Business news from Ukraine

PATIENT ORGANIZATIONS URGE MPS TO PASS BILL ON CONTROLLED ACCESS CONTRACTS

Patient organizations call on the parliament of Ukraine to adopt at the final reading bill No. 4662, which will provide the possibility of purchasing medicines under controlled access contracts and the Ministry of Health will be given an opportunity of developing the appropriate regulatory framework for the implementation of the controlled access contracts mechanism by the end of 2021.
“Three weeks ago, we wrote open letters to [Chairman of the Parliament Dmytro] Razumkov from all patient organizations (over 30) with a request to bring this bill into the hall. We also wrote letters to the chairmen of all factions with a request to support this bill. We hope that they will support it, since patients need it,” Chair of the Council of the Orphan Diseases of Ukraine NGO Tetiana Kulesha said at a press conference at Interfax-Ukraine on Monday.
According to her, the controlled access contracts mechanism will allow purchasing drugs with a 20-50% discount. Pharmaceutical companies are ready to supply drugs at a reduced cost on conditions of confidentiality and without using public tender procedures, since there is no alternative drug and there cannot be a better offer. Under this procedure, some countries purchase medicines for more than 250 diseases.
“Patients are not provided with the necessary drugs, because they are expensive, unregistered in the country and the state practically does not buy them. The mechanism for the procurement of such drugs under controlled access contracts is effective in 15 countries of the world. This week we are submitting for the second reading the corresponding bill to introduce such a mechanism in Ukraine,” MP Oksana Dmytrieva (the Servant of the People parliamentary faction) said.
According to her, the Ministry of Health will need up to three months to develop a regulatory framework, and after its introduction, the controlled access contracts mechanism will operate for three years as a pilot project.
“Our model of public procurement, unfortunately, does not cover the purchase of all the necessary drugs, in particular for orphan patients. The bill will create special conditions to provide such patients with drugs,” MP Oleksiy Movchan (the Servant of the People faction) said.
As reported, the bill was adopted at the first reading in the spring of 2021.

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UKRAINIAN ECOLOGY MINISTRY INTENDS TO SUBMIT BILL ON LIMITING USE OF DISPOSABLE PLASTIC

A bill on limiting the use of disposable plastic products may be registered at the Verkhovna Rada in October, Minister of Environmental Protection and Natural Resources Roman Abramovsky has said.
According to him, the bill provides for a year after its adoption, a ban on production, import and sale of a number of disposable plastic goods in Ukraine, which are proposed to be replaced with similar ones made from alternative harmless materials, including corn starch.
“From such materials, practically without changing the technology, you can make the same products as from plastic. There will be no big problems for re-equipment of production. We are constantly in contact with business and manufacturers, and most confirm that significant transformations will not be needed […] We came to the conclusion that it is inexpensive, 10-15% of capital investments,” the minister said during a press breakfast in Kyiv on Wednesday.
The bill proposes to limit the use of plastic disposable tableware, cutlery, straws, food containers, lids for drinks containers, sanitary cotton swabs, plastic base-holders for balloons and other products made from polystyrene and oxo-biodegradable plastic.
In addition, special labeling is provided for goods that do not fall under the restrictions (wet wipes, feminine hygiene products, diapers, cigarettes with filters).
At the same time, manufacturers of such products are subject to extended liability, in particular, they will be required to recycle a certain share of the plastic produced.
“The discussion about liability is still ongoing, although the bill is already ready for registration. This is a difficult issue, since excessive liability is associated with corruption risks. Today, the following figures are proposed: the primary fine for the provision of prohibited products on the market is from UAH 18,000 to UAH 51,000, repeated violation within one year – from UAH 85,000 to UAH 175,000,” Abramovsky said.
At the same time, the minister noted the lack of statistical information on production of plastic products in Ukraine.

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UKRAINE APPROVES BILL ON STATE CONTROL OF PRODUCTS WITH GMOS

The Cabinet of Ministers has supported the submission to the Verkhovna Rada of a draft law on state regulation of genetic engineering activities and control over the circulation of products containing genetically modified organisms (GMO), this initiative is conducting a comprehensive review of the existing legislation in the field of handling GMO products, and also allows implementing EU regulations in force in the Ukrainian legislation.
The government made the corresponding decision without discussion at a meeting on August 4.
“Imperfect legal regulation of GMO handling makes it impossible to effectively control the circulation of GMO products and creates conditions for the illegal use of unregistered GMO products. Thus, state regulation in the field of GMO handling should be revised, modernized and brought in line with EU legislation,” an explanatory note to the document reads.
This bill provides for the delineation of powers of the authorities to eliminate duplication of functions in the field of GMO circulation, improvement of the system for assessing the risks of the impact of GMOs on human health and the environment, the introduction of European mechanisms for state registration and labeling of products with GMOs, strengthening state control in the sphere of handling GMOs.
The bill introduces a new type of permits – “permits for the import of unregistered GMOs for carrying out genetic engineering activities in a closed system” with a gradation of the levels of risks they create from 1 to 4.
It is assumed that this bill will regulate the creation, labeling and use of GMOs and genetically modified products, control of compliance with legislation in this industry. In addition, the document prohibits the circulation of food products containing GMOs (or produced with their use) prior to the state registration of the corresponding source of origin of GMOs.

