5/24/2010

Health Financing
Application of Budget
Impact Analysis in
Russian Health Care
System
y What is next?
Andrey Kulikov How to spend money?
Senior Researcher, Laboratory of Pharmacoeconomics
I.M. Sechenov Moscow Medical Academy On what?
May 17, 2010

Possible Options
Disease Approach

• Selection of the most widespread diseases (arterial

Disease approach hypertension, etc.) for priority financing using
preliminary pharmacoeconomic analysis.
and/or •Selection of the most expensive diseases (breast
cancer, etc.) for priority financing using preliminary
medicinal approach? pharmacoeconomic analysis.

Medicinal Approach Budget Impact Analysis

Recent innovations make impossible things

ordinary
• Selection of new drugs for treatment of new disaeses
(Cinacalcet for the treatment of secondary Cultured human ear

hyperparathyroidism in patients with terminal stage of

chronic renal failure on dialysis, etc.) for priority
financing using preliminary pharmacoeconomic
analysis.
How much should we
pay for these
benefits?

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 5/24/2010

Budget Impact Analysis Actually

there are two financing issues

Increased life expectancy

due to new drugs leads to
Budget Impact
increase in costs How much?
Analysis

Is it good Cost-
investment of effectiveness
money? analysis
y
Forecast of the annual number of
patients with breast cancer, who
require Herceptin for 20 years (2000-
2020)

The Concept of Budget The Concept of Budget

Impact Analysis Impact Analysis

•This type of analysis involves assessment of all costs
related to the introduction of new medical technologies
or drugs in current practice taking into account its
efficiency
•Cost estimation is based on the actual frequency of
new technology application and per-use cost
•The final result is the sum of money you can either
save or spend on the application of the estimated
medical technology
•Budget impact analysis (BIA) is used to keep informed
decision-makers and persons responsible for all budget
levels
• The concept of BIA is based on the request of the
budget recipient – to determine the level?
•Opposed to CEA where concept depends on the needs
of society, BIA should be sufficiently flexible to evaluate
different combinations of treatment depending on the
object of research – for example, Nurses Service
Organization

The Concept of Budget Current conditions Key factor Influence on New conditions

Impact Analysis General group of patients

NEW
General group of patients

Distribution area Preventive interventions

NEW
•Health budget may have very narrow focus – for Patients Patients

example, national programs % of diagnosed Diagnosis

% in treatment Treatment
•The model can cover various budget items as wide as Target
g group
g p of patients
p
NEW
Target
g ggroup
p off ppatients
possible – for example, including hospice or without it
Hospitalization
Current treatment
•In this case BIA will be able to provide both all Examination
Another treatment Consumable
NEW resources
Consumable resources
necessary information to decision-makers and complete (in-patient,
(in-patient,
out-patient,
overview of the economic impact of innovation out-patient,
appointment to physician)
appointment to physician
introduction in clinical practice – for example, the Cost of unit New treatment
or procedure
additional birth of children NEW
Cost of disease
Cost of disease DIFFERENCES

Budget Impact Analysis

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Budget Impact Budget Impact

Analysis Analysis
Universal models for federal and regional levels
The obtained results in the hypothetical region /RF in general
(for example, vaccination against tick-borne encephalitis, prognosis for 16
depending on the introduced variables
years )
Region
persons from 12 to 50 years old 650 MAIN RESULTS of modeling for 16 years
Encepur (1p/1 dosage), rub
persons from 50 years and older 650
Population persons from 12 to 49 years old 50000
The cost of 1 prevented case of tick-borne encephalitis, rub. 3 046 875
persons from 50 years and older 50000
Morbidity, % persons from 50 years and older 0,01 The cost of one saved year of life, rub. 7 169 118
persons from 50 years and older 0,01
The level of deaths, depending on the strain (from 0,5 to 20%),% 0,5 The cost of one prevented case of disability, rub. 6 093 750
Long-term neurological disorders leading to disability , % 50
The data for calculating the loss in GDP Budget impact, savings, rub. 3 101 033 710
GDP in 2008 (Rosstat preliminary data ) (trillion,) 41,54
Population of Russia (mln) 142 Discounting (5%)
Number of working days in 2008 250
Budget impact, savings, rub. 1 364 847 636
Number of disability days (light and moderate disorders): 30
Ягудина Р.И., Куликов А.Ю., 2009 Ягудина Р.И., Куликов А.Ю., 2009

