Health Care Committee

The Committee was established in 2000 as a platform for discussing health care system issues. The Committee members cover companies involved in researching, developing and manufacturing pharmaceutical products, medical equipment and devices and conducting clinical trials in Ukraine.

Follow the committee

Advocacy Diary

Meetings
Letters
21/06/2018
Health Care

Natalia Sergienko, Executive Director of the Health Committee of the European Business Association, was the…

12:00
12:00
13/12/2017
Health Care

MOH leadership commented on key issues for the pharmaceutical community

15:00
15:00
27/09/2017
Health Care, Clinical Trials

Clinical Trials Subcommittee (CTS) held a semiannual summary meeting. The representatives of top-management of 33…

14:19
14:19
25/07/2017
Health Care

The Steering Committee members (EBA HCC members) met with the Consortium of Consultants on the…

23:22
23:22
24/07/2017
Health Care, Clinical Trials

EBA Clinical Trials Subcommittee Board representatives met with the leadership and leading experts of the…

23:23
23:23
07/06/2017
Health Care

MOH State Expert Center and EBA agreed a number of issues on drugs’ registration

11:35
11:35
20/05/2017
Health Care, Clinical Trials

Congratulations on International Clinical Trials Day!

18:07
18:07
04/04/2017
Health Care, Clinical Trials

EBA Clinical Trials Subcommittee held a wide-format meeting with the leadership of the State Expert…

16:52
16:52
17/03/2017
Health Care

EBA HCC Registration Subcommittee Head Angela Kupich and EBA HCC Executive Director Natalia Serhienko took…

20:31
20:31
16/03/2017
Health Care

EBA HCC Medical Devices Subcommittee Head Elizaveta Volobueva took part in the meeting with Yevhen…

20:31
20:31
Health Care

EBA HCC Executive Director Natalia Serhienko took part in the Workshop on the Essential Medicines…

20:09
20:09
15/03/2017
Health Care

EBA HCC representatives met with Pavlo Kovtonyuk, Deputy Minister of Health of Ukraine, andn Yuriy…

20:10
20:10
14/03/2017
Health Care

EBA HCC Executive Director Natalia Serhienko took part in the meeting of Public Council at…

20:09
20:09
03/03/2017
Health Care

EBA HCC Head Georgiy Viktorov took part in the meeting with Volodymyr Groysman, Prime Minister…

20:13
20:13
Health Care

EBA HCC experts met with the experts of the Ministry of Economy and Trade and…

20:09
20:09
21/06/2018
Health Care

Natalia Sergienko, Executive Director of the Health Committee of the European Business Association, was the moderator on session “Establishment of the National Health Service of Ukraine”, which was attended by Oleg Petrenko, Head NSZU during Ukrainian Pharmaceutical Congress June 21, 2018.

12:00
12:00
13/12/2017
Health Care

MOH leadership commented on key issues for the pharmaceutical community

15:00
15:00
27/09/2017
Health Care, Clinical Trials

Clinical Trials Subcommittee (CTS) held a semiannual summary meeting. The representatives of top-management of 33 CTS member-companies were traditionally present at this special EBA meeting. Such meetings are regularly organizedon biannual basis. During the meeting the Q1-3 results were presented.

14:19
14:19
25/07/2017
Health Care

The Steering Committee members (EBA HCC members) met with the Consortium of Consultants on the EBRD project devoted to the improvement of the pharmaceutical sphere legislation to discuss the project progress and further steps.

23:22
23:22
24/07/2017
Health Care, Clinical Trials

EBA Clinical Trials Subcommittee Board representatives met with the leadership and leading experts of the State Expert Center of the Ministry of Health and discussed topical issues such as

23:23
23:23
07/06/2017
Health Care

MOH State Expert Center and EBA agreed a number of issues on drugs’ registration

11:35
11:35
20/05/2017
Health Care, Clinical Trials

Congratulations on International Clinical Trials Day!

18:07
18:07
04/04/2017
Health Care, Clinical Trials

EBA Clinical Trials Subcommittee held a wide-format meeting with the leadership of the State Expert Center of the Ministry of Health of Ukraine – Tetiana Dumenko, Liudmyla Kovtun and leading experts. Such meeting provided an opportunity to Subcommittee company members to raise questions and receive professional answers, also to receive a feedback on state enterprise operations.

16:52
16:52
17/03/2017
Health Care

EBA HCC Registration Subcommittee Head Angela Kupich and EBA HCC Executive Director Natalia Serhienko took part in the SEC Workshop “Reasons for changes and current requirements for Ukrainian pharmacovigilance legislation”.

20:31
20:31
16/03/2017
Health Care

EBA HCC Medical Devices Subcommittee Head Elizaveta Volobueva took part in the meeting with Yevhen Kapinus, State Secretary of the Ministry of Finance of Ukraine on the Draft Law No.3180 and the possibility for the single 7% VAT rate for medical devices.

