About 40% of blood plasma used to make plasma-derived medicines for European patients is given by US donors

18. 9. 2023

Interview with Maarten Van Baelen, the Executive Director of PPTA Europe and an expert in plasma and plasma derived medicinal products in the EU.

  1. Dear Maarten, would you please briefly introduce yourself and PPTA to our readers? 

I’m Maarten Van Baelen, I’m the Executive Director of PPTA Europe. I’m a pharmacist by background, therefore patient access to medicines is really a personal driver for me.

The Plasma Protein Therapeutics Association (PPTA) is a dynamic trade association that represents a unique sector of the biologics and biotechnology industry. PPTA represents more than 1,000 human plasma collection centers in North America and Europe, as well as the manufacturers of lifesaving plasma protein therapies. Our members produce approximately 80% of the plasma protein therapies in the U.S. and 60% of those manufactured in Europe.

2. How do you see the current situation of patients on plasma derived medicinal products (PDMP) therapies in the EU? 

Most European countries currently have a deficit in the plasma they need to produce medicines that meet their patients’ needs. Today, plasma comes from a combination of in-country and imported donations. About 40% of this lifegiving material used to make plasma-derived medicines for European patients is given by donors in the US who are compensated. In Europe today, most countries provide some form of compensation, all in line with the principle of Voluntary Unpaid Donations. Austria, Czech Republic, Germany and Hungary have policies where donors can receive a fixed-rate allowance, for expenses and inconveniences related to the donation. The fixed-rate allowance covers financial and non-financial losses related to the donation and is financially neutral for the donor.

In the coming decade European countries will see an increased need for plasma-derived medicines to treat their patients for a range of rare diseases and critical medical conditions. While demand for blood components for transfusion remains relatively stable, a European Commission survey (2014) shows that demand for plasma derivatives is increasing by some 6% per year.

The patient population that these plasma-derived medicines can treat has been growing steadily in recent years for four reasons: more people are being diagnosed with conditions thanks to the increased precision of medical diagnostics; more are being diagnosed early; people benefiting from these treatments are living longer; and there is more clinical evidence of these therapies’ benefits for patients. To meet this anticipated increase in need for plasma-derived medicines, and the donated plasma needed to produce them, health sector policy makers will need to put strategies in place to ensure a safe and stable supply of this blood component.

3. What changes for the benefit of EU patients do you expect with the upcoming EU Directive? 

The revision of the current European Union Blood, Tissues and Cells Directive brings an opportunity to strengthen this legal framework to encourage new approaches that will increase the collection of plasma across Europe, which are needed to manufacture plasma-derived medicinal products.

The EU’s original legal framework for blood and blood components was not developed with the need to increase plasma collection in mind. A growing clinical need for plasma-derived medicines, and an increasing dependency on plasma from the US, requires a policy change in how we collect plasma in Europe. The updated EU Blood Legislation, the SoHo Regulation, and national public health regulations need to:

  • Explicitly recognise the unique nature of plasma that is used for manufacturing of plasma-derived medicinal products (PDMPs), as it is fundamentally different from whole blood and other labile blood components.
  • Support the EU’s policy of ‘Open Strategic Autonomy’ and address Europe’s reliance on plasma from the US, by encouraging the creation of a stronger European plasma donation ecosystem.

4. The beginning of October marks the international plasma awareness week. How can patients and patient organisations help in raising awareness? 

International Plasma Awareness Week (IPAW) is held annually during the first week of October. A joint effort of PPTA and its member companies, IPAW was launched in 2013 to raise greater awareness about the importance of donating plasma. Many people living with life-threatening, chronic, and genetic diseases rely on plasma as a treatment; unlike traditional pharmaceuticals, the source material for most plasma protein therapies is human plasma.

Although the Association and all our members are grateful every day for each person who rolls up their sleeve to donate plasma and help save someone’s life, IPAW offers all of us a dedicated week to show our appreciation and to share the stories of dedicated donors. This year’s IPAW will be celebrated from October 2-6.

And how can each individual help?

Post content to your social media accounts acknowledging IPAW. Consider using any of the following hashtags in your social media content:

#IPAW2023

#PlasmaDonorsSaveLives

#EUNeedsMorePlasma

Learn more about the impact of donating plasma by visiting one of our websites (list below) and reading firsthand patients’ and donors’ experiences and share these stories with your friends and family.

5. To conclude, do you have any message to share with the HAE Junior patient community in the Czech Republic?

PPTA is proud that medicines such as C-1 Esterase that are made from plasma can make significant improvements in a child’s quality of life. Children are our future and with support from your parents, you can share your story with decision makers.

Attaining stable and safe access to human plasma from European donors to produce critical medicines for European patients is a goal voiced by most countries’ health services.

Europe’s decision makers are faced with an evolving public health landscape. There is a growing population of patients that can benefit from plasma-derived medicines. Medical research is identifying new indications that plasma can control and cure. Likewise, more precise diagnoses mean that more existing plasma-treatable conditions are being identified.

The Czech Republic should be a voice towards other countries to step up their efforts to increase plasma collection, with the Czech collection system being a role model in which public and private sector coexist and donors can be compensated with a fixed-rate allowance.

Maarten Van Baelen                                                                                                                         

Executive Director PPTA Europe

Maarten is the Executive Director of the Plasma Protein Therapeutics Association (PPTA). Prior to joining PPTA in 2019, Maarten worked as Market Access Director and Medical Affairs Manager at Medicines for Europe, the trade association representing the European generic, biosimilar and valued added pharmaceutical industries. In addition, during that time, Maarten was advisor to the Board of the European Medicines Verification Organization (EMVO).

After graduating as a pharmacist from KU Leuven, Maarten spent several years working in medical affairs roles in the pharmaceutical and medical devices industry, while also being a practicing pharmacist. Maarten also obtained an MBA from the Solvay Brussels School Economics & Management and the École des Ponts Business School in Paris.

Links:

www.GivingPlasma.org 

www.HowIsYourDay.org

www.EUNeedsMorePlasma.com

www.Donatingplasma.org

Contact:

HAE Junior non-profit organisation
Wichterlova 2372/8, 
Prague 8, 182 00
Organisation ID 08749787

info (at) haejunior.cz

Contact for journalists:
media@haejunior.cz

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