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The World Needs Plasma:From The USA And Other Countries
Plasma Product Biotechnology MeetingMalta
May 18, 2017
Jan M. BultPresident & CEO
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PPTA Manufacturers
Plasma derived therapies andRecombinant therapies;Manufacturing sites in USA, Austria, Belgium, Switzerland, and Italy95 Collection centers
Plasma derived therapies;Manufacturing site inGermany 33 Collection centers
Plasma derived therapies and Recombinant therapies;Manufacturing sites in USA, Australia, Germany, Switzerland; 172 Collection centers
Plasma derived therapies;Manufacturing sites inSpain and USA187 Collection centers
Plasma derived therapies;Manufacturing sites inItaly, Hungary and USA19 Collection centers
Plasma derived therapies; Manufacturing site in United Kingdom; 38 Collection centers
Plasma derived therapies; Manufacturing site in Canada; 1 Collection center
Status May 1, 2017
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Mission
The mission of PPTA is to promote the availability
of and access to safe and effective
plasma protein therapeutics for all patients in the world
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全球静脉注射用和皮下注射用免疫球蛋白 (IVIG/SCIG) 需求量 1984 -2014公吨
全球白蛋白需求量 1984 -2014公吨 全球 VIII 因子需求量 1984 -2014 血浆衍生品（百万国际单位）
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Clinical use of plasma protein therapies
0.00
50.00
100.00
150.00
200.00
250.00
0.00
1.00
2.00
3.00
4.00
5.00
6.00
7.00
8.00
9.00
10.00FVIII v. IG Use in Selected Countries
2015 FVIII Usage (IU/cap) Data from WFH 2014 IG Sales Volume (gram/thousand residents) Data from MRB
FVIII
IU p
er c
apita
IG g
ram
per
thou
sand
resi
dent
s
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United States Centers 2005 - 2016
299 315349
389 399 401 404 411 427478
530
601
0
100
200
300
400
500
600
700
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United States Collections 2003-2016
12,64
4,462
10,31
7,674
10,36
8,480
12,44
2,214
15,32
6,821
18,81
7,869
22,02
8,860
19,80
7,473
23,57
3,488
26,21
4,019
29,39
1,097
32,54
9,644
35,46
4,612
38,29
6,234
0
5,000,000
10,000,000
15,000,000
20,000,000
25,000,000
30,000,000
35,000,000
40,000,000
45,000,000
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9.8
12.814.9
17.6 18.6
16.3
18.2
25.627.9
33.636.2
6.6 6.9 7.4 8.58.5 8.2 7.8 8.1 8.9
9.0 8.7
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
40.0
1990 1993 1996 1999 2002 2004 2007 2010 2012 2013 2014
GLOBAL VOLUME OF PLASMA FOR FRACTIONATIONRecovered & Source in Liters
Source Plasma
Recovered Plasma
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• Serious loopholes in blood banking system results in 6 bakh liters (600,000 liters) blood wasted in 5 years
• States are mentioned as offenders wasting components• Units fresh frozen plasma wasted (could be used for albumin• Figures are alarming because blood shortage is chronic• Annual shortage is 3 million units of blood• Lack of coordination and absence of blood sharing network
India media coverage
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Recovered plasma destruction
• Freezing equipment• Storage• Transportation• Quality criteria
– Traceability– Testing– Time between collection and freezing
• Scattered blood collection centers• Collection methods not harmonized
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Is there a problem?