20:31
20:31
Health Care

EBA HCC Executive Director Natalia Serhienko took part in the Workshop on the Essential Medicines List with the representatives from of MOH and SEC.

20:09
20:09
15/03/2017
Health Care

EBA HCC representatives met with Pavlo Kovtonyuk, Deputy Minister of Health of Ukraine, andn Yuriy Bugay, E-Health Project Office Coordinator to discuss E-Health implementation in Ukraine.

20:10
20:10
14/03/2017
Health Care

EBA HCC Executive Director Natalia Serhienko took part in the meeting of Public Council at the State Administration of Ukraine on Medicinal Products and Drugs Control.

20:09
20:09
03/03/2017
Health Care

EBA HCC Head Georgiy Viktorov took part in the meeting with Volodymyr Groysman, Prime Minister of Ukraine to raise the issue of free circulation of drugs.

20:13
20:13
Health Care

EBA HCC experts met with the experts of the Ministry of Economy and Trade and MOH to discuss methods of price calculation in the context of the new regulations.

20:09
20:09
11/06/2019
Consumer Electronics, Retail, Food, Regulatory Affairs, Health Care, Wine and Spirits

Re:  Law of Ukraine “On ensuring the functioning of the Ukrainian language as a state”…

13:00
13:00
13/03/2017
Health Care

Re: main problematic issues of new MOH Order on Pharmacovigilance
To: Director of the…

17:59
17:59
Health Care

Re: format for the conformity assessment body’s ID-number that should be followed by applicants

15:57
15:57
10/03/2017
Health Care

Re: amendments to the Technical Regulations as regards the medical devices combined with a medical…

10:56
10:56
06/03/2017
Health Care

Re: draft amendments on reference pricing and reimbursement placed on MOH website for public discussion…

14:53
14:53
27/02/2017
Health Care

Re: Draft Law No.6012 dated 1 February 2017 that cancels VAT for local manufacturers

10:48
10:48
20/02/2017
Health Care

Re: MOH clarifications as regards the necessity to submit sanitary epidemiological conclusion during the customs…

13:45
13:45
16/02/2017
Health Care

Re: format of the conformity assessment body’s ID number that should be followed by manufacturers

10:40
10:40
15/02/2017
Health Care

Re: the list of documents for medical devices to be checked during the customs clearance…

16:38
16:38
14/02/2017
Health Care

Re: results of the meeting dated 6 February 2017 as regards the Draft MOH Order…

15:37
15:37
Health Care

Re: meeting request as regards the 7% VAT rate for medical devices
To: State…

10:32
10:32
09/02/2017
Health Care

Re: the need to elaborate the mechanisms of reference pricing and reimbursement
To: Prime…

10:23
10:23
27/01/2017
Health Care

Re: results of the meeting dated 26 January 2017 and further actions to introduce reference…

10:14
10:14
25/01/2017
Health Care

Re: results of the meeting on registration issues dated 13 January 2017 and further cooperation

15:10
15:10
Health Care

Re: EBA HCC proposals to the Draft MOH Order ‘On Approval of the Register of…

09:09
09:09
11/06/2019
Consumer Electronics, Retail, Food, Regulatory Affairs, Health Care, Wine and Spirits
Re:  Law of Ukraine “On ensuring the functioning of the Ukrainian language as a state” N...
13:00
13:00
13/03/2017
Health Care

Re: main problematic issues of new MOH Order on Pharmacovigilance
To: Director of the State Expert Center, Ms Tetiana Dumenko

17:59
17:59
Health Care

Re: format for the conformity assessment body’s ID-number that should be followed by applicants
To: Deputy Minister of Health of Ukraine, Mr Roman Ilyk

15:57
15:57
10/03/2017
Health Care

Re: amendments to the Technical Regulations as regards the medical devices combined with a medical drug prepared by SEC
To: Deputy Minister of Health of Ukraine, Mr Roman Ilyk

10:56
10:56
06/03/2017
Health Care

Re: draft amendments on reference pricing and reimbursement placed on MOH website for public discussion on 23 February 2017
To: First Vice Prime Minister – Minister of Economic Development and Trade of Ukraine, Mr Stepan Kubiv, Deputy Minister of Health of Ukraine, Mr Roman Ilyk

14:53
14:53
27/02/2017
Health Care

Re: Draft Law No.6012 dated 1 February 2017 that cancels VAT for local manufacturers
To: Chairman of the Verkhovna Rada of Ukraine, Mr Andriy Porubiy, Chair of the Committee on Taxation and Customs Policy of the Verkhovna Rada of Ukraine, Ms Nina Yuzhanina, Head of the Parliamentary Faction “Petro Poroshenko Bloc”, Mr Igor Gryniv

10:48
10:48
20/02/2017
Health Care

Re: MOH clarifications as regards the necessity to submit sanitary epidemiological conclusion during the customs clearance
To: Deputy Minister of Health of Ukraine, Mr Roman Ilyk