Budget Impact
One of Created Models
Analysis

Ягудина Р.И., Куликов А.Ю., 2009 Ягудина Р.И., Куликов А.Ю., 2008

Interface of Online Calculator

Budget Impact Analysis OPTIMA-2010

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Pharmacoeconomics of alcoholism Concept

Cooperation with IMS Health

Pharmacoeconomics of alcoholism Data Sources Pharmacoeconomics of alcoholism Analysis of direct costs

Data on the economic burden of

alcoholism in the Russian Federation were
obtained by mathematical calculations
taking into account the results of
information retrieval in the following
databases: Consultant Plus,
Plus, Pub Med
Med,,
Medline,, Central Scientific Medical Library
Medline Library,,
as well as open on-
on-line databases
databases..

Total costs
5 649 016 421,40р.

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Pharmacoeconomics of alcoholism Analysis of direct costs Pharmacoeconomics of alcoholism Analysis of indirect costs
Comparative characteristics costs on treatment Comparative characteristics of public indirect costs as a result of
of alcoholism clinical consequences excessive alcohol consumption by population

Total costs
251 870 245 766,40р.
Total costs
146 337 824 857,49р.

Pharmacoeconomics of alcoholism

The economic burden of

alcoholism
648 866 709 297 rubles annually

It is equivalent to 1,98 %
of GDP in RF

Special Journal and

Website

Thank You
for Your attention

Andrey Kulikov
Senior Researcher, Laboratory of Pharmacoeconomics
I.M. Sechenov Moscow Medical Academy
7677041@mail.ru

May 17, 2010

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Health Care Spending in Russia

Federal Law “On in 2005-2009
Circulation of Drugs”
Current Situation in
Chelyabinsk Region
O.V. Pribytkova
Chairman of the RSPOR Chelyabinsk Branch , Chief Freelance Clinical
Pharmacologist in Chelyabinsk, C.M.S.
A.M. Ustyugova, Deputy Head Of The Drug and Medical Equipment Supply
Management of the of the Ministry of Health in the Chelyabinsk region, C.Ph.S.
21.05.2010.

Source: Министерство финансов России, Институт проблем общественного здравоохранения (из доклада «Российский фармацевтический рынок в
период нестабильного экономического развития» к.ф.н. Давид Мелик-Гусейнова,генерального директора «Фармэксперта Аналитика и Консалтинг»,
каф. организации лекарственного обеспечения ММА им.Сеченова И.М.,ГУ ВШЭ Институт коммуникационного менеджмента)

Structure of the Russian Drug Market in 2009

Russian pharmaceutical market,
imported / domestic drugs 2007 - 2009 (mln. rub.)
498 500
+22,5%
in money terms in kind

+30%

imported domestic
Источник: ЦМИ «Фармэксперт» (из доклада «Российский фармацевтический рынок в период нестабильного экономического развития» к.ф.н. Давид Мелик-
Источник: ЦМИ «Фармэксперт» (из доклада «Российский фармацевтический рынок в период нестабильного экономического развития» к.ф.н. Давид Мелик- Гусейнова,генерального директора «Фармэксперта Аналитика и Консалтинг», каф. организации лекарственного обеспечения ММА им.Сеченова И.М.,ГУ
Гусейнова,генерального директора «Фармэксперта Аналитика и Консалтинг», каф. организации лекарственного обеспечения ММА им.Сеченова И.М.,ГУ ВШЭ ВШЭ Институт коммуникационного менеджмента
Институт коммуникационного менеджмента

The Share of Orphan Drugs

in the Russian Pharmaceutical Market
in monetary terms
CHELYABINSK
REGION

* ЦМИ «Фармэксперт»предварительные данные (из доклада «Российский фармацевтический рынок в период нестабильного экономического
развития» к.ф.н. Давид Мелик-Гусейнова,генерального директора «Фармэксперта Аналитика и Консалтинг», каф. организации лекарственного
обеспечения ММА им.Сеченова И.М.,ГУ ВШЭ Институт коммуникационного менеджмента

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The Consumption of Drugs Per Capita, TOP-10 Sales in the Commercial Sector
in money terms in the I-III quarters of 2009
in money terms
№ Yekaterinburg Omsk Chelyabinsk Tyumen Moscow RF

