful for those who analyze centralized procurement: public organizations, journalists, executive authorities, health care institutions, representatives of the pharmaceutical market, buyers. Patients and their relatives can also turn to him to understand from whom the MHU is purchasing and for what amounts.

Thus, the order, in particular, provides for the approval of:

1) Action Plan of the Ministry of Health of Ukraine on the implementation of decisions of the National Security and Defense Council of Ukraine of May 14, 2020 and March 23, 2021 “On the application, abolition, and amendment of personal special economic and other restrictive measures (sanctions)” put into effect by the Decree of the President of Ukraine of May 14, 2020 № 184/2020;
2) the form of information on the results of monitoring the implementation of restrictive measures (sanctions);
3) the form of information on the implementation and monitoring of the application of personal special economic and other restrictive measures (sanctions).

The text of the order is published at the link.

Thus, taking into account the minutes of the meeting of the working group for the preparation of medical and technical requirements for stationary digital angiographic X-ray systems, which are the subject of procurement from August 28, 2021 № 3 the order approved changes to medical and technical requirements for stationary digital angiographic X-ray systems. procurement at the expense of the state budget under the program “Development of the emergency medical care system and modernization and renewal of the material and technical base of health care facilities”, approved by the order of the Ministry of Health of Ukraine from July 3, 2021 № 1356.

The text of the order is published at the link.

As of August 5, 2021, the State Enterprise “Medical Procurement of Ukraine” has concluded agreements for the centralized purchase of 105 nomenclature items worth UAH 716 million for 2021 funds. Auctions have already been held for another 103 positions and contracting is underway. Tender procedures for the remaining 394 positions are ongoing.

According to the results of the auctions already held in Prozorro, the total amount of the winners’ proposals amounted to UAH 1.5 billion. The estimated amount of taxpayers’ savings in all current auctions is UAH 457 million or 24% of the expected value of UAH 1.9 billion.

The winners of the auctions are international and Ukrainian pharmaceutical manufacturers, as well as suppliers. We see a high interest in our procedures and competition in the market, which ensures lower prices. This became possible due to the work of our team’s specialists, high-quality preparation for tenders, as well as effective cooperation with our partners.

Thus, in accordance with the text of the Decree, the decision of the National Security and Defense Council of Ukraine of July 30, 2021 “On the state of the national health care system and urgent measures to provide Ukrainian citizens with medical care” was put into effect.

The Cabinet of Ministers of Ukraine to ensure by December 1, 2021 the development and approval of the Strategic Plan for the development of public health for the period up to 2030, defining deadlines for implementation and clear mechanisms to ensure equal access of citizens of Ukraine to timely, safe and quality emergency, primary, secondary (specialized), tertiary (highly specialized), palliative care and rehabilitation in the field of health care, providing, in particular:

– in terms of medical devices for market operators:
– submission of the draft Law of Ukraine “On Medical Devices”, developed in accordance with the norms of European directives, to the Verkhovna Rada of Ukraine by December 15, 2021;
– taking measures to minimize the harmful effects of self-medication on health, in particular, by establishing a moratorium until January 1, 2024 on the provision in television, radio, media of any advertising information about medicines, medical devices, prevention methods, diagnosis, treatment and rehabilitation;
– providing support in the Verkhovna Rada of Ukraine to the draft Law of Ukraine “On Amendments to the Criminal Code of Ukraine on Liability for Counterfeiting of Medical Products and Similar Crimes Threatening Health” (registration 91 4491) in order to implement the provisions of the Council of Europe Convention on Counterfeiting products and similar crimes threatening health care, ratified by the Law of Ukraine of June 7, 2012 № 4908 – VI.

In addition, the Government is instructed to organize and consult with international partners in bilateral and multilateral formats to gain and use international experience in the construction and operation of the national health care system, including to attract international technical assistance to receive health care facilities. state-of-the-art medical technologies and equipment, as well as to counteract the spread of acute respiratory disease COVID-19 caused by the coronavirus SARS-CoV-2 in Ukraine.

