?

..

-
. ..

. - .
.

:
, ,
,
How great is the danger of using unregistered in the Russian Federation of medicines
for the treatment of chronic hepatitis C?
I.V. Shestakova

Moscow State University of Medicine and Dentistry named after

A.I. Evdokimov

The essence of the problem application on the territory of the Russian Federation of unregistered medicines.
A deep analysis of legal acts. Characterized an administrative and criminal delinquencies in the sphere
of medical products circulation.

Keywords:
not registered drugs, treatment of chronic hepatitis C, the circulation of medical devices, delinquency

,
,
. 67- (2014) ,
,
,
-

110

.
.
-
(2013),
anti-HCV 5,9 (4,1% ), ()
3,5 4,7 . , ,
: 2013 . 56 146 -

..

?

, 2014 . 57 197, 2015 . 55 491 [1].

97% , .
.. (2014), .

2006 . 3,3 191,699 .,
18,3% [2]. ,
2006 . 2,3 2013 . 14,9 .
(476,7 .) [2].
3/4
, .

,
( ) , ..
, .
2011 .
20132020 ,

(), ,
[3].
(2015)
2020: , (
,
40%
, , ,
.) [4].
.. (2015),

,
. . 11 . , 70,5%
, 10,3% [5].
. 38 21.11.2011 323-


31.12.2014 532- :
,
() (); , , ()

()
; , [6].
, ,
, 2014 . 31.12.2014 532-

, ,
, , , [7].


. ,

, .
,
(, , .), ,
,
, , ,
.
. ,
,
,
()
, . ,
(. 1).

() (, !)

. , ,
.
, . , ,
, .
,
, ,
,
, .
, . ,

: , , 2 2016

111

112

, %

, %

(>10%):
(58%), (34%), ( 32%),
( 23%), (
21%), (11%)
(>10%):
,
, .
(110%):
, .
(0,11%): ,
,
. : ,

(
-
)
11

(>10%):
( 11%)

(>10%):
.
(110%):
,
,
,

0,9

(
-
)
0,3

(>10%):
(56%). (0,11%): .
:
,

14

(
-
)
3

(0,11%):

>5 (1%)

,
,
,

(110%):
, , (<5%)

(>10%):
(12%). (110%):
, ,
(<5%)

( 12.05.2016)

1.

(>10%):
.
(0,11%): , ,

(>10%):
(38%),
(6%),

(6%).
(110%):
(4%)

(>10%):
,

<1

:
, , ; 1
( )

(
)

(>10%):
( 27%),
(22%),
(17%).
(110%): ,
, ,
,
, ,
, ,
.
(0,11%):
, ,
,
, DRESS
,

(
-
)

(
-
)
(>10%):
(28%).
(110%): , ,
,
.
(0,11%):


(>10%):
, .
(110%): ,
, .
(0,11%):
, DRESS,
,
(>10%):
( 28%),
( 22%).
(0,11%):

(
-
)
(110%):
(7,4%),

(110%): (>5%),

,
,
,

(110%): ,
, (<5%)

(110%):
(7%),
(5%), , ,
,

( 12.05.2016)

(>10%):
(11%),

(110%): ,

,

(
)

(110%): ,

,

. 1

..

?

: , , 2 2016

113

114

(>10%):

(>10%):
( 46%),

( 44%),
( 25%), (
20%),
( 15%). (1
10%): ,
, , ,
,
, ,
,

(
-
)
,
, .

(>10%):
(39%),
(26%),
(13%),
(12%),
(29%). (1
10%):
,
,
,
.
(0,11%):
.

(
-
)

(>10%):
( 22%),
(16%). (110%):
(0,3%) :

(>10%):
(12%)

(
-
)

(110%):
(5%).
(
26 ):

,
10

,
,
,

(110%):
.

: ,
(>10%):
(18,3%),
, (12,3%).
(110%):,
(<5%)
(9%), (8%). 5%:
, ,
, ,
,

( 12.05.2016)

(>10%
): (22%),
(69%)

(
)

(110%): ,

: ,

(>10%):
. (1
10%):

. 1

 : , , 2 2016

(
-
)
,
,
.
(0,11%): ,
, ,
, , ,

,
,
,
.
(<0,1%): .