1 Heptral Arbidol Nurofen Arbidol Oscillococcinum Arbidol

2 Arbidol Yarina Arbidol Nurofen Arbidol Essentiale

3 Essentiale Viagra Actovegin VITRUM Linex Viagra

4 Ursosan Theraflu Viagra Theraflu Nurofen Actovegin

5 Plavix Pentalgin Terpincod Essentiale Essentiale Linex

6 Detralex Essentiale Broncholytin Viagra Viagra Pentalgin

Oscillococcinu
7 VITRUM VITRUM VITRUM Linex Cialis m

8 Linex Anaferon Concor Pentalgin Theraflu Theraflu

9 Xenical Actovegin Theraflu Actovegin VITRUM Mezim Forte

По данным ЦМИ «Фармэксперт» (из доклада проф.Р.И.Ягудиной зав. лабораторией фармакоэкономики,зав. 10 Actovegin Mildronate Pipolfen Heptral Xenical VITRUM
кафедрой лекарственного обеспечения с курсом фармакоэкономики ММА им. И.М. Сеченова)
Source: “Pharmexpert” За I-III кварталы 2009 г.

TOP-10 Sales in the Commercial Sector TOP-10 Sales in the DLO Sector
in kind in the I-III quarters of 2009 in money terms
Yekaterinburg Omsk Chelyabinsk Tyumen Moscow RF
Activated Activated Sverdlovsk Omsk Chelyabinsk Tyumen
Ascorbic acid Naftizin Citramon Activated Carbon Carbon Carbon # region region region region Moscow RF
Activated Activated 1 Oktanate Oktanate Velcade Gleevek Oktanate Velcade
Carbon Ascorbic acid Carbon Citramon Citramon Citramon
2 Velcade Gleevek Oktanate Velcade Velcade Oktanate
Acetylsalicylic
Citramon Activated Carbon Ascorbic acid Ascorbic acid Ascorbic acid acid 3 Gleevek Velcade Cerezyme Oktanate Gleevek Gleevek
4 Betaferon Betaferon Betaferon Рисполепт Mabtera Mabtera
Ferrogematogen Citramon Korvalol Naftizin Naftizin Ascorbic acid
5 Mabtera Novomiks Gleevek Temodal Arimidex Betaferon
Acetylsalicylic
Naftizin Valerian acid Ferrogematogen Вalidol Naftizin 6 Copaxone Copaxone Mabtera Rebif Lantus Copaxone

Acetylsalicylic 7 NovoSeven Rispolept Copaxone Symbicort Copaxone NovoSeven

Korvalol acid Valerian Paracetamol Korvalol Korvalol
8 Eprex Levemir Rebif Copaxone Eprex Eprex
Valerian Ferrogematogen Paracetamol Valerian Analgene Analgene
9 Hemoctin NovoRapid Hemoctin Betaferon Hemoctin Hemoctin
Acetylsalicylic
Paracetamol Analgene Naftizin acid Valerian Valerian 10 Cerezyme Lantus Seretide Eprex NovoSeven Lantus

Validol Korvalol Analgene Cough tablets Arbidol Paracetamol

Analgene Hawthorn Validol Validol Peroxide Validol

По данным ЦМИ «Фармэксперт» (из доклада проф.Р.И.Ягудиной зав. лабораторией фармакоэкономики,зав. кафедрой лекарственного
обеспечения с курсом фармакоэкономики ММА им. И.М. Сеченова) . Source: “Pharmexpert” in the I-III quarters of 2009

TOP-10 Sales in the DLO Sector Dynamics of the Average Packaging Cost
in kind
in the Commercial Sector
Sverdlovsk Chelyabinsk Omsk Tyumen
# region region region region Moscow RF
1 Enalapril Enalapril Enalapril Renipril Enalapril Enalapril

2 Amlodipine Vinpocetine Lisinopril Lisinopril Enap Enap

3 Tramadol Tramadol Amlotop Aminazin Mezim Forte Indapamide

4 Berodual Kardiket Phenobarbital Amlotop Kardiket Lisinopril

5 Indapamide Humulin Cordipin Pentalgin Atenolol Vinpocetine

6 Veroshpiron Piracetam Indapamide Pektrol Vinpocetine Kardiket

7 Kardiket Vasocardin Kardiket Cordipin Ketonal Mezim Forte

8 Cardiask Acecardol Diabeton Enap Amlotop Humulin

9 Beclasone Diclofenac Vasocardin Enalapril Glucophage Piracetam

Hydrochlorothiaz
10 ide Renipril Tramadol Vasocardin Indapamide Maninil

Source: “Pharmexpert” in the I-III quarters of 2009 Source: “Pharmexpert” *in the I-III quarters of 2009