– in terms of medicines for market operators:
-providing support in the Verkhovna Rada of Ukraine to the draft Law of Ukraine “On Medicinal Products” (registration № 5547) in order to harmonize the legislation of Ukraine in the field of circulation of medicinal products with the legislation of the European Union, namely:
– reforming the system of state bodies in the field of circulation of medicines, establishing a state body of European standard – authorized competent body and establishing proper communication of the newly formed body with the relevant structures of the European Union, improving approaches to licensing and inspection of activities related to the circulation of medicines. mandatory application of relevant good practices (GxP) at all key stages of drug circulation, bringing the procedure of state registration and liability of holders of registration certificates for medicinal products in line with European directives, the mandatory introduction of adapted to the European Union approaches to pharmacovigilance, promotion and advertising of medicines, as well as improving the requirements for the activities of pharmacies as health care facilities;
– harmonization of national legislation with the requirements of Directive 2002/46 / EC of the European Parliament and of the Council of the European Union on the harmonization of the laws of the Member States relating to organic food additives of 10 June 2002, in particular as regards the protection of the population from the adverse consequences of unfair distribution of biologically active supplements by establishing legislative restrictions on the sale of dietary and food supplements by health care institutions;
– ensuring the intensification of work on the signing of the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA Agreement) between Ukraine and the European Union in order to mutually recognize the results of inspections of the production of medicines for compliance with Good Manufacturing Practice (GMP) and quality control results means;

– taking measures to stimulate the development of domestic production of immunobiological drugs (vaccines, toxoids, immunoglobulins, sera, bacteriophages, other drugs for the specific prevention of infectious diseases) for the prevention of the most common infectious diseases in Ukraine and the world;

The decree came into force on the day of its publication.

The full text of the Decree and the decision of the National Security and Defense Council is available at the link.

The First Deputy Prime Minister – Minister of Economy of Ukraine Oleksiy Lyubchenko presented to business representatives the mechanisms of stimulating the economic sector developed by the Ministry of Economy. This happened during a meeting with the Ukrainian Business Council on September 7 in Kyiv.

“We audited our tools, analyzed the regulatory field, technical regulation measures and formulated proposals for business – where and how we can help with development. We are waiting for feedback and suggestions. Our task is to protect the interests of the state and create decent conditions for starting and developing private business, “Oleksiy Lyubchenko stressed.

Among the main measures, Deputy Minister Serhiy Telenyk called stimulating domestic production, forming demand for national products through support for highly localized enterprises, programs to compensate consumers for the cost of domestic products, interest rate reimbursement on loans, and support for investors.

It also provides support for measures on resource efficiency, development of production and market infrastructure, implementation of innovations, etc.

Priorities for adapting legislation to the requirements of European and international law in the direction of technical regulation and innovation policy were outlined. The proposals form a list of measures for commercial and trade protection of domestic producers, their protection from substandard competition, growing imports, etc.

According to Oleksiy Lyubchenko, the Ministry is intensifying its activities in these areas. He stressed the importance of hearing the wishes and problems of entrepreneurs to improve the business climate in Ukraine.

Representatives of the Business Council praised the initiative of the First Deputy Prime Minister and expressed readiness to cooperate.

During the meeting, the issues of de-shadowing of the economy, liberalization and modernization of labor legislation, formation of the Public Control Council under the newly established Bureau of Economic Security (BEB), improvement of the public procurement process, etc. were considered.

The Ministry of Economy establishes fruitful cooperation with business associations and their members, involves entrepreneurial assets in determining the priority areas of public policy, developing effective management decisions and their implementation.

On September 9, Deputy Ministers of Economy of Ukraine Serhiy Telenyk and Taras Kachka met with Deputy Head of the EU Delegation to Ukraine Remy Duflo to conclude the Agreement on Conformity Assessment and Acceptance of Industrial Goods (ACAA).

The parties outlined the progress in the negotiation process and compared the hours for further steps in the implementation of the Roadmap for preparation for the conclusion of “industrial visa-free travel”.

According to Serhiy Telenyk, the successful completion of the second phase will be a prerequisite for the launch of the EU Assessment Mission on Ukraine’s readiness to conclude the ACAA Agreement. The end result will be the conclusion of “industrial visa-free travel” in three priority sectors. We are talking about low-voltage electrical equipment, electromagnetic compatibility of equipment and machinery.