:
,

(110%): ,
.
(0,1 1%): ,
, , .
: (<0,1%):

(0,11%):

:
(

),

(
-
)
: ,
,

(
-
)
,
,
,

( 12.05.2016)

(
)

. 1

..

?

115

116

( 1 10%):
,
,
.
( 0,1
1%):
, , ,
,
, ,

(
-
)
(>10%):
( 24%),
( 23%).
( 1 10%):
,
, ,
,
.
( 0,1
1%): ,
,
,

(>10%):

(10%). ( 1
10%): . :

( 0,1
1%):

(
-
)

:

(>10%):
(21%),

(16%)

(
-
)
(>10%):
(16%)
,
,
,

(110%):

(>10%):
15%.
( 1 10%):
,

( 1 10%):
,

(<5%)

( 12.05.2016)

(>10%):
(24%)

( 1 10%):
(69%)

(
)

(>10%):

(1117%). (
1 10%):

( 1 10%):

. 1

(
-
)
, ,
, .
(<0,1%):

(110%): ,
.
(0,11%):
(>10%):
(
34%), (22%), (21%),
(12%). (1
10%): ,
, ,
, .
(0,1 1%):
, , , ,
, , ,
.
(<0,1%):
, ,

: ,

(110%):

(
-
)

(10%
):
(14%)

(
-
)

(110%): (>5%)

,
,
,

( 12.05.2016)

(>10%):
(15%),

(10%).
(0,11%): , ,

(
)

(110%):

. 1

..

?

: , , 2 2016

117

118

(110%):

,
,
,

(
-
)

(
-
)

(
-
)
,

(110%):
,
, , .
(0,11%):

( 12.05.2016)

(
)

. 1

.
( ).
,
, ().


, ,
( ),
( )
( ,
, ;
-
; -, ;
.), .
-
, ,
- .

, 2015 . (
28.11.2014 1273
2015 . 2016 2017 ), [8].
, ,


.
,
- , [9]; ,
[10], ,
.
, ,
, . -

..

?

,

. :
-, ,
.
, ,
, . , ( ), .

, , ,
( , ..)? , .
,
, . ,
,
,
, .
, , . ,
,
,
12.04. 2010 61-
( ),
,
,

[11].
, , ,
. 4 . 38
323- ,
, , ,
[6].
, .

,
, . ,
? ?
,
,
, ,
( -
).

, . , .
, ,
(, , ,
,
..).
,
.

, .

12 .
, ,
.
,
,
, , , .

:
21.11.2011 323- (. 26.04.2016) (. 38, 85, 95);
25.09.2012 970 ;
30.06.2004 323
( ) (. 5.1.2, 5.2.2, 5.5);
05.04.2013 196

( );
14.09.2012 175 ;
20.06.2012 12
,
, , ,
,
; 15.06.2012 7

;

: , , 2 2016

119

30.12.2001 195- (. 01.05.2016) ( , 13.05.2016)

(6.28, 6.33, 14.43, 14.44, 14.46, 19.4, 19.5, 19.7.8, 19.33);
13.06.1996
63- ( ) (. 235.1, 238.1, 327.2) [12, 13].
6.33 [14] , ,

, (
31.12.2014 532-) [7],
(
) 70 . 5 .

90 (. 2).

2. [22]
I.
( 21.11.2011 323-
, . 38)
6.28.
.

,

6.33. , ,

,

1. ,
,
,
,
,

,
,
.
2.
,
,
,
,

2 4 . .;
5 10 . .;
30 50 . .
70 100 . .;
100 600 . .;
1 5 .

90

II.
( 31.12.2014 532-
, ,
,
)
238.1. ,

,

1. ,

,
,
,

120

3 5


3

3 5 500 .
2 .
6 2


3

..

?

