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Advocacy achievements of the week

10/ 09/ 2021
  In the first week of the VRU work after the summer holidays, MPs made two important decisions in the field of electronic payments and clinical trials. It should also be noted that some regulatory issues in the field of subsoil use and examination of materials of clinical trials of medicines have been solved. The Verkhovna Rada passed a draft law on virtual assets On September 8, the Verkhovna Rada adopted basic draft law № 3637 on On Virtual Assets in the second reading and as a whole. The law is aimed at legalizing the cryptocurrency market in Ukraine. Thus, it determines the legal regime of virtual assets, as well as provides legal protection to market participants. The draft law was supported by 276 peoples deputies. The VRU Committee supported the draft law on compassionate medicine Also on September 8, during a regular sitting of the VRU Committee on Public Health, Medical Assistance and Medical Insurance, deputies decided to recommend the draft law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine to patients with compassionate medicines” (№ 5736) for adoption in the first reading by the Parliament. This draft law was developed and submitted to the Verkhovna Rada of Ukraine at the initiative of the EBA Clinical Trials Subcommittee. Adoption of these drafts will allow pharmaceutical manufacturers to implement programs for early access of patients to unregistered drugs in Ukraine, to import and provide free medicines to critically ill patients. At the same time, it will improve the situation with the treatment of such patients with the latest pharmaceutical developments and reduce the burden on the health care system to provide such patients with treatment. The procedure of obtaining a permit for special water use has been updated According to the EBA members, the Ukrainian Geological Survey (State Geologic and Subsoil Survey of Ukraine – UGS) does not require the reporting form No. 7-ГР (groundwaters) (annual) in the conclusion for issuance of special water use permit. It’s optional now – the company is free not to provide the document if it does not have a special permit for subsoil use. It will be recalled that in March of this year, EBA appealed to the Ukrainian Geological Survey with a request to abolish the mandatory obtainment of a permit for special water use by all enterprises that do not have a special permit for subsoil use. Introduction of prepayment for services on the expertise of materials of CT of medicines EBA CTS requested the State Expert Center of the MOH of Ukraine (hereinafter SEC) to settle down the issue of the extension of the launch of the expertise process of the clinical trials (CT) materials to 2-3 weeks since the SEC reverted to the launch of expertise of the CT materials only after payment. Such extensions negatively affect the general deadline for approval of the CT conduct and significant amendments (SA), which in turn negatively affects the attractiveness of Ukraine for CT sponsors.  In order to settle down this issue, the EBA CTS developed a proposal and suggested the SEC introduce the possibility of prepayment for expertise services prior to the submission of CT materials. As a result of the joint discussion of the SEC proposals, the SEC introduced a mechanism for payment in advance for services on specialized evaluation of the materials of CT/SA. This mechanism will foster the proper planning of expert work to optimize the general timing of expertise of materials of clinical trials of medicines. The European Business Association thanks MPs, representatives of the UGS, and the SEC for taking into account the positions of the community and making decisions that make life easier for business.

In the first week of the VRU work after the summer holidays, MPs made two important decisions in the field of electronic payments and clinical trials. It should also be noted that some regulatory issues in the field of subsoil use and examination of materials of clinical trials of medicines have been solved.

The Verkhovna Rada passed a draft law on virtual assets

On September 8, the Verkhovna Rada adopted basic draft law № 3637 on “On Virtual Assets” in the second reading and as a whole. The law is aimed at legalizing the cryptocurrency market in Ukraine. Thus, it determines the legal regime of virtual assets, as well as provides legal protection to market participants. The draft law was supported by 276 people’s deputies.

The VRU Committee supported the draft law on compassionate medicine

Also on September 8, during a regular sitting of the VRU Committee on Public Health, Medical Assistance and Medical Insurance, deputies decided to recommend the draft law of Ukraine “On Amendments to Certain Legislative Acts of Ukraine to patients with compassionate medicines” (№ 5736) for adoption in the first reading by the Parliament. This draft law was developed and submitted to the Verkhovna Rada of Ukraine at the initiative of the EBA Clinical Trials Subcommittee.

Adoption of these drafts will allow pharmaceutical manufacturers to implement programs for early access of patients to unregistered drugs in Ukraine, to import and provide free medicines to critically ill patients. At the same time, it will improve the situation with the treatment of such patients with the latest pharmaceutical developments and reduce the burden on the health care system to provide such patients with treatment.

The procedure of obtaining a permit for special water use has been updated

According to the EBA members, the Ukrainian Geological Survey (State Geologic and Subsoil Survey of Ukraine – UGS) does not require the reporting form No. 7-ГР (groundwaters) (annual) in the conclusion for issuance of special water use permit. It’s optional now – the company is free not to provide the document if it does not have a special permit for subsoil use.

It will be recalled that in March of this year, EBA appealed to the Ukrainian Geological Survey with a request to abolish the mandatory obtainment of a permit for special water use by all enterprises that do not have a special permit for subsoil use.

Introduction of prepayment for services on the expertise of materials of CT of medicines

EBA CTS requested the State Expert Center of the MOH of Ukraine (hereinafter SEC) to settle down the issue of the extension of the launch of the expertise process of the clinical trials (CT) materials to 2-3 weeks since the SEC reverted to the launch of expertise of the CT materials only after payment. Such extensions negatively affect the general deadline for approval of the CT conduct and significant amendments (SA), which in turn negatively affects the attractiveness of Ukraine for CT sponsors. 

In order to settle down this issue, the EBA CTS developed a proposal and suggested the SEC introduce the possibility of prepayment for expertise services prior to the submission of CT materials.

As a result of the joint discussion of the SEC proposals, the SEC introduced a mechanism for payment in advance for services on specialized evaluation of the materials of CT/SA. This mechanism will foster the proper planning of expert work to optimize the general timing of expertise of materials of clinical trials of medicines.

The European Business Association thanks MPs, representatives of the UGS, and the SEC for taking into account the positions of the community and making decisions that make life easier for business.

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