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Business has a record number of achievements this week

19/ 11/ 2021
  This week has brought a record high number of positive news for business. So here we have 9 key achievements in healthcare, clinical trials, electronic payments, industrial ecology, consumer electronics, woodworking, agrochemicals, tax, and regulatory areas. Consideration of draft law №5600 has been postponed This week, the Verkhovna Rada postponed consideration of draft law 5600, which proposes a number of odious changes to tax legislation. The EBA business community fully welcomes this decision. We thank peoples deputies who listened to business opinions.  The VRU approved the draft law on administrative procedure  The Verkhovna Rada supported draft law №3475 on Administrative Procedure, which sets out the guiding principles for administrative bodies in their interactions with business and citizens. These are the rule of law, equality before the law, the impartiality of public authorities, openness, timeliness, and efficiency. The draft law On Insurance was adopted in the second reading The Verkhovna Rada adopted in the second reading draft law №5315 On Insurance. This document introduces a new model of regulation aimed at creating a competitive market for insurance services in Ukraine. The key novelties include updated conditions for licensing insurers, the establishment of clear requirements for entry/exit of the insurer to the market, differentiation of approaches to determining the solvency of insurers, clarification of requirements for insurance contracts, regulation of insurance intermediaries. Ukraine is one step closer to the EU in terms of clinical trials regulation Moreover, the adopted draft law №5315 takes into account amendments on the regulation of insurance in clinical trials which were proposed by the EBA Clinical Trials Subcommittee experts. Thanks to these changes, Ukraine will move to a fully European model of liability insurance in clinical trials. The VRU supported the draft law on the timber market in the first reading The Verkhovna Rada adopted in the first reading the sectoral draft law On the wood market №4197-d. Business is pleased with the progress in this direction but emphasizes that the adoption of the draft law in the current version will not lead to the expected positive changes. Consideration of business comments in the development and adoption of the law - will be a big step forward. The first step was taken to regulate the compassionate use of medicines The Verkhovna Rada of Ukraine adopted as a basis in the first reading draft Law №5736 on compassionate drug use, developed with the participation of the EBA Health Care Committee. Thus, the document contains definitions of the programs under which seriously ill patients can gain gratis access to drugs unregistered in Ukraine for treatment (so-called compassionate use programs). It also provides the procedure and conditions of the implementation of such programs. Rules for the provision of information to consumers by radio equipment manufacturers will be simplified The EBA welcomes the adoption of the NKRZI Resolution №336 from 14 September 2021 and its recent registration with the Ministry of Justice of Ukraine. This Decision amends the rules for the provision of information by the manufacturer of radio equipment to consumers. It should be recalled that the EBA experts actively participated in the work of the NCCIR on the development of the draft Resolution. As a result, more balanced provisions have been developed, for example, regarding the possibility of specifying units of measurement and common words, such as “WiFi” or “Bluetooth” in Latin letters. A working group will be established at the Ministry of Environment to discuss the reform of industrial pollution At its meeting this week, the VRU Ecocommittee postponed consideration of draft laws in the field of industrial pollution control. These are draft laws №6004, 6004-1, and 6004-2. Thus, it was decided to establish a working group at the Ministry of Environment and discuss three legislative initiatives with all interested stakeholders. The EBA has previously called for a rejection of draft law №6004 as one that almost completely duplicates the first-failed draft law №4167. Instead, we insist on the support for draft law №6004-1 as one that takes into account the main comments from the business most affected by the reform. Besides, there was the launch of signing the conclusions of the state sanitary-epidemiological examination for CPPs and fertilizers. The European Business Association sincerely thanks MPs, government officials, and agencies for their very fruitful work this week!

This week has brought a record high number of positive news for business. So here we have 9 key achievements in healthcare, clinical trials, electronic payments, industrial ecology, consumer electronics, woodworking, agrochemicals, tax, and regulatory areas.

Consideration of draft law №5600 has been postponed

This week, the Verkhovna Rada postponed consideration of draft law 5600, which proposes a number of odious changes to tax legislation. The EBA business community fully welcomes this decision. We thank people’s deputies who listened to business opinions.

 The VRU approved the draft law on administrative procedure 

The Verkhovna Rada supported draft law №3475 on Administrative Procedure, which sets out the guiding principles for administrative bodies in their interactions with business and citizens. These are the rule of law, equality before the law, the impartiality of public authorities, openness, timeliness, and efficiency.

The draft law “On Insurance” was adopted in the second reading

The Verkhovna Rada adopted in the second reading draft law №5315 “On Insurance”. This document introduces a new model of regulation aimed at creating a competitive market for insurance services in Ukraine.

The key novelties include updated conditions for licensing insurers, the establishment of clear requirements for entry/exit of the insurer to the market, differentiation of approaches to determining the solvency of insurers, clarification of requirements for insurance contracts, regulation of insurance intermediaries.

Ukraine is one step closer to the EU in terms of clinical trials regulation

Moreover, the adopted draft law №5315 takes into account amendments on the regulation of insurance in clinical trials which were proposed by the EBA Clinical Trials Subcommittee experts. Thanks to these changes, Ukraine will move to a fully European model of liability insurance in clinical trials.

The VRU supported the draft law on the timber market in the first reading

The Verkhovna Rada adopted in the first reading the sectoral draft law “On the wood market” №4197-d.

Business is pleased with the progress in this direction but emphasizes that the adoption of the draft law in the current version will not lead to the expected positive changes. Consideration of business comments in the development and adoption of the law – will be a big step forward.

The first step was taken to regulate the compassionate use of medicines

The Verkhovna Rada of Ukraine adopted as a basis in the first reading draft Law №5736 on compassionate drug use, developed with the participation of the EBA Health Care Committee.

Thus, the document contains definitions of the programs under which seriously ill patients can gain gratis access to drugs unregistered in Ukraine for treatment (so-called compassionate use programs). It also provides the procedure and conditions of the implementation of such programs.

Rules for the provision of information to consumers by radio equipment manufacturers will be simplified

The EBA welcomes the adoption of the NKRZI Resolution №336 from 14 September 2021 and its recent registration with the Ministry of Justice of Ukraine. This Decision amends the rules for the provision of information by the manufacturer of radio equipment to consumers.

It should be recalled that the EBA experts actively participated in the work of the NCCIR on the development of the draft Resolution. As a result, more balanced provisions have been developed, for example, regarding the possibility of specifying units of measurement and common words, such as “WiFi” or “Bluetooth” in Latin letters.

A working group will be established at the Ministry of Environment to discuss the reform of industrial pollution

At its meeting this week, the VRU Ecocommittee postponed consideration of draft laws in the field of industrial pollution control. These are draft laws №6004, 6004-1, and 6004-2. Thus, it was decided to establish a working group at the Ministry of Environment and discuss three legislative initiatives with all interested stakeholders. The EBA has previously called for a rejection of draft law №6004 as one that almost completely duplicates the first-failed draft law №4167. Instead, we insist on the support for draft law №6004-1 as one that takes into account the main comments from the business most affected by the reform.

Besides, there was the launch of signing the conclusions of the state sanitary-epidemiological examination for CPPs and fertilizers.

The European Business Association sincerely thanks MPs, government officials, and agencies for their very fruitful work this week!

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