LIFE SCIENCES & HEALTHCARE IN UKRAINE
2017 in Review
-- Gulliver Business Center 1-A, Sportyvna sq. Kyiv 01601, Ukraine Tel. (38) 044 394 9040
HEALTHCARE REFORM . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Reform of the healthcare financing system . . . . . . . . . . . . . . . . . 3 E-Health: test mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Reorganisation of state-owned and municipal healthcare providers . . 5 Development of rural medicine . . . . . . . . . . . . . . . . . . . . . . . . 5 International clinical protocols & introduction of evidence-based medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Application of new clinical protocols . . . . . . . . . . . . . . . . . . . . 7
REFERENCE PRICING & REIMBURSEMENT . . . . . . . . . . . . . . . . . 8 Updated New National Essential Medicinal Products List . . . . . . . . . 8 Reimbursement Mechanism . . . . . . . . . . . . . . . . . . . . . . . . . 9 Maximum wholesale prices: DDD & external reference pricing . . . . . . 9 Affordable Medicinal Products Programme . . . . . . . . . . . . . . . . 10 Public procurement of medicinal products and medical devices . . . . 10 A new concept for the procurement of medicinal products and medical devices has been approved . . . . . . . . . . . . . . . . . . . . . . . . . 1 1
FAST-TRACK REGISTRATION OF MEDICINAL PRODUCTS . . . . . . . 1 1 Fast-track registration of medicinal products: timeline . . . . . . . . . 12
ANTI-CORRUPTION REGULATION . . . . . . . . . . . . . . . . . . . . . 13
YOUR CONTACTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Reform of the healthcare financing system
INSTITUTIONAL CHANGES --
Establishment of the National Healthcare Service of Ukraine (the "Service").
primary & tertiary
1 January 1 January
STATE GUARANTIES --
Programme of state guaranties of medical treatment for the public. The list and scope of healthcare services, devices and medicinal products to be financed from the state budget and provided to patients free of charge will be adopted annually as part of the state budget.
Payment for healthcare services provided to
patients in accordance with agreements
between healthcare providers and the Service
(effective from 2019).
Change in the model of financing the
healthcare system to the "money
follows the patient" principle: payment to healthcare providers
for healthcare services is to be based on unified
Collection and automatisation of processing medical and financial data on healthcare services provided to the public.
FREE CHOICE --
The patient's right to choose a doctor.
E-Health: test mode
Collection and automatisation of processing medical and financial data on healthcare services provided to the public
FINANCING E-Health allows for the implementation of a new model of financing the healthcare system in Ukraine to the "money follows the patient" principle.
PLANNING E-Health enables effective planning for the public procurement of healthcare services and medicinal products.
PERSONAL DATA PROTECTION
Access to patient's data subject to patient's consent UNLESS: there is a risk of mortality; consent cannot be obtained; pursuant to court decision.
of electronic medical information systems
E-Health testing -- (subject to consent and free of charge)
providing primary medical assistance
to provide primary medical
Participation of the Ministry of Health of Ukraine ("MoH")
in E-Health testing is mandatory.
Follow this link to E-Health website.
Reorganisation of state-owned and municipal healthcare providers
State-owned institutions State-owned enterprises
Municipal non-profit enterprises
Administrative and financial independence
Private healthcare providers are not limited in their choice of legal and organisational form. The privatisation of state-owned and municipal healthcare providers is not allowed.
Establishment of supervisory boards in state-owned and municipal healthcare providers.
Transparent and competitive selection and appointment of heads of stateowned and municipal healthcare providers.
Healthcare services should be provided to the public under agreements between the administrators of public funds and healthcare providers. Healthcare providers may provide healthcare services beyond the scope of the above-mentioned agreements based on separate fees (effective
from 1 January 2018).