, ,

,
,
*.
(*. 2. .
,
, 100 .
.)
2. , :
)
;
)

5 8
1 3 .
1
3

5

3. , . 1 2 ,
2

8 12
2 5 .
2
5

10

2 . 47
12.04.2010 61-
( ) ( ),
[11].
() ,
,
.

, ,
,
. ,

.

. , ,
2 : - (. 2).
,
2 109 ( 3

3 ), 2 3 ( 4

3
) [14].
,

2 118 ( 1
3 ) [15].
, , 23 2015 . 31.12.2014 532-

,
, ,
,
,
[7].
238.1
[16] , ,
(. 2).

2011 .
,
( ).

: , , 2 2016

121

238.1 .
04.02.2015
20-2/74 , , ,

[17],
[18], ,

.
, ,


,
.



( ,

, ()
, ;
, ,

,
,
-

,
() , ; , ) [19].
-
, ,
.
,
. , 1068
,
,
(, ) , [20].
1081
[20].

.
31.12.2014
532- , ,
,
,

, .

,
, - . ..
E-mail: prof.shestakova@yandex.ru

5. ..

1. . URL: http://rospotrebnadzor.ru/.
2. C.. 2013 . //

, // . 2015. 9. . 7377.

2014. 3. . 5459.
3.

6. 21.11.2011 323- (.

20132020

26.04.2016)

[ ]. URL: http://old.minpromtorg.gov.ru/

ministry/fcp/pharma_and_medical_in-dustry).

12191967/.

4. . URL: http://minpromtorg.gov.ru/

122

].

URL:

http://base.garant.ru/

7. . URL: http://base.garant.ru/70812574/.

..

?

8. 27.12.2012 1438 -

) [ ]. URL: http://www.consultant.ru/document/
cons_doc_LAW_10699/639472a621d0ccfce338497548ff5d396aa96045/.

, ,

16. 13.06.1996 63-

(. 30.03.2016) . 08.12.2003 162-

B C [ ]. URL: http://base.garant.

) [ ]. URL: http://www.consultant.ru/document/

ru/70291708/.

cons_doc_LAW_10699/2571bfa1719275becf1af077807e8d4748f14340/.

9. 17.06.1999 178- -

17. 13.06.1996

[ ]. URL:http://

532- (. 31 2014 .) [ ]. URL:

www.consultant.ru/document/cons_doc_LAW_23735/.

http://ivo.garant.ru/#/document/70833226/paragraph/1:3.

10. 12.04.2010 61- -

18. 04.02.2015 20-2/74 -

( ) [

, , -

]. URL: http://base.garant.ru/12174909/.

, -

11. . URL: http://base.garant.ru/.

12. . URL: http://www.consultant.ru/.

[ ]. URL:

13. -

legislation/204227/].

30.12.2001 195- (. 01.05.2016) [

]. URL: http://www.consultant.ru/document/cons_doc_LAW_3466
1/073006d2a2a599f5529cc8f48875a6a7625cf3b9/].
14. 31.12.2014 532- -

[http://www.1nep.ru/pro/

19. . URL: http://www.consultant.ru/law/

hotdocs/40858.html.
20. . URL: http://www.consultant.ru/document/
cons_doc_LAW_121250/.

21. ( )

, ,

26.01.1996 N 14- (. 29.06.2015) ( -

, 01.07.2015) [ ]. URL: http://

base.garant.ru/10164072/60/#friends

[ ]. URL:http://base.garant.ru/70833226/.
15. 13.06.1996 63-
(. 30.03.2016) . 07.12.2011 420-

22. .., ..

// . . 2015. 3. . 1019.

REFERENCES
1. Electronic resource. URL: http://rospotrebnadzor.ru/. (in Russian)

11. Electronic resource. URL: http://base.garant.ru/. (in Russian)

2. Romanova S.A. Pharmaceutical industry for 2013. 2014; 3: 5459.

12. Electronic resource. URL: http://www.consultant.ru/ (in Russian)

(in Russian)

13. The code of the Russian Federation about administrative offences

3. State program of the Russian Federation "Development of

from 30.12.2001 195-FZ (ed. from 01.05.2016) [Electronic resource].

pharmaceutical and medical industry for 2013-2020" [Electronic resource].