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Dynamics of the Average Packaging Cost The Russian Pharmaceutical Market: in crisis

in the DLO Sector

“…various intermediaries in
regions must have a heart! The
task of Governors is to solve the
problem with trade markup for
imported and domestic drugs, to
k
keep it iin some reasonable
bl lilimits.
it
If Governors do not do it,
I promise that law-enforcement
authorities will deal with it”

March 15, 2009

Source: “Pharmexpert” *in the I-III quarters of 2009

The Russian Pharmaceutical Market: in crisis Role of the State

in Protecting Citizens' Health
“Price of the same drug  The State is the guarantor of the Constitution
sometimes varies in two or
three times in different subjects
(article #41 of the Constitution of the Russian
of the Russian Federation. It Federation - “Protection of Citizens' Health”).
means that there is no order
in regions.
 Law "On Medicines" establishes the absolute
… the matter is the desire of
pharmaceutical companies priority of public control over the circulation of
and numerous intermediaries in drugs, because any activity in this area is
this chain to extract excessive connected with the constitutional right of
profits” citizens to receive medical care.

July 30, 2009

New Pricing System

History
 Institute of Drug Prices Registration has been
established as an anti-crisis measure after the
default in1998 (Постановление Правительства РФ ОТ 29.03.1999
N347 «О мерах государственного контроля за ценами на лекарственные
средства» вместе с «Порядком государственной регистрации отпускных
цен производителей и установления оптовых и розничных надбавок к
отпускным ценам производителей на лекарственные средства,
включенные в перечень жизненно необходимых
б и важнейших
й manufacturer’s price or wholesale company price.
лекарственных средств и изделий медицинского назначения», которое
впоследствии было заменено постановлением от 09.11.2001 г. N 782) to
limit selling prices of manufacturers and importers,
and also trade markup of distributors and
pharmacies for medicines included in the List of
vital and essential drugs.
 Executive authorities of the RF subjects were given
the right to establish any limitations of trade markup
at the retail drug market (постановления Правительства РФ от
30.07.94 г. N 890, от 07.03.95 г. N 239).
• Постановление Правительства РФ от 08.08.2009 №654 “О совершенствовании государственного регулирования
цен на жизненно необходимые и важнейшие лекарственные средства”
• Совместный приказ от 14.12.2009 МЗР №983Н и ФСТ №447-А “Об утверждении методики определения отпускных
цен производителей на ЖНВЛС”
• Приказ ФСТ от 11.12.2009 №442А “Об утверждении методики определения органами исполнительной власти
субъектов РФ предельных оптовых и розничных надбавок к фактическим отпускным ценам производителей на
ЖНВЛС”
Previous system Changes
1. Application for price registration – at the request of 1. Application for price registration is indispensable
the manufacturer. (medicines without registered selling price can not
be represented on the drug market).
2. Retail p
price could be based either on the 2. Price is based on the actual pprice of foreign
g
manufacturer indicated in the customs declaration
or on the actual selling price of domestic
3. Lack of “transparency” in selling price formation. manufacturer.
3. The introduction of price negotiation
4. RF subjects determined trade markup using its memorandum + price monitoring +
own methods. interdepartmental interchange of information.
4. Unified method for determining trade markup
5. Substantiation of the maximum selling price of
taking into account demographic and geographical
foreign manufacturer was carried out in foreign
peculiarities.
currency and in rubles according to the exchange
rate of the Central Bank of the Russian Federation 5. Substantiation of the maximum selling price of
to the date of price registration. foreign manufacturer is carried out in foreign
currency and in rubles since the time of crossing
the state border, since 2011 – in rubles.
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Wholesale and retail trade markup on vital and essential drugs. 2010
Drugs ## RF subject <50
Wholesale, %
>50 and <500 >500 <50
Retail , %
>50 and <500 >500
49 Republic of Sakha (Yakutia) 29 26 22 28 23 18
50 Republic of North Ossetia‐Alania  12 10 7,4 30 27 22
51 Republic of Tatarstan  15 13 11 32 30 23,4
vital and 52 Republic of Khakassia  17 17 15 30 27 23