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RULING PARTY PLANS TO SUPPORT BILL ON MEDICAL CANNABIS LEGALIZATION

First Deputy Head of the Servant of the People faction Oleksandr Korniyenko hopes that their faction will be able to collect 200 votes for the bill No. 5596 On Amendments to Some Laws on Regulation of Cannabis Treatment for Medical, Scientific and Scientific Activities.
“It seems that colleagues from other factions support it. Our faction will support, not unanimously, it is obvious: there are those who are against it. But I think we will give 200 votes,” Korniyenko told reporters after a meeting of the conciliation council on Monday.
As reported, the Verkhovna Rada intends to consider the bill on the treatment of cannabis for medical purposes on Tuesday at an extraordinary meeting initiated by President of Ukraine Volodymyr Zelensky.

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PROFILE COMMITTEE OF UKRAINIAN PARLIAMENT SUPPORTS BILL ON MEDICAL CANNABIS

The Parliamentary Committee of the Nation’s Health, Medical Assistance and Medical Insurance has supported a bill on the use of cannabis for medical purposes.
The committee adopted the corresponding bill No. 5596, developed by the MPs of different factions, at a meeting on Wednesday.
According to the explanatory note to the bill, it provides for the need to comply with Ukraine’s international legal obligations regarding the circulation of narcotic drugs, psychotropic substances and precursors.
The bill provides for the classification of hemp depending on the content of tetrahydrocannabinol (THC) in it: medical hemp (Cannabis) with a low content of THC in dry matter (0.2-1%) and Cannabis with a high content of THC (more than 1%), as well as industrial hemp, the content of THC in the dry mass of which does not exceed 0.2%
The bill proposes, in particular, to create regulatory conditions for the legal circulation of cannabis, in particular for use in medical practice, scientific and technical activities, to establish requirements and determine the features of controlled circulation of cannabis in certain areas of activity in accordance with the requirements of international law, to resolve issues related to organization of activities for the circulation of hemp at each stage of such a turnover, including, inter alia, operations for the import/export/transportation through the territory of Ukraine, storage and sale of hemp.
Also, the bill will define the requirements for business entities that can carry out operations related to the circulation of hemp, define and regulate the distribution of functions and powers of regulatory bodies that ensure the fight against illegal traffic in narcotic drugs, psychotropic substances and precursors, to control the use of hemp for purposes specified by law.
According to the authors of the document, it should give an impetus to the development of medical science and the pharmaceutical industry by introducing the possibility of using hemp for medical and research purposes, to help improve the level and quality of medical services for the population in the field of palliative medicine, the methods of which, in particular, are based on the use of medical hemp.
The bill should also ensure that patients can purchase and store cannabis for medicinal purposes as medically indicated and prescribed by a doctor.
The bill provides for amendments to the foundations of the legislation of Ukraine on health care regarding the consolidation of the human right to access the necessary medicines, including, among other things, drugs containing narcotic drugs and/or psychotropic substances and precursors, the law On Narcotic Drugs, Psychotropic Substances and Precursors regarding the provision of the possibility of using plants of the genus hemp for industrial, scientific and medical purposes, the law On the List of Permitting Documents in the Sphere of Economic Activity regarding the inclusion in this list of permits for the use of facilities and premises intended for the implementation of activities for the circulation of narcotic drugs, psychotropic substances and precursors.
At the same time, the committee rejected the alternative bill No. 5596-1.

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UKRAINIAN ECONOMY MINISTER COUNTS ON BILL ON LOCAL CONTENT WITH SUPPORT OF MANUFACTURER

Minister of Economy Ihor Petrashko expects to find such a version of the bill on amendments to the law on public procurement, which will satisfy international partners and will support the Ukrainian manufacturer.
“Without stimulating production in Ukraine and using public funds to purchase goods produced in Ukraine, there will be no significant progress in the country,” Petrashko told a news conference during the Ukrainian Forum “Ukraine 30. Coronavirus: Challenges and Responses” held on Tuesday.
According to the minister, all countries of the European Union and the United States use incentives to ensure that public funds primarily go to the purchase of those goods that are produced in their countries.
Petrashko said that at the moment consultations with the EU and the United States on the local content bill (No. 3739 on amendments to the law of Ukraine on public procurement) are underway, as the reaction to it is ambiguous.
The minister added that the use of non-price criteria will benefit Ukraine’s trade with the European Union and the United States.
“Therefore, we want to find a format of persuasion and find the version [of the bill] that will allow us to support the manufacturer,” Petrashko said.

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