Development of rural medicine
Development of healthcare
Telemedicine Additional social
guaranties and rewards for HCPs
Recruitment of qualified HCPs Advanced training for HCPs Development of telecommunication infrastructure & adoption of modern technologies
International clinical protocols & introduction of evidence-based medicine
The MoH is entitled to select the clinical guidelines to be applied in Ukraine as clinical
protocols without their
New clinical protocols are mandatory if there is no unified clinical protocol for the same illness and provided that such protocols are translated into Ukrainianand
approved by the MoH
Application of international clinical protocols
New clinical protocols are to be approved regardless of the existence or absence of a unified clinical
protocol for the same illness
New clinical protocols and standards of medical intervention (unified clinical protocols) may be introduced via elaboration of clinical
* The approved MoH list of clinical guideline sources is available here (in Ukrainian only).
Application of new clinical protocols
If a new clinical protocol and a unified clinical protocol exist concurrently for the same illness
the new clinical protocol may be applied subject to the
patient's consent* and doctor's clarification as to the
difference between concurrent protocols;
the application of a new clinical protocol excludes the application of the unified clinical protocol.
If there are, concurrently, new clinical protocols for the same illness
the doctor shall choose one of the concurrent clinical protocols;
the doctor shall notify the patient of his / her decision.
If full compliance with a new clinical protocol is impossible due to the unavailability of certain medicinal products, medical devices, etc.
the doctor shall notify the patient of healthcare institutions that can provide healthcare services in full compliance with the new clinical protocol; the doctor shall prescribe available generics / analogous medical devices / technologies (subject to the prior consent of patient); the doctor shall notify the healthcare department at the local state authorities of any inability to fully comply with the new clinical protocol.
* The approved MoH form of consent is available here (in Ukrainian only).
REFERENCE PRICING & REIMBURSEMENT
25 March 2017
-- the New National Essential Medicinal Products List ("NEML")
1 January 2018 -- the updated NEML
Until 1 January 2019
-- NEML is not applied to pilot project for reimbursement of insulins at a level not exceeding the reference price
1 April 2017 -- start of Affordable Medicinal
1 January 2018
-- state-owned and municipal healthcare providers are to procure medicinal products from the updated NEML
* Reimbursement of medicinal products for cardiovascular diseases, type II diabetes and
Updated New National Essential Medicinal Products List
NEML is based on the WHO Model List of Essential Medicines.
Maximum wholesale prices and retail margin for the retail market are to be applied to medicinal products listed on NEML.
NEML is to be applied to public procurement / reimbursement BUT
NEML is not applied to procurement through specialised procurement organisations;
NEML is not applied to the pilot project for reimbursement of insulins;
Medicinal products beyond NEML may also be procured if demand requirements are met;
Resolution No 1303 for a transition period: medicinal products beyond NEML may be procured and reimbursed if such medicinal products are registered in Ukraine and used pursuant to healthcare industry best practices.
Undertaking shall apply to public-fund administrators
Undertaking concludes agreement with public-fund administrators
Undertaking is to be included into register
Undertaking sells medicinal products to patients subject to medical prescription
Full or partial reimbursement
Undertaking reports to public-fund administrators on sales of medicinal products in the MoH approved form (twice a month)
The reimbursable price of a medicinal product shall not exceed the maximum wholesale price approved by the MoH.
The registry of maximum wholesale prices in Ukraine is available here (in Ukrainian only).
Maximum wholesale prices: DDD & external reference pricing
DDD* = Dose of a unit of PDF** /
Calculation of DDD quantum
Calculation of price for PDF
Registered price = registered price for a pack / number of units per pack
Medicinal product's DDD price = Registered price / DDD amount
Calculation of a medicinal product's DDD price in reference
Calculation of reference price
in reference countries
Reference price = Median (Medicinal product's DDD price1 ... Medicinal product's DDD priceN)
DDD maximum wholesale price = Median (Reference price1 ... Reference priceN)
Calculation of DDD maximum
* DDD is the assumed average maintenance dose per day for a medicinal product used for
its main indication in adults.
** PDF Pharmaceutical Dosage Form. *** Reference countries Poland, Hungary, Czech Republic, Latvia and Slovak Republic.
Affordable Medicinal Products Programme
On 1 April 2017, reimbursement of medicinal products for cardiovascular diseases, type II diabets and bronchial asthma started.