essential Others 53 Republic of Udmurtia 

54 Republic of Chuvashia 
11
13
10
11,5 10
9 40
30
30
26
20
20
55 Rostov Region  15 12 8,8 25 20 13
drugs 56 Ryazan Region  16 14 10 29 23 17
57 St. Petersburg  20 15 14 28 22 18
58 Samara Region  23 17 12 37 32 27
 Approved by the Decree of the RF Government, 30.12.2009 59 Saratov Region 
g 17 14 10 37 30 18
60 Sakhalin Region  43 25 15 50 45 20
#2135-р. 61 Sverdlovsk Region  18 16 14 36 27 23
 Consists of 500 International Nonproprietary Names, 5400 62 Smolensk  Region
63 Stavropol  Region
16
15,3
14
13
12
10,7
30
29
25
25
18
16
РУ, including 208 combinations INN- dosage form (90 INN) 64 Tambov  Region 16 13 10 25 20 15
produced by domestic manufacturers, 399 INN- dosage 65 Tver Region
66 Tomsk Region
17
15
14
15
8,5
15
26,5
20
22,5
20
15,5
20
form (160 INN) – by foreign manufacturers. 67 Tula Region 20 18 12,5 28 22 15
68 Ulyanovsk Region  18 15 10 29 25 21
 223 names were excluded from the pre-existing List and 60 69 Khabarovsk  Region 30 20 12 40 25 15
names were added to it. 70 Khanty‐Mansi Autonomous Okrug  20 15 13 50 45 35
71 Chelyabinsk Region  25 22 20 40 37 35
 Annual revision of the List of vital and essential drugs. 72 Chechnya  16 14 12 30 27 24
73 Chukotka Region  28 14 11 130 77 65
74 Yaroslavl  Region 16,5 13,2 10 30 25 17

19 20

 Article 62. Dosage form should include indication of drug

Problems, questions dosage and its quantity in the secondary (consumer)
packaging.

 Some pharmaceutical manufacturers have not registered prices

of all presentations of its production up to April 1, 2010,
moreover concrete presentations are not mentioned in the List of
vital and essential drugs (for example: coated tablet, but there is
a coated INN with slow release) – as a result these drugs will
not enter the market. What should be done?

 Chapter 12, article 60 is devoted to the List of vital and essential

drugs, which must be developed according to the standards
based on clinical protocols and guidelines (but they have not
been developed yet) on widespread diseases, for the
calculation of financing for the Program of the State Guarantees
of Free of Charge and High-quality Health Care for Citizens of
the Russian Federation.

How to be sure in the quality?

 As a result some drugs (pyridostigmine  Compulsory registration of pharmaceutical

(solution for injection), desmopressin substances by Russian pharmaceutical
(tablets), etc., which are vital for patients with companies was revoked, and now there is no
diabetes insipidus, myasthenia and other need to carry out clinical trials for “old”
Russian drugs
drugs.
severe diseases), were not included in this
 The final date of conversion to the GMP
List, whereas drugs without proper evidence
Standard for all Russian pharmaceutical
of its effectiveness were included in it manufacturers – January 1, 2014.
(Arbidol, Kagotsel, Ingavirin, etc.)
 Delay in four years is determined by the fact
 Issues of changing principles of classification that “nowadays there are many cheap
of drugs in the List conventional drugs that do not have GMP
standard and can not be simultaneously
removed from the market”?!