URL: http://www.consultant.ru/document/cons_doc_LAW_34661/07300

URL: http://old.minpromtorg.gov.ru/ministry/fcp/pharma_and_medical_

6d2a2a599f5529cc8f48875a6a7625cf3b9/]. (in Russian)

in-dustry). (in Russian)

14. The Federal law from december 31, 2014 n 532-FZ "On amendments

4. Electronic resource. URL: http://minpromtorg.gov.ru/ (in Russian)

to certain legislative acts of the Russian Federation in countering

5. Kostromin P.A. Import substitution of drugs in Russia, by volume,

trafficking in counterfeit, counterfeit, substandard and unregistered

nomenclature and quality // Theory and practice of social development.

medicines, medical devices and adulterated dietary supplements

2015. No. 9. S. 73-77. (in Russian)

[Electronic

6. Federal law of 21.11.2011 323-FZ (ed. from 26.04.2016) "About

bases of health protection of citizens in the Russian Federation" [Electronic
resource]. URL: http://base.garant.ru/12191967/. (in Russian)
7. Electronic resource. URL: http://base.garant.ru/70812574/.
(in Russian)
8. The resolution of the Government of the Russian Federation

resource].

URL:http://base.garant.EN/70833226/.

(in Russian)
15. Criminal code of the Russian Federation from 13.06.1996
63-FZ (as amended on 30.03.2016) as amended by the Federal law
of 07.12.2011 420-FZ) [Electronic resource]. URL:http://www.
consultant.ru/document/cons_doc_LAW_10699/639472a621d0ccfce3384
97548ff5d396aa96045/. (in Russian)

of 27.12.2012 1438 On the financial provision of purchases of

16. Criminal code of the Russian Federation from 13.06.1996 63-FZ

diagnostic tools and antiviral drugs for the prevention, detection,

(as amended on 30.03.2016) as amended by Federal law from 08.12.2003

treatment monitoring and treatment of persons infected with the virus

162-FZ) [Electronic resource]. URL:http://www.consultant.ru/document/

human immunodeficiency and hepatitis B and C [Electronic resource].

cons_doc_LAW_10699/2571bfa1719275becf1af077807e8d4748f14340/.

URL: http://base.garant.ru/70291708/. (in Russian)

(in Russian)

9. Federal law dated 17.06.1999 178-FZ On state social assistance

17. Criminal code of the Russian Federation from 13.06.1996

[Electronic resource]. URL:http://www.consultant.EN/document/cons_

532-FZ (as amended on December 31, 2014) [Electronic resource].

doc_LAW_23735/. (in Russian)

URL:

10. Federal law dated 12 April 2010 No. 61-FZ On circulation

of medicines (with amendments and supplements) [Electronic resource].
URL: http://base.garant.ru/12174909/. (in Russian)

http://ivo.garant.ru/#/document/70833226/paragraph/1:3.

(in Russian)
18. Letter of the Ministry of health of Russia from 04.02.2015
No. 20-2/74 "On combating trafficking in adulterated, counterfeit,

: , , 2 2016

123

substandard and unregistered medicines, medical devices and adulterated

21. The civil code of the Russian Federation (part two) from 26.01.1996

dietary supplements [Electronic resource]. URL: [http://www.1nep.ru/

N 14-FZ (as amended on 29.06.2015) (with changes and additions entered

pro/legislation/204227/]. (in Russian)

into force on 01.07.2015) [Electronic resource]. URL: http://base.garant.

19.

Electronic

resource.

URL:

http://www.consultant.ru/law/

20. Electronic resource. URL: http://www.consultant.ru/document/

cons_doc_LAW_121250/.

124

ru/10164072/60/#friends (in Russian)

22. Mikheev M.A., Zhirnov A.D. Administrative and criminal liability

hotdocs/40858.html. (in Russian)

for violations in the sphere of circulation of medical products. Vestnik

Roszdravnadzora [Bulletin Roszdravnadzor]. 2015; 3: 109. (in Russian)