34 million inhabitants3 million outpatients128,000 inpatients95,000 surgeries
580 patients with PIDHandful adult PWH
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12th National People’s Congress 2017
An Kang Managing Director Hualan Biological People representative
- Urged review and modification “Blood Donation Law”- Use recovered plasma for fractionation- Plasma and its products are military strategic resource- Requested authorities to curtail albumin import to 40%
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• National Health and Family Planning Commission– 90 million women eligible for second child – 60% older than 35 year– Increased risk of complications in pregnancy
• Logistical challenges– Need for more obstetricians, pediatricians and midwives– Open night clinics to handle increase of patients
China child policy change
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• Increase of persons with genetic disorders
• Hemophilia calculations– 90 million women “eligible”– Assume 50% pregnancies = 45 million newborns– 22.5 million male newborns– Hemophilia A = 1 : 10,000– 2,250 boys with hemophilia A
• Regular supply constraints for Factor VIII and IG
But also
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• 2016 Births in China: 18,460,000– 11.5% increase compared to 2015– (900 children with hemophilia A)– One child policy from 1980’s to 2015– Second child policy in 2016– 50% willing to have second child
• Estimates of Rh negative in China– Total births: 18, 460,000– Rh negative = 0.2 % = 36,920– 45% second child: potential number hemolytic disease = 16,614 / year– No universal screening for Rh– No prophylaxis with anti-D IG
China child policy change
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ANTI-D IG MADE RH DISEASE PREVENTABLE
321 From Tovey L A. (1984) The contribution of antenatal anti-D prophylaxis to the reduction of the morbidity andmortality in Rh hemolytic disease of the newborn. Plasma Therapy Transfusion Technology 5: 99–104
1950 1960 1970 1980 1990
TODAY RH DISEASE RARELY SEEN IN EU - NA
Newborn deaths decreased afterIntroduction of anti-D prophylaxis (1)
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200,000 HEMOLYTIC DISEASE OF NEWBORN
33
HDN Global figures
114.00055.00026.900
Newborn deaths
Deaths in utero
Brain damage
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<1<5
15-20
20-25 25-30
30-40
3.4 MILLION BIRTHS ARE NOT PROTECTED CAUSING SERIOUS HEALTH AND SOCIAL BURDEN
Estimated rate of brain damagedue to Rh disease (n/100.000 live births)
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IMMUNIZATION COMPLEX PROCESS
35
CANDIDATE CANDIDATE QUALIFIED QUALIFIED
LONG PROCESS, OVER 24 MONTHS, TO OBTAIN A QUALIFIED PLASMA DONOR
ERYTHROCYTE DONOR PLASMA DONOR
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Plasma is a strategic resource
December 2016 Transfusion, Volume 56Paul E.W. Strengers and Harvey G. Klein
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Blood and Blood components
In accordance with the WHA resolution WHA63.12, WHO recognizes thatachieving self-sufficiency, unless special circumstances preclude it, inthe supply of safe blood components based on voluntary, non-remunerated blood donation, and the security of that supply areimportant national goals to prevent blood shortages and meet thetransfusion requirement of the patient population. All preparationsshould comply with the WHO requirements.
• Polyvalent IG PID• Hyper Immune Globulin anti-D, (anti-rabies, anti-tetanus)• Coagulation Factor VIII and IX
19th WHO List of Essential Medicines
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Plasma is a strategic resourceChanges in clinical practice in developed countries have reduced
the need for red cells and significantly reduced volume of recovered plasma
The need for PDMP’s worldwide continues to increase
Majority of plasma supplies for the manufacture of PDMP’s is met by commercial US industry
Geographic imbalance in plasma collection concerns that local disruptions of plasma supplies could result in regional and global
shortages of PDMP’s
Plasma collections should be increased outside the United States, including low and middle income countries
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Potential threats
Citations from the article:
- Emergence unexpected transfusion-transmissible infections- 1996 detection of vCJD prion caused termination of all plasma collections in
the UK and switch to US plasma- Economic and political factors- Military conflicts- Commercial consolidation- Changes in demand- Flow of medicines from low price to high price countries
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Page 3135
“Should some novel transmissible agent appear in theUnited States, a prion or a virus resistant to inactivationor removal technology used in the plasma fractionationindustry, US plasma collections could face a seriousthreat with disastrous consequences for global suppliesof plasma
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• Open up more centers outside of the United States• Allow public and private centers to compete• Increase efficiency in collection practices• Reduce the time to discuss definitions• Increase plasmapheresis as the primary method to collect
plasma for manufacturing• Increase quality of recovered plasma• Stop discarding recovered plasma for political reasons
• AND
For more plasma
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Rome Declaration
CALL ON NATIONAL AUTHORITIES TO:- Incorporate goal of self-sufficiency based on VNRD
- Introduce labeling requirements to distinguish between VNRD and paid
- Provide financial and other resources to move towards self-sufficiency
- Put in place agreements between blood system and fractionators for thefractionation of surplus recovered plasma from VNRD
AND
- Phase out in a programmed manner, the use of blood componentsfor transfusion, intermediates and PDMP obtained from paid orcompensated donors and family / replacement donors
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17Th World Health Assembly22-31 May, 2017
Principle 5
Policies governing compensation to persons whoprovide biological material for use as medical productsof human origin should seek to guard against theexploitation of vulnerable individuals and promote equityin donation. The best way to achieve these goals is toadhere to a policy of financial neutrality, in whichpersons who donate their biological materials for use asmedical products of human origin should neither benefitnor lose financially as a result of the donation. Countriesshould ensure that the burden of donating thesematerials does not fall primarily on economicallydisadvantaged groups
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There is nothing wrong in compensating / recognizing a donor for the time and effort made, when it is done in a well regulatedenvironment.
2002 Statement
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