4

 New Law does not specify developers of
federal programs for drug supply of the
population
 The order of social protection for citizens and
preferential or free drug supply for certain
categories of citizens have not been
determined yet
 Order of sales, payment, acquisition and
requirements for obtaining drugs by citizens,
and also the issue of the return of drugs to
the pharmacy were not specified in the Law
 According to the new Law medical staff is
allowed to sell drugs in rural areas without
pharmacies.
 On the one hand it may y increase the
availability of drugs, but it is impossible to
provide wide range of drugs, also it is
necessary to introduce licenses for
physicians and paramedics (because they
take part in selling medicines), if they do not
have any special pharmaceutical education.
 All drugs for in-patient treatment are
purchased at quotations and auctions. What
is the mechanism of price control? The
customer sets the maximum price, but
medicines included into the List of vital and
essential drugs have its own pricing
mechanism. How should we make lots?
 How to control the correct consumption of
drugs if there is no unique approach to
patient management and electronic patient
record?
5/24/2010
 There is no any information on
over-the-counter medicines.
 Is the previous List valid or not?
 If there is no item “release
conditions” in the instruction, how
to find data for prescription of
drugs?
 According to WHO requirements it is necessary to
register all clinical trials, even those which have
shown unfavorable results for pharmaceutical
companies - but it is not reflected in the Law.
 Guarantee for the independent conclusions of clinical
trials are not specified in the Law.
 The requirement to have 5 years experience of
carrying out clinical trials makes such work
inaccessible for young researchers.
 There is incorrect item on participation of mental
patients in clinical trials.
 The problem of conflict of interest among experts was
not reflected in the Law.
 There are more questions than
answers.
 It is necessary to move forward!
5
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The Legal 
The Legal Framework 
Framework of 
of Drug Supply 
Drug Supply 
in the Russian Federation 
in the Russian Federation 
1. Constitution of The Russian Federation .
2. Federal Laws:
 Federal Law "Health Care Framework  
Drug Supply Reform  Legislation"  app. ВС РФ 22.07.93 № 5487‐1
 Federal Law “On Medicines" from 22.06.98 № 
in the Russian Federation
in the Russian Federation.  86 ФЗ
86‐ФЗ
 Federal Law "Consumer Protection" from
What's new? 07.02.92  № 2300‐1
 Federal Law “On Narcotic Drugs and Psychotropic 
Salavat Suleymanov, MD, PhD, MSc, Professor,  Substances" from 08.01.98 № 3‐ФЗ 
Academician of the Russian Academy of Natural   Federal Law “On Licensing of Certain Activities" 
from 08.08.01 № 128‐ФЗ 
Sciences, Rector of the Institute of Post‐Graduate 
 Federal Law "On State Social Assistance " from
Education for Health Professionals, Head of the 
17.07.1999 № 178‐ФЗ
Department of Clinical Pharmacology and 
Pathophysiology 

The Legal Framework of Drug Supply  The Legal Framework of Drug Supply 
in the Russian Federation  in the Russian Federation 
3. RF Government Decree: 4. Orders of the Ministry of Health and Social 
 RF Government Regulation from 08.08.09 № 654 " On 
Development 
Improving the State Regulation of Prices on Vital and   Order of Ministry of Health and Social Development from
Essential Drugs". 12.02.2007 № 110 “On Appointment and Prescribing 
 RF Government Regulation from 06.07.06 №416 «On  Medicines Medical Equipment Health Products"
Medicines, Medical Equipment Health Products
Approval of Pharmaceutical Activity Licensing".  Order of Ministry of Health and Social Development from
 RF Government Regulation from 04.11.06  № 648 «On  18.09.2006 № 665 "On Approving the List of Drugs Available 
Approval of Licensing Activities Related to Circulation of  on Physician (paramedic) Prescription in Providing Free 
Narcotic Drugs and Psychotropic Substances". Medical Care for Certain Categories of Citizens"
 RF Government Directive from 30.12.09 №2135‐р «On   Order of Ministry of Health and Social Development from
Approval of the List of Vital and Essential Drugs" 14.12.2005 № 785 “On  Drug Sales”
 Order of Ministry of Health from 28.03.2001  №88 "On 
Implementation of the State Standard for Drugs".

Regulation of 
Regulation of Drug Application in 
Drug Application in  The Legal Framework of Drug Supply 
Hospital in the Khabarovsk Region
in  the Khabarovsk Region
Fundamental principles of 
 Government of Khabarovsk region Regulation from 25.12.2009 № 
drug application in hospital:  388‐пр “On Regional Program of State Guarantees of Free Of Charge 
 Development of the List of Vital and Essential  Medical Care for Citizens of the Russian Federation in the 
Drugs. Formulary lists
y were excluded  from the  Khabarovsk Region in 2010"
regulatory system.  Law of Khabarovsk region 29.12.2004 № 233  "On Some Categories 
of Citizens Entitled to Free Drug Supply Provided by the Regional 
 standards (protocols) of patients Budget"
management;  Government of Khabarovsk region Regulation from 01.11.2008 № 
 regulatory and legal framework for drug  255‐пр  " On the Regional Target Program "Prevention and Control 
application provided by the Ministry of Health  of Socially Significant Diseases (2009 ‐ 2011)"
and Social Development of the RF.  Order of Ministry of Health of Khabarovsk region from 14.08.2006 № 
251 " On the Drug Supply of Certain Categories of Citizens in 
Khabarovsk Region"