“This will contribute to the introduction of a new model of economic development of Ukraine, increase the competitiveness and innovation of our industry, attract investment, strengthen the image of Ukraine at the European and international levels,” said Serhiy Telenyk.

In turn, Taras Kachka stressed that one of the priorities of national policy is the development of industry.

“The conclusion of the ACAA Agreement will be another step towards the recognition by the European Union of the quality of Ukrainian industrial products and will facilitate access for our producers to EU markets. In addition, “industrial visa-free travel” will provide an incentive for the development of the domestic industry, attracting investment, increasing production and exports, “said Taras Kachka.

The Ministry of Economy has developed a draft Law of Ukraine “On Consumer Protection” (as amended). The new bill is designed to introduce effective mechanisms for regulating e-commerce. This was discussed during the meeting of the First Vice Prime Minister – Minister of Economy of Ukraine Oleksiy Lyubchenko with the Ukrainian Business Council on September 7.

“Regulation of e-commerce – the requirements of today. After all, the inability to identify an online seller causes insecurity of consumer rights and budget losses due to non-registration of sellers as entrepreneurs. Therefore, to solve these problems, we are initiating a mechanism of voluntary identification in the register of online stores by sellers of goods in e-commerce, “said Deputy Minister of Economy of Ukraine Iryna Novikova during the meeting.

The draft Law of Ukraine “On Consumer Protection” (as amended), developed by the Ministry of Economy, contains rules that stipulate that entrepreneurs who carry out electronic sales will be required to post information about themselves as a business entity and a list of information about products.

The bill provides a definition of “electronic trading platform (marketplace)” and “electronic product comparison service (price aggregator)”;

liability is established for failure to provide complete information by the business entity regarding its identification.

The draft law is currently being considered by the Cabinet of Ministers.

The State Food and Consumer Service also has the right to apply to the Internet service provider to restrict access to the website of businesses that use unfair business practices, violate consumer protection legislation and which cannot be identified. Liability for providing inaccurate data is established

At the same time, the Ministry of Economy together with the Ministry of Finance are working to create a platform “E-buyer” for sellers who carry out business activities in online stores, including marketplaces, price aggregators, classifaids. This electronic service will allow to identify the seller by granting him the status of the State Food and Consumer Service “Verified seller”.

The Ministry of Finance also developed a draft Law of Ukraine “On Amendments to the Law of Ukraine” On E-Commerce “to introduce information by sellers to the central executive body that implements state policy in the field of state control over compliance with consumer protection legislation.” The draft law provides for the creation of a “Single state web portal for consumers in the field of e-commerce”, the introduction of a mechanism for verifying the authenticity of sellers’ data by introducing identification and verification for sellers and establishing responsibility for providing inaccurate data.

According to the AMCU, the Committee receives appeals from business entities regarding the need to stop the practice of selling drugs that contain active pharmaceutical ingredients in the form of “dietary supplements”.

The problem is that drugs that have similar therapeutic properties and contain the same active ingredients are marketed in different ways. Some – as medicines, and others – as dietary supplements. And this in turn entails different approaches to state control (supervision) of the circulation of these drugs and different conditions for their entry into markets.

The appeals to the AMCU state that this practice is used by certain business entities in order not to go through the procedure of registration of medicines, appropriate inspections and examinations.

That is, what should be registered as a drug is marketed as a “dietary supplement”. In this regard, the Antimonopoly Committee is conducting a study of these actions for compliance with legislation on the protection of economic competition. But we can already say that this situation has been caused by numerous gaps in the legislative sphere.

On July 27, at the initiative of the Antimonopoly Committee, the first working meeting on this issue was held with representatives of the State Service of Ukraine for Medicines and Drug Control.
The parties discussed the vision of this problem and agreed on cooperation aimed at resolving the issue of circulation of dietary supplements, which include active pharmaceutical ingredients to stop the unfair behavior of individual manufacturers (market operators).

The minutes of the working meeting has not been published yet.