13:45
13:45
16/02/2017
Health Care

Re: format of the conformity assessment body’s ID number that should be followed by manufacturers
To: First Vice Prime Minister – Minister of Economic Development and Trade of Ukraine, Mr Stepan Kubiv, Head of the State Service of Ukraine on Medicines and Drug Control, Ms Natalia Gudz

10:40
10:40
15/02/2017
Health Care

Re: the list of documents for medical devices to be checked during the customs clearance starting from the 1st of July 2017
To: Head of the State Fiscal Service of Ukraine, Mr Roman Nasirov

16:38
16:38
14/02/2017
Health Care

Re: results of the meeting dated 6 February 2017 as regards the Draft MOH Order ‘On Approval of the Register of Persons Authorized to Introduce the Medical Devices, Active Medical Devices and Medical Devices for In Vitro Diagnostics’

15:37
15:37
Health Care

Re: meeting request as regards the 7% VAT rate for medical devices
To: State Secretary of the Ministry of Finance of Ukraine, Mr Yevhen Kapinus

10:32
10:32
09/02/2017
Health Care

Re: the need to elaborate the mechanisms of reference pricing and reimbursement
To: Prime Minister of Ukraine, Mr Volodymyr Groysman, Minister of Cabinet of Ministers, Mr Oleksandr Saenko, Acting Minister of Health of Ukraine, Ms Ulana Suprun

10:23
10:23
27/01/2017
Health Care

Re: results of the meeting dated 26 January 2017 and further actions to introduce reference pricing and reimbursement
To: Minister of Cabinet of Ministers, Mr Oleksandr Saenko

10:14
10:14
25/01/2017
Health Care

Re: results of the meeting on registration issues dated 13 January 2017 and further cooperation
To: Director of the State Expert Center, Ms Tetiana Dumenko

15:10
15:10
Health Care

Re: EBA HCC proposals to the Draft MOH Order ‘On Approval of the Register of Persons Authorized to Introduce the Medical Devices, Active Medical Devices and Medical Devices for In Vitro Diagnostics’

09:09
09:09

Committee board

Chair

GeorgiyViktorov

Abbott Laboratories GmbH

AndriiStognii

Santen Oy

EvgeniyGaidukov

LLC AstraZeneca Ukraine

Registration Subcommittee

AngelaKupych

Maxima Health Research

Medical Devices Subcommittee

HennadiySergeev

BMT UA

Clinical Trials Subcommittee

LarisaSholokhova

Johnson & Johnson

Committee priorities

Ensure advertising and promoting of medical drugs based on the EU legislation and ensure equal competition for all market players
Harmonize legislation with the relevant EU legislation, remove barriers to the market access and circulation of medical drugs
Harmonize legislation in the clinical trials sphere and improve the image of clinical trials in Ukraine
Improve legislative framework, market access and circulation of medical devices
Clinical Trials Subcommittee
Medical Devices Subcommittee
Registration Subcommittee

Clinical Trials Subcommittee unites CRO and R&D pharmaceutical companies. It meets every third Tuesday of the month. The main activity of the Subcommittee is focused on the conduction of clinical trials in Ukraine, harmonization of the regulatory base in the respective sphere by cooperating with the state bodies.

Larisa Sholokhova – Co-Head of HCC Clinical Trials Subcommittee, 2019-2020; Serhiy Mykhaylov – Co-Head of HCC Clinical Trials Subcommittee, 2019-2020

Subcommittee priorities for 2019 were defined as:

  • facilitation of environment in the sphere of conduction of clinical trials in Ukraine;
  • cooperation with media for the improvement of public awareness and creation of positive image over the conduction of clinical trials in Ukraine;
  • lobbying the amendments to the respective regulations on the exemption of import of investigated medical drugs form VAT;
  • cooperation with government agencies;
  • cooperation with international Clinical trials organizations.

Subcommittee meetings take place upon necessity. Medical Devices Subcommittee is chaired by Hennadiy Sergeev.

The main activity is focused on the import and circulation of medical devices and equipment at the Ukrainian market.

Subcommittee priorities for 2019 were defined as:

  • simplification of the conformity assessment procedure for those medical devices, which possess EU certificates;
  • cooperation with the state authorities to improve the legislative framework in the area of medical devices.

Subcommittee meetings take place upon necessity. Registration Subcommittee is chaired by Angela Kupych.

The Subcommittee’s activity is focused on medical drugs’ accession and circulation issues.

Subcommittee priorities for 2019 were defined as:

  • harmonization of the medical drugs’ registration procedure with that of the European Union;
  • improvement of medical drugs’ quality control at different stages;
  • encouragement of amendments to the Ukrainian legislation for ensuring equal competition for all market players.
  • promote the best European practices in the pharmacovigilance area.

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