Ukraine: COVID-19 - Healthcare Newsletter | April 2020

COVID-19 update on healthcare regulations

Like many other countries in the world, Ukraine has been hit by a COVID-19 outbreak. The first COVID-19 case in Ukraine was confirmed on 3 March 2020. As of 9 April 2020, the total amount of COVID-19 cases is 1892.

Ukraine has taken a number of measures to prevent the spread of COVID-19. On 11 March 2020, the Cabinet of Ministers of Ukraine (CMU) introduced a quarantine and restrictions on operations of businesses until 3 April 2020. On 25 March 2020, the CMU extended the quarantine until 24 April 2020, with further restrictions on the operation of businesses that entail customers' visits, restrictions on movement of individuals, mandatory isolation/observation/hospitalization of individuals, etc. (for more details regarding these restrictions, please refer to this legal alert).

For violation of the quarantine rules, an administrative fine of up to UAH 34,000 (or USD 1,249) is possible for citizens, and a fine of up to UAH 170,000 (or USD 6,245) is possible for corporate officers.

For violation of sanitation rules and norms on the prevention of infectious diseases, criminal liability in the form of a fine of up to UAH 51,000 (or USD 1,874), up to six months arrest, restriction or imprisonment for up to three years are possible. Actions that cause death or other grave consequences are punishable by imprisonment for up to eight years.

In addition, to prevent the spread of COVID-19, Ukraine has taken a number of measures to simplify market access to certain pharmaceuticals, medical devices and protective gear; ease the tax burden on companies importing and selling same; simplify public procurement of same and other measures. An overview of key adopted measures is set forth below.

Update on healthcare reform

Despite public debate, healthcare financing reform at all levels of medical care was launched in accordance with the previously established timeline, i.e., on 1 April 2020. Starting from this date, the National Health Service of Ukraine will pay for services provided by healthcare facilities that entered into a services agreement with the National Health Service of Ukraine based on unified tariffs.

Products to combat COVID-19 are exempt from VAT and import duty

Importation and supply of certain pharmaceuticals, disinfectants, medical devices and personal protective equipment to combat COVID-19 are exempt from VAT and import duty based on Law No. 530-IX1 dated 17 March 2020 and Law No. 540-IX2 dated 30 March 2020. The list of exempted goods is set forth in Resolution of the CMU No. 2243 dated 20 March 2020 (as amended by Resolution of the CMU No. 2484 dated 29 March 2020). Customs clearance of such goods should be performed on a priority basis.

The exemption is temporary and is valid until termination of the quarantine introduced by the CMU.

As a matter of practice, the position of the customs authorities is that an importer may only enjoy this exemption for medical devices if the importer provides a letter from a healthcare facility/health department of local state administration confirming that the medical device is imported for the purpose of combating COVID-19.

Export of personal protective equipment is prohibited

The CMU prohibited export of certain personal protective equipment, including respirators and medical masks effective as of 22 March 2020. The list of goods prohibited for export is set forth in Resolution of the CMU No. 2235 dated 16 March 2020.

Relaxed conformity assessment requirements to medical devices and personal protective equipment

Based on Resolution of the CMU No. 2266 dated 20 March 2020, personal protective equipment, medical devices, in vitro diagnostics and active implantable devices set forth in Resolution of the CMU No. 2247 dated 20 March 2020 may be placed on the market without conducting conformity assessment set forth in applicable technical regulations.

To place products on the market in derogation of technical regulations, the applicant must submit to the State Labor Service of Ukraine (for personal protective equipment) or to the Ministry of Health of Ukraine (MOH) (for medical devices, in vitro diagnostics and active implantable medical devices) the application containing the following information: (i) purpose of importation, (ii) information on the manufacturer, (iii) name of the product, (iv) batch number or serial number, (v) batch volume, (vi) purpose of the product and (vii) mode of product's operation.

The State Labor Service of Ukraine or the MOH should issue a notification on introducing personal
protective equipment and devices into circulation in derogation of relevant technical regulations. The
notification should be issued on a free-of-charge basis. The term for issuing same notification is not
established.

The MOH clarified that to expedite the review of applications, it recommends submitting conformity certificates/declarations (if available) or a letter confirming that the products have not undergone conformity assessment procedure.

This measure is temporary and is valid for the validity period of the Law of Ukraine No. 530-IX8 "On Amending Certain Legislative Acts of Ukraine Aimed at Preventing Emergence and Spread of Coronavirus Disease (COVID-19)" dated 17 March 2020 ("Law on Combatting COVID-19").

Simplified procedure of public procurement of products to fight COVID-19

Based on the Law on Combatting COVID-19 and Resolution of the CMU No. 2259 dated 20 March 2020 (as amended by Resolution of the CMU No. 24810 dated 29 March 2020), procurement of goods, works and services required to combat COVID-19 may be performed based on an expedited and simplified procedure. Under same procedure, goods, works and services required to combat COVID-19 and itemized in Resolution of the CMU No. 22511 dated 20 March 2020 may be procured outside the Prozorro platform provided that the procurement report, procurement agreement and performance report are published on the Prozorro platform. The procurement entity is authorized to establish criteria for selecting successful bidders.

