P H A R M A M A R KE T
R E GU L ATORY UPDAT ES I N
JAN UARY 2 018
A New Register of Medicines Subject to
Reimbursement Approved
Within the government reimbursement program
“Affordable Medicines”, based on the results of
consideration of applications of manufacturers,
which were accepted from Jan 2, 2018 to Jan 11, 2018,
Order of the MOH of Ukraine No. 111 as of Jan 22,
2018 approved an updated Register of Medicines
Subject to Reimbursement.
The Register contains 239 items of medicines for the
treatment of cardiovascular diseases, diabetes of type
II and bronchial asthma, which is 41 more than in the
previous one.
Therefore, Order of the MOH No. 856 as of Jul 26th,
2017 has expired.
Introduction of the Medical Reform
On Dec 28, 2017, the President of Ukraine signed the
Law of Ukraine “On State Financial Guarantees for
the Provision of Medical Services and Medicines” and
the Law of Ukraine “On Increasing the Availability
and Quality of Medical Services in Rural Areas”.
These laws are the beginning of the medical reform,
and their adoption is long-awaited both in the
professional community and for patients.
The laws were off icially promulgated on Jan 3, 2018.
Moreover, the Law of Ukraine “On State Financial
Guarantees for the Provision of Medical Services
and Medicines” will come into force on Jan 30, 2018.
However, the Law of Ukraine “On Increasing the
Availability and Quality of Medical Services in Rural
Areas” has been in effect since Dec 31, 2017.
Changes to the Procedure for Realising
Preferential Drugs Adopted
On Jan 1, 2018, Resolution of the Cabinet of
Ministers No. 1009 of Dec 13, 2017 entered into force,
which amends Resolution of the Cabinet of Ministers
of Ukraine No. 1303 of Aug 17, 1998 “On Ordering
Gratuitous and Preferential Dispensing of Medicines
Prescribed by Doctors in the Case of Outpatient
Treatment of Individual Population Groups and for
Issue 29 Jan 2018
Certain Categories of Diseases”.
Thus, as a result of the adopted changes, pharmacies
have the right to release, free of charge and on
preferential terms, medicinal products registered
in Ukraine and included in the sectoral health
standards, regardless of whether they are included in
the National List of Essential Medicines.
We draw your attention to the fact that the list of
diseases for the treatment of which patients can
receive medicines free of charge and the list of
patients in the case of whose outpatient treatment
drugs prescribed by doctors are released free of charge
or on preferential terms, are approved in the annexes
to Resolution of the Cabinet of Ministers of Ukraine
No. 1303 dated Aug 17th, 1998.
A New Edition of the National List
Approved
On Dec 30, 2017, Resolution of the Cabinet of
Ministers of Ukraine No. 1081 dated Dec 13, 2017
came into force and approved the new edition of the
National List. The updated National List includes
427 INNs.
The project has been developed in accordance with
the recently adopted amendments to the Regulations
on the National List of Essential Medicines and
the Regulations on the Expert Committee on the
Selection and Use of Essential Medicines, which has
been mentioned here.
The National List in the revised edition will
become the basis for public procurement in 2018.
Subsequently, the National List will be supplemented
by new positions based on applications of
individuals and legal entities, in particular, holders
of registration certif icates, on the results of their
consideration by the Expert Committee. Applications
are accepted throughout the calendar year.
page 07