PA/PH/TS (09) 28 2 R
St b
Strasbourg,
April
A il 2010
EUROPEAN COMMITTEE (PARTIAL AGREEMENT) ON BLOOD
TRANSFUSION (CD-P-TS)
TS057 - Risk behaviours having an impact on blood
donor managment
Final terms of reference proposed for the ad hoc experts group
Project leader: Rut Norda
EDQM Responsible Scientific Officer: M.-E. Behr-Gross
For information :
CD-P-TS European Committee on Blood Transfusion
CD-P-TSobs
CD
P TSobs Observers of the European Committee on Blood Transfusion
TS057 Risk behaviors having an impact on blood donor management
Commission directive 2004/33/EC
Annex III: Eligibility criteria for donors
Permanent deferral, such as for
• Persons whose sexual behaviour puts them at high
risk
i k off acquiring
i i severe infectious
i f ti
di
diseases th
thatt can b
be
transmitted by blood
Temporary deferral
deferral, such as for
• Persons whose behaviour or activity places them at risk
of acquiring infectious disease that may be transmitted
by blood. Defer after cessation of risk behaviour for a
period determined by
p
y the disease in q
question and
availability of appropriate tests
A difference of opinion between the two Swedish
Competent Authorities - NBHW and the MPA
MPA was recommended by EMA to
consult EDQM and CD-P-TS
• Presentation of the Swedish case in November 2009 led
to the subordinate ad-hoc working group on
RISK BEHAVIOURS HAVING AN IMPACT ON BLOOD
DONOR MANAGEMENT (TS057)
M ti agenda
Meeting
d
• February 5, 2010, web-meeting 24 Sept 2010, additional
data collection July
July-Nov
Nov 2010
2010, 2nd meeting 17 Nov 2010
2010,
3rd meeting 24-25 Feb 2011
External meetings
• DHHS ABSCA 10-11 June 2010, Joint meeting of CA
and RC 27-28
27 28 Oct 2010
2010, EBA Board 25 March 2011
Participation in the WG TS 057
• European experts nominated by the European
Committee on Blood Transfusion of the Council of
Europe (CD-P-TS)
• European Commission (EC)
• European Medicines Agency (EMA)
• European Centre for Disease Control (ECDC)
• Unites States Food and Drug Administration (USFDA)
• World Health Organization (WHO)
• Blood Regulators Network
• European Blood Alliance (EBA)
• Health Canada
• Therapeutic Goods Administration (TGA Australia)
• American Red Cross
Data for 10 MS in TS057
• From the collection, testing and use of
blood and blood components in Europe
2006-2008: most recent information used
• from the collection of additional
information in TS 057
• from ECDC
• from
f
published
bli h d and
d unpublished
bli h d studies
di
10 MS in TS057
some 16,5 M WB collections per year
blood collections % first time
per 1000 pop
donors
Germany
59.4
18.3
Turkey
7.1
NA
France
36 7
36.7
43 3
43.3
UK
38.8
15.6
Italy
42.1
18.1
Spain
37.6
26.7
Netherlands
34.5
7.2
Greece
59 5
59.5
16 9
16.9
Sweden
53.7
15.3
donors only tested
at first visit
17.30%
NA
none
none
40%
none
all
none
all
Some other data from the additional
collection
• Data are not applicable for the whole country: 2/10
• National organisation: 3/10
• Donor questionnaires provided in English for the additional
data collection: 5/10
• Compliance studies: 4/10 reported studies of various
magnitude
• Risk modelling: 7/10
/ reported yearly assessment off RR or
formal studies.
Sexual risk behaviour
Definition, ranking and deferral for sexual „high risk“ behaviour arbitrary
i an iinternational
in
i
l perspective
i
MSM
Partner MSM
Sex worker
Partner HPC*
HPC
Partner IDU
Sex abroad
Sex worker client
Steady partner
Casual partners
* high prevalence country
Courtesy R Offergeld 24 Feb 2011
HIV infection by transmission group and
origin in EU/EEA countries, 2004 - 2009
Men who have sex with
men
Heterosexual
contacts
Other/undetermined
Heterosexual contacts
from countries with
generalised epidemics
Injecting drug use
Mother-to-child
transmission
Predominant transmission group: men who have sex with men
Data were not included from: Austria, Estonia and Poland.