Off-label use and expedited procedure for approving registration and clinical trial applications of pharmaceuticals to treat COVID-19

Based on Law No. 539-IX12 dated 30 March 2020 ("Law No. 539-IX"), the Parliament of Ukraine permitted offlabel use of certain pharmaceuticals. The off-label use is permitted in case a pharmaceutical has proven efficiency in treating COVID-19 and/or if a pharmaceutical is recommended by the authorities of the USA, EU member countries, the UK, Switzerland, Japan, Australia, Canada, China or Israel for treatment of COVID-19. In addition, the Parliament of Ukraine permitted using unapproved pharmaceuticals if same pharmaceuticals are recommended by authorities of the states set forth above for treatment of COVID-19.

At the same time, Law No. 539-IX does not provide guidance as to the form in which the same authorities should recommend pharmaceuticals for treating COVID-19 or guidance on how proven efficiency of the product in treating COVID-19 should be confirmed. Apparently, these criteria remain to be clarified by the MOH.

Use of unapproved pharmaceuticals and off-label use of approved pharmaceuticals are only permitted subject to obtaining the patient's consent. Such pharmaceuticals should be used in compliance with clinical protocol to be approved by the MOH.

Finally, legal timelines for approving registration (variation) and clinical trials (significant amendment)
applications of pharmaceuticals for treating COVID-19 should be significantly reduced. Based on Law No. 539-IX, the CMU must ensure that registration (variation) applications are approved within seven calendar days, while clinical trial (significant amendment) applications are approved within ten calendar days. These legal timelines will become effective once the CMU amends Resolution of the CMU No. 376 "On Approval of the Procedure for State Registration (Re-Registration) of Pharmaceuticals and Amounts of State Fee for Registration (Re-Registration)" dated 26 May 2005, and the MOH amends orders No. 426 "On Approval of the Procedure for Evaluation of Registration Materials for Pharmaceuticals Submitted for State Registration (Re-Registration) and Evaluation of Materials on Variations to Registration Materials during the Term of Registration Certificate" dated 26 August 2005 and No. 690 "On Approval of the Procedure for Conducting Clinical Trials for Pharmaceuticals and Reviewing Clinical Trial Materials" dated 23 September 2009.

Guidance on conducting clinical trials in view of spread of COVID-19

The regulator for clinical trials (the State Expert Center of the Ministry of Health of Ukraine ("State Expert Center")) has issued recommendations regarding conducting clinical trials in view of the spread of COVID-19 and responses to common questions regarding same.

Among other things, the State Expert Center noted that sponsors/sites/investigators may take the following safety measures (subject to compliance with certain restrictions):

  • Remote monitoring, provided that this does not create an extra burden on trial sites, and the subjects consent to sharing their personal information outside the trial site
  • Temporary halt of a trial/recruitment of new subjects
  • Withdrawal of subjects from a trial
  • Direct-to-patient shipment of trial products
  • Transfer of participants to other sites
  • Laboratory testing in laboratories outside of the trial site or at a patient's home
  • Visiting patients at their residential address by investigators for clinical and diagnostic tests
  • Use of telemedicine technologies
  • When there is a need to re-consent, investigators may obtain oral informed consent supplemented with email confirmation. Any consent obtained this way should be documented and confirmed by way of normal consent procedures at the earliest opportunity when the trial participants will be back at the regular sites.

Finally, clinical audits by the State Expert Center scheduled for Q1 2020 were rescheduled to Q2 2020.

Recommendations of the Antimonopoly Committee of Ukraine

The Antimonopoly Committee of Ukraine (AMC) has provided recommendations to 53 importers, domestic manufacturers, distributors and pharmacy chains to refrain from any actions that result in increasing prices of imported and domestic products disproportionately to the increase of the foreign exchange rate. The AMC highlighted that the increase in the foreign exchange rate has been the main reason for price increases for many years but highlighted that the COVID-19 pandemic increases the risk of economically unjustified price increases and artificial shortages of goods.

In addition, the Kyiv territorial department of the AMC initiated proceedings based on alleged similar actions of suppliers and manufacturers of medical masks in Kyiv and the Kyiv region that have or may result in prevention, restriction or distortion of competition. According to the Kyiv territorial department of the AMC, the proceedings were initiated due to fast growth in prices for medical masks in the absence of objective reasons for the fast growth of expenses for producing and/or selling same products. The proceedings are ongoing.

Finally, the AMC stated that it is monitoring the advertising of pharmaceuticals and methods of prophylaxis related to COVID-19 pandemic. Considering that there is no formally approved treatment for COVID-19, advertising of pharmaceuticals or methods of prophylaxis claiming to treat or prevent COVID-19 will be treated by the AMC as dissemination of misleading information and unfair competition. This violation is punishable by a fine in the amount of 5% of proceeds for 2019.

This article can also be accessed here.

 


1 https://zakon.rada.gov.ua/laws/show/530-IX
2 https://zakon.rada.gov.ua/laws/show/540-20
3 https://ips.ligazakon.net/document/KP200224?an=1
4 https://ips.ligazakon.net/document/KP200248?an=16
5 https://ips.ligazakon.net/document/KP200223?an=1
6 https://ips.ligazakon.net/document/KP200226?an=1
7 https://ips.ligazakon.net/document/KP200224
8 https://zakon.rada.gov.ua/laws/show/530-20
9 https://ips.ligazakon.net/document/KP200225?an=1
10 https://ips.ligazakon.net/document/KP200248?an=17
11 https://ips.ligazakon.net/document/KP200225?an=1
12 https://zakon.rada.gov.ua/laws/show/539-20

 


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