EU PIO Nordic Workshop 25 May 2019 Stockholm www.pptaglobal.org - - PowerPoint PPT Presentation

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Plasma Donation: Footprint in the EU

PIO – Nordic Workshop 25 May 2019 Stockholm

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• Alliance of 11 European private sector plasma

collectors

• 123 centers (2019):

Germany: 71 Austria: 17 Czech Republic: 14 Hungary: 21

• 2,4 million liter collected (2018)

Mission: Promote safe plasma collection practices in the EU with focus

• n donor health and donor safety to ensure patients access to safe

products

European Plasma Alliance

71

21 17 14

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IG use in selected countries

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Worldwide Polyvalent IgG Market

From 1986 - 2024

In 2024, based on a 3,9 grams of IgG per liter average yield, 290 tons of immunoglobulin will be produced from approx. 75 million liters of plasma

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Plasma Fractionated Worldwide

Type of plasma fractionated worldwide from 1996 – 2015 Private companies & non-profit organizations (Thousand Liters)

Total 2015 48.132.000 liters

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Source Plasma Collection by Region 2016-2025

From 2025 onward, US source plasma collections grow at a slower rate then earlier while European source plasma collections continue to grow slowly, and China has the highest growth rate (CAGR)

CAGR: 7,8 % CAGR: 7,3 % CAGR: 7,9 % CAGR: 4,5 %

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Plasma Collection EPA members in Europe 2018

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Plasma Collection EPA members by country

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• Plasma is the clear, straw-colored liquid

portion of blood that remains after red blood cells, white blood cells and platelets are removed

• It contains hundreds of proteins
• Insufficient levels of any one plasma

protein can cause a variety of chronic and life-threatening medical conditions

• Plasma protein disorder occur in a very

small patient population and can be considered as rare diseases

• Plasma protein therapies are unique

biological medicines manufactured from human plasma

What is Plasma

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• Whole blood donation

– Blood is taken from a vein in the arm – The blood flows through a tube into a sterile bag

• n a scale

– The whole process takes

• approx. 30 minutes

(medical exam and donation) – Can be done between 4-6 times/year

• Plasma donation

– Collected through plasmapheresis – Plasmapheresis removes a donors plasma and returns the remaining blood components – The whole process can take between 1 – 1,5 hrs – Can be done more frequently

Whole blood vs plasma donation

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The process of plasma collection

Registration

• Identification
• Donor

questionnaire

• Vital signs:
• Blood Pressure
• Body Weight
• Temperature
• Hemoglobin

(non-) invasive

Medical Check

• Physical

examination

• Last laboratory &

Questionnaire to be controlled

• Decision on

ability to donate

• r deferral

Donation

• Disinfection &

Venipuncture

• Lab-tubes to be

filled

• Plasmapheresis

machine with single-use sterile set:

• Needle, Tubing,

Plasma container, Citrate, Sodium Solution

• Disconnection of

plasma bag from tubing set

Laboratory

• On-site lab:
• Hb

(leucocytes)

• Central lab:

Each donation

• Serology
• NAT

Periodically

• IgG
• Total protein

Processing & Freezing

Weighing Labelling Freezing Storage

• Plasma on hold

until released by qualified person

• Shipping to

fractionator

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Incentives for Blood/Plasma Donation in EU

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Dynamics of Plasma Collection in EU

• Clinical needs of PDMPs have increased
• Patient Blood Management has impacted the

use of blood transfusion, thus less recovered plasma is available

• Only four counties in EU have well functioning

plasma collection systems in place

• However to meet clinical needs EU relies on

imports of the United States

• EU counties have to be encouraged to create

plasma collection programs with focus on donor health and patient needs

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What can we do to improve?

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• PPTA developed the International Quality Plasma

Program (IQPP) to further ensure quality and safety of source plasma.

• IQPP provides independent , third-party evaluation and

recognition of a center’s adherence to global voluntary standards for source plasma.

• Source plasma is collected from healthy donors that may

receive compensation. Source plasma is only used for making plasma protein therapies.

• IQPP certification is available to plasma

collectors worldwide that have been licensed by a competent national regulatory authority

Safety & Quality – A top priority

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• Revision of EU Blood Directive - Encourage

European Plasma Collection Systems

– Coexistence of private and public structures

• Donor compensation compatible with VUD
• Plasma for manufacturing lifesaving therapies is
• global. No national self sufficiency policies apply
• Coherence on donation frequency and volumes
• Plasma Master File – Reduction of burden.

Centers to be registered only once at EMA

Regulatory Steps

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• A number of EU member states continue to

support national self-sufficiency policies for plasma collection – Serve 100% of domestic need without outside support

• Such policies are “political” decisions, but for

the patient it could become a limitation to access to therapy

• Coexistence of private and public collectors is

key

Political Steps

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• Increase awareness for plasma donation and

the patients that rely on PPTs

– Education in European schools / universities – Media attention & TV campaigns in collaboration with blood establishments – Outreach to politicians – Listen to patients!!! – How is Your Day – Making the difference with plasma protein therapies

Increase Awareness

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• Donor safety and wellbeing as well as safe final products are the

priority: – Strict regulations should be in place – Strong Voluntary Industry Standards Program (IQPP) that goes beyond regulatory requirements

• State of the art plasma collection establishments
• Well trained staff
• Support training programs for countries with no experience in

plasma collection

• PPTs are different from pharmaceuticals with respect to starting

material, manufacturing time, cost structure, etc.

Efficient Plasma Collection Centers

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• Respect the different personalities of blood and

plasma donors and address them accordingly

• Meet individual expectations according to

different donor profiles

• The donation should not be perceived as a

medical situation but a positive experience they can share

• Trained personnel and positive attitude of staff
• Opening hours that suit donors

It is all about the donor!

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• EPA member companies are committed to provide plasma for safe and effective

therapies to patients worldwide

• Standards programs (IQPP) contribute to the safety and quality of plasma

therapies by going beyond regulatory requirements

• Plasmapheresis will contribute significantly to meet clinical needs for plasma in

the EU

• The plasma sector needs a specific recognition and framework in the EU

legislation

• It’s needed to develop plasmapheresis programs in EU MS to meet growing

patients needs

• The private sector of collectors can work in parallel with the public sector (as

shown in AT, DE, CZ HU)

• The private sector of collectors should be supported and not hindered by EU

regulation and MS

• Compensation for time and travel is compatible with VUD

Summary

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We Thank all Plasma Donors!