Plasma Donation: Footprint in the EU PIO – Nordic Workshop 25 May 2019 Stockholm www.pptaglobal.org
European Plasma Alliance • Alliance of 11 European private sector plasma collectors • 123 centers (2019): Germany: 71 71 14 Austria: 17 17 21 Czech Republic: 14 Hungary: 21 • 2,4 million liter collected (2018) Mission: Promote safe plasma collection practices in the EU with focus on donor health and donor safety to ensure patients access to safe products www.pptaglobal.org
IG use in selected countries www.pptaglobal.org
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 www.pptaglobal.org
Plasma Fractionated Worldwide Type of plasma fractionated worldwide from 1996 – 2015 Private companies & non-profit organizations (Thousand Liters) Total 2015 48.132.000 liters www.pptaglobal.org
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 % www.pptaglobal.org
Plasma Collection EPA members in Europe 2018 www.pptaglobal.org
Plasma Collection EPA members by country www.pptaglobal.org
What is Plasma • 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 www.pptaglobal.org
Whole blood vs plasma donation • Whole blood donation • Plasma donation – Blood is taken from a – Collected through vein in the arm plasmapheresis – The blood flows through – Plasmapheresis removes a tube into a sterile bag a donors plasma and on a scale returns the remaining blood components – The whole process takes approx. 30 minutes – The whole process can (medical exam and take between 1 – 1,5 hrs donation) – Can be done more – Can be done between frequently 4-6 times/year www.pptaglobal.org
The process of plasma collection Processing & Medical Check Donation Registration Laboratory Freezing • Disinfection & • On-site lab: • Identification • Physical Venipuncture Weighing - Hb examination • Donor (leucocytes) questionnaire • Lab-tubes to be • Last laboratory & Labelling filled • Central lab: • Vital signs: Questionnaire to Each donation Freezing • Plasmapheresis - Blood Pressure be controlled - Serology - Body Weight machine with Storage • Decision on - NAT single-use sterile - Temperature ability to donate Periodically set: • Plasma on hold • Hemoglobin - IgG or deferral (non-) invasive • Needle, Tubing, until released by - Total protein Plasma container, qualified person Citrate, Sodium • Shipping to Solution fractionator • Disconnection of plasma bag from tubing set www.pptaglobal.org
Incentives for Blood/Plasma Donation in EU www.pptaglobal.org
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 www.pptaglobal.org
What can we do to improve? www.pptaglobal.org
Safety & Quality – A top priority • 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 www.pptaglobal.org
Regulatory Steps • 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 www.pptaglobal.org
Political Steps • 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 www.pptaglobal.org
Increase Awareness • 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 www.pptaglobal.org
Efficient Plasma Collection Centers • 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. www.pptaglobal.org
It is all about the donor! • 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 www.pptaglobal.org
Summary • 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 www.pptaglobal.org
We Thank all Plasma Donors! www.pptaglobal.org
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