Source: ECDC/WHO. HIV/AIDS Surveillance in Europe, 2009
Source: ECDC/WHO. HIV/AIDS Surveillance in Europe, 2009
9
Notification rate of HIV in 10 MS of TS 057
12
10
8
Rate p
per
6
100 000 pop
4
GE
ER
SW
WE
GR
RE
NE
ED
IT
TA
FR
RA
SP
PA
0
UK
U
2
Notification
N
tifi ti (of
( f allll previously
i
l nott diagnosed
di
d iinfections)
f ti
) rate
t off HIV 20082008
2009 per 100 000 population : ECDC
MSM andd HIV in
i the
th generall population
l ti
% MSM in newly diagnosed HIV cases 2009*
70
60
50
%
40
30
20
10
3-10% of MSM are estimated to be HIV+ (UNGASS report)
*ECDC: HIV/AIDS surveillance in Europe 2009
Po
rtu
ga
l
Be
lg
iu
m
ly
Ne
th
er
la
nd
s
Ita
UK
Sw
it z
er
la
nd
Sw
ed
en
Fr
an
ce
Sp
ai
n
G
re
ec
e
G
er
m
an
y
0
PREVALENCE
C HIV NEW DONORS
O O S (ND)
( )
(x 100.000)
25
37.8
120.6
64.7
20
15
10
5
0
2001
2002
2003
2004
2005
2006
2007
FRA
GER
GRE
ITA
NED
SPA
SWE
SWI
UK
2008
Courtesy M Jansen & S Oyonarte 24 feb 2011
INCIDENCE
C
C HIV REPEAT DONOR
O O (RD)
( )
(x 100.000)
10
9
FRA
GER
GRE
ITA
NED
SPA
SWE
SWI
UK
8
7
6
5
4
3
2
1
0
2001
2002
2003
2004
2005
2006
2007
2008
Courtesy M Jansen & S Oyonarte 24 feb 2011
Trends of testing in Europe 2001-2008
HIV ND (prevalence)
i
increase:
ITA ((p=0.05),
0 05) NED ((p=0.034)
0 034)
decrease: FRA (p
(p=0.015),
) SWE (p
(p=0.034))
HIV RD (incidence)
increase: GRE (p=0.004)
SPA (p=0.050)
Courtesy M Jansen & S Oyonarte 24 feb 2011
HIV positive donors: % MSM
MS
Period 1
Period 2
F
France
50% (2007)
53% (2008)
Germany
51% (2001-2005)
43% (2006-2010)
Greece
53% (2003-2008)
Netherlands
31% (1995-2003)
Spain
74% (2008-2009)
Sweden
29% (1995-2003)
25% (2004-2009)
UK
29% (1996-2008)
(1996 2008)
19% (2009)
45% (2004-2008)
Courtesy R Offergeld 24 Feb 2011
M d lli
Modelling
studies
t di to
t interpret
i t
t risks
i k off
changes in donor deferral
• incidence and prevalence of markers in donor
populations;
p
p
; testing
g and handling
gp
performance: risk
factors for fast spread of new sexually transmitted
infections (STI)
emerging STI
• risk factors: many sexual partners per interval;
concurrency of partnerships; clustering and
assortativity (= the sexual network); long
asymptomatic phase of emergent infections,
Courtesy of Christel Kamp, Feb 2011
Safety and quality of blood components
Recruitment and selection
BLOOD DONOR
Blood collection
Testing
Preparation of components
Release and distribution to
Medicinal products or Transfusion
+4ºC
22 ºC
-40
40 ºC -70
70 ºC
Better informed communities
communities, present and
future blood donors
Improved compliance by a number of tools:
• improved
i
d quality
lit off iinformation
f
ti material
t i l
• ”state of the art” media techniques
• improved,
i
d standardised
t d di d questionnaires
ti
i
ffor d
donors
• improved delivery of questionnaires
• evaluation of compliance
Improved data collection for regular assessment
• standardised post-donation interviews for verified
positive donors
Courtesy M Heiden 24 Feb 2011
Sources of Data to Assess the Efficacy of
D
Donor
D
Deferrals
f
l (1)
Donor-derived data
•
Prevalence and incidence
•
Rates of deferral
deferral, post
post-donation
donation information
information,
other operational measures
•
Collection of same information by a different
mode
– Post-donation risk interview ((marker p
positive
donors)
– Post-donation risk survey
y ((all donors))
Courtesy A Williams 24 Feb 2011
S
Sources
off Data
D t tto A
Assess th
the Effi
Efficacy off
Donor Deferrals (2)
General population data
•
Marker prevalence
•
Limited general population behavioral risk
surveys
•
FT donors after one instance of donor
q alification vs.
qualification
s untested
ntested general pop
population
lation
Courtesy A Williams 24 Feb 2011
Ch
Channels
l for
f legislatory
l i l t
impact
i
t off the
th
work by CD-P-TS
• Proposal of a resolution to be adopted by
the Committee of Ministers
• Utilisation of the Guide to the collection,,
preparation and utilisation of blood
components (Rec 1995/15)
Burning questions
• Are data strong enough to support a
change in deferral criteria?
• Will we be able to uphold
p
the common
legislation?
Current synthesis from TS 057
• TS 057 has conducted its tasks
• and will present the proposed resoultion
and the report
p to the CD-P-TS in Nov 2011