Business news from Ukraine


Original Ukrainian medicines are not available in the markets of the United States and the European Union (EU) over the absence of state support for research in Ukraine, Director General of Research and Industrial Center Borschahivka chemical and pharmaceutical plant (Kyiv) Yulia Zdarevska has said. “Original Ukrainians medicines are not usually introduced in the United States and the EU, not because of their low efficiency, but because of the lack of state support in Ukraine for the development of original drugs at the state or regional levels,” she told Interfax-Ukraine, commenting on the results of research on the market for drugs with insufficient evidence base, initiated by Anti Corruption Action Centre (AntAC) with the support of the International Renaissance Foundation.
Zdarevska said that the lack of registration in the United States or Europe is not proof of the inefficiency of medicines.
“Throughout the world, the registration of the drug in the FDA and EMA is a voluntary decision, not an obligation. Therefore, the substitution of concepts is clearly visible, therefore we believe that the group of drugs mistakenly described in the report as “Medicines Without Proven Effectiveness” should be referred to as” Medicines, the Use of which in the United States or the EU was not Envisaged by the Developer,” she said.
The general director of the plant said that the cost of a full cycle of developing and approving a new original drug in the United States could reach $2 billion.
“These costs today are unaffordable for the Ukrainian pharmaceutical industry,” she said.
Zdarevska said that the studies that pharmaceutical companies conduct to register their own drugs include safety and efficiency studies in accordance with established requirements.
“If these studies are not conducted, the drug cannot be registered. Thus, while demanding the prohibition of drugs not registered in the FDA and EMA, the authors of the research, in the first place, call into question the activities of state (and not only Ukrainian) regulatory authorities,” she said.
At the same time, Zdarevska said that the use of medicines in only one or several countries is a global practice, and the only necessary confirmation of the quality, effectiveness and safety of the drug is the availability of public registration.
She also recalled that in Ukraine for many years there is a pharmacovigilance system that allows the continuous collection, analysis and use of all information on side effects and the experience of clinical use of medicines.
Zdarevska said that Ukrainian pharmaceutical companies also export their medicines to more than 60 countries.
Research and Industrial Center Borschahivka chemical and pharmaceutical plant is among top 20 largest pharmaceutical manufacturers in Ukraine. It is a member of the Association Manufacturers of Medications of Ukraine (AMMU).

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Ukraine has fulfilled a major part of conditions for receiving the first tranche of macro-financial assistance (MFA) from the European Union in the amount of EUR 500 million, acting Finance Minister of Ukraine Oksana Markarova has said.
“Most of the conditions for the first tranche have already been fulfilled. Some of them are in the process of implementation at the final stage. I think getting the first tranche is realistic enough,” she told Interfax-Ukraine on the sidelines of the 15th YES Conference organized by the Victor Pinchuk Foundation in Kyiv.
“The question is about reaching agreements with the IMF, which are also important for the MFA. We are working on this too, as soon as there is, I hope, a positive solution, then we will be able to [to get the MFA],” Markarova said.
Commenting on the specific conditions for the first tranche of the MFA, she said that the Finance Ministry had already approved seven general tax consultations since July.
“After we approved amendments to the Tax Code that enable the Finance Ministry to render these consultations, we did not actively use this tool. It’s my personal priority,” Markarova said.
She said that some legislative requirements are differently interpreted by tax offices in regions and courts, and the role of these generalized consultations is to provide equal interpretation, therefore, the ministry will use this tool.
Asked about the fulfillment of the requirement to ensure effective verification of information on beneficiaries in the public register, Markarova said that this requirement has already been practically fulfilled, as it is prescribed.
“This is a matter of changing the legal acts. There is already a clear understanding of what needs to be changed in the regulatory framework to make this possible. I think we will fulfill this condition,” the acting minister said, adding that there is no need for legislative amendments.
At the same time, she said that, in general, the verification of beneficiaries is a very complex issue. Markarova said that there is no country that can show how it works, in particular, this is a new experience for European partners of Ukraine.
The acting minister also said that the draft national budget for 2019 announced all the required funds for the work of the High Anti-Corruption Court.