198 -- medicinal
6,179 -- pharmacies
UAH 700 million --
of budgeted funds in 2017
Register of Reimbursable
Medicinal Products is being updated
From 100,000 to 200,000 -- patients monthly
UAH 1 billion --
of budgeted funds in 2018
It is expected that starting from 1 January 2018, medicinal products for chronic diseases UPD! of the stomach and duodenum, depression and depressive syndromes, prevention and
treatment of anaemia in the first trimester of pregnancy are also to be reimbursed.
Public procurement of medicinal products and medical devices
Specialised procurement organisations in 2017
United Nations International Children's
United Nations Development Programme
Crown Agents Limited
The list of medicinal products and medical devices subject to procurement by international specialised organisation has been extended.
Please follow this link to download the list and amendments to it (in Ukrainian only).
A new concept for the procurement of medicinal products and medical devices has been approved
Independent centralised procurement organisation established by the MoH
Pilot procurement projects
E-platform for procurement of medicinal products & medical devices at the national level
Exchange of experience with the relevant EU organisations
The procurement organisation will be entitled:
Independent centralised procurement organisation will start to procure medicinal products & medical devices
to procure medicinal products and medical devices at the national, local and international levels
to provide advisory support to customers
if there is a need to procure from international suppliers
to import medicinal products and medical devices, and
involve other organisations for their customs clearance, storage and distribution
FAST-TRACK REGISTRATION OF MEDICINAL PRODUCTS
Fast-track registration of medicinal products already registered in the US, Switzerland, Japan, Australia, Canada, and the EU.
The State Enterprise "State Expert Centre of the Ministry of Health of Ukraine" (the "Centre") reviews registration materials.
Registration within 17 days upon submition of the required registration materials to the Centre.
The Centre may request additional documents and information, which the applicant shall provide within 30 days.
Five years after its initial registration a medicinal product shall be re-registered. Thereafter the term for medicinal product trade is not limited, unless the MoH requires
additional registration after another five years.
Certain discrepancies with the reference dossier are acceptable.
Fast-track registration of medicinal products: timeline
application to the MoH in
a due form**
Applicant concludes an agreement with the
Centre on review of application
Applicant submits required registration
materials to the
The Centre reviews materials, checks information on
registration in reference
The MoH decides on registration of medicinal
product / refusal to register
1 DAY 14 DAYS 7 DAYS 10 DAYS 7 DAYS
The MoH provides a copy of application to the Centre
Applicant pays the Centre for review of documents
Application and materials are to be registered in an E-database
The Centre executes its
report in a due form**
* Applicant owner of the registration certificate and / or its representative. ** The approved MOH form is available here (in Ukrainian only). *** List of required documents is available here (in Ukrainian only). **** Websites are available at the following links: U.S. Food and Drug Administration,
Swissmedic, PMDA, TGA, Health Canada, European Medicines Agency.
Starting from 1 January 2018, public healthcare institutions are required to disclose information on charitable donations:
in a public place at the healthcare institution
on the official website of the healthcare institution and / or website of the authorities controlling the relevant institutions
* The approved MoH form is available here (in Ukrainian only).
in a form specified by
Certain categories of legal entities are required to put into effect an anti-corruption programme:
Any public / municipal company or business and companies with a state / municipal share of over 50
average number of recorded employees in the referred financial year exceeds 50
gross revenues derived from sales for such a period exceed UAH 70 million (approximately EUR 2.4 million)
All legal entities (irrespective of the form
of their ownership)
engaged in public procurement
cost of procurement exceeds UAH 20 million (approximately EUR 700,000)
The above-mentioned categories of legal entities shall adopt anti-corruption programmes based on the Model Anti-Corruption Programme approved by National Agency on Corruption Prevention.
External assessment at least once every
Internal assessment at least once
Compliance officer reports to management at least once
Detection of corruption risks
Internal and external corruption risks are distinquished in the Model Anti-Corruption Programme.
Toms Cihula Counsel, Head of Life Sciences & Healthcare Kinstellar Prague -- email@example.com T.: +420 221 622 233
Managing Partner Kinstellar Kyiv -- firstname.lastname@example.org T.: +380 44 394 9040
Associate Kinstellar Kyiv -- email@example.com T.: +380 44 394 9040