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2009‐2010
2009‐ Federal Law from 12.04.2010  Federal Law from 22.06.98  № 
№ 61‐ФЗ 86‐ФЗ    "On Medicines" 
What's new? "On Circulation of Drugs"
• Introduction of  "The Strategy of Pharmaceutical 
Industry Development in the Russian Federation until  16 chapters 13 chapters
2020"
71 articles 47 articles

New chapters "State Pharmacopoeia",  "State Regulation of Drug Prices for 
p p g g
• introduction of the new system of state pricing  Medical Application", “Storage of Drugs", " Destruction of Drugs ", 
regulation for medicines in the Russian Federation "Monitoring the Safety of Medicines" , etc.
Chapter “Implementation of State Registration of Medicines ” was 
significantly expanded.
Drug sales in medical and obstetrical stations and outpatient medical rooms 
• new Federal Law “On Circulation of Drugs"  were permitted.

What Was Not Described in the New 
Federal Law What Has Not Been Done?
• There is no definition of “Orphan Drugs"
Drug Insurance
• There are no indications for the standardization of 
information on medicines  We have postponed “the Concept of Drug Supply of 
g p y
• Registration of unwanted side effects is poorly  Population", including drug insurance, because of 
economic crisis... 
described
Today we depend on the import, and it is very difficult to 
regulate prices of imported drugs. In my opinion 
introduction of drug insurance without proper 
development of the domestic pharmaceutical industry is 
unwarranted financial risk for the Country. 
T.Golikova, interview in "Kommersant “, 5.02.2010

Competence of the Executive Authorities of the  Subject of the Russian Federation
RF Subjects in Drug Circulation Khabarovsk Region
(New Federal Law “On Drug Circulation")

• Control over pricing on medicines and 
1) Development and implementation of regional programs  medical products
for drug supply of population; (it is described in the 
current Federal Law “On Medicines") • Licensing control over pharmaceutical 
2) Limitation of trade markup and
Li it ti ft d k d retail markup of the 
t il k f th and medical activities in the
and medical activities in the 
actual selling prices established by the manufacturer for  separation of powers  with the 
medicines included in the List of Vital and Essential  Federal Office for the Supervision of 
Drugs; Health and Social Development 
3) control over pricing of medicines included in the List of  • Control over the Regional Program of 
Vital and Essential Drugs, wholesale organizations,  State Guarantees 
pharmacies and individual entrepreneurs who have a 
license for pharmaceutical activity. • Large sales of drugs within self‐
treatment are out of control 

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Analysis of the Gastroenterological Drugs 
Analysis of the Gastroenterological Drugs 
Consumption according to the 
Number of Sold Packages 
The results of the 
Khabarovsk Region interview of buyers in 
(according to the sales of 10 pharmacies ) 
2004  2009 
pharmacies
Drug Unit weight,  Drug Unit weight,  (110 participants)
% %
activated carbon 0,25 tab. #
activated
10
carbon 0 25 tab # 36 1
36,1 activated carbon 0,25 tab. #
activated
10
carbon 0 25 tab # 42 2
42.2
 Omeprazole 
O l was purchased without 
h d ith t
allohol tab. #10 9,5 pancreatin 9.8 prescription and administration ‐ 10% of 
drotaverine 3,8 omeprazole  5.5 buyers 
pancreatin 2,9 loperamide 4.9
Pancreatin was purchased in case of 
glaxenna тб. tab. #10 2,7 phospholipids 4.0
phospholipids 2,7 allohol 3.9
abdominal pain without prescription ‐ 11% of  
ranitidine 150 mg tab. # 20 2,4 linex 3.8
buyers 
silymarin 1,9 algedrat 3.4
algedrat 1,5 Smecta 2.5

Problems of the Russian Federation
Problems  of the Russian Federation Subject 
(Khabarovsk 
Khabarovsk Region
Region))

• Drug supply for remote and northern parts of the region (new 
pricing will not cover transportation costs);
• Inconsistency between the List in the Program of Essential 
Drugs Supply and standards of medical care;
• "Financial limits" do not cover the actual requirements in drugs 
for preferential categories of citizens (breach of the insurance 
principle);
• Absence of objective and complete assessment of drug supply 
in the region; 
• Minimal influence of social organizations on the executive 
authorities;
• The problem of destruction of drugs is not solved in the region.