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The representatives of Ukraine and the European Union have signed a memorandum of understanding and a loan agreement on providing the fourth program of macro-financial assistance to Ukraine (MFA IV) in the amount of EUR1 billion.
On the part of Ukraine, the documents were signed by Acting Minister of Finance Oksana Markarova and Governor of the National Bank Yakiv Smolii, from the side of the EU by Vice President of the European Commission for Euro and Social Dialogue, Financial Stability, Financial Services and Capital Markets Union Valdis Dombrovskis.
The ceremony of signing the loan agreement and the memorandum was attended by President of Ukraine Petro Poroshenko and Prime Minister of Ukraine Volodymyr Groysman.
After signing, the head of state thanked the European Commission and Dombrovskis for “the comprehensive and great support the European Union provides to the Ukrainian government and the Ukrainian people.”
“This is a great help in carrying out the reforms and supporting the reforms – not only financial, but also consultative – and you are rightfully a participant and co-sponsor of the reforms that have been held in Ukraine over the past four years,” Poroshenko said.

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More than a million Ukrainians have taken advantage of the visa-free regime with the EU since the introduction of a simplified system in June 2017. “More than a million Ukrainians have already taken advantage of the visa-free regime with the countries of the European Union since June 2017,” Ukrainian President Petro Poroshenko wrote on his Facebook page.
The press service of the Ukrainian State Border Guard Service, in turn, noted that a significant increase in passenger traffic to the European Union countries was associated with the beginning of the tourist season and vacations. In addition, from July to September every year, European countries note the demand for attendance by entrants and students of their educational institutions.
As reported, 500,000 trips of Ukrainians to the European Union were recorded in mid-May 2018.
In general, there are a great number of people going to the EU by air. About 35% of Ukrainians currently choose air travel to the EU. Poland is also a popular destination for crossing the border by road. The overwhelming majority of Ukrainians get into the EU countries through the border with this country.

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Exports of Ukrainian agrarian products to European countries in January-May 2018 increased by $13 million, or 0.6%, to $2.3 billion compared to the five months of last year, the Ministry of Agrarian Policy and Food reported on its website. “In the five months of 2018, we see the increase in our agricultural exports to the EU by almost $13 million compared to the same period in 2017. The largest share in the structure of agricultural exports to the EU was that of grains, which were exported for almost $862 million, sunflower oil worth $465.8 million, residues and waste products of the food industry for $220 million, oilseeds worth $211.5 million, poultry for $100.5 million,” the press service said citing Deputy Minister of Agrarian Policy and Food for European Integration Olha Trofimtseva.
According to her, exports of Ukrainian processed and niche agricultural products to EU markets also rose. In particular, juice exports for the period grew by $11 million, or 2 times, confectionery products from sugar by $8.3 million, or 89.4%, chocolate and other cocoa products by $6.5 million, or 66.2%, legumes by $6.5 million, or 2.4 times, eggs without shell and egg yolks by $6.1 million, or 20 times.
According to the ministry, the main importers of Ukrainian agrarian products were the Netherlands with a share of exports of 15.9%, Spain with 14.1%, Italy with 14%, Poland with 14%, Germany with 9.3%, and France with 6.8%.

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Trilateral negotiations of the European Union, Russia, and Ukraine on Russian gas transit via Ukraine after 2019 may begin in early July, according to European Commission Vice President Maros Sefcovic. “Time is a precious commodity. I hope to start working with Russia and Ukraine on the trilateral gas agenda in early July,” he wrote on Twitter. “Complex negotiations ahead,” Sefcovic wrote. He said in late May that the objective of these negotiations will be to determine details of gas transit via Ukraine after 2019 and guarantees of such transit.

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